louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01580982: Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer
Official title: Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung and Other Thoracic Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Neoplasms
Keywords: Oncogenes
Lung and Other Thoracic Cancers
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients considered for this study would be undergoing a standard care procedure

Brief summary: The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and/or from standard-of-care re-biopsy upon suspected tumor progression.

Detailed description: To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies
2. Aged 18 years or older
3. Either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy/surgical intervention with tumor tissue at University of Colorado or an outside institution available for medullar analysis.
4. Patients must have the ability to understand and willingness to sign an informed consent document.

Exclusion Criteria:

-

Primary outcomes:
measure: To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers.
timeFrame: To be determined upon funding
Secondary outcomes:
measure: To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies
timeFrame: To be determined upon funding
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Erin Schenk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01528982: Susceptibility to Pathological Gambling
Official title: Susceptibility to Pathological Gambling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Gambling
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to assess the risk factors for the development of pathological gambling.

Detailed description: This study will track up to 600 young adults (ages 18 to 29) for a two-year period, collecting variables such as gambling behavior, drug and alcohol use, psychiatry and medical history, family history, impulsivity, quality of life, self-esteem, and cognition. For some individuals who meet criteria as being impulsive, they will be randomized to receive an intervention to help reduce their impulsivity.

Eligibility criteria: Inclusion Criteria:

* Ability to understand the procedures and provide written consent
* Gambled at least 5 times in the past year
* Between the ages of 18 and 29 at intake

Exclusion Criteria:

* Inability to understand the procedures and provide written consent

Primary outcomes:
measure: Structured Clinical Interview for Pathological Gambling (SCI-PG)
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago, Department of Psychiatry
name: Jon E Grant, JD, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01229982: A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Official title: A Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L PPDS)in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open Angle Glaucoma
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
* Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion Criteria:

* Functionally significant vision loss, or progressive field loss within the last year.
* Contact lens wear at any time during the treatment period.
* Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
* Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
* Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
* Currently on chronic ocular topical medications
* Currently on any ophthalmic or systemic steroid therapy.
* Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
* History of macular edema
* History of chronic/recurrent inflammatory eye disease.
* History of a non-response to topical prostaglandin therapy.
* Subjects who have epiphora.

Primary outcomes:
measure: IOP change from baseline at 4 weeks
timeFrame: Baseline to 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: QLT Inc.
state: British Columbia
Study officials:
References:
Clinical trial NCT02791282: CTEPH DIAGNOSIS Europe - MRI
Official title: CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
MRI
SPECT
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: University of Giessen
name: Ludwig-Maximilians - University of Munich
name: Heidelberg University
First posted: 2016-06-06
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)

Detailed description: CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.

Eligibility criteria: Inclusion Criteria:

* Transthoracic echocardiography indicates pulmonary hypertension
* Patients with clinical suspicion for CTEPH, scheduled for SPECT
* Provided informed consent for the study
* Age \>18y

Exclusion Criteria:

* Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents)
* Women who are pregnant or breast feeding

Primary outcomes:
measure: The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard
timeFrame: 6 months
measure: The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Jens Vogel-Claussen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lasch F, Karch A, Koch A, Derlin T, Voskrebenzev A, Alsady TM, Hoeper MM, Gall H, Roller F, Harth S, Steiner D, Krombach G, Ghofrani HA, Rengier F, Heussel CP, Grunig E, Beitzke D, Hacker M, Lang IM, Behr J, Bartenstein P, Dinkel J, Schmidt KH, Kreitner KF, Frauenfelder T, Ulrich S, Hamer OW, Pfeifer M, Johns CS, Kiely DG, Swift AJ, Wild J, Vogel-Claussen J. Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale. Front Cardiovasc Med. 2020 Apr 9;7:51. doi: 10.3389/fcvm.2020.00051. eCollection 2020.
Clinical trial NCT01016782: Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Rosacea
Keywords: Inflammatory Rosacea
Rosacea
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 867
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 this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.

Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rosacea
* Good health with the exception of rosacea
* Papsules and pustules minimum and maximum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Subjects who have any systemic or dermatological disorders with the exception of rosacea

Primary outcomes:
measure: Reduction in the number of papules and pustules from Baseline to End of Treatment
timeFrame: 70 Days
Secondary outcomes:
measure: Reduction in the Investigator's Global Evaluation, Clear or Almost Clear
timeFrame: 70 Days
Other outcomes:
Locations:
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Angela C Kaplan
role: STUDY_DIRECTOR
References:
Clinical trial NCT01304420: Ultrasonography in Juvenile Idiopathic Arthritis
Official title: Changes in Joint-Cartilage as a Measure of Outcome in Juvenile Idiopathic Arthritis - Assessed by Ultrasonography and Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis, Oligoarthritis
Polyarticular Juvenile Rheumatoid Arthritis
Systemic Juvenile Idiopathic Arthritis
Keywords: Juvenile idiopathic arthritis
Ultrasonography
Cartilage
Cartilage biomarkers
Bone biomarkers
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2011-02-25
Enrollment: 95
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with Juvenile Idiopathic Arthritis, followed in dept of pediatric rheumatology, Aarhus University Hospital, Skejby

Brief summary: The purpose of this study is to analyse the usability of ultrasonography together with biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis. The investigators hypothesize that serum and urine markers of cartilage and bone synthesis and degradation, together with ultrasound measurements of joint cartilage thickness, are useful tools in the early evaluation of JIA patients, - as diagnostic, prognostic and monitoring methods.


Eligibility criteria: Inclusion Criteria:

* Juvenile idiopathic arthritis: Oligoarticular, polyarticular or systemic onset type.
* Informed consent from parents
* between 5-15 years of age

Exclusion Criteria:

* Other diagnoses that involves bones or cartilage
* Intraarticular steroid injections within 1 month of the trial investigation

Primary outcomes:
measure: Joint cartilage thickness
timeFrame: 1.5 years
Secondary outcomes:
measure: Level of different biomarkers in serum and urine
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Pediatric research dept, Aarhus Universityhospital, Skejby
state: Region Midt
Study officials:
References:
Clinical trial NCT02119520: PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Keywords: Periodontitis
Surgery
Growth Factors
Statins
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 96
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.


Eligibility criteria: Inclusion Criteria:

the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[IOPA\]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing \[SRP\]) in asymptomatic teeth.

Exclusion Criteria:

1) Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (\<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.

Primary outcomes:
measure: Percentage radiographic defect depth reduction
timeFrame: 9 months from baseline
Secondary outcomes:
measure: change in probing depth
timeFrame: 9 months from baseline
measure: change in relative attachment level
timeFrame: 9 months from baseline
measure: change in plaque levels
timeFrame: 9 months from baseline
measure: change in gingival bleeding
timeFrame: 9 months from baseline
measure: change in gingival margin levels
timeFrame: 9 months from baseline
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Govt dental college and research institute
state: Karnataka
Study officials:
affiliation: Professor
name: Avani R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05833620: Identification and Characterization of Genetic Variants in Hereditary Angioedema
Official title: Identification and Functional Characterization of Genetic Variants Associated With Specific Clinical Phenotypes in Hereditary Angioedema Due to C1 Inhibitor Deficiency: An Unbiased Approach
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
First posted: 2023-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with hereditary angioedema with C1INH deficiency (HAE-C1INH) from different regions of Spain will be included. Patients included in the study will be divided into two groups: a) symptomatic (≥ 18 years old), which will be those who present symptoms compatible with HAE-C1INH and who have a confirmed diagnosis and b) asymptomatic patients (≥ 22 years old), which will be those with a C1INH deficiency and who have not developed symptoms of HAE.

Brief summary: This project aims to analyse in an unbiased way the existence of genetic variants that contribute to explaining and predicting the differences in clinical expression between patients with HAE.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years old) with HAE-C1INH diagnosis (confirmed by mutation in SERPING1 gen or immunochemical study showing a decrease in C1INH function \<50% in two determinations together with a family history (symptomatic patients' group)
* Patients ≥ 22 years old with C1INH hereditary deficiency (confirmed by mutation of SERPING1 gene or immunochemical study showing a decrease in C1INH function \<50% in two determinations together with a family history) and who have not developed symptoms consistent with HAE-C1INH
* Signed informed consent.

Exclusion Criteria:

* No confirmed C1INH deficiency.
* Inability to sign the informed consent.
* Presence of recurrent angioedema with histaminergic characteristics (response to treatment with antihistamines, glucocorticoids and/or epinephrine)

Primary outcomes:
measure: Set of validated disease-modifying genetic variants in Spanish patients with HAE-C1INH
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
Clinical trial NCT00192920: Evaluation of the Quality of the Transfusion Practice at Rigshospitalet, Copenhagen University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhage
Blood Transfusions
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose is to evaluate and improve transfusion practice


Eligibility criteria: Inclusion Criteria:

* Hospitalized at Rigshospitalet, Copenhagen University Hospital

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Blood Bank, Rigshospitalet, Copenhagen University Hospital
name: Pär Johansson, MD, MPA
role: STUDY_CHAIR
References:
Clinical trial NCT01169220: Bowel Preparation for Inpatient Colonoscopy
Official title: Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Hemorrhage
Colon Cancer
Diverticulosis
Keywords: Colonoscopy
Bowel preparation
Lead sponsor: Santa Clara Valley Health & Hospital System
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.


Eligibility criteria: Inclusion Criteria:

* any diagnosis for which colonoscopy is indicated

Exclusion Criteria:

* ileus
* severe colitis/toxic megacolon
* gastric retention
* bowel perforation
* gastrointestinal obstruction
* gastroparesis that precludes oral bowel preparation
* pregnant or lactating women
* allergy to polyethylene glycol.
* unable to give consent

Primary outcomes:
measure: Quality of colon cleansing
timeFrame: 24 hours from study enrollment
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 24 hours from study enrollment
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
Study officials:
References:
Clinical trial NCT00772720: Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
Official title: Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.


Eligibility criteria: Inclusion Criteria:

1. Healthy male.
2. age between 18 and 45.
3. BMI between 19 and 25 kg/m2
4. Normal physical exam.
5. Blood analysis without relevant findings.
6. Negative serology for hepatitis B, Hepatitis C and HIV.
7. Negative urine test for abuse drugs.

Exclusion Criteria:

1. Severe psychiatric disease.
2. Dyslipemia.
3. Alcohol intake above 30 g per day.
4. Smokers
5. Xanthine intake above 5 coffee cup -equivalents per day
6. Use of any drugs in the last month
7. Participation in other trials in the last 3 months
8. Diseases capable to modify drug ADME
9. Drug allergy

Primary outcomes:
measure: Blood levels of total cholesterol
timeFrame: 7 days
Secondary outcomes:
measure: Changes in HDL, LDL and triglycerides
timeFrame: 7 days
measure: Oral glucose tolerance test
timeFrame: 7 days
measure: Mitochondrial DNA levels
timeFrame: 7 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
Study officials:
References: