louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06058169: Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2)
Official title: Pilot Investigation on the Effects of Sub Acute (12 Week) Home Base Whole-body Vibration Training in Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Whole Body Vibration
Osteo Arthritis Knee
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this proposal is to understand how the Vibrant Health Ultimate whole-body vibration (WBV) machine affects pain and inflammation in older adults. The investigators' hypothesize that sub-acute (12 weeks) WBV will lead to improvement in the level of knee pain and improve vascular function via a decrease in systemic inflammation.

Detailed description: Knee osteoarthritis (KO) is a leading cause of disability and medical cost. Whole body vibration (WBV) has emerged as an exercise alternative that may be more tolerable than traditional forms of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise, research supports that WBV can be very beneficial for your health. In fact, a single bout of WBV increases circulating concentrations of inflammatory markers. WBV is safe and effective, WBV training has been conducted in obesity, elderly, patients with diabetes, patients with lung disease, as well as patients with knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Symptomatic Osteoarthritic knee pain for at least 6 months.
* Mean and women
* Ages 40-75 years old

Exclusion Criteria:

* \<40 years old or \>75 years old
* History of balance issues
* History of falls
* Epilepsy
* Pregnancy
* The use of whole-body vibration in the past 6 months
* Previous knee surgery within last 3 years
* Unable to stand for at least 20 minutes (for whole body vibration training)

Primary outcomes:
measure: Change in Pain Pressure Threshold assessed using the Jtech Medical Echo Algometer
timeFrame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Secondary outcomes:
measure: Change in Pulse Wave Velocity (PWV)
timeFrame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
measure: Change in IL-6
timeFrame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
state: Georgia
Study officials:
References:
Clinical trial NCT06822569: Teen Health Choices & Wellness
Official title: Teen Health Choices & Wellness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Wellness, Psychological
Substance Use
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-02-12
Enrollment: 224
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.


Eligibility criteria: Inclusion Criteria:

1. be age 13 to 16 years
2. engage in a target health behavior on at least one recent occasion
3. speak, read, and understand English or Spanish
4. live in or near Rhode Island

Exclusion Criteria:

1. lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder
2. current psychotic symptoms or active suicidality (i.e., intent in the past 30 days)

Primary outcomes:
measure: Maximum subjective craving during cannabis cue exposure (rated on a 0 to 10 scale).
timeFrame: Baseline, 1 year, 2 years
Secondary outcomes:
measure: Maximum subjective positive effects of cannabis use in daily life (rated on a 0 to 10 scale).
timeFrame: Baseline, 1 year, 2 years
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
References:
citation: Morean ME, de Wit H, King AC, Sofuoglu M, Rueger SY, O'Malley SS. The drug effects questionnaire: psychometric support across three drug types. Psychopharmacology (Berl). 2013 May;227(1):177-92. doi: 10.1007/s00213-012-2954-z. Epub 2012 Dec 28.
citation: Tiffany ST, Singleton E, Haertzen CA, Henningfield JE. The development of a cocaine craving questionnaire. Drug Alcohol Depend. 1993 Dec;34(1):19-28. doi: 10.1016/0376-8716(93)90042-o.
Clinical trial NCT04312269: Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
Official title: Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Sleep
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the combination of myoelectric computer interface (MyoCI) training with targeted memory reactivation (TMR) in chronic stroke survivors. The study aims to determine whether this training-plus-sleep combination will generalize to improve arm motor function over an extended training protocol in stroke survivors.


Eligibility criteria: Inclusion Criteria:

* Age at enrollment is 21 or older
* Hemiparesis from first ever stroke affecting arm movement at least 6 months prior to screening
* Severe to moderate motor impairment (FMA-UE of 7-40)
* At least some voluntary shoulder and elbow muscle activation

Exclusion Criteria:

* Inability to follow instructions of the MyoCI task
* Visual impairment (such as hemianopia) preventing full view of screen
* Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest)
* Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
* Inability to understand or follow commands in English due to aphasia or other reason
* Diffuse or multifocal infarcts in both hemispheres
* Substantial arm pain preventing participation for 90 minutes a day
* Spasticity treatment (pharmacological or Botox) within last 3 months
* Ferromagnetic implants that are MRI incompatible

Primary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: change from baseline at 6 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function
timeFrame: change from baseline at 6 weeks
measure: Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function
timeFrame: change from baseline at 10 weeks
measure: Motor Activity Log (MAL)
timeFrame: change from baseline at 6 weeks
measure: Motor Activity Log (MAL)
timeFrame: change from baseline at 10 weeks
measure: Modified Ashworth Scale
timeFrame: change from baseline at 6 weeks
measure: Modified Ashworth Scale
timeFrame: change from baseline at 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Marc W Slutzky, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592969: Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official title: Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-14
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Currently treated with insulin NPH or are insulin-naive
* Body mass index (BMI) below 35.0 kg/m2
* HbA1c between 7.5-11.0%

Exclusion Criteria:

* Participation in any other clinical trial involving investigational products within the last 3 months
* History of drug or alcohol dependence
* Known impaired hepatic function
* Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Primary outcomes:
measure: HbA1c
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: PPBG values
measure: Glucose profiles
measure: Hypoglycemia
measure: Adverse events
Other outcomes:
Locations:
city: Mariano Acosta s/n
country: Argentina
facility: Novo Nordisk Investigational Site
city: Santa Efigenia
country: Brazil
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03637569: The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer
Official title: The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Cholangiocarcinoma
Gallbladder Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 1000
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: Patients who visit and treated at Samsung medical center.

Brief summary: In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.

Detailed description: Cachexia is frequently seen in pancreatic cancer(70-80%) and associated with reduced survival, reduced treatment tolerance and reduction in QoL. In recent studies, low-normal BMI have worse outcome (overall mortality) in cardiovascular, malignant, chronic disease (So called "obesity paradox") BMI is simple method but hard to define body composition because BMI is based on only weight and height. Skinfold thickness is strongly associated with body fatness than BMI. In this study, the ivestigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care).
* Age above 18 years old

Exclusion Criteria:

* Other malignant disease
* Underlying intestinal disease that cause absorprtion disorder
* Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)

Primary outcomes:
measure: Overall survival
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05556369: Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)
Official title: Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathies
Keywords: Cardiomyopathy
Hypertrophic
Dilated
ARVD
Restrictive
NGS
Gene mutation
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 288
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: NON_PROBABILITY_SAMPLE
Study population: Patient referred to Cardiology Department of Policlinico di Milano for the diagnosis of suspicious Cardiomyopathy or First degree relatives for cardiomyopathy.

Brief summary: Cardiomyopathy refers to a diverse group of myocardial diseases with multiple causes. In 1995, the World Health Organization classified cardiomyopathies into hypertrophic, dilated, restrictive, and mixed type. This classification is based on the pathophysiology of the disease. However, with rapid evolution of molecular genetics in cardiology, the American Heart Association in 2006 has classified cardiomyopathies into two major groups based on predominant organ involvement and etiology; Primary cardiomyopathies are those solely or predominantly confined to heart muscle and are relatively few in number. Secondary cardiomyopathies show pathologic myocardial involvement as part of a large number and variety of generalized systemic (multiorgan) disorders.Current evidence supports the use of genetic testing in clinical practice to improve risk stratification for clinically affected patients and their at-risk relatives for cardiomyopathies.


Eligibility criteria: Inclusion Criteria:

* Presence of structural cardiomyopathy
* First degree relatives for cardiomyopathy

Exclusion Criteria:

* Age \> 80
* Presence of sufficient conditions to explain the clinical condition of cardiomyopathy
* Peripartum cardiomyopathy

Primary outcomes:
measure: Genetic Characterization
timeFrame: 5 years
Secondary outcomes:
measure: Genetic and phenotypic characterization of the first degree relatives
timeFrame: 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
state: Lombardia
Study officials:
References:
Clinical trial NCT02441569: Common Engagement Strategies (Common Factors) for Childhood Anxiety
Official title: Common Engagement Strategies (Common Factors) for Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Georgetown University
First posted: 2015-05-12
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial examines the effectiveness of training pediatric primary care providers (nurse practitioners, doctors) to use of strategies that enhance family/youth empowerment and engagement during office visits for children with mild to moderate problems with anxiety. Children coming for routine care at one clinic are screened for anxiety symptoms and seen by either a specially trained provider or one of the clinic's other regular staff members.

Detailed description: Children who are thought to have mild to moderate anxiety will, via their parents, be offered the opportunity to receive treatment from their pediatric primary care provider. Providers will either use their existing anxiety approaches or will use those approaches combined with extra communication skills designed to promote patient and parent engagement in care. Children will be seen for up to 4 30-minute visits at 2 week intervals, with a follow-up telephone call 3 months later to asses the impact of treatment. Children with more severe anxiety (or those whose parents so desire) will be referred for specialized mental health care.

Eligibility criteria: Inclusion Criteria:

* Coming for well-child visit to designated clinical site;
* SCARED score 25 or greater

Exclusion Criteria:

* acute medical illness, SCARED 40 or greater

Primary outcomes:
measure: The Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Georgetown University Pediatric Clinic
state: District of Columbia
Study officials:
affiliation: Johns Hopkins University
name: Lawrence S Wissow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01948869: Efficacy/Safety Study to Explore a New Revised Topical Formulation in Atopic Dermatitis
Official title: An Investigator-blinded, Randomized, Monocentre, 3-arm, Pilot Trial to Compare the Efficacy and Safety of Two Topical Medical Devices in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With Untreated Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Phoenix
Mild atopic dermatitis
efficacy
safety
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.


Eligibility criteria: Inclusion Criteria:

* Male or female Caucasians aged between 18 and 60 years
* Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50
* Skin type I - IV according to Fitzpatrick
* Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and \</= 12) at Baseline
* Acute symptom of pruritus at Baseline

Exclusion Criteria:

* Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
* Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
* Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug \[NSAIDs\])
* Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
* UV-therapy or the use of solarium within 30 days before screening as well as during the trial
* Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Primary outcomes:
measure: Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
timeFrame: Up to 29 days
Secondary outcomes:
measure: Number of subjects with abnormal vital signs
timeFrame: Up to 10 weeks
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: Up to 10 weeks
measure: Erythema by means of chromametry
timeFrame: Up to 29 days
measure: Transepidermal water loss (TEWL) as a measure for skin barrier function
timeFrame: Up to 29 days
measure: Skin hydration by means of corneometry
timeFrame: Up to 29 days
measure: Intensity of pruritus by means of visual analogue scale (VAS)
timeFrame: Up to 29 days
Other outcomes:
Locations:
city: Münster
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03312569: Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses
Official title: A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Right Colon Disease
Malignant Right Colon Disease
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 306
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: Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease

Brief summary: To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies

Detailed description: This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older
* Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
* Subject undergoing intracorporeal or extracorporeal anastomosis proximal to mid-transverse colon

Exclusion Criteria:

* Subject is contraindicated for general anesthesia or surgery
* Emergent Case
* Subject has perforated, obstructing or locally invasive neoplasm (T4b)
* Subject with inflammatory bowel disease
* Subject with prior incisional hernia repair
* Planned right colectomy along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
* Metastatic disease with life expectancy of less than 1 year
* Pregnant or suspect pregnancy
* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
* Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

Primary outcomes:
measure: Incidence of incisional hernia at one year after index procedure.
timeFrame: 1 year
Secondary outcomes:
measure: Time to first flatus after index procedure
timeFrame: up to 1 week after index procedure
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California
state: California
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Intuitive Surgical Inc
name: Shilpa Mehendale
role: STUDY_DIRECTOR
References: