cyrilzakka/clinical-trials huggingface dataset:
Clinician Access to Soldier Suicide Information (CASSI)

The overall objective of this project is to conduct a feasibility study using data proved by Department of Defense National Center for Telehealth and Technology (T2) toward the ultimate goal of establishing a mechanism by which VA clinicians could access data on Veterans regarding suicidal thoughts and/or behaviors that occurred when they were on active duty, as documented in the Department of Defense Suicide Event Report (DoDSER).

As a first step toward the overall goal of this project, the investigators will use data from T2 to conduct the first stage of a feasibility study. Specifically, the investigators will attempt to match Social Security numbers (SSNs) of Soldiers who have had suicidal thoughts and/or behaviors in the DoDSER against SSNs of Veterans seeking mental health services at any VA in the United States. Once this first step has been accomplished, the investigators also aim to describe the group of Veterans with DoDSERs who are accessing VA services (i.e., demographic information, military service variables, and health care utilization variables) in an attempt to better understand this group. It is anticipated that if this study is successful, a next step would be to explore the possibility of DoDSER data sharing with VA partners toward attainment of the following long-term goals: 1. Sharing information on history of active duty suicidal thoughts and/or behaviors among discharged individuals seeking mental health services in VA systems; 2. Facilitating identification of these Veterans; 3. Reducing VA clinician burden though effective access to existing data that may help in assessment and treatment planning; 4. Lowering health care costs through effective early management; 5. Improving quality of care for Veterans seeking services through VA outpatient mental health clinics.

Eligibility Criteria:
Inclusion Criteria:

* Identified with a history of suicidal thoughts and/or behaviors, as recorded in the Army DoDSER

Exclusion Criteria:

* Death by suicide contained in the Army DoDSER (i.e., this information will not be sent to us by T2)
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

For children who use a power wheelchair, a powered wheelchair standing device (PWSD) may be considered for daily use. A PWSD allows a child to electronically move between sitting and standing and can be driven in either position. Existing published PWSD research in pediatrics is limited to boys with Duchenne muscular dystrophy (DMD).(1, 2) While these studies provide some insights into PWSD use in boys with DMD, they do not reflect PWSD use in children with other conditions. The purpose of this exploratory study is to determine the feasibility of a research protocol exploring use of a PWSD in children who have neurodevelopmental conditions other than DMD.


Eligibility Criteria:
Inclusion Criteria:

1. Is 5-17 years of age. NOTE: Participants must be under 18 for the duration of the study.
2. Diagnosed with a neurodevelopmental condition resulting in an inability to functionally ambulate.
3. Can safely assume and maintain a supported standing position
4. Has sufficient upper extremity and function to safely use a PWSD
5. Can communicate pain or discomfort through verbalization, vocalization, use of augmented communication, etc.
6. Can safely use the PWSD in areas of their home
7. Has at least one parent/caregiver who is able to converse in English and actively participate in a device-use education provided in English
8. The PerMobil PWSD can be set up to meet the child's specific needs
9. Medical Clearance to trial the PWSD
10. Participants must reside in Michigan

Exclusion Criteria:

1. Has a diagnosis of Duchenne muscular dystrophy.
2. Any reason that it would not be safe for the child to use a PWSD
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty

This research study is attempting to answer the question of whether 81 mg aspirin once daily is as effective as 81 mg aspirin twice daily in preventing blood clots after total joint replacement surgery.


Eligibility Criteria:
Inclusion criteria:

* \> 18 years of age
* Planning to undergo a primary total hip or knee arthroplasty

Exclusion Criteria:

* High risk patients for VTE as defined by:

  * History of venous thromboembolism
  * Active malignancy
  * Known pro thrombotic condition
* BMI \> 40
* Patients requiring anticoagulation for pre-existing conditions
* Patients with the contraindication for use of aspirin or nonsteroidal antiinflammatory drugs for reasons such as peptic ulcer disease, intolerance, others.
* Patients not fluent in the language of the informed consent form
* Prisoners
* Pregnancy
* Reported to have mental illness or belonging to a vulnerable population
Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

This study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a leukemia called CML (increase of white blood cells) after failure of standard therapy. It is also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in the digestive tract).

This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
* SWOG performance status 0-2.
* ANC greater than 1500, platelets greater than 100,000.
* Total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. Transaminase (AST and/or ALT) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis.
* Serum creatinine less than 1.25 x institutional upper limit of normal.
* Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.

Exclusion Criteria:

* Patient has received any other investigational agent- within 28 days of first day of study drug dosing.
* Patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
* Patient has another severe and/or life-threatening medical disease.
* Patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
* Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by Novartis.
* Patient had a major surgery within 2 weeks prior to study entry.
* Patients with symptomatic brain metastasis.
* Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study)
* Medical, social or psychological factors interfering with compliance.
* Patients under therapeutic coumadin therapy.
* Patients under routine systemic corticosteroid therapy.
Hemopatch Implication After Axillary Dissection for Breast Cancer

Aim of this randomized study is to assess the value of a different haemostatic sealant, the Hemopatch®, in axillary lymph node dissection (ALND) to reduce the incidence of seroma and seroma-related complications.

With the de-escalation of axillary lymph node dissection (ALND) to sentinel lymph node biopsy as a surgical procedure staging in breast cancer (BC), the physical and psychological morbidity has been improved significantly. However, ALND is still considered in a relevant number of BC patients as treatment for controlling locoregional axillary disease, and these patients present still important complications related to ALND, such as neuropathy, limitation of shoulder movement, arm lymphedema, and most commonly seroma evolution.

Multiple surgical devices with the intent to improve sealing of lymphatic and blood vessels have demonstrated contrasting results in the incidence of seroma formation after ALND and are no utilized routinary. Non-surgical devices, such as chemical medications, sealing small vessels by stimulating collagen and fibrinogen syntheses, also could improve to sealing of the lymphatic vessels. Additionally, fibrin glue-coated collagen patches and fibrin glue application to the surgical cavity were already tested in ALND patients with contrasting benefit in term of seroma prevention. Unfortunately, none of these studies provided a good solution to eliminate or reduce the incidence of seroma after ALND in BC treatment.

Aim of this randomized study is to assess the value of a different haemostatic sealant, the Hemopatch®, in axillary lymph node dissection (ALND) to reduce the incidence of seroma and seroma-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary breast cancer
* Mastectomy or breast conserving surgery
* Patients eligible for axillary dissection
* Male or female
* Any age
* Previous (or not) neoadjuvant treatments
* Any breast histotypes

Exclusion Criteria:

* Previous axillary surgery
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.

The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit on double-blind treatment), a phone visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment.

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

Eligibility Criteria:
Inclusion Criteria:

* The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment.
* The patient has provided written informed consent to participate in this extension protocol.
* Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study.

Exclusion Criteria:

* None.
THERAPEUTIC EDUCATION of SEXUAL DYSFUNCTIONS in WOMEN SURVIVORS of SEXUAL VIOLENCE and FEMALE GENITAL MUTILATION

Violence against women is a problem that affects women all over the planet, causing physical, emotional, and other repercussions for its survivors. Pelvic floor dysfunctions, especially female sexual dysfunctions, are among the most common physical consequences for women who have suffered sexual violence or female genital mutilation. Pelvic floor physiotherapy is the first-line treatment for these dysfunctions, with therapeutic education being one of its main strategies due to its importance in the cognitive approach and for promoting patient adherence to the proposed treatments. Women who are survivors of sexual violence and female genital mutilation, being at risk for these disorders, express the need to receive information about these dysfunctions and their possible treatments. However, it has been shown that their knowledge in this regard is limited. Therefore, a project is proposed with the objective of determining the effectiveness of an intervention based on therapeutic education in the prevention and management of sexual dysfunctions secondary to sexual violence or female genital mutilation. A group educational program is proposed, which allows survivor women to address these dysfunctions in a non-invasive way. Six sessions are planned to promote the development of various competencies: communicating their needs, integrating knowledge about their health problem, identifying and analyzing, decision-making and know-how, problem-solving, using healthcare resources and asserting their rights. This will provide these women a safe space to share their experiences, learn to manage them, acquire knowledge about the pelvic floor, related dysfunctions and their treatment, as well as self-efficacy tools for dealing with sexual dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

Women who have suffered sexual assault:

* Aged 18 and older
* No severe psychiatric disorders or any other condition that prevents them from answering questions and questionnaires
* Emotionally prepared to address the affected physical and sexual sphere

Women who have undergone Female Genital Mutilation:

* Aged 18 and older
* No severe psychiatric disorders or inability to answer questions and questionnaires
* Emotionally prepared to address the affected physical and sexual sphere

Exclusion Criteria:

* Women who have suffered sexual assaults in the context of trafficking of women and girls for sexual exploitation.
* Women who have difficulty understanding the Spanish language.
* Women who are not psychologically prepared to address their sexuality.
Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers

The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.


Eligibility Criteria:
Inclusion Criteria:

* 19 years to 55 years healthy volunteers adult at screening visit
* For male, weight is more than 55 kg, for female, weight is more than 50 kg.
* Body mass index(BMI) value : 18.5 to 25.0 kg/m2
* If female, should be included one at least as following

  * menopausal(menstruation for 2 years minimum)
  * surgery infertility

Exclusion Criteria:

* Any history of drug overdose or dependence
* Female who is pregnant or nursing
* AST, ALT \> ULN\*1.25
* Total bilirubin \> ULN\*1.5
* CPK \> ULN\*1.5
CCC Project- Acute Coronary Syndrome

To develop and implement quality improvement programs for the treatment of acute coronary syndrome (ACS) in China based on the successful experience of the AHA-Get with the Guidelines program. This program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients with discharge diagnosis as acute coronary syndrome (including STEMI, NSTEMI and UAP) in 150 tertiary and 100 secondary hospitals.

Exclusion Criteria:

None
Immune Monitoring to Facilitate Belatacept Monotherapy

* To determine the utility of novel blood-based immune monitoring tools (Allosure and Trugraf) to facilitate belatacept monotherapy.
* To determine the percent of belatacept-treated renal transplant patients that can be safely converted to belatacept monotherapy.

This study will examine whether renal transplant recipients treated with a belatacept-based immunosuppressive regimen can safely be weaned off all non-belatacept immunosuppression (mycophenolate, mTORi, prednisone) in a stepwise fashion. To this end, participants will undergo monthly "immune monitoring" using the Allosure (dd-cfDNA) and Trugraf (RNA profiling) blood tests to determine if they are in a state of immune quiescence. Only patients who are deemed to be immune quiescent, will continue to be weaned of non-belatacept immunosuppression.

Eligibility Criteria:
Inclusion Criteria:

* Age minimum 18 years
* Written informed consent
* Single kidney transplant recipient (i.e. no combined organ transplants)
* Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)
* At least 1 year after transplantation or after initiation of belatacept
* Stable renal function (eGFR \> 40 ml/min continuously during previous 6 months)
* Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA \< 1%; for Trugraf this corresponds to "TX" signature)
* No history of BK viremia in current allograft

Exclusion Criteria:

* History of biopsy-proven acute rejection
* Presence of donor-specific antibodies (at any MFI)
* Spot urine protein/creatinine ratio \> 0.5 g/g
IV Acetaminophen and Patent Ductus Arteriosus

This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants 23-30 weeks gestation,
* PDA requiring treatment

Exclusion Criteria:

* infection,
* congenital heart disease,
* genetic syndrome,
* NEC,
* pulmonary hypertension,
* hydrops,
* intestinal perforation,
* grade 3 or 4 IVH,
* serum creatinine \>1.5,
* previous treatment with a COX inhibitor.
National Project on Vaccines, COVID-19 and Frail Patients

This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.

The immune response to COVID-19 vaccination will be assessed at the following time points:

T0: the day of vaccination T1: the day of the booster dose according to the schedule of the two vaccines (Pfizer/BioNTech or Moderna) T2: between 5 and 7 weeks after T0 for those vaccinated with Pfizer/BioNTech and between 6 and 8 weeks after T0 for those vaccinated with Moderna.

* T3: 12 (± 1) weeks after T0
* T4: 24 (± 2) weeks from T0
* T5: 52 (± 2) weeks from T0 Prevention of SARS-CoV-2 infection will be assessed in terms of incidence of SARS-CoV-2 infections (NF molecular swab positive), and of SARS-CoV-2 infections requiring hospitalisation.

Eligibility Criteria:
Inclusion Criteria:

* Any subject undergoing SARS-CoV-2 vaccination with Pfizer-BioNTech or Moderna vaccines may be included in the study if they belong to at least one of the subgroups listed below:

  1. Hematological tumors
  2. Solid tumors
  3. Rheumatological diseases
  4. Neurological diseases

Exclusion Criteria:

* NA
Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy

Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke epilepsy are not known. Subclinical epileptiform discharges could contribute to the neuronal damage and influence functional outcome. Electro-encefalography (EEG) is the golden standard to detect interictal, ictal and subclinical epileptic brain activity.

Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together with the EEG results. The EEG results will be correlated with the occurence of epileptic seizures and functional outcome and mortality in the acute phase and in the long-term. When subclinical epileptic discharges are found on the EEG, patients will be asked to participate in a second part of the study where they will be randomised into a treatment (with an anti-epileptic drug) versus no-treatment group for a period of 6 months. Outcome parameters will be the occurrence of epileptic seizures, mortality and functional outcome.

Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the acute phase following stroke influences functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding

Exclusion Criteria:

* Patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

Eligibility Criteria:
Inclusion Criteria:

* Age: Greater than one month
* Weight: Greater than or equal to 3kg
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
* Decision-impaired adult and pediatric subjects who are unable to give consent and assent