louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04641455: Use of Mucolytic Solution Before Upper Endoscopy
Official title: Use of Mucolytic Solution Before Upper Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Gastroscopy
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study was designed to evaluate the effectiveness of the maximum dose of mucolytic solution used before upper endoscopy on the visibility of the gastric mucosa

Detailed description: Residual gastric content containing mucus, bubbles, bile and food particles may limit visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered before upper endoscopy are limited.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years, signed informed consent, diagnostic gastroscopy

Exclusion Criteria:

* age \< 18 years, interventional gastroscopy, known disease of the upper GI tract and/or history of surgery of GI tract, gastroscopy indicated of bleeding, dysphagia or ileus, liver cirrhosis, general anesthesia, allergy to mucolytic solution components, pregnancy

Primary outcomes:
measure: Visibility score" evaluated by blinded performing endoscopist
timeFrame: through study completion, an average of 5 months
Secondary outcomes:
measure: Visibility score" evaluated by two blinded endoscopists using 10 endoscopic images captured during endoscopy
timeFrame: through study completion, an average of 5 months
Other outcomes:
measure: Residual fluid in the stomach evaluated by blinded performing endoscopist
timeFrame: through study completion, an average of 5 months
measure: Duration of endoscopy
timeFrame: through study completion, an average of 5 months
Locations:
city: Ostrava
country: Czechia
facility: Digestive Diseases Center
Study officials:
affiliation: Digestive Diseases Center, Vítkovice Hospital
name: Michal Stepan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883855: Impact of Graft Thickness on Visual Gain After Descemet's Stripping Automated Endothelial Keratoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DSAEK Patient
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Were included in this study eyes who underwent a DSAEK for endothelial dysfunctions indication (mainly acquired after phacoemulsification or for Fuchs dystrophy) between early 2012 and mid 2015 at CHR Metz-Thionville (Mercy Hospital)

Brief summary: The aim of this study to determinate if there is a correlation between visual acuity gain in patients who underwent a Descemet's stripping automated endothelial keratoplasty (DSAEK) corneal keratoplasty and the central thickness of the graft.

Detailed description: Were included in this study eyes who underwent a DSAEK for endothelial dysfunctions indication (mainly acquired after phacoemulsification or for Fuchs dystrophy) between early 2012 and mid 2015 at CHR Metz-Thionville (Mercy Hospital) Were excluded eyes presenting pathologies (e.g. Age-Related Macular Degeneration, or diabetic macular edema) which are known to induce visual acuity decrease, non-related to the success of the graft and graft failure cases. Central graft thickness was measured in Anterior Segment Optical Coherence Topography (AS-OCT RS-3000 Nidek). Visual acuity gain was defined by the differential between pre-operative visual acuity (VA) and post operative best corrected visual acuity (BCVA) obtained during post-operative visits.

Eligibility criteria: Inclusion Criteria:

* patients with endothelial dysfunctions indication

Exclusion Criteria:

- eyes presenting pathologies (e.g. Age-Related Macular Degeneration, or diabetic macular edema) which are known to induce visual acuity decrease, non-related to the success of the graft and graft failure cases

Primary outcomes:
measure: Visual acuity gain after DSAEK lamellar keratoplasty
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00265655: Satraplatin for Patients With Metastatic Breast Cancer (MBC)
Official title: Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2005-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.

Detailed description: This is a Phase II open label, nonrandomized study for patients with metastatic breast cancer.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Eligibility criteria: 1. Has cytologically or pathologically confirmed breast cancer that is metastatic
2. Must have had prior HerceptinÒ therapy if patient has HER2+ (overexpressing) breast cancer. HER2 is considered overexpressed if it is 3+ by IHC or if the gene is amplified by Flourescence in situ hybridization (FISH)
3. Has had no more than 1 prior chemotherapy regimen for MBC
4. Has had no prior platinum-based therapy
5. Has an ECOG Performance Status (PS) 0-2

Primary outcomes:
measure: To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer
timeFrame: 1 year
Secondary outcomes:
measure: To determine duration of response
timeFrame: 6 weeks
measure: To determine progression-free survival (PFS)
timeFrame: 1 year
measure: To determine 1-year survival
timeFrame: 1 year
measure: To evaluate the toxicities of satraplatin in MBC patients
timeFrame: 6 weeks
measure: In patients with nonmeasurable MBC, to assess the clinical utility of serum CA27.29 (or CA15.3) and circulating tumor cells as predictors of time to disease progression
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: US Oncology
state: Texas
Study officials:
affiliation: US Oncology
name: Joyce O'Shaughnessy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05580055: Blood Testing at Entia
Official title: Blood Donation of Healthy Blood for Prototype Testing at Entia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers, enrolled by invitation only

Brief summary: The investigators are recruiting healthy volunteers to donate a finger prick blood sample or a small venous sample to Entia for the further development and testing of our blood analyser. The venous samples are taken by a registered nurse hired via a third party company. The results of the blood tests are not informed to the participants unless they explicitly ask for it.


Eligibility criteria: Inclusion Criteria:

* aged 18 years and above
* healthy with no known conditions

Exclusion Criteria:

* Has a known health condition, including blood-borne diseases
* Inadequate understanding of the English language (written and verbal) that would require a translator

Primary outcomes:
measure: The difference in counts of the device tested blood vs the gold standard tested blood.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Entia Ltd
Study officials:
References:
Clinical trial NCT06809855: The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar
Official title: The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar(Split Mouth Technique)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dexamethasone Administration
Post Extraction Complication
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient resembles the study group in which the patient is injected intramuscularly by a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar on one side and control group on which the impacted mandibular third molar on the other side is removed without usage of 8mg dexamethasone.
Primary purpose: PREVENTION

Brief summary: Evaluating the effectiveness of using a single immediate postoperative intramuscular Dexamethasone injection on pain, swelling, trismus and tissue healing in the first seven days.

Methods: A split mouth technique on 16 patients with bilateral similar impacted mandibular third molar were extracted; one side was given 8mg intramuscular injection of dexamethasone (study group) and the other side wasn't given injection (control group) and compare of the two sides were done in the following seven days.


Eligibility criteria: Inclusion Criteria:

* bilateral similar impacted lower third molar
* willing to do surgical extraction

Exclusion Criteria:

* Patients who are not fulfill the inclusion criteria
* allergic to dexamethasone
* who has medical diseases
* taking any medications
* pregnant or lactating women

Primary outcomes:
measure: post operative pain changes
timeFrame: each participant was seen at 1st, 3rd and 7th post-operative days
measure: Change in post operative swelling
timeFrame: each participant was seen at 1st, 3rd and 7th post-operative days
measure: Post operative Change in mouth opening
timeFrame: each participant was seen at 1st, 3rd and 7th post-operative days
Secondary outcomes:
measure: Tissue healing
timeFrame: Healing was assessed on the 7th postoperative day
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Baghdad
Study officials:
References:
Clinical trial NCT01270555: Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults
Official title: Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Substance Use Disorder (SUD)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients 18 years old or older, up to 60 years old.
* Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
* Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)

Exclusion Criteria:

* Any clinically unstable medical condition
* Clinically significant abnormal baseline laboratory values
* Mental retardation (I.Q. \<75) or Organic brain disorders
* Seizure disorder
* Patients with a history or an eating disorder including anorexia or bulimia nervosa
* Pregnant or nursing females
* Patients with current bipolar disorder
* Psychotic disorder of any type
* Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics)
* Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy)
* Patients demonstrating active withdrawal from substance abuse

Primary outcomes:
measure: Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
timeFrame: baseline and six weeks
measure: Self-reported Weekly Substance Use
timeFrame: baseline and six weeks
Secondary outcomes:
measure: Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity
timeFrame: baseline and six weeks
measure: Clinical Global Impressions (CGI) Scale of ADHD Severity
timeFrame: baseline and six weeks
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: baseline and six weeks
measure: Hamilton Depression Scale (HAM-D)
timeFrame: baseline and six weeks
measure: Beck Depression Inventory (BDI)
timeFrame: baseline and six weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01052155: Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients
Official title: Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Controlled substances
Opioids
Benzodiazepines
Illicit drugs
Immunoassay drug testing
Point of care (POC) testing
Liquid Chromatography Tandem Mass Spectometry
Lead sponsor: Pain Management Center of Paducah
Sponsor class: OTHER
Collaborators: name: Millennium Laboratories
First posted: 2010-01-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic pain management with or without controlled substance therapy.

Brief summary: Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)

Detailed description: Recruitment is indicated in patients with chronic pain management with or without controlled substance therapy.

This is a diagnostic accuracy study performed in an interventional pain management referral center in the United States.

Eligibility criteria: Inclusion criteria:

• Chronic pain management with or without controlled substance therapy.

Exclusion criteria:

None

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ambulatory Surgery Center, Paducah
name: Laxmaiah Manchikanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manchikanti L, Malla Y, Wargo BW, Fellows B. Comparative evaluation of the accuracy of benzodiazepine testing in chronic pain patients utilizing immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing. Pain Physician. 2011 May-Jun;14(3):259-70.
citation: Manchikanti L, Malla Y, Wargo BW, Fellows B. Comparative evaluation of the accuracy of immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing (UDT) opioids and illicit drugs in chronic pain patients. Pain Physician. 2011 Mar-Apr;14(2):175-87.
citation: Manchikanti L, Malla Y, Wargo BW, Cash KA, Pampati V, Damron KS, McManus CD, Brandon DE. Protocol for accuracy of point of care (POC) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (LC/MS/MS). Pain Physician. 2010 Jan-Feb;13(1):E1-E22.
Clinical trial NCT00227955: Comparing Various Treatments for Achieving and Maintaining Remission of Depression
Official title: Maintenance Therapies in Recurrent Depression-Study I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Major depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.

Detailed description: Depression is a serious illness that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left untreated, depression symptoms can last for years, and may worsen as time goes on. Even with treatment, however, it is possible for depression to recur. Remission is a main goal in the treatment of depression and it may be accomplished through various strategies. This study will evaluate the effectiveness of five combinations of treatments, including medication therapy and psychotherapy, in maintaining remission of depression symptoms.

All participants in this study will first be treated with imipramine for 7 to 11 months. Once remission of depression symptoms has been achieved and maintained for 20 weeks, participants will be randomly assigned to one of the following five maintenance treatments for 36 months: psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy alone; medication clinic treatment plus imipramine; or medication clinic treatment plus placebo. Assessments will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will include the time it takes for depression symptoms to recur, as well as scores on depression and mania severity scales.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of recurrent major depression

Exclusion Criteria:

* Unstable medical illness
* Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary)

Primary outcomes:
measure: Time to recurrence of depression symptoms
Secondary outcomes:
measure: Measured at Months 7, 11, and 36: Score on the Raskin Depression and Mania Severity Scales
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Cinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ellen Frank, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03484455: Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
Official title: A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: Organ Recovery Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-30
Enrollment: 142
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: Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).

Detailed description: Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* De novo liver transplant recipient
* Written informed consent required

Exclusion Criteria:

* Subject is a multi-organ transplant recipient
* Subject is antibodies blood group (ABO) liver incompatible
* Subject has severe systemic infection
* Subject is Human Immunodeficiency Virus (HIV) positive
* Subject has acute/fulminant liver failure
* Subject is pregnant

Primary outcomes:
measure: Number of patients in each arm with Early Allograft Dysfunction (EAD)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Strong Memorial Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Hospital
state: Virginia
Study officials:
affiliation: Organ Recovery Systems
name: Stan Harris
role: STUDY_DIRECTOR
affiliation: Organ Recovery Systems
name: Matthew Copithorne
role: STUDY_CHAIR
References: