louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02498093: Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty
Official title: Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty: Implementing Evidence Based Rehabilitation Into Clinical Practice, and the Influence of Supervised Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: Resistance training
Arthroplasty, Replacement, Hip
Professional-Patient Relations
Evidence-based practice
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-07-15
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.


Eligibility criteria: Inclusion Criteria:

* scheduled for total hip arthroplasty (THA)
* living nearby Trondheim
* diagnosis of primary osteoarthritis as the main cause for elective THA
* ASA score of I-III (stable)

Exclusion Criteria:

* muscular or skeletal disease which might influence the training and/or physical testing performance
* communication difficulties
* postoperatively discharged to a rehabilitation institution
* THA in the bilateral hip that is not fully rehabilitated.

Primary outcomes:
measure: Muscular strength
timeFrame: 3 months
measure: Muscular strength
timeFrame: 6 months
measure: muscular strength
timeFrame: 1 year
Secondary outcomes:
measure: Physical function
timeFrame: up to 1 year
measure: Bone mineral density
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, Faculty of Medicine
Study officials:
affiliation: Norwegian University of Science and Technology
name: Lars Jacob Stovner, prof
role: STUDY_DIRECTOR
References:
citation: Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
citation: Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. A randomized controlled trial on maximal strength training in 60 patients undergoing total hip arthroplasty. Acta Orthop. 2018 Jun;89(3):295-301. doi: 10.1080/17453674.2018.1441362. Epub 2018 Mar 1.
Clinical trial NCT00756171: Colesevelam Versus Placebo in Cholestatic Pruritus
Official title: Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Liver Disease
Keywords: Cholestatic
pruritus
of any cause
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.


Eligibility criteria: Inclusion Criteria:

* patients with pruritus as a result of a cholestatic disorder
* age above 18 years
* informed consent

Exclusion Criteria:

* use of cholestyramine
* pregnancy
* inability to understand or speak Dutch language
* malignancy/life expectancy \<6 months

Primary outcomes:
measure: 40% reduction of pruritus according to visual analogue scores
timeFrame: 3 weeks
Secondary outcomes:
measure: improvement in quality of life scores
timeFrame: 3 weeks
measure: Reduction in pruritus score/scratch lesions
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: Kuiper EM, van Erpecum KJ, Beuers U, Hansen BE, Thio HB, de Man RA, Janssen HL, van Buuren HR. The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: results of a double-blind, randomized, placebo-controlled trial. Hepatology. 2010 Oct;52(4):1334-40. doi: 10.1002/hep.23821.
Clinical trial NCT00537771: Liver Safety Under Upfront Arimidex vs Tamoxifen
Official title: A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared With Tamoxifen in Adjuvant Therapy in Postmenopausal Women With Hormone Receptor+ Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Early Breast cancer
adjuvant therapy
hormone receptor
hormonal therapy
anastrozole
tamoxifen
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 384
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.


Eligibility criteria: Inclusion Criteria:

* Histologically proven HR+ invasive breast cancer
* Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
* Postmenopausal woman

Exclusion Criteria:

* clinical evidence of metastatic disease
* previous adjuvant hormonal therapy for breast cancer
* liver diseases

Primary outcomes:
measure: Incidence of Fatty Liver Disease
timeFrame: At 48 weeks, 96 weeks, 144 weeks
Secondary outcomes:
measure: Incidence of Abnormal Liver Function
timeFrame: At 48 weeks, 96 weeks, 144 weeks
measure: Time to Treatment Failure
timeFrame: Within 3 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Nanning
country: China
facility: Research Site
state: Guangxi
city: Wuchang
country: China
facility: Research Site
state: Hubei
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Dalian
country: China
facility: Research Site
state: Liaoning
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Xian
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Tianjin
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Vivian Gu
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Fengping Liang
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Prof. Wang Shenming
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02932371: Evaluation of the ECOM™ Monitor for Continuous and Non-invasive Measure of the Cardiac Output in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Cardiac output
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of the study is to estimate the reliability of the determination of the cardiac output measured by the ECOM™ device. This study will be performed with the latest version of the software which should give better results than those published previously. Two techniques of measure of the cardiac output will be compared: the reference measure by trans-esophageal echography and the bioimpedance used by the ECOM™. monitor.


Eligibility criteria: Inclusion Criteria:

* Patients over18 years
* Needed cardiac surgery,
* Needed a monitoring by transesophageal ultrasound ,
* Benefiting from a social security scheme
* Having given their written consent.

Exclusion Criteria:

* Pregnant or breast-feeding women,
* Allergy to polyvinylchloride (PVC),
* The patients for whom a difficulty of ventilation with a mask or intubation is envisaged,
* Contraindication to transesophageal ultrasound, a steady cardiac arrhythmia, a flight or an aortic shrinkage.

Primary outcomes:
measure: Cardiac output
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie-Lannelongue
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
References:
Clinical trial NCT00188071: Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen
Official title: Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Keywords: medical abortion
analgesia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-16
Enrollment: 240
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: * To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics
* each treatment beeing allocated by randomization

Detailed description: * 240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval
* according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics :

  * paracetamol 1 gr
  * ketoprofen 100 mg
  * the association of both Postprocedure pain was recorded, by nurse, using a visual analog scale (VAS), 7 times before and after the procedure, until the discharge of the patient.
* if VAS was above 40 on two consecutive measurements a morphine injection was given.
* the number and total amount of morphine was recorded.
* satisfaction was recorded within the 3 postoperative day by a telephone inquiry.

Eligibility criteria: Inclusion Criteria:

* pregnant women
* medical abortion performed in day case surgery under local anesthesia
* informed written consent

Exclusion Criteria:

* under 18 year old

Primary outcomes:
measure: postoperative pain rating
Secondary outcomes:
measure: morphine consumption
measure: patient satisfaction
Other outcomes:
Locations:
city: Angers
country: France
facility: Dept of Anesthesia - CHU
Study officials:
affiliation: University hospital, Angers, FRANCE
name: Jean Claude Granry, MD
role: STUDY_CHAIR
affiliation: University hospital, Angers, FRANCE
name: Emmanuel Mucci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Anesthesia, CHU, Angers - France
name: Christine Monrigal, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05800093: Proteomics and Genomics Combined With CT to Predict CVD
Official title: Proteomics and Genomics Combined With CT to Predict CVD
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease Progression
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 310
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients between 50 and 75 years old with nonobstructive coronary artery disease

Brief summary: This study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* Adult patients between 50 and 75 years old
* Subjects at intermediate to high risk for ASCVD
* Asymptomatic patients without cardiac chest pain
* Evidence of atherosclerosis on baseline CCTA

Exclusion Criteria:

* Renal insufficiency, defined as eGFR \< 30 ml/min
* History of cardiovascular events (myocardial infarction, peripheral artery disease and ischemic stroke)
* Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid monotherapy
* Change in lipid lowering therapy in the last 6 months
* Use of more than two antihypertensive agents
* No coronary atherosclerosis at baseline imaging
* Active malignancy requiring treatment
* Atrial fibrillation
* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Primary outcomes:
measure: Coronary Artery Disease Progression
timeFrame: Through study completion, between 130-156 weeks
Secondary outcomes:
measure: Presence of obstructive stenosis
timeFrame: Through study completion, between 130-156 weeks
measure: Progression in number of significant (>50%) and severe (>70%) stenoses
timeFrame: Through study completion, between 130-156 weeks
measure: Total plaque volume progression
timeFrame: Through study completion, between 130-156 weeks
measure: Calcified plaque volume progression
timeFrame: Through study completion, between 130-156 weeks
measure: Non-calcified plaque volume progression
timeFrame: Through study completion, between 130-156 weeks
measure: Low-attenuation plaque volume progression
timeFrame: Through study completion, between 130-156 weeks
measure: Change in Pericoronary Adipose Tissue CT-Attenuation
timeFrame: Through study completion, between 130-156 weeks
measure: CAD-RADS progression (yes/no)
timeFrame: Through study completion, between 130-156 weeks
measure: Progression in number of high-risk plaque characteristics (yes/no)
timeFrame: Through study completion, between 130-156 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
affiliation: Amsterdam UMC
name: Erik SG Stroes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05407493: Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication
Official title: Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oroantral Fistula
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients with a clinical diagnosis of oroantral fistula among those referring to the Dental department of Siena University Hospital

Brief summary: The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.


Eligibility criteria: Inclusion Criteria:

Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .

Exclusion Criteria:

i) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.

Primary outcomes:
measure: Closure success
timeFrame: One month after surgery
Secondary outcomes:
measure: Patient reported Pain
timeFrame: Each week for one month
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Dipartimento di Odontostomatologia
Study officials:
affiliation: University of Siena
name: Nicola Discepoli
role: STUDY_DIRECTOR
References:
Clinical trial NCT03660293: Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
Official title: Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetic cardiomyopathy (DCM) is a distinct clinical entity of diabetic heart muscle that describes diabetes associated changes in the structure and function of the myocardium in the absence of coronary artery disease, hypertension, and valvular disease. Oxidative stress plays a critical role in DCM development. DCM can be diagnosed using the novel methods of echocardiography (tissue Doppler imaging, Speckling tracking techniques and more recent real time 4D echocardiography). There is a possible cardioprotective effect of statins, Captopril and L-Carnitine in type 1 diabetic children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.

Exclusion Criteria:

* Children with Congenital Heart Diseases.
* Children with acquired cardiac diseases.
* Children with other systemic diseases.
* Symptomatic diabetic cardiomyopathy.

Primary outcomes:
measure: The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
timeFrame: before and after 4 months of receiving cardio-protective agents
measure: The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
timeFrame: before and after 4 months of receiving cardio-protective agents
Secondary outcomes:
measure: The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.
timeFrame: first day
measure: The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction
timeFrame: first day
measure: Identification of risk factors for developing diabetic cardiac insult.
timeFrame: first day
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
References:
citation: Badreldeen A, El Razaky O, Erfan A, El-Bendary A, El Amrousy D. Comparative study of the efficacy of captopril, simvastatin, and L-carnitine as cardioprotective drugs in children with type 1 diabetes mellitus: a randomised controlled trial. Cardiol Young. 2021 Aug;31(8):1315-1322. doi: 10.1017/S1047951121000226. Epub 2021 Feb 4.
Clinical trial NCT03115593: Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
Official title: Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endometrial Cancer
Keywords: hysteroscopy
pipette
biopsy
endometrial cancer
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Endometrial cancer is the most common pelvic gynecological cancer in so-called developed countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95% for early forms, which represent more than 70% of diagnoses. The main risk factors are obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing incidence. Half a million new annual cases are expected in 2035.

The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the disease is estimated between 10 and 15%. Currently the recommendations are to make an evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type is the main predictor of the severity of the disease and acts as guideline for the treatment.It is therefore essential to have precise biopsy results before starting therapeutic management.

The most widely used technique is the blind biopsy by aspiration using a pipette because it is inexpensive, easy, without any specific equipment. However, recent studies showed that this technique has a poor sensitivity in the target population of postmenopausal women. Other studies have shown that targeted biopsies under hysteroscopic control could have a much higher sensitivity.

The main objective of this study is thus to compare the performance of the targeted biopsy under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the diagnosis of endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* postmenopausal patient.
* patient with postmenopausal metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result)

Exclusion Criteria:

* patients undergoing hormone replacement therapy for menopause (THM). This treatment may be the cause of benign bleeding in post menopause.

Primary outcomes:
measure: Histological result
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: Hôpitaux Iris Sud - Site Ixelles
city: Liege
country: Belgium
facility: CHR Citadelle
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
Study officials:
affiliation: CHU Brugmann
name: André Nazac, MD
role: PRINCIPAL_INVESTIGATOR
References: