rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME
Status: Recruiting

To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age: above 40 years old.  Patients with type two diabetes mellitus of more than 5 years duration. Patients with Best corrected visual acuity better than 3/60. Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit. No evidence of vitreomacular traction. Lens status: Pseudophakia or clear crystalline lens.  Exclusion Criteria:  Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological).  Ischemic maculopathy by FFA. Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally. Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula. Presence of proliferative diabetic fibrovascular membranes threatening or at the macula. Presence of diabetic optic atrophy or neuropathy. Presence of neovascular glaucoma. Cataractous lens either preoperatively or as intra or postoperative complication. Vitrectomized Eyes. A prior intraocular surgery within the past six-months. Lost follow up - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Disability in Patients With Non-specific Chronic Low Back Pain
Status: Recruiting

To investigate the reliability and sensitivity of the Turkish versions of the Roland-Morris Disability Questionnaire, The Quebec Back Pain Disability Scale, and the Oswestry Disability Index in patients with chronic non-specific low back pain and to increase confidence in their use in clinical practice and research by determining the most appropriate minimal clinically significant difference values for this patient population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Getting diagnosed with chronic non-specific low back pain Being able to read and speak Turkish Being between the ages of 18 and 65 Agreeing to participate in the research and signing the voluntary consent form  Exclusion Criteria:  Presence of systemic disease Cognitive impairment status (Mini-Mental State Examination <24), Recent (<12 weeks) history of myocardial infarction, cerebrovascular accident Presence of radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the lumbar region Having received any exercise therapy before Refusal of treatment or failure to comply with treatment - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 100 patients diagnosed with chronic nonspecific low back pain (documented history of low back pain lasting more than twelve weeks without a recognizable, specific pathoanatomical cause of the pain) who applied to the Physical Therapy and Rehabilitation Polyclinic of the hospitals in the Acıbadem Health Group and the Physiotherapy and Rehabilitation Department of Avicenna Ataşehir Hospital will be included in the study. Diagnoses will be made by Health Physical Medicine and Rehabilitation Doctors with at least 20 years of experience. - SamplingMethod: Probability Sample
Answerability and Minimal Clinical Significance of the Pain Questionnaires
Status: Recruiting

To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Getting diagnosed with chronic non-specific low back pain Being able to read and speak Turkish Being between the ages of 18 and 65 Agreeing to participate in the research and signing the voluntary consent form.  Exclusion Criteria:  Presence of systemic disease Cognitive impairment status (Mini-Mental State Examination <24), Recent (<12 weeks) history of myocardial infarction, cerebrovascular accident Presence of radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the lumbar region Having previously received any exercise therapy and/or training in pain neuroscience. Refusal of treatment or failure to comply with treatment - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 100 patients diagnosed with chronic nonspecific low back pain (documented history of low back pain lasting more than twelve weeks without a recognizable, specific pathoanatomical cause of the pain) who applied to the Physical Therapy and Rehabilitation Polyclinic of the hospitals in the Acıbadem Health Group and the Physiotherapy and Rehabilitation Department of Avicenna Ataşehir Hospital will be included in the study. Diagnoses will be given by Health Physical Medicine and Rehabilitation Doctors with at least 20 years of experience. At the first meeting, eligible participants will be informed about the study, potential participants will be screened in terms of inclusion criteria, and verbal and written informed consent will be obtained from eligible participants by the Helsinki criteria. - SamplingMethod: Probability Sample
Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers.
Status: Not yet recruiting

The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.

Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.

Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.

Hypotesis:

The krill oil will infleunce the gut barier integrity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  training experience of a minimum of five years, minimum training time per week 240 minutes, all competitors qualified for the Polish Youth Rowing Team, completing a food diary, finishing 2000m ergometer test.  Exclusion Criteria:  Probiotics, prebiotics and antibiotic therapy within the last three months, dietary regime, gastrointestinal diseases, lactose intolerance. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 24 Years - StdAgeList: Adult
Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction
Status: Recruiting

Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Videofluoroscopic swallowing study (VFSS) confirming incomplete/opening dysfunction of the cricopharyngeal muscle; No significant improvement in swallowing function after standardized rehabilitation treatment for more than 2 weeks (unchanged or decreased FOIS); Presence of swallowing initiation, with VFSS showing that the upward movement of the hyoid bone during swallowing is greater than half the height of the C3 vertebral body; Stable vital signs, alert consciousness, and cooperation with treatment;  Exclusion Criteria:  Patients with severe cognitive impairments, psychiatric disorders, and severe cardiopulmonary diseases; Abnormalities in the pharynx and larynx structures; Patients with malignant tumors; Patients with infections or wounds at the injection site; Patients allergic to botulinum toxin; Patients with bleeding tendencies or coagulation disorders. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes
Status: Not yet recruiting

This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being diagnosed with type 2 diabetes Be 18 years or older Ability to speak Turkish Ability to establish verbal communication Volunteering to participate in the research  Exclusion Criteria:  Presence of any psychiatric disease diagnosed by a physician Presence of diabetic ulcers on both feet and legs Presence of any amputation in the foot or leg Having myalgia in the foot, Foot fracture Edema in the feet - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Breast Cancer - Navigate - Prospective Cohort
Status: Not yet recruiting

The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.

TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.

Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age and older Diagnosed with non-metastatic breast cancer (stages I-III) An order placed for a post-operative chemotherapy cycle by a NM clinician Not have initiated a recommended post-operative chemotherapy cycle at the time of study enrollment Completed surgery for breast cancer First-time diagnosis of breast cancer Established care at Northwestern Medicine English-speaking as the navigation website is not yet available in other languages Access to internet on a smart phone or computer/tablet Any ethnic background We will only consider patients that sign an informed consent form  Exclusion Criteria:  Men will be excluded because the navigation website only contains content and resources for women. Men also make up less than 1% of all breast cancer diagnoses and the Breast Cancer-Navigate app/website content was developed for female breast cancer patients. Diagnosis of additional, life-threatening condition (e.g., end-stage renal disease, heart failure) which can interfere with timely planned adjuvant chemotherapy treatment for cancer. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Kidney Graft Tolerance KTOL
Status: Not yet recruiting

Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.

The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.

The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult donor-recipient pair. First or second kidney transplant from a related ABO-compatible living donor. BMI < 35 for recipients. Adult patients. Patients weighing over 50 kgs.  Exclusion Criteria:  Donor/recipient ABO incompatibility BMI > 35 for recipients - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study will use PBMCs from 15 patients receiving a kidney transplant from a living, ABO-compatible donor from their family or acquaintance. These PBMC will be obtained from blood samples taken before and 3 months after transplantation, in the context of normal patient management. The study will also use PBMC from the donor, taken before the transplant. - SamplingMethod: Non-Probability Sample
Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.
Status: Not yet recruiting

Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab [1] and aflibercept [2] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound [3] is that it extends the injection interval in the Treat and Extend (T&E) protocol, which is more extensive than with previous anti-VEGF agents.

The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.

As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female patient of legal age (≥18 years) with exudative AMD treated with IVT ranibizumab or aflibercept > 1 year. Patient whose IVT injection interval is strictly less than 12 weeks.  Exclusion Criteria:  Severe myopia (axial length > 26 mm or sphere < - 6 dioptres).  Presence of angioid striae. Presence of moderate or more severe diabetic retinopathy. History of diabetic macular edema. History of uveitis. Previous retinal vein occlusion (branch or central vein). History of pseudovitelliform macular dystrophy. Patient under guardianship or trusteeship Pregnant or breast-feeding woman - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study will retrospectively compare data from patients switched at centers in western France between the time of switch and 6 months after switch. - SamplingMethod: Non-Probability Sample
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
Status: Not yet recruiting

The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed informed consent form Subjects must be able to attend all scheduled visits and to comply with all trial procedures Subjects must be covered by public health insurance Contraception efficacy Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH))  Exclusion Criteria:  Subject unable to read or/and write Planned longer stay outside the region that prevents compliance with the visit plan Current pregnancy Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass). Previous reflux surgery BMI > 50 kg / m² for women and > 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases). Barrett oesophagus and esophagitis stage III and IV. Funditis No affiliation at the French social security scheme. Major protected by law. Deprivation of liberty by judicial or administrative decision. Participation to another clinical research program. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH)) - SamplingMethod: Non-Probability Sample
Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder
Status: Not yet recruiting

The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.

When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.

After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of bipolar disorder YMRS-score >13 Age 18-60 years Speaks and writes Danish at a level equal to mother tongue  Exclusion Criteria:  Not willing or able to adhere to the protocol Severe eye disorder or eye trauma Treatment with betablockers Sleep disturbances not related to BD (e.g, sleep apnea, restless legs syndrome) • • Substance abuse Unwilling to use the electronic self-monitoring system, the Monsenso system Prior/current use of BB glasses Current/planned pregnancy Night shift work Suicidality - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
Status: Not yet recruiting

This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:  Age: 50 or older, plus at least one of the following:  Mutation unknown or absent:  2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; OR 2+ affected first degree relatives (FDR), defined as blood related parents, siblings, or children)  Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:  CDKN2A/p16, PJS (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)  OR 1+FDR or second degree relative (SDR) with PDAC and a known P/LP mutation in one or more of:  ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53  HIGH-RISK OR WORRISOME PANCREATIC CYSTS:  18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria  High risk stigmata:  Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas Enhancing mural nodule ≥ 5 mm Main pancreatic duct ≥ 10 mm  Worrisome features:  Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct => 6 mm Cyst ≥ 3 cm Enhancing mural nodule < 5 mm Thickened/Enhancing cyst wall Main duct size 5-9 mm Pancreatitis Lymphadenopathy Increased CA 19-9 Cyst growth rate ≥ 5 mm /2 years  Exclusion Criteria:  * Is unable to provide informed consent  Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma) Current or prior history of PDAC or total pancreatectomy Is currently a prison inmate Is not able to speak or read English - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with pancreatic ductal adenocarcinoma (PDAC) family history, PDAC related genetic mutations or high risk or worrisome pancreatic cysts - SamplingMethod: Non-Probability Sample
The Effect of Emotional Freedom Techniques Application on Nurses
Status: Recruiting

Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being 18 years of age or older Working as a nurse in one of the surgical intensive care units Volunteering to participate in the study  Exclusion Criteria:  Working in a unit other than surgical intensive care units Not volunteering to participate in the research - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult