louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06046469: Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer
Official title: Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this work is to compare validity between CT and MRI in detecting muscular invasion in Patients with bladder cancer.


Eligibility criteria: Inclusion Criteria:

* patients with urinary bladder mass

Exclusion Criteria:

* bleeding tendency ,patients had chemo , radiotherapy

Primary outcomes:
measure: which is better to detect muscular invasion in bladder cancer CT vs MRI
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine Menofia University
state: Menofia
Study officials:
References:
Clinical trial NCT00742469: Rifaximin for Prevention of Travellers' Diarrhea
Official title: A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Keywords: TD
traveller's diarrhea
campylobacter
shigella
salmonella
E. coli
diarrhea
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Detailed description: To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Eligibility criteria: Inclusion Criteria:

1. travelling to Mexico within 72 hours of enrollment
2. read and understand English
3. in good health

Exclusion Criteria:

1. acute diarrhea within previous 7 days
2. taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.

Primary outcomes:
measure: Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: University of San Diego
state: Jalisco
Study officials:
References:
citation: Martinez-Sandoval F, Ericsson CD, Jiang ZD, Okhuysen PC, Romero JH, Hernandez N, Forbes WP, Shaw A, Bortey E, DuPont HL. Prevention of travelers' diarrhea with rifaximin in US travelers to Mexico. J Travel Med. 2010 Mar-Apr;17(2):111-7. doi: 10.1111/j.1708-8305.2009.00385.x.
Clinical trial NCT01122069: Contrast Echocardiography in Non-ST Elevation Myocardial Infarction
Official title: Contrast Echocardiography in Assessment of Myocardial Perfusion in Patients With Non-ST Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-ST-Elevation Myocardial Infarction
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2010-05-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 110 patients with acute non-ST elevation myocardial infarction

Brief summary: In patients with acute myocardial infarction, treatment logistics are primarily defined based upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without ST elevation (NSTEMI) are initially medically treated and recommended coronary angiography within 48-72 hours.

Early invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction (TIMI) risk score to identify patients who will benefit from early intervention due to high risk of new infraction and cardiovascular death. However, new research has suggested that TIMI risk score may not always identify patients with severe angiographic disease.

The purpose of this study was to assess if contrast echocardiography could be used to identify NSTEMI patients with angiographically severe disease independent of their TIMI risk score.


Eligibility criteria: Inclusion Criteria:

* acute non-ST elevation myocardial infarction

Exclusion Criteria:

* hemodynamic unstable
* mechanical prosthetic heart valve
* severly reduced pulmonary function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Heart Disease, Haukeland University Hospital
Study officials:
affiliation: University of Bergen, Bergen, Norway
name: Mai Tone Lønnebakken, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eskerud I, Gerdts E, Nordrehaug JE, Lonnebakken MT. Global Coronary Artery Plaque Area is Associated with Myocardial Hypoperfusion in Women with Non-ST Elevation Myocardial Infarction. J Womens Health (Larchmt). 2015 May;24(5):367-73. doi: 10.1089/jwh.2014.4920. Epub 2015 Feb 18.
citation: Lonnebakken MT, Nordrehaug JE, Gerdts E. No gender difference in the extent of myocardial ischemia in non-ST elevation myocardial infarction. Eur J Prev Cardiol. 2014 Jan;21(1):123-9. doi: 10.1177/2047487312454107. Epub 2012 Jul 2.
Clinical trial NCT01463969: High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)
Official title: High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PCOS
Keywords: PCOS and PTX3 levels
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 40 PCOS patients and 40 healty controls

Brief summary: In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR.


Eligibility criteria: Inclusion Criteria:

* Absence of significant abnormalities on physical examination except hirsutism
* No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
* Normal thyroid function and prolactin level
* Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease

Exclusion Criteria:

* Pregnant
* Possible ovarian tumors,
* Congenital adrenal hyperplasia or
* BMI greater than 35 kg/m2

Primary outcomes:
measure: Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome
timeFrame: 1 year
Secondary outcomes:
measure: Relationship of PTX3 with insuline resistance in patients with PCOS.
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Dep. of Endocrine and Metabolism
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Dep. of Endocrinology and Metabolism
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
affiliation: Gulhane School of Medicine Dep. of Endocrinology and Metabolism
name: Aydogan Aydogdu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02973269: DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Official title: A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Plantar Fasciitis
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
First posted: 2016-11-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent, including authorization to release health information
* Skeletally mature, male or female patients 18 to 65 years of age with diagnosis of plantar fasciitis
* Persistent heel pain for more than three months
* Women of child bearing potential must have a negative urine pregnancy test (UPT) at Screening Visit and must use an effective method of birth control during the course of the study

Exclusion Criteria:

* Previous surgery on the midfoot or hindfoot
* Neuromuscular disease
* Systemic muscle weakness
* Planning a pregnancy during the study
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit

Primary outcomes:
measure: Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
References:
Clinical trial NCT03003169: Mastectomy in Ambulatory Breast Surgery
Official title: Mastectomy in Ambulatory Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mastectomy
Keywords: surgery
breast cancer
quality of life
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 419
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population includes all the patients managed for total or partial mastectomy at the institute.

Brief summary: This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.


Eligibility criteria: Inclusion Criteria:

* patient managed for breast cancer surgery
* age \>18 years old
* understand and comply with the requirements of the study
* patient must be affiliated to a social security system

Exclusion Criteria:

* patient managed for a concomitant reconstructive surgery
* bilateral breast surgery
* patient already included in another clinical trial with an experimental molecule
* men
* patient deprived of liberty or under supervision
* neoadjuvant therapy

Primary outcomes:
measure: Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention.
timeFrame: 15 days
Secondary outcomes:
measure: Impact of type of hospitalization (ambulatory / conventional) depending on the type of surgery (total / partial mastectomy) on anxiety / depression of the patient 15 days after surgery.
timeFrame: 15 days
measure: Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
timeFrame: 15 days
measure: Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
timeFrame: 15 jours
measure: Estimate the conversion rate from ambulatory surgical to conventional surgery
timeFrame: 15 jours
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: MARCHAL FREDERIC, MD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.
Clinical trial NCT06808568: Expanded Access Program (EAP) STIMULAN VG
Official title: Expanded Access Program (EAP) STIMULAN VG
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Stage IV Pressure Ulcer
Diabetic Foot Osteomyelitis
Lead sponsor: Biocomposites Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Individual (single) patient expanded access may be considered.

Detailed description: Patients facing serious or life-threatening illnesses who have exhausted currently available treatment options and are ineligible or unable to participate in a clinical trial may decide to explore therapeutic use of investigational drugs with their healthcare providers.

Under these circumstances, single-patient access can be requested from a licensed treating physician on behalf of the patient.

Please contact expandedaccess@biocomposites.com for more information.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04077268: Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma
Official title: Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma in Poitiers Emergency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient add a head mild trauma and consult at the emergency of Poitiers

Brief summary: To study the future of traumatic brain injured patients at day 7 of their trauma

Primary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. The collection of this scale will be done by telephone contact, 7 days of admission to the emergency room.

Secondary judgment criteria:

* Compendium of the realization of the CT / time respected between the TCL and the CT / Hospitalization / 2nd CT to realize at 24 hours in the patients treated by TAC or AAP
* Application of the recommendations of the French Society of Emergency Medicine 2012: Become 7 days of patients classified according to whether or not the recommendations, .
* Become TCL patients under AAP or TAC
* Number of reconsultation, rehospitalization, new imaging within 7 days after TCL


Eligibility criteria: Inclusion Criteria:

* Patient of both sexes, at least 18 years old,
* Patient with mild head trauma, Glasgow 13-15
* Patient without tutorship or curatorship
* Affiliation to social security
* No opposition of the patient or relatives to participation in the study.

Exclusion Criteria:

* Patient already included in this study
* Refusal to participate in this search
* Patient undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).

Primary outcomes:
measure: Becoming of traumatic brain injured patients: becoming classified in alive with or without sequelae or death, by using scale of GOS E
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU of POITIERS
Study officials:
References:
Clinical trial NCT00857168: To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
Official title: A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypogonadism
Lead sponsor: Acrux DDS Pty Ltd
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Testosterone replacement treatment is the most effective way of treating hypogonadism in men.

Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).


Eligibility criteria: Inclusion Criteria:

* Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.

Exclusion Criteria:

* Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.

Primary outcomes:
measure: To evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). Also to evaluate the impact of washing.
timeFrame: April 2009
Secondary outcomes:
measure: To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.
timeFrame: April 2009
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: QPharm Pty Ltd
state: Queensland
Study officials:
affiliation: Acrux Pharma Pty Ltd
name: Tina Soulis, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00838968: The Efficiency of Postoperative Interferon-alpha Treatment in p48 Positive Patients With Hepatocellular Carcinoma
Official title: The Efficiency of Postoperative Interferon-alpha(IFNa) Treatment in p48 Positive Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
interferon-alpha
p48
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection.

Detailed description: BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients with hepatocellular carcinoma (HCC). P48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the Efficiency of Postoperative IFN-Alpha Treatment in p48 Positive Patients With HCC.

METHODS: An immunohistochemical study of P48 was performed on specimens that were collected from patients who underwent a curative resection of HCC. These patient with p48 Positive were randomized divided into a treatment group who received postoperative IFN-alpha therapy and a comparison group who not received. Besides the side effect, the overall survival rate and the disease-free survival rate will be observed.

Anticipated RESULTS: IFN alpha treatment improved the overall survival of p48 Positive patients with HCC after curative resection, probably by postponing recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients with p48 Positive who underwent a curative resection of HCC

Exclusion Criteria:

* None

Primary outcomes:
measure: 5-years survival rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
name: Hui-chuan Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05268068: A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
Official title: A Phase 1 Study in Healthy Chinese Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Risankizumab
ABBV-066
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.


Eligibility criteria: Inclusion Criteria:

- Body Mass Index (BMI) is \>= 19.0 to \<= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.

Exclusion Criteria:

- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Primary outcomes:
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to Approximately 140 Days
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to Approximately 140 Days
measure: Time to Cmax (Tmax)
timeFrame: Up to Approximately 140 Days
measure: Terminal Phase Elimination Rate Constant (β)
timeFrame: Up to Approximately 140 Days
measure: Terminal Phase Elimination Half-life (t1/2)
timeFrame: Up to Approximately 140 Days
measure: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
timeFrame: Up to Approximately 140 Days
measure: AUC from Time 0 to Infinity (AUCinf)
timeFrame: Up to Approximately 140 Days
measure: Apparent Clearance (CL/F) for Subcutaneous (SC) dosing
timeFrame: Up to Approximately 140 Days
measure: Clearance (CL) for Intravenous (IV) Dosing
timeFrame: Up to Approximately 140 Days
measure: Number of Anti-drug antibody (ADA) Titers
timeFrame: Up to Approximately 140 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital /ID# 212830
state: Shanghai
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: