louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668342: Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Official title: Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head Injury, Minor
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms are common post-injury, and few MTBI patients receive treatment or follow-up for these symptoms. Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly common form of communication, potentially allowing for accurate assessment of symptom patterns after MTBI and provision of basic education support . The investigators seek to assess the feasibility of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based symptom reports correlate with phone-based follow-up reports at 14 days and whether additional SMS-based educational feedback alters daily symptom patterns.

Detailed description: The investigators seek to assess the feasibility of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based symptom reports correlate with phone-based follow-up reports at 14 days and whether additional SMS-based educational feedback alters daily symptom patterns at 3-months.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of minor traumatic brain injury
* English speaking
* Owns a cell phone with SMS

Exclusion Criteria:

* Critically ill

Primary outcomes:
measure: Rivermead Post Concussive Questionnaire
timeFrame: 14 days
Secondary outcomes:
measure: Rivermead Post Concussive Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-Mercy Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian Suffoletto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06296342: Message Framing and Policy Support for Front-of-package Labeling
Official title: Effects of Message Framing on Policy Support for Front-of-package Nutrition Labeling Among Latino and Limited English Proficiency Populations.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Healthy
Keywords: front-of-package labeling
policy support
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: Stanford University
First posted: 2024-03-06
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support.

Detailed description: Participants will complete a between-subjects online randomized experiment. Participants will be randomized to 1 of 4 arms: 1) No framing (control), 2) Information framing, 3) Healthier choices framing, and 4) Industry framing. In each arm, participants will view 1 message developed for their randomly assigned arm and indicate their policy support.

Eligibility criteria: Inclusion Criteria:

* Identifying as Latino or Hispanic
* Ages 18-55 years old
* Residing in the United States

Exclusion Criteria:

* Not identifying as Latino or Hispanic
* Less than 18 or greater than 55 years old
* Not residing in the United States

Primary outcomes:
measure: Support for the front-of-package labeling policy, proportion
timeFrame: During exposure to intervention (i.e., message about policy), assessed during one-time online 10-minute survey.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Marissa G Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02668042: The Activity of Tissue Engineering Skin Substitutes
Official title: Living Tissue Engineering Skin Substitutes Safety and Efficacy Studies for the Treatment of Difficult to Heal Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Difficult to Heal Wounds
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds

Detailed description: This study for 6 months for a single center, open, randomized, controlled clinical trials before and after itself, test contains preliminary screening, treatment and follow-up after discharge of the patient.After treatment in patients with early debridement, in the case of no infection of living tissue engineering skin substitute transplantation, observe the wound healing after transplantation, chronic wound evaluation activity of tissue engineering skin substitutes in the efficacy and safety of wound healing after transplantation.

Eligibility criteria: Inclusion Criteria:

1. Meet difficult had 1 month or more to heal the wound patients
2. Who signed the informed consent of men or women older than 17 (pregnancy)
3. Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
4. The process of mental stability, can finish the test

Exclusion Criteria:

1. Known allergic to bovine collagen or gao min physique
2. the wound is greater than the10cm×10cm
3. People with mental illness, drug abusers and or other items
4. Pregnant women,Prepare a pregnancy or breast feeding women
5. 3 months participated in other similar experiment
6. Serious infectious disease not controller
7. With surgery, such as severe trauma stress situation
8. Can not meet the requirement of the long-term follow-up of patients

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Relative Wound Area Regression of 40% or More at 6 Week
timeFrame: 6 week
Other outcomes:
measure: Reduced pain
timeFrame: 6 months after treatment
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: xiaobing Fu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02998242: Apatinib in Combination With Stereotactic Body Radiation Therapy (SBRT) Treatment for Symptomatic Metastatic Prostate Cancer
Official title: Apatinib in Combination With SBRT Treatment for Symptomatic Metastatic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Chang'An Hospital
name: Hainan Medical College
First posted: 2016-12-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study safety and efficacy of apatinib in combination of radiotherapy in patients with symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate
* Metastatic and symptomatic prostate cancer (positive bone scan or measurable disease)
* Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
* Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
* Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
* No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
* Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

Exclusion Criteria:

* History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
* Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
* Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
* Active infection requiring therapy.
* Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.

Primary outcomes:
measure: biochemical disease free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02440542: Popliteal Nerve Block for Postoperative Pain Control in Ankle and Hindfoot Reconstruction
Official title: Popliteal Nerve Block for Postoperative Pain Control in Patients Undergoing Ankle and Hindfoot Reconstruction About the Talus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain, Postoperative
Keywords: Nerve block
Ankle
Talus
Pain, Postoperative
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients undergoing ankle or hindfoot reconstruction about the talus (ankle arthrodesis, subtalar arthrodesis, or ankle arthroplasty) who will be receiving a sciatic nerve block in the popliteal region while in the PACU, following surgery. Patients will be identified as potential subjects from within the practices of two fellowship-trained foot and ankle orthopaedic surgeons. Patients will be enrolled in the study by Informed Consent

Brief summary: The purpose of this study is to evaluate outcomes of popliteal nerve blocks for postoperative pain control in patients undergoing ankle and hindfoot reconstruction surgeries. The following outcomes will be analyzed: length of hospital stay, level of pain control, pain medication use, complications, and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years old
* Patients undergoing ankle, subtalar, pantalar, triple, or tibiotalocalcaneal arthrodesis (CPT codes 27870, 28715, 28725, or 28740)
* Patients undergoing total ankle arthroplasty (CPT code 27702)
* Patients with a preoperative surgical plan to receive a popliteal nerve block during the postoperative period
* Patients whom can be reasonably expected to understand and comply with patient-reported postoperative data collection and surveys

Exclusion Criteria:

* Patients undergoing an ankle or hindfoot reconstruction procedure whom are medically ineligible to receive a safe popliteal nerve block (i.e. patients with neuropathy)
* Patients with documented substance abuse (i.e. history of narcotic abuse could confound pain outcomes)

Primary outcomes:
measure: Pain rating
timeFrame: Postoperative- through 12 weeks
Secondary outcomes:
measure: Narcotic intake
timeFrame: Postoperative- through 12 weeks
measure: Hospital length of stay
timeFrame: Postoperative- through day of hospital discharge (discharge same day of surgery to approximately 3 days postop)
measure: Patient satisfaction
timeFrame: Postoperative- through first surgical follow-up (up to 3 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: University of Tennessee College of Medicine Chattanooga/Erlanger Health System
name: Jesse F Doty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02214342: Virtual Reality Based Balance Training in People With Mild Cognitive Impairment
Official title: Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distorted; Balance
Motor Deficit
Cognitive Deficit
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Banner Health
First posted: 2014-08-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment.

The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Mild Cognitive Impairment
* willingness to provide informed consent

Exclusion Criteria:

* severe neurologic, cardiovascular, metabolic, or psychiatric disorders
* severe visual impairment
* severe cognitive impairment
* dementia

Primary outcomes:
measure: Postural Balance
timeFrame: 4 weeks
Secondary outcomes:
measure: Gait performance
timeFrame: 4 weeks
measure: Cognitive status
timeFrame: 4 weeks
measure: Fear of falling
timeFrame: 4 weeks
measure: User experience
timeFrame: 4 weeks
measure: Depressive signs
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
Study officials:
affiliation: University of Arizona
name: Bijan Najafi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364142: A Blind Maneuver to Position an Endobronchial Blocker
Official title: A Blind Maneuver to Position an Endobronchial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: One Lung Ventilation
Endobronchial Blocker
Thoracic Surgery
Fiberoptic Bronchoscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing thoracic surgery

Brief summary: One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy.

Detailed description: The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to locate the blocker without the aid of FOB in patients undergoing thoracic surgery.

After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase. And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the position of the blocker is recorded and we will evaluate the success rate of proper blocker position.

Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery who need one lung ventilation

Exclusion Criteria:

* patients who have a lesion in trachea or mainstem bronchi
* severe tracheal deviation
* patients who do not agree to informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Hyon Bahk, PhD, MD
role: STUDY_CHAIR
References:
citation: Hong DM, Seo JH, Chang Kim H, Nam K, Bahk JH. A novel maneuver to blindly position bronchial blockers. Minerva Anestesiol. 2013 Oct;79(10):1126-31. Epub 2013 May 29.
Clinical trial NCT06575842: Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
Official title: Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: Anesthesia
Continuous glucose monitors
Accuracy
Pediatrics
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will have a clinical diagnosis of type 1 diabetes and be wearing a continuous glucose monitor as part of routine care.

Brief summary: This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.

Detailed description: This study is an observational study design that includes collection of continuous glucose data and venous blood glucose data (from either an IV or fingerstick) from a blood glucose meter. All subjects will be undergoing a surgical procedure that requires anesthesia. The primary outcome of this study is to evaluate the accuracy of the CGM glucose values in comparison to the reference glucometer glucose value during anesthesia. There is currently limited data on accuracy of CGMs during these events and therefore it is not know whether CGM glucose data is reliable to be used as the sole source of glucose monitoring during surgery.

Eligibility criteria: Inclusion Criteria:

1. Participants will be 2 to 26 years of age at the time of enrollment.
2. Participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period.
3. Participant currently wearing a continuous glucose monitor (for example: Dexcom G6 or G7; Freestyle Libre 2, 2 Plus, or 3; Medtronic Guardian 3 or 4; or future sensors as they become available) for home diabetes management and willing to share personal CGM data with the BDC clinical CGM account.

Exclusion Criteria:

1. Pregnancy.
2. Currently using hydroxyurea.
3. A condition that the investigator determines would prevent the patient from participation.

Primary outcomes:
measure: Accuracy of CGM compared to blood glucose using standard statistical methods including mean absolute relative difference (MARD).
timeFrame: Perioperatively (length of time will vary based on the operative procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
References:
Clinical trial NCT01732042: Retinal Venous Pressure (RVP) in Normals
Official title: Retinal Venous Pressure (RVP) in Normals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: retinal venous pressure
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: Determinate the standard values of the retinal venous pressure in a cohort of healthy subjects.

Detailed description: The retinal venous pressure (RVP) is an increasingly important dimension in the clinical assessment of retinal blood flow.

In literature only very few and also divergent data on the retinal venous pressure in healthy volunteers are described. A normal value study will provide us with an up-to-date database.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* eye diseases
* systemic diseases
* term medication (except contraceptives)
* pregnancy
* allergies to the ingredients Alcaine, Tropicamide and Phenylephrine

Primary outcomes:
measure: Retinal venous pressure
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Dept. of Ophthalmology
Study officials:
affiliation: University of Basel, Dept. of Ophthalmology
name: Josef Flammer, MD
role: STUDY_DIRECTOR
References: