louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00827736: Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
Official title: Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anal Fissure
Keywords: anal fissure
fissura ani
botox
ISDN
Nitric oxide donor
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic

Exclusion Criteria:

* pregnancy
* previous anal surgery
* Crohn's disease
* systemic causes of an anal fissure

Primary outcomes:
measure: macroscopic healing of the fissure
timeFrame: 4 months
Secondary outcomes:
measure: complications
timeFrame: 12 months
measure: fissure recurrence
timeFrame: 12 months
measure: fissure related pain
timeFrame: 12 months
measure: costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord Holland
Study officials:
affiliation: Onze Lieve Vrouwe Gasthuis
name: Michael Gerhards, MD
role: STUDY_DIRECTOR
References:
citation: Brisinda G, Maria G, Bentivoglio AR, Cassetta E, Gui D, Albanese A. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999 Jul 8;341(2):65-9. doi: 10.1056/NEJM199907083410201.
Clinical trial NCT02840513: Smartphone App and CO Self-monitoring for Smoking Cessation
Official title: Support by Smartphone App and Carbon Monoxide Self-monitoring for Smoking Cessation: a Randomised Controlled Trial Nested Into the Swiss HIV Cohort Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Smoking
HIV
Keywords: Smartphone app
CO self-monitoring
Lead sponsor: Basel Institute for Clinical Epidemiology and Biostatistics
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 81
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial is going to evaluate whether an intervention consisting of a smartphone application to assist smokers living with HIV to quit in combination with CO self-monitoring compared to stop smoking counselling by physicians during usual care results in higher self-reported and biochemically verified smoking cessation rates at 6 months.

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Eligibility criteria: Inclusion Criteria:

HIV-infected smokers ≥ 16 years and smoking ≥ 3 cigarettes /day enrolled into the Swiss HIV Cohort Study Willingness to quit smoking Speaking one or more of offical Swiss national languages or English Users of smartphone (specifically iPhone 5, 5c, 5s, 6, 6+ running iOS Version 8.0+; smartphones with resolution of at least 800x400 pixels running, Android Version 5.0+, and Android smartwatches) Informed consent

Exclusion Criteria:

Limitations in hearing, comprehension or vision problems that preclude full study participation Participants with a life expectancy of less than 12 months due to any serious medical condition

Primary outcomes:
measure: Self-reported abstinence biochemically verified by a carbon monoxide test in-person
timeFrame: 6 months
Secondary outcomes:
measure: Differences in the number of daily cigarettes smoked from baseline to 6-month follow-up and point prevalence of abstinence (ie, no smoking in the past 7 days) at 6-month follow-up.
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital of Basel
Study officials:
References:
Clinical trial NCT00742313: Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
Official title: Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bleeding
Keywords: Endoscopic
saphenous
vein
harvest
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2008-08-27
Enrollment: 50
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: This is a prospective, randomized trial to see in patients undergoing coronary artery bypass grafting and endoscopically-harvested greater saphenous vein, if using FloSeal Matrix in the endoscopically-harvested saphenous vein wound bed decreases bleeding and complications.

Detailed description: Purpose of Study: The primary objective of this study is to determine if using a hemostatic agent (FloSeal Matrix™) in the tunnel of the endoscopically harvested Greater Saphenous vein will decrease bleeding from that site. Secondary objectives are to determine if there is a decrease in the infection-rate at the site of the vein-harvested leg where the FloSeal Matrix™ was used compared to the ones where FloSeal Matrix™ was not used.

Background and Significance: FloSeal Matrix™ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. It works on wet, actively bleeding tissue and conforms to irregular wound surfaces. It is proven to control bleeding from oozing to pulsatile flow. The EVH wound bed is irregular and hemostasis is, at times, difficult to obtain using conventional procedures such as ligature or cautery.

Design and Procedures: This is a prospective, randomized clinical trial that compares the effects of applying FloSeal Matrix™ to the EVH wound bed to not applying FloSeal Matrix™ to the EVH wound bed.

Eligibility criteria: Inclusion Criteria:

1. Sign a consent form that has been approved by the Institutional Review Board.
2. Be at least 18 years of age.
3. Scheduled to undergo coronary artery bypass grafting with EVH.
4. Be able to return to Duke University Medical Center for post-operative visit.

Exclusion Criteria:

1. Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
2. Reported allergy to FloSeal Matrix™

Primary outcomes:
measure: Number of Participants With Decreased Bleeding
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: James E Lowe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04474613: Liquid Biopsy to Reduce Time to Treatment for Advanced Nonsquamous NSCLC Diagnosed at Outside Sites
Official title: Use of Liquid Biopsy to Reduce Time to Treatment for Patients With Advanced Nonsquamous Non-small Cell Lung Cancer Diagnosed at Outside Sites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 26
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 purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test done on a sample of blood to look for cancer cells.

Detailed description: Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable mutations will be considered for this study. The primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (TTT) in external participants with NSCLC. Secondary objectives examined will include time to actionable genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results.

A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with NSCLC. By studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.

Eligibility criteria: Inclusion Criteria:

* Participants with newly diagnosed, advanced nonsquamous NSCLC referred to the Cleveland Clinic Taussig Cancer Center from outside centers without prior testing results available for targetable genetic alterations
* Plan to receive systemic therapy at the Cleveland Clinic, OR plan to receive systemic therapy at an outside site while maintaining either intermittent follow up at Cleveland Clinic or with electronic health record access through Care Everywhere.

Exclusion Criteria:

* Prior therapy for this diagnosis of NSCLC
* Prior adequate molecular testing done for the current diagnosis of NSCLC

Primary outcomes:
measure: TTT measured in days
timeFrame: An average of 30 days
Secondary outcomes:
measure: Time to actionable genetic testing results
timeFrame: An average of 30 days
measure: Rate of actionable biomarker discovery
timeFrame: An average of 30 days
measure: Rate of appropriate guideline-directed therapy based upon testing results
timeFrame: An average of 30 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Nathan Pennell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01123213: Characteristics Predictive of Pessary Success
Official title: Characteristics Predictive of Pessary Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Patients Who Have Undergone a Pessary Fitting
Keywords: pelvic organ prolapse
pessary fitting
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 158
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have undergone a pessary fitting by physicians in the division of Urogynecology between the years of 2000 to 20008 will be eligible.

Brief summary: Pessaries are mechanical support devices worn vaginally to treat the symptoms of pelvic organ prolapse, such as vaginal pressure or a vaginal bulge. Pessaries are one of the options along with surgery and expectant management for pelvic organ prolapse. As the aging population grows, more patients will need treatment for pelvic organ prolapse. Various studies have been conducted previously to identify patient parameters predictive of successful pessary fitting and continued use. Our study is a retrospective chart review to identify patient characteristics predictive of successful pessary fitting and use, specifically focusing on the parameters of POPQ, pelvic organ prolapse quantification exam, and the ratio of the genital hiatus, which is the length of the vaginal opening, and total vaginal length.


Eligibility criteria: Inclusion Criteria:

* undergone a pessary fitting by physicians in the division of Urogynecology between the years of 2000 to 20008.

Exclusion Criteria:

* Patients will be excluded only if their chart does not contain the clinical data under review.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Women's Healthcare
state: California
Study officials:
affiliation: UCI Medical Center
name: Karen Noblett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03647813: Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients
Official title: Effects of Photobiomodulation Therapy in Salivary Analysis of Chronic Renal Failure Patients Undergoing Hemodialysis: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Xerostomia
Chronic Renal Failure
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: End-stage renal disease patients undergoing hemodialysis can present alteration in flow, concentrations and composition of saliva affecting oral health. This randomized placebo-controlled trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) in salivary parameters in chronic renal failure (CRF) patients undergoing hemodialysis. Forty-four patients with CRF on hemodialysis self-responded two questionnaires for oral health and salivary gland function perception. Thereafter, patients were clinically evaluated for the diagnosis of hypofunction of salivary glands and were randomly allocated into two groups: PBM group (n = 21), which received three irradiations of laser at ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point; and a placebo group (n = 17) that consisted of laser protocol with the device switched off. Patients were first submitted to sialometry and after to PBM or placebo intervention at baseline, 7 and 14 days. Non-stimulated and stimulated saliva were collected for salivary volume investigation and biochemical analysis of total protein, calcium and urea concentrations.


Eligibility criteria: Inclusion Criteria:

* Stable cardiopulmonary and neurological conditions;
* Hb\> 10.9 g / dl and Hematocrit\> 33;
* Absence of acute systemic infectious processes;
* Blood pressure \<140 mmHg and PAd \<90 mmHg in at least two measurements in two subsequent dialysis;
* No hypervolemia;
* Patients over 18 years-old;
* Signed a statement of informed consent.

Exclusion Criteria:

* Patients in intensive care unit;
* Hemodynamic instability, signs and symptoms of uremic syndrome related to the cardiovascular and neurological systems;
* Presence of acute systemic infectious processes;
* Presence of acute cardiovascular disease, systolic blood pressure \> 141 mmHg and / or diastolic blood pressure \> 91 mmHg;
* Significant anemia (Hb \<11 g / dl and Hto \<33%);
* Photosensitivity;
* Pregnancy.

Primary outcomes:
measure: Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)
timeFrame: Baseline, 7 days and 14 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04394013: A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period
Official title: A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: During the COVID-19 pandemic, individuals are having to stay at home in quarantine to reduce the risk of transmission of the virus. Depending on the number of occupants and the dwelling space available, this can lead to household crowding, which can have an effect on mental health. In addition, the closing of leisure facilities, including restaurants, cafes and, with the need to self-isolate and socially distance, has led to loneliness. The focus on "loneliness" has recently been on a rise, and being described as an epidemic, especially when it has been shown to be associated with various diseases as well as increased risk of mortality. Studies conducted on participants in isolation has shown increased mental health issues including anxiety, stress and depression.

Mindfulness intervention has been shown to alleviate mental health issues including loneliness. However, to date, there is limited studies examining the effectiveness of a remote mindfulness intervention. This proposal aims to deliver a remote mindfulness program that can be accessible by participants easily and even during the isolation period. This intervention will investigate the effectiveness and safety in elevating mental health issues faced by the general population.

Detailed description: Loneliness, mindfulness and quality of life will be assessed as the primary outcome of the study. A mindfulness video will be used as the intervention for participants, and is compared with a group with similar video content without mindfulness component. The effect of changes in primary outcome will be assessed between groups after 2-4weeks.

Eligibility criteria: Inclusion Criteria:

* Adult participants

Exclusion Criteria:

* None

Primary outcomes:
measure: Loneliness (UCLA-8 Loneliness Scale)
timeFrame: 2-4weeks
measure: Mindfulness (FFMQ)
timeFrame: 2-4weeks
measure: Quality of life (EQ-5D-5L Questionnaire)
timeFrame: 2-4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Subang Jaya
country: Malaysia
facility: Monash University Malaysia
state: Selangor
Study officials:
affiliation: Monash University Malaysia
name: Siew Li Teoh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00267813: The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers
Official title: The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: craving
nicotine
imaging
FDG
PET
smoking
Bupropion
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-21
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.

Detailed description: Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity after exposure to videotapes showing smoking and neutral scenes in Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking videotape and one with a neutral video separated by a week. So far we have compared the brain's metabolic activity in 6 abstinent smokers and 6 still smokers.

Eligibility criteria: Inclusion Criteria:

* Cigarette smokers (over 1 pack a day)
* Age 20-65, male-females

Exclusion Criteria:

* Dependence on other substances
* Psychiatric diagnosis
* Neurological disorder
* Obesity
* Young persons
* Pregnant women

Primary outcomes:
measure: Brain metabolic activity (FDG) in response to craving and neutral cues.
timeFrame: 30-40 minutes
Secondary outcomes:
measure: Subjective ratings of craving
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Nuclear Medicine
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Einat Even-Sapir, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Aviv M Weinstein, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Hedva Lerman, M.D
role: STUDY_DIRECTOR
References:
citation: Weinstein A, Greif J, Yemini Z, Lerman H, Weizman A, Even-Sapir E. Attenuation of cue-induced smoking urges and brain reward activity in smokers treated successfully with bupropion. J Psychopharmacol. 2010 Jun;24(6):829-38. doi: 10.1177/0269881109105456. Epub 2009 Jul 31.