rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Music Therapy and High-risk Pregnancy
Status: Recruiting

The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:

Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?
Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?
How does the risk of preterm birth modulate the future attachment bond between mother and child?

Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).

Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.

Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question.

Eligibility:
- EligibilityCriteria: Inclusion Criteria (clinical groups):  Age over 18 years old Adequate knowledge of the Italian language Consent to participate Condition of risk of preterm birth  Exclusion Criteria (clinical groups):  Positive history of mental retardation Difficulty understanding the Italian language Presence of diagnosis of psychiatric pathology Absence of informed consent  Inclusion Criteria (non-clinical group):  Age over 18 years old Adequate knowledge of the Italian language Consent to participate  Exclusion Criteria (non-clinical group):  Positive history of mental retardation Difficulty understanding the Italian language Presence of diagnosis of psychiatric pathology Absence of informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study.
Status: Recruiting

The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals over the age of 19 who are currently driving. Individuals capable of understanding and following the researcher's instructions. Individuals who can understand the purpose of the research and have consented to participate  Exclusion Criteria:  Those who have not signed the consent form. Individuals with a history of severe dizziness or epilepsy. Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes. Patients with severe shoulder pain. Patients whose range of motion in major joints is restricted by more than 50%. Pregnant women. Patients with pressure sores. Patients with limitations on simulator use due to heterotopic ossification. Patients with acute fractures. Other patients for whom participation in the study is expected difficult. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis
Status: Recruiting

The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:

Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis

Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.

Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All participants who had been diagnosed as knee osteoarthritis according to ACR criteria with symptom of knee pain Pain visual analog scare of 4 or higher  Exclusion Criteria: Participants who have  Cognitive impairment History of aller to Hyaluronic acid or its component History of knee arthropathy Concomitant with inflammatory arthritis Serious comorbidities or bedridden status Current pregnancy or lactation Currently use of symptomatic slow acting drugs for osteoarthritis (SYSADOA) Communication problem - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult
Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors
Status: Not yet recruiting

Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Primary disease: hematological malignancies (including acute leukemia, myelodysplastic syndromes), nonmalignant disorders (including severe aplastic anaemia)  Contraindication or intolerance to CNI  Glomerular filtration rate (GFR) 60-89 ml/min/1.73m2 before transplantation or allergy to CNI Intolerance to CNI during conditioning or within +45 days post transplantation, such as CNI nephrotoxicity (creatinine higher than the upper limit of normal), uncontrolled hypertension, neurological toxicity, or other conditions deemed by physician to be inappropriate for CNI Receiving haplo-HSCT for the first time  Exclusion Criteria:  Allergy or intolerance to study drugs Active infection Active GVHD Transplantation-associated thrombotic microangiopathy Key organ dysfunction: liver injury (total bilirubin more than 2 upper limit of normal) or heart injury (symptomatic heart failure or ejection fraction<50%) Eastern Cooperative Oncology Group (ECOG) score >2 Expected survival time <30 days Patients could not cooperate - HealthyVolunteers: No - Gender: All - MinimumAge: 14 Years - StdAgeList: Child, Adult, Older Adult
Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy
Status: Recruiting

Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.

Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between 18 and 50 years of age Able to cooperate and complete the questionnaires independently Stable vital signs with no serious cardiovascular or cerebrovascular diseases Voluntary participation  Exclusion Criteria:  Severely impaired in vision or hearing to accommodate VR devices Previous history of anxiety, depression, cognitive impairment, balance disorder, mental illness, or epilepsy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis
Status: Recruiting

Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between the ages of 10 and 18 American Society of Anesthesiologists (ASA) physical statusclassification of I-II Lenke 5 type adolescent idiopathic scoliosis  Exclusion Criteria:  A history of previous corrective surgery With sharp, angulated short-segmental scoliosis With congenital scoliosis requiring 3-column osteotomy - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort
Status: Not yet recruiting

This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants over 18 years old; Diagnosis of adrenocortical carcinoma with at least one clinical evaluation at the reference institution; Initial diagnosis or recurrence from the year 2000 onwards.  Exclusion Criteria:  Participants with insufficient clinical or pathological data in the medical records. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Data will be included from 150 participants diagnosed with adrenocortical carcinoma who meet the study's inclusion and exclusion criteria. Data will be collected from the medical records of the included research sites throughout Brazil. - SamplingMethod: Probability Sample
Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia
Status: Recruiting

Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged 20-80. Chronic kidney disease (CKD) patients. Iron deficiency anemia (male haemoglobin (Hb) ≤13 g/dL; female haemoglobin (Hb) ≤12 g/dL, ferritin ≤100 ng/mL, transferrin saturation ≤25%). Patients diagnosed as chronic insomnia by doctors according to international classification of sleep disorders-third edition (ICSD-3). Subjects who voluntarily participate in the trial plan and complete the consent form after explanation by doctors or project personnel.  Exclusion Criteria:  Patients taking iron supplements. Patients with non-chronic insomnia. Patients with alcoholism within one year. People with other serious diseases. Pregnant women or women who are still breastfeeding. Those who are unable to cooperate with the test progress. Patients with autoimmune abnormalities (ex. inflammatory bowel disease). People with non-iron deficiency anemia (ex. thalassemia). Those who are taking sleeping pills or sedatives. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Expected Difficult Airway Management
Status: Recruiting

In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Over 18 years old Meets the expected difficult airway criteria Being awakened after induction of anesthesia in another center At least one of the awake intubation criteria in the DAS 2022 guideline Elective surgeries  Exclusion Criteria:  Emergency surgeries Patients intubated with anesthesia Noncoopere patients - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who were previously evaluated for difficult airway criteria and predicted to have a difficult airway or who could not be ventilated or intubated after induction of anesthesia in another center. - SamplingMethod: Non-Probability Sample
Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Status: Not yet recruiting

Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.

Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells <10% in the primary tumor after nephrectomy.

Study Design:

Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.

Sample Size: 20 participants.

Patient Grouping: Non-randomized.

Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Voluntary consent to participate in this study and signing of an informed consent form.  Male or female participants aged ≥18 years and <80 years. Histologically diagnosed with clear cell carcinoma or predominantly clear cell renal cell carcinoma.  Clinical stage determined by CT or MRI: anyTN1M0 or anyTN0M1; IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs; and the primary tumor (unilateral or bilateral) is resectable.  ECOG performance status: 0 or 1. No clinically significant cardiac, bone marrow, hepatic, or renal function abnormalities.  A willingness and ability to comply with testing and follow-up procedures.  Exclusion Criteria:  Non-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.  Unable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Status: Not yet recruiting

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Histologically and/or cytologically confirmed TNBC. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease. Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease. At least one measurable lesion per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization. A life expectancy of at least 3 months. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator. Adequate organ and bone marrow function.  Key Exclusion Criteria:  Active second malignancy. Uncontrolled or clinical significant cardiovascular disease. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. Active infection requiring systemic therapy within 2 weeks of randomization. Active hepatitis B or hepatitis C virus infection. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. Known hypersensitivity to SKB264 or its excipients. Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors. Prior treatment with the same investigator's choice chemotherapy (except taxane). Pregnant or lactating women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Status: Not yet recruiting

To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.
To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing; Physical state is good: PS 0-2; Expected survival of more than 3 months; Aged 18-75 years old; Have not received systematic chemotherapy before; Did not receive cetuximab treatment; Liver, kidney and bone marrow functions are basically normal; The clearance period of chemotherapy and molecular targeted therapy is more than 4 weeks; Voluntary participation in the group, good compliance, can cooperate with the experiment observation, and sign the written informed consent.  Exclusion Criteria:  Patients with severe dysfunction of vital organs (heart, liver, kidney); Patients with other malignant tumors; Patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test); In the active phase of acute or chronic infectious diseases; People with a clear history of drug allergy or allergic constitution; Patients participating in other clinical trials; Other conditions in which the patient was considered inappropriate to participate in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score
Status: Not yet recruiting

Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients fully understand this study, voluntarily participate and sign the informed consent form Age equal or more than 18 years old Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0 Patients planning to undergo allogeneic hematopoietic stem cell transplantation, HCT-CI ≤ 3 or KPS ≥ 80%  Exclusion Criteria:  Patients who refuse to participate in this clinical study Patients with central nervous system involvement Patients with HIV seropositive Patients with other serious medical conditions with a life expectancy of less than six months Patients with severe psychiatric or psychological disorders - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult