louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06053008: The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
Official title: The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Individuals
Pain
Discomfort
Spine
Temporomandibular Disorder
Keywords: Geriatric individuals
Pain
Discomfort
Spine
Temporomandibular disorder
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 301
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: It is aimed to examine the relationship between pain perception, temporomandibular joint disorder severity and spine health in elderly individuals.

Detailed description: The research sample will consist of elderly individuals who reside in Tokat and Kırıkkale, are over 65 years old, have good cognitive status, and volunteer to participate in the study. According to the G\*Power analysis, if the sample size is α= 0.05, β= 0.80, acceptable correlation coefficient r= 0.70, and negligible correlation coefficient r= 0.20, 16 individuals are sufficient to measure the relationship between two parameters. Since the relationship between four parameters will be evaluated, 64 individuals are required.

Data for the study will be collected face to face by researchers using The Centrality of Pain Scale, Discomfort Intolerance Scale, Spine Functional Index, and Fonseca Anamnestic Index, which can be filled in by individuals themselves.

Statistical Package for Social Sciences (SPSS), version 22.0 computer package program for Windows, will be used for statistical analysis. Statistical data will be expressed as mean ± standard deviation (X±SD), median, or percentage (%). One Sample Kolmogorov Smirnov test will be performed to show the parametric or nonparametric distribution of the data. When parametric test assumptions are met, the relationship between parameters is determined by Spearman correlation test; When parametric test assumptions are not met, the relationship between the parameters will be examined with the Pearson correlation test. Statistical significance value will be accepted as p\<0.05.

Eligibility criteria: Inclusion Criteria:

* To be volunteer

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder

Primary outcomes:
measure: The Centrality of Pain Scale
timeFrame: up to 3 months
measure: Discomfort Intolerance Scale
timeFrame: up to 3 months
measure: Spine Functional Index
timeFrame: up to 3 months
measure: Fonseca Anamnestic Index
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
References:
Clinical trial NCT01444508: Effect of Colloid Versus Crystalloid on Coagulation
Official title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bloodloss
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.


Eligibility criteria: Inclusion Criteria:

* Patient more than 18 years old
* Indication for elective post-renal operation including cystectomy
* Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.

Exclusion Criteria:

* Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
* Pregnant or nursing
* Allergic
* Disturbance in electrolytes
* Patient under committee
* Patient joining another trial interfering the actual trial.

Primary outcomes:
measure: Effect of colloid versus crystalloid on laboratory coagulation.
timeFrame: 5-7 hours
Secondary outcomes:
measure: Effect of colloid versus crystalloid on the amount of bloodloss
timeFrame: 5-7 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
citation: Rasmussen KC, Johansson PI, Hojskov M, Kridina I, Kistorp T, Thind P, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg. 2014 Feb;259(2):249-54. doi: 10.1097/SLA.0000000000000267.
Clinical trial NCT03906708: Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature
Official title: Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Premature Lungs
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-04-08
Enrollment: 249
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruiting infants born between 24+0 and 36+6 weeks gestational age

Brief summary: The purpose of this study is to examine if infants are more likely to suffer from respiratory complications during their first year of life due to being born premature.

Detailed description: The overall objective of this study is to determine if infant respiratory morbidities after preterm birth are highly variable due to differential impairment of airway, parenchymal and vascular development that can be characterized as distinct physiologic phenotypes. If the nature and severity of these specific impairments of lung function are strongly associated with increased respiratory morbidities during infancy and that proteomic biomarkers can enhance the physiologic characterization of phenotype and prediction of late respiratory outcomes.

Eligibility criteria: Inclusion Criteria:

* Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.

Exclusion Criteria:

* Cardiopulmonary defects
* Chromosomal defects
* Structural abnormalities of the upper airway, chest wall, or lungs
* Neurological/Neuromuscular disorders
* Infant not considered viable
* Family unlikely to be available for long term follow up
* Mothers under the age of 18.
* Non English speaking

Primary outcomes:
measure: Infant lung development measured by diffusion lung capacity (DLCO).
timeFrame: By 5 months CGA.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Jeff Bjerregaard
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Robert Tepper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315808: Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM
Official title: Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM: Comparing the Concept of dx/dt With QD Diabetes Prediction Model. D.E.R.M.S Initiative (Doctor Enabled Risk Management System)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Wyckoff Heights Medical Center
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.

Brief summary: The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.


Eligibility criteria: Inclusion Criteria:

* No self-reported history of diabetes or pre-diabetes defined as per ADA criteria
* Age greater than 18 years
* Scheduled to receive HbA1c in participating clinic
* Able and willing to give legally effective consent
* Able and willing to participate in patient questionnaires(attached)

Exclusion Criteria:

* Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded.
* Baseline HbA1c level above 5.7
* Severe Anemia (defined as Hb less than 8gm/dL)
* Patients with hemoglobinopathies
* Pregnancy
* Polycystic ovarian disease

Primary outcomes:
measure: Study the rate of change of HbA1c in normal population with known risk factors of diabetes
timeFrame: one year
Secondary outcomes:
measure: Diabetes prediction model based on the rate of change in HbA1c
timeFrame: one year
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Wyckoff Heights Medical Center
state: New York
Study officials:
affiliation: Wyckoff Heights Medical Center, Brooklyn New York
name: Rekha Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wyckoff Heights Medical Center
name: Shitij Arora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127308: A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
Official title: An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion Balance And Metabolism Of [14C]-PF04971729 In Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Absorption
Distribution
Metabolism
and Excretion
Mass Balance
Metabolic Profile
Radiolabel Study
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-05-20
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is single dose study of radiolabeled \[14C\]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Female participants. Participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening

Primary outcomes:
measure: Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi).
timeFrame: Up to 7 Days
measure: Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin
timeFrame: Up to 7 Days
measure: AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
timeFrame: Up to 7 Days
measure: Maximum plasma concentration (Cmax) of ertugliflozin
timeFrame: Up to 7 Days
measure: Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
timeFrame: Up to 7 Days
measure: Ertugliflozin half life (t1/2)
timeFrame: Up to 7 Days
measure: Amount of Ertugliflozin and metabolites in plasma, urine, and feces
timeFrame: Up to 7 Days
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to 7 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
citation: Marshall JC, Liang Y, Sahasrabudhe V, Tensfeldt T, Fediuk DJ, Zhou S, Krishna R, Dawra VK, Wood LS, Sweeney K. Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure. J Clin Pharmacol. 2021 Sep;61(9):1220-1231. doi: 10.1002/jcph.1866. Epub 2021 Jun 19.
Clinical trial NCT01337908: A Study of Mood and Stress After Spinal Cord Injury
Official title: A Survey of Vulnerability Factors, Current Stress and Depression Risk in Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Depression
Keywords: depression
quality of life
disability
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Wayne State University
name: Santa Clara Valley Health & Hospital System
name: University of Washington
First posted: 2011-04-19
Enrollment: 377
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women with a traumatic spinal cord injury who are 18 years of age and older

Brief summary: This is a study of factors, such as pain, family support, psychological history and alcohol/substance use, that may influence whether a person experiences depression after their spinal cord injury.

Detailed description: The objective of this study is to examine the degree to which vulnerability factors are mediated by stress to increase risk for depression after SCI in a sample of adults who sustained their injuries after the age of 18 years. Participants will complete a written survey (about pain, daily activities, social support and life experiences) and a telephone interview that will provide information about these factors.

Eligibility criteria: Inclusion Criteria:

* Have a spinal cord injury
* Were age 16 years or older when injured
* Sudden onset of symptoms

Exclusion Criteria:

* Under 19 years old
* Less than 1 year post-injury
* had a non-traumatic injury

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Rehabilitation Institute of Michigan
state: Michigan
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT01854008: Urban Walking Circuits
Official title: Improving Physical Activity in Patients With Severe Chronic Obstructive Pulmonary Disease With Urban Walking Circuits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Chronic Obstructive Pulmonary Disease
Keywords: Exercise, Physical activity, Rehabilitation, COPD.
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 82
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
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 assess the effectiveness of the implementation of walking urban circuits in increasing the level of physical activity and exercise capacity in severe chronic obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* severe COPD (post-bronchodilator Forced expiratory volume in one second (FEV1)/ Forced vital capacity (FVC) \<0.7 and FEV1 \<50%) and stable disease defined as no exacerbation, hospital admission or change in treatment in the previous three months.

Exclusion Criteria:

* The exclusion criteria were: other significant respiratory disease (bronchiectasis, lung fibrosis, asthma, etc.), active smoking, severe cardiovascular, neurological, musculoskeletal and/or metabolic pathology that could interfere with the results, alcoholism (\>80g/day) or severe malnutrition (BMI\<19kg/m2).

Primary outcomes:
measure: walked in meters in the six minute walking test (6MWT)
timeFrame: Unlike walking meters of baseline and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mataro
country: Spain
facility: Eulogio Pleguezuelos
state: Barcelona
Study officials:
References:
citation: Pleguezuelos E, Perez ME, Guirao L, Samitier B, Ortega P, Vila X, Solans M, Riera A, Moreno E, Meri A, Miravitlles M. Improving physical activity in patients with COPD with urban walking circuits. Respir Med. 2013 Dec;107(12):1948-56. doi: 10.1016/j.rmed.2013.07.008. Epub 2013 Jul 23.
Clinical trial NCT05544708: Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management
Official title: Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: cardiometabolic disease
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized design
Primary purpose: TREATMENT

Brief summary: African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for a weight loss program in a real-world, community-based setting.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Resident of Petersburg, VA
* Interested in engaging community members in healthy lifestyle changes (e.g., walking, small changes to eating) and willing to engage in these behaviors her/himself

Exclusion Criteria:

* A diagnosis of type 1 diabetes mellitus.
* Currently being treated for cancer.
* Medical conditions that may increase risk for participating in unsupervised exercise, if medical clearance is not provided
* Hospitalization for depression or other psychiatric disorder within the past 12 months.
* Lifetime history of bipolar disorder or psychotic disorder.
* Currently pregnant or lactating, or planning to become pregnant within the study period.
* Current involvement in a weight loss program or current use of weight loss medication.
* Inability to speak, read and write English.
* Planning to move from the Petersburg area within the study period.
* Does not have sufficient numbers of individuals in their social network from which to recruit for the proposed study.

Primary outcomes:
measure: Feasibility: House Chat Leaders (HCL)
timeFrame: 18 months
measure: Feasibility: Participants
timeFrame: 18 months
measure: Feasibility: Delivery Model
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability: Attendance
timeFrame: 12 weeks
measure: Acceptability: Retention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Moghboeba Mosavel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177708: Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy
Official title: Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy Measured by MR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Encephalopathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Type C HE

Brief summary: There is increasing evidence that the pathophysiology of hepatic encephalopathy (HE) is tightly associated with low-grade cerebral edema. Uptake of ammonia in astrocytes leads to osmotic swelling caused by glutamine formation. Previous studies were performed in covert HE patients or used indirect methods.

Methods: The investigators wish to describes quantitative measurement of localized water content using MRI water mapping in a cohort of patients with cirrhosis during an episode of overt HE type C and again after recovery. Furthermore patients with cirrhosis and no history of HE and healthy subjects will be investigated as controls.


Eligibility criteria: Inclusion Criteria:

* Patients with type C HE during and after HE,
* Patients with stable cirrhosis and
* Healthy subjects

Exclusion Criteria:

* Patients with pace-maker
* Metal implants

Primary outcomes:
measure: Absolute brain water content measured by water mapping
timeFrame: Patients are recruited during an episode of acute HE, the patients are rescanned within a time frame of 6 weeks. Patients with stable cirrhosis and healthy subjects are scanned only once.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Gitte Dam, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: