louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06073158: Molecular Signatures of Esophageal Atresia
Official title: Oesomics Anastomose Molecular Signatures of Esophageal Atresia Comparison of Biopsies Taken During the First Year of Life With Those Taken During Anastomosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Atresia
Keywords: esophageal atresia
epigenetic
proteomics
metabolomics
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Although several studies have revealed signaling pathways as well as genes potentially involved in the development of esophageal atresia (EA), our understanding of the pathophysiology of EA lags behind improvements in the surgical and clinical care of patients born with this anomaly. However, a causative genetic abnormality can be identified in less than 10% of patients, even using more recent next-generation sequencing techniques. As most cases of EA associated with tracheoesophageal fistula (TOF) are sporadic, and the familial recurrence rate is low (1%), this suggests that epigenetic and environmental factors also contribute to the disease. Further investigations are needed to better understand the mechanisms underlying EA. That information can come from the oesophageal biopsies that are collected in routine care and long-term storage at the hospital. However, the impact of the length of the storage is still unknown.


Eligibility criteria: Inclusion Criteria:

* Anastomosis group :

Born with esophageal atresia Anastomosis performed in Lille hospital Parents consent

- Control group : Born with esophageal atresia

Exclusion Criteria:

* Both groups :

Parents refusing to participate in the study

Primary outcomes:
measure: Comparison of the mRNA expression from esophageal biopsies between long and short term storage
timeFrame: The biopsies will be collected during the first year of life
measure: Comparison of the metabolites identification from esophageal biopsies between long and short term storage
timeFrame: The biopsies will be collected during the first year of life
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
Study officials:
References:
Clinical trial NCT03306758: The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
Official title: The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asymptomatic Hyperuricemia
Gout
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 104
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: This study evaluate the serum uric acid lowering effect of sodium bicarbonate as well as its safety in patients with asymptomatic hyperuricemia or gout. Half of the participants will receive sodium bicarbonate only, while the other half receive none.


Eligibility criteria: Inclusion Criteria:

1. Sign informed consent form;
2. Serum uric acid ≥420mmol/L;
3. Within the age range of 18-65 years old;
4. Within the BMI range of 18-30kg/m2;
5. Both men and women are eligible

Exclusion Criteria:

1. General situations

   * Pregnancy or lactation；
   * Participants who can't take contraception during the study or within one month after the completion of the intervention;
   * Situations which will harm the participants;
   * Participants with bad compliance.
2. Taking part in another trail
3. Gout flares happening over the last one month;
4. Administration of medications over the last one month, including: allopurinol, Febuxostat,benzbromarone, and/or sodium bicarbonate；
5. urine pH\>7.0;
6. Hepatic function：ALT and/or AST and/or TB\>1.5 upper limit of normal (ULN);
7. Renal function：eGFR\<60 ml/min for MDRD and/or urine protein\>0.5g/24h；
8. Hypertension：\>140/90mmHg;
9. Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes);
10. Urinary stone,urinary infection;
11. Taking drugs ove the last one month and during the trial, including：thiazide diuretic, Loop diuretics, pyrazinamide,ethambutol, tacrolimus, niacin, aspirin, estrogen, losartan, amlodipine, reserpine, vitamin C，fenofibrate，atorvastatin， sulfonylureas，biguanides，NSAIDs;
12. Disease which influence serum uric acid, such as cancer, lymphoma, and etc.
13. Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc;
14. Blood donation or excessive loss of blood over the last 3 month.

Primary outcomes:
measure: Serum uric acid
timeFrame: 1 month after randomization
Secondary outcomes:
measure: Fraction excretion of uric acid
timeFrame: 1 month after randomization
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01957358: Resolving Grief After Spinal Cord Injury
Official title: Resolving Grief and Moving On After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the usefulness of the Grief Recovery Method in assisting persons with spinal cord injuries to achieve as complete a recovery as possible, thereby allowing for fuller participation in life.


Eligibility criteria: Inclusion Criteria:

\* Persons with a spinal cord injury who are willing to participate in the program.

Exclusion Criteria:

\* Unable or unwilling to participate.

Primary outcomes:
measure: Impact of Event Scale
timeFrame: At Sessions 1 and 18. (Baseline and month 4)
Secondary outcomes:
measure: Modified Grief Inventory
timeFrame: At Sessions 1and 18 (baseline and month 4).
measure: The Coping with Health Injuries and Problems
timeFrame: At sessions 1 and 18 (Baseline and month 4)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: WRHA Health Sciences Centre Rehabilitation Hospital
state: Manitoba
Study officials:
References:
Clinical trial NCT05390658: Risk Factors Analysis for Acute Myocardial Infarction Patients
Official title: Clinical Features and Risk Factors Analysis for Acute Myocardial Infarction Patients Received ECMO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AMI - Acute Mesenteric Ischemia
Extracorporeal Membrane Oxygenation Complication
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: I. Clinical symptoms: the typical angina pectoris symptoms of acute myocardial infarction are compressive pain in the precardiac area and the back of the sternum, accompanied by sweating, a sense of dying, and a sense of suffocation. Taking nitroglycerin tablets or quick-effect Xusuxin pills cannot alleviate the symptoms.

2. Typical ECG manifestations, such as pathological Q wave, ST-segment elevation, or pathological ST-segment depression, have corresponding lead changes.

3. Increased myocardial enzymes, including CK, CK-MB, and troponin, etc. The diagnosis of acute myocardial infarction can be made with two of these three indicators.

Brief summary: ECMO has been used to save the lives of many critically ill patients with cardiorespiratory dysfunction as important rescue therapy. Though the proportion of ECMO applied to this population has been increasing year by year, clinical outcomes of AMI remain poor with high in-hospital mortality. Thus, it is necessary to characterize clinical features and investigate potentially modifiable factors contributing to outcomes of AMI patients who received ECMO treatment.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Alzheimer's Disease Age more than 18

Exclusion Criteria:

Life expectancy \<1 year Prolonged cardiac arrest before VA-ECMO therapy (\>60 min) Iatrogenic myocardial infarction secondary to a percutaneous coronary intervention VA-ECMO implanted in another center before admission

Primary outcomes:
measure: Survival rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Genglong Liu
state: State...
Study officials:
References:
Clinical trial NCT02541058: Non-Invasive Chromosomal Evaluation of 22q11.2
Official title: Non-Invasive Chromosomal Evaluation of 22q11.2 Using Cell-free Fetal DNA From Maternal Plasma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 22q.11.2 Deletion/Duplication
Keywords: Velocardiofacial Syndrome
Shprintzen Syndrome
Conotruncal Defects
Chromosomal Abnormalities
22q, 22q.11.2
deletion
duplication
Lead sponsor: Roche Sequencing Solutions
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women carrying a fetus at risk or a confirmed fetus with 22q11.2 deletion/duplication. A person confirmed to have 22q11.2 deletion/duplication or a biologically related parent of a child that has chromosomal deletion/duplication in the region of 22q11.2.

Brief summary: This study is being conducted to develop and evaluate a cell-free fetal DNA test (Harmony) for non-invasive prenatal detection of 22q11.2 chromosomal deletion or duplication.


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥18 years of age and able to provide consent or, if under the age of 18, the patient has parental consent and child assent provided as required by the governing ethics committee.
2. If pregnant, patients must have a singleton pregnancy and be at least 10 weeks gestation at the time of the study blood draw.
3. Patients must meet at least one of the following conditions at the time of enrollment:

   1. are pregnant with abnormal fetal cardiac findings on ultrasound and is undergoing evaluation with prenatal genetic testing or planned post-natal genetic testing in the immediate newborn period;
   2. are pregnant with fetal ultrasound findings consistent with a 22q11.2 deletion/duplication phenotype and is undergoing evaluation with prenatal genetic testing or planned post-natal genetic testing in the immediate newborn period;
   3. are pregnant with a fetus known to have a 22q11.2 deletion/duplication confirmed by genetic testing with documentation is available;
   4. are biologically related parent of an enrolled child has chromosomal deletion/duplication in the region of 22q11.2;
4. If the site is selected to enroll control patients, they must be pregnant women undergoing prenatal genetic evaluation for 22q11.2 deletion/duplication.

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

1. Patient has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.

Primary outcomes:
measure: Performance of Ariosa 22q.11.2 deletion/duplication assay in prenatal patients
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussles
country: Belgium
facility: The Fetal Medicine Foundation Belgium
Study officials:
affiliation: Roche Sequencing Solutions
name: Frank Ong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05633758: Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure
Official title: Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF): A Multicenter, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Decompensated Heart Failure
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 0
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: The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.

Detailed description: AS DESCRIBED BY THE PRINCIPAL INVESTIGATOR (DR. HEYWOOD): The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age at time of enrollment.
* Admitted with acute decompensated heart failure based on history, physical exam, and laboratory parameters, must include both:

  1. At least 1 symptom of either dyspnea, orthopnea, or edema.
  2. At least 1 sign of rales on auscultation, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
* Be willing to comply with protocol-specified instructions
* Able to understand and grant informed consent.

Exclusion Criteria:

* Inability to give informed consent.
* Systolic BP \< 90 mmHg
* Creatinine clearance less than 20ml/min or creatinine greater than 2.5mg/dl.
* Serum Sodium less than 128meq/L, potassium levels less than 3.5meq/L
* Known adverse reaction to metolazone
* Inability to take oral medications
* Severe Aortic Stenosis (AVA \< 0.8cm³)
* History of Hypertrophic Obstructive Cardiomyopathy.
* Metastatic Carcinoma
* Severe Chronic Obstructive Pulmonary Disease (COPD), FEV \< 1L
* Severe dyspnea requiring prolonged CPAP or intubation
* Moderate/Severe Dementia

Primary outcomes:
measure: Total urinary output and negative fluid balance
timeFrame: 48 hours
Secondary outcomes:
measure: Change in weight
timeFrame: Day 2
measure: Degree of improvement in dyspnea
timeFrame: 6, 12, 24, 36, and 48 hours
measure: All cause mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Torrey Pines
state: California
Study officials:
affiliation: Scripps Health
name: James T Heywood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322958: Sonographic Assessment and Visualization of Ectopics in Emergency Medicine
Official title: Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Keywords: bedside ultrasound
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-03-25
Enrollment: 600
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women at risk of ectopic pregnancy in emergency department

Brief summary: Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.

Detailed description: Emergency Physicians who have undergone training according to the American College of Emergency Physicians Guidelines will be evaluated in the accuracy of performing pelvic ultrasounds among patients at risk for ectopic pregnancy.

Eligibility criteria: Inclusion Criteria:

* pregnant females in 1st trimester
* present to emergency department
* complaint of abdominal/pelvic pain or vaginal bleeding

Exclusion Criteria:

* previous ultrasound diagnostic of location of pregnancy

Primary outcomes:
measure: Clinical outcome of the pregnancy
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: John C. Stein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06728358: The Future Management of Patients With Neoplasms of the Gastro-intestinal Tract
Official title: Single-centre Prospective Study on the Identification of Clinical, Laboratory, Anatomopathological and Molecular Characteristics for the Future Management of Patients With Neoplasms of the Gastro-intestinal Tract
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Cholangiocarcinoma
Colon Cancer
Keywords: Pancreatic cancer, Bile duct cancer, Colon cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 300
Sex: ALL
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: The aim of the present study is to research histological and molecular markers in patients with neoplasia of the gastrointestinal tract.

Detailed description: The aim of the present study is to search for histological and molecular markers in patients with neoplasia of the gastrointestinal tract.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older;
* PS ECOG 0-2;
* Histological diagnosis of cancer of the gastro-enteric district: intestinal, pancreatic, biliary tract neoplasms;
* Radiological evidence of resectable/locally advanced/metastatic disease on the date of the first visit;
* Availability of tumour histological material;
* At least one visit following the first oncological visit.

Exclusion Criteria:

* Absence of histological diagnosis of neoplasm of the gastro-enteric tract;
* Lack of histological specimens on which to perform examinations.

Primary outcomes:
measure: Overall Survival
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Lisa Salvatore
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01330758: A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females
Official title: A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II Wet Granulation Tablet Formulation Compared to the Phase II/III Roller Compacted Tablet Formulation of AZD8931
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Healthy male and non-fertile female volunteers
Bioavailability
AZD8931
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A study to compare two different tablet formulations of AZD8931 in healthy males and females.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 to 55 years
* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
* Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
* Male subjects must be willing to use barrier methods of contraception
* Be willing and able to comply with study procedures, restrictions and requirements

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Any clinically significant abnormalities at screening
* Use of any prescribed or non-prescribed medication within 2 weeks
* Receipt of another NCE or participation in any other clinical trial within 3 months
* Subjects who have previously received AZD8931

Primary outcomes:
measure: To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation.
timeFrame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Secondary outcomes:
measure: To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).
timeFrame: From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK
name: Mary Stuart
role: STUDY_DIRECTOR
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Dr Darren Wilbraham, DICP, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Jason Clark, BSc
role: STUDY_DIRECTOR
References: