louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00715325: ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
Official title: Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colon Cancer
Keywords: colonoscopy
disposable
single use
Lead sponsor: Stryker GI Ltd.
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the ProtectiScope CS is capable to perform diagnostic and therapeutic colonoscopy.

Detailed description: The ProtectiScope CS is a disposable-based colonoscope incorporating a miniature video camera,integral light source along with single-use sleeves and application Channels.

The ProtectiScope CS is intended to provide visualization and therapeutic access to the Lower Gastrointestinal Tract, in adult patient populations.

Eligibility criteria: Inclusion Criteria:

* Subject between the ages of 18 and 80
* Subject is indicated for screening colonoscopy
* Subject is willing to sign informed consent form

Exclusion Criteria:

* Subject is suspected, based on radiographic or other clinical grounds, of suffering from one or more of the following: full or partial colonic obstruction; acute abdomen; gross hematochezia; severely ulcerated colon; diverticulitis; severe diverticulosis; toxic megacolon.
* Subject has active cardiac problems and history of heart failure, severe pulmonary diseases renal failure (creatinine \>2) uncontrolled diabetes and any other illness judged by investigator to substantiate exclusion.
* Subject has a history of significant other diseases.
* Subject has a history of psychiatric disorders which would prevent compliance with study instructions
* For female subjects, suspicion of pregnancy
* Subject has received treatment with another investigational drug or device within the past 30 days

Primary outcomes:
measure: To determine the success rate in reaching within working distance of the Cecum with no complications.
timeFrame: 1 month
Secondary outcomes:
measure: To assess the ability to perform routine therapeutic interventions such as biopsies, polypectomies, APC etc. as compared to therapeutic interventions with standard colonoscopes found in the literature.
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Carmel Medical Center
name: Ori Segol, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05817825: Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD
Official title: Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With Opioid Use Disorder Hospitalized With Serious Injection-related Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Serious Bacterial Infections
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Mclean Hospital
First posted: 2023-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The trial is an open-label, single-arm, pilot feasibility trial.
Primary purpose: TREATMENT

Brief summary: This study aims to test a remotely delivered IOP program ("SmartIOP") for OUD patients who are hospitalized for serious injection-related infections. This will be a pilot trial to assess the feasibility of the IOP program and examine OUD-related outcomes following discharge from the hospital.

Detailed description: The aim is to conduct a single-arm pilot study of 20 participants who are hospitalized for serious injection-related infections to complete the newly tailored program. The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach who will provide support and accountability to the participant. The feasibility of the intervention will be established by evaluating recruitment and the acceptability of the program according to a priori benchmarks. The study team will assess the program's preliminary efficacy by evaluating OUD-related outcomes for up to 28 days after discharge from the hospital. The study will be conducted at Brigham and Women's Hospital (BWH), an urban, 793-bed academic medical center located in Boston, MA, and a major teaching hospital for Harvard Medical School.

Eligibility criteria: Inclusion Criteria:

* English-speaking adults aged 18 and above
* Any DSM-5 substance use disorder
* Can identify at least 2 individuals who can act as points of contact following discharge from the hospital

Exclusion Criteria:

* Psychotic disorder, active suicidality, or homicidally
* Condition likely to be terminal during the study period
* Unable to perform consent due to impaired mental status

Primary outcomes:
measure: Feasibility of the intervention program
timeFrame: Immediately Post Intervention
Secondary outcomes:
measure: Illicit opioid use
timeFrame: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up
measure: Retention with MOUD treatment
timeFrame: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02227225: Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly
Official title: Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly Undergoing Non-cardiac Surgery: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Keywords: Postoperative Delirium
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postoperative inpatients

Brief summary: Postoperative delirium has been found to be associated with increased risk of future neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has been found to be associated with an increased risk of postoperative complication including delirium in the elderly.The purpose of this study is determine the factors affecting the incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the Singapore population.


Eligibility criteria: Inclusion Criteria:

* Elderly (\> 65 years) frail patients undergoing non cardiac surgery under anaesthesia lasting for \>60 minutes
* Patient willing and able to complete the requirements of this study.

Exclusion Criteria:

* disabling neuropsychiatric or neurological disorders(including severe dementia, Alzheimer's disease, schizophrenia, severe depression)
* patients suffering from delirium at selection;
* patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial;

Primary outcomes:
measure: postoperative delirium
timeFrame: upto 3 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT01980225: Implantation Rate of Vitrified-warmed Collapsed Blastocysts
Official title: Randomized Controlled Trial Comparing the Implantation Rate of Vitrified-warmed Blastocysts With and Without Artificial Shrinkage Before Vitrification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantation Rate of Vitrified Blastocysts
Keywords: vitrification, blastocyst, artificial shrinkage, collapse
Lead sponsor: Centre for Reproductive Medicine, Belgium
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In our centre, the implantation rate of frozen blastocysts (cryopreserved using vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when compared to data from other observational studies. Retrospective studies have shown that artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the blastocyst just before vitrification can have a positive effect on the survival after warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has shown a similar survival rate but an increase in the implantation rate of collapsed blastocysts compared to non-collapsed blastocysts.

The aim of the study is to investigate the effect of artificial shrinkage by laser-induced collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage embryos in a prospective randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* female age \<39 years
* at least 1 blastocyst available for cryopreservation

Exclusion Criteria:

* sperm origin: testicular or epididymal sperm extraction
* IVM (in-vitro maturation) cycles
* PGD cycles (preimplantation genetic diagnosis)

Primary outcomes:
measure: implantation rate of the embryo in the first frozen transfer cycle
timeFrame: approximately 10 weeks after the first frozen embryo transfer
Secondary outcomes:
measure: survival rate of warmed blastocysts
timeFrame: 0-30 minutes
measure: implantation rate per warmed blastocyst
timeFrame: approximately 10 weeks after first frozen transfer
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine
Study officials:
affiliation: Centre for Reproductive Medicine
name: Lisbet Van Landuyt, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Landuyt L, Polyzos NP, De Munck N, Blockeel C, Van de Velde H, Verheyen G. A prospective randomized controlled trial investigating the effect of artificial shrinkage (collapse) on the implantation potential of vitrified blastocysts. Hum Reprod. 2015 Nov;30(11):2509-18. doi: 10.1093/humrep/dev218. Epub 2015 Sep 12.
Clinical trial NCT01241825: The Effect of Chewing Gum on Small Bowel Transit Time
Official title: The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Transit Times
Keywords: capsule endoscopy
chewing gum
small bowel transit time
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 122
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes for a capsule endoscopy to travel through the stomach and small bowel, and to see if more/less capsule endoscopes reach the large bowel.

Detailed description: The subjects will include patients already referred to us for a capsule endoscopy (CE) in this unit. We have calculated how many patients we need from small bowel transit times from the last 100 patients who had a CE at our centre. We will include 122. These will be randomly divided into two groups. The patients (chew chewing gum) and the controls (do not chew chewing gum).

Eligibility criteria: Inclusion Criteria:

* All out-patients \> 19 years old presenting for capsule endoscopy

Exclusion Criteria:

* Patients on narcotics
* Patients on motility enhancing and/or slowing drugs should stop these at least 5 days prior to the procedure or be excluded from the study.
* Patients, who have proven or suspected obstruction of the bowel.
* Patients, who have had prior small bowel and/or gastric surgery.
* Patients with an ileostomy.
* Patients who have a known and/or have a history of swallowing disorder
* Patients with diabetes and/or hypo-/hyper- thyroidism
* Patients in whom the capsule become impacted at a stricture (these patients will be taken out of the study and given the necessary medical/surgical treatment).

Primary outcomes:
measure: Small bowel transit time
timeFrame: 6 hours
Secondary outcomes:
measure: Gastric transit time, cecal completion rate
timeFrame: 6 hours
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Robert A. Enns, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Eric Lam, Dr.
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Jennifer Telford, Dr.
role: STUDY_DIRECTOR
References:
citation: Ou G, Svarta S, Chan C, Galorport C, Qian H, Enns R. The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2014 Apr;79(4):630-6. doi: 10.1016/j.gie.2013.08.038. Epub 2013 Oct 7.
Clinical trial NCT00168025: Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Official title: A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Agammaglobulinemia
IgG Deficiency
Common Variable Immunodeficiency
Keywords: Immunoglobulin Intravenous
Agammaglobulinemia
Hypogammaglobulinemia
Common variable immunodeficiency
Immunoglobulin G
Children
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 89
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied.

A part of the patients are participating in a pharmacokinetic substudy.


Eligibility criteria: Key Inclusion Criteria:

* Patients with primary immunodeficiency
* Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months

Key Exclusion Criteria:

* Newly diagnosed PID
* Allergic reactions to immunoglobulins or other blood products
* Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
* Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine
* History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

Primary outcomes:
measure: Annualized rate of acute serious bacterial infections
Secondary outcomes:
measure: Number of infections
measure: Number of days out of work / school due to underlying PID
measure: Adverse events temporally associated with study drug infusion
measure: Trough levels of total IgG serum concentrations
Other outcomes:
Locations:
Study officials:
affiliation: CSL Behring
name: Program Director
role: STUDY_DIRECTOR
References:
citation: Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.
citation: Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; IgPro10 in PID study group. Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009 Jan;29(1):137-44. doi: 10.1007/s10875-008-9231-2. Epub 2008 Sep 24.
Clinical trial NCT00586625: Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 861
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety study for bepotastine besilate ophthalmic solution in normal volunteers


Eligibility criteria: Inclusion Criteria:

* Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria:

* No active ocular disease

Primary outcomes:
measure: Ocular Comfort
timeFrame: Day 8 & Day 22
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00192725: Tryptophan Depletion in Acute Mania
Official title: Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: bipolar disorder
acute mania
tryptophan depletion
placebo controlled add-on
Bipolar disorder- manic type
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Beersheva Mental Health Center
First posted: 2005-09-19
Enrollment: 40
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: Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are currently the most widely used drugs for the treatment of depression. Patients with bipolar disorder (BD) who are treated for depression with SSRIs might develop mania, which is believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in remitted depressed patients treated with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have clinical effects. However, RTD was not studied in acutely manic patients and could theoretically have antimanic properties. In this double blind randomized placebo controlled study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania.


Eligibility criteria: Inclusion Criteria:

* Acute mania
* Ability to provide written informed consent

Exclusion Criteria:

* Mixed affective states
* Suicidal ideation
* Uncontrolled systemic illness

Primary outcomes:
measure: Reduction in Young Mania Rating Scale score
timeFrame: Before and after intervention
Secondary outcomes:
measure: Clinical Global Impression
timeFrame: Before and after intervention
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Ehud Klein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03610425: A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
Official title: A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Lead sponsor: HonorHealth Research Institute
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.

Brief summary: Difference in outcome measures with the addition of post-operative evidence based bundle pre-operative education compared to standard pre-operative education given to patients prior to hysterectomy.

Detailed description: The purpose of this project is to evaluate whether there is a difference in outcome measures (length of stay, occurrence of readmission, and patient satisfaction) with the addition of a post-operative evidence-based bundle/standard pre-operative education compared to standard pre-operative education alone that is given to patients prior to a hysterectomy (open, vaginal, or laparoscopic).

Eligibility criteria: Inclusion Criteria:

* Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.

Primary outcomes:
measure: Length of Stay
timeFrame: 0 to 30 days
measure: Occurrence of Re-Admission
timeFrame: 0 to 30 days
measure: Patient Satisfaction
timeFrame: 0 to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Scottsdale Thompson Peak
state: Arizona
Study officials:
References: