louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02902276: Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill
Official title: Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Keywords: plasma citrulline
lipopolysaccharide
critically ill
Hospitalization in an Intensive Care Unit
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients requiring ICU admission for at least 48 hours, without chronic small bowel disease, without chronic renal failure (usual clearance of creatinine \< 50 mL/min), not pregnant.

Brief summary: In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome.

Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.


Eligibility criteria: Inclusion Criteria:

* Critically ill patients requiring ICU admission for at least 48 hours
* Adults

Exclusion Criteria:

* Chronic small bowel disease
* Chronic renal failure (clearance of creatinine \< 50 mL/min)
* Pregnancy

Primary outcomes:
measure: Plasma citrulline concentration
timeFrame: Up to 12 hours after admission in the unit
measure: plasma lipopolysaccharide concentration
timeFrame: Up to 12 hours after admission in the unit
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: CHU Besançon
name: Gaël Piton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06218576: Sensitivity Comparison of Follow-up MRI Between Acute Cerebral and Cerebellar Cortical Microinfarctions ( CMI )Microinfarctions
Official title: Sensitivity Comparison of Follow-up MRI Between Acute Cerebral and Cerebellar Cortical Microinfarctions ( CMI )
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Cerebral and Cerebellar Cortical Microinfarctions (CMI)
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient admitted to Nîmes University Hospital between February 2021 and June 2023 with initial MRI performed within one week after symptom onset, symptomatic brain infarction confirmed by DWI, and the presence of acute cerebral and/or cerebellar CMI

Brief summary: Cerebral cortical microinfarctions (CMI) are frequently observed on MRI and histology studies, especially in elderly patients and in patients with cognitive dysfunction. The majority of these studies analysed chronic cerebral CMI lesions.

The few studies reporting on temporal dynamics of MRI signal of acute cerebral CMI showed very low sensibility for persisting signal changes on follow-up MRI on standard MRI sequences. A retrospective study, analysing follow-up 3T MRI in 25 patients with acute cerebral CMI (defined as ≤10 mm on DWI), showed a chronic cerebral CMI detection rate of only 16% on T2-weighted and 5% on FLAIR imaging after a mean follow-up period of 33 months (with a very wide range of 0.5-142 months). Another 3T MRI study including seven patients showed disappearance of all acute cerebral very small-sized CMI (defined as \<5 mm size on initial DWI) on all follow-up MRI sequences (T1- and T2-weighted and FLAIR imaging, performed after one month).

Recently, it has been shown that chronic relatively small (\<20 mm) cerebellar cortical infarctions (based on diffusion-weighted imaging) were frequently observed in acute stroke patients, especially in case of cardioembolic stroke (with chronic small cerebellar cortical infarctions observed in 32% of cases). The high prevalence of these chronic small cerebellar cortical infarctions suggest a possible higher detection rate of chronic small-sized infarction in the cerebellum compared to the supratentorial brain.


Eligibility criteria: Inclusion Criteria:

Patients admitted to our stroke centre between February 2021 and June 2023 with the following inclusion criteria:

* age \>18 years,
* initial MRI performed within one week after symptom onset,
* symptomatic brain infarction confirmed by DWI,
* presence of acute cerebral and/or cerebellar CMI

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
measure: Chronic CMI
timeFrame: 6 monthes
measure: CMI localisations
timeFrame: 6 monthes
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 NCT04223076: Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery
Official title: Clinical Performance of Two 0.2% Chlorhexidine Mouth Rinses After Periodontal Surgery. A Blinded, Intra-individual Cross-over Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Periodontal Diseases
Periodontitis
Dental Plaque
Keywords: Periodontal Index
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intra individual cross-over, double intervention
Primary purpose: TREATMENT

Brief summary: Chlorhexidine is the gold standard of dental plaque prevention. Recent research have demonstrated that 0.2% Chlorhexidine solutions are more effective than 0.12% and 0.06% Chlorhexidine solutions. Several 0.2% solutions are available on the market. This study aimed to compare effectiveness of two commercially available 0.2% chlorhexidine mouthwashes. Patients, that after initial periodontal therapy, had a need for two periodontal surgeries, will be invited to join. After one surgical session, the patient will receive one 0.2% chlorhexidine solution, and after the next surgical session the patient will receive the other 0.2% chlorhexidine solution. Plaque and gingivitis will be recorded, as well as side effects.


