louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06789640: Impact of Vitamin C Supplementation on Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases
Official title: Impact of Vitamin C Supplementation on the Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease (CHD)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 20
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations

Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups


Eligibility criteria: Inclusion Criteria:

* Children in the first two years who will be for corrective surgery for heart diseases congenital heart diseases
* Pediatric patients whose parents or caregivers agree to be enrolled in the study.
* Risk Adjustment for Congenital Heart Surgery -1 (RACHS-1) for Evaluation of Mortality in Children Undergoing Cardiac Surgery : the first two categories (Thiagarajan and C. Laussen 2015)

Exclusion Criteria:

* Pediatric patients with associated comorbid conditions.

Primary outcomes:
measure: The improvemnents of Ejection Fraction between the two groups
timeFrame: 7-10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00857740: Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia
Official title: Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fibromyalgia
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2009-03-09
Enrollment: 50
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 investigate whether education about the neurophysiology of pain is able to improve central pain inhibition in patients with Fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Diagnose fibromyalgia
* Widespread pain
* Dutch speaking

Primary outcomes:
measure: Diffuse noxious inhibitory control
timeFrame: baseline, 14 days and 3 months follow-up
Secondary outcomes:
measure: pain pressure thresholds
timeFrame: baseline, 14 days and 3 months follow-up
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jessica Van Oosterwijck, Doctoranda
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03832140: Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy
Official title: Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pruritus
Monoclonal Gammopathy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had serum protein electrophoresis at Brest CHRU between 2014 and 2017, with and without gammapathy.

Brief summary: Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found.

Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. So the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls


Eligibility criteria: Inclusion Criteria for case :

Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Positive monoclonal gammopathy Non-opposition formulated

Inclusion Criteria for Control :

Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Negative gammopathy Non-opposition formulated

Exclusion Criteria:

Minor patient Major protected Patient with another haemopathy secreting a monoclonal immunoglobulin (lymphoma, LLC ...) Physical or mental incapacity Refusal to participe

Primary outcomes:
measure: Frequency of pruritus
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT00730340: Closure Method Study Following Tonsillectomy in Children
Official title: Decreased Morbidity With Closure of the Tonsillar Fossae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Tonsillectomy
Children
Keywords: Tonsillectomy, tonsillar fossa, wound closure
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.

Detailed description: This is a children's study. Patients experience significant postoperative pain, activity limitation and sometimes other significant postoperative complications. We are going to compare the effects of closing the tonsil wound versus non-closure. A daily journal will be kept (by the patient's parent or legal guardian)to log in measures of morbidity. Postoperative telephone calls will be made and scripted questions will be asked regarding any tonsillar hemorrhage requiring medical re-evaluation, and dehydration requiring medical re-evaluation. The patients will also be examined in the clinic at 10-14 days postoperatively to determine if the fossa remained closed or dehisced.

Eligibility criteria: Inclusion Criteria:

* Normal children between that ages of five to ten requiring a tonsillectomy

Exclusion Criteria:

* Children older than ten years of age.
* Those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.

Primary outcomes:
measure: Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure
timeFrame: 6 months
Secondary outcomes:
measure: The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced.
timeFrame: 10-14 days postoperatively
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Wayne E Berryhill, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01623440: Food Reward in Native American Women
Official title: Neural Correlates of Food Reward in Native American Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-identified Native American women between ages of 18 and 45.

Brief summary: This study aims to characterize the neurobiology of obesity in American Indians (AI) using functional MRIs to examine the correlation between brain response to food stimuli in AI women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI women look at images of fattening food, non-fattening food and non-food objects. Additionally examined is the effect of the drug naltrexone to suppress brain response to visual food cues and calorie intake in the women.

Detailed description: The study looks at both obese and lean women. Each woman comes in for two visits. Each woman takes both the Naltrexone or placebo (one during each visit). Research staff and participants are blinded. Drugs are not used as treatment, but rather to provide information for possible future treatments.

Hypotheses are:

1. Compared with their lean counterparts, obese women will demonstrate more fMRI activation in the brain in response to visual food cues.
2. Naltrexone will reduce the activation in reward-relevant brain sites in response to viewing photographs of fattening food as compared in placebo in both groups.
3. Naltrexone will suppress spontaneous intake of food in obese and lean AI women.

Eligibility criteria: Inclusion Criteria:

* Female
* Self-identified AI
* BMI over 30 OR between 20 and 24.9
* Must see clearly with or without glasses
* Capable of giving informed consent

Exclusion Criteria:

* Smokes more than one cigarette a day
* Drinks more than two alcoholic drinks a day
* Uses recreational drugs
* Is pregnant
* Has had weight loss surgery
* Other major medical problems (e.g. diabetes)
* Taking medications that alter appetite or body weight
* Significant food allergies

Primary outcomes:
measure: fMRI activation in the brain in response to visual food cue
timeFrame: With In 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Division of Endocrinology, Diabetes & Metabolism, University of Minnesota Department of Medicine
name: Tiffany Beckman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06770140: Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease
Official title: Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Crohn&#39;s Disease (CD)
Keywords: Ileocolonic resection
Blood microbiome
Postoperative recurrence
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified at the outpatient clinic at the dept. of gastroenterology or department of surgery or at a multidisciplinary meeting.

Brief summary: Crohn's disease, a chronic inflammation of the gastro-intestinal tract, is a disease with a complex pathogenetic background. Hereditary factors, environmental factors and the gut flora play a varying role in its onset, however, this role remains unclear to date. We hypothesize to detect tiny fragments of microbial DNA from the gut in the bloodstream, due to disruption in the natural defences of the gut lining. If this is true, it may hold the key to understanding why Crohn's disease recurs after surgery.

Our objective in this study is to test retrospectively, if we can detect any difference in microbial DNA from the blood of ileocolonic resection (ICR) patients that do and do not show recurrence at the time of follow-up endoscopy at 6 months.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Crohn's Disease
* Adult ≥ 16 years
* Undergoing an ileocolonic resection or reresection
* Written informed consent

Exclusion Criteria:

* Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
* Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
* Not willing to collect extra biosamples

Primary outcomes:
measure: Differences in bloodmicrobiome between recurrence & non recurrence patients.
timeFrame: From enrollment to the postoperative endoscopy (at 6 months follow-up).
Secondary outcomes:
measure: o To identify blood biomarkers predicting postoperative recurrence in Crohn's disease.
timeFrame: From enrollment to the postoperative endoscopy (at 6 months follow-up).
measure: o To identify histological parameters predicting postoperative recurrence in Crohn's disease.
timeFrame: From enrollment to the postoperative endoscopy (at 6 months follow-up).
measure: o To correlate blood biomarkers with fecal biomarkers predicting postoperative recurrence in Crohn's disease.
timeFrame: From enrollment to the postoperative endoscopy (at 6 months follow-up).
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South Holland
Study officials:
References:
Clinical trial NCT03990740: Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus
Official title: Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus (MYKE)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Keratoconus
Keywords: Metalloproteinase
Glycoprotein
Cornea
Direct epithelial-stromal interactions
Fibroblasts
Myofibroblasts
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Keratoconus patients requiring first optical corneal transplantation and controls with indication of orbital exenteration due to an orbital tumor.

Brief summary: Keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism.

Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Direct epithelial-stromal interactions (D-ESI) have a role in the induction of metalloproteinases (MMP) and the differentiation of fibroblasts into myofibroblasts via an EMMPRIN membrane glycoprotein (extracellular matrix membran MMP inducer - CD 147). On a healthy cornea, EMMPRIN's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus The hypothesis is that stromal thinning of the keratoconus could be related to increased expression of EMMPRIN by epithelial and stromal cells (resulting in increased MMP synthesis), with a preponderance at the most deformed areas.

The main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients.


Eligibility criteria: Inclusion Criteria:

* For the cases :

  - Suffering from keratoconus and requiring a first optical corneal transplant
* For the controls:

  * Orbital exenteration operation due to an orbital tumor
  * Absence of any anomaly of the ocular surface observed during the slit lamp examination at the last preoperative consultation

Exclusion Criteria:

* For the cases:

  * Keratoconus patient requiring a tectonic corneal transplant
  * Known pregnancy, or breastfeeding
* For the controls:

  * History of orbital radiotherapy
  * History of corneal surgery
  * History of corneal surface tumour
  * Eye surface abnormality noted in the preoperative period
  * Known keratoconus
  * Known pregnancy, or breastfeeding
  * Secondary exclusion if a keratoconus is diagnosed during the immunohistochemical analysis by visualization of Bowman membrane interruption

Primary outcomes:
measure: Comparison of alpha-SMA's (Smooth Muscle Actin) messenger RNA expression evaluated by quantitative PCR (RT-qPCR) in corneal stroma in keratoconus patients compared to non-keratoconus controls
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00875940: Right Ventricular Hypertrophy and Pulmonary Hypertension: A Correlation Analysis
Official title: Right Ventricular Hypertrophy and Pulmonary Hypertension: A Correlation Analysis Between Tc-99m Tetrofosmin SPECT Adn Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2009-04-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital population having diagnostic testing.

Brief summary: The study hypothesis is that a quantitative index can be derived from Tc-99m myocardial perfusion scans that accurately identifies the presence of left ventricular hypertrophy and pulmonary hypertension. Echocardiography provides the reference standard.


Eligibility criteria: Inclusion Criteria:

* Must have an interpretable Tc-99m myocardial perfusion scan and an interpretable echocardiogram.

Exclusion Criteria:

* Technically inadequate noninvasive test.

Primary outcomes:
measure: Sensitivity and specificity of quantitation of Tc-99m perfusion scans for identification of pulmonary hypertension.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References:
Clinical trial NCT05132140: Peripheral Choroidal Layer Response
Official title: Peripheral Choroidal Response to Pure Defocus and Oriented Blur Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to examine how the vascular layer of the eyeball (choroidal layer) responds when part of the visual field is exposed to specially generated visual stimulus. The study goal will be accomplished by producing specific blur visual stimulus at a particular visual field position and measure any consistent thickness change pattern in the choroidal layer.

We propose to test the hypothesis that regional changes in the choroidal thickness may be induced differently after short-term exposure to specific visual stimuli.


Eligibility criteria: Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between the ages of 18 and 40 yrs old
* Has normal best corrected visual acuity being 20/20 or better
* Has spherical refractive error between +1.00D and -6.00D.
* Is capable of fixating on the target.
* Has no prior ocular surgery.
* Has no ocular pathology except keratoconus.
* Can tolerate dilating eye drops

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Does not fall within above mentioned age group.
* Has chronic or systemic eye disease that would interfere with pupil dilation via eye drops.
* Underwent ocular surgeries or history of ocular trauma
* Has shallow anterior chamber angle and/or glaucoma.
* Has clinically significant dry eye.
* Has signs of any choroidal or retinal pathology, and abnormalities in the visual pathway
* Has spherical refractive error that exceeds the limits outlined above.
* Has binocular anomalies (e.g. convergence insufficiency, strabismus, pseudo-myopia, amblyopia).
* Is an adult unable to consent
* Is an individual who is not yet adult (infants, children, teenagers)
* Is a pregnant woman
* Is a prisoner
* Is a student for whom you have direct access to/influence on grades
* Is an economically and/or educationally disadvantaged person

Primary outcomes:
measure: choroidal thickness
timeFrame: up to 60 mins
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Houston
name: Geunyoung Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02500940: Comparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: Fujian Cancer Hospital
First posted: 2015-07-17
Enrollment: 54
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: The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma

Detailed description: Control group: Neoadjuvant chemotherapy with tri-weekly PF × 3 cycles (cisplatin 100 mg/m2, day 1, followed by 5-FU 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + IMRT ≧ 70 Gy/35 fractions

Test group: Neoadjuvant chemotherapy with weekly P-FL × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with 5-FU 2500 mg/m2 + Leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + IMRT ≧ 70 Gy/35 fractions

Eligibility criteria: Inclusion Criteria:

1. Histological proven NPC.
2. 2010 AJCC stage II-IVB.
3. Age ≧ 20 years old.
4. Performance status of ECOG ≦ 2.
5. Adequate liver, renal, and bone marrow functions 5-1 Serum total bilirubin level ≦ 2.5 mg/dl. 5-2 Serum creatinine ≦ 1.6 mg/dl or calculated CCr ≧ 60 cc/min. 5-3 WBC ≧ 3,000/ul 5-4 Platelet count ≧ 100,000/ul
6. Signed informed consent.

Exclusion Criteria:

1. Presence of distant metastasis.
2. Previous radiotherapy or chemotherapy.
3. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
4. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
5. Female patients who are pregnant or lactating.

Primary outcomes:
measure: Tumor response by RECIST version 1.1
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Acute toxicity by CTCAE deifnition
timeFrame: 6 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Vaterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Lin Jin-Ching, Ph.D
role: STUDY_CHAIR
References: