louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00915239: Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
Official title: Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether proton pump inhibitor (PPI) induced hypersecretion leads to acid related symptoms after treatment in healthy volunteers.

Detailed description: Treatment with proton pump inhibitors (PPI) has been shown to cause rebound hypersecretion of gastric acid. The clinical significance of this phenomenon is however unclear. This study aims to examine whether or not healthy volunteers, who over a relatively short period of time treated with a PPI, develop dyspeptic symptoms after cessation of therapy. Dyspeptic symptoms will be measured subjectively using a validated questionnaire, which is filled out each day. Gastric acid will be measured indirectly with measurement of acid secretion markers (Gastrin and chromogranin-A).

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* 18-70 years of age
* Informed consent
* No prior history of any GI disorder

Exclusion Criteria:

* Dyspeptic complaints
* H. pylori infection
* Ongoing treatment with pain-relieving medications (i.e., NSAID)
* Pregnancy or breast feeding

Primary outcomes:
measure: To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy.
Secondary outcomes:
measure: To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska Univeristy Hospital
Study officials:
References:
Clinical trial NCT02606539: Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms
Official title: Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gestational Trophoblastic Neoplasms
Keywords: gestaional trophoblastic neoplasm
hystrectomy
chemotherapy
methotrxate
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.

Detailed description: Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of B-hcg.

Eligibility criteria: Inclusion Criteria:

* females
* 40 years or more
* plateau or rising B- hCG titre
* without distant metastasis
* WHO score is less than 7

Exclusion Criteria:

* less than 40 years
* distant metastasis to lung and liver
* chronic medical diseases
* WHO score is more than 7

Primary outcomes:
measure: number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML
timeFrame: 1-6 months
Secondary outcomes:
measure: quality of life( questionairre)
timeFrame: 1-6 months
measure: complications from management
timeFrame: 1-6 months
measure: time interval for B-hCG reach less than 5 MU/ML
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
city: Mit Ghamr
country: Egypt
facility: Maher Elesawi Kamel Elesawi
state: Eldakahlia
Study officials:
affiliation: Mansoura University
name: Reda hemida, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01435239: The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Complications From General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-09-16
Enrollment: 78
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.


Eligibility criteria: Inclusion Criteria:

* children (0-9 years of age)
* children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic

Exclusion Criteria:

* patients with an abnormal airway
* patients with reactive airway disease
* patients with gastroesophageal reflux disease
* patients with chronic respiratory disease
* patients who has a history of an upper respiratory tract infection in the preceding 6-week period

Primary outcomes:
measure: The intra-cuff pressure
timeFrame: approximately 5 to 10 minutes after insertion of LMA.
measure: The leak volume
timeFrame: approximately 5 to 10 minutes after insertion of LMA.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Wallace CJ, Chambers NA, Erb TO, von Ungern-Sternberg BS. Pressure volume curves of paediatric laryngeal mask airways. Anaesthesia. 2009 May;64(5):527-31. doi: 10.1111/j.1365-2044.2008.05819.x.
Clinical trial NCT06312839: Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning
Official title: Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning : a Retrospective Monocentric Comparative Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Cancer
Keywords: Embolization
Ischemic conditioning
Esophagectomy
Lewis Santy
Anastomotic leakage
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-metastatic oesophageal cancer, eligible for curative surgery by oesophagectomy.

Brief summary: This retrospective monocentric comparative study aims to assess the efficacy of preoperative ischemic conditioning, in preventing anastomotic leakage in esophageal cancer surgery. Two groups were included : a surgery-alone group (control group) and a PreopAE group (study group) treated with an embolization procedure before esophagectomy. Collected data included patient characteristics, embolization procedure details, surgical outcomes, and postoperative complications.

The primary outcome was the efficacy of preoperative ischemic conditioning in preventing anastomotic leakage, assessed through CT scans. Secondary outcomes included analyzing safety of ischemic gastric conditioning, hypertrophy of the gastroepiploic artery in embolized patients and comparing hospital stay length and postoperative mortality.


Eligibility criteria: Inclusion Criteria:

* All patients older than 18 years with an indication for surgical esophagectomy with cervical anastomosis using the Lewis Santy technique or three stages approach.

Exclusion Criteria:

* Esophagectomy for ischemic or caustic oesophagitis, and patients lost for follow-up.

Primary outcomes:
measure: Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.
timeFrame: Day : 90
Secondary outcomes:
measure: Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.
timeFrame: Day : 90
measure: Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy.
timeFrame: Day : 90
measure: Safety of ischemic gastric conditioning
timeFrame: Day : 90
measure: Hypertrophy of the gastroepiploic artery
timeFrame: Day : 90
measure: Comparing hospital stay length
timeFrame: Day : 90
measure: Comparing postoperative mortality
timeFrame: Day : 90
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Rémi GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04953039: Use of Saliva for COVID-19 Diagnosis
Official title: Use of Saliva for Diagnosis of SARS-CoV2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Keywords: Salivary test
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 109
Sex: ALL
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 with suspected or confirmed SARS-CoV2 infection.

Brief summary: Aim of the study is to evaluate the presence of SARS-CoV2 RNA in the saliva of patients with suspected or confirmed COVID-19 in order to validate the analysis of this type of sample for the diagnosis of SARS-CoV2 infections.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age hospitalized in the COVID-19 wards of ASST Monza - San Gerardo Hospital with positive, weakly positive or negative nasopharyngeal swabs; initially assessed at the E.R.; symptomatic or asymptomatic with indication to hospitalization.
* Informed consent freely granted and acquired before the start of the study.

Exclusion Criteria:

* Patients with significant clinical conditions which could interfere with the study in the opinion of the researchers.

Primary outcomes:
measure: Presence of SARS-CoV2 RNA in the saliva of patient with suspected or confirmed COVID-19.
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST MONZA - Ospedale San Gerardo
state: MB
Study officials:
affiliation: ASST Monza - Ospedale San Gerardo
name: Giorgio Novelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06126939: A Study on the Effect of Education Training on Parents With Autism Based on Denver Model
Official title: A Study on the Effect of Education Training on Parents With Autism Based on Denver Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism
Parents
Keywords: denver model
training
Intervention effect
Lead sponsor: Hunan Normal University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to test the effects of parent training based on Denver model on parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, quality of life, etc . The main question\[s\] it aims to answer are:

* What is the status quo of autistic parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life
* Whether education and training based on Denver model can improve autism parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life

Participants will receive educational training based on the Denver model. The researchers will compare the Denver model of early intervention with parents who receive regular autism health guidance to explore the effect of early intervention Denver model


Eligibility criteria: Inclusion Criteria:

* The child meets the diagnostic criteria for autism in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders, and has been diagnosed by a physician；
* Parents of children aged 12-60 months with autism；
* Be the father or mother of the child, live with the child and take the main care of the child；
* Father ≥22 years old, mother ≥20 years old；
* Clear mind, normal intelligence, with normal cognitive ability.

Exclusion Criteria:

* Suffering from serious heart, liver and kidney diseases and mental illness;
* There are other family members suffering from serious illness or mental illness.

Primary outcomes:
measure: Trait Coping Style Questionnaire
timeFrame: One week before the intervention and one week after the intervention
measure: Illness Cognition Questionnaire-Parent version
timeFrame: One week before the intervention and one week after the intervention
measure: Depression Anxiety Stress Scales
timeFrame: One week before the intervention and one week after the intervention
measure: Guilt about Parenting Scale
timeFrame: One week before the intervention and one week after the intervention
measure: Beach Center Family Quality of Life Scale
timeFrame: One week before the intervention and one week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04278339: Study of Electrophysiological Markers Related to the Cognitive and Affective Processes Behind Empathic Behaviour in Schizophrenic Spectrum Disorder
Official title: Study of Electrophysiological Markers Related to the Cognitive and Affective Processes Behind Empathic Behaviour in Schizophrenic Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Disorders of social cognition, and empathy more specifically, are at the heart of schizophrenic pathology in that they are strongly linked to the social handicap of patients. It is therefore necessary to refine our knowledge of the cognitive and affective processes behind this empathic disorder and to identify objective and easily measurable markers (related to brain functioning collected by electroencephalography) of these processes with the subsequent aim of improving their management. It is also relevant to question the trait/status nature of these empathic disorders by studying these markers in individuals presenting more or less marked schizotypic traits and therefore more or less at risk of developing schizophrenia. Studying the possibility that empathy disorders may be part of the factors of developmental vulnerability for schizophrenia and identifying objective markers of this vulnerability could allow, in case of development of the pathology, a more rapid diagnosis and a more effective management.


Eligibility criteria: Inclusion Criteria:

* Common to all: good command of the French language, right-handed.
* Specific to patients: diagnosis of schizophrenia or schizoaffective disorder, clinical state stabilized according to the treating psychiatrist.

Exclusion Criteria:

* Common to all: having suffered a head injury with loss of consciousness lasting more than 5 minutes, participating in another project at the time of the present study, presenting an addiction to a toxic substance (excluding tobacco), presenting a mental retardation or neurological disorder (verified by a pre-recruitment interview and the administration of the Mini International Neuropsychiatric Interview for control subjects and on the basis of the information in the medical file for patients).
* Patient-specific: significant change (according to the doctor) in treatment in the previous month, currently hospitalized.
* Specific to controls: taking a psychoactive drug, having a mental disorder, being first-degree related to a patient with a disorder other than schizophrenia or schizoaffective disorder.

Primary outcomes:
measure: Evoked Related Potentials
timeFrame: On the first day
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Pasteur - Service de Psychiatrie
Study officials:
References:
Clinical trial NCT06054139: Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit
Official title: Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refeeding Syndrome
Keywords: hypophosphatemia
hypomagnesemia
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients receiving treatment in intensive care at Samsun University Hospital

Brief summary: Refeeding Syndrome is a condition that occurs when patients who are undernourished or undernourished suddenly start overfeeding, causing electrolyte disturbances and vitamin deficiencies, resulting in neurological and cardiac problems. It may even result in death. It is aimed to prevent the development of Refeeding Syndrome with nutrition in accordance with the guidelines. The aim of this study is to determine the risk factors for Refeeding Syndrome in Intensive Care Unit (ICU).

Detailed description: Nutritional support is an important part of treatment in intensive care patients. Especially existing comorbidities and developing acute problems before intensive care admission can cause serious malnutrition for patients. Refeeding syndrome is a serious, life-threatening condition accompanied by electrolyte and metabolic disorders as a result of rapid re-feeding following prolonged starvation or malnutrition. The condition may be accompanied by electrolyte disorders such as hypophosphatemia, hypokalemia and hypomagnesemia, as well as decrease in vitamin levels (especially vitamin B1), fluid imbalance and salt retention. The resulting imbalances can cause cardiac and neurological side effects, impaired organ functions and even death. The refeeding protocol should be individualized to each patient's clinical situation. In this study, although nutritional protocols in accordance with the guidelines are applied in patients with risk factors for the development of Refeeding Syndrome, whether Refeeding Syndrome develops and the facilitating factors will be investigated in ICU.

Eligibility criteria: Inclusion Criteria:

1. Patients are intensive care patients
2. Patients' age \> 18 -

Exclusion Criteria:

1. Diabetic ketoacidosis
2. Other risk factors for hypophosphatemia (patients on continuous hemodialysis, hyperphosphatemia treatment, parathyroidectomy)
3. Patients with pre-study hypophosphatemia (\< 0.65 mmol/L)
4. Patients with hyperparathyroidism
5. Terminal stage cancer patients
6. Patients with Glasgow Coma Scale ≤5
7. Patients with respiratory and metabolic alkalosis -

Primary outcomes:
measure: Occurrence of Refeeding Syndrome
timeFrame: from june 9, 2023 to june 9, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Şerife Seçgin
Study officials:
affiliation: SAMSUN UNIVERSITY HOSPITAL
name: ÖZGÜR KÖMÜRCÜ
role: STUDY_DIRECTOR
References:
Clinical trial NCT00133939: Proportional Ventilation and Ventilatory Synchronism
Official title: Proportional Ventilation and Ventilatory Synchronism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Proportional assisted ventilation
Pressure support ventilation
Synchronism during mechanical ventilation
Patients undergoing partial mechanical ventilation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will be studied during two kinds of ventilation. The first one is the proportional assisted ventilation during which the gas flow is theoretically adapted to the patient's muscular effort within the breath. The second is the pressure support ventilation during which the gas flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the first mode allows a better synchronism.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing partial ventilatory support

Exclusion Criteria:

* Patients failing the weaning process

Primary outcomes:
measure: Time lag between the onset of diaphragmatic electromyogram (EMG) signal and the zero crossing of the inspiratory flow, over five minutes
Secondary outcomes:
measure: Number per minute of failing breaths: breath with muscular effort without any inspiratory flow
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-Paul VIALE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganne O, Abisseror M, Menault P, Malhiere S, Chambost V, Charpiat B, Ganne C, Viale JP. Low-dose ketamine failed to spare morphine after a remifentanil-based anaesthesia for ear, nose and throat surgery. Eur J Anaesthesiol. 2005 Jun;22(6):426-30. doi: 10.1017/s0265021505000724.
citation: Mechet I, Lhuillier F, Blanchet MC, Pouyet M, Viale JP, Goudable J, Annat G, Scoazec JY, Boillot O, Liotard D, Merle E, Delafosse B. Liver function during extracorporeal whole liver perfusion in a pig model of acute ischemic liver failure. ASAIO J. 2004 Sep-Oct;50(5):503-11. doi: 10.1097/01.mat.0000136509.08283.b9.