cyrilzakka/clinical-trials huggingface dataset:
Improving Sleep in the Neurology In-Patient Population

We aim to test multiple interventions to improve sleep for Neurology inpatients, including 1) a sleep-friendly order set, and 2) a sleep menu. We will collect patient sleep data, including duration and quality, via actigraphy devices (FitBits). We will also conduct qualitative patient surveys to understand the impact of these interventions.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* 24 hours after admission to the general neurology (ward) service at the Hospital of the University of Pennsylvania
* Patients who are determined by the primary team to be clinically stable enough to forego serial overnight vital signs monitoring and neuro checks.
* Clinical stability criteria:
* Symptomatic stability \>24h after admission (no new or progressive neurologic symptoms for \>24 hours)
* Vital signs stability on admission for \> 24h while admitted
* Ability to verbally consent to study participation

Exclusion Criteria:

* Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
* Any additional clinical factors felt by the team to be incompatible with specific orders including requiring serial vital signs monitoring and neuro checks overnight
Computer-Based Alcohol Use Disorder Recovery System

The purpose of this grant is to develop and test a proven computer based quality improvement/behavior change e-Health system (CHESS--Comprehensive Health Enhancement Support System) to help prevent relapse in alcohol dependent patients being discharged from residential treatment. The investigators' primary hypothesis is that ACHESS (Addiction CHESS) will improve competence, relatedness and autonomy, which will reduce the days of risky drinking over a 12-month period.

The system to be tested (ACHESS - Addiction CHESS) will be delivered through a new modality (smart-phone rather than PC) to make access more widespread, focus on new patients (alcohol dependent patients leaving residential care), offer optional audio delivery to improve access for those who have literacy challenges and be enhanced with services tailored to relapse prevention. ACHESS will offer: 1) communication with peer support groups and addiction experts; 2) timely monitoring to assess risk of relapse, 3) reminders and alerts to encourage adherence to therapeutic goals; 4) addiction-related educational material and tools tailored to the needs of the particular patient, 5) access to selected Internet based resources and 6) communication with a care manager. Patients randomly assigned to ACHESS will learn to use it prior to discharge from residential care.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must be at least 18 years of age
* All subjects must be willing to participate in the study
* All subjects must be willing to identify two people who could provide contact information about their location for the next year
* If randomized into ACHESS, all subjects must agree to allow monitoring of their ACHESS usage, including internet browsing
* All subjects must pass a literacy test

Exclusion Criteria:

* Homelessness
* Psychiatric or medical condition that precludes participation in the study including: subjects with a history of suicidality, significant developmental/cognitive impairments that limit their ability to understand the material or have vision problems will not be included in this study.
The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis

The aim of this study is to investigate the safety and effectiveness of tocilizumab (Actemra®) using Chinese Rheumatology Information Platform (CRIP) on Chinese Rheumatology Data Centre (CRDC, http://www.crdc.org.cn/) in Chinese RA patients.

Tocilizumab (Actemra®) is a humanized monoclonal antibody targeting the human IL-6 receptor, which inhibits the binding of this cytokine to its receptor. It is the first monoclonal antibody developed for RA treatment with this mechanism of action and has been approved by regulatory authorities in China since 2013. Data from five phase III studies with over 4000 recruited patients have shown that tocilizumab at a dose of 8 mg/kg, in combination with methotrexate/DMARDs or as monotherapy, can produce a quick and clinically relevant improvement in RA signs and symptoms, health status, and prevent joint damage, for both patients who have not been previously treated with and refractory to methotrexate, other DMARDs or anti-TNF agents. However, in real-world clinical setting, the safety profile and treatment pattern with regard to the persistence on tocilizumab and the efficacy are not clear in China. The aim of this study is to investigate the safety and effectiveness of tocilizumab using Chinese Rheumatology Information Platform (CRIP) on Chinese Rheumatology Data Centre (CRDC, http://www.crdc.org.cn/) in Chinese RA patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age.
* Patients with a diagnosis of RA according to the revised (2010) ACR criteria.
* Patients per treating physician's judgment to treat with Tocilizumab.
* Signed written informed consent

Exclusion Criteria:

* Patients are receiving or have received any investigational agent 4 weeks (or 5 half-lives of investigational agent, whichever is longer) prior to enrollment of this study.
* Subjects with contra-indications to Tocilizumab therapy as detailed in the label (with known hypersensitivity to Tocilizumab or accessories; or with active infections.).
Cardiac Interventional ICE Imaging Trial

The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process.

This randomized controlled trial will enroll adult patients undergoing cardiac interventions, who will be randomly assigned to either the experimental device group or the control group.

The main endpoint of the INTELICE trial is the image quality rate of intracardiac echocardiography, which will be evaluated by three experienced sonographers from the core laboratory, while the operator's image quality assessment serves as a secondary endpoint. In addition, secondary endpoints include clinical success rate, technical success rate, procedure time, and evaluation for the experimental devices.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, ≤90 years, of any gender.
* Subjects deemed suitable for the utilization of ICE catheters during cardiac interventional procedures, as determined by investigators:

  1. Requirement for ICE imaging of the heart;
  2. Requirement for ICE imaging of great vessels;
  3. Requirement for ICE imaging of other intracardiac devices.
* Subjects themselves or their guardians must possess the ability to comprehend the purpose of this study, demonstrate adequate compliance with the protocol, and sign the informed consent form.

Exclusion Criteria:

* Anticipated vascular access (e.g., femoral vein, inferior vena cava, subclavian vein, internal jugular vein) cannot meet the procedure needs.
* PLT \<100\*109/L or INR \>1.5.
* Intracardiac blood clots or severe peripheral vascular disease (e.g., deep vein thrombosis, aneurysm, atherosclerosis).
* Sepsis, pyemia, or severe systemic infection.
* NYHA Class IV.
* History of cardiac or related cardiac areas surgery within 6 months.
* Inability to tolerate post procedure oral anticoagulants or antiplatelet drugs.
* Inability to tolerate or cooperate with the procedure.
* Pregnant or lactating women, women with a positive pregnancy test result within 7 days before enrollment.
* Participation in other clinical trials of drugs, biological agents or devices within 3 months before screening.
* Other exclusive circumstances determined by the investigators, where the subject is deemed unsuitable for enrollment.
A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

This study is being conducted to determine the side effects related to LY3437943 given as a single injection under the skin to healthy participants. Blood tests will be performed to check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3437943 or placebo. The study will last up to approximately 71 days for each participant, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for ease of blood sampling

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously completed or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have been treated with weight loss medications within 3 months of screening
Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

To determine test performance of transesophageal echocardiography performed by emergency physician ultrasound for the identification of blunt traumatic aortic injury in chest trauma.

This is a multicentre prospective observational trial. All trauma patients with suspected BTAI at the emergency department (ED) will undergo resuscitative transesophageal echocardiography to evaluate the thoracic aorta.

Resuscitative TEE is a minimally invasive procedure to evaluate all chest trauma patients. Besides the aorta, TEE can also provide other useful information regarding the hemodynamic status, cardiac function and lung pathology of the patient.

Patients will be recruited into the study by investigators who take informed consent from the patient or next of kin prior to the TEE procedure.

For all patients with suspected BTAI, CTA is mandatory to confirm the diagnosis of BTAI.

TEE findings of BTAI will be compared to CTA which will be considered the reference standard unless confirmation is available from surgical procedures or autopsy.

Inter-observer variability for normal or pathological TEE images interpretation is performed prior to the initiation of the study.

Eligibility Criteria:
Inclusion Criteria:

All trauma patients with suspected BTAI in the emergency department (ED) who undergo both TEE and CTA.

Exclusion Criteria:

1. Children (age under 18 years) will not be eligible for inclusion in this study.
2. Patients with contraindication to TEE such as suspected esophageal injury or pathology
Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)

The aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the treatment of facial actinic keratosis. We use randomized, double-blinded prospective study design. The efficacy will be assessed clinically, histopathologically and immunohistochemically.

Actinic keratoses (AKs) are superficial premalignant skin lesions that can progress into an invasive or metastatic squamous cell carcinoma. AKs can be treated with photodynamic therapy (PDT), of which cure rate compares to cryo surgery with an excellent cosmesis. In PDT the AK lesions are first curettaged, then a photosensitizer is applied on the skin and let to absorb for 3 hours. The skin is illuminated using a blue or red light source light source depending on the photosensitizer, which induces activation of protoporphyrin IX (PpIX) and phototoxic reaction destroying the cancer cells.

The approved photosensitizers in Europe are methyl-aminolevulinic acid cream, (MAL, Metvix™, Galderma), a patch containing 5-aminolevulinic acid (5-ALA, Alacare®, Spirig AG) and 5-aminolevulinic acid gel (BF-200 ALA, Ameluz®, Biofrontera AG) to be used with a red LED light (630-635 nm). In North America a 5-aminolevulinic acid stick (5-ALA, Levulan® Kerastick) can also be used with a blue light source (417 nm).

PpIX absorption peaks are within the visual spectrum of light, which allows PpIX daylight activation. During natural daylight PDT (NDL-PDT) protocol, PpIX is continuously activated during its development, whereas in conventional PDT (LED-PDT) using red LED lamps, large amounts of accumulated PpIX are momentarily activated.

Since skin field cancerization refers to presence of different degrees of visible and invisible dysplastic changes, the whole area should be treated to prevent the development of non-melanoma skin cancers (NMSCs). NDL-PDT enables treatment of field cancerization in one sitting whereas LED-PDT may need repeated illuminations to cover the whole area. NDL-PDT results in enhanced cost-efficacy due to reduced staff expenses, since there's no need for sensitizer absorption and illumination.

At the moment two photosensitizers have marketing authorization in Finland, ALA (Ameluz®) and MAL (Metvix™). We are piloting a study comparing the efficacy of these two light sensitizers in NDL-PDT. The efficacy of the treatments will be assessed clinically, histopathologically and immunohistochemically.

Eligibility Criteria:
Inclusion Criteria:

* actinic keratoses symmetrically on face or scalp
* age over 18 years
* there must be at minumum one ak sized 6mm2 symmetrically on both sides
* patients must be able to make the decision to attend independently

Exclusion Criteria:

* pregnancy
* lactation
* lack of compliance
Memantine in the Treatment of Kleptomania

The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.

The proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with kleptomania. The hypothesis to be tested is that memantine will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility Criteria:
Inclusion Criteria:

1. men and women age 18-65
2. current KM using the clinician-administered Structured Clinical Interview for Kleptomania (SCI-K)
3. stealing behavior within 2 weeks prior to enrollment.

Exclusion Criteria:

1. infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for kleptomania (KM)
2. unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen
3. history of seizures
4. myocardial infarction within 6 months
5. current pregnancy or lactation, or inadequate contraception in women of childbearing potential
6. a need for medication other than memantine with possible psychotropic effects or unfavorable interactions
7. clinically significant suicidality
8. current Axis I disorder determined by the Structured Clinical Interview for the DSM (SCID) and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence
9. lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID
10. current or recent (past 3 months) DSM-IV substance abuse or dependence
11. positive urine drug screen at screening
12. initiation of psychotherapy or behavior therapy within 3 months prior to study baseline
13. previous treatment with memantine; and 14) treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.
BMT-CARE: Psychosocial Intervention for Transplant Caregivers

The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption.

This is a randomized clinical trial to determine whether a psychosocial intervention (BMT-CARE) is effective at improving the quality of life and reducing psychosocial distress of caregivers and patients treated with hematopoietic cell transplant (HCT). The BMT-CARE intervention was developed with the goal of improving the experience and needs of caregivers of patients treated with HCT.

Caregivers will be randomized into one of the two study groups: BMT-CARE plus usual care, or usual care.

Participation in this study is expected to last up to 180 days after HCT.

Investigators expect that about 400 caregivers and up to 400 patients treated with HCT will take part in this research study.

The National Institutes of Health is supporting this research by providing funding.

Eligibility Criteria:
Caregiver Inclusion Criteria:

* Adult caregivers (≥18 years) who is a relative or friend whom the patient identified as living with them or having in-person contact with them at least twice a week.
* Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer.
* Ability to read and respond to survey questions in English, Spanish or with minimal assistance from an interpreter.

Caregiver Exclusion Criteria:

* Caregivers of patients undergoing HCT for a benign hematologic condition or undergoing outpatient HCT.
* Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.

Patient Inclusion Criteria:

* Adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic HCT.
* Ability to respond to questions in English, Spanish, or with minimal assistance from an interpreter.
the Multi-modal Evaluation of Agitation in Critically Ill Patients Based on Remote Video-Ultra-sensitive Detection Wave

The goal of this observational study is to learn about the effectiveness of the multi-modal evaluation for agitation behavior in critically ill patients based on remote video-Ultra-sensitive detection wave.

The main question it aims to answer is: evaluate the effectiveness of multi-modal evaluation monitoring system for agitated critically ill patients Participants already taking multi-modal evaluation monitoring system as part of their regular medical care for agitated critically ill patients will compare their effectiveness for agitation for 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients at risk of agitation in the ICU
* Patients with RASS score -2 and above
* ≦ 65 years old, ≧ 18 years old

Exclusion Criteria:

* The affected party refused to participate in this study
* Missing/incomplete information
* Vulnerable groups such as pregnant women, those who lack the capacity for civil conduct and do not have the consent of their legal representatives
* Maxillofacial trauma, burns, tumors, surgery, etc. affect facial expression
* Patients with limb impairment and amputation
* Spinal cord injury, limb movement/sensory limitations
* Patients with pre-existing neurological/psychiatric diseases
* Patients with malignant tumors
* Patients with infectious diseases
* Patients with terminal disease and dying disease
* Abnormal behavior due to head injury or craniocerebral disease
CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma

The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects with CD7+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled:

1. Eligible diseases: CD7 positive relapsed or refractory Leukemia and Lymphoma. ￚ Acute myeloid leukemia, previously identified as CD7+ ￚ Precursor T lymphoblast leukemia/lymphoma ￚ T-cell prolymphocytic leukemia ￚ T-cell large granular lymphocytic leukemia ￚ Peripheral T-cell lymphoma, NOS ￚ Angioimmunoblastic T-cell lymphoma ￚ Extranodal NK/T-cell lymphoma, nasal type ￚ Enteropathy-type intestinal T-cell lymphoma ￚ Hepatosplenic T-cell lymphoma
2. Patients 18 years of age or older, and must have a life expectancy \> 12 weeks.
3. CD7 is expressed in malignancy tissues by immuno-histochemical (IHC) or Flow cytometry.
4. Assessable disease as measured by laboratory and bone marrow examinations.
5. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
6. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR-pNK cells.
7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
8. Ability to give informed consent.

Exclusion Criteria:

1. Patients with symptomatic central nervous system (CNS) involvement.
2. Pregnant or nursing women may not participate.
3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
6. Previously treatment with any gene therapy products.
7. The existence of unstable or active ulcers or gastrointestinal bleeding.
8. Patients with a history of organ transplantation or are waiting for organ transplantation.
9. Patients need anticoagulant therapy (such as warfarin or heparin).
10. Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).