louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06892171: The Study of the Phenotype of Hereditary Xerocytosis
Official title: The Study of the Phenotype of Hereditary Xerocytosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Xerocytosis
Phenotype
Genotype
Keywords: xerocytosis
phenotype
genotype
PIEZO1
KCNN4 mutation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Kremlin-Bicetre Hospital, Paris
First posted: 2025-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hereditary xerocytosis is a dominant red blood cell membrane disorder characterized by an increased leakage of potassium from the interior to the exterior of the red blood cell membrane, leading to water loss, red cell dehydration, and chronic hemolysis. In 90% of cases, it is associated with heterozygous gain-of-function mutations in PIEZO1, a gene that encodes a mechanotransducer responsible for converting mechanical stimuli into biological signals. The remaining 10% of cases are linked to mutations in the GARDOS channel gene.


Eligibility criteria: Inclusion Criteria:

* Any patient diagnosed with hereditary xerocytosis according to the 2021 PNDS guidelines
* Covered by a social security plan
* Signature of the consent form for study participation by the patient, or for minors, by the parent(s)/legal representative(s).

Exclusion Criteria:

* patients with other hemolysis reason

Primary outcomes:
measure: identification of PIEZO1 mutations
timeFrame: 36 months
measure: identification of KCNN4 mutations
timeFrame: 36 months
measure: correlation between the identified PIEZO1 mutations and Hemoglobin levels
timeFrame: 36 months
measure: correlation between the identified KCNN4 mutations and Hemoglobin levels
timeFrame: 36 months
measure: correlation between the identified PIEZO1 mutations and reticulocytes levels
timeFrame: 36 months
measure: correlation between the identified KCNN4 mutations and reticulocytes levels
timeFrame: 36 months
measure: correlation between the identified PIEZO1 mutations and Ferritin levels
timeFrame: 36 months
measure: correlation between the identified KCNN4 mutations and Ferritin levels
timeFrame: 36 months
measure: correlation between the identified PIEZO1 mutations and MRI quantification of intrahepatic iron
timeFrame: 36 months
measure: correlation between the identified KCNN4 mutations and MRI quantification of intrahepatic iron
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT06312371: Intermittent Oro-esophageal Tube on Feeding Hesitancy in Stroke Patients
Official title: Intermittent Oro-esophageal Tube on Feeding Hesitancy in Stroke Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 80
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: SUPPORTIVE_CARE

Brief summary: The aim of this clinical trial is to compare Feeding Hesitancy of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Feeding Hesitancy of the two groups.

Detailed description: The study will last 15 days for each participant. The aim of this clinical trial is to compare Feeding Hesitancy of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Feeding Hesitancy of the two groups.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs.

Exclusion Criteria:

* complicated with other neurological diseases;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: Swallowing Quality of Life questionnaire
timeFrame: day 1 and day 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03737071: The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
Official title: The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fatty Liver
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Low Carbohydrate Diet versus Simple Calorie Restriction Diet
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.

Detailed description: In this study, the investigators will examine whether a low carbohydrate diet as compared to simple calorie restriction will change hepatic lipid content and mitochondrial flux in humans. Before and after a low carbohydrate diet and a simple calorie restriction intervention, rates of hepatic mitochondrial flux will be assessed using positional isotopomer analysis of 3-13C-lactate during a 3 hour basal period. Rates of whole body ketogenesis will be determined using \[13C4\]β-hydroxybutyrate, and whole body glucose metabolism will be measured using \[2H7\]glucose. Body composition will be determined with bioelectrical impedance; hepatic lipid content will be measured with MRS. Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.

Eligibility criteria: Inclusion Criteria:

* Age 18-70
* Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent

Exclusion Criteria:

* chronic liver disease other than NAFLD
* chronic disease associated with hepatic steatosis such as diabetes mellitus
* use of drugs known to affect hepatic steatosis
* contraindications for MRI
* pregnancy or nursing at the time of the study

Primary outcomes:
measure: Change in hepatic triglyceride content
timeFrame: 1 week
measure: Change in hepatic mitochondrial flux
timeFrame: 1 week
Secondary outcomes:
measure: Change in beta-hydroxybutyrate production rate
timeFrame: 1 week
measure: Change in glucose production rate
timeFrame: 1 week
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Biomedicum 2U
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Panu Luukkonen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02509871: Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2)
Official title: Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hormonal Therapy
Breast Cancer
Keywords: Body composition
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).


Eligibility criteria: Inclusion Criteria:

* postmenopausal women
* patients requiring hormonal treatment
* WHO performance status 0-2
* patients initially included in MetaCa (AU882) protocol
* Affiliation to a social security scheme (or be the beneficiary of such a plan)
* patients who signed the informed consent form

Exclusion Criteria:

* patients witg relapse, with metastases or other cancer
* concurrent treatment with a drug test, or participation in a clinical trial within \< 30 days
* patients carrying an electronic medical device (eg pacemaker)
* patients who refused to sign the consent form

Primary outcomes:
measure: Measure of body composition
timeFrame: After more than a year of hormonal therapy
Secondary outcomes:
measure: Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference
timeFrame: After more than a year of hormonal therapy
measure: Assessment of anxiety and depression scores measured by Questionnaire HAD
timeFrame: After more than a year of hormonal therapy
measure: Evaluation of quality of life measured by Questionnaire (QLQ-C30)
timeFrame: After more than a year of hormonal therapy
measure: Evaluation of the time sitting measured by Questionnaire IPAQ
timeFrame: After more than a year of hormonal therapy
measure: Evaluate the change in body composition longitudinally from the data of the study Metaca
timeFrame: Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ginzac A, Thivat E, Mouret-Reynier MA, Dubray-Longeras P, Van Praagh I, Passildas J, Abrial C, Kwiatkowski F, Boirie Y, Duclos M, Morio B, Gadea E, Durando X. Weight Evolution During Endocrine Therapy for Breast Cancer in Postmenopausal Patients: Effect of Initial Fat Mass Percentage and Previous Adjuvant Treatments. Clin Breast Cancer. 2018 Oct;18(5):e1093-e1102. doi: 10.1016/j.clbc.2018.06.010. Epub 2018 Jun 18.
Clinical trial NCT06469671: Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms
Official title: Artificial Intelligence - Assisted Colonoscopy in Diagnosis of Colorectal Neoplasms: Russian Multicenter Randomised Open - Label Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonic Neoplasms
Colonic Polyp
Diagnosis
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2024-06-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.

Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.

Detailed description: The primary outcome is adenoma detection rate per patient.

The secondary outcomes will be measured:

* Polyps detection rate (all type of lesions) per patient;
* Number of adenomas per patient;
* Number of polyps per patient;

Eligibility criteria: Inclusion Criteria:

* Screening coloscopy is needed

Exclusion Criteria:

* Indications for colonoscopy
* Previously detected colorectal neoplasms
* Previously performed colorectal surgery
* Colorectal cancer
* Inflammatory bowel disease

Primary outcomes:
measure: Adenoma detection rate
timeFrame: during the procedure
Secondary outcomes:
measure: Polyps detection rate
timeFrame: during the procedure
measure: Number of polyps
timeFrame: during the procedure
measure: Number of adenomas
timeFrame: during the procedure
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Airat Mingazov
Study officials:
affiliation: State scientific centre of coloproctology, Moscow
name: Sergey Achkasov
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073371: Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia
Official title: Local Anesthetics New Formulations: From Development to Clinical Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Anesthesia Efficacy
Keywords: Liposome
Prilocaine
Dental anesthesia
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-02-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.


Eligibility criteria: Inclusion Criteria:

* good health
* no history of allergy to the components of the local anesthetic formulations tested
* maxillary canine, lateral incisor, and first premolar responsible to electric stimulation

Exclusion Criteria:

* intake of any medication that would alter pain perception
* history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar
* systemic disease

Primary outcomes:
measure: Anesthesia success, onset and duration of pulpal and gingival anesthesia.
timeFrame: 10 minutes
Secondary outcomes:
measure: Injection pain - Visual Analogue Scale
timeFrame: 1 minute after the injections
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School
state: SP
Study officials:
affiliation: University of Campinas, Brazil
name: Eneida de Paula, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03928171: The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery
Official title: The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Pneumoperitoneum
Keywords: Laparoscopic surgery
Pneumoperitoneum
Peritoneal perfusion
Intra-abdominal pressure
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 30
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: Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg.


Eligibility criteria: Inclusion Criteria:

* Adults (≥ 18 years old)
* Scheduled for robot-assisted colorectal laparoscopic surgery

Exclusion Criteria:

* Severe liver- or renal disease
* Pregnancy or lactation
* Planned diagnostics or treatment with radioactive iodine \< 1 week after surgery
* BMI \>35 kg/m2
* Known or suspected hypersensitivity to indocyanine green, sodium iodide or iodine
* Hyperthyroidism or thyroid adenomas
* Use of medication interfering with ICG absorption as listed in the summary of product characteristics.

Primary outcomes:
measure: Peritoneal perfusion
timeFrame: 3 minutes after intravenous injection of indocyanine green
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Michiel C Warlé, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albers KI, Polat F, Loonen T, Graat LJ, Mulier JP, Snoeck MM, Panhuizen IF, Vermulst AA, Scheffer GJ, Warle MC. Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study. Int J Surg. 2020 May;77:8-13. doi: 10.1016/j.ijsu.2020.03.019. Epub 2020 Mar 17.
Clinical trial NCT02976571: Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief
Official title: Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-11-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

Detailed description: 4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline

Eligibility criteria: Inclusion Criteria:

* Elective laparoscopy

Exclusion Criteria:

* Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours

Primary outcomes:
measure: Pain level during movement, 8 hours after laparoscopy
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Wolfson medical center
Study officials:
affiliation: Wolfson Medical Center
name: Ohad Gluck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gluck O, Barber E, Feldstein O, Tal O, Kerner R, Keidar R, Wolfson I, Ginath S, Bar J, Sagiv R. The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial. Sci Rep. 2021 Jan 8;11(1):81. doi: 10.1038/s41598-020-80130-6.
Clinical trial NCT00178971: Serotonin 1A Agonists and Cognition in Schizophrenia
Official title: Serotonin 1A Agonists and Cognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2005-09-15
Enrollment: 60
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: Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with antipsychotic medications. Patients will be assigned to take active medication (Buspar)or placebo along with their prescribed antipsychotic medication for six weeks. Patients' memory and problem-solving ability will be tested before and after medication.

Detailed description: Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with olanzapine or risperidone for at least three months randomized to receive adjunctive treatment with a 5-HT1A agonist (buspirone, 15-30 mg/day)or placebo.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in the current research study.

1. Subjects will be males and females between 18-65 years of age;
2. Subjects will have a definite diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder;
3. The subjects or their legal guardian must sign the informed consent;
4. Subjects currently being treated with olanzapine or risperidone for a duration of at least 3 months

Exclusion Criteria:

1. Subjects who are pregnant or lactating
2. Subjects who have brain damage and/or neurological disorders
3. Subjects who have current substance dependence
4. Subjects unable to provide informed consent

Primary outcomes:
measure: This study will examine the effect on cognition of the addition of buspirone compared with addition of a sugar pill to patients treated with olanzapine or risperidone
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Psychiatric Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Herbert Y Meltzer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: