louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01546376: Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients
Official title: Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT
To Study HIV Viral Load of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2012-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive cancer patients Curative RT treatment

Brief summary: Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT and last weeks of RT .


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* HIV positive cancer patients
* Photon beam RT, conventional fraction \>= 4000 cgy in 4 weeks

Exclusion Criteria:

* CD4 count \< 200 cell/ml and not received anti retro viral

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT06867276: Low Level Laser Versus Polarized Light in the Treatment of Acne Vulgaris
Official title: Low Level Laser Versus Polarized Light in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Level Laser Therapy
Acne Vulgaris
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed to compare clinically the therapeutic applications between low level laser therapy (excimer laser) and non-laser polarized light (Bioptron prol) in the treatment of Acne vulgaris.

Detailed description: Traditional acne treatment often involves topical application, which can cause skin irritation and dryness, and oral antibiotic therapy, which is limited by antibiotic resistance. Newer procedures like laser and light-based therapies offer alternative treatments for patients who struggle with adherence or experience side effects or treatment failure. This study aims to compare the therapeutic application of laser and light therapies as an alternative to traditional acne treatments.

Eligibility criteria: Inclusion Criteria:

1. Female and male patients.
2. Age range between 18 and 25 years.
3. All patients will sign their informed consent to participate in the research procedure and to publish the data.
4. Definite clinical diagnosis of mild to moderate inflammatory lesions of facial Acne vulgaris (open and closed comedones, papules, pustules, and nodules) on the face that has been going on for at least 1 month.

Exclusion Criteria:

1. Patient's unwillingness to continue cooperation in the study
2. Photosensitive skin.
3. Pregnancy and breast feeding.
4. Women who use hormonal contraceptives.
5. Patients who had used oral retinoids or any other treatment for acne in the last month.
6. Patients with severe nodulocystic acne

Primary outcomes:
measure: assessment of change of Global Assessment Scale
timeFrame: At baseline and after 4 weeks
Secondary outcomes:
measure: assesment of change of digital facial photographs
timeFrame: At baseline and after 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References:
Clinical trial NCT01165476: Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities
Official title: An Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Keywords: treprostinil
bioavailability
bioequivalence
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the bioavailability of a single 1mg dose of treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent facilities.


Eligibility criteria: Inclusion Criteria:

* Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening
* Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening

Exclusion Criteria:

* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug
* Subject has a clinically significant history of neurological, cardiovascular,respiratory, endocrine, hematological, hepatic, renal, gastrointestinal,genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.

Primary outcomes:
measure: Treprostinil pharmacokinetics
timeFrame: 36 hours
Secondary outcomes:
measure: Clinical lab values
timeFrame: Days 0, 7 and 9
measure: Adverse event monitoring
timeFrame: From signing of ICF to end of study
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: PPD Development, LP
name: Aziz L Laurent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02240576: Possible Manifestation of Rhinitis After Nasal Fracture
Official title: Possible Manifestation of Rhinitis After Nasal Fracture
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nasal Fracture
Keywords: surgery for nasal fracture
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with nose reposition afterwards under general anaesthesia in the chirurgical day care centre (CDC) of Gasthuisberg.

Brief summary: We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a retrospective analysis of 310 patients with a nasal fracture in the past would be useful to investigate the incidence of IR in this cohort afterwards (5-10 y later).

Detailed description: The patient population will be recruited by sending patient questionnaires (form in addendum) to patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with nose reposition afterwards under general anaesthesia in the chirurgical day care centre (CDC) of university hospital (UZ) Leuven.

The control population (HC) will be recruited by sending a slightly adapted questionnaire (form in addendum) to patients who had surgery of the vocal cords under general anaesthesia in the CDC of UZ Leuven in the same period as the patient group. The control group will be age and sex-matched with the patient group.

Eligibility criteria: Inclusion Criteria:

* Presence of nasal fracture in 2005-2013 and
* Diagnosis ascertained by a Ear-Nose-Throat (ENT) specialist and
* Followed by nose reposition surgery under general anaesthesia and
* Described in the clinical operation report as "mobile nose bones" OR Available radiography

Inclusion criteria of the control group:

* Presence of problem on vocal cords without previous nasal fracture
* Surgery of the vocal cords under general anaesthesia in 2005-2013

Primary outcomes:
measure: Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.
timeFrame: at least 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven ENT
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Peter Hellings, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05295576: Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients
Official title: Effect of Non Surgical Periodontal Therapy on Levels of Il-17 and Il-18 in Chronic Periodontitis Patients Versus Periodontally Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aggressive Periodontitis
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic periodontitis patients

Brief summary: The current study was performed to study levels of Il-17 and Il-18 in aggressive periodontitis patients before and after non surgical periodontal therapy

Detailed description: Background:host defense factors are involved in pathogenesis of chronic periodontitis so, the current study is assessing levels of Il-17 and Il-18 in chronic periodontitis patients versus periodontally healthy controls.

Subjects and methods: Fifty subjects were included; twenty five of them are diagnosed with chronic periodontitis patients and twenty five are periodontally healthy subjects. Probing depth (PD), clinical attachment level (CAL), plaque index (PI) and gingival index (GI) were recorded for all the enrolled subjects. GCF levels of Il-17 and IL-18 were analyzed by enzyme-linked immunosorbent assay (ELISA).

Eligibility criteria: Inclusion Criteria:

* Medically free subjects .
* both genders .
* age range between 30 to 60 years old .

Exclusion Criteria:

* Subjects with periodontal surgeries in the last 6 months.
* Subjects with prior use of antibiotics in the last 6 months.
* Smokers.
* Pregnant and lactating females were excluded.
* Lactating females.

Primary outcomes:
measure: measure levels of Il-17 and Il-18 in chronic periodontitis patients
timeFrame: Change from Baseline Il-17 andIl-18 at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future university in Egypt
Study officials:
affiliation: Lecturer of Oral Medicine and Periodontology
name: Sarah M Elkot, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365676: GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms
Official title: Phase 3 Study Efficacy and Tolerance: The Use of 2 Phytomedicines in Association GAMALINE® 900mg + HIPERICIN® 300mg for the Treatment of Pre-Menstrual Syndrome (PMS) and Vasomotor Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Premenstrual Syndrome
Uterus; Hemorrhage, Preclimacteric or Premenopausal
Keywords: Edema
Depression
Hot Flashes
Anxiety
Irritability
PMS
Lead sponsor: Phytopharm Consulting Brazil
Sponsor class: NETWORK
Collaborators: name: Herbarium Laboratorio Botanico Ltda
name: Federal University of Health Science of Porto Alegre
First posted: 2011-06-03
Enrollment: 240
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as antidepressant will be prescribed together for treating women with Premenstrual Syndrome (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE® prescription alone.

Detailed description: Test with 2 female groups: 25-44 years old (reproductive age) and 45-55 years old (climacteric premenopausal age) complaining about all symptoms related with premenstrual syndrome.

Eligibility criteria: Inclusion Criteria:

* fertile women between 25-44 years old
* climacteric women between 45-55 years old

Exclusion Criteria:

* inferior age to 25 years old
* superior age to 55 years old
* post-menopausal
* under hormone therapy
* thyroid disease
* under psychiatric therapy or medication
* history for allergies and/or hypersensitivity to any component
* breast feeding or pregnancy
* no knowledge for writing and/or reading

Primary outcomes:
measure: PMS calendar
timeFrame: 240 days
measure: LAB Tests
timeFrame: T0 T1 and T6
Secondary outcomes:
measure: WHOQOL
timeFrame: 06 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Ambulatório de Ginecologia e Obstetrícia ISCMPA
state: RS
Study officials:
affiliation: UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre
name: Carla Vanin, MD MSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Phytopharm Consulting Brazil
name: Karla F Deud José, PharmD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02806076: RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode
Official title: Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.


Eligibility criteria: Inclusion Criteria:

* Child-Pugh class A
* patient with 1-2.5cm sized HCC
* 1 or 2 HCC lesions

Exclusion Criteria:

* maximum tumor diameter greater than 2.5cm
* Child-Pugh class B or C
* more than 3 HCC lesions
* invisible tumor even after US/CT or US/MR fusion
* presence of vascular tumor thrombosis or extrahepatic metastasis
* severe coagulopathy (PLT \< 50K, PT \< 50% of normal range)

Primary outcomes:
measure: 12 month local tumor progression (LTP) rate
timeFrame: 12 months after RFA
Secondary outcomes:
measure: 2. tumor seeding rate
timeFrame: 12 months after RFA
measure: Complication rate related with RFA
timeFrame: 1 month after RFA
measure: Technical success rate
timeFrame: 1 month after RFA
Other outcomes:
measure: Ablation time
timeFrame: 3 days after RFA
measure: Intrahepatic distant mets
timeFrame: 12 months after RFA
measure: Extrahepatic distant mets
timeFrame: 12 months after RFA
measure: Technical efficacy 1
timeFrame: 2 days after RFA
measure: Technical efficacy 2
timeFrame: 2 days after RFA
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00079976: Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official title: A Clinical Research Study to Evaluate the Safety and Efficacy of Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gram-Positive Bacterial Infections
Staphylococcus Infections
Vancomycin Resistance
Methicillin Resistance
Keywords: Staphylococcus aureus
Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-03-22
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Isolation of one of the following multi-antibiotic resistant bacteria: vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial infection
* Have a confirmed diagnosis of a serious infection (eg, bacteremia \[unless due to an excluded infection\], complicated intra-abdominal infection, complicated skin and skin structure infection, or pneumonia) requiring administration of intravenous (IV) antibiotic therapy

Exclusion Criteria:

* Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
* Anticipated length of antibiotic therapy less than 7 days
* For subjects with VRE, known or suspected hypersensitivity to tigecycline or linezolid, or other compounds related to these classes of antibacterial agents (eg, oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA, known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds related to these classes of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03612076: Cost Of Failure Following Reimplantation After a 2-Stage Exchange Strategy For Hip Or Knee Prosthetic Joint Infection
Official title: Cost of Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prosthetic Joint Infection
Keywords: prosthetic joint infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Heraeus Medical GmbH
First posted: 2018-08-02
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with prosthetic joint infection having had a 2-step exchange.

Brief summary: This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done.

A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation.

The aim of this study is to determine the global cost of management of prosthetic joint infection.


Eligibility criteria: Inclusion Criteria:

* patients with prosthetic joint infection having had a 2-step exchange and managed at the CRIOAc from at least the reimplantation (between 2013 and 2015)

Exclusion Criteria:

-

Primary outcomes:
measure: Global cost of management of PJI
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon - Hôpital de la Croix-Rousse
name: Tristan Ferry, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05188976: Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease
Official title: Validity Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Disease
Keywords: PetCO2
Lead sponsor: National Hospital Organization Minami Kyoto Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with respiratory disease such as COPD, IP

Brief summary: The investigators aim to evaluate the correlation between PetCO2, PaCO2, and PtcCO2 in patients with respiratory diseases. The investigators also evaluate the correlation between PetCO2, PaCO2, and PtcCO2 changes over time.

Detailed description: Partial pressure of carbon dioxide(PCO2) is mainly evaluated by partial pressure of arterial carbon dioxide (PaCO2), and is used as an index for prognosis and NPPV introduction in chronic respiratory failure. Arterial blood gas analysis for PaCO2 measurement is the most accurate test value, but it is invasive and frequent tests are difficult and cannot be performed at home. The transcutaneous PCO2 (PtcCO2) is a non-invasive measurement and its measured value is close to PaCO2, and it can be measured continuously, which is useful for monitoring patients with chronic respiratory failure. However, PtcCo2 has not been applied at home due to technical problems (necessity of calibration, periodic drift, etc.). The end-tidal pressure of expired CO2 (PetCO2) can be measured non-invasively, easily and continuously. PetCO2 is mainly used for patients undergoing mechanical ventilation, and its accuracy and stability have been evaluated. The investigators decided to investigate whether PetCO2 is useful for monitoring respiratory status in patients with respiratory disorder.

Eligibility criteria: Inclusion Criteria:

* Subjects with respiratory disorder.
* Subjects who are clinically stable for the last 2 weeks

Exclusion Criteria:

* Subjects who required treatment with antibacterial agents or oral/intravenous steroids for pneumonia or exacerbation of respiratory disease in the last 2 weeks.
* Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, and neurological disease.

Primary outcomes:
measure: Correlation between PetCO2, PaCO2, and PtcCO2
timeFrame: One to three months
Secondary outcomes:
measure: Correlation of changes over time between PetCO2, PaCO2 , and PtcCO2
timeFrame: One to three months
measure: Relationship between PetCO2 and respiratory symptoms evaluated by The COPD Assessment Test (CAT) and mMRC (modified British Medical Research Council)
timeFrame: One to three months
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
state: Kyoto
Study officials:
References: