rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Factors and Prognosis of Obstructive Pyelonephritis Patients
Status: Not yet recruiting

Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.

Most of the available data on this condition comes from small, retrospective, single-centre series.

To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.

The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients over 18 years of age Hospitalized in intensive care for management of acute obstructive pyelonephritis Patients affiliated to a Social Security System  Exclusion Criteria:  Pregnancy Opposition to data use Persons under legal protection (curatorship, guardianship), legal safeguards - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients meeting the eligibility criteria over the period 2015-2022 will be included in the study. - SamplingMethod: Non-Probability Sample
A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care
Status: Recruiting

The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:

i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program.

Eligibility:
- EligibilityCriteria: Inclusion criteria: |  Age ≥18 A self-reported diagnosis of ADHD Access to and ability to use a computer, smartphone and the Internet. Speaks, writes and reads Norwegian  Exclusion criteria:  In need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis. Ongoing psychological treatment for ADHD or other psychiatric illnesses. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Whole Heart Radiotherapy for End-stage Heart Failure
Status: Not yet recruiting

End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  at least 65 years of age End-stage heart failure NYHA class 3-4, LVEF ≤ 30% on maximum medical therapy with progressive symptoms/disease as defined by their primary cardiologist  Exclusion Criteria:  previous RT in the treatment field that precludes further RT active connective tissue disease interstitial pulmonary fibrosis Participants who are unable to be positioned in a manner where treatment can be safely delivered - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
NM32-2668 in Adult Patients With Selected Advanced Solid Tumors
Status: Recruiting

This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with histologically confirmed, advanced-stage protocol-specified solid tumors. Confirmed ROR1 tumor expression. Patients who have undergone at least one prior systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable or have medical contraindications to standard therapy.  Exclusion Criteria:  Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cell engaging therapy. Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 days prior to first dose of NM32-2668. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of NM32-2668. Wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of NM32-2668, or no recovery from side effects of such prior interventions. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures
Status: Not yet recruiting

The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:

Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.
Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.

Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Radiology confirmed anterior or lateral rib fractures either on X-ray or chest computed tomography CT pain score of 5/10. Patients must be able to verbalize how much pain they are having on an 11-point Numeric Rating Pain Scale perform an incentive spirometry and be able to cough on command  Exclusion Criteria:  isolated rib fractures that do not include ribs T3-T9 penetrating trauma, pregnancy requiring immediate surgical or procedural intervention known allergy to amide-type local anesthetics have a painful distracting injury - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors
Status: Recruiting

This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; Subjects with HR+/ HER2- advanced or metastatic breast cancer are preferred. Estimated life expectancy of at least 12 weeks  Exclusion Criteria:  Presence of visceral metastases with severe organ dysfunction Known active hepatitis B or C infection Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
Status: Not yet recruiting

This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'.

The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drug
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  PICC is anticipated to remain in place for at least 14 days Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol Body weight ≥50 kg and ≤130 kg during the screening period International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period Platelet count ≥100 x 10^9/L during the screening period as described in the protocol  Key Exclusion Criteria:  Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant History of prior venous thrombosis in the arm in which the PICC is to be placed History of known thromboembolic disease or thrombophilia Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (eg. Hemophilia A or B, von Willebrand's disease)  Note: Other protocol defined inclusion/exclusion criteria apply - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss
Status: Not yet recruiting

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy.

Parts A and B of the study are looking at several other research questions, including:

What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria  Part A  Male or female participants age ≥18 to ≤55 years of age at the time of screening  BMI ≥18 and ≤32 kg/m2, at the screening visit  Part B  Male or female participants ≥18 to ≤80 years of age at the time of screening BMI ≥30 kg/m2 History of 1 or more self-reported unsuccessful dietary attempts to lose weight  Key Exclusion Criteria  History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted Previous bariatric surgery or planned bariatric surgery History of hypertrophic cardiomyopathy Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening) History of poorly controlled hypertension, as defined in the protocol Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol Have history of use of marijuana/tetrahydrocannabinol (THC) within 3 months of enrollment and are unwilling to abstain from marijuana/THC use during the trial  Note: Other protocol-defined Inclusion/ Exclusion Criteria apply - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover.
Status: Not yet recruiting

By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 and ≤ 60 years. BMI (Body Mass Index: expressed as weight ratio in kg/height in m2) ≥ 35 kg/m2 with comorbidities or BMI ≥ 40 Kg/m2 without comorbidities. Absence of diagnosis of primary obesity. Absence of medical-psychiatric contraindications. Previous diet therapy and/or pharmacological history verified. Signing of the informed consent for the study. Patients who are clinical candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).  Exclusion Criteria:  Presence of chronic diseases of the digestive system, such as chronic intestinal diseases, malabsorption syndrome, diverticulosis of the colon. Current pregnancy and/or breastfeeding via self-declaration. Subjects suffering from endocrine pathologies (e.g. Cushing's disease, uncontrolled thyroid disease). Presence of known renal insufficiency or creatinine levels above 1.8 mg/dl and eGFR < 60 ml/min. Presence of chronic liver disease or ALT and AST levels above two standard deviations from normal levels. Presence of malignant pathology. Alcohol or drug abuse. Previous bariatric surgery. Severe psychological-psychiatric disorders. Difficulty adhering to the protocol due to language barriers or other reasons. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients
Status: Not yet recruiting

The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age ≥ 18 years; meeting the diagnostic criteria of stroke; any degree of dysphagia at admission; steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment. transferred out within three weeks of hospitalization in the neurology department.  Exclusion Criteria:  complicated with other neurological diseases; damaged mucosa or incomplete structure in nasopharynx; tracheostomy tube plugged; unfeasible to the support of parenteral nutrition; simultaneously suffering from liver, kidney failure, tumors, or hematological diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency
Status: Not yet recruiting

In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Primary adrenal insufficiency Disease duration of at least one year Substituted with hydrocortisone and fludrocortisone Wishing to fast during the month of Ramadan 2024  Exclusion Criteria:  Diabetes mellitus Renal insufficiency Hepatic insufficiency Cardiac insufficiency Respiratory insufficiency Use of hypoglycaemic agents Use of diuretics Use of glucocorticoids other than those prescribed for replacement Poor control of the disease (asthenia, malaise, melanoderma, discontinuation of treatment, etc.) Pregnancy Breast-feeding. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Determination of Body Awareness and the Functional Movement in Patients With COPD
Status: Not yet recruiting

The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls.

Eligibility:
- EligibilityCriteria: Inclusion Criteria for Chronic Obstructive Pulmonary Disease Group  Being under 55 years old To be literate, Having volunteered to participate in the research, Stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system, Being clinically stable for the last 2 weeks.  Exclusion Criteria for Chronic Obstructive Pulmonary Disease Group  Having history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery, Communication problems, Having a severe psychiatric disorder.  Inclusion Criteria for Healthy Control Group  Not having any cardiopulmonary system disease or chronic systemic disease, To be literate, Being under 55 years old Be willing to participate in the study. Not having balance problems, musculoskeletal, neurological and psychiatric disorders that could prevent performing the test procedures. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult - StudyPopulation: Patients with COPD and aged matched healthy controls will be included in this study. - SamplingMethod: Non-Probability Sample
Pulse Rate and Breathing Rate Accuracy
Status: Recruiting

The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate Participant must be 18 to 81 years of age (≥ 18 age to < 82) Participant must be willing and able to comply with study procedures and duration Participants or legally authorized representative must be able to read or write in English  Exclusion Criteria:  Participants who refuse or are unable to provide to sign an informed written consent for study Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.) Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported) Other known health condition, should be considered upon disclosure in health assessment form - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 81 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute inclusion of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, and Obesity). An attempt will be made to enroll a variety of skin tones. - SamplingMethod: Non-Probability Sample