louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05109208: The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction
Official title: Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Keywords: Radical Prostatectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.


Eligibility criteria: Inclusion criteria include:

* Age \> 40 years
* Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA \< 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer)
* International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction)
* Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization
* Planned bilateral nerves-paring prostatectomy

Exclusion criteria include:

* Moderate or severe ED based in IIEF criteria (score \< 21)
* History of prior pelvic or penile surgery
* Current or prior androgen deprivation therapy
* Planned non-nerve sparing prostatectomy

Primary outcomes:
measure: Change in Viscoelasticity
timeFrame: Baseline, 3 months, 6 months and 9 months post-prostatectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew J. Ziegelmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05400408: Chemical Profiling of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
Official title: Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Pancreatic Cancer
Lead sponsor: Scentech Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: DIAGNOSTIC

Brief summary: Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study

Detailed description: A diagnostic prospective study with no anticipated risks or constraints. Main Objective: To quantify differences in exhaled breath VOCs of patients with colorectal or pancreatic cancers compared with cohorts without cancer.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 85 years at the time of consent.
* Scheduled for colonoscopy or Endoscopic Retrograde Cholangio Pancreatography.
* Fasted \>6 hours, consuming water only.
* Able to provide informed written consent.

Exclusion Criteria:

* Lacks capacity or is unable to provide informed written consent.
* Pregnant or lactating woman.
* Histologically confirmed cancer in any organ.

Primary outcomes:
measure: identification of Volatile Organic Compounds that can be related to Colorectal malignancy.
timeFrame: Through the study completion, up to 1 year.
Secondary outcomes:
measure: Test Sensitivity and specificity for colorectal polyps.
timeFrame: Through the study completion, up to 1 year.
measure: Test Sensitivity and specificity for pancreatic cancer.
timeFrame: Through the study completion, up to 1 year.
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Haim Shirin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907408: Omics Techniques in Fatty Liver Disease
Official title: Precision Medicine in Fatty Liver Disease: How to Identify the Patient Who Develops Steatohepatitis Using Omics Techniques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: nonalcoholic fat liver disease
NASH
metabolic fat liver disease
risk factors
noninvasive markers
transcriptomics
metabolomics
proteomics
liver fibrosis
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Quaternary university hospital

Brief summary: Nonalcoholic steatohepatitis (NASH) is the most common cause of chronic liver disease in Western countries and one of the leading causes of liver transplantation in the world. Its spectrum ranges from simple steatosis to decompensated cirrhosis, resulting from progressive fibrosis due to inflammation and cellular injury. The reasons why patients with the same degree of steatosis have different evolutions are not sufficiently known. The objective of this project is to identify biomarkers that predict disease progression, using omics techniques, which can serve to develop new therapeutic strategies.


Eligibility criteria: Inclusion Criteria:

* Metabolic syndrome
* Liver steatosis detected on transient hepatic elastography performed in the last 12 months
* Steatosis with or without fibrosis confirmed histologically in a liver biopsy performed in the last 12 months

Exclusion Criteria:

* Concurrent liver disease (other than NAFLD)
* Chronic or prolonged use of any potential hepatotoxic drug or substance
* HIV infection
* Cancer (except basal cell carcinoma)

Primary outcomes:
measure: Steatosis, without fibrosis or inflammation
timeFrame: 12 months
measure: Steatohepatitis, with fibrosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Guilherme FM Rezende, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707108: Survival and Success of MIS C1 Implants- a Field Study
Official title: Survival and Success of MIS C1 Implants- a Field Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failure of Osseointegration of Dental Implant
Keywords: dental implants
bone loss
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the 1-year and 3-year survival and success of MIS® C1 implants with a length of 10-15mm.

Specific Aims

1. To study 1-year and 3-year implant survival rate C1 implants
2. To study 1-year and 3-year implant bone level changes of C1 implants

Detailed description: 10 implants will be allocated to each of the twelve dentists, for a total of 120 implants. One test implant per patient will be allowed into the study for a total of 120 patients.

The following data will be collected for each patient/implant:

1. Patient data including birthdate, health, surgery date.
2. Implant length, diameter
3. Insertion torque
4. Periapical radiographs (at insertion, and twelve months post surgery).
5. Post operative complications and adverse events.
6. Periodontal data around Ramfjord teeth (16, 21, 24, 36, 41, 44) : Plaque index, Gingival Index, Probing depth in six sites and Bleeding on probing in six sites, at baseline and twelve months post surgery.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-75.
2. Patient expresses his wish to restore the missing tooth/teeth with implant therapy.
3. Partial edentulism with available bone height for dental implants ≥ 10mm mm.

Exclusion Criteria:

1. Contraindicating medical conditions such as uncontrolled diabetes, untreated malignancies, pregnancy, previous/current bisphosphonate therapy.
2. Untreated periodontal disease, untreated caries, periapical pathology in contact with the location of the perspective implant.
3. Major bone augmentation in conjunction with implant placement. Localised bone augmentation in conjunction with implant placement, of up to 3 mm on 1-2 aspects of the implant will be allowed.
4. One stage immediate loading/restoration.

Primary outcomes:
measure: Survival Rate
timeFrame: 1 year post implantation
Secondary outcomes:
measure: 1 Year Implant Bone Level Changes
timeFrame: 1 year post implantation
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Jacob Horwitz, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893308: Metabolic Viral Host Properties
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCV Infection
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-05-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both male and female volunteers were recruited. with and without HCV infection, with and without Gaucher disease.

Brief summary: Patients' metabolic properties may affect their immune response. This study aims to assess the effect of hosts' metabolic properties to viral infection.

Detailed description: Blood samples were drawn from patients with Gaucher disease and healthy individuals, with and without HCV. Blood samples were tested for protein specific T cell proliferation, IFNg and IL-10 using ELISPOT assays, serum IFNg, IL-2, IL-6, IL-10 and IL-4 levels. FACS analysis was used for evaluation of lymphocytes subsets.

Eligibility criteria: Inclusion Criteria:

* inform consent

Exclusion Criteria:

* at patients request

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01488708: On Open-Label Study in Participants With Systemic Lupus Erythematosus
Official title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Connective Tissue Disease
Autoimmune Disease
Keywords: Lupus
SLE
Systemic Lupus Erythematosus
Immune System Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 1518
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: The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).


Eligibility criteria: Inclusion Criteria:

* Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)
* Given written informed consent
* Test negative for pregnancy at the time of enrollment
* Agree to use a reliable method of birth control

Exclusion Criteria:

* Unwilling to comply with study procedures
* Any condition that renders the participants unable to understand the nature and scope and possible consequences of the study
* Any condition that in the opinion of the investigator poses an unacceptable risk to the participants if study drug would be administered

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline through 4 years
Secondary outcomes:
measure: Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response
timeFrame: Week 48
measure: Proportion of Participants With a Reduction in Steroid Dose
timeFrame: Baseline through 4 years
measure: Change in SLE Disease Activity Index
timeFrame: Baseline, 4 years
measure: Occurrence of New Severe SLE Flares
timeFrame: Baseline through 4 years
measure: Proportion of Participants With Improvement in Lupus Quality of Life
timeFrame: 4 years
measure: Change in Anti-double-stranded Deoxyribonucleic Acid Level
timeFrame: Baseline, 4 years
Other outcomes:
Locations:
city: Irving
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST
role: STUDY_DIRECTOR
References:
Clinical trial NCT02875808: Cerebrospinal Fluid IL-6, IL-8 and PCT as Early Marker of an Intrathecal Infection in Neurosurgical Patients
Official title: Early Detection of CSF Infection in Neurosurgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrathecal Infection
External Ventricular Drainage Associated Infection
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients with an external ventricular drainage

Brief summary: The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.

Detailed description: The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.

Eligibility criteria: Inclusion Criteria:

* external ventricular drainage
* informed consent

Exclusion Criteria:

* no informed consent
* prior intrathecal infection
* prior systemic infection / sepsis

Primary outcomes:
measure: increasing IL-6, IL-8 and PCT prior to an clinically apparent intrathecal infection/ a detection with the goldstandard
timeFrame: 08/ 2014 - 12/ 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Department of Neurosurgery
Study officials:
References:
Clinical trial NCT00400608: A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
Official title: A Repeat-dose, Open-label, Randomized, Incomplete Block Design in Pediatric Subjects With Asthma, Ages 4 - 11 Years, to Compare Systemic Exposure and Pharmacodynamics of Fluticasone Propionate and Salmeterol Following Advair HFA 45/21mcg (2 Inhalations), ADVAIR® HFA 45/21mcg (2 Inhalations) With Aerochamber Plus Spacer and Advair Diskus 100/50 Twice Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: pediatrics
ADVAIR Inhaler
Asthma
ADVAIR DISKUS
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA

Detailed description: A repeat-dose open label randomized incomplete block design in pediatric subjects with asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following ADVAIR HFA 45/21mcg(2 inhalations), ADVAIR HFA 45/21mcg(2 inhalations) with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 twice daily

Eligibility criteria: Inclusion criteria:

* Subjects with mild asthma
* No significant medical conditions at screen
* Weigh at least 20 kg

Exclusion criteria:

* No clinical abnormalities at screen visit
* Asthma control at least 3 months prior with anti-steroidal medication only

Primary outcomes:
measure: PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS
timeFrame: 3 Weeks
Secondary outcomes:
measure: To assess the exposure of FP and Salmeterol following the doses of ADVAIR HFA and ADVAIR DISKUS as well as assessing safety measurements based on adverse event reporting
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT00845208: Network Support for Treatment of Alcohol Dependence
Official title: Network and Contingency Management for Alcohol Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Network Support
AA
Contingency Management
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-02-18
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Relapse is the most serious problem in alcoholism treatment. The overall aim of the present study was to determine if a treatment directed at changing the patient's social network, from one that reinforces drinking behavior to one that reinforces sobriety, can create the conditions necessary for long-term treatment success. In addition, we intended to determine if explicit reinforcement for this change of social network (Contingency Management or ContM) would be more effective than the same network support intervention without contingent reinforcement for change.


Eligibility criteria: Inclusion Criteria:

* meet DSM-IV criteria for Alcohol Dependence
* at least 18 years old
* Willing to accept random assignment to treatment conditions

Exclusion Criteria:

* acute medical or psychiatric problems that require inpatient treatment
* reading ability below the fifth grade level
* lack of reliable transportation to the treatment site
* excessive commuting distance to site
* current dependence on drugs (except marijuana)

Primary outcomes:
measure: Proportion Days Abstinent
timeFrame: Every 3 months out to 2 years
Secondary outcomes:
measure: Network Support for Abstinence
timeFrame: every 6 months out to 2 years
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Mark D Litt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Litt MD, Kadden RM, Kabela-Cormier E, Petry N. Changing network support for drinking: initial findings from the network support project. J Consult Clin Psychol. 2007 Aug;75(4):542-55. doi: 10.1037/0022-006X.75.4.542.
citation: Litt MD, Kadden RM, Kabela-Cormier E, Petry NM. Changing network support for drinking: network support project 2-year follow-up. J Consult Clin Psychol. 2009 Apr;77(2):229-42. doi: 10.1037/a0015252.
citation: Litt MD, Kadden RM, Tennen H. Treatment response and non-response in CBT and Network Support for alcohol disorders: targeted mechanisms and common factors. Addiction. 2018 Aug;113(8):1407-1417. doi: 10.1111/add.14224. Epub 2018 Apr 20.
Clinical trial NCT03446508: Investigating HD-tDCS in Improving Word Finding and Memory Retrieval in Individuals With MCI
Official title: Investigating Multi-electrode tDCS in Improving Word Finding and Memory Retrieval in Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: High definition transcranial direct stimulation
Mild Cognitive Impairment
Memory
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is attempting to improve word finding and memory retrieval problems persons with mild cognitive impairment (MCI) may have.

Detailed description: This study attempts to improve word finding and memory retrieval problems in persons with mild cognitive impairment (MCI). To remember and find words, the brain has to search for the correct memory and MCI can negatively affect this search. Studies have suggested that low level electrical stimulation of the memory retrieval circuit can improve memory recall. The purpose of this study is to find the exact influence of multi-electrode or High Definition transcranial Direct Current Stimulation (HD-tDCS) by targeting a frontal and a parietal brain area, and their roles in memory retrieval/word finding in MCI. By modulating ongoing activity in 6 sessions of HD-tDCS the study investigates whether HD-tDCS may be used as a way to improve memory retrieval/word finding evaluated by cognitive measures and electroencephalography (EEG) measures before the first session and after the last session of HD-tDCS with a follow-up session 1-month after the stimulation procedure.

Eligibility criteria: Inclusion Criteria:

1. Age between 40 and 90
2. Capable of understanding and signing an informed consent
3. Experiencing severe memory problems

Exclusion Criteria:

1. Severe organic co-morbidity
2. Pace maker / defibrillator
3. Pregnancy

Primary outcomes:
measure: Memory retrieval/word finding assessment.
timeFrame: Baseline (before the first HD-tDCS session), immediate post (immediately after the last HD-tDCS session) and 1 month follow up (1 month after the last HD-tDCS session)
Secondary outcomes:
measure: Electroencephalography (EEG).
timeFrame: Baseline (before the first HD-tDCS session), immediate post (immediately after the last HD-tDCS session) and 1 month follow up (1 month after the last HD-tDCS session)
Other outcomes:
Locations:
city: Richardson
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sven Vanneste, PhD
role: PRINCIPAL_INVESTIGATOR
References: