louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06744140: Role of MRI Breast in Detection of Ductal Carcinoma in Situ
Official title: Role of MRI Breast in Detection of Ductal Carcinoma in Situ
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma in Situ
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To Evaluate the breast Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma In Situ (DCIS) lesions among high-risk breast cancer patients while keeping the histopathology as a GOLD standard

Brief summary: "This study investigates the role of Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma in situ (DCIS) in high-risk breast cancer patients.

Detailed description: Improved detection rates of DCIS in high-risk patients. Enhanced diagnostic accuracy, reducing false positives and negatives. Ductal Carcinoma in situ (DCIS) is a non-invasive breast cancer where abnormal cells are confined to the milk ducts.

The Breast Imaging Reporting and Data System (BI-RADS) is a standardized scoring system used to classify breast imaging findings. Scores range from 0 (incomplete) to 6 (known biopsy-proven malignancy)."

Eligibility criteria: Inclusion Criteria:

* High-risk breast cancer patients with a family history of breast cancer or genetic predispositions (e.g., BRCA mutations).
* Patients aged 30-65 years.
* Patients willing to undergo breast MRI screening for DCIS detection.

Exclusion Criteria:

* Patients with contraindications to MRI imaging (e.g., pacemakers, claustrophobia).
* Patients with a history of prior breast surgery or interventions that may interfere with imaging interpretation.

Primary outcomes:
measure: sensitivity & specificity
timeFrame: 12 Months
measure: BIRADS scores
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: INMOL hospital
state: Punjab
Study officials:
References:
Clinical trial NCT04929340: Prevention of Recurrent Caries With Lactobacilli PRECAL
Official title: Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Early childhood caries
Probiotic bacteria
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to compare the effect of drops containing probiotic bacteria (Lactobacillus reuteri 17938, Lactobacillus reuteri PTA 5289, Biogaia AB, Sweden) on the incidence of dental caries with placebo drops in preschool children undergoing comprehensive restorative treatment under general anesthesia or conscious sedation. The project will be conducted at three specialist centers (Umeå University, Umeå, Sweden, Maxillo-facial unit, Halmstad Hospital, Sweden; Eastman Institute, Stockholm, Sweden) and employ a randomized placebo-controlled design with two parallel arms. The study will be performed double-blind and neither the parents nor the clinicians will be aware of the content of the drops. The follow-up period is one year.


Eligibility criteria: Inclusion Criteria:

* Preschool children, 2-5 year of age
* with Early childhood caries (ECC) or
* severe Early childhood caries (S-ECC)
* scheduled for restorations and extractions under general anesthesia or any form of sedation
* The obligate requirement is that the child should be fully treated and managed with aspect to caries within a period of not more than two months.

Exclusion Criteria:

* medically comprised children
* children with severe cognitive problems or dysfunctional families
* families planning to relocate within the next year

Primary outcomes:
measure: dental caries
timeFrame: 6 months
measure: dental caries
timeFrame: 12 months
Secondary outcomes:
measure: visible supra-gingival plaque
timeFrame: 6 months
measure: visible supra-gingival plaque
timeFrame: 12 months
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Barntandvården Halmstad
city: Stockholm
country: Sweden
facility: Eastmaninstitutet Pedodonti, Stockholm
city: Umeå
country: Sweden
facility: Tandläkarhögskolan Umeå
Study officials:
affiliation: Umeå University
name: Pamela Hasslöf
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasslof P, Granqvist L, Stecksen-Blicks C, Twetman S. Prevention of Recurrent Childhood Caries with Probiotic Supplements: A Randomized Controlled Trial with a 12-Month Follow-Up. Probiotics Antimicrob Proteins. 2022 Apr;14(2):384-390. doi: 10.1007/s12602-022-09913-9. Epub 2022 Jan 26.
Clinical trial NCT02370940: Regular Consumption of High Phytate Reduces Inhibitory Effect of Phytate on Iron Absorption
Official title: Regular Consumption of High Phytate Diet Reduces Inhibitory Effect of Phytate on Nonheme Iron Absorption in Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Bioavailability
Keywords: Iron bioavailability
phytate
serum iron curve
hepcidin
iron status
Lead sponsor: Iowa State University
Sponsor class: OTHER
Collaborators: name: HarvestPlus
First posted: 2015-02-25
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate whether regular consumption of phytate dampens its negative effect on nonheme iron absorption.

Detailed description: Phytate is one of the main inhibitors of nonheme iron absorption. High phytate consumption is of concern in developing countries because of the high prevalence of iron and zinc deficiency in these countries. In this study, we investigated the effect of habitual consumption of a high phytate diet on the inhibitory effect of phytate on nonheme iron absorption. Thirty-two non-anemic female subjects with ferritin ≤ 30µg/L were randomized into two groups, after matching for ferritin concentration. Each group consumed either high or low phytate foods that were provided for 8 wk. Iron bioavailability from a high phytate test meal was measured using area under the curve (AUC) for serum iron at baseline and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Marginal iron status (Serum ferritin \<30ug/L)
* BMI in the range 18.5-24.9kg/m2
* Willing to modify diet to increase or decrease phytate intake
* Willing to give multiple blood samples at beginning and end of study

Exclusion Criteria:

* Pregnant
* Lactating
* Smoker
* Anemic (hemoglobin \<120 g/L)
* Has gastro-intestinal disease/condition that can affect absorption

Primary outcomes:
measure: Area under the curve for serum iron for assessing bioavailability
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Iowa State University
name: Manju B Reddy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armah SM, Boy E, Chen D, Candal P, Reddy MB. Regular Consumption of a High-Phytate Diet Reduces the Inhibitory Effect of Phytate on Nonheme-Iron Absorption in Women with Suboptimal Iron Stores. J Nutr. 2015 Aug;145(8):1735-9. doi: 10.3945/jn.114.209957. Epub 2015 Jun 3.
Clinical trial NCT06861140: Exploring the Influence of Trptophan on the Treatment of Pouchitis
Official title: Untersuchung Des Einflusses Einer Tryptophanreichen Diät Auf Das Therapeutische Potential Von Probiotika Nach Antibiotischer Therapie Bei Chronischer Pouchitis (Try Pro Pouch). Eine Prospektive Randomisierte Kontrollierte Doppelblinde Interventionsstudie
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pouchitis
Keywords: Pouchitis
Antibiotics
Probiotics
Tryptophan
Metabolites
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief summary: Patients with a pouch frequently suffer from chronic inflammation of the intestinal tract, called pouchitis. Pouchitis is routienly treated with repeated courses of antibiotics and probiotics, which does not stop the inflammation from recurring and exposes the patients to the risk of developing antibiotic -resistant pouchitis. Experimental data suggest that the effectiveness of the antibiotic and probiotic treatment can be prolonged by high consumption of trypotophan, an aminoacid present in everyday food. The Try Pro Pouch study aims to compare the consumption of high amounts of tryptophan against placebo in patients with pouchitis.

Detailed description: Participants with chronic pouchitis receive either a weight adapted supplement containing etiher trypotophan or a placebo after completing the standard treatment with antibiotics or probiotics for their pouchitis. Endoskopy will be performed, stool and blood will be sampled, symptoms will be monitored.

Eligibility criteria: Inclusion Criteria:

* Pouchitis (PDAI \>= 7)
* indication for the application of antibiotics and probiotics
* Age \>=18 years
* Informed consent

Exclusion Criteria:

* major surgery planned druing the intervention
* high risk for malnutrition (NRS 2002 \>=3/ BMI \<18,5 kg/m\^2)

Primary outcomes:
measure: Increase of the proportion of FoxP3+ CD4+ T cells in gut biopsies
timeFrame: from enrollent to end of treatment at 12 weeks
Secondary outcomes:
measure: Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota
timeFrame: from enrollent to end of treatment at 12 weeks
measure: Increase of 3-IPA-levels in blood and stool
timeFrame: from enrollent to end of treatment at 12 weeks
measure: Higher rates of therapeutic response defined by PDAI
timeFrame: from enrollent to end of treatment at 12 weeks
measure: Decreased number of prescribed antibiotics druing follow-up
timeFrame: from enrollent to end of observation at 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinkum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik
name: Samuel Huber, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02127840: Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Official title: Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Aldosteronism
Keywords: primary aldosteronism
adrenal adenoma
arterial hypertension
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: University Hospital Hradec Kralove
First posted: 2014-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The project is aimed to determine the value of synacthen infusion on the results of adrenal venous sampling in patients examined for primary aldosteronism

Detailed description: We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.

Eligibility criteria: Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy

Primary outcomes:
measure: To verify whether Synacthen infusion may influence the results of adrenal venous sampling in patients with primary aldosteronism
timeFrame: End of clinical examination procedure, i.e. within 4 week after adrenal venous sampling is performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Jiri Ceral, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02485340: The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache
Official title: The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Detailed description: There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: 5-ISMN induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs

Eligibility criteria: Inclusion Criteria:

Healthy:

* healthy subjects of both sexes
* age 18-70 years
* weight 50-90 kg.
* Females were requested to use effective contraception.

Migraine patients:

* Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes
* 18-70 years
* 45-95 kg.

Exclusion Criteria:

Healthy:

* Any type of headache (except episodic tension-type headache \< 1 day per week)
* Serious somatic or psychiatric disease
* Pregnancy
* Intake of daily medication (except oral contraceptives).

Migraine patients:

* Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week)
* Serious somatic or psychiatric disease
* Pregnancy, and intake of daily medication (except oral contraceptives).

Primary outcomes:
measure: Median headache score 0 hours after sumatriptan/placebo
timeFrame: 0 hours
measure: Median headache score 2 hours after sumatriptan/placebo
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Emma Katrine Hansen
state: Glostrup
Study officials:
affiliation: Danish Headache Center
name: Emma Katrine Hansen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04262440: The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients
Official title: The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS

Brief summary: The optimal amount caloric intake were still controversy in critically ill patients in literature. There were no significant outcome difference with different caloric intake in acute lung injury patients. In order to identify the optimal amount caloric intake in acute lung injury patients, we conduct a prospectively observational study to see whether the caloric differences influence hospital mortality.

Detailed description: The is a prospectively observational study. The data including basic demographic data, daily PN/EN caloric intake, days of ICU stay, days of hospital stay, hospital mortality, days of ventilator use.. will be collected. Statistic analysis included chi-square, student t test, logistic regression and ROC curve will be applied to analyze the different characteristics between survived and died patients. Also we can figure out the optimal cut value of caloric intake with best outcome by ROC curve analysis. We plan enrolled 200 participants within study period.

Eligibility criteria: Inclusion Criteria:

Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS (2012 Berlin Criteria)

Exclusion Criteria:

Expected ICU stay less than 72 hours

Primary outcomes:
measure: Hospital mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
state: 台中市
Study officials:
affiliation: Department of Critical Care Medicine, Taichung Veterans General hospital
name: CHEN-YU WANG, MHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02498340: Diet Challenge in G6PD Deficient Egyptian Children: A One- Year Prospective Single Center Study With Genotype - Phenotype Correlation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Glucose-6-Phosphate Dehydrogenase Deficiency
Keywords: G6PD
genotype
phenotype
diet restriction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is prevalent and add a burden on families in Egypt and Middle East due to lifelong diet restriction, non-fava beans diet is main food for most families in the region and parents and doctors consider it as a prohibited food whatever the genetic or clinical phenotypes. The effective management is avoiding a spectrum of food and drugs causing oxidative stress. No data is available about the hazards of consumption of non-fava beans diet.

Detailed description: Investigate the effect of challenge of non-fava beans diet on occurrence of hemolysis in both common and rare mutations causing G6PD deficiency in Egyptian children as well as making a genotype-phenotype correlation. Patients and Methods: The study will include all G6PD deficient children who were regularly followed up in Pediatric Hematology Center, Ain Shams University over last decade from 2004-2014 who stopped eating non fava-bean diet since their diagnosis as G6PD deficient and willing to participate in the diet challenge. They will be enrolled in a one year prospective study involving quantitative analyses for enzymatic activity, and molecular typing of G6PD enzyme using a polymerase chain reaction-amplification refractory mutation system (PCR-ARMS) technique. Patient's medical records will be reviewed as history of blood transfusion and G6PD level at diagnosis. Initial phase will be dietetic challenge with ingestion of non-fava beans taken in small amount (10-20 gm/day for 3 successive days ) for children with haemoglobin level ≥ 11 gm/dl with daily clinical and laboratory monitoring by complete blood count, and markers of hemolysis as well as measurement of malondialdehyde (MDA) level both basal and at study end. A drop of Hb of ≥0.5 gm/dl and / or appearance of hemoglobinuria is considered a significant hemolysis. Patients who will not meet the definition of significant hemolysis will be prospectively followed up for one year with follow up during their chronic exposure by complete blood count and hemolysis markers/ 3 months.

Eligibility criteria: Inclusion Criteria:

* All children with proved enzymatic deficiency of G6PD.
* Patients who met the criteria of hemoglobin level at study time ≥ 11 gm/dl

Exclusion Criteria:

* patients with another enzyme deficiency

Primary outcomes:
measure: Diet challenge
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Hematology clinic, Ain Shams University
Study officials:
References:
Clinical trial NCT06125444: Impact of Hyperuricemia on Psoriatic Arthritis
Official title: IImpact of Hyperuricemia on Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Hyperuricemia
Rheumatisms
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old), with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC and subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist

Brief summary: Psoriatic arthritis and gout (linked to hyperuricemia) are two rheumatisms well known to rheumatologists. There are epidemiological and physiopathological arguments in favor of a non-fortuitous link between these two rheumatisms, which to date has not been established. There is currently no recommendation to treat hyperuricaemia without an episode of gout attack. We hypothesize that there is a link between hyperuricemia and severity of rheumatism. This would ultimately modify the therapeutic management of hyperuricemic patients followed for psoriatic arthritis.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC
* Subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist
* Among these two populations, all subjects for whom at least one serum uric acid assay was available in the medical file
* Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject who met the inclusion criteria but whose analysis of the medical file (anamnestic, clinical, biological and radiological data) led to a diagnostic reversal and therefore did not present with psoriatic arthritis
* Subject under guardianship or curatorship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospectively determine the impact of hyperuricemia on the response to psoriatic arthritis treatments: inventory of the latest treatments in progress and the response to treatment according to the treating rheumatologist
timeFrame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Rhumatologie - CHU de Strasbourg - France
Study officials:
References: