louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01099605: Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
Official title: Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hemorrhoids
Keywords: hemorrhoidectomy
pain management
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2010-04-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over the past decade, continuous wound infiltration systems have been introduced to treat a variety of post-surgical pain. These systems, commonly referred to pain pumps by patients, possess a catheter(s) attached to a reservoir of local anesthetic that directly infuses into the surgical site to provide local pain control thus avoiding the common and less desirable systemic effects of oral narcotic pain medication. Due to its portability, another benefit associated with these wound infiltration systems is its use as an outpatient pain control modality. Despite the apparent benefits, the verdict on the system's effectiveness in treating pain - throughout a variety of surgical fields - varies between very effective in reducing post-operative pain and reducing overall narcotic consumption for several days to completely ineffective with no reported changes in perceived pain or overall narcotic use.

Through a randomized trial comparing plain saline to a common local anesthetic, The investigators hope to evaluate the effectiveness of these pain pumps as an outpatient modality for pain management following hemorrhoidectomy patients. The investigators hypothesize that there will be a significant benefit in pain relief with the use of these pumps.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for hemorrhoidectomies at NMCP

Exclusion Criteria:

* Any patient with co-existing active purulent infection (i.e. abscess).
* Any patient who has had previous surgical intervention for his/her hemorrhoidal disease. Previous simple incision to treat a thrombosed hemorrhoid is not considered a surgical intervention for the purposes of this study. The minimal scar produced by a small incision would not alter post-operative pain following removal of a hemorrhoidal column.
* Any patient allergic to local anesthetics or oral pain medications
* Any patient with a history of chronic pain
* Any patient allergic to or has had an adverse reaction (i.e. history of gastrointestinal bleed) to a non-steroidal anti-inflammatory drugs (NSAIDs)
* Any patient pregnant patient

Primary outcomes:
measure: VAS pain scales
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
References:
Clinical trial NCT00749905: Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
Official title: A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colon Preparation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-09-09
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination


Eligibility criteria: Inclusion Criteria:

* Age \>18 and \<75
* Colon study indicated for colo-rectal carcinoma screening
* After colonoscopy for any indication failed due to technical causes
* Patients who decline an indicated colonoscopy

Exclusion Criteria:

* Significant heart failure (NYHA grade III-IV)
* Renal failure (Creatinine \> 1.2 mg/dl)
* Known or suspected intestinal strictures
* Known or suspected mesenteric adhesions
* History suggestive of bowel obstruction
* Vomiting and/or aspirations
* Symptoms of dysphagia
* Pace-maker or AICD implanted
* Known allergy or intolerance to any of the study drugs
* Pregnancy
* Illicit drug abuse or alcoholism
* Inability to provide an informed consent

Primary outcomes:
measure: Colon cleanliness
timeFrame: one week from capsule examination
Secondary outcomes:
measure: Tolerability of preparations
timeFrame: within 1 day of completing preparation
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT01398605: Physical Activity in Postmenopausal Women
Official title: Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Disorder
Keywords: Postmenopausal women
Physical activity
Cardiovascular risks
Cardiac function
Dose-response
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged 40 to 80 years and age matched men without major diseases

Exclusion Criteria:

* Known cardiac disease, excessive weight change during last year, cancer and mental disorders

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: 3 months
measure: Waist circumference
timeFrame: 3 months
measure: Lab data (lipid profile, CRP, insulin resistance)
timeFrame: 3 months
measure: QT interval and corrected QT interval (QTc)
timeFrame: 3 months
measure: Cardiovascular fitness
timeFrame: 3 months
measure: Heart rate recovery after exercise test
timeFrame: 3 months
Secondary outcomes:
measure: Myocardial perfusion
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06949605: Quantitative Xylazine Measurement in ED
Official title: Quantitative Xylazine Measurement Among Non-Fatal Opioid Overdose Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Overdose
Substance Use Disorders
Keywords: Opioid
Xylazine
Substance Use
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-29
Enrollment: 15
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: All participating sites will enroll all opioid ODs presenting to Mount Sinai Hospital and Elmhurst Hospital Emergency Departments, regardless of whether or not a consultation by a medical toxicologist was requested (i.e., all consecutive opioid ODs).

Brief summary: Quantitative Xylazine Measurement Among Non-Fatal Opioid Overdose (OD) Patients in the Emergency Department (ED)

Detailed description: Xylazine, a veterinary medication and alpha-2 agonist drug with clinical effects including prolonged sedation and skin/soft tissue wounds, has been increasingly detected with fentanyl in the illicit opioid supply. Due to its rapid emergence, limited knowledge exists regarding xylazine's health effects. In this proposed research, Dr. Love will measure xylazine and its metabolites in blood and urine samples using laboratory and point-of-care assays. Working at two New York City emergency departments, Dr. Love will collect waste serum and urine from opioid overdose patients to measure xylazine and its metabolite concentrations. The researcher will also perform qualitative assessment of urine samples with xylazine test strips to characterize urine xylazine detection using a harm reduction tool.

Eligibility criteria: Inclusion Criteria:

* ED patient
* Opioid OD (both NPS and non-NPS)
* Availability of waste blood specimens for analysis
* Availability of waste urine specimens for analysis

Exclusion Criteria:

- Children under 18

Primary outcomes:
measure: Xylazine Concentration in Blood
timeFrame: 6 months
Secondary outcomes:
measure: Xylazine Strip Specificity and Sensitivity
timeFrame: 6 months
Other outcomes:
Locations:
city: Elmhurst
country: United States
facility: NYC Health + Hospitals/Elmhurst
state: New York
city: New York
country: United States
facility: Icahn School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Jennifer Love, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01197105: Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children
Official title: Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gingivitis
Plaque Accumulation
Keywords: gingivitis
schinus terebinthifolius
natural products
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis.


Eligibility criteria: Inclusion Criteria:

* Age group: 10-12 years old
* Presence of at least 20 dental elements
* Do not use orthodontic fixed appliances
* Simplified Oral Hygiene Index (S-OHI) is greater than 2
* Levels of Microbiological Streptococcus mutans in saliva high (\> 10,000 CFU / mL) (JENSEN; BRATTHALL, 1989)
* Susceptibility to form biofilm and gingival inflammation
* Absence of systemic disease
* Not be under the use of antiseptic mouthwash in the last 3 months

Exclusion Criteria:

-

Primary outcomes:
measure: Gingival inflammation (Blood gingival index)
timeFrame: baseline
measure: Plaque amount
timeFrame: Baseline
Secondary outcomes:
measure: Gingival inflammation (Blood gingival Index)
timeFrame: After 7 days (t1)
measure: Gingival inflammation (blood gingival index)
timeFrame: After 14 days (t2)
measure: Plaque amount
timeFrame: After 7 days (t1)
measure: Plaque amount
timeFrame: After 14 days (t2)
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Francisco Campos Statal School
state: Paraíba
Study officials:
References:
citation: GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
Clinical trial NCT01410305: Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults
Official title: Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: Vitamin D Deficiency
HIV+ Children
HIV+ Young Adults
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Emory-Children's Center
First posted: 2011-08-05
Enrollment: 290
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.

Brief summary: The relationship of Vitamin D levels in children and young adults to atherosclerosis.


Eligibility criteria: Inclusion Criteria - Documentation of HIV Infection Between ages of 8 and 25

* On stable ART for at least 12 weeks for the HIV+ patients
* Cumulative duration of ART for at least 48 weeks for HIV + patients
* Healthy child/young adult with age and race matched to HIV+ patient for the HIV- controls
* Absence of HIV based on medical and medication history

Exclusion Criteria:

* Taking \> 800 IU of Vitamin D per day
* Parathyroid or Calcium disorders
* Acute illness and active inflammatory condition
* Chronic illnesses that include malignancy, diabetes, CAD
* Pregnancy and lactation
* Creatinine Clearance \<50 ml/min
* Hgb \< 9.0 g/dL
* AST and ALT \> 2.5 upper limits of normal

Primary outcomes:
measure: Vitamin D levels
timeFrame: One time point at entry
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Chldren's Center
state: Georgia
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center, Case Western Reserve University
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Grace McComsey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory-Children's Center
name: Allison Ross Eckard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517005: An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus
Official title: An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: B12 Deficiency Vitamin
Energy Supply; Deficiency
Mood
Keywords: Vitamin Deficiency
Energy
Mood-states
focus
Lead sponsor: Sourse
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-26
Enrollment: 38
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to examine the effects of Sourse's Hype Bites at being able to increase vitamin B12 levels to promote positive health outcomes. Participants will consume Hype Bites daily. Participants will also take surveys and blood samples to examine both the subjective experience of taking Hype Bites as well as changes in biomarkers across the trial.


Eligibility criteria: Inclusion Criteria:

* BMI \< 40 On a stable, consistent dietary regimen Must be on a vegan or vegetarian diet May experience the feeling of being tired often/several times a week. May experience brain fog May experience negative mood states

Exclusion Criteria:

* Females who are pregnant or breastfeeding Currently take vitamin B12 during the past four weeks Chronic conditions such has oncological of psychiatric disorders Anyone with IBS or IBD Anyone with a previous severe allergic reaction Anyone unwilling to follow the study protocol

Primary outcomes:
measure: Examine if Hype Bites increase vitamin B12 in the blood
timeFrame: 8 weeks
Secondary outcomes:
measure: examine the subjective improvements noticed by the study participants when supplementing with vitamin B12.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592605: Thyroid Disease Serum Repository
Official title: Thyroid Disease Serum Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Disease
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: Thyroid disease is more common among females and is increasing in incidence.

Otolaryngology faculty members and residents will perform head and neck examinations as part of the subject's routine care. If the participant is noted to have thyroid disease, they will be asked if they would like to participate in the research portion by having approximately 10cc's of blood drawn. Faculty and staff will complete a data collection sheet that will contain demographic and clinical data.


Eligibility criteria: Inclusion Criteria:

* Participants with benign or malignant thyroid disease.

Primary outcomes:
measure: To gather demographic and cultural information on approximately 1000 men and women with thyroid disease between the years 2007 and 2012 at the University of Arkansas for Medical Sciences.
timeFrame: 2007-2012
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Brendan Stack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02062905: OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 2 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Allergic Conjunctivitis
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2014-02-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

* History of ocular surgical intervention within the past 3 months
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* Use any of the following disallowed medications during the period indicated

Primary outcomes:
measure: Ocular Itching
timeFrame: 14 days post insertion
Secondary outcomes:
measure: Conjunctival Redness
timeFrame: 14 days post insertion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02585505: Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus
Official title: Tissue Distribution of F18-FDG Labeled Autologous Bone Marrow Derived Stem Cells in Patients With Type2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2015-10-23
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stem cells have promising potential in treating diabetes. However the therapeutic outcome in diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.

Detailed description: Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.

Eligibility criteria: Inclusion Criteria:

* • Patients with type 2 diabetes mellitus between 30 and 65 years of age.

  * Duration of diabetes ≥ 5 years.
  * Failure to triple OHA in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}.
  * Requiring insulin therapy for last six month
  * On stable doses of insulin (≥0.4 IU/kg/day, Vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months.
  * GAD antibody negative status.

Exclusion Criteria:

* Patients with type 1 diabetes mellitus or secondary diabetes
* Patients with serum creatinine \> 1.5 mg/dL
* Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
* History of cholecystitis/ cholelithiasis/ cholecystectomy.
* Seropositivity for HIV, HBsAg and HCV.
* History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.

Primary outcomes:
measure: Increase in glucagon stimulated C peptide level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00999505: Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
Official title: A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Amantadine
Residual symptoms
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-10-21
Enrollment: 40
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: Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.


Eligibility criteria: Inclusion Criteria:

* Under antipsychotics with residual symptoms

Exclusion Criteria:

* Pregnancy
* Lactation

Primary outcomes:
measure: Scores in Brief Psychiatric Rating 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, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: