louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00804713: Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Official title: Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Latent Tuberculosis Infection
Keywords: TB
tuberculosis diagnosis
TB screening
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Clinical Research Program
First posted: 2008-12-09
Enrollment: 2017
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk recruits without affecting the identification of higher-risk recruits. The secondary hypothesis is that many discordant results between the TST and IGRA may be explained by cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.


Eligibility criteria: Inclusion Criteria:

* Any recruit, age 18 years or older, undergoing routine entry-level medical processing at Fort Jackson

Exclusion Criteria:

* If they have history of severe reactions to TST (e.g., blistering, scar, or symptoms of immediate hypersensitivity)
* If they are unwilling to provide written consent for the study
* If they are unwilling to provide Health Insurance Portability and Accountability Act (HIPAA) authorization

Primary outcomes:
measure: TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
timeFrame: 48-72 hrs post administration
Secondary outcomes:
measure: Positive QFT-GIT Result
timeFrame: 48-72 hours after enrollment
Other outcomes:
measure: T-Spot Result
timeFrame: 48-72 hours
measure: Battey Skin Test Result
timeFrame: 48-72 hours after administration
measure: TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results
timeFrame: 48-72 hours after adminstration
Locations:
city: Columbia
country: United States
facility: Fort Jackson, SC
state: South Carolina
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: James Mancuso, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mancuso JD, Tribble D, Mazurek GH, Li Y, Olsen C, Aronson NE, Geiter L, Goodwin D, Keep LW. Impact of targeted testing for latent tuberculosis infection using commercially available diagnostics. Clin Infect Dis. 2011 Aug 1;53(3):234-44. doi: 10.1093/cid/cir321.
Clinical trial NCT02080013: Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
Official title: Prospective, Randomized Study of Endovenous Segmental Radiofrequency Versus 1320 nm Laser Ablation for the Treatment of Great Saphenous Vein Reflux (RVLAb Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 5
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: our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.

Detailed description: Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible

Exclusion Criteria:

* Exclusion criteria consisted of:
* Current deep vein thrombosis (DVT)
* Thrombus in the vein of interest
* Previous GSV treatment
* Pregnancy
* Known malignancy
* Significant arterial disease (ankle : brachial pressure index below 0•8)
* Use of anticoagulant medication.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vascular Surgery Department, Ain Shams University
name: Hossam M. Saleh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05041413: Helping Moms Quit Pilot Trial
Official title: Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Postpartum women
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-13
Enrollment: 30
Sex: FEMALE
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 this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit.

Detailed description: This pilot trial will evaluate a text message intervention (Moms Quit) to be initiated with postpartum women within one month of delivery. Moms Quit is a tailored program to support smoking abstinence among new mothers who are either current smokers or quit during their most recent pregnancy. Investigators will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. Investigators hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.

Eligibility criteria: Inclusion Criteria:

* Less than one month postpartum
* Live delivery
* Smoked at least 100 cigarettes/lifetime
* Smoked anytime during their most recent pregnancy
* English-speaking
* Own a mobile phone
* Provide an email address
* Willing to receive intervention-related texts
* Willing to complete surveys
* Willing to provide a saliva sample at the end of the study

Exclusion Criteria:

* Women whose pregnancy did not result in live birth
* On a 7-point scale, participant indicates that they are not interested in quitting or staying quit in the next 6 months (Not at all = 1).

Primary outcomes:
measure: Days abstinent in the past 30 days
timeFrame: 12 weeks post-randomization
Secondary outcomes:
measure: 7 day point prevalence abstinence
timeFrame: 12 weeks post-randomization
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT01882413: A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 204
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with planned cataract removal surgery

Brief summary: This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo cataract removal surgery

Exclusion Criteria:

* Current use of eye drops or oral medications for allergic conjunctivitis
* Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
* Use of a contact lens within 4 weeks

Primary outcomes:
measure: Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
timeFrame: Up to 60 Days Prior to Surgery
Secondary outcomes:
measure: Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
timeFrame: Up to 60 days prior to cataract surgery
measure: Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention
timeFrame: Up to 60 days prior to cataract surgery
measure: Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining
timeFrame: Up to 60 days prior to cataract surgery
measure: Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs
timeFrame: Up to 60 days prior to cataract surgery
measure: Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms
timeFrame: Up to 60 days prior to cataract surgery
measure: Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms
timeFrame: Up to 60 days prior to cataract surgery
measure: Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears
timeFrame: Up to 60 Days Prior to Surgery
measure: Percentage of Participants With Elevated MMP-9 With Punctal Plugs
timeFrame: Up to 60 Days Prior to Surgery
measure: Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2
timeFrame: Up to 60 Days Prior to Surgery
measure: Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32
timeFrame: Up to 60 Days Prior to Surgery
Other outcomes:
Locations:
city: Brandon
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Barrie
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Boisbriand
country: Canada
state: Quebec
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03558113: Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence
Official title: Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence in Comparison to Visual Tactile Method: Diagnostic Accuracy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Secondary Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' restorations will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made.
Primary purpose: DIAGNOSTIC

Brief summary: A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera

Detailed description: Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera

Eligibility criteria: Inclusion Criteria:

* Patients should be over 18 years of age. Patients should have an acceptable oral hygiene level. Patients must have at least one posterior resin composite restoration

Exclusion Criteria:

Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion.

Primary outcomes:
measure: reliability and reproducibility of intra oral light fluorescence camera using kappa strength
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01385813: Inflammatory Markers in Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: pre-eclampsia
inflammatory markers
serological biobank
To assess whether the inflammatory markers could be useful
in order to identify pregnant women at risk to
develop preeclampsia
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 129
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study comprised 43 pregnant women who developed preeclampsia and 86 pregnant women who fulfilled a normotensive pregnancy.

All women were of Caucasian origin, and were nulliparous.

Brief summary: This is an investigation of inflammatory markers in women destined to develop preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Caucasian origin

Exclusion Criteria:

* Previous diseases e.g. cardiovascular disease, diabetes, hypertension, inflammatory bowel disease, serious organ disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01679613: Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers
Official title: Relative Bioavailability of Nintedanib Given Alone and in Combination With Ketoconazole at Steady State in Healthy Male Volunteers (an Open-label, Randomised, Two-way Cross-over Clinical Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)
timeFrame: 1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration
measure: Maximum Measured Concentration (Cmax)
timeFrame: 1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration
Secondary outcomes:
measure: Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)
timeFrame: 1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1199.161.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Luedtke D, Marzin K, Jungnik A, von Wangenheim U, Dallinger C. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):533-541. doi: 10.1007/s13318-018-0467-9.
Clinical trial NCT00380913: Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
Official title: A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Neuropathies
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

Detailed description: The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetic peripheral neuropathic pain
* Chronic daily pain present for at least 2 months
* On stable analgesic regimen for one month
* Baseline pain score greater than 40mm on a visual analog scale

Exclusion Criteria:

* Hypersensitivity to compounds in study drug or similar drugs
* Pregnant or lactating females
* Drug or alcohol abuse
* Unstable medical condition

Primary outcomes:
measure: The Average Pain Score at target site.
Secondary outcomes:
measure: The Worst Pain Score at target site.
measure: The Pain at Night Score at target site.
measure: Quality of Life measures
measure: Patient satisfaction with treatment
measure: Safety will be assessed through the collection of AEs and vital signs.
Other outcomes:
Locations:
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Naples
country: United States
facility: Naples Anesthesia and Pain Associates
state: Florida
city: West Palm Beach
country: United States
facility: Lazlo Mate, MD
state: Florida
Study officials:
affiliation: NEMA Research, Inc.
name: Joseph V Pergolizzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nema Research
name: Charlotte Richmond, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03905213: Prevention of Surgical Wound Infection
Official title: Impact of the Use of Three Dressings in the Prevention of Surgical Wound Infection in Patients Undergoing Mayor Cardiac Surgery: a Clinical Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2019-04-05
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized in three groups
Primary purpose: PREVENTION

Brief summary: To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery

Detailed description: It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.

Eligibility criteria: Inclusion Criteria:

* patient scheduled to cardiac surgery.
* signed informed consent form

Exclusion Criteria:

* hypersensibility to dressings

Primary outcomes:
measure: prevention of surgical wound infection
timeFrame: surgery date up to 6 months
Secondary outcomes:
measure: hospital stay
timeFrame: from hospitalization until an average of 1 year
measure: antimicrobial consumption
timeFrame: from surgery date until an average of 1 year
measure: dressing consumption cost
timeFrame: from surgery date until an average of 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Gregorio Marañón Hospital
name: Maria Jesus Perez Granda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617213: Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma
Official title: Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.


Eligibility criteria: Inclusion Criteria:

* Must be 18 to 75 years of age.
* ECOG performance status of 0, 1 or 2.
* Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible.
* Patients who are pregnant are ineligible.
* Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
* Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
* Patients must be HIV and HTLV-I,-II antibody sero-negative.
* Patients must have adequate visceral organ function

Exclusion Criteria:

* Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
* Patients are ineligible if they are receiving any other investigational agents.

Primary outcomes:
measure: Event Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease Response
timeFrame: 2 years
measure: Overall survival
timeFrame: 4 years
measure: Grade > 2 toxicities
timeFrame: 4 years
measure: Incidence of infections
timeFrame: 4 years
measure: Treatment related Mortality
timeFrame: 4 years
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Mary J. Laughlin, MD
role: PRINCIPAL_INVESTIGATOR
References: