louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00587210: Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel
Official title: Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: Crohn Disease
Inflammatory Bowel Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 34
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: Gastroenteroloy Clinic; Inflammatory Bowel Disease Clinic

Brief summary: The purpose of this study is to assess the exam quality and accuracy of MR using a new oral contrast agent for the evaluation of Crohn Disease in the small bowel.

Detailed description: Crohn Disease is an inflammatory condition that involves the small bowel. Patients usually undergo multiple imaging exams in the diagnosis and surveillance of the disease. CT has been shown to have excellent results for detecting active inflammation. In the United States MR has lagged behind CT in utilization for imaging the small bowel. An advantage of MR over CT is the lack of radiation exposure to the patient. A new oral contrast agent is available that provides good distension of the small bowel and allows improved identification of active inflammation. The purpose of this study is to compare the accuracy of MR to CT using this new oral contrast agent and to assess exam quality.

Eligibility criteria: Inclusion Criteria:

* Known or suspected Crohn Disease
* Undergoing colonoscopy and CT enterography

Exclusion Criteria:

* Contraindication to MR

Primary outcomes:
measure: exam quality
timeFrame: one time point
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeff L Fidler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005210: Sex Steroids, Obesity and Lipids in Adolescent Females
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Hypercholesterolemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To prospectively explore the relationships of endogenous sex steroid hormones and obesity and their interactions with lipoprotein cholesterol and apolipoprotein levels in nine and ten year old Black and white adolescent girls for five years during puberty.

Detailed description: BACKGROUND:

In 1987, there was growing evidence that androgens, particularly when elevated, had an unfavorable effect on lipo/apo levels, tending to lower HDL cholesterol (HDLC) and raise LDL cholesterol (LDLC). Previous studies confirmed that although pre-pubertal boys and girls had similar lipo/apo levels, post-pubertal boys had a higher ratio of LDLC/HDLC than girls, in part because of their androgen levels. Such lipo/apo levels had been associated with an increased risk of coronary heart disease. There was also evidence that obese girls tended to be hyperandrogenic and thus had unfavorable lipo/apo levels and a higher risk of coronary heart disease. This study sought to elucidate whether high androgen levels preceded or were a consequence of obesity.

DESIGN NARRATIVE:

The longitudinal study was ancillary to the National Growth and Health Study (NGHS), a multicenter study which investigated the occurrence of obesity in Black and white adolescent girls, predictors of the transition to the obese state, the correlates of the transition, and the relationship of the transition to other coronary heart disease risk factors. As part of the NGHS, participants from the Cincinnati, Ohio and Washington, D.C. public and parochial schools received physical examinations with attention to pubertal staging and anthropometric measurements including weight, height, and skinfold thickness. Along with NGHS blood samples, additional blood was obtained in years 1, 3, and 5 for measurements of lipids, lipoprotein cholesterols, apolipoproteins A1, A2, and B, and sex steroid hormones including plasma total and free testosterone, dehydroepiandrosterone sulfate, estradiol, and testosterone estrogen binding globulin.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lucky AW, Biro FM, Huster GA, Leach AD, Morrison JA, Ratterman J. Acne vulgaris in premenarchal girls. An early sign of puberty associated with rising levels of dehydroepiandrosterone. Arch Dermatol. 1994 Mar;130(3):308-14. doi: 10.1001/archderm.130.3.308.
Clinical trial NCT01588210: Fluoride Concentration in Inter-proximal Fluid From Dental Sealants
Official title: Fluoride Concentration in Inter-proximal Fluid From Dental Sealants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Keywords: caries
sealant
fluoride
prevention
community dentistry
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: WHO Collaborating Centre for Epidemiology and Community Dentistry
First posted: 2012-04-30
Enrollment: 2776
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are: year of birth between 2000 and 2002, informed consent signed by parents/guardians, presence of at least two permanent first molars completely erupted.

Exclusion Criteria:

* The exclusion criteria are: demineralized lesions and hypomineralized permanent molar, carious lesions or presence of filling on the occlusal surface of the first permanent molar, fixed orthodontic treatment.

