louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05431855: Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV
Official title: Self-management of HIV and Alcohol Reaching Emerging Adults: Project Engage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: University of Florida
name: University of Michigan
First posted: 2022-06-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, participants will be asked to wear a wrist alcohol biosensor for 30 days and report alcohol use using a ecological momentary assessment (EMA) app. A subset of the sample will be micro-randomized to test two engagement strategies--reciprocity and personalized feedback via the eWrapper app to promote their engagement with the biosensor.

Detailed description: YPLWH (N = 160, 136 after 15% attrition, 18-29 years of age, estimated to include 73% male, 26% female, 1% transgender, 70% racial and ethnic minorities) will be asked to wear a wrist alcohol biosensor (BACtrack Skyn) for 30 days and report their alcohol use using daily ecological momentary assessment (EMA). A subset of the sample will also be micro-randomized twice daily to test two empirically-based engagement strategies - reciprocity and personalized feedback. Data from the 30-day MRT will be used to (a) develop and validate the algorithm for alcohol detection based on Skyn data; and (b) address scientific questions concerning which engagement strategy works best, for whom and under what conditions in terms of facilitating proximal engagement in biosensor wearing. We will also collect alcohol biomarker (i.e., PEth) at 1-month follow up.

Eligibility criteria: Inclusion Criteria:

* 18 years and 0 months to 29 years and 11 months
* Currently reside in Florida
* Report having had at least 1 alcoholic drink in the last 30 days
* Able to read and understand English
* Have internet access via smartphone, tablet or computer
* Be diagnosed as HIV positive and;
* Willing to provide informed consent.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults
* Individuals who are not diagnosed as HIV+
* Prisoners
* Pregnant women

Primary outcomes:
measure: Engagement in biosensor wearing
timeFrame: Within 12 hours after prompted engagement strategy
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: The University of Florida
state: Florida
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT03821155: Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?
Official title: Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Neuritis
Keywords: Vestibular Neuritis
SHIMP (suppressing head impulse paradigm)
SVV (subjective visual vertical)
Vestibular rehabilitation
Prednisolone
v-HIT (video head impulse test)
Vestibular Neuronitis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to two different treatments:

1. corticosteroid treatment ("prednisolone")
2. combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation
Primary purpose: TREATMENT

Brief summary: To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.

Detailed description: Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years of age
2. Medical history compatible with vestibular neuritis
3. Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.

Exclusion Criteria:

1. Former medical history with vestibular dysfunction
2. Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
3. Onset of symptoms 14 days before recruitment to the study
4. Focal neurological symptoms/signs
5. Contraindication to prednisolone treatment
6. Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.

Primary outcomes:
measure: Suppressing head impulse paradigm (SHIMP)
timeFrame: 6 month
measure: Subjective visual vertical (SVV)
timeFrame: 6 month
measure: Video head impulse test (v-HIT)
timeFrame: 6 month
measure: Dizziness handicap inventory (DHI) questionnaire
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology, Head & Neck Surgery and Audiology
state: North Denmark Region
Study officials:
affiliation: Aalborg University Hospital
name: Dan D Hougaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Martin H Wolder, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01785355: The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients
Official title: Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Disease
Chronic Kidney Disease
Keywords: periodontal disease
CKD
nutrition
inflammation
anemia response to ESA
quality of life
hemodialysis
Lead sponsor: Anemia Working Group Romania
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Haemodialyzed patients with Periodontal Disease

Brief summary: Several studies revealed a direct relationship between the severity of periodontal inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other source of inflammation but PDD, proper dental treatment of the disease decreased CRP to normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007) Moreover, a direct link between high levels of CRP and atherosclerotic complications has been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann J, et al. 1998).

Detailed description: Patients will be recruited according to eligibility criteria. Initial oral and general status will be evaluated and recorded. The evaluated parameters are listed at the study description section. Also, quality of life will be assessed by using the SF-36 and OHIP-14 questionnaires.

Patients will undergo a series of dental interventions with the final scope of eliminating all oral inflammation. Participants will also be instructed regarding correct oral hygiene habits.

Following dental and periodontal treatments, the oral and general status will be reassessed and the obtained dat analysed.

Eligibility criteria: Inclusion Criteria:

* Hemodialyzed patients with periodontal disease

Exclusion Criteria:

* Malignancies, Diabetes
* Patient refusal to participate

Primary outcomes:
measure: Modification of nutritional status
timeFrame: 6 months
Secondary outcomes:
measure: Modification of inflammatory status
timeFrame: 6 months
Other outcomes:
measure: Modification of periodontal disease index
timeFrame: 3 months
measure: Modification of the quality of life, as assessed by SF-36 and OHIP-14
timeFrame: 6 months
measure: Modification of anaemia response to epoetin
timeFrame: 6 months
Locations:
city: Bucharest
country: Romania
facility: CMI "Dr Slusanschi Oana"
Study officials:
affiliation: University of Medicine and Pharmacy Bucharest
name: Oana Slusanschi, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01204255: Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers
Official title: Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy, no evidence of disease
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society, Inc.
First posted: 2010-09-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.

Detailed description: OBJECTIVES:I. To study the absorption of the three components in the topical ABH gel in 10 healthy volunteers, and determine if there are any adverse effects. OUTLINE: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. After completion of study treatment, patients are followed up for 5 hours.

Eligibility criteria: Inclusion Criteria:

* Completed a medical screening questionnaire
* English speaking
* No allergies to the drugs
* Able to complete the forms
* If a woman of childbearing age, agree to use contraception

Exclusion Criteria:

* History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age)
* Use of any medication that would contraindicate benzodiazepine administration
* Pregnant or nursing

Primary outcomes:
measure: Lorazepam, Diphenyhydramine, Haloperidol Absorption
timeFrame: 4 hours
Secondary outcomes:
measure: Side Effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Thomas Smith
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03973255: Whole Body Vibration In Vestibular Rehabilitation
Official title: Efficacy Of Biofeedback Training And Whole Body Vibration Therapy In Vestibular Rehabilitation Of Unilateral Vestibular Weakness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disease
Keywords: Vestibular rehabilitation
Vestibular weakness
Whole Body Vibration
Biofeedback
Posturography
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the efficacy of home based vestibular rehabilitation program, posturographic biofeedback training and whole body vibration therapy on balance, fall risk, functional mobility, vertigo symptom severity and functions in patients with unilateral vestibular weakness.

Detailed description: A total of 90 patients who were diagnosed as unilateral vestibular weakness were included in this prospective randomized controlled study. They were randomized into three groups each consisting of 30 patients. Home based vestibular rehabilitation program was given to all groups. Fall risk yielded by posturography, Berg balance scale, Timed Up-and-Go test, vertigo visual analogue scale and Dizziness Handicap Inventory were used for comparison.

Eligibility criteria: Inclusion Criteria:

Adult patients who had unilateral vestibular weakness and persistent dizziness at least two months after acute period were included Bithermal caloric test showing hyporesponsiveness higher than 30% or unresponsiveness of the horizontal canal of the affected ear accepted as unilateral vestibular weakness.

Exclusion Criteria:

Bilateral vestibular weakness, Recurrent vestibulopathy, Benign paroxysmal positional vertigo, Concomitant neurological or psychiatric disease, Severe visual or auditory impairments and orthopedic problems in the lower extremities

Primary outcomes:
measure: fall risk
timeFrame: 30 days
measure: Berg balance scale
timeFrame: 30 days
measure: Timed Up-and-Go
timeFrame: 30 days
measure: vertigo visual analogue scale
timeFrame: 30 days
measure: Dizziness Handicap Inventory
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444755: The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
Official title: Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Locally advanced gastric cancer
neoadjuvant chemotherapy
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen in patient with resectable locally advanced gastric cancer in comparison with surgery alone.

Detailed description: Adenocarcinoma of the stomach ranks as the fourth most commonly diagnosed cancer and as the second leading cause of cancer-related death in the world. Radical resection with free-margin gastrectomy and extended lymphadenectomy is the preferred surgical strategy in Japan and Asian centers.

Unfortunately, only one-half of surgically treated patients with gastric cancer will achieve a complete resection without residual disease (R0) resection. Moreover, due to, the absence of routine screening programs for gastric cancer, the majority of the patients will be symptomatic at the time of diagnosis in our country.

Additionally, recent treatment strategies were focused for downsizing or decreasing to loco-regional recurrence.

In this reason, we hypothesize that preoperative chemotherapy may improve the R0 resection rate or disease free and/or overall survival rate.

Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of stomach
* T3 or T4
* N1 or N2
* M0
* No evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal dissemination or Krukenberg tumor.
* No involvement of the esophagus with \> 2cm
* An age of 18-90 years
* A Karnofsky Performance status with 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
* No previous chemotherapy, radiotherapy for any malignancy.
* No previous surgery for gastric cancer
* No evidence obstructive or bleeding symptoms.
* Adequate renal and hepatic function
* Written informed consent

Exclusion Criteria:

* Synchronous or metachronous malignancy diagnosing within 5 year
* Pregnancy or lactation in female patients
* Any immunosuppressive condition (acquired or iatrogenic)
* Any infectious toxic or mental condition preventing neoadjuvant therapy

Primary outcomes:
measure: Survival
timeFrame: After 2 years from therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
Study officials:
affiliation: Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey
name: Atilla Celik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04585555: Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)
Official title: Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Abdominal Compartment Syndrome
Intraabdominal Hypertension
Cardiovascular Surgery
Lead sponsor: Potrero Medical
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay.

Brief summary: The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

Detailed description: The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiovascular surgery intervention(s).

The secondary objective is to determine the incidence of IAH and ACS in the cardiovascular surgery population and the correlation of these diagnoses to the diagnosis of AKI.

Eligibility criteria: Inclusion Criteria:

1. Adult (age ≥ 18).
2. Monitored on the Accuryn® Monitoring System during hospital stay.
3. Patient is undergoing cardiovascular surgical intervention(s).

Exclusion Criteria:

1. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as prisoners or those detained in a penal institution.

Primary outcomes:
measure: Urine Output (UO)
timeFrame: 30 days
measure: Intra-Abdominal Pressure (IAP)
timeFrame: 30 days
measure: Temperature (T)
timeFrame: 30 days
measure: Intraabdominal Hypertension (IAH)
timeFrame: 30 days
measure: Abdominal Compartment Syndrome (ACS)
timeFrame: 30 days
measure: Acute Kidney Injury (AKI)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Amit Prabhakar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05717855: Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
Official title: Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 2D Ultrasound
Cavum Septum Pellucidum
Septooptic Dysplasia
Optic Chiasma
Willis Polygon
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-08
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of prenatal optic chiasm (OC) is important for the differential diagnosis of septo-optic dysplasia (SOD), which is a congenital optic disc anomaly, and the absence of the cavum septum pellucidum (CSP). Septo-optic dysplasia is associated with a wide range of neurological abnormalities, including hypoplasia of the visual pathways, CSP agenesis, and developmental delay.

Detailed description: Up to now, optic chiasm measurement were all done in the third trimester. in the present study, OC will be measure directly in a 2D ultrasound in coronal plane within the second trimester. In fetuses with SP agenesis, the morphology and width of the OC visual pathway may be a suitable tool to assess its development. It can also assist in the difficult task of providing prenatal counseling when faced with a diagnosis of CP agenesis. therefore In the present study, it was planned to show the optic chiasm in the screening of septooptic dysplasia by ultrasound between 16-20 weeks of gestation, and to measure the optic chiasma width and length, and to determine the mean values in the second trimester.

Eligibility criteria: Inclusion Criteria:

* aged greater than 18 years old
* having singleton pregnancy

Exclusion Criteria:

* being under the age of 18
* having IVF pregnancy
* having multiple pregnancy
* comorbidity during pregnancy
* smoking history
* presence of familial genetic disease

Primary outcomes:
measure: Calculation of average width of OC according to gestational week in millimeter
timeFrame: 2 months
measure: Calculation of average height of OC according to gestational week in millimeter
timeFrame: 2 months
measure: Calculation of average area of OC according to gestational week millimeter square
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
References:
Clinical trial NCT02279355: Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pressure Ulcer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 126
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total about 130 adult surgical patients underwent surgical procedures and admitted in intensive care unit (ICU) using electronic documentation applications from Jan 2012 through Dec 2013.

Brief summary: The aim of this retrospective study is to overall evaluate and validate preoperative and intra-operative risk factors for postoperative pressure ulcers in critically ill postoperative patients.


Eligibility criteria: Inclusion Criteria:

* Patients in ICU with a greater than 48 hours
* Underwent a surgical procedures,
* Absence of pressure ulcer present at admission to the ICU and developed a stage II or higher pressure ulcer, deep tissue injury, or unstageable ulcer, as defined by the pressure ulcer staging guidelines of the National Pressure Ulcer Advisory Panel.

Exclusion Criteria:

* Patients will be excluded from the study if they had been diagnosed with pressure ulcer before the surgery
* Pediatric patients

Primary outcomes:
measure: independent preoperative risk factors
timeFrame: up to1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute Yonsei University College of Medicine
name: Sung Won Na, MD
role: PRINCIPAL_INVESTIGATOR
References: