rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
Status: Not yet recruiting

The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated.

There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study: Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative. Age ≥ 18 years at the time of consent. Eastern Cooperative Oncology Group (ECOG) of 0-2. The subject must have histologically or cytologically confirmed epithelial ovarian, peritoneal or fallopian tube cancer and must have a histological diagnosis of a high-grade serous histology based on local histopathological findings. Subject must have recurrent platinum-resistant or platinum-refractory disease defined as: A disease that has progressed by imagining while receiving platinum OR Disease that has recurred within 6 months of the last receipt of platinum-based chemotherapy. Rising CA-125 only is not considered as platinum-resistant or refractory disease. Having received at least 2 prior regimens (including front-line therapy).  Exclusion Criteria:  Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. The subject is not willing and not able to comply with study procedures based on the judgment of the investigator or protocol designee.  10. The subject is not willing to undergo a biopsy prior to treatment, after infusion, and at the time of disease progression ), and the tumor is determined to be safe by the treating investigator for biopsy collection. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients
Status: Not yet recruiting

It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.

There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI > 40 kg/m2 age > 18 years scheduled for elective surgery under general anesthesia have the ability to comprehend the rationale for the study and provide consent  Exclusion Criteria:  pregnancy, risk of aspiration of gastric content patients using glucagon-like peptide(GLP)-1 agonists emergency cases upper airway disease or airway anatomical abnormalities presence of major cardiovascular, respiratory, or cerebral vascular disease if the provider anesthesiologist indicates an awake technique to secure the airway - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
Status: Recruiting

This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects enrolled at US sites participating in the 165-501 study.  Exclusion Criteria:  Legal incapacity or limited legal capacity without legal guardian representation. Subject is unable or unwilling to provide informed consent for the additional interventional burden of the study (blood sampling). - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Subjects enrolled at US sites participating in the 165-501 study. - SamplingMethod: Non-Probability Sample
Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy
Status: Not yet recruiting

The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients undergoing elective laparoscopic sleeve gastrectomy  ASAA I or grade;  volunteered in this trial and signed informed consent; ④ age 18-65 years; ⑤ BMI> 30kg / m2.  Exclusion Criteria:  chronic pain; severe liver dysfunction (total bilirubin 2 mg dl-1); severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2); pregnancy or lactation; preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block; -dementia or significant neurological disorders (such as stroke, epilepsy, intracranial tumors, PD, etc.); history of alcohol or drug abuse - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
A UK Registry for Metabolic and Bariatric Endoscopic Interventions
Status: Recruiting

In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to regain normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. We hope over time this will improve our knowledge about treating obesity with endoscopy and support future access and funding to these treatments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure. Age ≥ 18 years old Able to give written informed consent.  Exclusion Criteria:  Any bariatric or metabolic endoscopic procedure performed outside the UK. Any bariatric or metabolic endoscopic procedure not currently listed within the registry protocol or agreed by the steering committee. Unable to provide written informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients within the United Kingdom (UK) who have, or plan to, undergo a primary or revisional bariatric or metabolic endoscopic procedure for the treatment of obesity or metabolic disease in the UK - SamplingMethod: Non-Probability Sample
Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome
Status: Recruiting

The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals.

Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Non-diabetic individuals: adults (18-70 Years) with glycated hemoglobin (HBA1C)<5.7 and/or Fasting blood glucose <100 mg/L and with no classic symptoms of hyperglycemia  Pre-diabetic: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria :  glycated hemoglobin (HBA1C) =5.7-6.4% Fasting blood glucose level = 100 mg/dL to 125 mg/dL. Fasting is deﬁned as no caloric intake for at least 8 hours.  Diabetic patients: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria:  glycated hemoglobin (HBA1C) ≥6.5% Fasting blood glucose ≥126 mg/dL. A random plasma glucose ≥200 mg/dL. Random is any time of the day without regard to the meals.  Exclusion Criteria:  Pediatric and elderly subjects Pregnant subjects Those with active Myocardial infarction Those with acute decompensated heart failure Patients with pacemaker Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: patients aged 18-70 Years either diabetic, pre-diabetic or non-diabetic should not have one of the following criteria:  Pediatric and elderly subjects Pregnant subjects Those with active Myocardial infarction Those with acute decompensated heart failure Patients with pacemaker Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation Amputated patients - SamplingMethod: Non-Probability Sample
Metreleptin in Anorexia Nervosa
Status: Not yet recruiting

The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreletpin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Current diagnosis of AN according to DSM-5 (American Psychiatric Association [APA], 2013) diagnosed with SCID-5 (First et al., 2015) BMI > 13 kg/m2; BMI ≤ 17.5 kg/m2; body weight > 35 kg Hospitalisation in the Eating Disorders Unit, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital of Zurich Ability to understand German language- Age range: 18 - 40 years Depressive symptoms: HAMD-17 ≥ 8 Negative pregnancy test, non-lactating and double birth control Informed Consent as documented by signature  Exclusion Criteria:  Illicit drug intake within last month; current alcohol use disorder Severe psychiatric and/or severe somatic comorbidities; f. e. lifetime diagnosis of schizophrenia, bipolar disorder, inflammatory bowel disorders, diabetes mellitus, autoimmune disorders, pancreatitis, neurological disorders, cancer including lymphoma Acute suicidality or current serious non-suicidal self-injury - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer
Status: Not yet recruiting

Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.

The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.

To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.

A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients referred for a 2 week wait cancer pathway endoscopy for the following indications Or Upper abdominal mass consistent with stomach cancer Or Stable upper gastrointestinal bleeding Or  Aged 55 and over with weight loss and any of the following:  Upper abdominal pain Reflux Dyspepsia  Exclusion Criteria:  Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion) Previous gastro-duodenal surgery, Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will consist of those patients referred primarily from their general practice for a cancer pathway endoscopy at the study site. - SamplingMethod: Non-Probability Sample
Protocol Optimization in CT for the Quantification of BMD
Status: Not yet recruiting

Bone mineral density is an important measurement to detect osteoporosis.

The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:

How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA
How can we optimize the CT scan for bone mineral density

Participants will undergo:

Clinically indicated CT scan on day of inclusion
Study related DXA scan on a separate appointment

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Informed Consent signed by the subject Referral to a regular clinically indicated CT examination covering the lumbar area (e.g., Abdomen, Thorax + Abdomen, Neck + Thorax +Abdomen) Informed written and oral consent (interpreter present in case of foreign language patients) No contraindication to the clinically indicated CT examination  Exclusion Criteria:  Patients < 18 years Pregnant women Vulnerable subjects Contraindications to the clinically indicated CT scan Multiple Myeloma Diffuse bone metastasis Fixateur interne in the lumbar spine Kyphoplasty in the lumbar spine Enterally administrated contrast agent Obtaining informed consent is not possible Withdrawal of consent orally or in writing Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject Immobility (patients confined to a wheelchair or to bed) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy
Status: Recruiting

The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR).

The main questions it aims to answer are:

mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment
proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment
proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment
mean changes in BCVA and CMT from baseline to monthly follow-up time point
complications and adverse effects

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  symptomatic patients aged 18 years or above with center involved diabetic macular edema in the involved eye and without clinically significant diabetic macular edema in the fellow eye defined on the basis of spectral-domain optical coherence tomography (OCT) central macular thickness (CMT) ≥300 μm measured by OCT the involved eyes diagnosed as severe non-proliferative diabetic retinopathy (sNPDR) confirmed by two independent experienced ophthalmologists based on the ETDRS standard seven field color fundus photographs  Exclusion Criteria:  concomitant or previous macular diseases that may hinder visual improvement other than diabetic retinopathy (e.g., retinal vein occlusion, age-associated macular degeneration, uveitis, vitreomacular traction or epiretinal membrane) history of glaucoma or optic neuropathy of any kind previous vitreoretinal surgery or pan-retinal photocoagulation intravitreal injection anti-VEGF drugs within 6 months or intravitreal injection glucocorticoid within 3 months macular focal/grid laser photocoagulation within 3 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1
Status: Not yet recruiting

The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.

The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.

In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Histologically confirmed diagnosis of breast cancer; Any disease stage; Patient must be receiving (i.e., with at least 4 remaining cures) or about to start palliative or curative neoadjuvant or adjuvant chemotherapy for their breast cancer at Centre Léon Bérard; Willingness and ability to comply with the study requirements; Patient must be covered by a medical insurance; Patient must understand, speak, read and write French.  Exclusion Criteria:  History of condition contraindicating the use of virtual reality (e.g., epilepsy, severe motion sickness); Brain metastases; Any medical or psychosocial condition that would compromise the patient's compliance to the study procedures or would likely interfere with the completion of Patient-Reported Outcomes; Patients under tutorship or curatorship; Patients already included in another clinical trial ongoing at Centre Léon Bérard. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult