louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02897336: Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica
Official title: Ultrasound-guided Caudal or Interlaminar Injection? A Comparative Study of Epidural Corticosteroid Injections in the Treatment of Lumbar Disk Herniation-related Sciatica
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sciatica
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 0
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: An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica.

Detailed description: An open-label randomized trial conducted in one centre to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica. 30 male and female patients will be included in each group. The primary outcome measure will be a 30% decrease in lower limbs pain as assessed by a visual analog scale.

Eligibility criteria: Inclusion Criteria:

* radicular pain (sciatica or cruralgia) for more than 2 weeks
* failure of analgesics and NSAIDs
* without neurological deficiency (motor weakness lower or equal to 3/5)
* a lumbar disk herniation on MRI or CT dating less than 3 months

Exclusion Criteria:

* history of lumbar surgery
* history of epidural injection during the last 3 months
* radicular pain not due to disk herniation
* a contraindication to epidural injection (infection, diabetes)
* history of allergic reaction to corticosteroid
* patient under legal guardianship

Primary outcomes:
measure: lower limbs pain
timeFrame: day 15
Secondary outcomes:
measure: Oswestry questionnaire
timeFrame: day 15 - month 1 - month 3 - month 6
measure: A decrease of radicular pain with a pain numerical scale lower or equal to 3/10
timeFrame: day 15 - month 1 - month 3 - month 6
measure: neurological deficiency assessed by neurological examination
timeFrame: day 15 - month 1 - month 3 - month 6
measure: drugs
timeFrame: day 15 - month 1 - month 3 - month 6
measure: medical outcome
timeFrame: day 15 - month 1 - month 3 - month 6
measure: resumption of work
timeFrame: day 15 - month 1 - month 3 - month 6
measure: number of patients with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: day 15 - month 1 - month 3 - month 6
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT05394636: Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy
Official title: Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Amyloid Angiopathy
Siderosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sporadic probable CAA patients (according to the modified Boston criteria) presenting with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS, between September 2009 and January 2022 in Nîmes University Hospital, France

Brief summary: Cerebellar superficial siderosis (SS) has been recently reported to be present in about 10% of both hereditary (n=50) and sporadic (n=46) cerebral amyloid angiopathy (CAA) patients on 3T MRI using susceptibility-weighted imaging (SWI) in the majority of patients. In that study, cerebellar SS was associated with a higher number of supratentorial lobar and superficial cerebellar macrobleeds (although cerebellar SS was not directly located adjacent to these cerebellar macrobleeds). It is unclear if cerebellar SS is caused by in situ leakage of cerebellar leptomeningeal vessels or rather represents hemorrhagic diffusion from cerebellar parenchymal micro/macrobleeds or from supratentorial bleeding sources via the tentorium cerebelli (TC).


Eligibility criteria: Inclusion Criteria:

* CAA patients (according to the modified Boston criteria)
* with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS

Exclusion Criteria:

* Patients with recent trauma,
* Patients with anticoagulation treatment,
* Patients with pathological blood coagulation tests (activated partial thromboplastin time \[aPTT\] ratio=patient's aPTT/normal control aPTT\] \>1.2; or partial thromboplastin time \[PTT\] \<75%) or platelet count (\<100 x 109/L)
* Patients with inflammatory CAA

Primary outcomes:
measure: MRI analyse : presence of cerebellar SS
timeFrame: baseline
measure: MRI analyse : Location of cerebellar SS
timeFrame: baseline
measure: MRI analyse : characteristics of cerebellar SS
timeFrame: baseline
measure: MRI analyse : characteristics of cerebellar SS
timeFrame: baseline
measure: MRI analyse : Presence of cerebellar macrobleeds
timeFrame: baseline
measure: MRI analyse : Presence of cerebral macrobleeds
timeFrame: baseline
measure: MRI analyse : Characteristics of cerebral macrobleeds
timeFrame: baseline
measure: MRI analyse : Characteristics of cortical SS
timeFrame: baseline
measure: MRI analyse : hemosiderin
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT03811236: Cold-induced Brown Fat Activation and Hepatic Steatosis
Official title: Cold-induced Brown Fat Activation and Hepatic Steatosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as well as higher activity thereof are associated with a favourable metabolic phenotype. Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity of BAT which significantly increased in size and activity during these studies. These changes were accompanied by improvements in body fat mass as well as insulin sensitivity. Non-alcoholic fatty liver disease (NAFLD) is estimated to advance to the primary cause of liver cirrhosis and hepatocellular carcinoma in the following years. Besides predisposing genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the main factors contributing to this excessive hepatic lipid accumulation.

The aim of this study is to investigate whether BAT recruitment via cold-acclimation results in decreased hepatic lipid content in overweight/obese patients with NAFLD.


Eligibility criteria: Inclusion Criteria:

* body mass index 28 - 40 kg/m\^2
* hepatic lipid content \> 10 %

Exclusion Criteria:

* endocrine disease, except treated hypo-/hyperthyroidism and hypertriglyceridemia (\<500 mg/dl) and untreated type II diabetes mellitus (fasting glucose \< 140 mg/dl)
* use of beta-blockers, alpha-blockers and rilmenidine
* chronic kidney disease
* inflammatory bowel disease
* active malignant disease
* autoimmune disease
* chronic alcohol abuse or alcohol consumption greater than 30g/d for men or 20 g/d for women
* transferrin saturation \> 40%
* serum alpha-1 antitrypsin \< 90 mg/dl
* serum ceruloplasmin \< 20 mg/dl
* positive serology for autoimmune hepatitis
* positive hepatitis serology
* liver cirrhosis
* portal hypertension
* pregnancy
* contraindications for magnetic resonance imaging

Primary outcomes:
measure: Hepatic lipid content (%)
timeFrame: Six weeks
Secondary outcomes:
measure: Brown adipose tissue volume (ml) / activity (SUVmean)
timeFrame: Six weeks
measure: Basal metabolic rate (kcal/day/kg fat-free body mass)
timeFrame: Six weeks
measure: Cold-induced non-shivering thermogenesis (%)
timeFrame: Six weeks
measure: Body fat mass (kg)
timeFrame: Six weeks
measure: Insulin sensitivity
timeFrame: Six weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Florian Kiefer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05986136: Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
Official title: Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and chronic fatigue; events that may culminate in life-threatening complications. The pathogenesis of IBD has been characterized as complex/multi-factorial that includes disruption of intestinal epithelial barrier with consequent translocation of commensal microbial products as the prime event that instigates severe immune responses and intestinal inflammation.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Both male and female will be
* Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

* Breast feeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies
* Addiction to alcohol and / or drugs
* Known allergy to the dapagliflozin

Primary outcomes:
measure: The primary endpoint is the change in mayo score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
References:
Clinical trial NCT00271336: Pentoxifylline in the Treatment of NEC in Premature Neonates
Official title: Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Necrotizing Enterocolitis
Keywords: NEC
Premature Infants
TNF
Pentoxifylline
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2005-12-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.

Detailed description: Preterm neonates with a clinical suspicion of necrotizing enterocolitis (NEC) will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1. Treatment group: to receive IV pentoxifylline (5 mg/kg/hour to run over 6 hour x 6 days) and 2. Placebo group: to receive an equal volume of ½ normal saline to run over 6 hours x 6 days.

Eligibility criteria: Inclusion Criteria:

* Preterm infants \<1750 gm. birth weight
* Abdominal x-ray consistent with NEC (dilated loops, bowel wall edema, fixed or persistent dilated loop with (or without pneumatosis)

Exclusion Criteria:

* Abdominal perforation

Primary outcomes:
measure: To demonstrate that fewer of the babies who are treated with PTX will progress to serious NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement], and/or death related to NEC.
timeFrame: Three years
Secondary outcomes:
measure: To demonstrate lower levels of TNF alpha,fecal calprotectin;Improved SMA blood flow;Quicker radiographic resolution; Decreased feeding intolerance after acute NEC episode; and lower NEC associated long term morbidity.
timeFrame: Three years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Cathy Hammerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138436: A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
Official title: A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcers
Keywords: Venous Leg Ulcers, VLU
Lead sponsor: Skingenix, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 5
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: This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

Detailed description: To assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Able and willing to provide informed consent.
3. Able and willing to comply with protocol visits and procedures.
4. A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.

Exclusion Criteria:

1. Ulcer of a non-venous hypertensive pathophysiology.
2. Known or suspected allergy to any of the components of MEBO.
3. Malignancy on target ulcer limb.
4. Received another investigational device or drug within 30 days of enrollment.
5. Non-compliance in the screening or run-in period.

Primary outcomes:
measure: Incidence of complete healing of the target ulcer within the 8-week treatment period.
timeFrame: 8 week treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Robert Kirsner, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04086836: Swedish Study on STroke After TAVR
Official title: Swedish Study on STroke After TAVR. A Nationwide All-comers Study of the Risk of Stroke After Transcatheter Aortic Valve Replacemant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Stroke
Keywords: TAVR
Stroke
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 4600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pateints recieving a TAVR device in Sweden during study period

Brief summary: This study aims at studying the frequency of late stroke after transcatheter aortic valve replacement/implantation

Detailed description: Since the start of transcatheter aortic valve implnatations/replacements (TAVR/TAVI) implantations in Sweden in 2008 all procedures have been added to a national database, which now contains 5000+ procedures. At the same time, all admissions to the hospital is also recorded with diagnosis in a separate database. We intend to make a nation-wide complete follow up of all TAVR/TAVI patients in swede that has received the diagnosis of stroke after the implantation. In addition data will also be collected from the national stroke database for detailed information of the cases

Eligibility criteria: Inclusion Criteria:

All patients that has under TAVR/TAVI in Sweden between 2008 and 2018 Exclusion Criteria: Patients unable to follow up due to emigration or missing social security number

Exclusion Criteria:

Periprocedural stroke

Primary outcomes:
measure: Stroke
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
Study officials:
References:
Clinical trial NCT00384436: Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Official title: Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

Detailed description: Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.

Eligibility criteria: Inclusion Criteria:

* Patients must meet DSM-IV criteria for Major Depressive Disorder.
* Patients must have severe depression.
* MADRS greater than or equal to 30

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients who are considered a suicide risk.
* Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
* Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
* Patients with history of any psychotic disorder or any psychotic feature.

Primary outcomes:
measure: Time to premature discontinuation
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
Other outcomes:
Locations:
city: St Louis
country: United States
facility: For information regarding investigative sites, contact Forest Professional Affairs
state: Missouri
Study officials:
References:
citation: Bose A, Tsai J, Li D. Early non-response in patients with severe depression: escitalopram up-titration versus switch to duloxetine. Clin Drug Investig. 2012 Jun 1;32(6):373-85. doi: 10.2165/11631890-000000000-00000.
citation: Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28.
Clinical trial NCT06448936: Quality of Life in Patients With Difficult-to-Treat Basal Cell Carcinoma: An Evaluation of Impact and Surgical Outcomes.
Official title: Assessment of Quality of Life in Patients Undergoing Surgery for Difficult-to-treat Basal Cell Carcinoma of the Face in Stage IIA or IIIB According to the European Association of Dermato-Oncology Classification.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Basal Cell Carcinoma
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sequential recruitment of patients undergoing surgery for difficult-to-treat basal cell carcinoma of the face in stage IIA or IIIB, according to the European Association of Dermato-Oncology (EADO) classification.

Brief summary: FACE-QoL is an observational, prospective, multicenter study aimed at evaluating the impact of surgical treatment on quality of life in patients with stage IIA and IIIB difficult-to-treat basal cell carcinoma of the face, according to the European Academy of Dermato-Oncology classification, using patient-reported outcomes.

The main questions the study seeks to answer are:

Can surgery, as the gold standard treatment, lead to an improvement in the quality of life of patients with difficult-to-treat basal cell carcinoma in functionally and cosmetically challenging sites of the face (i.e., stage IIA and IIIB)? Which clinical and individual variables have the greatest impact on patients' quality of life? Participants will complete questionnaires assessing their quality of life and the impact of the disease on their daily lives.


Eligibility criteria: Inclusion Criteria:

* Clinical or histological diagnosis of difficult-to-treat basal cell carcinoma (DTT-BCC) classified as stage IIA or IIIB according to the EADO classification.
* Tumor location: face.
* Intervention: surgical treatment of facial stage IIA and IIIB difficult-to-treat basal cell carcinoma.
* Sufficient knowledge of spoken and written Italian by the patient.

Exclusion Criteria:

* Known psychiatric or substance abuse disorders that may interfere with cooperation and compliance with trial requirements.
* Inoperable or metastatic difficult-to-treat basal cell carcinoma.
* Contraindications to surgery related to the patient's condition.
* Previous radiation therapy involving the field of the target lesion.

Primary outcomes:
measure: Surgery in difficult-to-treat basal cell carcinoma
timeFrame: 1 year
Secondary outcomes:
measure: Predictive variables
timeFrame: 1 year
measure: Validation of the NAFEQ score.
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Andrea Paradisi
role: PRINCIPAL_INVESTIGATOR
References: