louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02139618: Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage
Official title: A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Facial Photodamage
Keywords: Randomized-controlled-trial
Methyl-Aminolevulinate
Daylight
Photodynamic-therapy
Lead sponsor: Fundación Dermabase
Sponsor class: OTHER
Collaborators: name: Grupo de Investigacion Dermatologica (GRID)
name: IPS Universitaria-Universidad de Antioquia
First posted: 2014-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage


Eligibility criteria: Inclusion Criteria:

* Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
* Patients willing to participate
* Signed informed consent

Exclusion Criteria:

* Pregnant or nursing females
* Subjects with any photosensitizing disorder
* Any active infectious skin disorder
* History of herpes simplex in the face
* Subjects with less than 6 months of any previous rejuvenation interfering treatments
* History of systemic isotretinoin in the last year
* Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments
* History of hypersensitivity reactions
* Activities with high sun exposure during 48 hours after treatment
* Clinical suspicion of any systemic or local malignancy

Primary outcomes:
measure: Global photodamage improvement
timeFrame: 1 month after third session
Secondary outcomes:
measure: Pain measurement
timeFrame: After 2 hours of sun exposure in each session
measure: Specific Photodamage score
timeFrame: 1 month after the third session
measure: Sun irradiance and illuminance quantification
timeFrame: During the 2 hours of each session
measure: Adverse events
timeFrame: From recruitment until 1 month after the third session
measure: Therapy tolerance
timeFrame: 1 week after sessions 1,2 and 3
measure: Quality of life assessment (Skindex-29 Instrument)
timeFrame: Basal and 1 month after the third session
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: IPS Universitaria
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia. Medellin, Colombia
name: Gloria Sanclemente, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03628118: A Research on Hidden Blood Loss in Open Radical Hysterectomy and Pelvic Lymphadenectomy
Official title: A Research on Hidden Blood Loss in Open Radical Hysterectomy and Pelvic Lymphadenectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hidden Blood Loss
Open Radical Hysterectomy
Cervical Cancer
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The planned sample size was based on data from a previous study, in which the standard deviation was 5. We assumed an one-tailed α error of 0.05 and a sampling error of 1.0. we propose to enroll 105 participants and allow for a dropout rate of 10% for an effective sample size of 100.

Brief summary: The aim of this cross-sectional study is to evaluate the hidden blood loss in patients who underwent open radical hysterectomy and identity its risk factors.

Detailed description: The electronic medical data of 100 patients who undergo open radial hysterectomy in the following year to treat cervical cancer will be analyzed retrospectively in this study. The amount of hidden blood loss will be calculated according to Gross's formula. And multiple linear regression analysis will be employed to identify its risk factors.

Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 20-80 who are confirmed with cervical cancer and are treated with open radical hysterectomy and pelvic lymphadenectomy.

Exclusion Criteria:

1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
2. Suspected or identified as other tumors of genital tract;
3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
4. Other diseases or heavy injuries that will interfere with the results;
5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Primary outcomes:
measure: the volume of hidden blood loss (mL)
timeFrame: 10 months after surgery
Secondary outcomes:
measure: the risk factors of hidden blood loss
timeFrame: 10 months after surgery
measure: the volume of total blood loss (mL)
timeFrame: 10 months after surgery
measure: the volume of visible blood loss (mL)
timeFrame: 10 months after surgery
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: TING LI
state: Zhejiang
Study officials:
References:
Clinical trial NCT06577818: Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
Official title: Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns - a Multi-centre, International Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 554
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-Compression to 1-Ventilation (3:1 C:V) ratio. However, the optimal chest compression technique during cardiopulmonary resuscitation is uncertain and identified as a critical gap in evidence. The International Consensus Statement advises to use the 3:1 C:V ratio based on animal studies, and states that there are no clinical trials to support this approach and called for more research. There continues to be uncertainty about the optimal chest compression technique during cardiopulmonary resuscitation.

This trial will compare if in newborn infants with cardiac arrest in the delivery room does providing CC+SI (a new chest compression technique) compared to 3:1 C:V decreases the incidence of mortality at hospital discharge.

This will be a multi-centre international cluster randomized trial.


Eligibility criteria: Inclusion Criteria:

* Newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate
* Newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth
* No known major congenital or chromosomal malformation. All newborns who meet inclusion criteria will be enrolled as the centres agreed to change their local hospital policy during the trial. The inclusion criteria are designed to be pragmatic and provide useful knowledge translation for most of the patient population in the future.

Exclusion Criteria:

- Newborns born outside of study centers and transported to centers after delivery.

Sex, race, and ethnicity are not part of the exclusion criteria for this trial, and as such it should represent the combined demographics of all centers involved.

Primary outcomes:
measure: Neonatal mortality
timeFrame: 0-40 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
Study officials:
affiliation: University of Alberta
name: Georg Schmolzer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616018: Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Official title: Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Induced Liver Injury
Keywords: acetaminophen
protein adducts
hepatic function
drug safety
non drinkers
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2008-02-14
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.


Eligibility criteria: Inclusion Criteria:

1. age 21 years or older
2. provide written informed consent
3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers

Exclusion Criteria:

1. History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
2. Currently taking isoniazid
3. Consumption of any alcoholic beverage during the run-in period
4. A detectable serum acetaminophen at baseline
5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
6. Platelet count less than 125,000/cc at baseline
7. Positive pregnancy test at baseline (female participants only)
8. Currently adheres to a fasting type diet as determined by self report
9. Currently has anorexia nervosa as determined by self report
10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
11. Known hypersensitivity to acetaminophen

Primary outcomes:
measure: Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts
timeFrame: Day 0, 4, 7, 9, 11, and 14.
Secondary outcomes:
measure: Alanine Aminotransferase (ALT)
timeFrame: Day 0, 4, 7, 9, 11, and 14.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Rocky Mountain Poison and Drug Center
state: Colorado
Study officials:
affiliation: Denver Health/Rocky Mountain Poison & Drug Center
name: Kennon Heard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464318: Low-dose Digital Radiographs in the Idiopathic Scoliosis
Official title: Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Keywords: idiopathic scoliosis
radiographs
low dose
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 105
Sex: ALL
Minimum age (years): 9
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected or known idiopathic scoliosis selected at the Rizzoli Orthopaedic Institute

Brief summary: The aim of the study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.

Detailed description: The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years).

The young patients need to undergo several radiographic controls for a correct therapeutic balance. However, the repeated radiation exposures is associated with a greater risk of carcinogenesis even if reduced with a digital imaging technique.

The aim of this study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.

Eligibility criteria: Inclusion Criteria:

* patients with suspected or known idiopathic scoliosis
* patients able to maintain orthostasis without medical devices
* patients from 9 to 20 years old

Exclusion Criteria:

* patients with known congenital, syndromic, neurological scoliosis
* patients not able to maintain orthostasis
* obese patients
* low back pain or known tumor pathology
* patients with vertebral arthrodesis
* patients younger than 9 years old, or older than 20 years old

Primary outcomes:
measure: Repeatability and reproducibility
timeFrame: baseline (day 0)
Secondary outcomes:
measure: Repeatability and reproducibility
timeFrame: baseline (day 0)
measure: Radiation exposure
timeFrame: baseline (day 0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
affiliation: Rizzoli Orthopaedic Institute
name: Milva Battaglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02694718: A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
Official title: A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Sanofi-Synthélabo (Schweiz) AG
First posted: 2016-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pathological complete tumor response rate.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor
* Eastern Cooperative Oncology Group performance status 0-2
* Adequate values of laboratory parameters

Exclusion Criteria:

* Evidence of distant metastases
* Previous Chemotherapy or immunotherapy for colorectal cancer
* Previous radiotherapy to the pelvis
* Pre-existing condition which would deter radiotherapy
* Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix
* Clinically significant cardiac disease or myocardial infarction within the last 12 months
* Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
* Organ allografts
* Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues
* Dihydropyrimidine dehydrogenase (DPD) deficiency
* History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Tumor Response
timeFrame: Up to Week 16
Secondary outcomes:
measure: Percentage of Participants With Sphincter-preservation
timeFrame: Up to Week 16
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 16
measure: Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer
timeFrame: Up to Week 16
measure: Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes
timeFrame: From screening to Week 16
measure: Percentage of Participants With Pathological Incomplete Tumor Response
timeFrame: Up to Week 16
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Basel
country: Switzerland
city: Chur
country: Switzerland
city: Luzern
country: Switzerland
city: St. Gallen
country: Switzerland
city: Zürich
country: Switzerland
city: Zürich
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT02450318: Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
Official title: Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonobstructive Coronary Artery Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease.

Detailed description: Women are more likely to have nonobstructive coronary artery disease (CAD) . The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease. Endothelium-dependent and -independent dilation, arterial stiffness and wave reflection will be measured at baseline and after walking on a treadmill at a slow pace for 47 minutes. Endothelium-dependent dilation will be measured using brachial artery flow-mediated dilation via high resolution ultrasonography. Endothelium-independent dilation will be measured using brachial artery dilation to sublingual nitroglycerin. Arterial stiffness and wave reflection will measured using applanation tonometry.

Eligibility criteria: Inclusion Criteria:

* women with non-obstructive coronary artery disease documented within the past 5 years by coronary angiogram as no coronary arteries with stenosis greater than 50% lesions
* age 18 to 89 years
* able to complete maximal graded exercise test

Exclusion Criteria:

* use of tobacco products within the previous six months
* use of oral contraceptives or hormone replacement therapy within the prior year
* pregnancy (positive urine pregnancy test) or lactation
* history of hepatic disease or infection with hepatitis B, C or HIV

Primary outcomes:
measure: Change in endothelium-dependent dilation
timeFrame: Baseline, 15 minutes after exercise and 1 hour after exercise
Secondary outcomes:
measure: Change in endothelium-independent dilation
timeFrame: Baseline, 15 minutes after exercise
measure: Change in arterial stiffness and wave reflection
timeFrame: Baseline, 15 minutes after exercise and 1 hour after exercise
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Integrative Cardiovasculal Physiology Laboratory
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra Christou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757718: Sleep Disordered Breathing and Gestational Hypertension
Official title: Sleep Disordered Breathing and Gestational Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Gestational Hypertension
Preeclampsia
Keywords: Sleep Disordered Breathing
Obstructive Sleep Apnea
Gestational Hypertension
Preeclampsia
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.


Eligibility criteria: Inclusion Criteria:

* Women with singleton pregnancies who have the diagnosis of gestational hypertension.

Exclusion Criteria:

* Inability to comply with study parameters
* Delivery expected within 48 hours

Primary outcomes:
measure: Effectiveness of the two treatment arms at treating sleep disordered breathing.
timeFrame: single night
Secondary outcomes:
measure: Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.
timeFrame: single night
measure: Acceptability of therapy
timeFrame: single night
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: John K Reid, MD
role: PRINCIPAL_INVESTIGATOR
References: