louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00790634: Mechanisms of Fronto-Subcortical Dysfunction: Comparing PD and OCD
Official title: Characterizing Mechanisms of Fronto-Subcortical Dysfunction: A Comparison Between Parkinson's Disease and Obsessive-Compulsive Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Obsessive-Compulsive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: University of Haifa
name: Israel Science Foundation
First posted: 2008-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: private and hospital-based clinics, healthy volunteers

Brief summary: The purpose of this study is to characterize and compare irregularities in dopaminergic function in fronto-subcortical circuits, between Parkinson's Disease patients (ON and OFF medication) and patients with obsessive-compulsive disorder, by examining performance on cognitive tasks involving cognitive flexibility, decision-making, and attentional bias.


Eligibility criteria: Inclusion Criteria:

* idiopathic PD or
* OCD
* for control group - age-matched to study groups

Exclusion Criteria:

* psychotic symptoms (past or present)
* head injury with loss of consciousness
* other neurological conditions (excepting PD in PD group)
* for OCD group - use of dopaminergic medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00535834: Studying Stored Samples From Patients With Localized Prostate Cancer Treated on Clinical Trial NCI-00-C-0154
Official title: Data Analysis for 00-C-0154, A Randomized Phase II Study of a PSA-based Vaccine in Patients With Localized Prostate Cancer Receiving Standard Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
adenocarcinoma of the prostate
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-26
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of blood in the laboratory from patients before and after treatment may help doctors learn more about the effects of the treatment on cells.

PURPOSE: This clinical trial is studying samples collected from patients with localized prostate cancer who received treatment on clinical trial NCI-00-C-0154.

Detailed description: OBJECTIVES:

Primary

* Evaluate the formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy in prostate cancer patients previously enrolled on clinical trial NCI-00-C-0154.
* Evaluate immunologic response.

Secondary

* Clone the underlying tumor antigens discovered through SEREX.

OUTLINE: Samples previously collected on clinical trial NCI-00-C-0154 (whole blood, serum, and peripheral mononuclear blood cells) are analyzed for immunologic responses and evidence of formation of anti-tumor antibodies. Western blot is used to detect any evidence of vaccine-induced autoantibody responses. If there is an indication of response, SEREX is used to clone the underlying antigens.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of localized adenocarcinoma of the prostate
* Received treatment on clinical trial NCI-00-C-0154

PATIENT CHARACTERISTICS:

* Consented the use of their collected blood cells for future research while enrolled on NCI-00-C-0154

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Immunologic response
measure: Incidence of formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy by western blot and SEREX
Secondary outcomes:
measure: Cloning of any underlying tumor antigens discovered in this process
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: James Gulley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05416034: Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy
Official title: Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Muscular Atrophy Type II
Keywords: exoskeleton
spinal muscular atrophy
care
quality of life
robotics
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
First posted: 2022-06-13
Enrollment: 3
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the impact of the use of a pediatric exoskeleton on the quality of life of children, specifically in the psychological and care dimensions. Other objectives are to evaluate changes at the physical and functional level.


Eligibility criteria: Inclusion Criteria:

* Patients between 4 and 9 years old
* Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II

Exclusion Criteria:

* Weight over 40 Kg
* Hip-knee distance less than 22 cm or greater than 38cm
* Knee-ankle distance less than 21 cm or greater than 37cm
* Distance between trochanters less than 24 cm or greater than 40cm
* Joint range limit greater than 20º

Primary outcomes:
measure: Phenomenological Interviews
timeFrame: 2 months
measure: Care impact
timeFrame: 2 months
measure: Participant observation
timeFrame: 2 months
Secondary outcomes:
measure: Upper limb Function
timeFrame: 2 months
measure: Number of Steps
timeFrame: 2 months
measure: Muscle Strength
timeFrame: 2 months
measure: Number of participants with abnormal vital signs
timeFrame: 2 months
measure: Respiratory rate (breaths/min)
timeFrame: 2 months
measure: Oxygen saturation
timeFrame: 2 months
measure: Self percieved fatigue
timeFrame: 2 months
measure: Motor Function
timeFrame: 2 months
measure: Duration of time walking in each session.
timeFrame: 2 month
measure: Blood pressure
timeFrame: 2 months
measure: Social behaviour
timeFrame: 2 months
measure: Exploration
timeFrame: 2 months
measure: Sense of agency
timeFrame: 2 months
measure: Emotional impact
timeFrame: 2 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
References:
Clinical trial NCT01850134: Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.
Official title: Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects will be eligible for the study if they meet all of the following inclusion criteria:

  1. Diagnosis of Type 2 Diabetes.
  2. Age between 18 and 75 years.
  3. HbA1c \> 6.0 but ≤ 8.5
  4. If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
  5. BMI \> 18.5 kg/m2 and \< 40.0 kg/m2.
  6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.
  7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

* Subjects will be excluded from the study if they meet any of the following criteria:

  1. Use of exogenous insulin or GLP-1 agonists for glucose control.
  2. Diagnosis of Type 1 diabetes.
  3. History of diabetic ketoacidosis.
  4. Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
  5. Active malignancy.
  6. Significant cardiovascular event \< 12 weeks prior to study entry.
  7. End stage organ failure or status post organ transplant.
  8. Active metabolic, hepatic, or gastrointestinal disease.
  9. Chronic, contagious, infectious disease.
  10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
  11. History of fainting or other adverse reactions in response to blood collection.
  12. Clotting or bleeding disorders.
  13. Allergy or intolerance to study product ingredient.

Primary outcomes:
measure: Hunger
timeFrame: Treatment Visit 1 and Treatment Visit 2
Secondary outcomes:
measure: Fullness
timeFrame: Treatment Visit 1 and Treatment Visit 2
measure: Desire to Eat
timeFrame: Treatment Visit 1 and Treatment Visit 2
measure: Prospective Consumption
timeFrame: Treatment Visit 1 and Treatment Visit 2
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Clinical Research
state: Illinois
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Amy Devitt-Maicher, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01102634: Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Blood Lactate and Excessive Post-exercise Oxygen Consumption (EPOC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and EPOC


Eligibility criteria: Inclusion Criteria:

* with normal health (no known history of cardiovascular, pulmonary, metabolic or musculoskeletal diseases)

Exclusion Criteria:

* unable to communicate and follow the exercise procedures

Primary outcomes:
measure: Blood lactate level
timeFrame: Before exercise
measure: Blood lactate level
timeFrame: Immediately post exercise
measure: Blood lactate level
timeFrame: 15 minutes post exercise
measure: Oxygen consumption
timeFrame: Measurements continued during exercise and until heart rate returned to baseline
Secondary outcomes:
measure: Heart rate
timeFrame: Measurements continued during exercise and until heart rate returned to baseline
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Cardiopulmonary and Exercise Physiology Laboratory, The Hong Kong Polytechnic University
state: Hong Kong
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Alice Jones, PhD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362334: IOL Power Calculation Using Dual Schiempflug Analyzer
Official title: Precision of Optical Biometry and Intraocular Lens Power Calculation Using Dual Schiempflug Analyzer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: dual Sheimpflug analyzer
intraocular lens power
optical low-coherence reflectometry
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 140 eyes of patients who scheduled for cataract surgery

Brief summary: This study evaluates the various ocular parameters which are necessary for ocular biometry and the calculated IOL powers using both dual Schiempflug analyzer and optical low-coherence refelctometry.

Detailed description: The measured keratometry, axial length, anterior chamber depth, lens thickness, white-to-white corneal diameter, and calculated IOL powers using various formulas including Hoffer Q, Holladay I, SRK II and SRK T measured by dual Schiempflug analyzer and optical low-coherence refelctometry will be compared.

Eligibility criteria: Inclusion Criteria:

* axial length between 21.0 and 27.0 mm
* older than 20 years old

Exclusion Criteria:

* other ophthalmic diseases such as severe dry eye, glaucoma, and age-related macular degeneration
* previous ophthalmic surgery including cataract surgery, and refractive surgery
* very dense media which cannot be measured by the optical biometries
* severe zonulysis

Primary outcomes:
measure: Ocular parameters
timeFrame: Single point
measure: Calculated IOL powers
timeFrame: Single point
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
Study officials:
affiliation: Clinical associate professor
name: Kyung Eun Han, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06038734: Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.
Official title: Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Gastric Emptying
Gastroparesis
Keywords: GLP-1 agonists
retained gastric contents
glucagon-like peptide receptor-1 agonists
perioperative
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include non-critically ill adults 18 years and older undergoing various elective surgical procedures at the University of North Carolina Medical Center

Brief summary: Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.


Eligibility criteria: Inclusion Criteria:

* GLP-1 agonist use within previous 30 days
* Appropriately fasted per standard guidelines

Exclusion Criteria:

* History of gastric surgery / gastric volume reduction
* Critical illness
* Inability to provide informed consent
* \<18 years of age

Primary outcomes:
measure: Retained gastric contents
timeFrame: At time of pre-operative assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Lindsey Gouker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03291834: Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
Official title: A Study on Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: type 1 diabetes mellitus
sports
child
adolescent
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital

Brief summary: On the basis of a questionnaire the participation at sports activities of children and adolescents with type 1 diabetes mellitus will be studied. The occurrence of hypoglycemia and hyperglycemia will be evaluated, as well as the measures to prevent these complications.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital

Exclusion Criteria:

-

Primary outcomes:
measure: Participation at sports
timeFrame: August 2017
measure: Occurence of hypoglycemia or hyperglycemia
timeFrame: August 2017
Secondary outcomes:
measure: Measures taken to prevent hypoglycemia or hyperglycemia
timeFrame: August 2017
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Guy G Massa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871334: Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
Official title: A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Melanoma
Advanced Urothelial Carcinoma
Lead sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.


Eligibility criteria: Inclusion Criteria:

* Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
* ECOG score 0 or 1;
* Part B: At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:

* Known hypersensitivity to any ingredient of TWP-101;
* Receiving any anti-cancer drugs;
* History of serious systemic diseases;
* History of serious autoimmune diseases;
* Pregnancy or lactating women.

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: From the first dose of study drug up to 4 weeks
measure: Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.
timeFrame: From enrollment until 90 days after the last dose
Secondary outcomes:
measure: Objective Response Rate (ORR) by RECIST Version 1.1
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Duration of Response (DOR)
timeFrame: From first dose to disease progression, an average of 2 years
measure: Disease control rate (DCR).
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Progression free survival (PFS).
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Maximum measured plasma concentration (Cmax) of TWP-101.
timeFrame: From first dose until 90 days after the last dose
measure: Time to maximum plasma concentration (Tmax) of TWP-101.
timeFrame: From first dose until 90 days after the last dose
measure: Half-life (T1/2) of TWP-101.
timeFrame: From first dose until 90 days after the last dose
measure: Immunogenicity profile of TWP-101.
timeFrame: From first dose until 90 days after the last dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04552834: Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes
Official title: Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Microbiome
Keywords: short term outcomes
long term outcomes
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 500
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: adult patients admitted to the intensive care unit

Brief summary: This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.

Detailed description: During this study investigators will longitudinally collect discarded stool biosamples throughout the MICU admission when available. Stool Bio specimens will be recorded/coded and processed by the investigators. Stool Bio specimens will be analyzed for 16sRNA and metabolomics. Surveys will be conducted at study entry, in addition to 6 months and 12 months following discharge.

By longitudinally sampling discarded biospecimens from subjects throughout their MICU admission in additionally to describing long term following up. We will be able to correlate changes in the microbiome with clinical data, and follow up surveys to identify factors that may impact the composition of the microbiome and their impact on clinical outcomes.

Eligibility criteria: Inclusion Criteria:

adult patients admitted to the intensive care unit

Exclusion Criteria: none

Primary outcomes:
measure: Long Term Mortality
timeFrame: up to 1 year
Secondary outcomes:
measure: hospital mortality
timeFrame: 28 day
measure: ICU length of stay
timeFrame: hospitalization up to 6 weeks
measure: Hospital length of stay
timeFrame: hospitalization up to 6 weeks
measure: Functional Status Score
timeFrame: up to 12 months after discharge
measure: Cognitive Dysfunction
timeFrame: Up to 12 months after discharge
measure: Quality of Life score
timeFrame: up to 12 months after discharge
Other outcomes:
measure: ICU re-admission
timeFrame: up to 12 months
measure: ICU related complications
timeFrame: up to 6 weeks
measure: Ventilator days
timeFrame: up to 4 weeks
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Bhakti Patel
role: PRINCIPAL_INVESTIGATOR
References: