rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
Status: Not yet recruiting

The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed. Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist. Age >18 years. Because of the rarity of this disease and limited data on treatment efficacy in subjects 18 years of age, children are excluded from this study. Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.  Subjects must have normal organ and marrow function as defined below:  Total bilirubin within normal limits AST (SGOT) ≤ 2.5 X institutional upper limit of normal ALT (SGPT) ≤ 2.5 X institutional upper limit of normal  Bone marrow:  Absolute neutrophil count (ANC) ≥ 1,500/mm3 Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL Subjects must have the ability to understand and the willingness to sign a written informed consent document. Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically. Treatment naive for MIBC.  Exclusion Criteria:  Presence of hydronephrosis. Presence of multifocal disease that is not amenable to complete resection with partial cystectomy. Presence of distant carcinoma in situ. Presence of clinical N+ or M+ disease. Presence of cT4+ disease. Non-urothelial histology. Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma. Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings
Status: Not yet recruiting

The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question[s] it aims to answer are:

To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure).
To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)

Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  aged 18 years or older, have a diagnosis of schizophrenia spectrum and other psychotic disorders or major depression or bipolar disorder, ( - have a history of any type of criminal justice system involvement (i.e., arrest, conviction, incarceration, or probation/parole), reside in the community and receive services from the Center for Excellence in Community Mental Health or one of their partner agencies and, have moderate or higher levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI).  Exclusion Criteria:  an intellectual or developmental disability, incarceration at the point of study enrollment, non-English speakers. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury
Status: Not yet recruiting

The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age at the time of enrollment: Any adult ages 18 and over Spinal Cord Injury: ASIA C or D injury at level C1-T1 Duration of incomplete spinal cord injury minimum 1 years clinical/fundamental Spasticity with a of MAS score >3 present in upper extremities. Fluent in English If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording. Appropriate social support if required during an off-medication state. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes. Feels comfortable going off certain spasticity related medication during in-person study visits Lives in the United States  Exclusion Criteria:  Sensory deficits in palma manus resulting in missing inter digit discrimination of the fingertips. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies. Any current drug or alcohol abuse. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators. Pregnancy, breast-feeding or wanting to become pregnant. Physical limitations unrelated to spasticity that would affect motor ratings. Craniotomy Brain surgery Patient is unable to communicate properly with staff (i.e., severe speech problems) Medications that may affect relevant synaptic plasticity Concurrent Botox treatment A type of hairstyle that would impede the use of an EEG cap. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy
Status: Not yet recruiting

To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.  Exclusion Criteria:  history of coagulation or bleeding disorders or if they were under antithrombotic treatment. associated malignancy, renal impairment or allergy to TA. - HealthyVolunteers: No - Gender: Female - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult
Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section
Status: Not yet recruiting

one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnant >36 weeks singleton baby American Society of Anesthesiologists (ASA) physical status 2 Age : between 18 years old and 35 years old  Exclusion Criteria:  Pregnant women with cardiac disease and history of psychiatric illness Pregnant women who received spinal anesthesia and converted to general anesthesia Women who have sensitivity to local anesthetics, Women who have Eclampsia, abruption placenta or placenta previa Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's Heart
Status: Not yet recruiting

The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with clinically validated diagnoses of HCM (n=150) and athlete's heart (n=150) will be identified by pre-screening of the clinic appointments for each of the specialty HCM and Sports Cardiology clinics or in the CV fellows' clinic (in patients with an established diagnosis and no pending testing). All diagnoses will need to be supported by unequivocal imaging and other ancillary data per our standard of care and at the determination of clinic experts.  Exclusion Criteria:  Any exception to the above criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Outpatients scheduled for appointments in the sports cardiology or HCM clinic at Mayo Clinic in Rochester, MN will be approached to participate in the study. - SamplingMethod: Non-Probability Sample
First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133
Status: Not yet recruiting

In this clinical trial we will test a new approach for decolonization of S. aureus.

As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Must be ≥ 18 years at the time of signing the informedconsent. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. Nasal colonization with methicillin-susceptible S. aureus (MSSA) Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15  Exclusion Criteria  Nasal colonization with methicillin-resistant S. aureus (MRSA) Nasal traumata including nose penetrating foreign bodies (e.g. piercings) Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease Acute or known chronic diseases of the nose or the paranasal sinuses Acute or known chronic diseases of other parts of the respiratory tract Running nose due to other reasons (e.g. allergic diseases)7. Positive serological HIV, hepatitis A, B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded. Women during pregnancy and lactation. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. Participation in other clinical trials or observation period of competing trials, in the 12 weeks prior to screening. Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test Systemic antibiotic treatment in the 12 weeks prior to screening. Intranasal eradication therapy in the 12 weeks prior to screening. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1)
Status: Recruiting

This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of type 1 diabetes mellitus. Age ≥ 18 years. Signed Informed consent  Exclusion Criteria:  Age < 18 years. Pregnancy in progress. Type 2 diabetes mellitus. Secondary diabetes - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia
Status: Recruiting

To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age between 15 and 65 years, diagnosed with chronic insomnia based on the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017), no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.  Exclusion Criteria:  diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REM behaviour disorder, and restless legs syndrome, history of head trauma or presence of serious organic diseases, presence of comorbid anxiety or depression, as assessed by a Hamilton Anxiety Scale [HAMA] score of 17 or Hamilton Depression Scale [HAMD] score of 14. - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - MaximumAge: 65 Years - StdAgeList: Child, Adult, Older Adult
A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes
Status: Recruiting

A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Willingness to use the system Generally healthy Enjoys the smell of peach or orangeade.  Exclusion Criteria:  Silicone allergy IBS, bariatric surgery, pregnancy participation in another clinical study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
The Regulatory Role of miRNA 27 Follistatin Like Protein-1 Gene in Multiple Scelerosis
Status: Not yet recruiting

Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination of the central nervous system. Young women between the ages of 20 and 40 are primarily targeted by this disabling disorder. Till now there are no sufficient mechanisms to explain the pathophysiology of multiple sclerosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with MS based on the revised McDonald criteria. Female patients will only be included. 20- 45 years old. Drug naïve.  Exclusion Criteria:  1. Patients with other neurodegenerative and autoimmune disorders. 2. Pregnant females. 3. Co-existing chronic hypertension, diabetes, and epilepsy 4. chronic renal or hepatic diseases - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 45 Years - StdAgeList: Adult - StudyPopulation: Study subjects:  Inclusion criteria:  Patients diagnosed with MS based on the revised McDonald criteria. Female patients will only be included. 20- 45 years old. Drug naïve.  Exclusion criteria:  Patients with other neurodegenerative and autoimmune disorders. Pregnant females. Co-existing chronic hypertension, diabetes, and epilepsy Chronic renal or hepatic diseases - SamplingMethod: Probability Sample
MEdication Counselling Models for Outpatient oRal antIcoaguLation
Status: Not yet recruiting

The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥18 years old taking oral anticoagulants using smartphones that can access the telepharmacy application agreeing to participate  Exclusion Criteria:  pregnancy or lactation having cancer having immunodeficiency disorders or using immunosuppressants renal impairment (creatinine clearance <30 mL/min) hepatic impairment (Child-Pugh B or C cirrhosis) heart failure (class IV, New York Heart Association) history of myocardial infarction or stroke within the latest 2 months - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)
Status: Recruiting

The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using three currently available platforms:

DaVinci®;
Hugo®;
Versius®.

The questions it aims to answer are:

Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?

Participants will be invited to join one of these three experimental group:

surgery with the DaVinci platform;
surgery with the Hugo platform;
surgery with the Versius platform.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patient aged between 18 and 90 years old; patient with localized kidney tumor suitable for partial nephrectomy; patient able to understand and sign the informed consent; patient compliance with the follow-up program.  Exclusion Criteria:  patient who do not fall within the inclusion age range; patient not suitable for partial nephrectomy; patient unable to understand and sign the informed consent; patient unable to follow the monitoring program; patient refusal to participate to the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status
Status: Recruiting

The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The patients will be enrolled into the study based on the following inclusion criteria:  Patients with generalized gingivitis patient with generalized periodontitis . patient with healthy periodontium . Both genders above 18 y to 60 y .  Exclusion Criteria:  The patients will not be enrolled into this study based on the following exclusion criteria:  pregnant women . smokers .  Patients on medications that cause xerostomia as diuretics , antidepressants  ,bronchodilators ,antihistaminics , antiepileptic ( etc ..)  Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the during the study . molars according to camera specifications handicapped patients para functional habits as mouth breathing and tongue thrusting - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: A total of 45 of consecutive patients attending the periodontology outpatient clinic Patients will be selected according to the previously mentioned inclusion and exclusion criteria to be examined clinically and thermographically then they will be clustered into 3 clusters gingivitis , periodontitis and healthy patients based on the clinical diagnosis and each cluster will consist of 15 patients . - SamplingMethod: Probability Sample
A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
Status: Not yet recruiting

The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.

The main question[s]it aims to answer are:

Does SCThrive improve patient activation?
Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?
Are any improvements maintained 3 months after treatment?

Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).

Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient of a participating SCD Clinic Confirmed diagnosis of SCD 13-21 years of age  Exclusion Criteria:  Another chronic disease (which would complicate measurement of patient activation) Non-English-speaking Cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation. - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 21 Years - StdAgeList: Child, Adult