louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06497764: Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)
Official title: A Pilot, Randomized, Non-blinded, Single-center Study of the Efficacy of a Vibrational Anesthesia (VA) Device on Reducing Pain During Platelet Rich Plasma (PRP) Scalp Treatment for Alopecia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alopecia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.


Eligibility criteria: Inclusion Criteria:

* Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of.
* Able to participate in study procedures.
* Able to provide consent.

Exclusion Criteria:

* Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation.
* Patients unable to consent.

Primary outcomes:
measure: Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure
timeFrame: End of procedure (About 10 minutes, Day 1)
Secondary outcomes:
measure: Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kristen Lo Sicco
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02021864: Vitamin D Treatment and Hypocalcemic Pregnant Women
Official title: Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Complications
Keywords: hypocalcemia, pregnancy, vitamin D
Lead sponsor: Sina Hospital, Iran
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. .
* Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs.
* Participants will randomly assigned in to two groups of intervention and control groups .Randomization will be done by random number generator. Intervention group will receive weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily prenatal multivitamin.
* At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.


Eligibility criteria: Inclusion Criteria:

gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (BMI) of 19-26 -

Exclusion Criteria:

moderate to sever hypocalcemia(ca\<8mg/dl), gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs

-

Primary outcomes:
measure: percentage of hypocalcemic subjects at the ens of study
timeFrame: 12-14 weeks
Secondary outcomes:
measure: Changing of maternal mean calcium level
timeFrame: 12-14 weeks
Other outcomes:
measure: maternal weight gain
timeFrame: 12-14 weeks
measure: neonatal serum calcium level
timeFrame: 12-14 weeks
measure: neonatal growth indices
timeFrame: 12-14 weeks
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin university of medical science, Kosar hospital
Study officials:
References:
Clinical trial NCT02398864: Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy
Official title: Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mediastinal Lymphadenopathy
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 120
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: To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy

Detailed description: There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging. Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance usually for the staging of lung cancer or evaluation of enlarged lymph nodes. In addition, lung lesions or masses can be visualized and biopsied in the same sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible bronchoscopy. It provides ultrasonographic images and permits needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

Eligibility criteria: Inclusion Criteria:

* adults (18 Years and older) with mediastinal lymphadenopathy.

Exclusion Criteria:

* known or suspected malignancy
* no informed consent
* pts with anterior mediastinal lesions
* contraindications to EBUS

Primary outcomes:
measure: Sensitivity of EBUS-diagnosis
timeFrame: 2 years
Secondary outcomes:
measure: Risk factors related with the development of complications
timeFrame: 2 years
measure: Risk factors related with the procedure
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Hannover Medical School
name: Thomas Fuehner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01107964: Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Official title: Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome
Recent Diagnosis of Dry Eye Syndrome
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: The American Society of Cataract and Refractive Surgery Foundation
name: GlaxoSmithKline
First posted: 2010-04-21
Enrollment: 27
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 investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
* Schirmer Test \< 8 mm/5 minutes
* Fluorescein tear break-up time \< 8 seconds
* No current use of dry eye treatment (except artificial lubrication)
* Signature on consent form

Exclusion Criteria:

* Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye
* Eyelid or eyelash abnormalities
* Alteration of the nasolacrimal apparatus
* Treatment with drugs affecting tearing
* Concomitant ocular therapies
* Topical ophthalmic steroids taken during the 4 weeks before the study
* Pregnant/breast-feeding women
* History of liver disease
* History of fish and/or shellfish allergy or hypersensitivity
* History of corn allergy or hypersensitivity
* Treatment with systemic anticoagulation therapy
* Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)

Primary outcomes:
measure: Change From Baseline of the Ocular Surface Disease Index Score at Day 45
timeFrame: Baseline and Day 45
Secondary outcomes:
measure: Change From Baseline of Schirmer-1 Test Value at Day 45
timeFrame: Baseline and Day 45
measure: Change From Baseline of Lissamine Green Staining Score at Day 45
timeFrame: Baseline and Day 45
measure: Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45
timeFrame: Baseline and Day 45
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Eye Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: David Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195364: Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain
Official title: Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Inflammation
Keywords: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis who completed trial 0881A1-301-EU in Spain who fulfill inclusion/exclusion criteria, treated in rheumatology units

Brief summary: The purpose of this study is to evaluate long-term safety of etanercept in patients with rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU


Eligibility criteria: Inclusion Criteria:

* To have completed 0881A1-301-EU study in Spain
* Clinical diagnosis by ACR revised criteria of rheumatoid arthritis.

Exclusion Criteria:

* Hypersensibility to etanercept or any of its components
* Significant concurrent medical disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06098664: Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
Official title: Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Artificial Intelligence
Deep Neural Network
Electrocardiogram
Pulmonary Vein Isolation
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients scheduled for a PVI will be consecutively screened and enrolled in the study. The inclusions will be stratified to the DNN score.

Brief summary: Atrial fibrillation (AF) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. Progression of AF is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by cardiovascular comorbidities and AF itself. This results in complex electrical conduction disorders, which is defined as electropathology. The aim of our study is to evaluate whether an artificial intelligence (AI)-enabled ECG algorithm (on an ECG in Sinus Rhythm) can predict electropathology in patients with AF who undergo a first PVI.


Eligibility criteria: Inclusion Criteria:

* Provide signed and dated informed consent.
* First PVI-procedure
* Age is 18 years or higher.
* 12-lead ECG available in SR during the last 14 days.

Exclusion Criteria:

* Mitral insufficiency of grade 3 or 4.
* Participating in another study that may interfere with participation in this study

Primary outcomes:
measure: Low voltage area
timeFrame: During atrial voltage mapping, prior to PVI procedure.
Secondary outcomes:
measure: Transition zone voltage area
timeFrame: During atrial voltage mapping, prior to PVI procedure.
measure: Conduction delay
timeFrame: During atrial voltage mapping, prior to PVI procedure.
measure: Conduction delay score
timeFrame: During atrial voltage mapping, prior to PVI procedure.
measure: Conduction time from sinus node to Bachman bundle
timeFrame: During atrial voltage mapping, prior to PVI procedure.
measure: Total LA conduction time
timeFrame: During atrial voltage mapping, prior to PVI procedure.
measure: Left atrial appendage ejection velocity.
timeFrame: Immediately prior to PVI procedure.
measure: Left atrial size
timeFrame: Prior to PVI procedure.
measure: Pericardial adipose tissue volume
timeFrame: Prior to PVI procedure.
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References:
Clinical trial NCT00184964: Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis
Official title: The Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis With Histological Examination of the Resected Specimen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Non Small Cell Lung
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.

This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery.

The resection specimen will be compared to the preoperative imaging.


Eligibility criteria: Inclusion Criteria:

-Patients with non small cell lung cancer and atelectasis, who are eligible for surgery.

Exclusion Criteria:

* age \< 18 years
* pregnancy

Primary outcomes:
measure: Histological validation of CT-PET image fusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radiation oncologist, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
name: Jan Bussink, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06343064: Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
Official title: A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non-Small-Cell Lung Cancer
Keywords: Non-Small-Cell Lung Cancer
EGFR
NSCLC
Lung Cancer
MET Amplified
MET Expression
Lead sponsor: Avistone Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-02
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC

Detailed description: Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or MET amplification following EGFR-TKI treatment failure.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.
2. Aged at least 18 years old.
3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
4. EGFR mutations, including exon 19 deletion and exon 21 L858R.
5. C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI.
6. At least one measurable lesion as defined by RECIST V1.1.
7. ECOG performance status 0 to 1.

Exclusion Criteria:

1. Previous treatment with MET inhibitors or HGF-targeted therapy.
2. There are mutations of ALK or ROS1.
3. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
4. Pregnant or nursing women.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
timeFrame: 3 years
measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol.
timeFrame: 28 days
measure: Overall Response Rate (ORR）
timeFrame: 3 years
Secondary outcomes:
measure: Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC)
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max)
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max)
timeFrame: From date of first dose up until 28 days post last dose
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00222664: Qidong Hepatitis B Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Liver Neoplasms
Liver Diseases
Keywords: hepatitis B
hepatocellular carcinoma
prevention
vaccination
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Qidong Liver Cancer Institute
name: Merck Institute for Therapeutic Research
First posted: 2005-09-22
Enrollment: 80000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of chronic hepatitis B in young adolescents and the incidence/mortality several decades later from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.


Eligibility criteria: Inclusion Criteria:

all infants born in Qidong between September 1983 and November 1990

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Qidong
country: China
facility: Qidong Liver Cancer Institute
state: Jiangsu
city: Beijing
country: China
facility: Cancer Institute, Chinese Academy of Medical Sciences
city: Oxford
country: United Kingdom
facility: Clinical Trial Service Unit and Epidemiological Studies Unit
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Zongtang Sun, MD
role: STUDY_DIRECTOR
affiliation: University of Oxford
name: Richard Peto, Msc
role: STUDY_DIRECTOR
References:
citation: Sun Z, Zhu Y, Stjernsward J, Hilleman M, Collins R, Zhen Y, Hsia CC, Lu J, Huang F, Ni Z, et al. Design and compliance of HBV vaccination trial on newborns to prevent hepatocellular carcinoma and 5-year results of its pilot study. Cancer Detect Prev. 1991;15(4):313-8.