louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01226914: A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasm
Goiter
Keywords: EVICEL, Fibrin Sealant, Thyroidectomy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2010-10-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized placebo-controlled double-blind trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Objectives

* To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B).
* To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives
* To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups.
* To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS).
* To compare the length of hospital stay between the two groups of patients.


Eligibility criteria: Inclusion Criteria

* Patients must have an initial diagnosis of thyroid neoplasmcarcinoma or goiter that requires total or hemithyroidectomy.
* Patients must have an ECOG performance status of 0-2
* Laboratory values must be within the following ranges:

  * Platelet count \> 100 k/mm3
  * Hemoglobin \> 10.0 g/dL
  * WBCs \> 3.0 k/mm3
  * Total bilirubin \< 2.6
  * Serum Creatinine \< 2.0
  * PTT and PT/INR within institutional normal limits
* Patients must sign informed consent for study participation

Exclusion Criteria

* Evidence of distant metastasis of thyroid carcinoma
* Recurrent thyroid cancer
* Prior thyroid surgery or surgery to the neck.
* Patients with diagnosed coagulation disorders
* Prior irradiation to the neck area
* Prior chemotherapy for the current diagnosis
* Patients on therapeutic warfarin
* Patients with psychological or cognitive issues that, in the opinion of the investigator, will make them unable to adequately report pain levels
* Patients in an immune deficient state

Primary outcomes:
measure: To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B).
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Joshua Hornig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Shaun A Nguyen, M.D.,CPI
role: STUDY_DIRECTOR
References:
Clinical trial NCT00550914: Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP
Official title: A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Respiratory Papillomatosis
Keywords: Papilloma, Papillomatosis, Laser, Laser Surgery
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: Rady Children's Hospital, San Diego
First posted: 2007-10-30
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with severe JORRP

Brief summary: The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the time interval between surgeries and improve voice outcomes in children with severe RRP.


Eligibility criteria: Inclusion Criteria:

1. Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention
2. Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP

Exclusion Criteria:

1. Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.
2. Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.
3. Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
4. Children whose families do not sign an informed consent to enter into the study.
5. Children whose families anticipate discontinuing care at a participating institution during the study period

Primary outcomes:
measure: Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis
timeFrame: One Year
Secondary outcomes:
measure: Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score
timeFrame: One Year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Christopher Hartnick, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03063814: Effects of App-based Versus Personal On-site Instruction on Neuromuscular Activity in Injury Prevention Exercises
Official title: Immediate Effects of App-based Versus Personal On-site Instruction on Neuromuscular Activity in Injury Prevention Exercises: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Injury
Injury, Knee
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: Metropolitan University College
First posted: 2017-02-24
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Therefore, the aim of the present study was to evaluate neuromuscular characteristics observed during a single bout of selected and validated injury preventive exercises instructed by an app (in accordance with 'Get set - Train smarter') versus gold standard instruction, supervision and feedback provided on-site by an expert. The present evaluation targets a population of female football and handball players without any previous exposure to injury prevention training.


Eligibility criteria: Inclusion Criteria:

* female handball or football player (≥ 18 years old) competing at sub-elite level (i.e., 2-3 weekly training sessions)

Exclusion Criteria:

* previous traumatic knee injury, lower limb injury at the time of testing and/or previous engagement in injury prevention practices.

Primary outcomes:
measure: Normalized hamstring EMG
timeFrame: 5 minutes after instruction
Secondary outcomes:
measure: Normalized quadriceps EMG
timeFrame: 5 minutes after instruction
measure: Joint angle
timeFrame: 5 minutes after instruction
Other outcomes:
Locations:
city: Hivdovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Metropolitan University College
name: Mette K Zebis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04387214: COVID-19 Pandemic and Academic Performance of Veterinary Students
Official title: The Impact of COVID-19 Pandemic on the Academic Performance of Veterinary Medical Students and Researchers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 1426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Veterinary students and researchers

Brief summary: The study aims to analyze the effect of COVID-19 pandemic on the academic performance of veterinary students, veterinarians, and researchers during the lockdown.


Eligibility criteria: Inclusion Criteria:

* Veterinary students and researchers

Exclusion Criteria:

-

Primary outcomes:
measure: Measure the effect of COVID-19 pandemic on the academic performance of veterinary medical students
timeFrame: 13/4/2020 - 10/8/2020
measure: Measure the average studying time
timeFrame: 13/4/2020 - 10/8/2020
measure: Evaluate on-line education during COVID-19 pandemic lockdown
timeFrame: 13/4/2020 - 10/8/2020
measure: Evaluate on-line education in practical lessons during COVID-19 pandemic lockdown
timeFrame: 13/4/2020 - 10/8/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
References:
Clinical trial NCT00172614: The Roles of Cytokines in the Mechanism of Insulin Resistance and Energy Balance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome X
Cachexia
Insulin Resistance
Keywords: metabolic syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Insulin resistance and disturbances in energy homeostasis are associated with body weight changes, such as diabetes, hypertension, hyperlipidemia, obesity, cancer cachexia, aging, and acute or chronic infectious diseases. Cytokines secreted by adipose tissue and inflammatory cells play important roles in the pathological conditions. Several novel cytokines were disclosed recently, but their functions have not been well known. Further investigation of these cytokines, resulting in insulin resistance and energy homeostasis, is very important to elucidate the mechanisms and develop new therapeutic strategies.

Detailed description: We are studying patients with body weight change, increased or decreased. Healthy people are the control group. We are recording body weight, body height, and physical exam results. In addition, we are drawing peripheral blood for further biochemical and cytokine assays.

Eligibility criteria: Inclusion Criteria:

* Insulin resistance condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jaw-Shiun Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04989114: Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis
Official title: Effectiveness of Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Comparison to Standard Care in Children With Bronchiolitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiolitis Acute Viral
Bronchiolitis
Bronchiolitis Acute
Bronchiolitis, Viral
Nasal Continuous Positive Airway Pressure
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
Collaborators: name: King Edward Medical University
First posted: 2021-08-04
Enrollment: 96
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the effectiveness of nasal continuous positive airway pressure in reducing respiratory distress in children with bronchiolitis

Detailed description: In this study, after taking consent from caretakers, patients of brochiolitis will be randomly assigned to either a standard care group or a nasal continuous positive airway pressure group. Both groups will be followed for respiratory distress. Respiratory distress will be compared by using Seattle sore of respiratory distress.

Eligibility criteria: Inclusion Criteria:

* Children presenting with history of cough, and tachypnea and wheezing on clinical examination

Exclusion Criteria:

* Patients needing mechanical ventilation at the time of admission
* Patients whose caretakers refuse written informed consent
* Patients having consolidation on chest X-Ray

Primary outcomes:
measure: reduction in seattle score
timeFrame: after 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Muhammad Haroon Hamid, MBBSFCPSFRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02208414: Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques
Official title: A Randomized Double-Blind Placebo-Controlled Crab Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques in NTU Campus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Allergies
Keywords: Food Allergies
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to determine whether NAET procedures are effective in the treatment of crab or shrimp allergy.

Hypothesis: experimental group will show a significant improvement over the control group in allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp extract.

Detailed description: Nambudripad allergy elimination techniques (NAET) were developed by Dr. Devi Nambudripad in 1983. Many patients have been relieved of allergy and allergy-related disease by this treatment.

Lack of well-controlled clinical study prevents NAET from being accepted as a treatment option in current medical system.

The aim of this project is to conduct a double blind-placebo controlled study of applying NAET to treat crab or shrimp allergy.

The parameters to be measured are allergic symptom, crab- or shrimp-specific IgE and skin test before and after NAET treatment

Eligibility criteria: Inclusion Criteria:

* Older or equal to 20 years old
* History of allergic to crab or shrimp
* Positive serum crab- or shrimp-specific IgE

Exclusion Criteria:

* History of anaphylactic shock
* On medication of anti-histamine or steroid
* Pregnancy

Primary outcomes:
measure: Change from Baseline in allergic symptoms at 6 months
timeFrame: before NAET and 6 months after NAET
Secondary outcomes:
measure: Serum crab- or shrimp-specific IgE
timeFrame: before NAET, 1 month, 3 months and 6 months after NAET
measure: Skin test
timeFrame: before NAET, 1 month and 6 months after NAET
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Cha Ze Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034514: 4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
Official title: 4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 35
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 develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.


Eligibility criteria: Inclusion Criteria:

* Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung cancer of any histology to be treated using radiotherapy will be eligible for this study. Note that we will carefully consider the inclusion of cases with turbulent flow or greater flow velocities (Cabahug et al., 1996; Crawford et al., 1990) and COPD cases (Magnant et al., 2006) due to the impaction of aerosol particles in central airways.
* Allowable type and amount of prior therapy. Any types and amounts of prior therapy will be allowed for this study.
* Age restriction and/or gender/ethnic restrictions
* Patients must be greater than or equal to 18 years of age.
* There are no gender or ethnic restrictions.
* Life expectancy restrictions - None.
* ECOG or Karnofsky Performance Status
* Not employed. Note that patients will need to be sufficiently healthy to undergo audiovisual (AV) biofeedback to generate high quality 4D-CT images.
* Requirements for organ and marrow function None.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Children (less than 18 years of age), pregnant women, Stanford employees or students, or prisoners will be excluded from this study.

Primary outcomes:
measure: The overall correlation between the 4D-CT and the SPECT ventilation images.
timeFrame: 24 months
Secondary outcomes:
measure: The difference between the local ventilation at simulation and during the treatment. Dose-volume or functional dose-volume metrics. The regression coefficient between the regional ventilation and time. The mean dose to the high-functional lung region.
timeFrame: 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Billy Loo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00500214: Ilioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Postoperative Hyposthesia
Keywords: inguinal hernia
herniorrhaphy
mesh repair
ilioinguinal neurectomy
postoperative pain in cases and controls during one year.
postoperative hyposthesia in cases and controls during one year.
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-07-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: this study was designed to evaluate the effect of routine excision of the ilioinguinal nerve in an attempt to decrease the incidence of chronic inguinodynia in patients who undergo open anterior hernia mesh repair.

Detailed description: As chronic pain is the 2nd most common complication following open hernia repairs and it causes limitations and dysfunctions for the patients and also according to some previous studies elective ilioinguinal neurectomy could result in less postoperative pain,we decided to perform a randomized double blind clinical trial.The primary goal of this study was evaluation of the effect of this type of neurectomy on postoperative pain and hyposthesia.

Eligibility criteria: Inclusion Criteria:

* having an age of over 18 years

Exclusion Criteria:

* Those with diabetes, incarcerated, bilateral and recurrent hernias and visual problems were excluded from the investigation.

Primary outcomes:
measure: postoperative pain using VAS (visual analogue scale)
timeFrame: 1 year
Secondary outcomes:
measure: postoperative hyposthesia using VAS (visual analogue scale)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: fatemeh malekpour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02013414: Fusion Targeted Biopsy of the Prostate
Official title: Molecular Image-directed, 3D Ultrasound-guided Biopsy of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-12-17
Enrollment: 9
Sex: MALE
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 objective of the proposed study is to evaluate a new, molecular image directed, three-dimensional (3D) ultrasound guided biopsy system in human patients. The current biopsy uses ultrasound imaging as guidance. However, the procedure uses two-dimensional (2D) ultrasound images and has sampling errors thus some cancers can be missed from the standard 2D image-guided biopsy. In this study, an FDA-approved ultrasound device will be used to obtain three-dimensional (3D) images of the prostate from a commercially available ultrasound scanner. The clinician can use the 3D images to guide biopsy, record the core location of the biopsy sites, and perform re-biopsy to the same sites in a patient follow-up examination. This system can also use images from magnetic resonance imaging (MRI) or positron emission tomography (PET) and then fuse PET or MR images with 3D ultrasound images to guide the needle to a suspicious tumor target as seen on MRI or PET. We think that this fusion targeted biopsy technology will help to improve the accuracy of the current systematic biopsy approach for prostate cancer detection.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years or older
* Abnormal uptake in prostate necessitating a biopsy
* Able to provide informed consent

Exclusion Criteria:

* Age less than 18
* Cannot provide informed consent
* Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation)

Primary outcomes:
measure: Cancer Detection by Targeted and Standard Biopsy Approaches
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Baowei Fei, PhD, EngD
role: PRINCIPAL_INVESTIGATOR
References: