rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis
Status: Not yet recruiting

In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  People between the ages of 20-65, who were diagnosed with RA according to ACR criteria by the PAU Rheumatology clinic and who volunteered to participate in the study, will be included.  Exclusion Criteria:  Patients with RA who have a neurological disease that may affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident), a psychiatric disease that affects cooperation, heart failure and lung pathology that affect daily living activities, and those with other concurrent autoimmune and rheumatic diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: PAU Romatology clinic - SamplingMethod: Probability Sample
Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease
Status: Not yet recruiting

It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  M-protein related cardiac disease aged 18 and above (at least one of the following criteria is met): (1) Systemic amyloidosis of the affected heart; (2) Presence of M component and presence of arrhythmia, cardiac enzyme abnormalities, cardiac function abnormalities, and exclusion of other diagnosable cardiac diseases; ECOG score 0-2; Sign a written informed consent form.  Exclusion Criteria:  Acute myocardial infarction; Severe functional abnormalities in important organs such as lungs, liver, and kidneys (the carbon monoxide diffusion ability caused by chronic respiratory diseases is 50% lower than expected); Major surgery, radiation therapy, infections requiring systemic antibiotic treatment, or other serious infections within 14 days after enrollment; Individuals with mental illness, comprehension disorders, or other reasons that make it difficult to control themselves; Pregnant or lactating women, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial. If the patient is male, refuse to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study; Diagnosed or treated another malignant tumor within 2 years prior to enrollment; Individuals with allergies to daratumumab, bortezomib, or dexamethasone components or more severe allergic constitutions; HIV infected individuals (HIV antibody positive); Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen positive and/or hepatitis B core antibody positive, hepatitis B virus DNA more than 1x103 copies/mL; hepatitis C virus RNA more than 1x103 copies/mL); Participate in another clinical trial 30 days after the start of the trial and throughout the entire trial period; The researcher determined that patients who are not suitable to participate in this study; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Observe patient data from Beijing Chaoyang Hospital affiliated with Capital Medical University, Beijing Chuiyangliu Hospital, and Beijing Boren Hospital. - SamplingMethod: Non-Probability Sample
A Study of LY3841136 in Japanese Participants With Obesity or Overweight
Status: Not yet recruiting

The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female participants who agree to contraception requirements Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive Have had a stable weight for the 3 months  Exclusion Criteria:  Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus Have a history of chronic medical conditions involving the heart, liver, or kidneys Have a history of any malignancy within the past 5 years Have a history or presence of a GI disorder Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
Status: Not yet recruiting

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Have Type 2 Diabetes (T2D) Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol) Have moderate or severe renal impairment  Have been on the following stable diabetes treatment during 90 days prior to screening  basal insulin (≥20 International Units (IU)/day) with or without metformin and/or SGLT2 inhibitor Are of stable weight for at least 90 days prior to screening Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)  Exclusion Criteria:  Have Type 1 Diabetes (T1D) Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema Have a history of unstable or rapidly progressing renal disease Have a prior or planned surgical treatment for obesity Have New York Heart Association Functional Classification III or IV congestive heart failure Have had acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening Have a known clinically significant gastric emptying abnormality Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. Have any lifetime history of a suicide attempt Had chronic or acute pancreatitis Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients
Status: Not yet recruiting

Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.

The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:

will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area. Vital teeth. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. No periodontal therapy carried out in the past 6 months. Ability to sign an informed consent form. Patients age ≥18 years old. Patients who are cooperative, motivated, and hygiene conscious. Systemically free according to Cornell Medical Index.  Exclusion Criteria:  Patient undergoing orthodontic treatment. Pregnant females or breast feeding. Smokers. Teeth mobility greater than grade I. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)
Status: Recruiting

Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  diagnosis of acute myeloid leukemia ability to receive treatment for acute myeloid leukemia at the research center elevated values of CLL1A and CD45RA positive cells at the time of diagnosis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults diagnosed with acute myeloid leukemia, undergoing systemic chemotherapy (high or low intensity) - SamplingMethod: Non-Probability Sample
Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation
Status: Recruiting

Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  PD diagnosis  Exclusion Criteria:  severe cognitive and psychiatric comorbidities H&Y>3 levodopa-induced dyskinesia and tremor-dominant phenotype history of additional neuropsychiatric disorders intake of medications acting on brain excitability or plasticity contraindications to non-invasive brain stimulation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Study of STP938 in Advanced Solid Tumours
Status: Not yet recruiting

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.

The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.

Eligibility:
- EligibilityCriteria: Main Inclusion Criteria:  Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. Male or female aged ≥ 18 years. Advanced disease not curable by available therapies and requires systemic therapy. Histologically confirmed diagnosis of eligible cancer type. Must have tumor tissue available for biomarker testing. Measurable disease (Part 1) and measurable disease per RECIST (Part2) Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Life expectancy > 3 months as assessed by the Investigator. Adequate organ function (bone marrow, hepatic, renal function and coagulation). All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.  Main Exclusion Criteria:  Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements. Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression Active malignancy within 2 years of study enrollment Prior radiation within 2 weeks of start of therapy. Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or <5 half-lives since completion of previous investigational therapy, whichever is shorter. Uncontrolled intercurrent illness. Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months. Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. Subjects with corrected QT interval >470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).
Status: Recruiting

Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with histological-molecular diagnosis according to WHO 2016 classification: IDH-wildtype glioblastoma (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH-mutated glioblastoma (9445/3), glioblastoma NOS (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic or gliomatosis cerebri pictures of first diagnosis Not previously treated (with chemo and radiotherapy) or treated only surgically (total, near partial, partial, biopsy). Males and females between the ages of 3 and 30 years old Life expectancy ≥ 12 months karnofsky/Lansky ≥ 80 % Adequate hematologic function: Absolute leukocyte count ≥ 2.0 x 109/l, Hemoglobin ≥ 10 g/dl, Platelet count ≥ 50 x 109/l Adequate liver function: Total bilirubin ≤ 2.5 x ULN, ALT/AST ≤ 5.0 x ULN Adequate renal function:Serum creatinine ≤ 1.5 x ULN Written informed consent from the patient, parents or legal guardians Patient's willingness during treatment and ability to comply with the protocol  Exclusion Criteria:  Evidence of any other serious disease or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe syndromes congenital syndromes, heart disease) Performance of a course of 1st-line chemotherapy at the same time as study initiation Concurrent participation in other research projects Pregnancy or lactation status Use of inappropriate contraceptive methods - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 30 Years - StdAgeList: Child, Adult
Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors.
Status: Not yet recruiting

The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Non-functioning pituitary tumor Diagnosed > 6 months from enrollment, i.e. found on MRI.  Exclusion Criteria:  Planned pituitary surgery Planned radiotherapy Poor Danish skills Patient is considered by the treating physician unsuitable for follow-up by telephone or video - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Keeping it Simple Study (KISS)
Status: Recruiting

Problem: The number of patients living with chronic musculoskeletal (MSK) pain has steadily increased over the past decade with costs rising equally. Long-standing pain is associated with significant maladaptive beliefs about pain, psychological characteristics and associated behaviors which involve structural and functional neurobiological characteristics which share common pathophysiological mechanisms as chronic pain. The investigators recent priority setting partnership investigated the research priorities from 1000 patients with chronic MSK pain, relatives, and clinicians. Better pain education was rated as one of the three most important research areas.

Solution: Pain science education has the potential to target maladaptive psychological and behavioral components that may contribute to the maintenance of chronic pain. The KISS project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this is successful in disrupting maladaptive cycles contributing to chronicity, this may improve outcomes for many thousand citizens.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients referred for rehabilitation in the municipalities Køge, Holbæk, and Solrød With chronic (>3 months) musculoskeletal pain. Adult patients (≥18 years) - no upper limit Able to understand, speak, and write Danish.  Exclusion Criteria:  Known cognitive deficits (e.g., dementia). Diagnosed with cancer or other serious pathologies, e.g., cauda equina. Pregnancy Drug addiction defined as the use of cannabis, opioids, or other drugs. Neurologic or psychiatric diagnoses that hinder participation, e.g., stroke and borderline. Lack of ability to cooperate. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH
Status: Recruiting

The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  A subject aged ≥19 years to ≤75 years  Meeting all of the following criteria:  Screening MRI-PDFF with ≥8% steatosis Screening MRE with liver stiffness ≥2.5 kPa ALT or AST ≤250 IU/L at screening Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study Voluntarily provide written consent to participate in the study  Exclusion Criteria:  A subject who has past or current history of liver diseases  A subject who has the following medical or surgical history  Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class  A subject who has the following concomitant diseases  liver disease, uncontrolled hypertension, uncontrolled DM, etc.  A subject who has taken the following medications  Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc. A subject who has taken IP of another study A subject who does not agree with appropriate methods of contraception - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult