rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
Status: Recruiting

The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children from 2 years old to under 16 years old are diagnosed with hepatitis B chronic disease AND HBsAg or HBV DNA: positive for at least six months AND Liver enzyme ALT: continuously increased by> 70 for male and > 50 for female (> 2 x ULN) AND The virus is proliferating: HBV DNA above 20,000 IU/mL (if HBeAg positive) OR HBV DNA above 2,000 IU/mL (if HBeAg negative) AND A parent or legal guardian of the pediatric patient obtains consent for them to participate in research.  Exclusion Criteria:  HIV and hepatitis C co-infection Patients have other chronic liver disease (Wilson, autoimmune hepatitis) Patients are being treated with immunosuppressive drugs Psychomotor retardation, cerebral palsy, brain sequelae - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: Pediatric patients with chronic hepatitis B are indicated for drug treatment antiviral treatment at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. - SamplingMethod: Non-Probability Sample
Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
Status: Recruiting

The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults (≥18 years) Expected stay in the hospital ≥2 days  Admitted for surgery with expected duration of surgery >2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff  RR > 21 breaths pr minute RR < 11 breaths pr minute Pulse (P) > 91 beats pr minute Pulse (P) < 50 beats pr minute SpO2 < 94 % without oxygen supplementation Systolic BP < 110 mmHg Systolic BP > 220 mmHg  Exclusion Criteria:  Participant expected not to cooperate with study procedures. Allergy to plaster or silicone. Pacemaker or Implantable Cardioverter Defibrillator (ICD) device. Inability to give informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 20 Patients in the general ward (surgical or medical) will be monitored with wCVSM and answer a questionnaire afterwards. 20 nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift (including a shift where monitoring is initiated or a shift where the patient is discharged). Therefore, multiple nurses can be interviewed per patient. Patients will in addition have vital signs monitored as per standard practice. Participants will be recruited from wards at the study sites. - SamplingMethod: Non-Probability Sample
Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
Status: Not yet recruiting

The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.

Primary Objectives

To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
To develop a central database of genomic and clinical findings.

Secondary Objectives

To assess event free and overall survival data of patients enrolled on this study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 1-18.99 years  Diagnosis of acute leukemia / lymphoma as below:  Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample). Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and <25% bone marrow blasts and less than 1,000 circulating blasts/ microL. Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible).  Exclusion Criteria:  Pregnant or breastfeeding Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy. Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).  Note: the intention of this exclusion criterion is to only enroll participants who may subsequently enroll on an SJALL therapeutic trial. If participant is screened as a potential participant for subsequent SJALL trials and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.  Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 18 Years - StdAgeList: Child, Adult
Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age
Status: Recruiting

According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pediatric patients (0-18 years old) at the time of the initial observation Patients affected by active and latent TB, as defined by the criteria of the World Health Organization Patients exposed to TB who are found to be non-infected at the end of the window period Informed consent signed by parents/legal guardian or by the patient who has reached the legal age of consent, assent of the minor  Exclusion Criteria:  None - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Week - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: During the study, data will be collected on patients affected by active TB, latent TB, and TB-exposed non-infected individuals from each participating center. The study will take place at the main pediatric centers in Italy that consecutively admit patients diagnosed with active and latent TB, as well as individuals exposed to tuberculosis who are seen at participating clinical centers. - SamplingMethod: Non-Probability Sample
Azithromycin Reduction to Reach Elimination of Trachoma B
Status: Not yet recruiting

The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Provision of appropriate informed consent Stated willingness to comply with all study procedures Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial  Exclusion Criteria:  Does not consent to participation Unwilling to comply with all study procedures Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Month - MaximumAge: 9 Years - StdAgeList: Child
The Influence of Sound on Stress, Anxiety, and Mood
Status: Not yet recruiting

Multiple studies have highlighted music's ability to evoke diverse emotional states. Past research reveals that factors like musical elements, and the environment impact how people respond emotionally to music. For instance, faster tempos tend to heighten arousal, while minor key compositions evoke more arousal compared to major key compositions. In efforts to induce specific emotions post-stress, the research found that both pleasant and sad music aided stress recovery. Similarly, other researchers noted that positively rated music was more effective in reducing stress than negatively rated music, especially low arousal compositions over high arousal ones. Several studies focused on applying music to reduce stress and anxiety. In addition to man-made musical tones, the positive impact of natural surroundings on emotional state has been widely explored. A psycho-evolutionary viewpoint was offered, suggesting that humans have evolved in natural settings, making us inherently attuned to them physically and psychologically. A non-threatening natural environment, rich in aesthetically pleasing elements like visible escape routes, greenery, and water, tends to reduce stress and generate interest. In this study, the researchers are exploring how different sounds-man-made instrumental music versus natural sounds-affect stress, anxiety, and mood among the students of Medgar Evers College. Using an experimental approach, the researchers will assess pretest stress levels (via the perceived stress scale (PSS), anxiety (generalized anxiety disorder (GAD-7), and mood (four-dimensional mood scale (4DMS) among a sample of students. After randomly dividing them into two groups, each group will listen to one of the designated sounds (man-made music or nature sounds) for 30 minutes daily over 15 days. The researchers will then have them retake the stress, anxiety, and mood scales for post-test comparison. Statistical analysis (mixed ANOVA) will help to compare scores within and between groups. Ultimately, this study aims to determine the influence of tonal input on stress and anxiety levels among students, crucial given the significant stress they often experience.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being a student at Medgar Evers College, CUNY Being 18 years old or older  Exclusion Criteria:  Having hearing problems - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa: A Hybrid-Effectiveness Trial
Status: Not yet recruiting

The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder.  Exclusion Criteria:  Participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Bruxism and Underlying Psichological Factors
Status: Recruiting

The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Self-reported Bruxism  Exclusion Criteria:  Refused patients - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Self-reported bruxists - SamplingMethod: Non-Probability Sample
Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Status: Not yet recruiting

The overall goal of this protocol is to investigate [18F]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in [18F]DPA-714 binding in PD participants during a 24-month interval.

Primary Objectives

To compare [18F]DPA-714 binding in prodromal and manifest PD and healthy volunteers.
To determine the longitudinal change in [18F]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.

Secondary Objectives

To evaluate the correlation between baseline [18F]DPA-714 and PPMI clinical and biomarker outcomes.
To evaluate the correlation between the longitudinal change of [18F]DPA-714 and PPMI clinical and biomarker outcomes
To acquire safety data following injection of [18F]DPA-714

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  A prodromal PD and Healthy participant enrolled in PPMI Clinical protocol A PD participant enrolled in PPMI Clinical protocol who has not started symptomatic treatment at time of enrollment or in the first 2 years of participation. Able to provide informed consent Must have screening genetic testing documenting high binder at the at the known TSPO gene polymorphism (rs6971)  Male or Female (Females must meet additional criteria specified below, as applicable)  • Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of [18F]DPA-714  Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).  Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.  Females of childbearing potential must not be pregnant, breastfeeding or lactating. Includes a negative urine pregnancy test prior to injection of [18F]DPA-714 on day of PET scan.  Exclusion Criteria:  Exposure to a total effective dose equivalent of 50 millisievert (mSv) for the whole body, which is the annual limit established by the US Code of Federal Regulations , during the past year. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Home Tele Rehabilitation Therapy for Vascular Dementia
Status: Not yet recruiting

To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging at least 6 months post stroke At least some active movement in the affected upper extremity (MRS 1 or more in shoulder elbow or wrist) Ability to provide informed consent, or LAR able to provide consent Expressed willingness to comply with all study procedures and attend all study-related visits for both the patient and at least one caregiver. Age ≥ 18. Ability to follow one-step commands. Community-dwelling with transportation to evaluation sessions. Ability to operate the therapy system with minimal assistance, including sufficient corrected vision to perceive objects from a distance of 5 feet. Modified Ashworth Scale Score 3 or less in the involved upper extremity Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand  Exclusion Criteria:  Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions even with help from caregiver). Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.) Patients with severe uncontrolled medical problems that would render intensive rehabilitation unfeasible or unsafe (e.g. cardiovascular disease, unstable cardiac arrhythmia, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others). Concurrent participation in other experimental upper extremity rehabilitation trials that would interfere with results. Non-English-speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However, we plan to include them once funding has been secured in the subsequent larger trial. Pregnancy Prisoners - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 110 Years - StdAgeList: Adult, Older Adult
Preoperative Oral Carbohydrate on Gastric Emptying
Status: Recruiting

The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between the ages of 18-65 Elective laparoscopic cholecystectomy planned under general anesthesia American Society of Anesthesiologists (ASA) class I-II physical condition  Exclusion Criteria:  Patients with gastroesophageal reflux and gastrointestinal motility disorders diabetes mellitus Mental retardation, previous neurological disease symptoms (syncope, dementia, Alzheimer, etc.) Chronic alcoholism Difficult Intubation Patients with ASA physical status classes ≥III Patients with a body mass index of 35 and above History of Meniere and motion sickness Presence of previous history of postoperative nausea and vomiting Smoking - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries
Status: Not yet recruiting

This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:

What are the risk factors for clinically relevent postoperative pancreatic fistula in different pancreatic surgeries?
What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries？

Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Scheduled for Elective pancreaticoduodenectomy or distal pancreatectomy or duodenum-preserving pancreatic head resection.  Exclusion Criteria:  1.Patients with functional pancreatic neuroendocrine tumors were excluded. 2.Patients with previous pancreatic surgery were excluded. 3. Patients with severe pancreatitis were excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy from March 2024 to October 2024. - SamplingMethod: Probability Sample
PET Imaging of 68Ga-Her2-affibody in Tumors With High Her2 Expression
Status: Not yet recruiting

This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - patients with confirmed or suspected cancer; Signed written informed consent  Exclusion Criteria:  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult