louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04220502: Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae
Official title: Depilatory Cream's Affect on the Occurrence of Pseudofolliculitis Barbae
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Pseudofolliculitis Barbae
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing an experimental to control group
Primary purpose: PREVENTION

Brief summary: Comparing the amount of papules, macules, pustules, and irritation caused by pseudofolluculitis barbae in subjects using depilatory cream versus traditional shaving methods.

Detailed description: Comparing an experimental group that will remove facial hair with magic shave powder gold, and a control group that will continue using traditional shaving methods. Both the subject and a physician will make observations to determine the efficacy of depilatory creams in reducing pseudofolliculits barbae.

Eligibility criteria: Inclusion Criteria:

* Male
* PFB patient

Exclusion Criteria:

* Failed sensitivity testing

Primary outcomes:
measure: Investigator Global Assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient Global Assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Wayne State University Physician Group Dermatology
state: Michigan
Study officials:
affiliation: Wayne State University
name: Steven Daveluy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daniel A, Gustafson CJ, Zupkosky PJ, Candido A, Kemp HR, Russell G, McMichael A. Shave frequency and regimen variation effects on the management of pseudofolliculitis barbae. J Drugs Dermatol. 2013 Apr;12(4):410-8.
citation: Kindred C, Oresajo CO, Yatskayer M, Halder RM. Comparative evaluation of men's depilatory composition versus razor in black men. Cutis. 2011 Aug;88(2):98-103.
Clinical trial NCT02348502: Sustained Viral Response in Patients Achieved HBsAg Level≤100 IU/ml After Completed Interferon Treatment
Official title: Sustained Viral Response and HBsAg Level Changes in Chronic Hepatitis B Patients Who Achieved HBsAg Level≤100 IU/ml After Completed Interferon Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: HBsAg loss
interferon
HBV reaction
Hepatitis B
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population in this study were composed of patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level after interferon treatment, and serum HBsAg and HBV DNA would be tested every 3 months for 96 weeks after finished treatment. Sustained viral response defined as serum HBV DNA maintaining undetectable during the observation period. HBsAg loss is defined as HBsAg level reached the value lower than the low limited value.

Brief summary: Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.

Detailed description: The patients with chronic hepatitis B and achieved HBsAg level≤100 IU/ml after completed interferon treatment will be enrolled and observed for 96 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is HBV DNA reaction. The secondary endpoints is HBsAg loss.

Eligibility criteria: Inclusion Criteria:

* patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level by interferon treatment

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver

Primary outcomes:
measure: the rate of sustained viral response
timeFrame: 96 weeks
Secondary outcomes:
measure: the rate of HBsAg loss
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: liver disease center, Beijing Ditan Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01559402: Oxygenation Test During General Anesthesia
Official title: Application of Protective Ventilation Improves Oxygenation During and After Anesthesia. Is it Possible That a Special Procedure, an Oxygenation Test, Can Replace Arterial Blood Gases When Evaluating Oxygenation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study investigates if applying a special ventilatory strategy during anesthesia for laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates oxygenation with blood gas samples but also with a new method that might give more information without the use of blood gas samples.

Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction and maintenance of anesthesia is performed with either a continuous positive airway pressure (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in comparison to a technique without CPAP but with a PEEP of 10 cm H2O.

Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative period if emergence from anesthesia is performed without high levels of oxygen.


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective surgery of Morbid Obesity.
* ASA 1-2. (ASA = American Society of Anesthesiologists classification).
* "Body mass index" (BMI) ≥ 35 but \< 50

Exclusion Criteria:

* "ASA 3"
* Anticipated difficult intubation.
* Major bleeding.
* Problems with ventilation necessitating protocol aberrations.
* Obstructive sleep apnea syndrome with CPAP treatment at home.
* Angina Pectoris

Primary outcomes:
measure: Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.
timeFrame: Change in SpO2 from 5 min before start of anesthesia, to 5 min after intubation, 5 min before extubation and 1 hour after extubation.
Secondary outcomes:
measure: Arterial blood gas values for saturation (SaO2)
timeFrame: 5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.
measure: Arterial oxygen tension (PaO2)
timeFrame: 5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Operationskliniken, Västmanlands sjukhus Västerås
Study officials:
affiliation: Uppsala University Hospital
name: Göran Hedenstierna, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03911102: Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Official title: A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Keywords: Lateral canthal wrinkle
Crow's feet lines
LCL
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
* Be outpatient, male or female subjects, in good general health, 18-65 years old
* Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
* Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

* Active skin disease, infections, or inflammation at the injection sites
* History of clinically significant bleeding disorders
* Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
* Planned or anticipated need for surgery or hospitalization through the end of the study
* Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study

Primary outcomes:
measure: Percentage of Participants With None or Mild in LCL Severity at Maximum Smile
timeFrame: Week 4 After LCL Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento, CA Site
state: California
city: Sarasota
country: United States
facility: Sarasota, FL Site
state: Florida
city: Itasca
country: United States
facility: Itasca, IL Site
state: Illinois
city: Arlington
country: United States
facility: Arlington, VA Site
state: Virginia
Study officials:
References:
Clinical trial NCT02603302: Radiation Dose Escalation in Locally Advanced Rectal Cancer
Official title: Phase II Study of Neoadjuvant Radiotherapy Dose Escalation in Association With Chemotherapy for the Treatment of Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: rectal cancer
radiotherapy
escalated dose
interval
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a one arm study where patients with locally advanced rectal cancer will receive neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to 59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete response).

Detailed description: Introduction:

Rectal cancer is a highly prevalent disease all over the world. In Brazil, it is the second most common cancer among women (after breast tumors), with an estimated incidence of 17.2 cases per 100,000 inhabitants and is the third most common cancer in men (after prostate and lung cancers), with an estimated incidence of 15.4 cases per 100,000 inhabitants.

Goals:

The aim of this study is to evaluate the pathologic complete response (pCR) of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant radiochemotherapy (RCT) employing anticancer drugs at standard dose and interval extended to surgery with or without adjuvant neoplastic therapy.

Procedures:

Neoadjuvant chemoradiotherapy with radiation dose escalation associated with radiosensitizing therapy and surgery with a total mesorectal excision (TME), 8 weeks after completing neoadjuvant treatment.

Eligibility criteria: Inclusion Criteria:

* Locally advanced rectal cancer, 0-15 cm from anal verge, cT3/4 or cN+

Exclusion Criteria:

* Metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor

Primary outcomes:
measure: Pathologic complete response
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Brasilia Univeristy Hospital
state: DF
Study officials:
affiliation: Brasília University
name: Marcos Santos, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06613802: Prevalence of Gabapentinoids and Opioids in Geriatric Falls Patients
Official title: Prevalence of Gabapentinoids in Geriatric Falls Outpatients in Aalborg in 2013-2014, 2018-2019, and 2023
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gabapentin
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The entire sample will be included. It is expected that the prevalence in 2013 is twice (6%) that of the background population (3%). Sample size calculations at 80% power and 5% significance based on differences in population between 2023 (estimated 20%, which is twice that of 2023 background population of 10%) shows that 90 participants are required. Thus it is expected to include the whole of 2013, 2018 and every second patient in 2023 based on this. However, if the prevalence is lower than expected in 2013 then 2014, 2019 and all patients in 2023 will be included.

Brief summary: This study investigates the prescription patterns of gabapentinoids (gabapentin and pregabalin) in a geriatric fall clinic in Aalborg, Denmark, between 2013 and 2023. Gabapentinoids, often prescribed for neuropathic pain, have seen increased off-label usage, particularly as alternatives to opioids. Despite the lack of robust evidence supporting their efficacy in many neuropathic and non-neuropathic pain conditions, their use has grown, especially in elderly populations. This raises concerns about their potential side effects, such as drowsiness, dizziness, and the risk of falls, especially when combined with opioids.

The study aims to determine the prevalence of gabapentinoid and opioid prescriptions in the clinics and for what type of pain they are prescribed. Furthermore, the study will look into the development in opioid prescriptions and concomitant gabapentinoid/opioid usage in this population.

The study is a retrospective chart review of patient charts from the years 2013-2014, 2018-2019, and 2023, analyzing patient characteristics, comorbidities, medication lists, and pain classifications.


Eligibility criteria: Inclusion Criteria:

* patient in the geriatric fall clinic at Aalborg University Hospital in either 2013-2014, 2018-2019, or 2023

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of gabapentionoids
timeFrame: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
measure: Prevalence of opioids
timeFrame: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
Secondary outcomes:
measure: Pain characteristics for each year
timeFrame: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04367402: COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients (COST ACTION)
Official title: COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Azienda Ospedaliera San Paolo
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size: 200 symptomatic patients with no other characteristics; 200 health people with no other characteristics; 200 asymptomatic individuals to recruit after the restrictions have ended with no other characteristics.

Brief summary: The aims of this study is to define the genetic bases of COVID-19 related disease heterogeneity in frail population, to carry out a retrospective study on individuals w/wo symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis and on the presence of genetic profiling and to explore the therapeutic potential of the modulation of ACE2 expression.


Eligibility criteria: Inclusion Criteria:

* adult patients (\> 18 years old)

Exclusion Criteria:

* inability to understand and want;
* mentally incapacitated.

Primary outcomes:
measure: Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.
timeFrame: 6 months
Secondary outcomes:
measure: ACE2 expression in patients with COVID-19 infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: AO San Paolo
state: IT
Study officials:
References:
Clinical trial NCT01045902: BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
Official title: Prospective, Multi-center, Randomized, Non-blind Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Sulbactam/Ampicillin in the Treatment of Pulmonary Abscess and Aspiration Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Aspiration
Lung Abscess
Keywords: Pulmonary Abscess
Aspiration Pneumonia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 139
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 purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18 years or above
* The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment

Exclusion Criteria:

* Known hypersensitivity to fluoroquinolones and/or ß-lactams
* Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis

Primary outcomes:
measure: Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
timeFrame: Up to 30 days after end of treatment with study medication for serious adverse events
Secondary outcomes:
measure: Clinical Response
timeFrame: Regulary doing i.v. treatment
Other outcomes:
Locations:
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Nürnberg
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Treuenbrietzen
country: Germany
state: Brandenburg
city: Frankfurt
country: Germany
state: Hessen
city: Hildesheim
country: Germany
state: Niedersachsen
city: Rotenburg
country: Germany
state: Niedersachsen
city: Lüdenscheid
country: Germany
state: Nordrhein-Westfalen
city: Oberhausen
country: Germany
state: Nordrhein-Westfalen
city: Paderborn
country: Germany
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01859702: Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Official title: Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Aqueous Humor
Moxifloxacin
Vigadexa
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.


Eligibility criteria: Inclusion Criteria:

* Requires cataract surgery;
* Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
* Able to follow instructions and willing to attend all study visits;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
* History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
* Use of medications, as specified in protocol;
* Severe dry eye syndrome;
* Use of contact lenses two days before surgery until the last visit;
* External eye disease, infection or inflammation of the eyes or eyelids;
* Excessive bleeding tendency;
* No vision in the eye not included in the study;
* Pregnant or breastfeeding;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Aqueous Humor Concentration of Moxifloxacin
timeFrame: Day 3 (operative day)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Abayomi Ogundele, PharmD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo, Ophthalmology Service
name: Mauro Silveira de Queiroz Campos, MD
role: PRINCIPAL_INVESTIGATOR
References: