cyrilzakka/clinical-trials huggingface dataset:
Sleep Quality in High School Students With Asthma

The overall goal of this project is to develop and to preliminarily validate a novel intervention to be delivered in the high school setting that integrates two evidence-based, school-based interventions for urban adolescents with proven efficacy: (1) Asthma Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and behaviors in urban adolescents.

The aim for Phase I is to develop and integrate school-based interventions to improve asthma self-management and sleep hygiene in urban high school students via interviews.

The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the intervention procedures; and (2) to assess the preliminary evidence of the effects of the intervention on improving sleep quality in urban high school students with persistent asthma over a 2-month follow-up period.

This record is for Phase I only.

Sleep quality among adolescents is poor and asthma's impact is significant among adolescents. Asthma control is an important risk factor for poor sleep and poor academic performance. In addition, poor asthma control, poor sleep hygiene, and poor sleep quality are more likely in urban settings. Interventions to promote sleep quality by targeting both asthma control and sleep hygiene in this vulnerable population are lacking.

To adapt ASMA and Sleep-Smart, the investigators will use a 3-step iterative process that will consist of (1) interviewing high school students and their caregivers, (2) interviewing high school teachers and (3) conducting separate focus groups with students and caregivers. The investigators hypothesize that the intervention will be feasible and acceptable. This study is a multi-site trial and collaboration between Columbia University Medical Center and Rhode Island Hospital (RIH).

Eligibility Criteria:
ADOLESCENT-CAREGIVER DYADS (20 adolescents with persistent asthma and poor sleep, and their caregivers - 10 in Step 1 and 10 in Step 3)

Inclusion Criteria:

1. a prior asthma diagnosis in the prior 12 months;
2. use of prescribed asthma medications;
3. persistent asthma (defined as (i) daytime symptoms 3+ days a week, (ii) night awakenings 3+ nights per month, (iii) 2+ Emergency Department visits or (iv) 1+ hospitalization for asthma); and
4. sleep duration \< 8 hours

Exclusion Criteria:

1. report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
2. A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
3. active immunotherapy;
4. additional pulmonary disease; and
5. significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses.

SCHOOL TEACHERS (4 high school teachers - 2 from New York and 2 from Rhode Island in Step 2)

Inclusion Criteria:

- Teach at the high school level.

Exclusion Criteria:

- Unwilling to participate in the study.
Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth

Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based practice (EBP) for the treatment of posttraumatic stress disorder (PTSD) and posttraumatic stress symptoms (PTSS) among children and adolescents. In the current study, data were collected from youth receiving TF-CBT in specialized child and adolescent mental health services (CAMHS) and their caregivers in 2018-2021.

Implementation of TF-CBT is a state-wide initiative, funded by the Norwegian Ministry of Health and Care Services, and is without costs for the clinics and patients. The Norwegian Center for Violence and Traumatic Stress Studies (NKVTS) is responsible for the project. TF-CBT trainers at NKVTS train therapists at the participating CAMHS in TF-CBT. Data are collected to monitor the training and patient outcomes. Data are collected anonymously to support and ensure high-quality treatment and also provide the opportunity to investigate the effect of the implementation of TF-CBT in Norwegian CAMHS. In the period 2018-2021, additional data were collected as part of a larger study where the aim was to investigate the effect of the implementation leadership support on implementation outcomes (ClinicalTrials.gov Identifier: NCT03042832).

Data were collected through online questionnaires before, during, and after TF-CBT was provided based on usual care. Routine procedures for trauma exposure screening and related posttraumatic stress symptoms were implemented. Those who scored above a predefined clinical cut-off were enrolled into TF-CBT based on the child and her or his caregiver's consent.

The aim of the study is to investigate the patient outcomes and therapeutic processes in TF-CBT.

Eligibility Criteria:
Inclusion Criteria:

* Referred to Norwegian CAMHS
* Screened for trauma exposure and PTSS

Exclusion Criteria:

* Below the age of 6 and above the age of 18
Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During previous studies of the CXL procedure, the surface epithelial cells have been removed. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection as no epithelial barrier will be broken, faster visual recovery and improved patient comfort in the early postoperative healing period.

The objective of this study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with riboflavin 0.1% for reducing corneal curvature. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, we will compare the two groups with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* A diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery
* Vision with contact lenses or glasses is worse than 20/20
* Corneal thickness greater than 375 microns at the thinnest point

Exclusion Criteria:

* Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
* Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
* Clinically significant corneal scarring in the CXL treatment zone
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
* Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer

The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.

A prospective randomized comparison of the modified delta-shaped gastroduodenostomy in totally laparoscopic surgery and Billroth-I anastomosis in laparoscopy-assisted surgery for distal gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the modified technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years (including 18 and 75 years old)
* Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
Results of Repair of Triangular Fibrocartilage Complex Tears Using Mini Anchor:

The Triangular fibrocartilage complex (TFCC) is a grouping of ligaments and cartilage in the wrist The TFCC is comprised of six major components: the distal radioulnar ligaments (dorsal and volar), central articular disk, meniscus homolog, ulnar collateral ligament, ECU subsheath, and the ulnolunate (UL)/ulnotriquetral (UT) ligaments.

This is important for wrist motion, stabilization, and overall hand function, including grip strength may progress to persistent pain, instability of the distal radioulnar joint, and arthritis if left untreated..

The TFCC vascularity is supplied by the anterior interosseous and ulnar arteries, although only a quarter of the TFCC is perfused. The limited vascularity of the TFCC, combined with its intricate soft tissue structure and torsional and axial stresses, makes the TFCC prone to frequent injury while maintaining a limited ability to heal.

Injuries like a fall on the outstretched hand or a forced ulnar deviation of the wrist can lead to an acute TFCC tear.

TFCC tears are a common cause of ulnar sided wrist pain and can be caused by chronic degeneration or traumatic injury.

Acute or chronic triangular fibrocartilage complex (TFCC) tears may result in persistent ulnar-sided wrist pain, loss of grip strength, and loss of function for patients.

A combination of clinical history, physical examination, and magnetic resonance imaging (MRI) may be used to diagnose a TFCC lesion, but confirmation of pathology requires an arthroscopic assessment. Arthroscopic assisted repair techniques have revolutionized surgical management Treatment of TFCC using mini anchor arthroscopically providing many benefits.

Functional outcome using Mayo wrist score after arthroscopic repair of triangular fibrocartilage complex tears using mini anchor


Eligibility Criteria:
Inclusion Criteria:

- Peripheral traumatic tears of triangular fibrocartilage complex in both sexes aged from teenagers to sixty.

b. Exclusion criteria:

1. Degenerative tears of triangular fibrocartilage complex. 2. Central- or radial-sided triangular fibrocartilage complex tears. 3. Tears associated with bony injuries.

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Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer

Phase I trial to study the effectiveness of radiation therapy plus topotecan in treating patients who have non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and radiation therapy may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of topotecan and chest irradiation in patients with non-small cell lung cancer.

II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.

III. Determine the degree of antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of topotecan and thoracic radiotherapy.

Beginning on day 1, patients receive topotecan IV continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2, 3, or 6 weeks. Cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (MTD) of each therapy is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Six additional patients are treated at the MTD. Patients who fail to achieve complete remission (CR) and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21 at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123. Treatment continues every 4 weeks in the absence of unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven non-small cell lung cancer
* Eligible for chest irradiation with 3,000 to 6,000 cGy (based upon standard radiotherapy indications)
* Measurable or evaluable disease
* Measurable disease defined as bidimensionally measurable lesion on physical exam or radiograph (CT or MRI acceptable)

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: 0-2
* Life expectancy: At least 12 weeks
* WBC at least 4,000/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 mg/dL
* AST less than 3 times normal
* Alkaline phosphatase less than 3 times normal
* Creatinine no greater than 1.5 mg/dL
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No more than 1 prior chemotherapy regimen allowed
* At least 4 weeks since prior chemotherapy and recovered
* No prior radiotherapy
* Recovered from toxic effects of any prior therapy
Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease

OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful vaso-occlusive crisis in patients with sickle cell disease.

II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic use, and length of hospitalization of these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to hydroxyurea use.

Patients are randomized to treatment poloxamer 188 or placebo. Treatment begins within 12 hours of presentation with crisis. Patients receive poloxamer 188 or placebo by continuous infusion for 48 hours. Pain is assessed before, during, and after treatment.

Patients are followed on days 7-14 and 28-35.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Sickle cell disease confirmed by electrophoresis or high pressure liquid chromatography
* At least one prior documented painful crisis episode but no greater than 10 crises per year for the last two years
* Sudden onset of acute pain lasting 4-12 hours and involving at least one site
* Severe crisis pain that requires parenteral analgesics and hospitalization, but not within the preceding 2 weeks

--Prior/Concurrent Therapy--

* Surgery: At least 2 weeks since prior major surgery No concurrent surgery
* Other: At least 2 weeks since prior puncture of noncompressible vessels No prior therapy using poloxamer 188 No concurrent investigational drug No concurrent use of nonsteroidal anti-inflammatory drugs

--Patient Characteristics--

* Hematopoietic: No significant bleeding or bleeding disorder
* Hepatic: ALT no greater than 2 times normal
* Renal: No active renal disease Creatinine no greater than 1.0 mg/dL OR Creatinine clearance greater than 50 mL/min Protein less than 300 mg/dL
* Cardiovascular: No evidence of acute myocardial ischemia or infarction
* Neurologic: At least 6 months since prior cerebrovascular accident or seizure
* Other: Not pregnant Fertile patients must use effective contraception during and for at least 30 days after treatment No history of chronic bacterial osteomyelitis No history of drug or alcohol abuse At least 6 months since prior use of illicit drug Have adequate IV access No crisis with life-threatening complications such as: Hepatic or splenic sequestration Acute chest syndrome Aplastic crisis No known infection or infection with encapsulated organism No evidence of septic shock Not concurrently hospitalized for other conditions Not concurrently on hypertransfusion program
Extended Physiotherapy After Intensive Care Unit (ICU) Stay

Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. The objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-ICU patients.The study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.

The study design is a before and after study. A control group was included for three months and received standard amount of physical therapy at surgical wards, corresponding to 1.75 employment. An intervention group was then included for six months and received extended amount of physical therapy corresponding to an extra 0.5 employment for study participants (2-4 patients/day). The primary outcome was physical function measured with the Chelsea Critical Care Physical Assessment Tool (CPAx), in the ICU and the surgical ward.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* ICU stay \>48 hours
* Understand the Swedish language

Exclusion Criteria:

• Patients palliative care with no intention of rehabilitation
Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy

This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen \[PSA\] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Pathological diagnosis of adenocarcinoma of the prostate
* First or later line of chemotherapy
* Serum testosterone \< 50ng/mL
* ECOG 0-2
* Serum PSA \> or = 5ng/mL
* PSA progression (2 rises above a reference value)
* Bone scan within 60 days of enrollment
* Computed tomography (CT) scan
* If measurable disease, bone scans every 6-8 months

Exclusion Criteria:

* Systemic radiation
* Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
* Brain metastases
Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy

Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.


Eligibility Criteria:
Inclusion Criteria:

* Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination
* Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination.

Exclusion Criteria:

* Patients who are unwilling or medically unable to lie down for 30 minutes.
* Pregnant women
Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.

To compare the changes in heart function, induced after sedation with midazolam or dexmedetomidine, using cardiac magnetic resonance imaging (MRI).

This study is a randomized unmasked study, in which participant will be allocated by the envelop method into the dexmedetomidine (DEX) group or into the midazolam (MID) group.

The study will test the hypothesis that the use of dexmedetomidine leads to less negative impact on ventricular function compared to midazolam.

The study will include patients who will meet the inclusion criteria. A previous, yet unpublished, pilot study assured that a number of 15 participants in each arm is sufficient to detect statistical significant results with a statistical power of ≥ 80%. After signing the informed consent, a one-session cardiac MRI will be performed in each fasting participant before and after sedation administration (see arms and intervention). The following parameters will be recorded: end diastolic and end systolic volume, left and right ventricle stroke volume and flow velocity through the mitral valve during early and late diastole. A monitor will record values of mean blood pressure, pulse and blood oxygen saturation in 5-minute intervals.

The acquired data will be transferred to an offline workstation for postprocessing and quantification. In participants we will calculate left ventricular volumes using the well-known Simpson's formula by segmenting of endocardial borders on end-diastolic and end-systolic frames on every slice through the left ventricle.

The quantitative flow measurement will be performed using phase contrast quantification flow mapping.

Statistical analyses will be performed using STATISTICA software (data analysis software system, version 13 TIBCO Software Inc). All values will be presented as average ± standard deviation. Analysis of variance for repeated measures with post hoc Fisher's LSD test will be used for statistical testing of significant differences in each group and between the groups before and after sedation, respectively. Significance level will be accepted at α\<0.05.

The participants will be monitored during sedation administration and 6 hours following sedation cessation to avoid complications that could be associated with sedation administration such as hypotension or rhythm disturbances.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were admitted due to chest pain, in whom acute coronary syndrome, pulmonary embolism and acute aortic syndrome were ruled out
* Age ≥18 and ≤ 65 years
* No contraindication to provide cardiac MRI
* No known allergy to Midazolam or Dexmedetomidine
* Signed informed consent
* No history of heart, hepatic, renal or respiratory failure

Exclusion Criteria:

* Atrial fibrilation
* Claustrophobia
* Heart Failure
* Renal Failure
* Hepatic disease
* Respiratory insufficiency
* Fertility and lactation
* Patients who cannot cooperate or refuse to sign the consent.