louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00212537: Disease Modifying Genes in Severe Asthma
Official title: Disease Modifying Genes in Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma and normal
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 941
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals approached for participation in the Research Registry shall be able to read or comprehend English. Since participation in the Research Registry does not involve a risk of physical harm, women of childbearing potential will not be queried as to pregnancy status or tested for pregnancy unless they are requested to undergo a methacholine challenge test. There are no additional inclusion/exclusion criteria.

Brief summary: Gene and protein bank to study disease modifying and susceptibility genes and proteins in urban patients with asthma.


Eligibility criteria: Inclusion Criteria:

* Ages 18 and above

Exclusion Criteria:

* Greater than 10 pack year tobacco history
* Lung diseases other than asthma

Primary outcomes:
measure: To recruit and characterize a cohort of subjects with asthma who reside in a high pollution, high asthma risk neighborhood
timeFrame: five yeARS
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Joan Reibman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patrawalla P, Kazeros A, Rogers L, Shao Y, Liu M, Fernandez-Beros ME, Shang S, Reibman J. Application of the asthma phenotype algorithm from the Severe Asthma Research Program to an urban population. PLoS One. 2012;7(9):e44540. doi: 10.1371/journal.pone.0044540. Epub 2012 Sep 13.
citation: Liu M, Rogers L, Cheng Q, Shao Y, Fernandez-Beros ME, Hirschhorn JN, Lyon HN, Gajdos ZK, Vedantam S, Gregersen P, Seldin MF, Bleck B, Ramasamy A, Hartikainen AL, Jarvelin MR, Kuokkanen M, Laitinen T, Eriksson J, Lehtimaki T, Raitakari OT, Reibman J. Genetic variants of TSLP and asthma in an admixed urban population. PLoS One. 2011;6(9):e25099. doi: 10.1371/journal.pone.0025099. Epub 2011 Sep 22.
citation: Reibman J, Marmor M, Filner J, Fernandez-Beros ME, Rogers L, Perez-Perez GI, Blaser MJ. Asthma is inversely associated with Helicobacter pylori status in an urban population. PLoS One. 2008;3(12):e4060. doi: 10.1371/journal.pone.0004060. Epub 2008 Dec 29.
Clinical trial NCT02603237: Metabolic Response to Fat and Glucose
Official title: Metabolic Response to Fat and Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Healthy
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The study will compare plasma and urine post-prandial metabolomics after fat and glucose oral load according to lifestyle factors.

Detailed description: The metabolic response in plasma and urine, pre- and post-load tests in people with specific dietary lifestyles will be tested. This project will focus on fat and glucose induced changes of targeted metabolic pathways that have been related to diabetes and obesity risk.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* On a stable dietary habits

Exclusion Criteria:

* Pregnancy
* Malabsorption disorders
* Present or former cancer
* Any oral medication that affect glucose or fat absorptions
* Cholesterol lowering drugs (i.e. Statins)
* other drugs: fibrates, MTX, or vitamin supplements
* Diabetes (type 1 and type 2)
* Alcoholism
* Weight losing diet during the last 4 months
* Liver diseases
* Renal dysfunction
* Gastric resection.

Primary outcomes:
measure: Plasma levels of branched chain amino acid
timeFrame: Changes between baseline and 2 hours
measure: Plasma Trimethylamin N-oxide
timeFrame: Changes between baseline and 2 hours
measure: Plasma glucose level
timeFrame: Changes between baseline and 2 hours
measure: Plasma glucose
timeFrame: Changes between baseline and 2 hours
measure: Plasma level of acetyl-CoA
timeFrame: Changes between baseline and 2 hours
Secondary outcomes:
measure: Plasma malonyl-CoA
timeFrame: Changes between baseline and 2 hours
measure: Plasma phosphatidylcholine
timeFrame: Changes between baseline and 2 hours
measure: Plasma insulin
timeFrame: Changes between baseline and 2 hours
measure: Plasma leptin
timeFrame: Changes between baseline and 2 hours
measure: Plasma Lactate
timeFrame: Changes between baseline and 2 hours
measure: Plasma pyruvate
timeFrame: Changes between baseline and 2 hours
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of Saarland
state: Saarland
Study officials:
affiliation: Universität des Saarlandes
name: Rima Obeid
role: STUDY_DIRECTOR
References:
Clinical trial NCT04830332: Correlation of Peritoneal Fluid CA-125 Levels With Postoperative Tumor Histology
Official title: Correlation of Preoperative Serum and Intraoperative Peritoneal Washing Fluid CA-125 Levels With Postoperative Tumor Histology in Patients With Endometrial Carcinoma: a Prospective-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Carcinoma
Keywords: Endometrial carcinoma, CA-125, lymphovascular invasion
Lead sponsor: Erdemli State Hospital
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this prospective study, we aimed to investigate whether serum and abdominal washing fluid CA-125 levels correlated with postoperative histopathological parameters in patients with endometrial carcinoma.

Detailed description: Endometrial cancer was diagnosed with histopathological examination of the samples obtained by dilatation and curettage. Preoperative serum CA-125 levels were determined in all patients. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. In addition to routine preoperative investigations, MRI was done in patients who were thought to have an extension outside the uterus.

During surgery, abdominal exploration was performed first, and then an abdominal fluid sample was obtained for cytological examination and measurement of CA-125 level. One hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Subsequently, total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH + BSO) were performed.

Eligibility criteria: Inclusion Criteria:

* Women with endometrial carcinoma

Exclusion Criteria:

* Previous history of any other malignancy
* Endometriosis
* Diagnosed with pelvic infection or with any other potential disease such as acute pancreatitis, colitis, diverticulitis, pericarditis, polyarteritis nodosa, Sjögren's syndrome and SLE

Primary outcomes:
measure: Abdominal washing fluid CA-125 levels
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Reseacrh Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Suleyman G Doluoğlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563732: Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
Official title: An Open-Label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Lecozotan SR and a Single Oral Dose of Digoxin When Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects.

Secondary: To assess the safety and tolerability of the coadministration of lecozotan SR and digoxin.


Eligibility criteria: Inclusion Criteria:

* Women of non childbearing potential and men aged 18 to 55 years at screening.
* Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight 50 kg (BMI = weight (kg)/\[height (m)\]

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any clinically important deviation from normal limits in physical examination, vital signs or clinical laboratory test results.

Primary outcomes:
measure: Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02905409: Study of Surgery in Patients With Idiopathic Macular Hole
Official title: A Randomized, Double-masked, Multicenter, Controlled Study of Effects of Internal Membrane Peeling Surgery in Patients With Idiopathic Macular Hole Measured by Optical Coherence Tomography.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Idiopathic Macular Hole
Surgery
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
name: Beijing Hospital
name: Peking Union Medical College Hospital
First posted: 2016-09-19
Enrollment: 228
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: The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.

Detailed description: The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.

Eligibility criteria: Inclusion Criteria:

* patients with IMH
* patients signed the ICF
* patients with course of IMH less than 3 years

Exclusion Criteria:

* patients with hyper myopia
* patients with traumatic macular hole
* accompanied or secondary of other fundus disease
* open or reopen after receiving MH surgery
* patients with retinal detachment
* received vitrectomy due to other diseases
* glaucoma cannot be controled by medication
* patients with other retinal or choroidal disease that may affect VA
* poor patients compliance
* poor condition that cannot undertake the surgery
* dioptric media opacities which make it difficult to exam fundus or measure on OCT

Primary outcomes:
measure: Anatomical closure grades in OCT
timeFrame: 6 months
measure: Change of anatomical closure grades in OCT
timeFrame: 1 month, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Change from baseline in BCVA (best corrected visual acuity).
timeFrame: 1 month, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Mingwei Zhao, M.D
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College
name: Hong Dai, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tongren Hospital of Capital Medical University
name: Wenbin Wei, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College
name: Youxin Chen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03201809: Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
Official title: Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
Primary purpose: TREATMENT

Brief summary: This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.


Eligibility criteria: Inclusion Criteria:

* presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement.

Exclusion Criteria:

* pregnant, prisoners, cannot consent, history of chronic pain or pain medication use

Primary outcomes:
measure: Post-operative Narcotic Usage
timeFrame: post operation up to 2 days
Secondary outcomes:
measure: Post-operative Anti-emetic Usage
timeFrame: post operation up to 2 days
measure: Post-operative Self-reported Pain Scores
timeFrame: post operation up to 2 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Michael S Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02627209: The Serum Angiotensin Converting Enzyme and Lysozyme Levels in Patients Non-infectious and Infectious Uveitis
Official title: Non-infectious and Infectious Uveitis Diagnosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcoidosis
Tuberculosis
Keywords: Angiotensin converting enzyme
Lysozyme
Ankylosing spondylitis
Behcet's disease
Sarcoidosis
Syphilis
Tuberculosis
Ocular inflammation
Lead sponsor: Dünyagöz Hospital
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 280
Sex: ALL
Minimum age (years): 9
Maximum age (years): 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases.

Detailed description: Increased serum levels of angiotensin converting enzyme and lysozyme are considered as inflammatory markers for diagnosis of sarcoidosis which is an autoimmune inflammatory disease. Sarcoidosis, ankylosing spondylitis and Behcet's disease are the most common autoimmune inflammatory diseases involving the eye.

Elevated serum angiotensin converting enzyme levels have also been reported in tuberculosis. Syphilis and tuberculosis are the most common infectious diseases involving the eye.

Eligibility criteria: Inclusion Criteria:

* Subjects have ocular inflammation diagnosed as sarcoidosis, ankylosing spondylitis, behcet's disease
* Subjects have ocular infection diagnosed as tuberculosis and syphilis
* Subjects have refractive errors only

Exclusion Criteria:

* Subjects using ACE inhibitors, systemic steroids, immunosuppressive or immunomodulatory therapies

Primary outcomes:
measure: Analysis of serum angiotensin converting enzyme level
timeFrame: 1 day
Secondary outcomes:
measure: Analysis of serum lysozyme level
timeFrame: 1 day
Other outcomes:
Locations:
city: Cankaya
country: Turkey
facility: DunyaGoz hospital Tunus caddesi no.28 kavaklidere
state: Ankara
Study officials:
affiliation: DunyaGoz Hospital, Etiler, yanarsu sokak no.1 besiktaş Istanbul Turkey
name: Ioannis Pallikaris, MD
role: STUDY_CHAIR
References:
citation: Birnbaum AD, Oh FS, Chakrabarti A, Tessler HH, Goldstein DA. Clinical features and diagnostic evaluation of biopsy-proven ocular sarcoidosis. Arch Ophthalmol. 2011 Apr;129(4):409-13. doi: 10.1001/archophthalmol.2011.52.
citation: Sen DK, Sarin GS. Immunoassay of serum muramidase (lysozyme) in ocular diseases. Indian J Ophthalmol. 1987;35(5-6):103-7.
citation: Sahin O, Ziaei A, Karaismailoglu E, Taheri N. The serum angiotensin converting enzyme and lysozyme levels in patients with ocular involvement of autoimmune and infectious diseases. BMC Ophthalmol. 2016 Feb 16;16:19. doi: 10.1186/s12886-016-0194-4.
Clinical trial NCT03165409: Cost of Adverse Events Related to How Often Follow-Up Occurs Among Patients With Cancer That Has Spread
Official title: Economic Burden of Adverse Events Associated With Follow-Up Frequency Among Patients With Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 1828
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who were diagnosed with metastatic melanoma and initiated at least 1 treatment for metastatic melanoma after 2011 will be identified from the IMS PharMetrics Plus US Claims Database and included in the study sample. Patients must have had continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date. The population from the CheckMate-067 (CA209-067) clinical trial will also be included. The population consists of all patients who received at least 1 dose of study drug.

Brief summary: This study is a real-world retrospective claims analysis to assess and compare AE-related HCRU and medical costs among patients with different follow-up frequency after initiating a melanoma therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with metastatic melanoma
* Initiated at least 1 treatment for metastatic melanoma after 2011
* Continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date
* Patients who received at least 1 dose of study drug in CA209-067

Primary outcomes:
measure: Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with less frequent general outpatient visits
timeFrame: Approximately 5 years
measure: Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with more frequent general outpatient visits
timeFrame: Approximately 5 years
measure: Treatment-related and all-cause AE costs for nivolumab/ipilimumab combination therapy for metastatic melanoma
timeFrame: Approximately 5 years
measure: Treatment-related and all-cause AE costs for nivolumab monotherapy for metastatic melanoma
timeFrame: Approximately 5 years
measure: Treatment-related and all-cause AE costs for ipilimumab monotherapy for metastatic melanoma
timeFrame: Approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol-Myers Squibb
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01264809: Exercise Consultation for Type 2 Diabetes Patients in Real Life
Official title: Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: Clinique Antilles-Guyane
First posted: 2010-12-22
Enrollment: 80
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: HEALTH_SERVICES_RESEARCH

Brief summary: The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in France and especially in the French West Indies.This chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle modification and medication. Despite numerous studies supporting the benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80% of this population remain sedentary. Promotion of physical activity in current diabetes care seems to be inadequate.

The aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with Type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 DM diagnosed within 10 years prior the inclusion
* 18-70 years old
* Signed written informed consent
* Diabetes treatment regimens :

  * diet only
  * oral antidiabetic drug
  * oral antidiabetic drugs with long acting insulin analog
  * oral antidiabetic drugs with GLP 1 analog

Exclusion Criteria:

* Minors
* Patients with concurrent medical conditions preventing exercise
* Pregnancy or intention to become pregnant during the study
* Inability to read and write French
* History of participating in our education program during the past two years
* Usual sporty activities
* Change in diabetes treatment during the three months prior to study enrollment
* No written informed consent

Primary outcomes:
measure: Change in daily physical activity measured by SenseWear Pro3 Armband®. Participants were instructed to wear the monitor for seven days during all waking hours except bathing.
timeFrame: 3 months
Secondary outcomes:
measure: Benefits obtained after the physical activity counseling
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort-de-France
country: France
facility: CHU de Fort-de-France- Hôpital Pierre Zobda Quitman
state: Martinique
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Haut Lévêque
Study officials:
affiliation: CHU de Fort-de-France
name: Cédric FAGOUR, MD
role: PRINCIPAL_INVESTIGATOR
References: