louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03649555: Reliability of [18F]-FTC-146 Brain Uptake in Healthy Controls
Official title: Reliability of [18F]-FTC-146 Brain Uptake in Healthy Controls
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Controls
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to understand the reliability of \[18F\]-FTC-146 brain uptake in healthy controls.

Detailed description: The purpose of this study is to understand the reliability of \[18F\]-FTC-146 brain uptake in healthy controls under test and retest conditions.

Eligibility criteria: Inclusion Criteria:

1. ages 18-65
2. either gender and all ethno-racial categories
3. capacity to provide informed consent
4. Female participants are expected to use an effective method of birth control throughout the study

Exclusion Criteria:

1. Any current or lifetime psychiatric diagnosis
2. Current or past use of psychotropic medication
3. Pregnant or nursing females
4. Major medical or neurological problem
5. Presence of metal in the body that is contraindicated for MRI scans

Primary outcomes:
measure: Reliability under test retest conditions
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Department of Psychiatry and Behavioral Sciences
state: California
Study officials:
affiliation: Stanford University
name: Carolyn Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04421950: The Blueberry Study
Official title: Plasma and Urine Profiles of Blueberry Derived Polyphenols After a Short Term Intervention With Blueberry in Children With Typical Low Fruit and Vegetable Consumption.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 44
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child

Detailed description: This is a double blinded randomized control trial aiming to characterize the profile of polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented short term with wild blueberry powder. The study will assess if a short-term supplementation (5 days) with wild blueberry powder impacts immune responses as well as markers for cardiovascular and bone health. Up to 44 children will be recruited. The participants will attend three visits at Arkansas Children's Nutrition Center.

Eligibility criteria: Inclusion Criteria:

* Eats \<1.5 cup of fruit and \<2.0 cup of vegetables per day
* Boys or girls
* All ethnicities
* All BMIs

Exclusion Criteria:

* Known allergy to blueberries
* Epilepsy
* Asthma
* Chronic kidney disease
* Hormonal disease
* Autoimmune disease
* Bleeding disorders
* Chronic infections
* Type 2 and Type 1 diabetes mellitus
* Attention deficit hyperactivity disorder
* Opposition defiant disorder
* Autistic spectrum disorder
* Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
* If the participants/parents perceive barriers with adhering to low-polyphenol meals
* Parent or child refusal to stop nutritional supplements
* Parent or child refusal to have blood drawn

Primary outcomes:
measure: Plasma and urine levels of blueberry derived polyphenols and their metabolites
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Number and percentage of lymphocytes cluster of differentiation 4 (CD4), lymphocytes cluster of differentiation 8 (CD8) and natural killer (NK) cells
timeFrame: up to 2 weeks
measure: T-lymphocyte responsiveness to immune stressors
timeFrame: up to 2 weeks
measure: Endothelial function by brachial artery flow mediated dilation
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Reserach Institute
name: Eva Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03540550: Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour in Healthy Humans
Official title: Modification of the Gut Microbiota Following the Consumption of Inulin-rich Vegetables: Effect on Gut Tolerance, Transit, Behaviour and Digestion in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health effects through changes in the gut microbiota. However, their effect on gut sensitivity and nutritional behaviour is a matter of debate.

The investigators evaluated, in healthy individuals, the impact of shifting from their usual food habits towards a diet based on the daily consumption of ITF-rich vegetables on gut microbiota, gastro-intestinal symptoms and food-related behaviour.


Eligibility criteria: Inclusion Criteria:

* BMI between 20 and 25 kg/m²
* Caucasian ethnicity
* Hydrogen producers (assessed by hydrogen breath test)

Exclusion Criteria:

* Smokers
* Laxative consumption (\<4 weeks)
* Severe intestinal problems
* Psychiatric problems or use of antipsychotic
* Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (\<6 weeks)
* Specific dietary practise (vegetarian, vegan,...)
* Specific dietary treatment (\<6 weeks) (e.g. high protein diet)
* Excessive alcohol consumption (\>3 glasses/day)
* Consumption of the following drugs: proton pump inhibitor, antidiabetic drugs, cholesterol lowering drugs
* Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)

Primary outcomes:
measure: Gut microbiota composition
timeFrame: 33 days
Secondary outcomes:
measure: Gut microbiota fermentation in vivo
timeFrame: 33 days
measure: Gut microbiota fermentation in vitro
timeFrame: 14 days
measure: Gastrointestinal Symptoms
timeFrame: 33 days
measure: Appetite-related feelings
timeFrame: 33 days
measure: Correlation of gastrointestinal symptoms with gut bacteria
timeFrame: 33 days
measure: Short chain fatty acids production
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Jean-Paul Thissen, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hiel S, Bindels LB, Pachikian BD, Kalala G, Broers V, Zamariola G, Chang BPI, Kambashi B, Rodriguez J, Cani PD, Neyrinck AM, Thissen JP, Luminet O, Bindelle J, Delzenne NM. Effects of a diet based on inulin-rich vegetables on gut health and nutritional behavior in healthy humans. Am J Clin Nutr. 2019 Jun 1;109(6):1683-1695. doi: 10.1093/ajcn/nqz001.
Clinical trial NCT05328050: Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)
Official title: Local Registry for Data Collection of Patients With Achondroplasia / Hypochondroplasia for Epidemiological, Care and Research Studies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achondroplasia
Hypochondroplasia
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Achondroplasia / Hypochondroplasia afferent to IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Brief summary: This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of achondroplasia/hypochondroplasia
* Patients (and/or Parents legal guardian when required) able to provide informed consent

Exclusion Criteria:

* Absence of diagnosis of achondroplasia/hypochondroplasia
* Patients (and/or Parents legal guardian when required) not able to provide informed consent

Primary outcomes:
measure: Registry of Achondroplasia and Hypochondroplasia Patients
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Medical Genetics Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
Study officials:
References:
Clinical trial NCT02302950: A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
Official title: A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection
Keywords: HIV infection
raltegravir use
women
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected minority women at Thomas Street Health Center that picked up raltegravir in 2013

Brief summary: Raltegravir is the first marketed strand-transfer inhibitor of HIV-1 that was FDA approved in 2007. It is currently one of the preferred treatment regimens for HIV by the Department of Health and Human Services. It has become a widely used antiretroviral therapy option for HIV infected patients. It provides good tolerability and a favorable lipid profile for patients when compared to some other antiretroviral treatment options. Little data is reported about efficacy in a minority patient population. Moreover, data in an indigent minority population in the United States has not been aggregated before. Therefore this study will investigate the efficacy of raltegravir in minority women residing in Houston, TX who are HIV infected.


Eligibility criteria: Inclusion Criteria:

1. HIV-infected women who picked up raltegravir in the year 2013 at Thomas Street Health Center.
2. Minority women -Black/African American, Hispanic/Latino

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Assess the efficacy of raltegravir in study participants by measuring CD4 count and viral load
timeFrame: 24 weeks of therapy
Secondary outcomes:
measure: Capture data on concomitant conditions that may have led to participants switching to raltegravir from medical records (eg. Diabetes mellitus)
timeFrame: 24 weeks of therapy
measure: Assess tolerability of raltegravir by capturing symptoms
timeFrame: 24 weeks of therapy
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
Study officials:
References:
Clinical trial NCT02725450: The Influence of Motor Imagery in Fine Motor Skills
Official title: The Influence of Motor Imagery in Fine Motor Skills of Individuals With Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Retardation and Developmental Disabilities With No Organic Condition
Keywords: Motor Imagery
Fine motor skills
Disabled
Lead sponsor: Instituto Politécnico de Castelo Branco
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to ascertain whether the application of Motor Imagery together with normal practice improves fine motor skills in disabled individuals.

Detailed description: Imagery is a cognitive process that can play an important role on the planning and execution of different movements or actions. The main purpose of this study is to ascertain whether the application of Motor Imagery together with normal practice improves fine motor skills in disabled individuals. In this study participated 42 subjects of both genders with disabilities, with a mean age of 37 (SD=12). Subjects were randomly divided in two groups: a control group and an experimental one. The study procedures were applied on five different tasks of the Psychomotor Battery of fine motor skills (BPM). This instrument was applied in two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest). Both groups performed the tasks twice a week for a month. Motor imagery sessions were added on in the experimental group. Participants on the experimental group were asked to mentally imagine themselves recreating tasks they had performed earlier on the initial assessment. For the analysis of the results, descriptive and inferential statistics were used. The T-test for independent samples, and the T-test for paired samples were applied.

Eligibility criteria: Inclusion Criteria:

* institutionalized individuals
* individuals with disabilities who were able to perform motor tasks

Exclusion Criteria:

* individuals with hearing disability
* individuals with visual disability
* individuals without motor autonomy

Primary outcomes:
measure: Fine Motor Skill evaluated with Bateria Psicomotora (BPM)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Politécnico de Castelo Branco
name: Pedro AD Mendes, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02968550: Shunt Evaluation With ALPE System in Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Thoracic Diseases
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 41
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 undergoing thoracoscopic surgery

Brief summary: . The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (OLV) at different levels of positive end expiratory pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during OLV.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus.
* patients American Society of Anesthesiologists Physical Status Classiﬁcation score of 1-3

Exclusion Criteria:

* Patients with hemodynamic instability,
* Patients with severe chronic respiratory failure
* Patients with preoperative anemia (hemoglobin \<10 g 100 ml-1)
* Patients requiring unplanned conversion to thoracotomy

Primary outcomes:
measure: Pulmonary shunt evaluated with ALPE system
timeFrame: every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes
Secondary outcomes:
measure: predictors of high intraoperative shunt
timeFrame: The outcome is assessed 15 minutes after one lung ventilation
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Anna
Study officials:
References:
citation: Beck DH, Doepfmer UR, Sinemus C, Bloch A, Schenk MR, Kox WJ. Effects of sevoflurane and propofol on pulmonary shunt fraction during one-lung ventilation for thoracic surgery. Br J Anaesth. 2001 Jan;86(1):38-43. doi: 10.1093/bja/86.1.38.
Clinical trial NCT00237250: Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Official title: Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prediabetic State
Keywords: Pre-diabetes
vildagliptin
IGT
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* Body mass index (BMI) in the range 23-45

Exclusion Criteria:

* Diagnosis of diabetes
* Serious cardiovascular events within the past 6 months
* Use of insulin or any oral antidiabetic agent
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change in area under the 0-2 hour prandial glucose curve at 12 weeks
Secondary outcomes:
measure: Adverse event profile after 12 weeks of treatment
measure: Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment
measure: Change in HOMA B at 12 weeks
measure: Change in fasting insulin at 12 weeks
measure: Change in fasting proinsulin/insulin ratio at 12 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Foley JE, Rendell M, Landin-Olsson M, Holst JJ, Deacon CF, Rochotte E, Baron MA. Effects of the dipeptidyl peptidase-IV inhibitor vildagliptin on incretin hormones, islet function, and postprandial glycemia in subjects with impaired glucose tolerance. Diabetes Care. 2008 Jan;31(1):30-5. doi: 10.2337/dc07-1616. Epub 2007 Oct 18.
Clinical trial NCT01841450: Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Official title: A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: Primary open-angle glaucoma (POAG)
Trabecular meshwork
iStent
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 360
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Detailed description: The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Eligibility criteria: Inclusion Criteria:

* mild to moderate primary open-angle glaucoma
* currently treated with ocular hypotensive medication
* pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
* subject scheduled to undergo cataract surgery

Exclusion Criteria:

* primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
* retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

Primary outcomes:
measure: Rate of sight-threatening adverse events
timeFrame: 36 months
Secondary outcomes:
measure: Other adverse events
timeFrame: 36 months
Other outcomes:
measure: Diurnal IOP reduction ≥ 20%
timeFrame: Baseline and 24 months
Locations:
city: Irvine
country: United States
state: California
city: Montebello
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Edgewood
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Jackson
country: United States
state: Michigan
city: Saint Joseph
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Kingston
country: United States
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02469350: Serious Game for Parkinson's Disease Patients
Official title: Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Gait and balance disorders
serious game
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2015-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* Gait and balance disorders
* Chronic bilateral deep brain stimulation of the subthalamic nucleus (\> 1 year).

Exclusion Criteria:

* Dementia
* Ongoing severe medical condition that prevented assessments

Primary outcomes:
measure: Feasibility questionnaire
timeFrame: once a week
Secondary outcomes:
measure: Acceptability questionnaire
timeFrame: once a week
measure: biomechanical parameters of gait and balance
timeFrame: at inclusion, 3 weeks, 6 weeks and 18 weeks
measure: kinematics parameters of gait and balance
timeFrame: at inclusion, 3 weeks, 6 weeks and 18 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM, CIC Neurosciences
Study officials:
affiliation: GHPS, APHP, Paris
name: Marie-Laure Welter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuic D, Vinti M, Karachi C, Foulon P, Van Hamme A, Welter ML. The feasibility and positive effects of a customised videogame rehabilitation programme for freezing of gait and falls in Parkinson's disease patients: a pilot study. J Neuroeng Rehabil. 2018 Apr 10;15(1):31. doi: 10.1186/s12984-018-0375-x.