louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01095016: A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients
Official title: An Open-label, Randomized, Cross-over, Active-controlled Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Taiwan Otsuka Pharm. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2010-03-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable asthma patients


Eligibility criteria: Inclusion Criteria:

* Male or females outpatients aged ≥18 years old with uncontrolled or partly controlled asthma; Stability was assessed during the past 14 days the patients remained in the same severity class by 2006 GINA guideline (uncontrolled, partly controlled) and had no acute exacerbations by investigator judgment;
* Pulmonary function test: Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; Positive result of Brocho-provocation test;

Exclusion Criteria:

* Hypersensitivity to β2-agonist or lactose;
* Hospitalization due to asthma during the previous 3 months;
* Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
* Oral or systemic corticosteroids in the previous 4 weeks;
* Inadequately controlled hyperthyroidism;
* Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system or respiratory disease other than asthma(e.g. COPD), or any other disorder which may interfere wth the study evaluations or affect subject safety;
* Patients receive an investigational drug within 30 days prior to admission to the study;
* Patients with significant alcohol, drug or medication abuse as judged by the investigator;
* Females who are pregnant or breast-feeding; (exception: Females of child-bearing age might be included, if in the opinion of the investigator, they are using adequate contraceptive precautions);
* Subjects who are heavy smoker (more than 10 packs year) or who are smoking within previous 6 months.

Primary outcomes:
measure: The change of Forced Expiratory Volume in 1 second (FEV1) value
timeFrame: 12 months
Secondary outcomes:
measure: The change of Peak Expiratory Flow Rate (PEFR)
timeFrame: 12 months
measure: The change of Forced Vital Capacity (FVC)
timeFrame: 12 months
measure: Device acceptance
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Cung Memorial Hospital
Study officials:
affiliation: Chang Cung Memorial Hospital
name: Yu-Hsiu Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02210416: Costs of Complications in Inguinal Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Complication
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 968
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing laparoscopic inguinal hernia repair (TAPP or TEP) during 2002-2011 A sample of 528 patients undergoing open flat mesh repair in 2002-2011.

Brief summary: Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of short-term advantages compared to open hernioplasties with mesh. In the prevailing economic climate, the total costs of treatment is a subject of intense research. This study is designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a special emphasis in costs of treatment, complications and convalescence.


Eligibility criteria: Inclusion Criteria:

* patients treated surgically for inguinal hernia between 2002-2011

Exclusion Criteria:

* none

Primary outcomes:
measure: cost of complication
timeFrame: 3 years
measure: cost of primary treatment
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital
Study officials:
References:
Clinical trial NCT00497016: Does Statin Therapy Reduce Sympathoexcitation in Hypertension?
Official title: Does Statin Therapy Reduce Sympathoexcitation in Hypertension?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
statin
sympathetic
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2007-07-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A number of patients with hypertension have increased central sympathetic activity. Statins seem to inhibit central sympathetic output. This study assesses the effect of statins on central sympathetic activity in hypertension patients.


Eligibility criteria: Inclusion Criteria:

* (Known) hypertension
* stable drug therapy for at least 2 months
* age 18-70 jaar
* BMI 18-35 kg/m2
* Sinusrhythm

Exclusion Criteria:

* Recent cardiovascular event \<6 mnd
* Plasma Creatinin:
* female: \>120 mmol/L
* male: \>133 mmol/L
* use of:
* tricyclic antidepressants
* alpha-1 -and/or alpha-2 blockers
* disease of the autonomic nervous system (Parkinsons disease, Shy- Drager syndrome, etc)
* Albuminuria \>300 mg/dag

Primary outcomes:
measure: change in central sympathetic activity
Secondary outcomes:
measure: change in cholesterol levels, renin and aldosteron
Other outcomes:
Locations:
city: NIjmegen
country: Netherlands
facility: Radboud University Medical Center Nijmegen
Study officials:
affiliation: Radboud University Medical Center
name: Cees J Tack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomes ME, Tack CJ, Verheugt FW, Smits P, Lenders JW. Sympathoinhibition by atorvastatin in hypertensive patients. Circ J. 2010 Nov;74(12):2622-6. doi: 10.1253/circj.cj-10-0427. Epub 2010 Oct 9.
Clinical trial NCT02223416: A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: female
volunteers
Lead sponsor: Gedeon Richter Plc.
Sponsor class: INDUSTRY
First posted: 2014-08-22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in healthy female volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult female subjects
* 18-55 years of age (inclusive)
* BMI must be between 18.5 and 27 kg/m2 (inclusive)

Exclusion Criteria:

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0-4 hours
measure: Peak Plasma Concentration (Cmax)
timeFrame: 0-4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Celerion (UK)
Study officials:
References:
Clinical trial NCT05707416: Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors
Official title: Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Root Resorption of Maxillary Incisors
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will be directed to evaluate the effect of low-level laser therapy on root resorption during orthodontic intrusion of upper incisors.


Eligibility criteria: Inclusion Criteria:

* Patients with age range between 12-16 years.

  * Overbite \> 40% indicated for maxillary intrusion.
  * Mild to moderate crowding of upper incisors.
  * All permanent teeth erupted (excluding 3rd molars).
  * No previous orthodontic treatment.
  * Good oral hygiene with no previous periodontal surgery

Exclusion Criteria:

* Transverse and/or vertical skeletal dysplasia or craniofacial malformation.

  * Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly.
  * Patients with root resorption, impacted canines, or dental anomalies.
  * Poor oral hygiene
  * Present or history of periodontal diseases.
  * Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.
  * History of trauma affecting the maxillary incisors.
  * Endodontically treated upper anterior teeth.

Primary outcomes:
measure: linear amount of root resorption
timeFrame: change in linear root resorption at 4 months
measure: volumetric amount of root resorption
timeFrame: change in volumetric root resorption at 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naşr
country: Egypt
facility: Al Azhar Univertsity
Study officials:
References:
citation: Goel P, Tandon R, Agrawal KK. A comparative study of different intrusion methods and their effect on maxillary incisors. J Oral Biol Craniofac Res. 2014 Sep-Dec;4(3):186-91. doi: 10.1016/j.jobcr.2014.11.007. Epub 2014 Dec 6.
Clinical trial NCT01099124: Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)
Official title: Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: M2ES
NSCLC
Phase I Trial
Advanced NSCLC
Recurrent NSCLC
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-70 years old;
2. Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
3. No contraindication for chemotherapy;
4. ECOG performance scale 0-2;
5. No history of anti-angiogenesis therapy;
6. Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria:

1. Concurrent use of other anti-cancer agents;
2. Allergic history to M2ES and biological agents;
3. Pregnant or breast-feeding women;
4. With other malignancy;
5. With severe cardiopulmonary disease;
6. Uncontrolled brain metastasis patients;
7. Other conditions that are regarded for exclusion by the trialists.

Primary outcomes:
measure: Adverse events incidence,including severe adverse events incidence
timeFrame: one year
Secondary outcomes:
measure: Tumor response rate and disease controlled rate
timeFrame: one year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institude and Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institude and Hospital
name: Kai LI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021524: BPO vs Hibiclens Soap for Surgical Preparation
Official title: Randomized Trial of Hibiclens vs Benzoyl Peroxide Soap for Surgical Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Propionibacterium Acnes
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).


Eligibility criteria: Inclusion Criteria:

* Male subjects
* Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center
* Subjects between ages 18-89

Exclusion Criteria:

* Subjects who self-report very sensitive skin
* Subjects who are sensitive to benzoyl peroxide
* Subjects who are allergic to chlorhexidine
* Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery)
* Subjects who had recent use of acne treatment
* Subjects who are not fluent in English.

Primary outcomes:
measure: Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate
timeFrame: Day of Surgery
measure: Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate
timeFrame: Day of Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Frederick Matsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01030224: This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects
Official title: A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Single Ascending Doses in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
First time in human
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
* Healthy male and female volunteers. Females must be of non childbearing potential.

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
* History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Primary outcomes:
measure: Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
timeFrame: Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.
Secondary outcomes:
measure: Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine
timeFrame: Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Dr. Ralph A Schutz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434524: Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids
Official title: The Evaluation About the Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The long-term outcomes of branched-chain amino acid (BCAA) administration in patients undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of oral supplementation with BCAA on the prevention for the development of liver tumorigenesis in patients undergoing liver resection.

Detailed description: This study might demonstrate a tendency of the improvement in the cumulative tumor recurrence rate after hepatectomy for liver neoplasm in the Livact group compared to that in the Control Group. The investigators believe that BCAA seems to be a remarkable benefit for liver resection, especially on its reduction in the recurrence of liver cancer. This treatment regimen has potential to offer benefits for clinical use selectively, especially for patients with chronic liver diseases.

Eligibility criteria: Inclusion Criteria:

* These patients were scheduled for elective liver resection to treat hepatocellular carcinoma or adenocarcinoma of the liver.

Exclusion Criteria:

* a body-weight loss greater than 10% during the 6 months prior to surgery,
* the presence of distant metastases, or
* serious impairment of organ function due to respiratory, renal, or heart disease.

Primary outcomes:
measure: Postoperative tumor recurrence rate
timeFrame: 5 years follow up
Secondary outcomes:
measure: nutritional status
timeFrame: 5 years follow up
Other outcomes:
Locations:
city: Nankoku
country: Japan
facility: Kochi Medical School
state: Kochi
Study officials:
affiliation: Kochi Medical School
name: Takehiro Okabayashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04909424: Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)
Official title: Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: Enterococci
Infective endocarditis
Antibiotic prophylaxis
TAVI
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 100
Sex: ALL
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: In hospital patients for pre TAVI assessment at Clinique Pasteur

Brief summary: The general rules of antibiotic prophylaxis in surgery or interventional medicine include the choice of an antibiotic active on the bacteria most frequently encountered in surgical site infections. This antibiotic must cover, the bacteria present on the skin and recognized as responsible for surgical site infections.

The aim of this study is to identify bacteria found in skin flora in the inguinal region of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Flora found will allow to evaluate the impact of skin preparation and antibiotic prophylaxis protocols as they are currently practiced.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for aortic valve replacement by TAVI procedure with trans femoral approach
* Patient with pre-TAVI assessment performed at Clinique Pasteur
* Patient affiliated or beneficiary of a social security scheme
* Patient accepting to participate and having given his no objection

Exclusion Criteria:

* TAVI procedure by non-trans femoral approach
* Protected patients: Adults under guardianship or other legal protection; Pregnant or breastfeeding woman; Hospitalized without consent.

Primary outcomes:
measure: Enterococci prevalence
timeFrame: At Day 0 at TAVI intervention time (preoperative)
Secondary outcomes:
measure: Skin flora of the groin
timeFrame: At Day 0 at TAVI intervention time (preoperative) before skin disinfection
measure: Skin flora of the groin
timeFrame: At Day 0 at TAVI intervention time (preoperative) after skin disinfection
measure: Infectious events
timeFrame: From day of TAVI to 1 year after intervention
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Clinique Pasteur
name: Eric Bonnet, MD
role: STUDY_CHAIR
affiliation: Clinique Pasteur
name: Nicolas Combes, MD
role: STUDY_CHAIR
affiliation: Clinique Pasteur
name: Benoit Fontenel, MD
role: STUDY_CHAIR
References: