louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02007096: Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?
Official title: Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ventral Hernia
Umbilical Hernia
Incisional Hernia
Postoperative Complications
Pain, Postoperative
Keywords: Transabdominal plane block
ventral hernia
umbilical hernia
incisional hernia
hernia repair
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

Detailed description: Patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a Transabdominal Plane Block injection or a placebo saline injection. The injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. Patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. Patients in both arms are medically cleared by the surgeon. Currently there are no studies that look at the use of Transabdominal Plane Block in ventral hernia repairs.

Eligibility criteria: Inclusion Criteria:

* age 18 and older
* elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount Sinai Hospital

Exclusion Criteria:

* age younger than 18
* allergic reaction to bupivacaine
* allergic reaction to opioids
* opioid substance abuse

Primary outcomes:
measure: Post-operative Opioid Use
timeFrame: up to 24 hours
Secondary outcomes:
measure: Pain Score
timeFrame: 1 hour postoperatively
measure: Operating Procedure Time
timeFrame: Procedure begin time to procedure end time
measure: Pain Score
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Celia M Divino, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fields AC, Gonzalez DO, Chin EH, Nguyen SQ, Zhang LP, Divino CM. Laparoscopic-Assisted Transversus Abdominis Plane Block for Postoperative Pain Control in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial. J Am Coll Surg. 2015 Aug;221(2):462-9. doi: 10.1016/j.jamcollsurg.2015.04.007. Epub 2015 Apr 22.
Clinical trial NCT02628496: Confocal Laser Microlaryngoscopy (CLMx)
Official title: Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laryngeal Dysplasia
Laryngeal Neoplasm
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 0
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: The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions.

In order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. While in the operating room, prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard protocol, and the diagnostic results from CLM and the formal biopsy will be compared.


Eligibility criteria: Inclusion Criteria:

* Patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy.
* Patient will have vocal fold leukoplakia or other abnormal epithelial changes.
* Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have a history of radiation to the neck.
* Patient must not have a documented reaction to fluorescein
* Patient must not have a previous history of laryngeal cancer.
* Patient must not have a history of allergy or bronchial asthma.
* Patient must not be pregnant or breastfeeding.

Primary outcomes:
measure: Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe
timeFrame: Day of surgery (Day 1)
measure: Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe
timeFrame: Day of surgery (Day 1)
measure: Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe
timeFrame: Day of surgery (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Joseph Bradley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05922696: Cholecalciferol Supplementation in Hemodialysis Patients
Official title: Impact of Cholecalciferol Supplementation in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anemia
Hemodialysis Complication
Vitamin D Deficiency
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is prospective single-blind randomized study, in Ain Shams University hospital) in Egypt, to assess the impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients

Detailed description: This Srudy is to assess the Impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients in terms of increase of Hgb \>11 g/dl, transferrin saturation (TSAT) of ≥ 30%, and ferritin levels to achieve a range of (300 to \< 800 ng/ml), and effect on Epoetin Dose needed. This study is also to adress the factors affecting the correcetion of Anemia by Cholecalciferol supplementation, such as oxidative stress and Inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* : Male or female patients who are willing to participate in the trial should have been on maintenance hemodialysis sessions for not less than 3 months, aged between 18-70 years old, clinically stable (no prior hospitalization on the past three months), with serum 25(OH)D levels of less than 30 ng/ml and their iPTH levels of 150-800 pg/ml, and hemoglobin levels of less than 11 mg/dl.

Exclusion Criteria:

* Patients with previous or known hypersensitivity to cholecalciferol,
* Patients who are already on cholecalciferol therapy, or patients on immunosuppressants.
* Blood transfusion in the past 4 month, and patients who had anemia for other than renal causes,
* Those who were participating in another clinical trial within the past 4 weeks or pregnant/breastfeeding female patients were excluded as well.

Primary outcomes:
measure: Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml
timeFrame: 3 months
Secondary outcomes:
measure: Increase in hemoglobin (Hgb) levels (11-13 mg/dl),
timeFrame: 3 months
measure: TSAT levels to be ≥ 30%
timeFrame: 3 months
measure: Ferritin levels to be > 300 ng/ml, but not exceeding 800 ng/ml
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
References:
Clinical trial NCT05124496: Validation of HyperDetector for SARS-CoV-2
Official title: Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: SARS-COV2 Infection
Lead sponsor: HyperSpectral APD
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals obtaining Rt-PCR test

Brief summary: To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2

To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples.

To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.


Eligibility criteria: Inclusion Criteria:

* Subjects at COVID-19 testing site for Rt-PCR test.

Exclusion Criteria:

* Minors under the age of 5

Primary outcomes:
measure: Sensitivity
timeFrame: By 12/30/2022
measure: Specificity
timeFrame: By 12/30/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: HyperSpectral APD, LLC
state: Virginia
Study officials:
affiliation: HyperSpectral APD, LLC
name: Lauren Stack
role: STUDY_DIRECTOR
References:
Clinical trial NCT04635696: Ethyl Chloride for NPWT
Official title: Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Negative pressure wound therapy (NPWT) has been shown to improve wound care outcomes for acute and chronic wounds as well as for surgical incision sites. We have found that patients report significant pain during dressing changes specifically with the removal of the clear adhesive drape. Upon review of the literature, there were multiple studies related to pain and the removal of the sponge (filler) but limited studies relating to the pain associated with the removal of the drape. The patient reported pain with drape removal has led to increased psychological stress and decreased compliance with the dressing change protocol. Application of a topical anesthetic to the drape during the dressing change has the potential to decrease the pain experienced by the patient. An FDA approved ethyl chloride spray is a topical anesthetic that can be sprayed onto the outer perimeter of the drape during the dressing change as a means to decrease pain. We hypothesize that the use of ethyl chloride spray will result in patients experiencing less pain leading to decreased psychological stress, improved compliance with dressing changes, and overall improved customer satisfaction.


Eligibility criteria: Inclusion Criteria:

* an orthopaedic/trauma wound and/or surgical incision
* treatment with NPWT as a hospital inpatient
* minimum of at least one NPWT dressing changes or discontinuation of NPWT prior to discharge.
* dressing change in enterostomal therapy department

Exclusion Criteria:

* cognitive impairment preventing informed consent
* history of hypersensitivity to cold/vapocoolant
* outpatient NPWT

Primary outcomes:
measure: Patient-reported post procedure pain
timeFrame: immediately after drape removal
measure: Patient-reported during procedure pain
timeFrame: during drape removal
Secondary outcomes:
measure: Change in pain score from pre-procedure to post-procedure
timeFrame: immediately prior to drape change to immediately following drape change
measure: Change in pain score from pre-procedure to during procedure
timeFrame: immediately prior to drape change to during drape change
Other outcomes:
Locations:
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
Study officials:
References:
citation: Tank JC, Georgiadis GM, Bair JM, Rice A, O'Mara Gardner K, Chen JT, Redfern RE. Does The Use of Ethyl Chloride Improve Patient-Reported Pain Scores With Negative Pressure Wound Therapy Dressing Changes? A Prospective, Randomized Controlled Trial. J Trauma Acute Care Surg. 2021 Jun 1;90(6):1061-1066. doi: 10.1097/TA.0000000000003157.
Clinical trial NCT02408796: Open-Label Study of OTO-201 for Treatment of AOMT
Official title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Supra-Tympanostomy Tube Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Otitis Media
AOMT
Keywords: Acute otitis media with tympanostomy tubes
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
* Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of sensorineural hearing loss
* Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
* Subject has a history of known immunodeficiency disease

Primary outcomes:
measure: Number of Ears With Otorrhea (Drainage From the Middle Ear)
timeFrame: Day 29
measure: Feasibility of Administration Questionnaire
timeFrame: Day 1
Secondary outcomes:
measure: Number of Ears With no More Otorrhea (Drainage From the Middle Ear)
timeFrame: Day 15
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California Ear, Nose and Throat
state: California
city: Fort Lauderdale
country: United States
facility: South Florida Pediatric Otolaryngology
state: Florida
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associates
state: North Carolina
city: Matthews
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associates
state: North Carolina
city: Orangeburg
country: United States
facility: Carolina Ear, Nose and Throat
state: South Carolina
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01284296: Comparison of Three Methods of Hemoglobin Monitoring
Official title: Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine or Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digital Block
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study will further investigate the Masimo SpHb \[FDA Approved\] continuous non-invasive hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the effect of enhanced circulation to the finger (which will be attached to the sensor) following a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb).

Detailed description: We have completed a study with 20 patients using the latest version of the SpHb monitor software and finger sensor.

The purpose of this study is to assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb) following the digital block.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female 18 y/o or older
* ASA Classification 1, 2 or 3
* Scheduled to undergo spine or hip revision surgery

Exclusion Criteria:

* Pregnant or nursing
* Patients who in the study investigators clinical judgement would not be suitable for research.

Primary outcomes:
measure: Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.
timeFrame: A minimum of 2-4 differences recorded approximately hourly during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ronald D Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06362096: A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
Official title: ve Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 72
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib


Eligibility criteria: Inclusion Criteria:

1. aged ≥ 18 years, ≤75 years
2. Her2-positive recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
3. Did not receive any systemic antitumor therapy in the advanced stage;
4. At least one measurable lesion was present according to RECIST1.1 criteria.
5. The ECOG score is 0 to 1
6. The functional major organs must be normal
7. Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up

Exclusion Criteria:

1. Have received any systematic antitumor therapy at the recurrence/metastasis stage;
2. Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any stage of breast cancer
3. Patients judged by the investigators to be unsuitable for systematic chemotherapy.
4. Patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases);
5. Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment.
6. Serious heart disease or discomfort
7. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the use and absorption of medications.

Primary outcomes:
measure: Incidence of ≥ grade 3 diarrhea
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
name: Xiong huihua
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05761496: Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.
Official title: Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Stricture
Stent Stenosis
Keywords: Biliary stricture
Plastic stent
Self Expandable Metal stent
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 871
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring for the first time drainage of malignant distal biliary stricture

Brief summary: Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures


Eligibility criteria: Inclusion Criteria:

* Malignant distal biliary stricture
* Need for Palliative and pre-operative biliary drainage
* Age \> 18
* Signature of the informed consent

Exclusion Criteria:

* Previous endoscopic/radiological biliary drainage
* Stricture close to the main hepatic confluence(\< 2 cm)
* Duodenal stenosis
* Post- surgical altered anatomy
* Benign disease

Primary outcomes:
measure: Evaluation of the potency of biliary stents (plastic and metal)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Gemelli IRCCS, Rome, Italy
name: Andrea Tringali, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07021196: The ICT Based Prescription of Physical Activity for Oncology Patients at Their Home
Official title: The ICT Based Prescription of Physical Activity for Oncology Patients at Their Home: the EASYDOM Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by breast or prostatic cancer eligible for adiuvant treatment

Brief summary: Study evaluating the efficacy of ICT-based prescription of physical activity in oncology patients


Eligibility criteria: Inclusion Criteria:

* Female patients affected by breast cancer eligible for adiuvant treatment
* Male patients affected by prostatic cancer eligible for adiuvant treatment

Exclusion Criteria:

* Active life stily before enrollment

Primary outcomes:
measure: tollerance to exercise
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
References: