louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04820634: Using Virtual Reality to Improve Job Reentry in Adults With TBI
Official title: Using Virtual Reality to Improve Job Reentry in Adults With TBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 60
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 purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI.

Detailed description: The current study will examine a virtual reality (VR) intervention entitled "Virtual Reality Job Interview Training (VR-JIT)" which targets social competency skills needed for successful job interviewing, and its efficacy when applied to individuals with traumatic brain injury (TBI). Preliminary evidence suggests that the VR-JIT is successful in individuals with autism spectrum disorder and schizophrenia in improving interview abilities. However, the efficacy of VR-JIT has not been evaluated in TBI populations.

Eligibility criteria: Inclusion Criteria:

* I am between the ages of 18 and 65.
* I have a diagnosis with moderate to severe TBI.
* I am at least one year post injury.
* I am able to speak and read English fluently.

Exclusion Criteria:

* I have a history of multiple sclerosis, stroke, seizures or another neurological injury or disease in the past (like brain tumor or epilepsy).
* I have a history of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
* I am currently taking steroids and/or benzodiazepines as determined by study staff review of my medications.

Primary outcomes:
measure: Change in Mock Job Interview Score at 1 month
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Lab Director
name: John DeLuca, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06753734: Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics
Official title: A Cohort Study in Women at High Risk for Gestational Diabetes Based on Breath Metabolomics
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gestational Diabetes
Lead sponsor: Tianjin Central Hospital of Gynecology Obstetrics
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population in this study include pregnant women aged 18-55 years and at 11-14 weeks gestation with at least one risk factor for GDM

Brief summary: This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model.


Eligibility criteria: Eligibility Criteria

* 18-55 years old
* 11-14 weeks of pregnancy
* at least one risk factor for GDM
* signed a written informed consent

Exclusion Criteria:

* Diabetes mellitus or abnormal glucose metabolism before pregnancy
* Hyperemesis gravidarum (urine ketone positive))
* Thyroid dysfunction
* Asthmatic patients
* Hypertensive diseases that are difficult to control
* Severe hepatic and renal insufficiency or severe electrolyte disturbance
* Malignant tumor
* Acute inflammation
* lung disease
* Patients with gastritis, duodenum and other digestive system diseases
* Those with upper respiratory or oral problems who cannot cooperate with expiratory collection
* smoker

Primary outcomes:
measure: Incidence of gestational diabetes mellitus
timeFrame: 24-28 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
Study officials:
References:
Clinical trial NCT05923034: Pulmonary Infection After Ischemic Stroke
Official title: Pulmonary Infection and Clinical Pneumonia After Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Had a Computed Tomography Scan of the Chest Within 24 Hours After Stroke Onset
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: had a computed tomography scan of the chest within 24 hours after stroke onset

Brief summary: To assess the frequency of signs of pulmonary infection on a chest CT and development of clinical diagnose of poststroke pneumonia，and its effect on functional outcome in patients with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

Have a computed tomography scan of the chest within 24 hours after stroke onset

Exclusion Criteria:

-

Primary outcomes:
measure: With radiological signs of pulmonary infection
timeFrame: 24 hours
Secondary outcomes:
measure: development of clinical poststroke pneumonia
timeFrame: 2 weeks or at discharge
measure: modified Rankin Scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: An Hui
city: Baoding
country: China
facility: People Hospital of Rongcheng
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Xingtai
country: China
facility: People Hospital of Ningjin
state: Hebei
city: Shihezi
country: China
facility: Shihezi Municipal Hospital
state: Xinjiang
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT01423734: The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases
Official title: Pilot Study To Assess The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro-enteropancreatic Neuroendocrine Tumor
Secondary Malignant Neoplasm of Liver
Keywords: ADRENAL GLAND
MRI
11-122
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 20
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: Potential research patients will be identified by doctors from the Gastrointestinal Oncology Service.

Brief summary: Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used to see how tumors respond to treatment. If tumors shrink after therapy, doctors continue with the same treatment. On the other hand, growing tumors in a patient can bring about a change in therapy. Unfortunately, it often takes three to six months, or even longer before the investigators see tumors shrink or grow on scans. Doctors are looking for new imaging tools that can look at how tumors respond early on during treatment. This study will help us decide if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a helpful imaging tool.


Eligibility criteria: Inclusion Criteria:

* Histopathologic evidence of well differentiated neuroendocrine tumor of gastroenteropancreatic origin
* Evidence of metastatic disease of at least 2.0 cm in the liver by MRI or CT imaging.
* Patient ≥18 years of age on the day of signing informed consent.

Exclusion Criteria:

* Any contraindication to MRI based on departmental MR questionnaire
* Inability to cooperate for an MR exam
* Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy or one that would not interfere with the MRI results is allowed.
* Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.

Primary outcomes:
measure: reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.
timeFrame: 2 years
Secondary outcomes:
measure: evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases
timeFrame: 2 years
measure: evaluate the reproducibility perfusion insensitive diffusion coefficients (ADC high) of liver metastases
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Richard Kinh Gian Do, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02689934: Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia
Official title: Efficacy of Red Yeast Rice Based Nutraceutical (Monacolin K 10 mg/Dose) Plus Probiotic (Bifidobacterium Longum BB536 ®) in Patients With Moderate Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia
bifidobacterium longum BB536
red yeast rice
monacolin K
lactoflorene colesterolo
Lead sponsor: Montefarmaco OTC SpA
Sponsor class: INDUSTRY
First posted: 2016-02-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* 18 ≤ men or women ≤ 70
* men or female. Female must be postmenopausal or surgically sterile
* 130 mg/dl ≤ LDL-C ≤ 200 mg/dl
* patients in primary cardiovascular prevention

Exclusion Criteria:

* pregnancy and lactating
* patients with chronic diseases
* patients with serious hepatic diseases
* patients with serious renal diseases
* patients with thyroid diseases
* diabetes mellitus or glycemia \>126 mg/dl
* uncontrolled or severe hypertension
* obesity(BMI\>30)
* smoking status
* drug or nutraceutical that can interfere with the experimental treatment

Primary outcomes:
measure: Percent Change in LDL-C From Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)
timeFrame: 12 weeks
measure: Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins
timeFrame: 12 weeks
measure: Changes in Vital Signs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda
state: Mi
Study officials:
affiliation: ASST Grande Ospedale Metropolitano Niguarda Cà Granda
name: Giuliana G Mombelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruscica M, Pavanello C, Gandini S, Macchi C, Botta M, Dall'Orto D, Del Puppo M, Bertolotti M, Bosisio R, Mombelli G, Sirtori CR, Calabresi L, Magni P. Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study. Nutr J. 2019 Feb 22;18(1):13. doi: 10.1186/s12937-019-0438-2.
Clinical trial NCT05930834: Exercise Training and Insulin Sensitivity
Official title: Exercise Training and Adipose Tissue Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Exercise
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Regular exercise participation is known to reduce cardiometabolic disease risk but the impact that exercise training has on adipose tissue (AT) metabolism is poorly understood, particularly in humans. It is well established that exercise training improves whole-body glucose levels and increases insulin sensitivity, and this can occur within one or two weeks. These effects are usually due to adaptations in skeletal muscle, the tissue responsible for the majority of glucose disposal. However, many studies have now determined that exercise training also results in adaptations in AT that improve whole-body metabolic health by improving glucose uptake into the AT.

Skeletal muscle is thought to account for approximately 75-85% of glucose uptake , and this process is impaired in .individuals who are insulin-resistant state. It is postulated that the increased level of adiposity that accompanies severe obesity would result in higher dependency on AT for glucose uptake as the AT would be a bigger "sink". Thus the role of AT in inducing whole body insulin resistance is still unclear, particularly in individuals with obesity.

This study will examine the changes in AT glucose uptake before and after 4 weeks of exercise training in obese individuals and establish if there are sex differences.


Eligibility criteria: Inclusion Criteria:

* non-smokers, weight stable (\<4 kg) within the last 6 months will be recruited for this study.
* sedentary (not engaged in planned physical activities and performing less than a total of 2 h of physical activity per week during the last 6 months) men and women whose BMI is classified as obese (\>30 kg/m2).

Exclusion Criteria:

* cardiovascular disease, uncontrolled hypertension (no beta blockers), smokers, pregnant, have any recent changes in hormonal birth control, or on any medications known to impact metabolism.
* All participants will be regular sleepers with a duration of 7-9 hours/night.
* Subjects with orthopedic limitations will not be included.

Primary outcomes:
measure: GLUT4 protein expression
timeFrame: 4 weeks
measure: TB1CD4 protein expression
timeFrame: 4 weeks
Secondary outcomes:
measure: percent body fat
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Misouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jill Kanaley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837134: Telemedical Coaching for Weight Loss
Official title: TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Metabolic Syndrome
Keywords: telemedicine
overweight
obesity
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial is to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.

Detailed description: In an occupational health care setting employees with overweight and/or metabolic syndrome will be randomized into a three arm 12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic transfer into a personalized online portal, which could be monitored from both, the participant and the study centre. The TMC group weekly will get care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group will remain in routine care.

Eligibility criteria: Inclusion Criteria:

* employed at Boehringer Ingelheim Pharma GmbH for at least 2 years
* older than 40 years
* overweight or obese or metabolic syndrome

Exclusion Criteria:

* not willing to participate

Primary outcomes:
measure: weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: cardiometabolic risk factors
timeFrame: 12 weeks
measure: quality of life
timeFrame: 12 weeks
measure: physical activity
timeFrame: 12 weeks
Other outcomes:
measure: eating behaviour
timeFrame: 12 weeks
Locations:
city: Düsseldorf
country: Germany
facility: West-German Centre of Diabetes and Health
Study officials:
affiliation: West-German Centre of Diabetes and Health
name: Stephan Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kempf K, Rohling M, Martin S, Schneider M. Telemedical coaching for weight loss in overweight employees: a three-armed randomised controlled trial. BMJ Open. 2019 Apr 11;9(4):e022242. doi: 10.1136/bmjopen-2018-022242.
Clinical trial NCT04247334: Inhibitory Control: Effects of Modulation
Official title: Brain Circuitry of Inhibitory Control: Effects of Modulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Young Adults
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Inhibitory control is relevant to many clinical disorders, including substance abuse/dependence, obsessive-compulsive disorder, and attention-deficit hyperactivity disorder. This proposal is designed to assess brain networks related to response inhibition in healthy young adults, and use neuromodulation to change these networks and behavioral performance on a response inhibition task. Having an understanding of the brain mechanisms involved in response inhibition may enable us to improve pre-existing treatments for disorders with inhibitory control difficulties.


Eligibility criteria: Inclusion Criteria:

1. Low (\<1sd below the mean on the BRIEF-Inhibit) or high (\>1sd above the mean on BRIEF-Inhibit scale)
2. English fluency to ensure comprehension of study measures and instructions.

Exclusion Criteria:

1. Presence of medical conditions contraindicated for tDCS, including history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or women of childbearing age not using effective contraception, or any other serious medical conditions or health problems that would interfere with participation (e.g., skin condition)
2. Inability to undergo MRI
3. Current substance abuse disorder
4. Currently prescribed psychiatric medications.
5. Active mania or psychosis

Primary outcomes:
measure: fMRI connectivity at rest
timeFrame: 2 weeks
measure: fMRI connectivity during a stop signal task
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT05456334: New Treatments for Actinic Keratoses of the Scalp
Official title: New Treatments for Actinic Keratoses of the Scalp
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Photodamaged Skin
Actinic Keratoses
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: half-side comparative randomized controlled study
Primary purpose: TREATMENT

Brief summary: This blinded controlled 2-year study on 120 patients with 2 or more actinic keratoses, compare the efficacy and tolerability of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy compared to daylight photodynamic therapy.

Detailed description: Actinic keratoses are premalign skin lesions with increasing prevalence, causing a rising burden on the health care system. In this blinded controlled study we assess the efficacy of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy to daylight photodynamic therapy. It is a prospective, randomized and blinded split-head comparative study during the years 2016- 2024. 120 patients are recruited based on referral or from patients attending the clinic, with 2 or more actinic keratoses on the head, 60 to the pulsed dye-laser study and 60 to the fractional laser study. Follow-up appointments are 6 months, 1 year and 2 years post treatment. Patient reported maximal pain during treatment is documented.

Eligibility criteria: Inclusion Criteria:

* at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks)

Exclusion Criteria:

* pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area

Primary outcomes:
measure: Patient complete (%, P) or partial clearance (%, P)
timeFrame: 2 year
measure: Lesion-specific clearance (%, P)
timeFrame: 2 year
Secondary outcomes:
measure: Patient reported pain
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00000334: Comparison of Buprenorphine and Methadone - 3
Official title: Pharmacological Comparison of Buprenorphine and Methadone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Washington D.C. Veterans Affairs Medical Center
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare agonist and antagonist profile associated with buprenorphine vs. methadone during opiate withdrawal.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Withdrawal severity
measure: Opiate agonist symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA
state: District of Columbia
Study officials:
affiliation: Washington D.C. Veterans Affairs Medical Center
name: Steven Deutsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: