louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00166478: Exisulind Prior to Radical Prostatectomy
Official title: A Prospective Controlled Phase II Study of Preoperative Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-14
Enrollment: 130
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy. Participants will be followed for total of 2 months from the time of starting study drug.


Eligibility criteria: Males 40 years of age and older with prostate cancer who are scheduled to undergo surgical removal of the prostate at Mayo Clinic Rochester, Mayo Clinic Jacksonville, or Mayo Clinic Arizona may be eligible for this protocol.

Primary outcomes:
measure: 4 week changes in apoptosis biomarkers
Secondary outcomes:
measure: 4 week changes in surrogate endpoint biomarkers
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bradley C. Leibovich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757978: Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms
Official title: Phase 4 Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms in Patients Using Clozapine. A Randomized, Double-Blind, Placebo Controled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
negative symptoms
clozapine
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Memantine as an add-on therapy to clozapine may improve schizophrenia negative symptoms and cognitive functioning.


Eligibility criteria: Inclusion Criteria:

* Under clozapine with negative symptoms

Exclusion Criteria:

* Pregnancy
* Lactation

Primary outcomes:
measure: Score in Brief Psychiatric Raring Scale
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Clarissa S Gama, PhD
role: STUDY_DIRECTOR
References:
citation: de Lucena D, Fernandes BS, Berk M, Dodd S, Medeiros DW, Pedrini M, Kunz M, Gomes FA, Giglio LF, Lobato MI, Belmonte-de-Abreu PS, Gama CS. Improvement of negative and positive symptoms in treatment-refractory schizophrenia: a double-blind, randomized, placebo-controlled trial with memantine as add-on therapy to clozapine. J Clin Psychiatry. 2009 Oct;70(10):1416-23. doi: 10.4088/JCP.08m04935gry.
Clinical trial NCT05889078: The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
Official title: The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Affect
Wellness, Psychological
Depressive Symptoms
Anxiety Disorders and Symptoms
Stress
Sleep
Non-suicidal Self-injury
Keywords: Positive affect
Negative affect
Wellbeing
Walking intervention (nature vs urban)
Postsecondary students
Young adults
Stress
Sleep quality
Non-suicidal self-injury
Mindfulness
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomized controlled trial is to examine the effects of a walking intervention (3 walks per week for a period of 4 weeks) in a nature vs. urban setting on the wellbeing of young adult postsecondary students. We will examine changes in positive and negative affect for participants assigned to the nature condition vs those assigned to the urban condition (primary outcome). We will also examine changes in reported depression and anxiety symptoms, perceived stress levels, sleep quality, mindfulness and wellbeing (secondary outcome).


Eligibility criteria: Inclusion Criteria:

* aged 18-25 years
* speaks English
* had working smartphone that can track walk routes using a smartphone application

Exclusion Criteria:

* inability to walk for 45 minutes due to serious medical reasons (eg surgery)
* heart condition

Primary outcomes:
measure: Change in baseline positive affect at 4 weeks
timeFrame: 4 weeks (1x per week for 4 weeks)
measure: Change in baseline negative affect at 4 weeks
timeFrame: 4 weeks (1x per week for 4 weeks)
Secondary outcomes:
measure: Change in baseline depression symptoms at 5 weeks
timeFrame: 5 weeks (1 week following completion of study intervention)
measure: Change in baseline anxiety symptoms at 5 weeks
timeFrame: 5 weeks (1 week following completion of study intervention)
measure: Change in baseline perceived stress levels at 5 weeks
timeFrame: 5 weeks (1 week following completion of study intervention)
measure: Change in baseline sleep quality at 5 weeks
timeFrame: 5 weeks (1 week following completion of study intervention)
measure: Change in baseline mindfulness at 5 weeks
timeFrame: 5 weeks (1 week following completion of study intervention)
measure: Change in baseline levels of wellbeing at 5 weeks
timeFrame: 5 weeks (1 week following completion of study intervention)
measure: Change in baseline non-suicidal self-injury at 5 weeks
timeFrame: 5 weeks (1 week following completion of study intervention)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
References:
Clinical trial NCT02023307: Use of V-Loc Suture for Mid-face Lifting in Short-flap Rhytidectomy
Official title: Use of the V-Loc Suture for Mid-Face Lifting in Short-flap Rhytidectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Use of the Vloc Suture
Elevation of the Mid-face
Lead sponsor: Lifestyle Lift
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate and measure the Vloc suture's ability to elevate the mid-face when using a short flap, short incision technique in during a traditional face-lift. The objective of this study is to assess the suture's potential in elevating the mid-face when a traditional Lifestyle facelift is performed. We hypothesize that the Vloc suture will elevate the mid-face more effectively when using a short flap, short incision technique on a traditional facelift.

Detailed description: A total of 25 patients who are already receiving a traditional Lifestyle Lift will be asked to participate. Once the consent form has been signed by the patient, the facelift will be performed as scheduled and the Vloc suture will be added to the mid-face area. Each patient will be added to a database and their progress will be tracked with photos taken before, at 6 weeks, and at 6 months following the procedure. All data stored will be locked into a hard drive that can only be accessed by the research staff and the doctor. The text data will be used by research staff for reports and articles.

\* you must already have purchased and scheduled a facelift procedure with Lifestyle Lift to participate in this trial. The addition of only the V-loc suture is at no cost.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to receive a Lifestyle Lift will be asked to participate. The first 25 patients who have consented will be included into the study.

Exclusion Criteria:

* Any patient who is not able to receive a facelift for whatever reason, or who do not want a facelift will not be apart of this study

Primary outcomes:
measure: Elevation of the mid-face
timeFrame: Initial- 6 weeks
Secondary outcomes:
measure: No Retention of Mid-face
timeFrame: initial-6 Months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Lifestyle Lift
state: New Mexico
Study officials:
References:
Clinical trial NCT00779207: Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly
Official title: Effect of Weight Loss and Exercise on Intrahepatic and Intramyocellular Fat in Obese Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: obesity
aging
exercise
diet
weight loss
physical function
Obesity in the Elderly
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of weight loss and exercise on liver and muscle fat.

Detailed description: Obesity causes serious medical complications and impairs quality of life. Moreover, both aging and obesity cause metabolic and physical dysfunction. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on Intrahepatic and Intramyocellular fat in obese elderly men and women. The central hypothesis is that in obese elderly subjects, weight loss will improve metabolic and physical function while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 20 elderly (65-85 years old) obese men and women (body mass index \[BMI\] \> 30 kg/m2) with physical frailty will be randomized to 2 treatment groups: 1)10% weight loss, 2) 10% weight loss plus exercise training.

Eligibility criteria: Inclusion Criteria:

* Obese (BMI 30 or greater)
* Elderly (age 65 years or older)

Exclusion Criteria:

* Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years

Primary outcomes:
measure: Intrahepatic fat Intramyocellular fat
timeFrame: 6-month
Secondary outcomes:
measure: Insulin sensitivity Physical Function
timeFrame: 6-month
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dennis T Villareal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.
Clinical trial NCT00000107: Body Water Content in Cyanotic Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Keywords: Cyanotic Congenital Heart Disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-01-19
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL

Brief summary: Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial natruretic peptide (proANP) which most likely results in chronic dehydration, leading to reduced oxygen transport to tissues and shortness of breath with activity. The purpose of this study is to characterize adults with cyanotic congenital heart defects with respect to their body composition (water and fat-free mass) and resting metabolic rates. The study consists of several measures of how much body water, fat and lean tissue a subject has, and measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic congenital heart disease will be recruited along with healthy noncyanotic control subjects matched for age, gender, and body weight.


Eligibility criteria: Inclusion Criteria:

* Resting blood pressure below 140/90

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT03896607: Liver and the Spleen Stifness in Adult Patients With Gaucher's Disease Using Ultrasound Shear Wave Elastography
Official title: Prospective Study: Shear-Wave Elastography of the Liver and the Spleen in Adult Patients With Gaucher's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gaucher Disease
Liver Fibrosis
Spleen; Fibrosis
Keywords: shear wave elastography
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 18
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: adult patient with Gaucher disease.

Brief summary: The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher Disease(GD) by using Shear Wave Elastography- SWE to evaluation fibrosis of the tissue and to check the correlation of fibrosis with the biomarkers of disease severity.

Detailed description: To assess liver and spleen stiffness measurement using Shear Wave Elastography-SWE and evaluate liver and spleen fibrosis in patients with Gaucher Disease. To compare the elastography with the biomarkers that taken at the GD haematology clinic and to check the correlation with severity of liver and spleen fibrosis.

SWE is a safe with diagnostic accuracy regarding the liver (\& Spleen) fibrosis. Estimating spleen fibrosis is an innovative approach in liver disease and Gaucher.

The evaluation of fibrosis with this relatively new and safe method could avoid complications and invasive procedure in GD patients .

Eligibility criteria: Inclusion Criteria:

1. Patients with Gaucher disease over the age of 18 years.
2. Patients able to sign informed consent form.
3. Women are not pregnant.
4. Patients who read and understood the contents of the consent form and gave their written consent to participate in the study.

Exclusion Criteria:

1. Participants under the age of 18.
2. Pregnant women.
3. Participants are unable to sign an informed consent form.
4. Participants with known liver disease not associated with Gaucher disease such as liver cirrhosis, patients with HBV, HBC or liver cirrhosis.

Primary outcomes:
measure: Shear Wave Elastography of liver to asses liver fibrosis in Gaucher disease patients.
timeFrame: 0-2 hours
Secondary outcomes:
measure: Shear Wave Elastography of spleen to asses spleen fibrosis in Gaucher disease patients.
timeFrame: 0-2 hours
Other outcomes:
measure: Biomarkers of the Gaucher Disease
timeFrame: Up to 1 month
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
state: Tsafon
Study officials:
affiliation: haemek medical center
name: ziv neeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06299007: Awareness of Iron Status Evaluation in UGIB
Official title: Awareness of the Need for the Evaluation of Iron Status Among Hospitalized Patients With Acute Upper Gastrointestinal Bleeding.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Bleeding
Keywords: upper gastrointestinal bleeding
Anemia
iron status
iron deficiency
Lead sponsor: Hat Yai Medical Education Center
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 867
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were admitted because of acute UGIB at Hatyai Hospital between January 2016 and December 2019.

Brief summary: BACKGROUND: Data on the awareness of the need to evaluate iron status and IDA prevalence in acute UGIB are limited.

OBJECTIVES: This study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (IDA) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (UGIB).


Eligibility criteria: Inclusion Criteria:

* patients \&gt; 18 years of age who were admitted because of acute UGIB and were diagnosed with anemia from UGIB during hospitalization.

Exclusion Criteria:

* patients who had previously undergone endoscopy at another institution before admission
* patients who had a definite cause of UGIB that was inconclusive
* incomplete data for analysis.

Primary outcomes:
measure: iron status measurement
timeFrame: During admission
Secondary outcomes:
measure: Iron deficiency anemia
timeFrame: During admission
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Hatyai Hospital
state: Songkhla
Study officials:
References:
citation: Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group. Ann Intern Med. 2019 Dec 3;171(11):805-822. doi: 10.7326/M19-1795. Epub 2019 Oct 22.
citation: Stein J, Connor S, Virgin G, Ong DE, Pereyra L. Anemia and iron deficiency in gastrointestinal and liver conditions. World J Gastroenterol. 2016 Sep 21;22(35):7908-25. doi: 10.3748/wjg.v22.i35.7908.
citation: Kulnigg S, Stoinov S, Simanenkov V, Dudar LV, Karnafel W, Garcia LC, Sambuelli AM, D'Haens G, Gasche C. A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol. 2008 May;103(5):1182-92. doi: 10.1111/j.1572-0241.2007.01744.x. Epub 2008 Mar 26.
citation: Cotter J, Baldaia C, Ferreira M, Macedo G, Pedroto I. Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding: A systematic review. World J Gastroenterol. 2020 Dec 7;26(45):7242-7257. doi: 10.3748/wjg.v26.i45.7242.
Clinical trial NCT02647788: Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
Official title: Pilot Study, Blinded Randomized Control Trial, Single Center Study to Compare Acetaminophen & Codeine Versus Ibuprofen/Acetaminophen for Pain Control and Patient Satisfaction After Ambulatory Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Pain, Postoperative
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 144
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 purpose of this research study is to find out if taking Acetaminophen with Ibuprofen (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.

Detailed description: Primary Objective:

To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen).

Secondary Objective:

To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction.

Sixty-three patients enrolled for each group (non-opioid and opioid). Approximately 145 patients will be required to achieve complete data for 63 patients in each group (assuming 15% lost to follow-up \& failure to comply with study protocol).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.

Exclusion Criteria:

* ASA\> 3;
* Coagulopathy;
* Renal disease,
* Liver disease,
* History of recent gastro-intestinal bleeding
* Pregnancy.
* Diagnosis of chronic pain currently taking opioid pain medication or with a history of drug abuse.
* Patients with a self-described allergy to ASA, acetaminophen, NSAIDS and codeine.
* All patients receiving a brachial plexus block for anesthesia and/or analgesia

Primary outcomes:
measure: Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score
timeFrame: Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores
Secondary outcomes:
measure: Quality of Recovery-9 (QoR-9).
timeFrame: Postoperative Day 2
measure: Number of Pills Used
timeFrame: From the time of surgery to first clinic visit (post-op day 6 to 8)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04363788: Needle Stick Injuries in Emergency Medical Service Practice
Official title: Should we Use Double Gloves During Procedures With Suspected/Confirmed COVID-19 Patient?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Needle Stick
Injuries
Glowe
Keywords: needle stick injuries
SARS-CoV-2
COVID-19
personal protective equipment
paramedic
emergency medical service
Lead sponsor: Lazarski University
Sponsor class: OTHER
Collaborators: name: Medical University of Bialystok
name: Poznan University of Medical Sciences
First posted: 2020-04-27
Enrollment: 300
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical profession (paramedics, nurses, physicians) working in Emergency Medical Service performing prehospital advance life support

Brief summary: During the pandemic era, medical personnel should wear full protective suits. However, they limit the performance of medical procedures. One of the main questions is whether to use double gloves. The study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* Medical profession (paramedics, nurses, physicians) working in Emergency Medical Service

Exclusion Criteria:

* Not meet the above criteria
* Wrist or low back diseases

Primary outcomes:
measure: Number of visible puncture
timeFrame: 1 day
Secondary outcomes:
measure: WLT
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Lazarski Univeristy
Study officials:
References: