cyrilzakka/clinical-trials huggingface dataset:
Pilot Trial of Mobile Technology for Adolescent Suicidality

The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents.

This double blind, randomized controlled trial will evaluate the preliminary efficacy of two digital interventions among 114 adolescent participants, and their parents/guardians, in reducing suicidal ideation in the adolescent participants. Adolescent participants, parent/guardian participants, and research assessors will be blinded to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients (of any sex), ages 13 to 17 years
2. Patients who were recently hospitalized and have:

   1. attempted suicide or
   2. have documented SI and a history of attempted suicide, as verified by the Columbia-Suicide Severity Rating Scale (C-SSRS).

   Hospitalized is defined as admission to a medical or psychiatric service for further assessment and care including observation units, intensive care or other medical units and psychiatric units.
3. Patient owns a smartphone capable of downloading and running apps
4. Patient is willing and able to complete enrollment procedures
5. Patient and Parent/Guardian are willing to assent/consent to medical record review for one year following randomization to collect suicide attempt data
6. Patient and Parent/Guardian are able to understand the nature of the study and sign documentation of written informed assent (Patient) and consent (Parent/Guardian)
7. Patient and Parent/Guardian understand written and spoken English
8. Patient is willing to agree to release of information to their Parent/Guardian and providers when clinically indicated

Exclusion Criteria:

1. Patients who are acutely intoxicated or in detoxification at the time of enrollment
2. Patients who are currently enrolled in other treatment studies for the symptoms and behaviors targeted
3. Patients who are incapable of understanding and following through with the study procedures (e.g., cognitive impairment)
4. Patients with a psychiatric or medical condition or custody arrangement that, in the opinion of the PI, may compromise, interfere, limit, affect or reduce the patient's ability to provide informed consent, complete the study, or may adversely impact the safety of the patient or the integrity of the data. Examples of considerations include terminal illness where death would be anticipated before completing study procedures, active psychosis at the time of assent, severe or unstable medical condition.
5. Patients whose discharge plans include transfer to inpatient care, as confirmed by the index hospitalization discharge summary/plan.
Southend Imaging Study

The study objective is to correlate global cognition and episodic memory performance to resting state fMRI functional connectivity. This is a non-treatment, prospective, natural history data collection study in a cross-sectional cohort of patients with cognitive impairment.

At present, Magnetic Resonance Imaging (MRI) is widely used along with other tests to help diagnose dementia, however diagnosis still remains challenging. There is currently a focus on the usefulness of resting state functionalMRI (RS fMRI) as a way of establishing differences in functional connectivity between healthy subjects and those with various neurodegenerative disorders. Although the potential for RS fMRI to be used as a biomarker for neurological diseases looks promising, further research is needed, especially regarding validation of normal values and seed-based functional connectivity. Further research into this area will help to improve the ability to appropriately classify new subjects and ultimately allow use of RS functional connectivity as a biomarker. This is a nontreatment, prospective, natural history data collection that aims to analyse functional connectivity in a cohort of patients with suspected cognitive impairment. Correlation of global cognition and episodic memory performance to resting state fMRI functional connectivity will be evaluated. Patient population will include patients over the age of 18 with cognitive impairment and age and gender matched controls. Eligible patients will have to complete neuropsychological and clinical assessments and complete an fMRI scan prior to enrolment.Study duration is estimated at 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Cognitive impairment
* Age from 18 to 100 years
* On stable medication for 1 month before the screening visit; on or off cholinesterase inhibitors
* Fluency in English and adequate premorbid intellectual functioning

Exclusion Criteria:

* Any contraindication to MRI scanning
* Clinically significant psychiatric disorder (e.g. depression)
* Current clinically significant illness that could confound the results of the study
* History of alcohol or drug dependence or abuse
* Current use of anticonvulsant or narcotic medications.
Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects must be between 18 and 50 years of age
* Subjects must have GAD
* Subjects must be in otherwise good general health

Exclusion Criteria:

* Subject has a documented history of HIV, hepatitis B or hepatitis C.
* Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.
* Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder.
* Subject has presence or history of antisocial personality or other severe disorder
* Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).
* Subject has history of seizures, including febrile seizures.
* Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD.
* Subject is undergoing or has undergone electroconvulsive therapy.
* Subject is a current smoker or has smoked within the last 12 months.
* Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.
Edible Oils in the Treatment of Constipation of Hemodialysis Patients

The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the treatment of constipation of patients undergoing hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Constipated patients by Rome III criteria
* Hemodialysis \> 3 months

Exclusion Criteria:

* Diagnosis of gastrointestinal disease other than constipation
* Previous intolerance to the oils used in the study
* Cognitive limitations
Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).

Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.

Eligibility Criteria:
Inclusion criteria:

* cytological confirmation of AML;
* relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days;
* confirmation of FLT-3 activating mutation positive status after point of initial relapse;
* aged 18 years or older;
* written informed consent;
* ability to understand and comply with study restrictions;
* no comorbid conditions that would limit life expectancy to less than 3 months;
* ECOG Performance Score of 0, 1,or 2;
* women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry

Exclusion criteria:

* bilirubin \> 2x ULN;
* ALT/AST \> 3x ULN;
* serum creatinine \> 1.5 mg/dL;
* resting ejection fraction of left ventricle l \< 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine \[MEC\];
* untreated or progressive infection;
* any physical or psychiatric cdtn that may compromise participation in the study;
* known CNS involvement with AML;
* any previous treatment with a FLT-3 inhibitor;
* requires current treatment for HIV with protease inhibitors;
* active GI ulceration or bleeding;
* use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation

The use of Allosure to identify and quantify circulating donor-derived cell-free DNA to quantitate allograft injury in the early post-transplant period and determine its relationship to allograft failure.

Single Center Prospective Cohort Study on De-Novo Lung Transplant recipients. AlloSure will be drawn as part of routine blood draws and sent to CareDx for analysis of dd-cfDNA. All data will be collected and stored in the hospital EMR, this will be examined with the AlloSure results to correlate outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Denovo lung transplant recipient
* Ability to understand written and spoken English

Exclusion Criteria:

* Previous transplant or multi-organ transplant
* Unable to have blood draw for medical reason
TRISCEND JAPAN Study

A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic tricuspid regurgitation (TR) despite medical therapy
* TR graded as severe or greater
* Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion Criteria:

* Tricuspid valve anatomic contraindications
* Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
* Hemodynamic instability
* Refractory heart failure requiring advanced intervention
* Currently participating in another investigational study
FAAH Inhibitor Trial for Adults With Tourette Syndrome

The purpose of this trial is to examine the safety, tolerability and feasibility in the use of a FAAH inhibitor for the treatment of adults with Tourette syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Adult between 18-60 years of age
* Meet DSM IV criteria for the diagnosis of Tourette's syndrome
* Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline
* On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial.
* Accepted method of birth control

Exclusion Criteria:

* Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ\<70).
* Current use of medications that have significant effects on the cannabinoid or dopamine systems. Subjects will be specifically excluded for recent use (within last 8 weeks) of antipsychotic medications, dopamine agonists or psychostimulants.
* Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.
* Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
* Positive pregnancy test or drug screening test
* History of cannabis dependence
* Significant Medical Comorbidity
Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment, and Outcome

Intraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant risk factors for the development of neurodevelopmental delays in preterm infants. The purpose of this study is to determine 1) the incidence of progressive post-hemorrhagic ventricular dilatation (PHVD) in infants with severe intraventricular hemorrhage (IVH), 2) the effect of ventricular dilatation on brain status (cerebral oxygenation, electrical activity, and biomarkers of cerebral damage and repair), and 3) if using ventricular measurements, derived from cranial ultrasound to guide removal of cerebral-spinal fluid through an Omaya reservoir, will help resolve ventricular dilatation and decrease the need for ventriculo-peritoneal (VP) shunt insertion. The hypothesis of this research project is that, by using ventricular measurements to guide the frequency of CSF removal, the rate of VP shunt insertion will be decreased in preterm infants with severe IVH and PHVD. The investigators further hypothesize that cerebral injury, as measured by cerebrospinal fluid (CSF) concentration of biomarkers of neuronal and glial damage and inflammation, will decrease over time with resolution of PHVD.

When an infant has severe IVH noted on cranial ultrasound, s(he) will receive weekly ultrasounds to evaluate progression of ventricular dilatation (standard of care). After the infant is enrolled in this study, Near-Infrared Spectroscopy (NIRS) and Amplitude integrated Electroencephalogram (aEEG) will be performed 1-2 times per week. After Omaya reservoir insertion, ventricular dimensions, based on weekly (standard of care) cranial ultrasounds, will determine frequency of CSF removal. NIRS and aEEG will continue 1-2 times per week to coincide with CSF removal. In addition, 1-2 times per week aliquots of CSF will be stored for evaluation of biomarkers. We will evaluate the impact of IVH and PHVD over time on cerebral oxygenation (NIRS) and cortical electrical activity (aEGG) starting at the time of identification of IVH and correlate these measurements to ventricular dimensions. If an Omaya reservoir is required to control PHVD, we will use ventricular dimensions to guide the frequency of CSF removal and continue to evaluate brain status by measuring cerebral oxygenation (NIRS) and cortical electrical activity (aEGG).

Eligibility Criteria:
Inclusion Criteria:

* severe IVH
* receiving weekly head ultrasounds for monitoring

Exclusion Criteria:

* no or minimal IVH
Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients

This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.

Osteoporosis is common in postmenopausal women and the elderly, and has been recognized by the World Health Organization as the second most prevalent metabolic bone disease worldwide. Most patients show no obvious symptoms, but a fall or sudden exertion can cause fragility fractures. Once fractures occur, complications such as acute pain, prolonged bed rest, and restricted mobility can significantly impact the quality of life and even increase mortality. Furthermore, managing these conditions requires substantial medical and social resources.

Currently, anti-osteoporosis medications are classified into two major categories: antiresorptive and anabolic agents. Studies have confirmed that both types can increase bone mineral density (BMD) and reduce fracture risk. However, each medication has usage limitations.

Denosumab is a potent antiresorptive drug, but long-term use can lead to rare side effects such as atypical femoral fractures (AFF) and medication-related osteonecrosis of the jaw (MRONJ). Additionally, stopping Denosumab can cause a severe rebound in bone resorption markers (CTX), leading to rapid BMD loss and an increased fracture risk. Managing drug discontinuation remains a major clinical challenge.

Eligibility Criteria:
Inclusion Criteria:

* 1. Postmenopausal women aged 50-90 years
* 2. BMD T-score \< -3.0 at any lumbar vertebra
* 3. Physically and mentally capable of understanding and complying with the study protocol and follow-up
* 4. Signed informed consent

Exclusion Criteria:

* 1. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
* 2. Allergy to Romosozumab or Denosumab
* 3. Secondary osteoporosis
* 4. Autoimmune disease
* 5. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
* 6. Hypercalcemia or hypocalcemia
* 7. Metabolic bone diseases
* 8. Primary or metastatic bone tumors
* 9. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)
* 10. Planned dental procedures (e.g., extractions, implants) within the next year
* 11. History of stent placement, myocardial infarction, stroke, or coronary artery disease
* 12. Renal disease (Creatinine \> 1.5 mg/dL) or dialysis patients
* 13. Smoking more than one pack per day (except for those who have quit for over ten years)
Rivastigmine Mini-Tablet for Alzheimer's Disease

The objective of this study is to evaluate the efficacy and safety of rivastigmine mini-tablets in individuals diagnosed with mild to moderate Alzheimer's disease (AD).

Rivastigmine has received approval for the treatment of Alzheimer's disease. The rivastigmine mini-tablet represents an innovative drug formulation designed to address swallowing difficulties by reducing the size of the dosage form, while also minimizing gastrointestinal side effects through an optimized drug release mechanism. This multi-center, observational study aims to evaluate the effectiveness, safety, and patient compliance associated with rivastigmine mini-tablets in individuals diagnosed with Alzheimer's disease. Assessments will be conducted at the 3rd, 6th, and 12th months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or older
* Meet the National Institute of Aging-Alzheimer's Association clinical criteria for probable Alzheimer's disease
* Have a Mini-Mental State Examination score of 10 to 24 at Screening and Baseline
* Geriatric Depression Scale score \<=7 at Screening
* Hachinski Ischemic Scale \<=4 at Screening
* Brain MRI should meet: no infarcts in key areas (thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, etc.), ≤ 2 stroke lesions \> 1.5 cm in diameter, and Fazekas Scale - assessed white matter lesion grade

  * 2.
* Patients whose caregivers are well-informed about the patients' condition and, if possible, live with them.
* Provide written informed consent

Exclusion Criteria:

* Any systemic or neurological condition that could contribute to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease
* Any psychiatric diagnosis or symptoms (hallucinations, major depression, delusions, etc) interfering with study procedures
* An advanced, severe or unstable disease of any type (cardiac, respiratory, gastrointestinal, renal disease, etc) that may interfere with efficacy evaluations
* Subjects treated with medication for dementia two weeks prior to baseline
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML

The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.


Eligibility Criteria:
Inclusion Criteria:

* Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
* After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
* At least 20% blasts in blood or marrow.
* Must have a minimum of 50% leukemic blasts that express CD33.
* ECOG performance status score of 0 to 2.
* WBC less than 30,000/µL

Exclusion Criteria:

* No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
* No other active systemic malignancies treated with chemotherapy within the last 12 months.
* Must not have received previous chemotherapy (except hydroxyurea) for AML.
* Must not have significantly abnormal kidney or liver disease.
* Must not have known human immunodeficiency virus (HIV).