Eligibility criteria: Inclusion Criteria:

Periodontitis, stage III and IV

Exclusion Criteria:

Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension

Primary outcomes:
measure: Plaque index
timeFrame: 14 days intervention period
measure: Gingival Index
timeFrame: 14 days intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Erik Mauland
Study officials:
affiliation: University of Oslo
name: Anne Merete Aass, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05451927: Trial to Examine the Effect of Natural Anti- Obesity Agent (Phaseolus Vulgaris) Among Women of Lahore
Official title: A Randomized Double Blind Study to Examine the Effect of Natural Anti-obesity Agent Among Women of Lahore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Weight loss
Lead sponsor: University of the Punjab
Sponsor class: OTHER
Collaborators: name: University of the Punjab
First posted: 2022-07-11
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This double-blind randomized placebo-controlled trial will test the hypothesis that administration of Phaseolus Vulgaris supplementation to women in Lahore, Pakistan, who are overweight will induce the weight loss (Primary outcome) and changes in body composition (Waist circumference) secondary outcome.


Eligibility criteria: Inclusion Criteria:

* BMI ranges from 25-40
* Consistently stable body weight for at least 6 months
* Good general health
* No ongoing drug treatment for weight reduction
* Commitment to avoid any changes in lifestyle throughout the test period
* Age between 18-45 years
* Women resident of Lahore

Exclusion Criteria:

* Pregnant or breast-feeding females
* People with Type 2 diabetes
* People with any other chronic diseases
* Weight reduction treatment during the 6 months prior to the study

Primary outcomes:
measure: Body weight
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Akhuwat Medical Centre
state: Punjab
city: Lahore
country: Pakistan
facility: Niazi Medical Centre
state: Punjab
Study officials:
affiliation: University of the Punjab
name: Aisha Sadiqa, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765127: An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)
Official title: An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study to Monitor the Safety and Utilization of Asenapine (Sycrest) in the Primary Care Setting in England
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar I Disorder
Lead sponsor: Drug Safety Research Unit, Southampton, UK
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-01-10
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prescribed asenapine for any indication by NHS GPs in England.

Brief summary: This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.


Eligibility criteria: Inclusion Criteria:

* Patients prescribed asenapine for any indication by NHS GPs in England.
* Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered.

Exclusion Criteria:

* patient no longer registered with the practice
* patient for whom no information is provided on study questionnaire
* patients for whom information provided on study questionnaire relates to another antipsychotic drug
* patients for whom the index date is an improbable date (i.e. before market launch date)
* patients for whom the GP reports that the patient did not take or was never prescribed asenapine

Primary outcomes:
measure: Incidence rate of selected important identified and potential risks
timeFrame: At least 3 months after drug is first prescribed.
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Drug Safety Research Unit (for data collation and analysis only)
state: Hampshire
Study officials:
affiliation: Drug Safety Research Unit
name: Saad Shakir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05362227: High-Volume Vs Low-Volume Preparation in Emergency Department
Official title: Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GastroIntestinal Bleeding
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS).

The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.


Eligibility criteria: Inclusion Criteria:

* males or females
* \> 18 years and \<85 years,
* hemodynamically stable,
* able to sign informed consent
* requiring colonoscopy
* anemia (loss of at least 2 g/dl of Hb) with or without active bleeding

Exclusion Criteria:

* suspected or confirmed pregnancy,
* hemodynamically unstable patients,
* patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation,
* toxic megacolon,
* major colonic resection,
* heart failure (Class III or IV NYHA),
* severe liver failure,
* end-stage renal disease

Primary outcomes:
measure: intestinal cleansing
timeFrame: during colonscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico universitario a. Gemelli
name: Veronica Ojetti, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610727: Staccato Prochlorperazine Single Dose PK Study
Official title: Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Keywords: Migraine, Prochlorperazine aerosol
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2008-02-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stage 1: open-label, single-dose stage with 3 treatment periods divided into 2 phases Stage 2: double-blind, placebo-controlled, dose-escalation treatment period
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine

Detailed description: The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.

Eligibility criteria: Inclusion Criteria:

* Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.

Exclusion Criteria:

* Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.

Primary outcomes:
measure: Time to Peak (Tmax)
timeFrame: 24 hours
Secondary outcomes:
measure: Absolute Bioavailability of Inhaled Prochlorperazine
timeFrame: 24 hours
measure: Dose Proportionality of Inhaled Prochlorperazine by Power Analysis
timeFrame: 24 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: Alexza Pharmaceuticals, Inc.
name: Daniel A Spyker, MD
role: STUDY_DIRECTOR
References:
citation: Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1.
Clinical trial NCT03395327: Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer
Official title: Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients managed for localized hormone-sensitive breast cancer but not receiving adjuvant chemotherapy.

Brief summary: The 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life".

The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment.

None of these studies specifically assessed the early impact on the quality of sexual life of patients.

The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Female gender
* Histologically proven non-metastatic breast cancer
* Indication of adjuvant hormone therapy
* Patient able to understand a newsletter and to agree to participate

Exclusion Criteria:

* Age under 18 years
* Pregnant woman
* Adjuvant chemotherapy
* Patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship)
* Persons protected or deprived of their liberty
* Male

Primary outcomes:
measure: score FSFI (Female Sexual Function Index)
timeFrame: 3 month after adjuvant hormone therapy
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
Study officials:
References:
Clinical trial NCT03877627: The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma
Official title: The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Carcinoma
Lymphadenectomy
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
Primary purpose: TREATMENT

Brief summary: The aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management.

Detailed description: The clinical data including surgical procedure, the situation of sentinel lymph node imaging and pathological results of patients with endometrial carcinoma treated in our hospitals between April 2019 and April 2021 will be analyzed in this study to clarify the homogeneity of imaging evaluation, sentinel lymph node development evaluation and pathological results.

Eligibility criteria: Inclusion Criteria:

1. Females who are diagnosed with endometrial carcinoma;
2. Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease;
3. Patients who are agreed to participated in this prospective cohort study.

Exclusion Criteria:

1. Patients who still have the will to have pregnancy;
2. Patients who have other diseases or heavy injuries that will interfere with the results;
3. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Primary outcomes:
measure: the number (s) of pelvic and abdominal lymph node metastasis
timeFrame: 1 year during the perioperative period
measure: the percentage (%) of pelvic and abdominal lymph node metastasis
timeFrame: 1 year during the perioperative period
measure: the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis
timeFrame: 1 year during the perioperative period
measure: the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients
timeFrame: 1 year during the perioperative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06390527: Ultrasonography in Diagnosis of Polyneuropathy
Official title: Optimization of Ultrasound Sheer Wave Elastography for the Evaluation of Peripheral Nerve Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Polyneuropathies
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
First posted: 2024-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral polyneuropathy recruited from the electronic database at the institute of Clinical Neurophysiologym Division of Neurology, University Medical Centre Ljubljana, Slovenia, and distributed in groups with different types of polyneuropathy.

Brief summary: The main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Clinical signs of particular polyneuropathy not explained by other causes

Exclusion Criteria:

* Entrapment or compression neuropathies
* Nerve trauma
* The diagnosis of vasculitic neuropathy, neuralgic amyotrophy, diabetic radiculo-plexo-neuropathy, hereditary neuropathy with liability to pressure palsies and motor neuron disorders including monomelic amyotrophy.

Primary outcomes:
measure: Clinical examination
timeFrame: Through study completion, an average 2 years.
measure: Electrodiagnostic studies
timeFrame: Through study completion, an average 2 years.
measure: Ultrasonography
timeFrame: Through study completion, an average 2 years.
measure: Patient history
timeFrame: Through study completion, an average 2 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: