cyrilzakka/clinical-trials huggingface dataset:
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab

125 postmenopausal women treated with Dmab for 3 or more years who will reach osteopenia with denosumab will be randomized into three groups: i) zoledronate infusion (5mg) at 6 months after last Dmab dose (single Zol group) ii) zoledronate infusion (5mg) at 6 and 12 months after last Dmab dose (double Zol group) iii) alendronate 70mg orally weekly for 12 months (ALN group) All women will receive no further treatment during the 2nd year of the study.

Participating centers: ECTS affiliated bone centers

Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the lumbar spine at 24 months; ii) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; iii) changes at levels of bone turnover markers throughout the study; iv) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral; v) clinical parameters: height change, VAS for back pain, and use of analgesics

Eligibility Criteria:
Inclusion Criteria:

• Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia

Exclusion Criteria:

* a bone disease other than postmenopausal osteoporosis
* use of medications other than bisphosphonates or SERMS affecting bone metabolism during the last 12 months before entering the study
* creatinine clearance \<60 mL/min/1.73 m2
* liver failure
* any type of cancer
* uncontrolled endocrine diseases
* serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)
Predictive Value of Osteopontin for Contrast Nephropathy

Early detection of contrast induced nephropathy by using osteopontin as an early marker for prediction

People who undergo coronary angiography are at risk of contrast-associated acute kidney injury (CA-AKI) .

The prevention therapy is the main approach to address CA-AKI, minimizing the volume of contrast media and intravenous hydration before and after the procedure which may not be appropriate for those with heart failure .

Given limited treatment options once CA-AKI develops and an unfavourable associated prognosis, early identification of those at risk of CA-AKI is crucial.

Also, there is studies was linking CA-AKI with a higher mortality rate and adverse future cardiovascular events, and risk for future CA-AKI events .

Mehran and colleagues described CA-AKI risk score predicting both CA-AKI and cardiovascular events after angiographic procedures.

however, studies have also investigated the role of different biomarkers in prediction of AKI like osteopontin, in 2020, a consensus statement was released regarding how best to incorporate kidney biomarkers into clinical practice.

Osteopontin is an extracellular structural protein synthesized by various cell types like osteoblasts, smooth muscle. and found in the loop of Henle and distal nephrons in normal kidneys. Recent studies have found that osteopontin has a critical role in tubulogenesis, cell apoptosis, promotion of cell regeneration. Lorenzen and colleagues found that critically ill patients with AKI have higher osteopontin concentrations than critically ill patients without AKI.

Few studies have investigated the role of osteopontin in the detection of AKI.

Eligibility Criteria:
Inclusion Criteria:

- patients undergoing coronary with or without intervention between 2022and 2024 were prospectively enrolled at the study.

Patients were referred for angiography for various acute and nonacute indications, including acute coronary syndromes, heart failure, abnormal stress tests, stable chest pain, claudication, and routine preoperative evaluation.

Patient with CKD stage 1 or 2 only

Exclusion Criteria:

* Pt has history of contrast induced nephropathy before. Patient known to have Chronic kidney disease stage 3A upto 5D Pt has contraindication for coronary angiograghy.
Combining Exercise and Cognitive Training to Improve Everyday Function

The purpose of this randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. The study will enroll 109 men and women, age 55-75 years who are in stable health and without contraindications to exercise or evidence of dementia or cognitive impairment. Individuals will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and Home Exercise and Health Education. Participants will undergo measurements of cognitive function, physical performance, and complete questionaires about daily activities, physical activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after baseline.


Eligibility Criteria:
Inclusion Criteria:

* age 55-75 years (inclusive)
* English-speaking
* sufficient visual and auditory perception to complete testing
* available informant (someone who knows the individual well)
* Clinical Dementia Rating of 0 (non-demented per the screening assessment).

Exclusion Criteria:

* participation in a regular exercise program in last 6 months
* participation in a cognitive training program in last 6 months
* inability to walk on a treadmill or ride an exercise bike
* less than a 10th grade education
* mild cognitive impairment or dementia
* cigarette smoking within the previous year
* history of alcohol or substance abuse
* BMI greater than 35
* insulin-dependent diabetes
* major and/or unstable medical, neurological, or psychiatric disorder, including:

  * active congestive heart failure
  * unstable angina
  * effort angina
  * nocturnal angina
  * MI within previous 6 months
  * ECG evidence of serious arrhythmias and/or acute myocardial ischemia reflected by ST-segment depression of 0.3 mm
  * resting blood pressure above 170 systolic or 100 diastolic
  * chronic infections
  * advanced arthritis
  * contractures or weakness due to CVA that would prevent adequate performance of the exercises.
  * disabling stroke
  * late stage renal or liver disease
  * major affective disorder with active symptoms
68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian Cancer

This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.

II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.

SECONDARY OBJECTIVES:

I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.

EXPLORATORY OBJECTIVES:

I. To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.

II. To determine the relationship between 68Ga-PSMA PET uptake, diffusion weighted imaging, and MRI-derived tumor perfusion.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. After about 60 minutes, patients undergo PET/magnetic resonance imaging (MRI) for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.

After completion of study, patients are followed up at 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound):

   1. adnexal mass
   2. abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)
2. Female,
3. Age \>= 18 years
4. Creatinine \</= 1.5 mg/dL
5. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
Nerve Morphology in Diabetic Patients

The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients with CTS.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of carpal tunnel syndrome based in clinical history and symptoms
* Confirmed by nerve conduction studies

Exclusion Criteria

* Other focal nerve entrapments
* Cervical radiculopathy
* Inflammatory joint disease
* Renal failure
* Thyroid disorders
* Previous wrist fracture
* Long-term exposure to vibrating tools
* Age under 18
Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom

Post-Covid(PoC)-patients with fatigue symptoms respond very differently to physical rehabilitation programs. While PoC-patients with psychological symptoms benefit little from physical interventions, fatigue and exercise capacity improves significantly without the presence of psychological symptoms. RCT studies on effects of psychotherapy or the combination of phsical activity with psychotherapy in PoC are not yet available. Therefore, the aim is to investigate the unimodal effects of psychotherapy and exercise therapy or the combination of both on fatigue in PoC patients with fatigue in a randomized clinical trial. Patients will be assigned to the three intervention groups (psychotherapy, physical rehabilitation, combination of both) stratified for sex, gender and BMI status.

The intervention duration is 3 months with therapeutic online sessions for 50 min every 2 weeks. After another 3 months without intervention, the sustainability will evaluated. Secondarily, the investigators analyzes which patient benefits most from which therapeutic approach and seek for specific predictors of patient´s individual response.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 and
* diagnosed post-Covid-19 syndrome: (positive PCR or antibody test) and Fatigue Assessment Scale (FAS) ≥ 22 points

Exclusion Criteria:

* Current participation in another intervention study
* Illnesses or functional disorders that potentially explain the fatigue symptoms otherwise
* Any illness or impairment that the examining physician judges to preclude participation in a physical training intervention
* Suicidality or severe mental illness (e.g. mania, acute phase of schizophrenia) that requires acute treatment.
Theta Burst Stimulation in Young Adults With Depression

For the proposed 2-year study, the investigators will conduct a within-subject, counterbalanced investigation using functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) to examine the acute effects of theta-burst stimulation (TBS) on function in dorsomedial prefrontal cortex (dmPFC) in 35 young adults with depression (18-25 years, 50% female).

Each participant will undergo 3 sessions of TMS, one each of continuous and intermittent TBS--with the goal of decreasing or increasing dmPFC responding, respectively--and one of sham TBS. Session order will be counterbalanced, with a double-blind approach to condition. Brain function, behavior, and mood will be assessed before and after each TBS session. Broadly, the investigators predict that inhibitory TBS to the dmPFC will enhance neural, behavioral, and subjective aspects of reward function by reducing dmPFC function and dmPFC connectivity with the ventral striatum (VS).

Eligibility Criteria:
Inclusion Criteria:

• DSM-5 Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), Other Specified Depressive Disorder, or Other Unspecified Depressive Disorder

Exclusion Criteria:

* Bipolar disorder, substance dependence, or lifetime history of psychosis
* Neurological disorder (e.g., seizure disorder)
* Pregnant
* MRI contradictions: claustrophobia, permanent orthodontic devices, metal implants or other forms of metal in the body that cannot be removed
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores

This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale (PCS) scores undergoing mastectomy with immediate tissue expander or implant placement.

Potential subjects will be prescreened for PCS score; pre-qualified patients will be invited to the investigative site for informed consent and full screening within 30 days of randomization. Patients providing informed consent and meeting all study eligibility criteria will be enrolled in the study on the day of surgery (Day 1).

Subjects will receive study drug just prior to anesthesia induction. Study assessments will be entered by subjects in the electronic diary from Day 1 through Day 21. Follow-up visits will occur on Days 7 and 21 (± 2 days).

Eligibility Criteria:
Inclusion Criteria:

* Score of 16 or greater on the PCS scale
* Scheduled to undergo unilateral or bilateral mastectomy with immediate tissue expander or implant placement
* American Society of Anesthesiologists Physical Status Classification System ≤ 3
* Medically stable for this surgery with general anesthesia and intrathecal administration of study drug as determined by the Investigator
* Body mass index of 18-45 kg/m2
* Have a stable medical regimen (for prescribed medications) for ≥ 7 days before randomization
* Able to read and understand study instructions in English or Spanish, and willing and able to comply with all study procedures

Exclusion Criteria:

* Prior breast surgery in the index breast (either breast for bilateral surgery) in the last two years, other than biopsies and small/moderate volume lumpectomies
* Induction chemotherapy or plans for adjunctive chemotherapy or any radiotherapy within 21 days of surgery
* Known spinal deformities or cutaneous infection in the lumbar area that would preclude intrathecal administration of study drug
* Planned use of liposomal formulated or long-acting local anesthetics, extended release opioid formulations (e.g., Oxycontin), long half-life opioids (e.g., methadone), or drugs with potential for adverse cognitive or memory effects (e.g., ketamine, scopolamine, or propranolol) preoperatively and/or at any time through the duration of the study
* Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
* Current neurologic disorder, which could confound the assessment of pain
* Unstable mental condition which would prevent the patient from understanding the nature and scope of the study and/or evidence of an uncooperative attitude in the opinion of the Investigator
* Women who are pregnant or nursing
* Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned treatment in a clinical trial during this study
* Previous participation in any study involving brivoligide injection
Clopidogrel Use and Long-term Safety After Drug-Eluting Stents Implantation

The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

Prospective, two arms, open-labeled, randomized multi-center trial of approximately 2,000 patients enrolled at 19 centers in Korea. Among all patients enrolled in the ZEST (Comparison of the Efficacy of Zotarolimus-Eluting Stent versus Sirolimus-Eluting Stent versus PacliTaxel-Eluting Stent for Coronary Lesions) trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization will be randomized to discontinue clopidogrel therapy at 12 months after DES implantation. All patients will be followed for another 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Among the participants in the ZEST trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization
2. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Contraindication to antiplatelet therapy
2. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
3. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
4. Bleeding diathesis
5. Recent stroke within 6-months
6. Concurrent organ damage (creatinine level \> 2.0mg/dL or AST and ALT \> 3 times upper normal reference values)
7. Patients with left main stem stenosis (\>50% by visual estimate)
Use of Device Data to Predict Frailty in Individuals

This is an investigation to examine the correlation and predictive ability of activity measures obtained from cardiovascular implantable electrical devices.

Technology is providing new opportunities to gain insight into patient health in a manner far superior to what can be obtained from routine office visits. For geriatric patients, frailty is one such measure, which has been shown to have a negative correlation with outcomes, including hospitalizations, complications following invasive procedures, and overall mortality. Methods to quantify frailty have been highly limited and somewhat controversial, largely because of their cross-sectional nature. Efforts to obtain longitudinal measures of frailty using activity monitors and other wearable devices have been promising, although they are limited by patient cooperation and cost.

In addition to their therapeutic functions, cardiovascular implantable electrical devices (CIEDs) collect large amounts of data on individuals in whom they are implanted, which can be accessed during office visits as well as remotely. Importantly, the data is obtained passively and routinely from all patients, requiring little to no additional effort or expense. The possibility that activity measures from CIEDs could be used to evaluate frailty, as well as other outcomes, would provide a powerful tool for clinicians to apply data science directly to patients.

This pilot investigation will assess the feasibility of using CIED-derived activity data to predict frailty, and other outcomes, in older populations. The investigators plan to enroll subjects in whom CIEDs are implanted from the University of Colorado Hospital Device clinic, and analyze their data to assess the correlation of daily activity with frailty measures, as well as with cardiac and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals followed in the UCH device clinic
* Individuals with CIED implanted
* Age over 65

Exclusion Criteria:

* Unable/unwilling to provide informed consent
Delayed Sleep Timing in Teens Study

This study will (1) comprehensively characterize the substance use disorder (SUD) risk profile associated with adolescent Delayed Sleep Phase (DSP), and (2) probe whether SUD risk is diminished by altering sleep/circadian timing.

Mounting evidence indicates that delayed sleep phase (DSP) may confer risk for adolescent substance use (SU) and SUDs. However, the exact nature of this link and the mechanisms underlying it remain unclear. Circadian misalignment, a mismatch between late sleep hours and early school start times, is a compelling potential contributor to elevated SU in adolescent DSP with plausible neurobehavioral mechanisms. The investigators hypothesize that DSP-associated circadian misalignment decreases impulse control and increases reward sensitivity, thereby increasing SUD risk.

This study will, for the first time, (1) comprehensively characterize the SUD risk profile associated with adolescent DSP, and (2) probe whether SUD risk is diminished by altering sleep/circadian timing. The study will assess both established markers of SUD risk and putative neurobehavioral mechanisms (impulsivity and reward sensitivity). Specifically, the investigators will employ a comprehensive, multi-method approach to examining DSP's role in SUD risk, combining laboratory, experimental, and longitudinal studies. The investigators will recruit a sample of 150 eleventh and twelfth graders (16-19 y/o), divided between 100 DSP and 50 normal phase teens. The investigators will focus on cannabis and alcohol use given their prevalent use in adolescents and evident links to DSP.

In the experimental study, the investigators will probe whether stabilizing circadian phase in the DSP group (n=100) by using sleep scheduling and chronotherapeutic approaches (i.e., dim light in the evening and bright light in the morning) improves sleep and neurobehavioral function relevant to SUD risk.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-19 years
* Currently in 11th or 12th grade and enrolled in a traditional high-school; or cyber school with synchronous classes (not home-schooled)
* Physically and psychiatrically healthy, as determined by instruments described below
* Provision of written informed consent and assent

Additional inclusion criterion for Experimental protocol

* Meets operational definition of delayed sleep phase (DSP; weekend bedtime ≥1 AM)

Exclusion Criteria:

* Significant or unstable acute or chronic medical conditions
* Past or current bipolar disorder or psychotic disorder
* Past or current substance use disorder other than alcohol use disorder or cannabis use disorder
* Past month recreational drug use other than alcohol, cannabis, and nicotine
* Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
* Medications that interfere with sleep and/or reward function (antidepressants, and stimulants prescribed for ADHD are permitted)
* Conditions that would interfere with the MRI procedures (e.g., non-removal ferromagnetic devices)