Primary outcomes:
measure: Inter-proximal fluid fluoride concentration
timeFrame: 21 days after application
Secondary outcomes:
measure: caries incidence
timeFrame: 24 months
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
state: Sardinia
city: Milan
country: Italy
facility: WHO CC University of Milan
Study officials:
References:
citation: Cagetti MG, Carta G, Cocco F, Sale S, Congiu G, Mura A, Strohmenger L, Lingstrom P, Campus G; Italian Experimental Group on Oral Health. Effect of Fluoridated Sealants on Adjacent Tooth Surfaces: A 30-mo Randomized Clinical Trial. J Dent Res. 2014 Jul;93(7 Suppl):59S-65S. doi: 10.1177/0022034514535808. Epub 2014 May 20.
citation: Campus G, Carta G, Cagetti MG, Bossu M, Sale S, Cocco F, Conti G, Nardone M, Sanna G, Strohmenger L, Lingstrom P; Italian Experimental Group on Oral Health. Fluoride concentration from dental sealants: a randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):23S-8S. doi: 10.1177/0022034513484329. Epub 2013 May 20.
Clinical trial NCT04417010: To Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
Official title: A Prospective Study to Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: KRAS Gene
Colorectal Cancer
Liver Metastasis
Safe Margin
Radiofrequency Ablation
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men or women 18 years of age or older

Brief summary: To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status


Eligibility criteria: Inclusion Criteria:

1. Diagnosed as liver metastasis of colorectal cancer;
2. There are no more than 3 liver metastases and all the lesions are not more than 5 cm; or no more than 6 liver metastases and all the lesions are not more than 3.0 cm;
3. The primary lesion of colorectal cancer has been treated curatively or is planned to undergo curative treatment;
4. KRAS gene test results can be obtained for primary or metastatic foci;
5. Signing informed consent voluntarily;
6. Men or women who have reached the age of 18;
7. Ultrasound or ultrasound contrast can clearly show the lesion and guide RFA treatment;
8. Platelet count\> 50,000/mm3, prothrombin activity\> 50%;
9. Child-Pugh grade A or B of liver disease, but no hepatic encephalopathy or/and ascites;
10. Subjects are willing to return to the research center for research follow-up;
11. Life expectancy ≥ 6 months-

Exclusion Criteria:

1. suffer from but not limited to the following serious diseases: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening arrhythmia in the past 6 months;
2. During pregnancy or lactation. Before receiving research treatment, women of childbearing age must have a negative serum pregnancy test;
3. Any known allergic reactions to the intravenous imaging agent used in this study;
4. There is portal vein or hepatic vein tumor infiltration/carcinoma;
5. International normalized ratio of prothrombin\> 1.5 times the upper limit of normal value (UNL) of the research center;
6. Platelet count \<50,000/mm3, absolute neutrophil count \<1500/mm3, or heme value \<10.0g/dL;
7. Serum creatinine ≥2.5mg/dL or calculated creatinine clearance (CrCl) ≤25.0ml/min;
8. Serum bilirubin\>3.0mg/dL;
9. Serum albumin \<2.8g/dL;
10. Body temperature \>101°F (38.3°C) immediately before study treatment;
11. being treated with other research drugs;
12. Heart failure NYHA function grade is III or IV .

Primary outcomes:
measure: local tumor progression
timeFrame: 2020-06-01-2023-05-31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00826410: Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery
Official title: Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Digestive System Diseases [C06]
Digestive System Neoplasms [C04.588.274]
Keywords: Laparotomy
Surgical site infection
Drainage
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 200
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 aim of the study is to determine wether subcutaneus suction drain (type redon-drain) protect against surgical side infection by laparotomy in general surgery.

Detailed description: If subcutan drains inserted during wound closudsure after laparotomy avoid subcutaneous haematoma and seromas by suction, these drains shout protect against surgical site infections. This is the ratio why such drain are in use in many countries. To test whether this hypothesis is true or not we pland this study.

Eligibility criteria: Inclusion Criteria:

* indication for laparotomy
* age older 18 years
* informed consent

Exclusion Criteria:

* organ transplantation
* operation for abdominal hernia
* appendectomy by McBurney incision
* redo-operation

Primary outcomes:
measure: number of surgical site infections according to CDC guidelines after laparotomy in general surgery
timeFrame: 30 days after operation
Secondary outcomes:
measure: risk factors for surgical site infections
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Visceral and General Surgery , University of Freiburg, Germany
state: BW
Study officials:
affiliation: Department of Visceral and General Surgery University of Freiburg, Germany
name: Peter K Baier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01573910: An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients
Official title: An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial conjunctivitis
Anti-infective
Antibiotics
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 985
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.


Eligibility criteria: Inclusion Criteria:

* Chinese.
* Diagnosis of bacterial conjunctivitis based on clinical observation.
* Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent.
* Willing to complete all required study procedures and visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women who are pregnant, lactating, or planning a pregnancy.
* Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye.
* Planned contact lens wear during the course of the study.
* Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
* Suspected fungal, viral, or Acanthamoeba infection.
* Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study.
* History of recent surgery.
* Presence of concomitant systemic viral infection.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Clinical Cure Rate
timeFrame: Day 9
measure: Microbiological Success Rate
timeFrame: Day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Alcon (China) Ophthalmic Product Co., Ltd.
Study officials:
affiliation: Alcon Research
name: Helen Yu, Lead CSM
role: STUDY_DIRECTOR
References:
Clinical trial NCT06173310: DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
Official title: DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline-resectable Pancreatic Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age 19 years or older).
* Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.
* Patients with signed informed consent.

Exclusion Criteria:

* Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer.
* Participants with safety contraindications to MRI examination (determined by standard clinical screening).
* Participants who are pregnant, lactating or are planning to become pregnant during the study.
* Participants who are planning to father a child during the study.

Primary outcomes:
measure: To measure the reproducibility of qDCE-MRI measurement of BRPC.
timeFrame: 6 weeks +/- 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
Study officials:
affiliation: University of Alabama at Birmingham
name: Harrison Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02013310: HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
Official title: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing HT-0712 With Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Associated Memory Impairment (AAMI)
Lead sponsor: Dart NeuroScience, LLC
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 119
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in subjects with Age-Associated Memory Impairment (AAMI)


Eligibility criteria: Main Inclusion Criteria:

* Complaints of memory loss in everyday life
* Performance at least one standard deviation below the mean established for young adults on standardized memory tests
* Absence of dementia
* Intact global intellectual function

Main Exclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease
* Evidence of dementia
* Evidence of psychiatric or neurological disorder that could influence cognition or contributed to the subject's memory loss
* Use of any drugs that could influence cognition

Primary outcomes:
measure: Cognitive Drug Research™ (CDR) Study Specific Test Battery
timeFrame: Weekly over the course of 6-weeks
Secondary outcomes:
measure: Paired Associated Learning and Memory Test
timeFrame: Weekly over the course of 6-weeks
measure: Subject Global Impression Scale of Cognition (SGI-Cog)
timeFrame: Weekly over the course of 6-weeks
Other outcomes:
Locations:
city: Sun City
country: United States
state: Arizona
city: Long Beach
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Atlantis
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Marlton
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Cordova
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Dart NeuroScience, LLC
name: Philip Perera, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01369810: Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or Chronic Obstructive Pulmonary Disease
Official title: Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or COPD in Iceland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Keywords: Epidemiological
asthma
COPD
reimbursement
switch
outcomes associated with the change in reimbursement
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010

Brief summary: To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure


Eligibility criteria: Inclusion Criteria:

* All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010

Primary outcomes:
measure: To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure
timeFrame: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
Secondary outcomes:
measure: To map out the development of asthma and COPD treatment in Iceland after the change in reimbursement
timeFrame: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
measure: To investigate health economic outcomes
timeFrame: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: University of Iceland
name: Unnur Steina Björnsdottir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iceland
name: Sveinbjörn Gizurason
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Georgios Stratelis, MD
role: STUDY_DIRECTOR
References: