louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03824873: Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta
Official title: Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss
Keywords: Internal iliac artery
Internal iliac artery ligation
Placenta previa
Placenta accreta
cesarean hysterectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Placenta previa accreta
* Previous 2 cesarean section
* completed her family
* Hemoglobin \> 11 gm/dl
* Elective cesarean hysterectomy

Exclusion Criteria:

* Anemia ( Hemoglobin \< 11 gm/dl)
* Not completed her family
* BMI \> 35 Kg/m2
* Bleeding tendency
* Emergengy cesarean section
* Thrombophilia

Primary outcomes:
measure: Amount of blood loss
timeFrame: intraoperative
measure: Amount of Blood transfusion needed in mililiters
timeFrame: 24 hours
Secondary outcomes:
measure: change of hemoglobin
timeFrame: 24 hours
measure: change of hematocrit
timeFrame: 24 hours
measure: operative time
timeFrame: intraoperative
measure: incidence of injury of important structures during operation
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT01932073: Laser Therapy for the Management of Radiation Dermatitis
Official title: Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Keywords: Radiation
dermatitis
radiodermatitis
radiotherapy induced
skin reactions
low level laser therapy
breast cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 79
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes.

LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma
* Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
* Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
* Provide signed informed consent

Exclusion Criteria:

* Previous irradiation to the same breast
* Metastatic disease
* Mastectomy surgery
* Concurrent chemo-radiotherapy
* Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)

Primary outcomes:
measure: Radiation Dermatitis Grade
timeFrame: 3 months (during radiation therapy and one month after)
measure: Radiation Dermatitis Assessment
timeFrame: 3 months (during radiation therapy and one month after)
measure: Pain
timeFrame: 3 months (during radiation therapy and one month after)
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 months (during radiation therapy and one month after)
measure: Impact of Radiation Dermatitis
timeFrame: 3 months (during radiation therapy and one month after)
measure: Satisfaction with therapy
timeFrame: 3 months (during radiation therapy and one month after)
Other outcomes:
measure: Moist desquamation
timeFrame: 6.5 weeks (during radiation therapy)
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital - Oncology department
Study officials:
affiliation: Jessa Hospital
name: Jeroen Mebis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05608031: 6th Month EWL% After Sleeve Gastrectomy to Get a Better Sleep Quality
Official title: Which Value of 6th Month EWL% After Sleeve Gastrectomy is Needed to Get a Better Sleep Quality?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disturbance
Obesity, Severe
Surgery
Keywords: Laparoscopic sleeve gastrectomy
Pittsburgh sleep quality index
Obesity
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-07
Enrollment: 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Demographic parameters of the patients, preoperative and follow-up weight, body mass index (BMI), percentage of excess weight loss (EWL%), and percentage of excess BMI loss (EBMI%) were noted. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was applied to all patients preoperatively. Survey data were recorded and PSQI scores were calculated. Appropriate nutrition and physical activity programs were administered to all patients postoperatively under the control of a nutritionist.

Brief summary: Obesity, caused by caloric intake over output, has become a global health problem. The relationship between sleep and obesity is widely discussed in the literature. Little is known regarding the compliance of sleep quality and patients' weight loss. This study aimed to review how sleep quality is affected by bariatric surgery, examine whether compliance with sleep quality can be predicted after bariatric surgery, and assess its correlation with excess weight loss.

Detailed description: A cross-sectional study was conducted among patients that underwent bariatric surgery (laparoscopic sleeve gastrectomy). Sleep quality was assessed using the Pittsburgh sleep quality index (PSQI) scale preoperatively and at the 6th postoperative month. Survey data were recorded and PSQI scores were calculated. A PSQI global score above 5 indicates poor sleep quality. The participants were divided into two groups good sleep quality and poor sleep quality. Descriptive statistics and Spearman correlations were applied. Logistic regression analysis was performed to predict sleep quality.

Eligibility criteria: Inclusion Criteria:

Patients who underwent LSG for morbid obesity after being considered suitable for bariatric surgery by multidisciplinary evaluation were included in this study. Patients with aged 18-65 years, BMI \> 40 and BMI \> 35 and comorbid disease were included.

Exclusion Criteria:

Patients treated for sleep disorders have been excluded.

Primary outcomes:
measure: good sleep quality
timeFrame: 6 months
measure: poor sleep quality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital
state: Ümraniye
Study officials:
References:
Clinical trial NCT01215331: Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?
Official title: Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational Diabetes Mellitus
Treatment
Insulin
Metformin
Glyburide
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2010-10-06
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gestational diabetes mellitus takes place in 2 steps. First, it is the consequence of insulin resistance due to the modifications of the pregnancy hormonal environment, and second, of the deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion. This physiopathology is closely connected to the one of type 2 diabetes. Insulin, indeed, can remedy these 2 etiologies, but it is logical to think about using oral hypoglycemic agents which have been created to treat them: they are a natural choice because they improve insulin sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a sulfonylurea). It also seems natural to use them in combination, glyburide being added to metformin if needed.

OUR GENERAL RESEARCH HYPOTHESIS IS THAT: in pregnant women with gestational diabetes mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed) allows a glycemic control comparable to the one obtained with insulin, but with a better acceptability from women and a better health status, diabetes treatment satisfaction and well-being and a reduced postnatal depression.


Eligibility criteria: Inclusion Criteria:

* women,
* age ≥ 18 yrs,
* with gestational diabetes at 24-28 weeks (Canadian Diabetes Association (CDA) criteria),
* who need a pharmacological treatment following the failure of the diet and exercise,
* to understand and read French or English.

Exclusion Criteria:

* known type 1 or type 2 diabetes,
* treatment interfering with glucose metabolism,
* allergies to one of the components of the treatment,
* hepatic or hematologic diseases.

Primary outcomes:
measure: Glycemic control
timeFrame: 36 and 37th week of gestation
Secondary outcomes:
measure: Acceptability of the treatment
timeFrame: 8-12 weeks after delivery
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche clinique du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01565031: Prediction of Future Risk in Patients With Controlled Asthma
Official title: A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Hospital Universitario Lucus Augusti
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital Clinic of Barcelona
name: Hospital Galdakao-Usansolo
name: Complexo Hospitalario Universitario de A Coruña
First posted: 2012-03-28
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Well-controlled asthmatics who are regularly under the care of Allergy or Pneumology specialists.

Brief summary: The optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research setting)- for asthmatic patients in this clinical setting.

HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines.

METHODS The investigators designed a prospective, multicenter, observational study at five centers in cities across Spain.

The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss of control. The investigators will consider the following variables in the risk factor analysis: documented history of previous bronchial obstruction (FEV1/FVC \< 70%), coefficient of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.

The score model will be prospectively validated in an independent set of 113 patients.


Eligibility criteria: Inclusion Criteria:

* Adults (age between 18 and 80.
* Asthma under control during the last 3 months.
* Treated with a combination of ICS and long-acting beta-agonist (LABA.
* Classified as "moderate asthma" by their attending physician.

Exclusion Criteria:

* Active smoking.
* Pregnancy.
* Treatment with oral corticosteroids, omalizumab or immunotherapy.

Primary outcomes:
measure: Loss of asthma control.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lugo
country: Spain
facility: Pneumology Service
Study officials:
affiliation: Servicio Galego de Saude
name: Luis Perez de Llano, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02562131: PET-MR-PSA Prostate Cancer Recidive Study
Official title: 18F-Fluciclovine PET/MRI for Detection of Recurrent Prostate Cancer After Radical Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer Recurrent
Keywords: PET-MR
recidive
PET/MR imaging
18F-Fluciclovine
radical treatment
recurrence
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-09-29
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim in 2 years is 80 prostate cancer patients with biochemical relapse following radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy.

Brief summary: Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. The aim of this study is to evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for detection of recurrent prostate cancer.

Detailed description: The patients follow standard treatment and follow-up after the PET/MRI exam, which will be determined by the patient's treating urologist and/or oncologist. Data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. The imaging findings will be compared with the reference standard to assess the sensitivity and specificity. The diagnostic accuracy of combined PET/MRI and MRI-only (the current clinical standard) will be compared.

Eligibility criteria: Inclusion Criteria:

* the criteria for biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer must be fulfilled (two consecutive measurements with PSA \> 0.2 ng/ml following radical prostatectomy or PSA \> 2.0 ng/ml above the nadir following definitive radiotherapy)
* potential candidates for salvage treatment based on age and co-morbidity.

Exclusion Criteria:

* general contra-indications for a PET/MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
* impaired renal function defined as estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2

Primary outcomes:
measure: Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, PET center
Study officials:
affiliation: The Norwegian University of Science and Technology (NTNU)
name: Tone F Bathen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107831: Physical Function in Patients With Chronic Obstructive Pulmonary Disease
Official title: Physical Function in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: Pulmonary rehabilitation
Exercise
Field walk test
Physical performance test
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: Western Norway University of Applied Sciences
First posted: 2019-09-27
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (COPD) after participating in pulmonary rehabilitation.

Detailed description: Patients with COPD who are participating at pulmonary rehabilitation (PR) at Haukeland University Hospital will be asked and consecutive enrolled to the study. Before and after PR the six-minute walk test, incremental- and endurance shuttle walk test, 30 sec sit-to-stand test and stair test will be used to evaluate change in physical capacity and -performance.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD, Forced expiratory volume in 1 sec (FEV1)/Forced vital capacity (FVC) \<0.7 and FEV1\<80% of predicted value.
* Able to walk corridor and stairs
* Norwegian speaking

Exclusion Criteria:

* COPD exacerbations requiring medical treatment last 4 weeks prior to inclusion led to deferment of inclusion
* Not safe to exercise (e.g unstable angina)
* mental illness and drug abuse that makes group treatment not suitable

Primary outcomes:
measure: 6-minute walk test
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Incremental Shuttle walk test
timeFrame: up to 6 weeks
measure: Endurance shuttle walk test
timeFrame: up to 6 weeks
measure: 30 second sit to stand test
timeFrame: up to 6 weeks
measure: Stair test
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Sandsli
country: Norway
facility: Bente Frisk
Study officials:
affiliation: Haukeland University Hospital, Dept. of Physiotherapy
name: Else Sterndorff, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00571831: The Effect of a Blue Light Filtering IOL
Official title: The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: to Compare the Effect of Two Types of IOLs
on the Incidence of Cystoid Macular Edema
After Cataract Surgery
Keywords: macula edema
intraocular lens
prospective randomized parallel clinical design
Lead sponsor: Showa University
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).

Detailed description: The following parameters were measured for evaluation of blood retinal barrier disruption.

* the incidence of macular leakage by fluorescence angiography (FA)
* the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)
* the thickness of the macula by optical coherence tomography (OCT)

Results

* the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P\<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months.
* the VFP significantly decreased in both group from 3 to 12 months.
* the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.

Eligibility criteria: Inclusion Criteria:

* cataract patients
* All eligible for intraocular lens implantation

Exclusion Criteria:

* Patients had undergone an intraocular operation
* Patients had hypertensive retinopathy
* Patients had diabetic retinopathy
* Patients had ange-related macular degeneration
* no observable fundus
* The cataract operation was more than 30 minutes in duration

Primary outcomes:
measure: To measure FA, VEP and OCT.
timeFrame: At 3 and 12 months after IOL implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Showa University Hospital
Study officials:
affiliation: Department of Ophthalmology, School of Medicine, Showa University
name: Ryohei Koide, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04738331: Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database
Official title: Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database : CovPCR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
SARS-CoV Infection
Keywords: SARS-Cov2 infection
Tested for SARS-Cov2 infection with RT-PCR test
CT
epidemiology
reproduction number
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 10000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French population with a RT-PCR test for SARS-Cov2 infection

Brief summary: Analysing ths spread of COVID-19 epidemics in a timely manner is key to implementing public health control strategies. The investigators propose to analyse a large set of laboratory SARS-CoV-2 RT-PCR data to explore potential links between Ct values and epidemic parameters.


Eligibility criteria: Inclusion criteria:

- A SARS-Cov2 RT-PCR result with a known sampling date

Exclusion criteria:

- Patient refusing to participate in research

Primary outcomes:
measure: Detecting co-factors associated with Ct values
timeFrame: 1 day
Secondary outcomes:
measure: Detecting associations with epidemic spread
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Vincent Foulongne, PhD
role: STUDY_DIRECTOR
References: