louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00249574: Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1
Official title: HCV Treatment of IDUs After Buprenorphine Stabilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Heroin Dependence
Keywords: heroin addiction
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Organization to Achieve Solutions in Substance Abuse (OASIS)
First posted: 2005-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis C after stabilizing them on buprenorphine.

Detailed description: This is a prospective pilot safety study based on the hypothesis that active, street-recruited heroin users can be successfully treated for hepatitis C after stabilization on buprenorphine. Eligible subjects will be actively using heroin and have hepatitis C viremia; screening will occur at street-based sites like syringe exchange programs. Those who are eligible will sign informed consent, and then be asked to attend 3 weekly educational sessions about hepatitis C and addiction as well as undergo an intake interview. After this, subjects will be inducted onto buprenorphine/naloxone combination therapy (Suboxone) and receive this medication for 12-24 weeks. Once reaching the 12-24 week study time point, subjects will have the option of a 12-week Suboxone taper, or instead of undergoing 6-12 months of hepatitis C treatment with pegylated interferon and ribavirin while being maintained on Suboxone. Once completing hepatitis C treatment, subjects will undergo a 24-week Suboxone taper, or be transitioned to outpatient Suboxone therapy by a medical provider.

Eligibility criteria: Inclusion Criteria:

* Active heroin or other illicit opioid use
* Active hepatitis C
* No medical or psychiatric contraindications
* Able to sign informed consent

Exclusion Criteria:

* No opiate dependence
* Age \<18
* Unable or uninterested in attending weekly group sessions

Primary outcomes:
measure: Safety assessments
Secondary outcomes:
measure: Effectiveness of medication
measure: Compliance
Other outcomes:
Locations:
city: Oakland
country: United States
facility: O.A.S.I.S.
state: California
Study officials:
affiliation: Organization to Achieve Solutions in Substance Abuse (OASIS)
name: Diana L Sylvestre, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03184974: Open Lung PEEP in Thoracic Surgery
Official title: Individualized Open Lung PEEP in Thoracic Surgery: A Prospective Multicenter Observational Study in 17 Spanish Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Ventilation Therapy; Complications
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 690
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 one lung ventilation during thoracic surgical procedures

Brief summary: During thoracic surgical procedures, while ventilating with a protective tidal volume, an open lung approach consisting of a recruitment maneuver followed by an individualized positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance (Open-lung PEEP, OL-PEEP) would decrease driving pressure. To test this hypothesis, we performed a multicenter observational study in 17 Spanish teaching hospitals of patients undergoing one lung ventilation (OLV). In addition, we analyzed the association between the driving pressure and the prevalence of postoperative pulmonary complications (PPCs), and finally the association between the individualized PEEP and relevant patient preoperative or intraoperative variables.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing one lung ventilation

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: Postoperative. One week
Secondary outcomes:
measure: Descriptive analysis of the open lung PEEP
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05547074: A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma
Official title: Development and Validation of a New Prognostic Score Model Combining TNM Stage With Immune Risk Factors for Postoperative Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms Pancreatic
Keywords: pancreatic ductal adenocarcinoma
prognostic model
tumor-infiltrating immune cell
staging
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 302
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PDAC cases that underwent surgical resection (including radical or palliative surgery) from January 2016 to August 2019 were retrospectively reviewed and the survival follow-up (more than 14 months) was performed.

Brief summary: The AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. This study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative PDAC patients.


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed PDAC
2. Achievement of surgical resection (including radical or palliative surgery)

Exclusion Criteria:

1. Lost to follow-up
2. Simultaneous presence of other tumors
3. Died in three months after surgery

Primary outcomes:
measure: overall survival
timeFrame: after pancreatic cancer surgery until october 31, 2020
Secondary outcomes:
measure: disease-free survival disease-free survival disease-free survival disease-free survival
timeFrame: after pancreatic cancer surgery until october 31, 2020
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital, Medical College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital, Medical College of Zhejiang University
name: Tingbo Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00072774: Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Three Fixed Doses (100 Mg, 200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depressive Disorder, Major
Melancholia, Involutional
Depression, Involutional
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-11-13
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.


Eligibility criteria: Inclusion Criteria:

* Outpatients
* Sexually active women participating in the study must use a medically acceptable form of contraception
* Subjects must have a primary diagnosis of major depressive disorder

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
citation: Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
citation: McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
citation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.
citation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
Clinical trial NCT02364674: Transplant Optimization Using Functional Imaging
Official title: Transplant Optimization Using Functional Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis Obliterans
Lung Transplant Rejection
Keywords: HRCT
High Resolution Computed Tomography scans
Functional Respiratory Imaging
FRI
Computed Tomography
CT
Bronchiolitis Obliterans
BOS
Lung Transplant
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of BOS over time will be monitored using non-rigid image registration methods.


Eligibility criteria: Inclusion Criteria:

* Male or female patient ≥ 18 years old
* Written informed consent obtained
* Patient who had undergone a lung transplant a year ago or more.
* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
* The patient must be able to perform the lung monitoring at home.

Exclusion Criteria:

* Pregnant or lactating female
* Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Primary outcomes:
measure: Airway Volume (iVaw)
timeFrame: 12 months
measure: Airway Resistance (iRaw)
timeFrame: 12 months
measure: Specific Airway Volume (siVaw)
timeFrame: 12 months
measure: Specific Airway Resistance (siRaw)
timeFrame: 12 months
measure: Lobe volumes (iVlobes)
timeFrame: 12 months
measure: Air trapping
timeFrame: 12 months
measure: Internal Lobar Airflow Distribution
timeFrame: 12 months
measure: Low Attenuation or Emphysema Score
timeFrame: 12 months
measure: Blood Vessel Density or Fibrosis Score
timeFrame: 12 months
measure: Airway Wall Thickness
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Gibson
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: David Lederer, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: James Lee, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809874: Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects
Official title: Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Lipaemia
Postprandial Incretins
Postprandial Inflammation
Keywords: Postprandial Period
Postprandial Lipaemia
Incretins
Subclinical Inflammation
Obesity
Atherosclerosis
Triglyceride
Lipoproteins
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Obesity Research Centre
name: Nordic Centre of Excellence
name: Arla Foods
First posted: 2008-12-17
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.

Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.


Eligibility criteria: Inclusion Criteria:

* BMI \>30 kg/m2 \& \<45 kg/m2

Exclusion Criteria:

* Diabetes
* lipid lowering drugs
* Liver-, Kidney- and/or Heart Disease
* Serious Hypertension (160/110)

Primary outcomes:
measure: Triglyceride
timeFrame: 0h- 1h- 2h- 4h- 6h- 7h- 8h postprandial
Secondary outcomes:
measure: Incretins
timeFrame: 0h -1h -2h -4h -6h -7h -8h Postprandial
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Nutrion
Study officials:
affiliation: Department of Endocrinology and Metabolism, Aarhus University Hospital
name: K Hermansen, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05796674: Clareon IOL Retrospective Data Collection
Official title: Post Market Clinical Follow-up (PMCF) Pilot Study for the Clareon UVA IOLs Using Retrospective Data Collection From the WaveTec AnalyzOR Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aphakia
Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 1090
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).

Information is entered into the WaveTec AnalyzOR Database by medical professionals post cataract surgery.

Brief summary: The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.

Detailed description: In this retrospective postmarket study, the WaveTec AnalyzOR Database will be reviewed. All available data that meet the data selection criteria as of the data cutoff will be analyzed.

Eligibility criteria: Data Selection Criteria (eyes):

* Must have undergone cataract extraction by phacoemulsification with implantation of a Clareon UVA IOL (CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, or CCA0T0) using the WaveTec ORA System.
* Must have a BCDVA in the WaveTec AnalyzOR Database from ≥ 10 days after surgery.
* Predicted residual refractive error spherical equivalent (SE) ≤ 0.75 D.

Primary outcomes:
measure: Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit
timeFrame: Month 1 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Research, LLC
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Lead, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT04895774: Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
Official title: Stool Collection From Healthy Donors for the ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota: Bacteria / Host Interaction Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbial Colonization
Lead sponsor: Nutri & Co
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The research will be carried out on 4 healthy volunteers. The research will be carried out by the coordinating team of the INRAE MetaGenoPolis Unit.

Brief summary: To design and understand the mechanism of action of different combinations of nutraceuticals coupling bacteria, fibers and polyphenols, which can act on the 4 pillars simultaneously via an innovative ex-vivo model approach coupled with functional and quantitative metagenomics.

Detailed description: The objective of the study is to collect fresh stools from 4 healthy volunteers, in order to study the mechanism of action of probiotic strains, polyphenols and fibers, alone or in combinations. These fresh stools will be cultured in vitro in fermenters, and the samples taken at different culture times will be analyzed in terms of microbial composition (shotgun metagenomic analysis) and their cellular activity (functional metagenomic analysis).

Eligibility criteria: Inclusion Criteria:

* Person with a low fiber diet (\<17g / day).

Exclusion Criteria:

* Taking antibiotics and / or transit modulators in the 3 months preceding the sample;
* Colonoscopy in the last 3 months;
* Person under legal protection measure (curators, tutors, etc.).

Primary outcomes:
measure: Bacterial growth
timeFrame: Day 1 to Day 15
measure: PH evolution
timeFrame: Day 1 to Day 15
measure: Quantity of Co2 production
timeFrame: Day 1 to Day 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02315274: Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
Official title: Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes, Pregnancy
Keywords: Type 1 diabetes
Pregnancy
Glycemic variability
Between visit contact
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.
Primary purpose: TREATMENT

Brief summary: Hypothesis:

Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.

Detailed description: Patient will have weekly contact through the Mayo Patient On-line Services to send in their blood glucose readings and to receive recommendations back regarding insulin dose changes. Information will be analyzed regarding the magnitude of change in insulin dosing and in glycemic variability.

Eligibility criteria: Inclusion Criteria:

* Adult pregnant women with type 1 diabetes utilizing either an insulin pump or multiple daily injection insulin program to manage their diabetes

Inclusion Criteria:

* Female with type 1 diabetes and pregnancy
* EDD prior to November 15, 2014
* 18 years of age and older
* On insulin pump or multiple daily injection insulin program
* Signed patient consent form

Exclusion Criteria:

* Exclusion Criteria:

  * Female with type 1 diabetes and pregnancy under age 18 or older than age 45
  * Female with type 2 diabetes or gestational diabetes and pregnancy

Primary outcomes:
measure: Glucose variability
timeFrame: Baseline to 9 months
Secondary outcomes:
measure: Changes is severe hypoglycemia
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT05474274: PAIN (Pain AI iNtervention) Platform for Patients at Home
Official title: Development of the PAIN (Pain AI iNtervention) Platform for Patients at Home
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pain
Keywords: Physiological markers for pain intensity
AI to objectively measure pain intensity
Medication over-use
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 or older undergoing low-risk outpatient plastic surgery procedures with expected pain intensities ranging from mild to severe will be included in the study.

Brief summary: The purpose of this research is to identify physiological markers to determine pain intensity and build an Artificial Intelligence (AI) enabled system to objectively measure pain intensity. Researchers hope to personalize pain medication regimens to help prevent medication over-use.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing low-risk outpatient plastic surgery procedures with expected pain intensities ranging from mild to severe.

Exclusion Criteria:

* Patients with treated or untreated cardiopulmonary syndromes.
* Patients with treated or untreated ophthalmologic pathologies.
* Patients with skin pathologies that prevent us from using the TENS device.
* Patients with pathologies or conditions preventing them from appropriately using their voice.
* Patients with barriers to effective communication.
* Patients with poor digital literacy.
* Patients incapable of taking oral medication.
* Patients who are currently taking medical therapy for chronic pain.
* Patients with a previous diagnosis of severe anxiety disorders.
* Patients who are immobile at baseline.

Primary outcomes:
measure: Using machine Learning for Postoperative Pain Pain Prediction
timeFrame: 8 months
Secondary outcomes:
measure: Physiologic variable %Δ defining the physiologic biomarker's change in measurements after pain medication
timeFrame: 8 months
measure: Physiologic variable absolute Δ defining the physiologic biomarker's change in measurements after pain medication
timeFrame: 8 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Antonio Forte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: