louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01382407: Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab
Official title: Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Metastatic
Keywords: skin rash reaction
ERBITUX® (cetuximab)
acne
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2011-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients above the age of 18 years, who have been diagnosed with confirmed KRAS-WT mCRC, and are starting treatment with cetuximab, will be informed of the study.

Brief summary: The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.

Detailed description: The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab

Eligibility criteria: Inclusion Criteria:

* Age above 18 years.
* Histology or cytology proven KRAS-WT mCRC.
* Performance status ≤3 (Eastern Cooperative Oncology Group \[ECOG\] classification)
* Life expectancy of more than 12 weeks.
* Written informed consent.
* In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.

Exclusion Criteria:

* Past systemic immune therapy for disease other than cancer.
* Past immune or other target therapy for cancer (not including bevacizumab).
* Presence of acne or acneiform rash prior to starting treatment with cetuximab.
* Patients with treatment plan of cetuximab and capecitabine combination.
* For female patients: the patient is pregnant or lactating.

Primary outcomes:
measure: Relationship between acne and skin rash
timeFrame: Within Erbitux treatment period (upto 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Oncology Institute, Rambam Health Care Campus
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Gil Bar-Sela, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05012007: Reminder Modality for CRC Screening
Official title: Reminders for FIT (Fecal Immunochemical Test) Kits Via Different Modalities: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer screening
Adherence
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2021-08-19
Enrollment: 2653
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening.

Detailed description: This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different reminder modalities in improving adherence to annual CRC screening.

Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation using permuted block randomization (with random block sizes of 3 and 6) to the following interventions:

1. Control arm: No reminder

   a. Intervention Type: No intervention
2. Arm 2: Automated phone reminder

   a. Intervention Type: Standard reminder via phone (audiocare)
3. Arm 3: Text reminder a. Intervention Type: Standard reminder via text (VEText)

Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)

Eligibility criteria: Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.

Inclusion Criteria:

* Veterans assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
* At least 1 year of prior data available (evidence of at least one outpatient visit).
* Due for annual CRC screening

Exclusion Criteria:

* Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment.
* No indication of current receipt of hospice care or record of recent death in the administrative data.
* No personal history of CRC or history of prior colectomy.

Primary outcomes:
measure: Percentage of returned FIT Kits
timeFrame: three months post randomization
Secondary outcomes:
measure: Percentage of returned FIT Kits
timeFrame: six months post randomization
Other outcomes:
measure: Interim analysis
timeFrame: At 50% (n = 1327) of estimated sample size
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Ashok Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System
name: Stefanie Deeds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03131388: Clinical Performance Evaluation of AMH Assay
Official title: Clinical Performance Evaluation of AMH Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti-Mullerian Hormone
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 277
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women presenting to fertility clinics for fertility assessment

Brief summary: The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population.

Detailed description: same as brief summary

Eligibility criteria: Inclusion Criteria:

* ≥ 21 and \< 46 years of age
* Regular menstrual cycle
* Both ovaries present

Exclusion Criteria:

* Evidence of PCOS
* Confirmed ovarian endometrioma
* Ovarian surgery prior to enrollment
* Being treated for cancer
* Hormonal contraceptive use prior to enrollment
* Currently pregnant

Primary outcomes:
measure: Measurement of AMH as an aid for fertility assessment
timeFrame: Day 2 to 4 of menstrual cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: BRI
state: Arizona
city: Palo Alto
country: United States
facility: Stanford
state: California
city: San Diego
country: United States
facility: FSMG
state: California
city: Newark
country: United States
facility: RAD
state: Delaware
city: Clearwater
country: United States
facility: WRMG
state: Florida
city: Swansea
country: United States
facility: Vios Fertility
state: Illinois
city: Waltham
country: United States
facility: BIVF
state: Massachusetts
city: Bryn Mawr
country: United States
facility: Mainline Fertility
state: Pennsylvania
city: Philadelphia
country: United States
facility: Univ Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: CARE
state: Texas
city: Webster
country: United States
facility: CORM
state: Texas
city: Seattle
country: United States
facility: PNWF
state: Washington
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Beckman Coulter
name: Fred Siebert
role: STUDY_DIRECTOR
References:
Clinical trial NCT04014088: Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)
Official title: A Randomized Controlled Trial Comparing Helmet Continuous Positive Airway Pressure (CPAP) vs Facemask CPAP for Treatment of Acute Cardiogenic Pulmonary Edema In The Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cardiogenic Pulmonary Edema
Keywords: helmet CPAP
facemask CPAP
pulmonary edema
non invasive ventilation
Lead sponsor: Hospital Raja Permaisuri Bainun
Sponsor class: OTHER_GOV
First posted: 2019-07-10
Enrollment: 164
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: This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP.

Detailed description: Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute cardiogenic pulmonary edema. The appropriate interface is necessary to provide comfort and lead to the success of NIV.

NIV delivered via facemask had been used widely. However, it was associated with leaks and discomfort to the patient.

Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.

Eligibility criteria: Inclusion Criteria:

* All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema

Exclusion Criteria:

1. Age less than 18 years old
2. Low GCS (less than 8), altered mental status
3. Hemodynamic instability, impending cardiopulmonary arrest
4. Use of vasopressors, inotropes
5. Exacerbation of asthma or chronic respiratory failure
6. Urgent need for endotracheal intubation
7. Absence of airway protective gag reflex
8. Elevated intracranial pressure
9. Tracheostomy
10. Pregnant
11. Upper airway obstruction
12. Injuries or surgery to head and neck less than 6 months upon presentation
13. Claustrophobia
14. Blind or poor vision
15. Medico-legal related cases

Primary outcomes:
measure: Respiratory Rate
timeFrame: 1 hour
Secondary outcomes:
measure: Heart Rate
timeFrame: 1 hour
measure: Partial Pressure of Arterial Oxygen Level
timeFrame: 1 hour
measure: Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen
timeFrame: 1 hour
measure: Dyspnea Scale
timeFrame: 1 hour
measure: Partial Pressure of Arterial Carbon Dioxide level
timeFrame: 1 hour
measure: Rate of Intubation
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Emergency Department, Hospital Raja Permaisuri Bainun
name: Adi Osman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637688: Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula
Official title: Growth and Plasma Amino Acid Levels in Infants With Cow's Milk Protein Allergy and Treated With a Newly Innovated Amino Acid Formula (NAAF) Compared to a Commercial Amino Acid Formula (AAF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cow Milk Allergy
Keywords: cow milk allergy
amino acid formula
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 81
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * population who are diagnosed cow's milk protein allergy via a double-blind placebo-controlled food challenge and consume either a newly innovated amino acid formula or a commercial amino acid formula
* population from a well-baby clinic

Brief summary: The purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula.

Detailed description: Severe cases of cow's milk protein allergy are treated with the amino acid formula. The amino acid formula is composed of essential and non-essential amino acids, vegetable oils with or without MCT oil, and glucose polymer from various carbohydrate sources. Such formula is also fortified by minerals, trace elements,and vitamins.

Eligibility criteria: Inclusion Criteria:

* Singleton
* Clinical diagnosis of cow's milk protein allergy

Exclusion Criteria:

* Other diseases

Primary outcomes:
measure: Growth and protein status
timeFrame: 4 weeks
Secondary outcomes:
measure: Growth
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Asso.Prof. Narumon Densupsoontorn
name: Narumon Densupsoontorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svasti J, Wasant P, Tiensuwan M, Sawangareetrakul P, Srisomsap C, Pangkanon S, Boonpuan K, Liammongkolkul S. Normal plasma free amino acid levels in Thai children. J Med Assoc Thai. 2001 Nov;84(11):1558-68.
citation: Burks W, Jones SM, Berseth CL, Harris C, Sampson HA, Scalabrin DM. Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid. J Pediatr. 2008 Aug;153(2):266-71. doi: 10.1016/j.jpeds.2008.02.043. Epub 2008 Apr 9.
Clinical trial NCT00042588: A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Sepsis
Keywords: Safety and Efficacy
Community-Acquired Pneumonia, Sepsis
Lead sponsor: ICOS Corporation
Sponsor class: INDUSTRY
First posted: 2002-08-05
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 objective of this study is to demonstrate the safety and efficacy of IC14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of community-acquired pneumonia.
* Evidence of systemic inflammatory response to infection.

Exclusion Criteria:

* Atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator.
* Presence of organ failure.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: ICOS Corporation
state: Washington
Study officials:
References:
Clinical trial NCT06455488: MANAGE-VT Registry - MANAGEment of Ventricular Tachycardia Outcomes Registry
Official title: MANAGEment of Ventricular Tachycardia Outcomes Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Tachycardia
Keywords: ventricular arrhythmia
ventricular tachycardia
ventricular fibrillation
stroke
Lead sponsor: CorVita Science Foundation
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who have been diagnosed and have evidence of ventricular tachycardia and are over the age of 18. Every patient was presented with a consent form and was given a description of the study in a clinical setting.

Brief summary: Data collection registry for patients with ventricular tachycardia to help physicians give better care for patients clinically and procedurally.

Detailed description: After consent from a patient the research team will input patients data from many different categories. There is a link to the PDF for the consent form, a patients anticoagulant medications will be assessed, their ventricular tachycardia (VT) history will be inputted, and their date of birth and zip code will inputted. The research team will then input any EKG's, echocardiograms, VT ablations, ICD's, S-ICD's, lab results, and comorbidities.

Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years old
* Must not be

Exclusion Criteria:

-

Primary outcomes:
measure: Recurrence of Ventricular Tachycardia
timeFrame: July 20, 2020 - Present
measure: Number of Participants with Risk of Sudden Cardiac Death
timeFrame: July 20, 2020 - Present
measure: Prevent Risk of Stroke
timeFrame: July 20, 2020 - Present
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Corvita Science Foundation
state: Illinois
Study officials:
References:
Clinical trial NCT00441688: Prospective Epidemiological Study Of The Prevalence Of HLAB*5701 In HIV-1 Infected Patients
Official title: Prospective Epidemiological Study of the Prevalence of HLAB*5701 in HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection, Human Immunodeficiency Virus
Keywords: Human Immunodeficiency virus
HLAgenetics polymorphism
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2007-03-01
Enrollment: 974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: OTHER

Brief summary: This study is a cross sectional observational study to evaluate the prevalence of HLA-B\*5701 in the major French ethnotypes.

Any HIV-1 infected subject will be eligible for this study including antiretroviral therapy (ART) naÃ-ve and experienced subjects irrespective of abacavir use, as well as subjects previously tested for HLA-B\*5701. Subjects will be approached during a standard clinic visit, and all subjects will be consented prior to any study specific procedure. Subjects will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B\*5701 status by central and local methodologies.


Eligibility criteria: Inclusion criteria:

* HIV-1 infected patients, ART naive or experienced over the age of 18 years.
* Patients must be either affiliated to or beneficiary of a social security category.
* Patient is willing and able to understand and provide written informed consent prior to participation in this study.

Exclusion criteria:

* none

Primary outcomes:
measure: Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population
timeFrame: Day 1
measure: Number of participants with positive HLA-B*5701 screening results obtained with local laboratory
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01050088: Sucrose Analgesia in Infants Undergoing Casting for Club Foot
Official title: Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clubfoot
Keywords: clubfoot
casting
ponseti
discomfort
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies.

Detailed description: Babies who were born with congenital clubfeet are currently being treated by the conventional Ponseti method. This procedure is done in an outpatient clinic setup. The procedure is painless but may cause some discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies. The control group will consist of patients who will get 5cc saline pre cast application, while the study group will be given 5cc of Sucrose solution. Patients and physicians are blinded to the treatment they get. Outcome measures will include pulse rate and oxygenation as an accepted measure of discomfort.

Eligibility criteria: Inclusion Criteria:

* All otherwise healthy babies who need casting for congenital clubfeet

Exclusion Criteria:

* All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers.

Primary outcomes:
measure: Pulse rate, Blood oxygenation
timeFrame: During casting
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider Children's Medical Center
name: Danielw M Weigl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schneider Children's Medical Center
name: Kalman Katz, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04842188: Furcation Treatment With L-PRF and aPDT
Official title: Evaluation of Leukocyte Platelet Rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Furcation Involvement: Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Furcation Defects
Keywords: platelet rich fibrin
photodynamic therapy
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 32
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To treat grade II periodontally diseased furcation areas Leukocyte-Platelet Rich Fibrin (L-PRF) combined with antimicrobial Photo-Dynamic Therapy (a-PDT) was used.

Detailed description: randomized, triple-blinded study (patient, clinician and biostatistician). Twenty-four patients with Grade II furcation involvement were recruited in this study.

Control group only received L-PRF, while study group used a combination of L-PRF and aPDT Attachment level, pocket depth, horizontal component and gingival recession, also radiographic Bone depth, width, height and volume were were recorded at baseline and postoperatively after 6 months

Eligibility criteria: Inclusion Criteria:

* Grade II furcation involvement
* age range 18- 50 years
* 3 mm or more vertical probing depth

Exclusion Criteria:

* systemic disease
* abnormal clotting and bleeding
* smokers,
* root caries or restoration
* Grade II mobility
* periapical lesions

Primary outcomes:
measure: Clinical evaluation of Vertical clinical attachment level VCAL
timeFrame: 6 months
measure: clinical evaluation of vertical pocket depth VPD
timeFrame: 6 months
measure: clinical evaluation of furcation horizontal component FHC
timeFrame: 6 months
measure: clinical evaluation of gingival recession REC
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of dentistry, kafrelsheikh University
Study officials:
References: