louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02403206: Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Official title: Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intumescent Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 406
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.


Eligibility criteria: Inclusion Criteria:

* Willing to undergo cataract surgery.
* Able to lie flat in a supine position.
* Able to understand and willing to sign the Informed Consent Form (ICF).
* Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or lactating mothers.
* Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
* Corneal opacity that would interfere with the laser beam.
* Presence of blood or other material in the anterior chamber.
* Hypotony or presence of corneal implant.
* Poorly dilating pupils.
* Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
* Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
* Any contraindication to cataract surgery.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Capsular Tears (Anterior or Posterior) During Surgery
timeFrame: Day 0 (operative day)
Secondary outcomes:
measure: Operating Time in the Eye to Complete Entire Cataract Procedure
timeFrame: Day 0 (operative day)
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Manager, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT04721106: Korea Post Marketing Surveillance (PMS) Study of Vizimpro
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Vizimpro®
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Neoplasms
Keywords: EGFR NSCLC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 187
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients to whom Vizimpro can be prescribed as per the local labeling (the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor EGFR-activating mutations

Brief summary: Vizimpro will be approved for the treatment of EGFR NSLCL 1L in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Vizimpro after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Vizimpro will be observed.


Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Vizimpro® naïve patients to whom Vizimpro® can be prescribed as per the local labeling (the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations
2. Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Patients to whom Vizimpro® is contraindicated as per the local labeling. A. Hypersensitivity to the active substance or to any of the excipients of this product.

   B. This medicinal product contains lactose. Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
2. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.

Primary outcomes:
measure: Incidence of adverse events categorized according to physical organ and disease/symptom
timeFrame: From Day 1 of first administration dose up to the date of at least 28 calendar days following the last administration
Secondary outcomes:
measure: overall response rate
timeFrame: Day 1 until progression or drop out of study
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01081106: Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer
Official title: Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Robert H. Lurie Cancer Center
First posted: 2010-03-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see whether low level laser therapy can help maintain normal hair growth on the scalp in people receiving chemotherapy, which is generally associated with hair loss.

Detailed description: Chemotherapy is a common treatment given to patients with breast cancer. Many chemotherapy drugs cause rapid hair loss. While hair loss is temporary, this side effect is a significant concern for patients. Low level laser therapy has been shown to help make hair grow. It is hoped that it may stop hair loss from occurring.

Participants will be receiving 20 to 30 minute laser sessions to their scalp twice a week beginning two weeks before treatment begins until one week past the last chemotherapy session. . Photographs will be taken during each study participant's initial visit, during treatment visits, and one month following the final chemotherapy treatment.

Eligibility criteria: Inclusion Criteria:

* Participants must have breast cancer and must be starting chemotherapy with Adriamycin or a taxane-based therapy.
* Participants must be 18 years old or older
* Participants must be female
* Participant must agree to comply with therapeutic and follow-up schedule.
* Patient must signed informed consent form.

Exclusion Criteria:

* Participants cannot have sensitivity to the laser light.
* Participants cannot have used any topical or oral products to grow hair within 3 months of enrollment to this study.
* Participants cannot be pregnant, lactating or planning on pregnancy during therapeutic schedule.

Primary outcomes:
measure: 10 Point Scale to evaluate hair loss
timeFrame: Photographs evaluated weekly during treatment, one month post chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Jamie Van Roenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410006: Neurofibromatosis Type 1 Patient Registry
Official title: Neurofibromatosis Type 1 Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurofibromatosis Type 1
Keywords: NF1
neurofibromatosis
NF
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 2391
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all individuals diagnosed with Neurofibromatosis Type 1.

Brief summary: The Neurofibromatosis Type 1 (NF1) Patient Registry Initiative (NPRI) is a web-based registry that asks participants to fill out a 30-minute online questionnaire to collect information about the spectrum of medical and social problems experienced by children and adults with NF1. The information gained from your participation may one day help doctors develop personalized treatments for individuals living with NF1.

We are currently enrolling individuals with NF1 who either (1) HAVE previously been diagnosed with a brain tumor younger than 18 years or (2) HAVE NEVER had a brain tumor. Please note: there is no therapy associated with this study. Individuals may participate in the registry by going to https://nf1registry.wustl.edu/


Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed by a healthcare provider with Neurofibromatosis Type 1

Exclusion Criteria:

* Individuals without a healthcare provider diagnosis of Neurofibromatosis Type 1

Primary outcomes:
measure: Neurofibromatosis Type 1
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kimberly J Johnson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02617706: Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery
Official title: A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Standard of Care to Assess Postoperative Wound Infection Rate in Colon and Rectal Resections
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Anorectal Surgeries
Keywords: Anorectal surgeries
infection
topical oxygen
Lead sponsor: Neogenix, LLC dba Ogenix
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).

Detailed description: Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment

Eligibility criteria: Inclusion Criteria:

* Elective colo-rectal surgery with or without anastomosis and with or without stoma
* Patient age: 18-80

Exclusion Criteria:

* Pregnancy

  * Anesthesiology ASA score of 4 or above
  * fever or existing signs of infection at the time of surgery
  * Diabetes Mellitus type I or II with HbA1C level 12% or more
  * Persons with decubitus or diabetic ulcers
  * Subjects with peritoneal metastases
  * Patients with severe malnutrition as indicated by Prealbumin value of \<20
  * BMI ≥50

Primary outcomes:
measure: Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test.
timeFrame: 30 days
Secondary outcomes:
measure: Severity of infection measured with the Southampton Scoring System
timeFrame: 30 days
measure: Number of days until patients surgical site is healed
timeFrame: 30 days
measure: Resource utilization - cost of treatments, hospital stays, bandages, nursing care
timeFrame: 30 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Department of General Surgery Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Neogenix,LLC
name: Sarang Sarangapani, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05476406: Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health
Official title: The Effects of äKwä Premium Skincare System on Improving Overall Skin Health and Beauty in Adults: An Exploratory Placebo-Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sin Health
Skin Hydration
Skin Wrinkles
Skin Porphyrins
Facial Skin Red Spots
Facial Skin Red Vasculature
Lead sponsor: 4Life Research, LLC
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One Active group and one Control group
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.

Detailed description: The äKwä 6-step skincare system is comprised of various skincare products intended to be applied both morning and night. Some of the notable ingredients included in the product formulas are fermented green tea water, other ferments, niacinamide, antioxidants, and a variety of natural plant extracts. The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.

Eligibility criteria: Inclusion Criteria:

* Individuals could participate who were at least 18 years old and in good health.

Exclusion Criteria:

* had allergies or contraindications to any ingredient of products,
* had a history of any acute or chronic disease that could interfere with or increase the risk of study participation
* had any medical procedures, such as laser resurfacing, or plastic surgery to the test sites within the last 12 months (including Botox, Restylyn, or other fillers)
* chronic skin allergies (dermatitis, eczema, psoriasis)
* had been treated for skin cancer within the last 12 months or have damaged skin near the facial area (e.g., sunburn, tattoos, scars, or other disfigurations)
* pregnant or planning to become pregnant in the following 12 weeks, or lactating

Primary outcomes:
measure: Skin Hydration
timeFrame: 30 days
measure: Red Spot Count
timeFrame: 30 days
measure: Red Vascular Count
timeFrame: 30 days
measure: Porphyrin Count
timeFrame: 30 days
measure: Wrinkles
timeFrame: 30 days
measure: Pores
timeFrame: 30 days
measure: Texture
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sandy
country: United States
facility: 4Life Research
state: Utah
Study officials:
affiliation: 4LIFE
name: David Vollmer, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02897206: Imipenem Prophylaxis in Patients With Acute Pancreatitis
Official title: Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pancreatitis
Keywords: Acute pancreatitis
Antibiotic prophylaxis
Imipenem-cilastatin
Infected pancreatic necrosis
Infection
Organ failure
Lead sponsor: University Hospital Rijeka
Sponsor class: OTHER
Collaborators: name: University of Rijeka
First posted: 2016-09-13
Enrollment: 98
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 is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. All patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.


Eligibility criteria: Inclusion Criteria:

* diagnosis of acute pancreatitis defined by the Revised 2012 Atlanta Criteria
* first manifestation of acute pancreatitis regardless of etiology
* APACHE II ≥ 8 calculated within the first 24 hours of admission
* onset of symptoms \< 72 hours before admission

Exclusion Criteria:

* age \< 18 years
* pregnant and breastfeeding women
* active and documented infection at admission
* concomitant antibiotic treatment or antibiotic treatment present within 72 hours before enrollment
* acute pancreatitis diagnosed at surgery
* active malignancy
* known immune deficiency
* patients with chronic pancreatitis
* patients unwilling to participate in the trial

Primary outcomes:
measure: Infectious complications
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Number of patients with Systemic Inflammatory Response Syndrome (SIRS)
timeFrame: 30 days
measure: Local complications
timeFrame: 30 days
measure: Systemic complications
timeFrame: 30 days
measure: Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal)
timeFrame: 30 days
measure: Surgical interventions
timeFrame: 30 days
measure: Serious adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: University Hospital Rijeka
Study officials:
affiliation: Department of Gastroenterology, University Hospital Rijeka
name: Davor Stimac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poropat G, Radovan A, Peric M, Mikolasevic I, Giljaca V, Hauser G, Milic S, Stimac D. Prevention of Infectious Complications in Acute Pancreatitis: Results of a Single-Center, Randomized, Controlled Trial. Pancreas. 2019 Sep;48(8):1056-1060. doi: 10.1097/MPA.0000000000001368.
Clinical trial NCT02951806: Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Official title: Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itching
Lead sponsor: Dr. Soliman Fakeeh Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in postpartum patients and 69% in non-pregnant patients including males and females (1). Some researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and effective way to reduce the incidence and severity of hypotension during cesarean section under spinal anesthesia (2). In this new research I want to investigate the effect of slow injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence of itching In this double blind randomized study two hundred parturient will be randomly allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will be those with allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. Onset and level of sensory block will also be recorded.


Eligibility criteria: Inclusion Criteria:

* Elective and emergency cesarean section parturient.

Exclusion Criteria:

* Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Primary outcomes:
measure: ( 0 - 10) Itching scale
timeFrame: 60 min
Secondary outcomes:
measure: Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia
timeFrame: 60 min
Other outcomes:
measure: Hypotension ( yes or no)
timeFrame: 60 minutes
Locations:
Study officials:
affiliation: Doctor Soliman Fakeeh Hospital
name: Amr A Keera
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03280706: Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial
Official title: Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice During Labor at Term: Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Pregnancy Vomits
Keywords: Gastric Emptying
labor
maltodextrin
orange juice
coffee
ultrasound
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.

Detailed description: Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral area in right lateral decubiti. All solutions will have the same volume and total of calories.

Eligibility criteria: Inclusion Criteria:

* Pregnancy at term
* Fasted with an emptying stomach (assessed by ultrasound)
* During Labor
* No diabetes, esophageal disease, obesity
* Not emergency
* High risk of need of general anesthesia

Exclusion Criteria:

* Vomiting before the end of the protocol
* Did not drink the whole solutions
* Ultrasound not performed for any reason

Primary outcomes:
measure: Change from Baseline Gastric antral area
timeFrame: baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University Hospital of Brasilia University
state: Distrito Federal
Study officials:
affiliation: Hospital Universitario de Brasilia
name: Gabriel MN Guimaraes, MsC
role: STUDY_CHAIR
References: