louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04650191: Surfactant Protein Genetic Variants in COVID-19 Infection
Official title: Surfactant Protein Genetic Variants in COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with positive COVID-19 infection will be enrolled regardless of age and sex after obtaining informed consent.

Brief summary: Surfactant protein plays important role in innate immunity against respiratory viral infections. However, investigators have shown that the surfactant protein polymorphisms are associated with severity of various pulmonary diseases such as respiratory syncytial virus (RSV), tuberculosis, pediatric acute lung injury. COVID-19 virus gains entry through the respiratory system and responsible for death due to acute respiratory failure. There is a considerable heterogeneity in presentation of COVID-19 infection from asymptomatic patients to severe infection requiring intensive care and some may die. Considering reports of COVID-19 related deaths/severe disease in the same family, it is possible that genetics play an important role in severity of COVID-19 infection. Investigators propose to study the association of surfactant proteins in COVID-19 patients. Key Objectives: a) Characterize genetic markers within the surfactant protein genes in COVID-19 positive patients, b) To determine if there is a correlation between certain genetic markers and the severity of COVID-19 infection which may be used as a prognostic marker, c) To correlate genetic markers with immune studies.


Eligibility criteria: Inclusion Criteria:

The major inclusion criteria is a confirmed diagnosis of COVID-19 infection performed on nasopharyngeal secretions by enzyme immunoassay or culture in patients.

Exclusion Criteria:

Patients unable to sign informed consent will be excluded.

Primary outcomes:
measure: Correlation of surfactant protein genetic variants with severity of COVID-19 infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00915291: Evaluating Effectiveness of Educational Intervention to Help Physicians Address Inappropriate Patient Requests for Direct-to-Consumer Advertised Prescription Medications
Official title: Sound Prescribing Study - Assessing the Impact of Pharmaceutical Marketing and Promotional Practices on Physician Prescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosacral Muscle Strain
Keywords: medical education
clinical decisionmaking
pharmaceutical marketing
Lead sponsor: American Medical Association
Sponsor class: OTHER
Collaborators: name: Attorney General Consumer & Prescriber Education Grant
First posted: 2009-06-08
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications.

Detailed description: Since changes in FDA regulation direct-to-consumer advertising (DTCA), pharmaceutical companies have expended increasing resources to market their products to the public. This has led to increased awareness of diseases and potential treatments, but it has also created more public demand for medications that may not be appropriate for a patient's clinical presentation. This study aims to provide physicians with the knowledge and skills required to help them address inappropriate DTCA medication requests from patients.

Eligibility criteria: Inclusion Criteria:

* Resident physicians in internal medicine or family medicine specialties at participating study sites

Exclusion Criteria:

* Completed less than 10 months of residency

Primary outcomes:
measure: Decision to prescribe celecoxib
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Omaha
country: United States
facility: Creighton University School of Medicine
state: Nebraska
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas at Houston Medical School
state: Texas
Study officials:
affiliation: American Medical Association
name: Audiey C Kao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04921891: Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block
Official title: Comparison of Block Success in Patients Undergoing Ultrasound-guided Infraclavicular Brachial Plexus Block With Bilateral Upper Extremity Perfusion Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Perfusion Index
Keywords: Infraclavicular block
Perfusion index
Ultrasonography
Block assessment
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.

Detailed description: Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.

Eligibility criteria: Inclusion Criteria:

* Ages of 18-75
* Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
* ASA I-II-III patients

Exclusion Criteria:

* Patients who will refuse this method
* Neurological deficits,
* Diabetes mellitus,
* Local anesthetic allergy,
* Morbidly obese,
* Peripheral vascular disease, coronary artery disease, or coagulopathy

Primary outcomes:
measure: Evaluation of whether perfusion index is a reliable and objective method to indicate block success
timeFrame: 6 hours postprocedurly
Secondary outcomes:
measure: Determining of a cut-off value for PI and PI ratio for a successful block.
timeFrame: Up to 6 hours after the procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
state: Bakirkoy
Study officials:
References:
Clinical trial NCT00185991: Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Official title: Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chorioamnionitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.


Eligibility criteria: Inclusion Criteria:

- clinical diagnosis of chorioamnionitis

Exclusion Criteria:

- maternal renal disease, intrauterine fetal death, allergy to gentamicin

Primary outcomes:
measure: Afebrile at 24 hours and no endometritis
timeFrame: 24 hours after delivery
Secondary outcomes:
measure: Neonatal outcomes
timeFrame: Time of delivery to time of discharge
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Yehia El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyell DJ, Pullen K, Fuh K, Zamah AM, Caughey AB, Benitz W, El-Sayed YY. Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):344-349. doi: 10.1097/AOG.0b013e3181cb5c0e.
Clinical trial NCT05296291: RCT: Titanium vs FCZ vs Zirconia Framework
Official title: RCT Study of Posterior Implant Supported Bridges Made of Various Prosthetic Materials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Prosthesis Failure
Lead sponsor: Branemarkkliniken
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years, zirconia-based implant-supported bridge designs have begun to be used more and more as an alternative to metal ceramic bridges. Another new material that has been introduced in the clinic is the high translucent monolithic zirconia, which has only been investigated a few follow-up studies with short follow up duration.

The aim being to evaluate the clinical outcome of implant-anchored posterior bridges, made from

1. high-translucent monolithic zirconia,
2. zirconia ceramic with porcelain and
3. metal ceramics. The hypothesis is that high-translucent monolithic zirconia has lower rate of complications since surface porcelain veneering is not required.

A total of 60 research subjects will be included in the study. Patients in need of a permanent implant-supported bridge, located posterior of the canine in the upper or lower jaw will be asked for participation. Each subject will be treated according to standard treatment protocols with implants from Nobel Biocare, the Branemark implant system and then be randomly assigned to obtain one of the following three type of bridges.

20 research subjects will be included in each of the three study arms. The prosthetic treatment will be carried out according to standard clinic protocol.

All research subjects will be evaluated after 1, 3, 5 years. X-rays and photos will be taken at the installation of the bridges and after 1 and 5 years of follow-up or more frequent, depending on individual indication of the patient and the associated standard clinical care protocol.

Personal data, implant survival, marginal bone loss and biological and technical complications related to the implants will be recorded. Survival of the bridge, technical and biological complication related to the bridge will also be recorded


Eligibility criteria: Inclusion Criteria:

edentulous behind the canine in the maxilla or mandible

* older than 18 years

Exclusion Criteria:

* younger than 18 years
* active periodontitis

Primary outcomes:
measure: Complication rate
timeFrame: From placement of prosthetic Bridge until last follow-up of the study after 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: B R Å N E M A R K C L I N I C
Study officials:
References:
Clinical trial NCT01028391: 30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)
Official title: A 30-Week Extension to: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 317
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: A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.


Eligibility criteria: Inclusion Criteria:

* Patients must complete the double-blind base study (MK-0431-064-00)(NCT00397631) and have at least 75% compliance with study medication during the base study treatment period.
* Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods

Primary outcomes:
measure: Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54
timeFrame: Baseline and 54 Weeks
Secondary outcomes:
measure: Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54
timeFrame: Baseline and Week 54
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Yoon KH, Shockey GR, Teng R, Golm GT, Thakkar PR, Meehan AG, Williams-Herman DE, Kaufman KD, Amatruda JM, Steinberg H. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011 Feb;65(2):154-64. doi: 10.1111/j.1742-1241.2010.02589.x.
citation: Yoon KH, Steinberg H, Teng R, Golm GT, Lee M, O'Neill EA, Kaufman KD, Goldstein BJ. Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: a 54-week study. Diabetes Obes Metab. 2012 Aug;14(8):745-52. doi: 10.1111/j.1463-1326.2012.01594.x. Epub 2012 Apr 17.
Clinical trial NCT01250691: Effects of Isolated Rooms on the Prevalence of Hospital Acquired Pneumonia in a Respiratory ICU
Official title: Epidemiologic Study of Hospital Acquired Pneumonia in a Respiratory ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Intensive Care Unit
Keywords: pneumonia
ICU
isolation room
clinical epidemiology
infection control
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the patients who had been admitted to the ICU during this period were included in the study

Brief summary: This study will carry out in the ICU. Objectives of the study are to determine the frequency of HAP and the effect of isolated rooms on the frequency of pneumonia in the ICU.

Detailed description: In the present study, it was aimed to determine the incidence, causative agents, antimicrobial resistance, and risk factors for lower respiratory tract infections in patients followed in the ICU for the last 4 years. The effect of reconfiguration from a ward-type ICU consisting one large room to an ICU with isolated rooms with two beds on the incidence of HAP was also determined.

Eligibility criteria: Inclusion Criteria:

* adult patients,
* admitted to the ICU

Exclusion Criteria:

* trauma, surgery or burned patients
* patients under 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Merkez
city: Eskisehir
country: Turkey
facility: Osmangazi University
state: Merkez
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Eskisehir Osmangazi University, Medical Faculty
name: Irfan Ucgun, As.Prof.Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01220791: Methylprednisolone Addition in IVF Treatment of Infertile Couples
Official title: Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: In Vitro Fertilization
Keywords: methylprednisolone
IVF
progesterone
corticosteroid
late follicular phase
pregnancy rates
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: BioGenesis
name: HRG
First posted: 2010-10-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment

Detailed description: The aim is to investigate any potential advantages of adding cortisone supplementation from the follicular phase onwards with regard to premature luteinization, oocyte quality, embryo quality and pregnancy outcome.

Eligibility criteria: Inclusion Criteria:

* less than 36, more than 10 antral follicles, FSH\<12

Exclusion Criteria:

* endometriosis stage III\&IV,

Primary outcomes:
measure: Progesterone rise above 1.5ng.ml on the day of HCG
timeFrame: up to 14 days of follicular ovarian stimulation
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: Follow pregnancy until delivery
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Biogenesis
state: Pylaia
Study officials:
affiliation: BioGenesis
name: Basil Tarlatzis, Professor
role: STUDY_CHAIR
References:
citation: Bider D, Menashe Y, Goldenberg M, Dulitzky M, Lifshitz A, Dor J. Dexamethasone as an adjuvant therapy for anovulatory, normoandrogenic patients during ovulation induction with exogenous gonadotropins. J Assist Reprod Genet. 1996 Sep;13(8):613-6. doi: 10.1007/BF02069638.
Clinical trial NCT00390091: Study of LJP 394 (Abetimus Sodium) in Lupus Patients
Official title: A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Nephritis
Kidney
SLE
Systemic Lupus Erythematosus
Nephritis, Lupus
Lead sponsor: La Jolla Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.

Detailed description: STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Eligibility criteria: Inclusion Criteria:

* Males or females between 12 and 70 years old.
* Diagnosis of Systemic Lupus Erythematosus (SLE)
* Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study.
* Ability to have weekly intravenous (IV) administration of study drug.

Exclusion Criteria:

* Prior exposure to abetimus sodium within 6 months prior to screening.
* Patients not on stable medications for 30 days prior to screening.
* Patients with acute or chronic infections.

Primary outcomes:
measure: The assessment of the safety and pharmacodynamic effect of abetimus sodium at
measure: doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in
measure: patients with SLE will be based on laboratory data from the central laboratory
measure: and confirmed by supporting data. The pharmacodynamic effic will be assessed
measure: using historical placebo effect as a control.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
affiliation: La Jolla Pharmaceutical Company
name: Matthew D Linnik, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03495791: Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
Official title: Web (YouTube) Based Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Arthritis, Rheumatoid
Keywords: RA
Rheumatoid Arthritis
Arthritis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will provide an educational intervention through means of a video to educate subjects on the risk of cardiovascular health on Rheumatoid arthritis.

Detailed description: Subjects will be randomized into an interventional group and non-interventional group. Both groups will perform several surveys before an educational intervention may be given. Both Groups will come back 3 months post visit to complete additional surveys.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnoses of Rheumatoid Arthritis of at least 3 months by a Rheumatologist

Exclusion Criteria:

* Inability to communicate in English.

Primary outcomes:
measure: Heart Disease Knowledge Questionnaire
timeFrame: 3 Months
measure: Heart Disease Fact Questionnaire
timeFrame: 3 Months
Secondary outcomes:
measure: Statues of Hyperlipidemia treatment
timeFrame: 1 Year
measure: Cholesterol
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: