louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02665247: Impact of Sleep Workshops in College Students
Official title: Impact of Sleep Workshops in College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Insomnia
Sleep Deprivation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood, anxiety and well-being measures in a sample of college students. College students have a high prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and insomnia. Sleep disorders in college students negatively affect mood, social functioning, physical safety, and academic performance. Rarely recognized by the students themselves, these conditions are therefore often untreated. Participants in this study will be randomly assigned to receive the College Sleep Improvement Plan (C-SIP) or a control session. Participants will be asked to track their sleep as well as complete questionnaires; a subset of participants will be asked to wear an activity monitor.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled in classes at the NYU Washington Square campus

Exclusion Criteria:

* Students previously enrolled in the "While You Were Sleeping" course at NYU

Primary outcomes:
measure: Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline
timeFrame: 13 weeks
measure: Change in Epworth Sleepiness Scale (ESS) score from baseline
timeFrame: 13 weeks
measure: Change in Fatigue Severity Scale (FSS) score from baseline
timeFrame: 13 weeks
measure: Change in Health Behaviors Survey (HBS) score from baseline
timeFrame: 13 weeks
measure: Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline
timeFrame: 13 weeks
measure: Change in Perceived Stress Scale (PSS) score from baseline
timeFrame: 13 weeks
measure: Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
timeFrame: 13 weeks
measure: Change in Sleep Hygiene Index (SHI) score from baseline
timeFrame: 13 weeks
measure: Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline
timeFrame: 13 weeks
measure: Change in Sleep Student Behavior Survey (SSBS) score from baseline
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Jess Shatkin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05841147: Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban
Official title: Reduction of Microembolism After Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms by Administration of Tirofiban：A Randomized, Controlled, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intracranial Aneurysm
Keywords: Aneurysm
Tirofiban
Stent-Assisted Coil Embolization
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group: An intravenous bolus (6µg/kg) over a 3 min period and a maintenance dose of 0.1µg/kg/min for 18 hour were used in this group.

The control group: The same dose of normal saline was used instead of tirofiban.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to investigate whether intravenous injection of tilofiban can reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.The main questions it aims to answer are:

* Is it safe to inject tirofiban intravenously during interventional treatment of intracranial aneurysms？
* What dose of tirofiban is safe and effective?

Detailed description: We aim to reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.

Eligibility criteria: Inclusion Criteria:

* Age was between 18 and 75 years old;
* Unruptured aneurysm with surgical indications;
* Stent assisted coil embolization treatment was received ;
* The patient was willing to receive intervention treatment.

Exclusion Criteria:

* Complicated with hemorrhagic cerebrovascular diseases such as cerebral vascular malformations and moyamoya disease or their medical history;
* Recent (within 1 year) bleeding symptoms such as gastrointestinal bleeding, clinically significant urinary/reproductive tract bleeding, and skin blueness;
* Dissecting aneurysm, pseudoaneurysm, and bullous aneurysm;
* A known history of coagulation disorders, platelet abnormalities, or thrombocytopenia; 5. Platelet count less than 150 × 109/L；
* A history of major surgical procedures or severe physical trauma within one month;
* Severe uncontrolled hypertension (systolic blood pressure\>160mmHg and/or diastolic blood pressure\>100mmHg);
* Hemorrhagic retinopathy;
* Chronic hemodialysis;
* Renal insufficiency.

Primary outcomes:
measure: Microembolism
timeFrame: Within 72 hours after surgery
Secondary outcomes:
measure: The incidence of microembolism
timeFrame: Within 48 hours after surgery
Other outcomes:
measure: Hemorrhage
timeFrame: Within 48 hours after surgery
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
Study officials:
References:
Clinical trial NCT03911947: Evaluation of the Effectiveness of Vibroacoustic Therapy in the Complex Treatment of Acute Respiratory Failure
Official title: Assessing the Ventilatory Parameters in Patients With Acute Respiratory Failure After Vibroacoustic Pulmonary Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: Vibroacoustic therapy, acute respiratory failure, pneumonia
Lead sponsor: Astana Medical University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monitoring of treatment of patients with respiratory failure, the list of therapeutic measures which includes vibroacoustic therapy
Primary purpose: TREATMENT

Brief summary: Evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure

Detailed description: Assessing the dynamics of changes in physical, instrumental and laboratory parameters in patients with acute respiratory failure taken in the study according to the inclusion criteria and comparing the results with the control group, studying the effectiveness of vibroacoustic lung therapy.

Eligibility criteria: Inclusion Criteria:

* adults
* P/F less 300 torr
* ARDS by Berlin convention

Exclusion Criteria:

* children
* acute stroke
* acute coronary syndrome
* DVT
* implanted pacemaker
* rib fracture
* infection on chest

Primary outcomes:
measure: Change of time spent on ventilation
timeFrame: 1-2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: City clinical hospital №7
city: Astana
country: Kazakhstan
facility: City clinical hospital №1
city: Astana
country: Kazakhstan
facility: National Cardiac Surgery Center
city: Astana
country: Kazakhstan
facility: Scientific Research Institute of Traumatology and Orthopedics
city: Shymkent
country: Kazakhstan
facility: Regional cardiology center
Study officials:
References:
Clinical trial NCT03142347: Remote Endarterectomy vs Remote Endarterectomy + Drug Coated Balloon (DCB) Angioplasty in Patients With the Femoral Artery Occlusive Disease
Official title: Remote Endarterectomy vs Remote Endarterectomy Supplement DCB Balloon Angioplasty in Patients With the Femoral Artery Occlusive Disease (TASCII D)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Artery Occlusion
Keywords: remote endarterectomy
DCB balloon
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2017-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison effectiveness two methods revascularization of the superficial femoral artery: remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with steno-occlusive lesion of the femoro-popliteal segment of TASCII D

Detailed description: Given that more and more devices appear to deliver cytotoxic drugs into the depth of atherosclerotic plaque, it is interesting to study the effect of these drugs when applied directly after plaque removal.

Eligibility criteria: Inclusion Criteria:

* Patients with occlusive lesions of C and D type femoral artery and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford)
* Patients who consented to participate in this study.

Exclusion Criteria:

* Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
* Decompensated chronic "pulmonary" heart
* Severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 mL / min);
* Polyvalent drug allergy
* Cancer in the terminal stage with a life expectancy less than 6 months;
* Acute ischemic
* Expressed aortic calcification tolerant to remote endarterectomy
* Patient refusal to participate or continue to participate in the study

Primary outcomes:
measure: the change of lumen in target vessel
timeFrame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Secondary outcomes:
measure: Vessel wall thickness
timeFrame: 3 days after the operation, 6 month, 12 month, 2 years
measure: Number of participants with limb salvage
timeFrame: 3 days after the operation, 6 month, 12 month, 2 years
measure: Number of participants with complications in long-term period after the operation.
timeFrame: 3 days after the operation, 6 month, 12 month, 2 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Study officials:
affiliation: cientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
name: Andrey Karpenko
role: STUDY_DIRECTOR
References:
Clinical trial NCT00762047: A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Official title: Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence
Lead sponsor: Carbon Medical Technologies
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions.

The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.


Eligibility criteria: Inclusion Criteria:

* History of fecal incontinence;
* Incontinence episodes over a 14-day period;
* Eighteen years of age or older;

Exclusion Criteria:

* Abnormalities of the external sphincter greater than 10 mm;
* Fibrosis of the tissue at the likely injection sites;
* Has a condition that could lead to significant postoperative complications
* Rectal varices;
* Cancer of the rectum or colon, undergoing active treatment;
* Crohn's disease or ulcerative colitis;
* Chronic diarrhea unmanageable by drugs and/or diet;
* Rectal bleeding;
* Pregnant or within one year postpartum.

Primary outcomes:
measure: The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
timeFrame: 6 month
measure: Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
timeFrame: Throughout study
measure: The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02667847: Preoperative Anxiety Evaluation: a New Visual Smileys Scale
Official title: Preoperative Anxiety Evaluation: a New Visual Smileys Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety, Preoperative
Keywords: preoperative anxiety assessment
levels of preoperative anxiety using two different scales
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 patients undergoing surgery at Cedars Sinai Medical Center

Brief summary: Preoperative anxiety is a complex clinical concept with both physiological and psychological consequences.

Detailed description: This study looks at the need for a more user friendly, rapid tool for measuring preoperative anxiety, specifically by evaluating the visual smileys scale.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old
* undergoing surgery at Cedars Sinai Medical Center

Exclusion Criteria:

* did not receive sedative or narcotic prior to the interview

Primary outcomes:
measure: Anxiety level, as measured by verbal rating scale or visual smileys scale
timeFrame: up to 5 minutes
Secondary outcomes:
measure: scale preference
timeFrame: up to 5 minutes
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
Clinical trial NCT02158247: Determining the Depth of Endotracheal Tube Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Intubation
Individualized Depth of Endotracheal Intubation
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are taking operation in the university hospital

Brief summary: 1. Airway length from the medial incisor to carina is divided into four segments ; the length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to vocal cords and vocal cords to carina.
2. Determining the mean length of each segments with the direct laryngoscope, videolaryngoscope and fiberoptic bronchoscope at the time of endotracheal intubation.
3. Making a new formula to determine the proper individualized depth of intubation on the basis of the length of segments
4. Virtual experiment : comparing the new formula with conventional method of determining the depth of endotracheal intubation


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to take general anesthesia with endotracheal intubation

Exclusion Criteria:

* Patients undergoing general anesthesia with face mask ventilation or laryngeal mask airway

Primary outcomes:
measure: Comparison of Airway Length Between Male and Female
timeFrame: Endotracheal intubation time
measure: Airway Length vs Height in Male
timeFrame: Endotracheal intubation time
measure: Airway Length vs Height in Female
timeFrame: Endotracheal intubation time
Secondary outcomes:
measure: Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male
timeFrame: Endotracheal intubation time
measure: Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male
timeFrame: Endotracheal intubation time
measure: Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female
timeFrame: Endotracheal intubation time
measure: Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female
timeFrame: Endotracheal intubation time
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Department of Anesthesia and Pain Medicine, Daejeon St Mary's hospital
Study officials:
References:
Clinical trial NCT04571047: Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment
Official title: Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients registered with a diagnosis of colorectal cancer in Sweden between 2008-2016

Brief summary: We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with colorectal cancer 2008-2016 in Sweden

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Length of stay
timeFrame: 90 days
measure: Re-operations within 3 months
timeFrame: 90 days
measure: Re-admissions within 3 months
timeFrame: 90 days
measure: Radical surgery
timeFrame: 90 days
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Universitetssjukhuset
name: Eva Angenete
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02868047: Establishing Standards for Normal Pancreatic EUS
Official title: Establishing Standards for Normal Pancreatic EUS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Keywords: chronic pancreatitis
endoscopic ultrasound
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients who are scheduled for an elective EUS for evaluation of their pancreas. Patients will be those with and without suspected chronic pancreatitis.

Brief summary: There is tremendous variability in regard to provider perception of findings on EUS for chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to determine the validity of minimal standard criteria.

Detailed description: Chronic pancreatitis is a very challenging disease to diagnose as their is no gold standard for diagnosis. Increasingly, endoscopic ultrasound (EUS) has been used as a means of diagnosing chronic pancreatitis. However, there are questions about whether intra-rater reliability and/or validity are high enough to warrant using EUS to make the diagnosis of chronic pancreatitis.

The purpose of this observational study is to determine the degree of correlation between two expert endosonographers in evaluating minimal standard criteria (MST) in the same patient during the same EUS exam. Patients both with and without chronic pancreatitis will be included in the study to try and determine the validity and reliability of back-to-back EUS examinations.

Eligibility criteria: Inclusion Criteria:

* Undergoing upper EUS for evaluation of the pancreas

Exclusion Criteria:

* pregnancy
* age less than 18
* inability to provide written informed consent

Primary outcomes:
measure: Number of Patients with Hyperechoic Strands
timeFrame: Day 1
measure: Number of Patients with Hyperechoic Foci
timeFrame: Day 1
measure: Number of Patients with Lobular Contour
timeFrame: Day 1
measure: Number of Patients with Cysts
timeFrame: Day 1
measure: Number of Patients with Duct Irregularity
timeFrame: Day 1
measure: Number of Patients with Ductal Calculi
timeFrame: Day 1
measure: Number of Patients with Hyperechoic Duct Wall
timeFrame: Day 1
measure: Number of Patients with Dilated Dilated Side Branches
timeFrame: Day 1
measure: Number of Patients with Dilated Pancreatic Duct
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: