louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03779152: Regulation of CCL18 by Corticosteroids in Severe Asthma
Official title: Regulation of CCL18 by Corticosteroids in Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients consulting for either asthma or chronic rhinitis and meeting the criteria of the control group.

Brief summary: The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.


Eligibility criteria: Inclusion Criteria:

1. control subjects =

   * non-atopic and non-smoking
   * cutting to negative pneumoallergens,
   * Total IgE levels less than 100 ku / L
   * no clinical history of asthma
   * without background treatment
2. patients with intermittent asthma =

   * being asymptomatic between asthma attacks,
   * with symptoms less than once a week
   * having a forced expiratory volume per second (FEV1) of at least 80% of the theoretical.
   * treated by ß2 mimetics on demand and will not have inhaled corticosteroids.
3. severe asthma insensitive to corticosteroid therapy =

   * continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)\] airway obstruction fixed with FEV1 ranging from less than 15% after 7 days of oral corticosteroid therapy to 40 mg / day of prednisolone;
   * Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
4. Severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)\]

   * reversibility of FEV1 after treatment with oral corticosteroids.
   * Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
5. controlled moderate asthma treated with inhaled corticosteroids \<1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months.

Exclusion Criteria:

* existence of a chronic inflammatory pathology other than asthma
* active smoking
* pregnant or lactating women
* have received oral corticosteroid treatment in the previous 3 weeks,
* have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.

Primary outcomes:
measure: Correlation between CCL18 rate and asthma phenotypes by elisa test
timeFrame: Baseline: one session
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Calmette, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Benoit Wallaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00611052: Prevention of Adolescent Major Depression
Official title: "Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Disorder
Keywords: Depressive Disorder
Depressive Disorder, Major
Mental Health
Prevention
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: University of Helsinki
name: University of Eastern Finland
name: Kuopio University Hospital
name: City of Vantaa
name: City of Kuopio
name: City of Turku
First posted: 2008-02-08
Enrollment: 65
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other selected mental health parameters are investigated.


Eligibility criteria: Inclusion Criteria:

* mild to moderate level depressive symptoms (RBDI self-report scale)
* adequate knowledge of the Finnish language
* informed consent from the adolescent (all) and his/her parent (under 15 years)
* healthy controls comprise subjects with no depressive symptoms

Exclusion Criteria:

* ongoing major depression, dysthymia or bipolar disorder
* ongoing other severe psychiatric illness precluding group participation
* mental retardation

Primary outcomes:
measure: Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)
timeFrame: 3 months, 6 months, 12months, 24 months, 36 months
Secondary outcomes:
measure: Suicidality (diagnostic interview, self-report scale)
timeFrame: 3 months, 6 months, 12 months, 24 months, 36 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital and Kuopio University
city: Turku
country: Finland
facility: Turku Primary Health care and Adolescent Psychiatric clinic
city: Vantaa
country: Finland
facility: Vantaa Primary Health Care
Study officials:
affiliation: National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services
name: Mauri J Marttunen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03006952: Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy
Official title: Comparative Effects of add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on Serum NT-PRO BNP and Proteinuria in Type 2 Diabetics With Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nephropathies
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 59
Sex: ALL
Minimum age (years): 38
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein

Detailed description: Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes patients with nephropathy that might relate to its effect on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein.

Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used in type 2 diabetes patients with nephropathy for treatment of diabetes complications.

NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* age\>30 and age\<70, urinary albumin excretion (UAE) ≥150 mg/24 h

Exclusion Criteria:

* any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/L, glomerular filtration rate (GFR)\<30mL/min/1.73 m and intolerance of pentoxifylline

Primary outcomes:
measure: N terminal brain natriuretic peptide (NT-pro BNP)
timeFrame: 3 months
Secondary outcomes:
measure: Highly sensitive C-reactive protein (hsCRP)
timeFrame: 3 months
measure: Urinary albumin excretion
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: estimated glomerular filtration rate
timeFrame: 3 months
measure: serum creatinine concentrations
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran
name: Alireza Esteghamati, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04083352: Ketone Supplementation in Individuals With PTSD
Official title: The Effects of Exogenous Ketone Supplementation or a Ketogenic Diet in Individuals With PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Ketosis
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a 6-week period of ketone salt supplementation affects physiological, emotional, cognitive, and/or behavioral health markers in individuals with PTSD.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with PTSD

Exclusion Criteria:

* Pregnant, younger than 18 or older than 65

Primary outcomes:
measure: Change in Comprehensive Metabolic Panel
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in Complete Blood Count
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in Cognitive Performance
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in Blood Pressure
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in Urinalysis
timeFrame: Pre- and Post- 6-week supplemental period
Secondary outcomes:
measure: Change in Insomnia
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in Emotional Health
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in Emotional Health
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in Emotional Health
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in alcohol use
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in PTSD
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in PTSD
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in pain
timeFrame: Pre- and Post- 6-week supplemental period
measure: Change in PTSD
timeFrame: Pre- and Post- 6-week supplemental period
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
References:
Clinical trial NCT06234852: Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.
Official title: The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus, SLE
Keywords: Systemic Lupus Erythematosus
Glucocorticosteroid
Flare
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Detailed description: Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (\< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Eligibility criteria: Inclusion Criteria:

* Aged; 20 years
* Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.
* Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
* Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.

Exclusion Criteria:

* Pregnant or pregnancy planning
* Unable to follow the schedules
* Overlap with other autoimmune disease, except secondary SjS and APS
* Co-morbid with any other condition which required prednisolone treatment
* Documented adrenal insufficiency

Primary outcomes:
measure: Any flare according any of 3 definitions
timeFrame: 24 weeks
Secondary outcomes:
measure: Any increase in clinical SLEDAI-2K
timeFrame: 24 weeks
measure: Any changes in immunology
timeFrame: 24 weeks
measure: Any increase in damage accrual
timeFrame: 24 weeks
measure: Changes in quality of life
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Study officials:
affiliation: Phramongkutklao College of Medicine and Hospital
name: Rattapol Pakchotanon, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01326052: Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
Official title: Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Defecatory Disorders After Left Colonic or Rectal Resection
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 150
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: The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate.


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 80 years
* BMI\<35
* Presence of symptomatic diverticular disease
* ASA I-III

Exclusion Criteria:

* age \> 80 years
* BMI\>35
* ASA IV
* Hinchey III-IV
* Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)

Primary outcomes:
measure: Change from preoperative time in anorectal function
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Constipation
timeFrame: 6 and 12 months
measure: Incontinence
timeFrame: 6 and 12 months
measure: Quality of life
timeFrame: 6 and 12 months
measure: Postoperative complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
Study officials:
References:
Clinical trial NCT06799052: Cervical Preparation for Same-Day Dilation & Evacuation
Official title: Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abortion, Second Trimester
Procedural Pain
Procedural Complication
Keywords: Cervical Dilation and Evacuation (D&E)
Transcervical single-balloon catheter
Osmotic dilators
Adequate dilation
Patient satisfaction
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a noninferiority parallel randomized control trial of two cervical preparation methods prior to same-day D\&E.
Primary purpose: TREATMENT

Brief summary: This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.

The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time.

Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.


Eligibility criteria: Inclusion Criteria:

* Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)
* Able to provide informed consent
* English- or Spanish-speaking
* Singleton intrauterine pregnancy

Exclusion Criteria:

* Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
* Fetal demise or known fetal anomaly
* BMI \>45
* Incarceration or other inability to give informed consent
* Decide to undergo cervical preparation overnight prior to next-day D\&E

Primary outcomes:
measure: Dilation & Evacuation (D&E) Operative time
timeFrame: at end of procedure about 20 minutes
Secondary outcomes:
measure: Participant preoperative pain
timeFrame: every hour until procedure, on average 3 hours
measure: Participant satisfaction
timeFrame: after dilation, on average 3 hours
measure: Cervical dilation
timeFrame: beginning of procedure, on average 3 hours
measure: Number of participants with adequate cervical dilation
timeFrame: beginning of procedure, on average 3 hours
measure: Number of participants with surgery completed in the same day
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Obstetrics and Gynecology
name: Anjanique Mariquit Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02271152: FAST Mapping During Atrial Fibrillation
Official title: Focal Electrical Source and Trigger Mapping During Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 80
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: Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide with a prevalence of 8% in the elderly. AF is responsible for frequent hospitalizations, stroke, heart failure and mortality. AF catheter ablation is an important treatment strategy for patients suffering from AF, but the success rate remains low after conventional pulmonary vein isolation (PVI). The mechanism perpetuating AF is poorly understood. Focal electrical sources and triggers (FAST) may sustain AF in some patients, which makes them a potential therapeutic target for ablation. However, finding FAST is very challenging due to complex nature of AF electrical signals. In this study, the investigators will attempt to localize focal electrical sources and triggers (FAST mapping) in patients undergoing AF ablation using custom software that evaluates periodicity and waveform morphology. Patients will be randomized to one of two AF ablation strategies, namely FAST mapping/ablation + PVI vs. PVI alone. The investigators will determine which strategy leads to better clinical outcome postablation.


Eligibility criteria: Inclusion Criteria:

* All patients must be over the age 18 and have a clinical indication for their first catheter ablation of AF because of symptomatic AF.
* This will include patients with either high burden paroxysmal (\>4 self-terminating episodes of AF within the last 6 months with two episodes lasting at least 6 hours within the last year) or persistent AF (lasting ≥7 days, but which can still be converted to sinus rhythm).

Exclusion Criteria:

* The major exclusion criteria will include:

  * long-standing persistent AF (ie. AF which cannot be converted to sinus rhythm, or where multiple attempts at restoring sinus rhythm have failed)
  * rheumatic valvular disease
  * hypertrophic cardiomyopathy
  * uncorrected cardiac shunts (eg. secundum ASD)
  * severe mitral regurgitation or mechanical mitral valve
  * left atrial size \>55 mm (echo derived parasternal long axis view).

Primary outcomes:
measure: Time to first symptomatic atrial fibrillation recurrence postablation
timeFrame: 3 months postablation
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT04407052: Double Trigger in Patients With Low Proportion of Mature Oocytes
Official title: Double Trigger in Patients With Low Proportion of Mature Oocytes. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility, Female
Keywords: IVF
HCG
GnRH agonist trigger
Lead sponsor: Riyadh Fertility and Reproductive Health center
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle triggered by HCG.


Eligibility criteria: Inclusion Criteria:

* Patients with history of low proportion of mature oocytes in previous IVF attempt (triggered by HCG).
* Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

Exclusion Criteria:

* Endometriosis
* PCOS

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: First day after oocyte retrieval
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: First 5 weeks after oocyte retrieval
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Riyadh Fertility and Reproductive Health center
Study officials:
affiliation: Riyadh Fertility and Reproductive Health center
name: Usama M Fouda, Prof.
role: STUDY_CHAIR
References:
citation: Zilberberg E, Haas J, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG, for final oocyte maturation (double trigger), in patients with low proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.