louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04234932: Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
Official title: Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Glaucoma, Open-Angle
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate changes in optical coherence tomography angiography of the optic nerve and macula following topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution.


Eligibility criteria: Inclusion Criteria:

* Normal ocular health

Exclusion Criteria:

* Females who are or may be pregnant or who are nursing
* Uncontrolled hypertension
* Allergy to netarsudil or latanoprost

Primary outcomes:
measure: Peripapillary capillary perfusion density
timeFrame: 90 minutes
Secondary outcomes:
measure: Macular capillary perfusion density
timeFrame: 90 minutes
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of the Incarnate Word
state: Texas
Study officials:
References:
Clinical trial NCT03077932: An App to Aid in Transitioning Off Opioid Medication
Official title: A Smartphone App to Facilitate Buprenorphine Discontinuation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Use Disorder
Opiate Withdrawal Syndrome
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators propose to develop a smartphone app (called BetterOFF) that will help patients manage opioid withdrawal during opioid medication taper and detoxification. The BetterOFF smartphone intervention will be a resource patients can access anytime and anywhere. If the BetterOFF intervention were to be effective in helping patients discontinue opioid medication, it could be integrated into the standard of care of office-based clinical practices, as well as substance use programs, thereby having a substantial public health impact.

Detailed description: Many of the growing number of patients prescribed long-term opioid medication (for a variety of reasons including a history of illicit opioid use or management of chronic pain) will express an interest in discontinuing medication. However, many patients, physically dependent on opioids, fear the withdrawal symptoms that inevitably occur with opioid medication discontinuation and will experience a decrease in their self-efficacy for abstinence at the end of a taper. As a result, tapering is often slow and done hesitantly, and relapse rates after an opioid taper are high and associated with broad consequences, including significant negative physical, mental, and social problems. Even with optimal tapering protocols, patients need novel approaches to manage the discontinuation of opiate agonist treatment. Given this important gap in opioid treatment delivery, we propose to develop a theoretically-driven, smartphone-delivered intervention (Better Off app) to help patients effectively manage the experience of opioid medication discontinuation.

Eligibility criteria: Inclusion Criteria:

* between 18-65 years of age;
* currently receiving opioid medication;
* interesting in discontinuing opioid medication
* has a smartphone

Exclusion Criteria:

* non-English speaking.

Primary outcomes:
measure: Opiate use
timeFrame: 1 month post-taper
Secondary outcomes:
measure: Fear of withdrawal symptoms
timeFrame: 1 month post-taper
measure: Opiate Withdrawal
timeFrame: Baseline to 1 month post-taper
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Ana Abrantes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00383032: Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction
Official title: Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2006-10-02
Enrollment: 72
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Data from other countries have suggested that oral mifepristone used as a cervical ripening agent may decrease induction to delivery time in midtrimester inductions. To our knowledge, there are no trials comparing mifepristone to laminaria in a standard clinical setting with standardized misoprostol induction protocol to examine the issue of induction to delivery time. We hypothesize that mifepristone will work at least as well as laminaria for midtrimester cervical ripening prior to induction of labor with misoprostol.


Eligibility criteria: Inclusion Criteria:

* pregnant women with fetal anomalies, aneuploidy, or demise at 15-22 weeks gestation
* age greater than 16
* able to speak English

Exclusion Criteria:

* prior uterine scar or
* allergy or history of bad reaction to any of the study drugs or
* history of chronic adrenal failure or
* porphyria or
* concurrent long-term corticosteroid treatment

Primary outcomes:
measure: induction to delivery time
Secondary outcomes:
measure: pain
measure: delivery within 24 hours
measure: need for post-partum D&C
measure: adverse events
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Karen George, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4.
Clinical trial NCT05706532: Cardiovascular and Cerebrovascular Control in Healthy Subjects
Official title: Cardiovascular and Cerebrovascular Control in Healthy Adult Subjects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Autonomic Nervous System
Cerebral Autoregulation
Keywords: autonomic nervous system
heart rate variability
cerebral autoregulation
peripheral resistances
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.

To this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.

The interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.


Eligibility criteria: Inclusion Criteria:

* age \>18
* sinus rhythm
* informed consent signed

Exclusion Criteria:

* age \<18
* presence of autonomic nervous system diseases or dysfunctions

Primary outcomes:
measure: Evaluate the state and interactions of autonomic function and cerebrovascular control
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
References:
Clinical trial NCT02726932: Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery
Official title: Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis
Keywords: Peritonitis
Inflammatory Markers
Patient Outcome Assessment
Classification
Multiple Organ Failure
Intraabdominal Infections
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients operated for complicated intra-abdominal infection in a single university hospital.

Brief summary: The purpose of this study is to analyze the correlation between intra-abdominal view and patient recovery in secondary peritonitis, and to create a new classification based on these results. Additionally, a variety of inflammatory markers from blood samples will be collected in order to analyze their correlation with patient outcomes.


Eligibility criteria: Inclusion Criteria:

* adult patients \> 18 years old
* operated for complicated intra-abdominal infection

Exclusion Criteria:

* another diagnosis requiring ICU level care at the same time
* acute pancreatitis
* acute mesenteric ischaemia due to occlusion in superior mesenteric artery or vein
* peritonitis due to timely diagnosed trauma
* missing informed consent or inability to understand it

Primary outcomes:
measure: Mortality
timeFrame: 90 days
measure: ICU admission
timeFrame: 90 days
measure: Length of hospitalization
timeFrame: 90 days
measure: Reoperations
timeFrame: 90 days
measure: Complications
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital, Abdominal Center, Gastrointestinal Surgery
name: Panu Mentula, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Tolonen M, Sallinen V, Leppaniemi A, Backlund M, Mentula P. The role of the intra-abdominal view in complicated intra-abdominal infections. World J Emerg Surg. 2019 Mar 29;14:15. doi: 10.1186/s13017-019-0232-7. eCollection 2019.
Clinical trial NCT01702532: Nicotine Mouth Film for Craving Relief.
Official title: A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: provoked craving
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 320
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: Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.


Eligibility criteria: Inclusion Criteria:

* BMI within the range of 19-35 kg/m2;
* Current cigarette smokers who have smoked regularly daily for at least a year,
* Participants who smoke their first cigarette more than 30 minutes after waking up

Exclusion Criteria:

* Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
* Any participant whose CO level rises during the sequestration period (i.e., the subject's two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.

Primary outcomes:
measure: The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds
timeFrame: Pre-dosing post-provocation to 50 seconds
Secondary outcomes:
measure: The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
timeFrame: Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Los Angeles Clinical Trials
state: California
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06401200: Radiographic and Clinical Evaluation In Bar
Official title: Marginal Bone Loss and Soft Tissue Health Around Implants in Selective Laser Melted Versus Milled Cobalt Chromium Bar Retained Mandibular Overdenture:(Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental
Keywords: SLM
Milled
Bar overdenture
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the aim of this study was to assess the marginal bone loss and soft tissue outcomes of milled and selective laser melted cobalt chromium bar retaining implant mandibular overdenture. Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.

Detailed description: Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.

Eligibility criteria: Inclusion Criteria:

* completely edentulous patient.
* age range (50-60) years old.
* adequate bone volume in canine area bilaterally to receive implant of 3.7 mm diameter and 13mm length verified by CBCT for all patients.
* sufficient inter arch space (13-14mm) to accommodate bar construction
* normal maxillo-mandibular relation-ship
* (Angel's class I)
* proper oral hygiene

Exclusion Criteria:

* patients with metabolic or systemic disease that may affect osseointegration.
* history of radiation therapy.
* history of bisphosphonate intake
* heavy smoking and bad habits as bruxism.

Primary outcomes:
measure: Radiographic Evaluation (Vertical Marginal bone loss in millimeters)
timeFrame: at 6 and 12 months
Secondary outcomes:
measure: Probing depth in millimeters.
timeFrame: at 0,6 and 12 months
measure: modified Plaque Index.
timeFrame: at 0,6 and 12 months follow up
measure: modified Gingival Index
timeFrame: at base line, 6 and 12 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
state: Minia
Study officials:
affiliation: Minia University
name: Eman A Asfahani, PHD
role: STUDY_CHAIR
affiliation: Minia University
name: Hussein A Elhady, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT01357200: Feeding Trial in the Obese Critical Care Population
Official title: Enteral Formula Tolerance in the Obese Critical Care Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Obesity
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill obese adults

Brief summary: This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.

Detailed description: Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Surgical or Medical intensive care unit (ICU) patient
* Body mass index (BMI) ≥ 30

Exclusion Criteria:

* pregnant or lactating
* unable to access gastrointestinal (GI) tract for feeding via tube
* other contraindication to tube feeding
* admitted with burns
* severe head trauma

Primary outcomes:
measure: time to feeding goal achievement
timeFrame: up to 5 days
Secondary outcomes:
measure: gastrointestinal measures assessment
timeFrame: daily for up to 11 days
measure: percent of nutrition goal met
timeFrame: up to 5 days
measure: serum biochemical markers assessment
timeFrame: daily for up to 11 days
measure: assessment of frequency and nature of adverse events
timeFrame: daily for up to 11 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References:
Clinical trial NCT05008900: Timing of Post-prostatectomy PSMA Imaging
Official title: A Phase II Randomized Feasibility Study Comparing Early Salvage Radiotherapy Versus Surveillance With Delayed Repeat PSMA PET/CT Imaging in Patients Presenting With Early Biochemical Relapse of Prostate Cancer Following Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Prostatectomy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will randomize patients presenting with early BCR with a negative baseline PSMA PET/CT, to upfront SRT or surveillance. Early BCR is defined as a PSA relapse of \>0.1 to \<0.3 ng/mL. Patients in the surveillance arm will be monitored with PSA every 3 months. A repeat PSMA PET/CT will be undertaken when the PSA reaches a target level of \>0.5 to \<1.0 ng/mL. Both early radiation treatment and surveillance with repeat PSMA PET/CT imaging are within patterns of practice locally; therefore, the investigators believe that there is clinical equipoise on this subject.


Eligibility criteria: Inclusion Criteria:

* Histologically-proven prostate cancer
* pT1-T4 pN0/Nx cM0
* PSA at BCR \>0.1 - \<0.3 ng/mL post-radical prostatectomy
* PSMA PET/CT negative at BCR post radical prostatectomy
* Planned SRT to prostate bed +/- pelvic lymph nodes
* ECOG 0 or 1
* Age ≥ 18 years
* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

Exclusion Criteria:

* Active or post prostatectomy androgen deprivation use
* Previous pelvic radiotherapy
* Other contraindications to radiotherapy

Primary outcomes:
measure: Surveillance with delayed PSMA PET scan
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
Study officials:
References:
Clinical trial NCT01105000: Human Papilloma Virus (HPV) Knowledge and Attitudes and the Role of (SES) Socioeconomic Status and Ethnicity
Official title: The Role of Socioeconomic Status and Ethnicity in Influencing HPV Vaccine Knowledge and Attitudes in Adult Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV
Keywords: HPV
HPV vaccine
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women attending Gynecology clinic

Brief summary: This is a survey study to assess the vaccination knowledge and attitudes of women in an inner city Gynecology clinic. Results of this study will help determine which factors influence vaccination knowledge and attitudes. This may help improve future vaccination tools.


Eligibility criteria: Inclusion Criteria:

* all women attending gynecology clinic

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02554500: Bone Microcirculation After Remote Ischemic Preconditioning
Official title: Effects of Remote Ischemic Preconditioning in Bone Microcirculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intact Scaphoid Bone
Intact Metacarpal Bone
Fractured Scaphoid Bone
Fractured Metacarpal Bone
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning (RIPC) on scaphoid bones and metacarpal bones and metatarsal bones in a human in-vivo setting for the first time.


Eligibility criteria: Inclusion Criteria:

* Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone.
* Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
* Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid bone.
* Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.

Exclusion Criteria:

* below 18 years of age
* scar tissue above measuring focus
* osteoporosis or comparable bone disease
* medication that influences bones

Primary outcomes:
measure: Change in microcirculation (composite outcome measure)
timeFrame: Baseline and 1 minute post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Tobias Kisch, MD
role: PRINCIPAL_INVESTIGATOR
References: