cyrilzakka/clinical-trials huggingface dataset:
Family-based Crisis Intervention With Suicidal Adolescents in the ED

The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents within a single ED visit so that they may return home safely with their families. This study is a randomized clinical trial of FBCI v. TAU in an urban Emergency Department.

In current practice, treatment as usual (TAU) for suicidal adolescents includes evaluation, with little or no intervention provided in the Emergency Department (ED), and disposition, usually to an inpatient psychiatry unit. The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents within a single ED visit so that they may return home safely with their families. The intervention works intensively with both the adolescent and the family, so that the caregiver has the knowledge and skills to help the adolescent after discharge.

In this study, suicidal adolescents (ages 13-18) and their families presenting for psychiatric evaluation to a large pediatric ED were randomized to receive FBCI or treatment as usual (TAU). Patients and caregivers completed self-report measures of suicidality, family empowerment, and satisfaction with care provided at pre-test, post-test, and 3 follow up time-points over a one-month period. Clinicians contacted the adolescent and caregiver at these timepoints to administer the questionnaires and assure safety planning was being carried out.

Eligibility Criteria:
Inclusion Criteria:

* adolescent presenting to the ED with suicidality
* presence of a consenting parent or legal guardian with whom the adolescent resided.

Exclusion Criteria:

* either adolescent or parent/guardian lacked fluency in English;
* adolescent was not medically stable, including intoxication;
* adolescent demonstrated cognitive limitations prohibiting completion of research instruments;
* adolescent presented with active psychosis;
* adolescent required physical or medication restraint in the ED.
Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate

Shivering is a common post-anesthetic complication occurring in up to 65% of patients undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram, blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could therefore result in better postoperative outcomes or reduce the incidence of post-surgical complications.

Magnesium sulfate (MgSO4) has anti-shivering effects. Moreover, it has potential neuroprotective effects and may enhance neuroprotection against the effects of hypothermia. Intrathecal MgSO4 administration provides effective perioperative analgesia and can prolong the period of anesthesia and sensory blockade without any additional side-effects. However, most of the research on the role of MgSO4 in the prevention of shivering has focused on intravenous infusion of this drug. Few clinical trials have examined the effect of adding intrathecal MgSO4 to anesthetic agents such as bupivacaine to suppress anesthesia-related shivering in patients. Similar to infusion studies, we hypothesized that the addition of intrathecal injection of MgSO4 to bupivacaine would improve perioperative shivering in female patients undergoing elective caesarean section. Few previous studies evaluated neuroaxial anti-shivering effects of intrathecal magnesium and none evaluated the anti-shivering effect of intrathecal MgSO4. Therefore, we elected to use the lowest dosage (25 mg MgSO4) that was formerly utilized for investigation of analgesic effects.

Magnesium sulphate is an intracellular cation with various physiologic functions such as enzyme activation, nerve signal conduction, protein synthesis and vasomotor tonicity regulation. Magnesium sulphate has been used in various clinical situations including preeclampsia, tocolysis, arrhythmias, myocardial ischemia, bronchial asthma and postoperative shivering.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 35years.
2. Undergo elective cesarean section under spinal anesthesia.
3. ASA physical status I-II.
4. Singleton pregnancy.
5. At least 38 weeks gestation.

Exclusion Criteria:

1. Women with history of cardiac, liver or kidney diseases.
2. Women with allergy to amide local anesthetics or medication included in the study.
3. Women with any neurological problem.
4. Any contraindication of regional anesthesia.
5. Failed or insatisfactory spinal block.
6. Preoperative temperature more than 38⁰ C.
Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes mellitus diagnosed at least 3 months with FPG level \<=240mg/dL and HbA1c between 6.5% and 10% inclusive.
* Must be diet controlled - OR - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
* Must have a BMI:\<=35kg/m2, 20 to 70 years of age inclusive.
* Woman must be of non-childbearing potential.

Exclusion criteria:

* Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
* Clinically significant hepatic enzyme elevation.
* History of metabolic disease other than T2DM.
* Previous use of insulin as a treatment for diabetes within 3 months.
* History of severe gastrointestinal disease.
* Clinically significant cardiovascular disease.
* Significant renal disease as defined by screening lab test.
* History of drug (including albumin or albumin containing agents) allergy.
* History of alcohol or drug abuse.
* Donation of blood in excess of 400mL within previous 4 months.
* Previously received any GLP-1 mimetic or any other albumin-containing products.
Effect of Stent Size on Dyssynchrony

the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough

Background: the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough Aim: to study short term effect of stent size and number on left ventricular mechanical dyssynchrony after elective PCI to LAD artery.

Patients and methods: the study included 150 adult patients with electively stented LAD lesion with DES. Patients were evaluated pre PCI then follow up at 1m and 3m using tissue synchronization image (TSI).

Eligibility Criteria:
Inclusion Criteria:

* adult patients with electively stented LAD lesion with DES were enrolled in the study. Patients were evaluated pre PCI then follow up at 1m and 3m after PCI using TSI.

Exclusion Criteria:

* patients with Bundle branch block (BBB),
* Previous percutaneous coronary intervention (PCI),
* Previous coronary artery bypass graft (CABG),
* Rhythm other than sinus,
* Rheumatic heart disease,
* Prosthetic valve,
* Complicated or unsuccessful procedure,
* Patients with significant degenerative changes,
* Patients with previous STEMI,
* and dropped patients from follow up were excluded from the study.
17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.

The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week.
* The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
* A singleton gestation.

Exclusion Criteria:

* Multifetal pregnancy.
* The subject has or will have a cervical cerclage in place.
Health Literacy in People With Chronic Obstructive Pulmonary Disease

Health literacy refers to personal and relational factors affecting a person's ability to acquire, understand and use information about health and health services. In a need assessment study it was found that, the health services need to focus on health literacy factors in the follow up of patients with chronic obstructive pulmonary disease (COPD).

Thus, this project evaluate the effect a of a health literacy partnership health promotion intervention (hospital, municipalities, university) after discharge from hospital with the use of motivational interviewing and tailored follow-ups on re-admission, health literacy, self-management quality of life and cost in people with COPD compared with usual care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD,
* Above 18 years,
* Admitted to a medical department at the main intervention hospital, l
* Live in the sites belonging to the intervention hospital.

Exclusion Criteria:

* Not diagnosed with COPD,
* Not above 18 years,
* Not admitted to a medical department at the main intervention hospital, and
* Not living in the sites belonging to the intervention hospital.
* Cognitive failure
* Patients that are investigated or treated for cancer
Mobilaser Study to Help With People Who Are Having Problems With Their Gait

Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with Parkinson's disease and Parkinsonism.

Can patients walk faster and have less freezing when using the mobilaser then when not using it

Eligibility Criteria:
Inclusion Criteria:

* Parkinsonian patients with Freezing of Gait or Gait hesitation.
* Must have evidence of bradykinesia ambulating (stride reduction or reduced arm swing)
* Must have a constant caregiver

Exclusion Criteria:

* No cardiopulmonary contraindications to ambulation, e.g., unstable angina pectoris;
* Severe arthritis;
* Cerebellar or sensory ataxia;
* Recent knee or hip surgery
Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection

The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients diagnosed as EGC and treated by ESD with following criteria:1) Differentiated mucosal cancer without ulcer 2) Differentiated mucosal cancer with ulcer, ≤ 3 cm 3) Differentiated minute (\<500 μm) submucosal invasive cancer, ≤ 3 cm 4) Undifferentiated mucosal cancer without ulcer, ≤ 2 cm
* Consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of EGC and treated by ESD

Exclusion Criteria:

* Coagulopathy : International normalized ratio \[INR\] \> 1.5 or platelet count \<50,000 cell/cubic millimeter)
* Impaired renal function : Cr \> 1.2 mg/dL
* Pregnancy or breast-feeding
* Age \< 20 years
* Allergy to fluorescein dye
* Inability to provide informed consent
Evaluating the Effect of Bathing Additives in Atopic Dermatitis

This proposed project will be an open-label, split-arm, randomized controlled pilot study. Up to 60 patients diagnosed with atopic dermatitis (eczema) will be enrolled in the study. The purpose of this study is to understand the change in skin barrier function and skin microbial composition in patients with atopic dermatitis following dilute bleach bath/soak and dilute vinegar bath/soak.

Atopic dermatitis (AD), also known as eczema, is an inflammatory skin condition that affects children and adults and causes skin redness, dryness and itching. Dilute bleach baths are standard of care for treatment of AD and work to decrease skin inflammation and modulate the skin microbiome. Dilute vinegar (acetic acid) has been reported to have similar effects on the skin. The purpose of this study is to evaluate the change in skin barrier function and skin microbial composition following baths or gauze soaks with dilute bleach and dilute vinegar.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, at least 5 years of age
* Subjects, parents/legal guardians must be able to comprehend and read the English language
* Subjects must have a diagnosis of atopic dermatitis (AD) by a board-certified dermatologist

Exclusion Criteria:

* Subjects who do not fit the inclusion criteria
* Subjects unable or unwilling to comply with the study procedures
* Concurrently have other inflammatory skin conditions
* Prior known allergies to any components of the materials used
* A subject who in the opinion of the investigator will be uncooperative or unable to comply with study procedures
* Subject unable to speak or read the English language
* Those that are pregnant, prisoners or cognitively impaired
Determining Molecular Drivers of Radiation Dermatitis

This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin or a rash on swollen, reddened skin).


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving standard-of-care postoperative radiation therapy (2-2.7 Gy per fraction) to the breast and/or chest wall for breast cancer treatment.
* Tissue diagnosis of breast cancer.
* Age \> 18 years
* Signed informed consent.
* Complete blood count within normal limits within the preceding 2 weeks.

Exclusion criteria:

* Induction chemotherapy or biologic therapy
* Concurrent chemotherapy or biologic therapy
* Autoimmune disease with skin manifestations - psoriasis, dermatomyositis, scleroderma, eczema, polymyositis
* Allergy to lidocaine anesthesia
* Known bleeding diathesis (anticoagulation with warfarin, coagulation/bleeding disorders, vitamin C or K deficiency, thrombocytopenia)
* History of keloids or easy scarring
FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and quantify liver fibrosis.

Noninvasive monitoring of liver fibrosis is an unmet and critical need within the clinical management of children with chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation of children with liver disease, subsequent surveillance liver biopsy is rarely performed in children because of its inherent invasiveness and risks. Therefore, our understanding of the natural history of fibrosis progression in children is limited. The patchy nature of fibrosis in many important pediatric liver diseases \[e.g. biliary atresia (BA) and cystic fibrosis liver disease (CFLD)\] limits the utility of sequential liver biopsy even if it were to be employed in clinical practice in pediatrics. Thus, non-invasive means of assessing liver fibrosis throughout the liver would be highly desirable and clinically useful in pediatric hepatology. ChiLDReN is poised and uniquely qualified to conduct a comprehensive longitudinal assessment of the utility of FibroScan™-specific elastography, liver stiffness measurement (LSM) as a measure of hepatic fibrosis in children with serious chronic cholestatic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Age less than 21 years at the time of enrollment
* Participants enrolled in a ChiLDReN based prospective observational cohort study (PROBE, BASIC, or LOGIC)
* Willingness and ability to participate in the study for up to 24 months
* One of the following three diagnoses

  * Biliary atresia per ChiLDReN criteria or,
  * Alpha-1 antitrypsin deficiency (PiZZ or SZ) or,
  * Alagille Syndrome per ChiLDReN criteria

Exclusion Criteria:

* BA with known situs inversus or polysplenia/asplenia
* Presence of clinically significant ascites detected on physical examination
* Open wound near expected FibroScan probe application site
* Use of implantable active medical device such as a pacemaker or defibrillator
* Known pregnancy
* Prior liver transplant
* Unable or unwilling to give informed consent or assent
Stroke and Cerebrovascular Diseases Registry

This is a single institutional registry database for the patients with stroke and cerebrovascular diseases. Stroke is the fifth leading cause of death in the United States. Despite extensive research, most of the patients die or suffer from varying degree of post-stroke disabilities due to neurologic deficits. This registry aims to understand the disease and examine the disease dynamics in the local community.

Stroke is the fifth cause of all-cause mortality in US http://www.cdc.gov/stroke/facts.htm Early identification and treatment not only prevent mortality but also morbidity. Recent advancement in the imaging and diagnostic technique and novel therapeutic modalities has dramatically helped to downgrade stroke from the list of top mortality index in the last 3 years. However, studies determining factors which help predict stroke outcome are still underway and much work needs to be done in this direction. Many factors currently are used to predict stroke outcome with varying results, for e.g. NIHSS is a good predictor of stroke outcome at 3 months; however, the investigators need better predictors, outcome scales or outcome measures which are easy, reliable and has better specificity and sensitivity.

Acute Brain injury, Transient Ischemic Attack is a special category of a neurological condition wherein there is an impending devastating outcome if workup is not completed in a timely fashion. There is an urgent need to do investigations with high-risk patients to prevent stroke and further mortality and morbidity. The abcd2 score can help us to risk stratify the TIA and to predict the chances of stroke in this specific cohort. However, investigators need better identifiers than already present, to improve the patient changes in secondary prophylaxis of stroke prevention http://www.stroke.org/sites/default/files/resources/tia-abcd2-tool.pdf?docID

There is also some correlation of clinical and biochemical predictors in subarachnoid, cerebral venous thrombosis including Hunt and Hess, SAH score, WFNS-SAH grading among others with variable predictive quality. (Rosen et al; Neurocritical Care; April 2005, Volume 2, Issue 2, pp 110-118: Subarachnoid hemorrhage grading scales).

Eligibility Criteria:
Inclusion Criteria:

1. All patients with a diagnosis of Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis seen in UNMH.
2. Age \>1 years of age.

Exclusion Criteria:

1. Patients who don't have the diagnosis of Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis.
2. Patients who have Epidural Hematoma, Subdural hematoma.
The Foot Exercises in Patellofemoral Pain

The purpose of this study is to investigate the additional effects of Short Foot Exercises on pain, biomechanical characteristics and functionality of lower extremity in patients with patellofemoral pain.


Eligibility Criteria:
Inclusion Criteria:

* aged between 25-60
* diagnosed as patellofemoral pain syndrome

Exclusion Criteria:

* Pregnancy
* Having walking disability
* Having a trauma, knee surgery or other arthritis
Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia

Functional dyspepsia (FD) is a common gastrointestinal disease, which is associated with decreased life quality and increased medical cost. Antipsychotic drugs were demonstrated to be effective in relieving symptoms in FD patients, especially for patients with refractory FD. However, the use of those drugs was associated with obvious adverse events. Cognitive behavioral therapy (CBT) has extensive applications and exhibited potential treatment effects in clinical practices, especially for treating anxiety, depression, pain or stress disorders. Several previous RCT studies have confirmed the effects of psychological intervention on improving dyspepsia in FD patients. Our hypothesis was that 8-week smartphone-based CBT would be non-inferior to conventional pharmacotherapy in reducing FD-related symptoms in patients with refactory FD.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80
2. Refractory functional dyspepsia (patients with Rome IV functional dyspepsia remained symptomatic after treatment of 8 weeks of proton pump inhibitor and 4 weeks of prokinetics)
3. Negative or unrelated-to-FD symptom findings of gastroscopy, upper abdominal ultrasound, Hp test and routine blood tests within the past 1 year.

Exclusion Criteria:

1. Severe mental illness (PHQ-9 ≥20 or GAD-7 ≥15) or suicidal ideation;
2. Known hp infection, active gastrointestinal peptic ulcer, cholecystitis, gallstones, suspected or known bowel obstruction, gastroparesis, major gastrointestinal surgery etc.;
3. Known or suspected malignant tumor, significant heart/brain/liver/kidney diseases, obvious hematologic abnormalities or endocrine diseases etc., which may be -related to FD symptoms;
4. Known or suspected drug-related FD (e.g.NSAIDs-related FD);
5. Unable to access to mobile networks or unable to manage mobile APP properly.
6. Allergy or other contradictions to flupenthixol or melitracen
7. Taking any antipsychotics drugs or CBT interference within 12 weeks
8. Pregnant or lactating women;
9. Unable to provide informed consent.