louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03429530: Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma
Official title: Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: miRna in HCC
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be carried out in Al-Raghy hospital (Assiut university), in collaboration with Medical Microbiology \&Immunology Department.

Eighty patients with HCV related chronic liver disease will be included. GroupI; 20 patients with chronic HCV GroupII; 20 patient with chronic HCV related liver cirrhosis GroupIII; 40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma Control group: (group IV) Sex and age matched 20 healthy blood donors will also be included as a control group

Brief summary: The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

Detailed description: Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues.

miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.

Eligibility criteria: Inclusion Criteria:

* RNA extraction and quantitative Real-Time PCR analysis
* Diagnosis of HCV will be based on detection of anti-HCV antibodies
* Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available
* Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan

Exclusion Criteria:

* HBV or autoimmune or metabolic liver disease
* serological evidence of human immunodeficiency virus (HIV) infection
* malignancy in other organs
* After intervention in treatment of hepatocellular carcinoma

Primary outcomes:
measure: the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.
timeFrame: basline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06175130: Cross-sectional Dietary Intake Survey on Ivorian School-Aged Children and Women of Reproductive Age
Official title: Cross-sectional Dietary Intake Survey on Ivorian School-aged Children (6-12 yo) and Women of Reproductive Age (15-50 yo)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet; Deficiency
Keywords: Nutrient Inadequacy
Dietary Patterns
Food Intake
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
Collaborators: name: Société de Nutrition de Côte d'Ivoire
First posted: 2023-12-18
Enrollment: 846
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy children and women living in the cities of Ivory Coast

Brief summary: A cross-sectional dietary intake study was conducted with 423 Ivorian school aged children (SAC, 6-12 years) and 423 women of reproductive age (WRA, 15-49 years) from four cities, recruited by two-stage random sampling.

Detailed description: A cross-sectional dietary intake study was conducted with 423 Ivorian school aged children (SAC, 6-12 years) and 423 women of reproductive age (WRA, 15-49 years) from four cities, recruited by two-stage random sampling. Dietary intake data were collected by multiple pass 24-hour recall. For a sub-sample (10% subjects) two-day non-consecutive multiple pass 24-hour recall was collected.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* illness or disease

Primary outcomes:
measure: Mean usual nutrient intake per day
timeFrame: Standard multiple pass 24-hour recall
Secondary outcomes:
measure: Nutritional status (Prevalence of stunting, underweight, overweight and obesity)
timeFrame: on the spot measurement
measure: Food intake per day per person
timeFrame: Standard multiple pass 24-hour recall
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: FrieslandCampina Research and Development
Study officials:
References:
Clinical trial NCT00560430: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Official title: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Metabolic Syndrome
Hypertriglyceridemia
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-11-19
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome. Specific parameters will be tested before treatment and after 3 months of treatment. Placebo will be compared to 2 different doses of telmisartan per day.


Eligibility criteria: Inclusion Criteria:

* Abd. obesity (BMI\>25kg/m²) and waist circumference ≥95cm (men),≥80cm (women)
* Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
* Triglycerides 150-400 mg/dl
* Normal stress test
* Normal carotid ultrasound
* Normal fundoscopy

Exclusion Criteria:

* Diabetes mellitus
* Secondary cause for insulin resistance
* LDL-cholesterol \>190 mg/dl
* Atherosclerotic disease
* Blood pressure \>160 mmHg (systolic) and/or \>100 mmHg (diastolic)
* Regular alcohol consumption (\>30 g/day)
* Contraindication against telmisartan
* Antihypertensive medications
* Lipid lowering therapy
* Malignancy
* Pregnancy or Lactation
* Women without adequate contraception

Primary outcomes:
measure: change in IL-6
timeFrame: 14 weeks
Secondary outcomes:
measure: change in fasting lipids;
timeFrame: 14 weeks
measure: change in postprandial lipid metabolism
timeFrame: 14 weeks
measure: change in inflammatory parameters
timeFrame: 14 weeks
measure: change in glucose metabolism
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Cardiovascular Research, University Berlin
city: Munich
country: Germany
facility: Med. Dept. 2, University Munich
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Klaus G Parhofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06491030: Post-Operative Thoracolumosacral Orthosis for PJK
Official title: The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Proximal Junctional Kyphosis
Adult Spinal Deformity Surgery
Thoracolumbosacral Orthosis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Aspen Medical Products
First posted: 2024-07-08
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.


Eligibility criteria: Inclusion Criteria:

* 30-75-years-old
* Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium.

Exclusion Criteria:

* Osteoporosis (defined as a T-score \<-2.5 at the time of surgery)
* Body mass index (BMI) \>35 kg/m2
* Revision fusions
* Fusions for trauma
* Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
* An underlying inflammatory arthropathy

Primary outcomes:
measure: The incidence of proximal junctional kyphosis development
timeFrame: This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.
Secondary outcomes:
measure: Change in patient reported outcome measures
timeFrame: 6 week and 6-month time points
measure: Change in patient reported outcome measures
timeFrame: 6 week and 6-month time points
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Overland Park
country: United States
facility: University of Kansas
state: Kansas
city: New York City
country: United States
facility: Hospital for Special Surgery
state: New York
city: Bellaire
country: United States
facility: University of Texas Health, Houston
state: Texas
city: Dallas
country: United States
facility: Texas Back Institute
state: Texas
city: Seattle
country: United States
facility: Virgina Mason Franciscan Health
state: Washington
Study officials:
References:
Clinical trial NCT02900430: Invasives Aspergillosis in Acute Myeloid Leukemia
Official title: The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Invasive Aspergillosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients treated for acute myeloid leukemia by intensive chemotherapy

Brief summary: Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.

Detailed description: Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* acute myeloid leukemia
* intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation)

Exclusion Criteria:

* \< 18 years
* pregnancy
* no intensive chemotherapy (palliative treatment, azacytidine...)

Primary outcomes:
measure: Incidence of invasive aspergillosis in acute myeloid leukemia
timeFrame: 1 year
Secondary outcomes:
measure: Efficiency of antifungal prophylaxis by posaconazole
timeFrame: 1 year
measure: Impact of antifungal prophylaxis by posaconazole about construction/demolition periods
timeFrame: 1 year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: Department of Hematology, Brest Teaching Hospital
name: Gaelle Guillerm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hematology, Brest Teaching Hospital
name: Lenaig Le Clech, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507530: Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
Official title: Investigating The Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuromuscular Diseases
Duchenne Muscular Dystrophy
Dystrophy
Dystrophy, Muscular
Keywords: physiotherapy and rehabilitation
fear of falling
quality of life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Duchenne Muscular Dystrophy, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Neuromuscular Diseases Unit.

Brief summary: For ambulatory children with DMD, physiotherapy is aimed at protecting ambulation, improving motor performance to the best level and increasing quality of life. The investigators think that the treatment of children with Duchenne Muscular Dystrophy may become more effective with physiotherapy programs based on the comprehensive physiotherapy evaluation results, including the evaluation of fear of falling. This study investigates the fear of falling in children with Duchenne Muscular Dystrophy and questioning whether their fear of falling affects their quality of life and their physical performance.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist,
* Being volunteer,
* Being between 6 and 15 years old,
* Being between levels 1-5 according to the Brooke Lower Extremity Functional Classification developed to classify lower extremity functions in children with DMD,
* Being able to cooperate with the physiotherapist's directives.

Exclusion Criteria:

* Being between levels 6-10 (children who do not have independent ambulatory ability) according to the Brooke Lower Extremity Functional Classification,
* Not being able to cooperate with the physiotherapist's directives,
* End of the volunteering.

Primary outcomes:
measure: Fear of Falling
timeFrame: 15-30 minutes
Secondary outcomes:
measure: History of Falls
timeFrame: 15-20 minutes
measure: Posture Analysis
timeFrame: 15-20 minutes
measure: Performance Evaluation
timeFrame: 6 minutes
measure: Evaluation of Energy Consumption
timeFrame: 15-20 minutes
measure: Fatigue
timeFrame: 15-20 minutes
measure: Balance Assessment
timeFrame: 15-20 minutes
measure: Functional Walking Assessment
timeFrame: 5-10 minutes
measure: Gait Analysis
timeFrame: 15-20 minutes
measure: Ambulation Assessment
timeFrame: 15-20 minutes
measure: Quality of Life
timeFrame: 15-20 minutes
measure: Activity Limitation
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
References:
Clinical trial NCT06803030: Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms
Official title: A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ureteral Stent-Related Symptom
Keywords: Mirabegron
Tamsulosin
Solifenacin
Lead sponsor: Bir Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Nepal Health Research Council
First posted: 2025-01-31
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.

Detailed description: Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.

Eligibility criteria: Inclusion Criteria:

• Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones

Exclusion Criteria:

* Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
* Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
* Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
* Preoperative febrile Urinary Tract Infection (UTI)
* Pregnancy or breastfeeding;
* A single kidney
* Moderate or severe cardiovascular or cerebrovascular disease
* Hepatic dysfunction
* History of pelvic surgery or irradiation
* History of bladder or prostate surgery
* Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the Ureteral Stent Symptom Questionnaire(USSQ) pain score
* Allergy to any medication

Primary outcomes:
measure: alleviating Ureteral stent related symptoms
timeFrame: 2 weeks
Secondary outcomes:
measure: early removal of ureteral stent
timeFrame: before 2 weeks
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: NAMS, Bir Hospital
state: Bagmati
Study officials:
References:
Clinical trial NCT02731430: Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery
Official title: Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia (ASA) II-III patients.
* Aged 30-50 years.
* The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity.

Exclusion Criteria:

* Patients with a known allergy to the study drugs.
* Advanced cardiac, respiratory, renal or hepatic disease.
* Coagulation disorders.
* Infection at or near the site of intrathecal injection.
* Drug or alcohol abuse.
* Psychiatric illnesses that may interfere with perception and assessment of pain.

Primary outcomes:
measure: Total postoperative analgesic consumption.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Visual analogue scale (VAS) scores
timeFrame: 24 hours postoperative
measure: Time to first request of rescue analgesia.
timeFrame: 24 hours postoperative
measure: Tolerability as assessed by the incidence of side effects
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02406430: Prognostic Factors in Epiretinal Membrane Surgery
Official title: Preoperative Prognostic Factors and Predictive Score in Patients Operated on for Combined Cataract and Idiopathic Epiretinal Membrane.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membranes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 142
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on for combined cataract and idiopathic epiretinal membrane

Brief summary: Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected visual acuity appeared to be reliable prognostic factors. Combining these factors with analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical coherence tomography provides a predictive score to estimate individual chances of good visual recovery


Eligibility criteria: Inclusion Criteria:

* symptomatic idiopathic epiretinal membrane operated on between April 2009 and September 2012 at the university hospital of Dijon, France.
* All patients signed informed consent for the surgical procedure.

Exclusion Criteria:

* Patients were excluded if they presented any cause of secondary epiretinal membrane (including diabetic retinopathy, vein occlusion, ocular inflammation, retinal detachment, or previously vitrectomized eye), high myopia (axial length ≥ 26 mm or spherical equivalent ≥ 6 diopters), severe media opacities with weak SD-OCT signal strengths, or any macular or optic nerve disease. Patients with a follow-up of less than 12 months were excluded and only one eye was included in those with bilateral epiretinal membranes.

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 1 year after the surgery
Secondary outcomes:
measure: To set up a predictive score for a >= 20/20 best corrected visual acuity
timeFrame: 1 year after the surgery
Other outcomes:
Locations:
Study officials:
References: