louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05769387: Multihormonal Deficiencies and miRNA Profile in Chronic Heart Failure: Effects of Combined Hormonal Replacement Therapy
Official title: Multihormonal Deficiencies and miRNA Profile in Chronic Heart Failure: Effects of Combined Hormonal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Ischemic or Idiopathic Dilated Cardiomyopathy
Lead sponsor: IRCCS SYNLAB SDN
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollment of no. 250 subjects with CCI. The patients will be recruited from among patients belonging to the UOC of Internal Medicine with Cardiology and Respiratory Address of the AOU Federico II in Naples and the Division of Cardiology "San Giovanni di Dio and Ruggi d'Aragona" Salerno

Brief summary: The results from this study will be useful to gain detailed information on the correlation related to pathophysiological aspects between endocrine system and clinical status of patients with heart failure, and to identify factors correlated with the progression and prognosis of ICC


Eligibility criteria: Inclusion Criteria:

* ischemic or idiopathic dilated cardiomyopathy, stable medications for at least three months including ß-blocker that must be started at least 6 months before entering the study, fraction of left ventricular ejection less than or equal to 49%

Exclusion Criteria:

* Age \< 18 years, Inability to perform a bicycle ergometer exercise test. Diabetes mellitus in poor glycometabolic control and/or proliferative retinopathy or nonproliferative retinopathy severe grade. Severe renal failure; Hepatic cirrhosis advanced. Active neoplastic disease or history of malignancy. Patients with severe acute illness caused by complications from open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. Active infection or sepsis. Any allergies to growth hormone, testosterone, vitamin D, or other excipients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or methacresol. Acute Coronary Syndrome within the previous 6 months

Primary outcomes:
measure: Evaluation of the association between hormonal deficits (single or multiple), miRNA profile and clinical/functional indices in patients with heart failure
timeFrame: 1-48 months
measure: Evaluation of clinical and morphological effects where necessary in patients With multiple hormonal deficits in addition to standard medical therapy
timeFrame: 1-48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: IRCCS Synlab SDN
Study officials:
References:
Clinical trial NCT03779087: Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection
Official title: Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Eradication rate
Rescue treatment
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Detailed description: The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Eligibility criteria: Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)

Exclusion Criteria:

* previous allergic reactions to the study medications,
* history of gastrectomy,
* use of antibiotics within the previous 4 weeks,
* pregnant or lactating women,
* coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).

Primary outcomes:
measure: Number of Participants in Which H. Pylori Was Eradicated
timeFrame: sixth week after the end of anti- H. pylori therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Ping-I Hsu, Bachelor
role: STUDY_CHAIR
References:
Clinical trial NCT01219387: Evaluation of Anti-mullerian Hormone Levels as Predictive of IVF Outcomes in Women Over 38 Years Old
Official title: Evaluation of Serum Anti-Mullerian Hormone (AMH) and Inhibin B Levels as Early Predictors of a Successful IVF Cycle in Women Over 38 Years Old.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AMH Levels
Inhibin B Levels
IVF Patients Over 38 Years Old
Keywords: AMH
inhibin B
infertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
Collaborators: name: Organon
name: Merck Sharp & Dohme LLC
First posted: 2010-10-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing IVF treatment who are over the age of 38 years.

Brief summary: The present study is designed to evaluate the basal serum levels of anti-mullerian hormone (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and pregnancy rate in women 38 years old or older that are undergoing an IVF cycle.

Detailed description: Specifics aims are: a) to describe AMH and inhibin levels on day 3 previous to ART cycle; b) to analyze the association between these hormone levels and the retrieved metaphase II oocytes quantity; c) to analyze the association between these hormone levels and quality embryo score d) to analyze the association between these hormone levels and the number of gestational sacs per transferred-embryo (implantation rate); e) to analyze the association between these hormone levels and the pregnancy rate; f) to make a prediction model for pregnancy rate by using a multivariable regression analysis.

Patient participation includes signing the consent and having additional tubes of blood drawn at a regularly scheduled blood draw. This blood is used to run the study tests (AMH and inhibin levels).

Eligibility criteria: Inclusion Criteria:

1. Women 38 years old or older at the time of initiating treatment

Exclusion Criteria:

1. Uterine disease: malformation, septum, submucosal myomas, endometrial polyps Advanced endometriosis with endometrioma (s)
2. No uterus
3. Single ovary

Primary outcomes:
measure: AMH levels as predictive of oocyte quality
timeFrame: within 3 months
measure: AMH levels as predictive of embryo quality
timeFrame: within 3 months
measure: AMH levels as predictive of implantation and pregnancy outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Reproductive Medicine Assoicates of New Jersey
state: New Jersey
city: Allentown
country: United States
facility: Reproductive Medicine Associates of PA at Lehigh Valley
state: Pennsylvania
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Paul A Bergh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04583033: Sleep Well for Healthy Brain
Official title: Lifestyle Stressors of Hippocampus and Alzheimer's Disease (AD) Related Brain Regions: Potential for Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Quality Sleep
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2020-10-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality.


Eligibility criteria: Inclusion Criteria:

* English-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. In addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment.

Exclusion Criteria:

* pregnant women
* cognitively impaired subjects not able to provide consent
* prisoners
* Subjects 55 years of age and older that meet criteria for mild cognitive impairment.
* Subjects with any neurological disorder.
* Any other condition that in the opinion of the investigator may affect the participation in this study

Primary outcomes:
measure: Rate of brain tissue volume loss in specific brain regions
timeFrame: Year 2
Secondary outcomes:
measure: Cognitive Performance
timeFrame: Year 2
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Noam Alperin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03635333: Effects of E-Cigarette Flavors on Adults TCORS 2.0
Official title: Effects of E-Cigarette Flavors on Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-08-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

Detailed description: This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.

Eligibility criteria: Inclusion Criteria:

* Ages 18-24 years or 35 -50 years
* Able to read and write
* Smoking \> 10 cigarettes or cigars/day
* Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
* Not seeking treatment to stop smoking
* No regular use of e-cigarettes

Exclusion Criteria:

* Daily use of other drugs including prescribed psychoactive drugs
* Any significant current medical or psychiatric condition
* Known hypersensitivity to propylene glycol
* Pregnant or lactating females

Primary outcomes:
measure: Change score in liking/wanting of e-cigarette
timeFrame: Baseline (+10 minutes) to end of lab session (+40 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC, Substance Abuse Center
state: Connecticut
Study officials:
References:
Clinical trial NCT02122133: CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
Official title: CARE: A Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intracranial Aneurysms
Keywords: IC aneurysms, coil embolization, PC 400, radiation exposure,
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-24
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.

Brief summary: The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms.
* Patients treated with conventional coils should be treated per their IFU.
* Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed.

Exclusion Criteria:

* Pre-planned use of multiple coil systems and/or flow diverters.

Primary outcomes:
measure: 1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].
timeFrame: At immediate post-procedure
measure: 2. Procedural serious adverse events
timeFrame: Procedural serious adverse events up until 3 days or discharge, whichever occurs first.
Secondary outcomes:
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
Study officials:
affiliation: Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004
name: Abhineet Chowdhary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04152733: Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population
Official title: Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Desaturation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 82
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population


Eligibility criteria: Inclusion Criteria:

* Children aged \<7 years
* ASA class I, II

Exclusion Criteria:

* Respiratory disease
* Pneumothorax
* Increased ICP
* Nasal bleeding
* Previous airway surgery
* Trauma
* Pulmonary hypertension

Primary outcomes:
measure: Incidence of desaturation
timeFrame: During deep sedation (during approximately 1 hour after propofol infusion)
Secondary outcomes:
measure: Minimum pulse oximeter value
timeFrame: During deep sedation (during approximately 1 hour after propofol infusion)
measure: Incidence of peripheral pulse oximeter value lower than 90%
timeFrame: During deep sedation (during approximately 1 hour after propofol infusion)
measure: Incidence of changes in oxygen flow (control group) or FiO2 (HF group)
timeFrame: During deep sedation (during approximately 1 hour after propofol infusion)
measure: percutaneous CO2 value
timeFrame: During deep sedation (during approximately 1 hour after propofol infusion)
measure: Oxygen reserve index value
timeFrame: During deep sedation (during approximately 1 hour after propofol infusion)
measure: Incidence of manual ventilation
timeFrame: During deep sedation (during approximately 1 hour after propofol infusion)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03156933: Alternative Splicing and Leukemia Initiating Cells
Official title: Alternative Splicing and Leukemia Initiating Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 11q23 acute myeloid leukaemia

Brief summary: Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML) are frequent. It have been shown that some splicing variants had a prognostic value in AML.

AML are characterized by their propensity to relapse because of the persistence of leukaemia initiating cells (LICs).

The aim of this study is to determine the splice variants on AML initiator cells and define a splicing pattern.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years-old
* Patients treated at the south lyon hospital center
* Patients with a diagnosis of acute myeloid leukemia confirmed in cytology and whose involvement of the 11q23 locus was confirmed by in situ hybridization
* Patients for whom a sample is available in the cytogenetic laboratory of the south lyon hospital center

Exclusion Criteria:

None

Primary outcomes:
measure: Polymerase chain reaction
timeFrame: 1 month
measure: Ribonucleic acid sequencing
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'hématologie du Centre Hospitalier Lyon Sud
Study officials:
affiliation: Service d'hématologie du Centre Hospitalier Lyon Sud
name: Etienne PAUBELLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00324233: Evaluation of Residual Urine After Intermittent Catheterisation
Official title: Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Residual urine
Hematuria
Ultra sound
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2006-05-10
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.


Eligibility criteria: Inclusion Criteria:

* Male
* 18 years and above
* A negative urine dip-stick
* Have signed informed written consent to participate

Exclusion Criteria:

* The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

Primary outcomes:
measure: Residual Urine Measured by Ultra Sound
timeFrame: 2
Secondary outcomes:
measure: Subjectively Measured Handling
measure: Subjectively Measured Insertion of the Catheter
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: København Ø
Study officials:
affiliation: Rigshospitalet, Denmark
name: Per Bagi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05455333: Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families
Official title: Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Infant Epilepsy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 75
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged ≤ 12 years, hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021.

Brief summary: To determine the paraclinical and therapeutic interest of genetic diagnosis in early onset epilepsy.


Eligibility criteria: Inclusion Criteria:

* Children aged ≤ 12 years,
* hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021.

Exclusion Criteria:

- Children with secondary epilepsy (with infection trauma)

Primary outcomes:
measure: Measurement of event densities
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Génétique Médicale IGMA - Hôpitaux Universitaires de Strasbourg
Study officials:
References: