louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00702117: Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Official title: Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Tachycardia, Ventricular
Brugada Syndrome
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 123
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates 3 different populations:

It is an open, randomized, parallel-group study comparing the effectiveness of intravenous (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :

1. recent-onset atrial fibrillation versus iv flecainide
2. sustained monomorphous ventricular tachycardia versus iv procainamide

The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of Brugada syndrome


Eligibility criteria: Inclusion Criteria:

* AF: Patients with isolated, idiopathic, sustained, symptomatic, recent onset(\>10 minutes to \<24 hours) atrial fibrillation.
* VT: Patients with ventricular tachycardia with good haemodynamic tolerability attending the emergency room or induced at the electrophysiology lab during testing for ventricular arrhythmias.
* Brugada Sd (BrS): First-degree relatives of a patient with Brugada Syndrome with a ECG non-diagnostic of the BrS.

Exclusion Criteria:

* General: Pregnancy
* AF: Pre-existing heart disease.
* Secondary AF
* 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block).
* LVF\<40%.
* Moderate-severe liver failure.
* AF with haemodynamic compromise.
* VT:VT with haemodynamic compromise.
* BrS:Pre-existing heart disease.
* 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block).
* Moderate-severe liver failure.

Primary outcomes:
measure: Proportion of patients with reversion of atrial fibrillation
timeFrame: 1 hour
measure: Proportion of patients with reversion of ventricular tachycardia
timeFrame: 15 min
measure: Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Donostia
country: Spain
facility: Hospital Donostia
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Servicio de Cardiología, Hospital Clínic
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References:
Clinical trial NCT02449317: Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast Induced-acute Kidney Injury
Official title: Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: X-ray Contrast Media Adverse Reaction
Keywords: contrast induced acute kidney injury
bioimpedance
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 56
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: PREVENTION

Brief summary: Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury

Detailed description: Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration for the prevention of contrast induced-acute kidney injury

Eligibility criteria: Inclusion Criteria:

1. Age 18-90 yr
2. Chronic kidney disease stage 3 \& 4 (eGFR 15-60 ml/min/m2)
3. elective cardiac catheterization

Exclusion Criteria:

1. Contrast media administration in the past 14 days
2. congestive heart failure (NYHA III-IV, ascites , pleuropericardial effusion ,severe valvular heart disease
3. Kidney transplant status or RRT
4. Emergency cardiac catheterization
5. Allergy to radiographic contrast media
6. Unstable renal function (change in serum creatinine ≥ 0.5 mg/dl or 25% within 14 days prior to the study
7. Not inform consent
8. left ventricular ejection fraction \< 40 %
9. Liver cirrhosis child B or C
10. Dosage of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker changed in past 2 wk

Primary outcomes:
measure: serum creatinine at 48-72 hours after contrast administration
timeFrame: 48-72 hr
Secondary outcomes:
measure: serum creatinine at 2 weeks after contrast administration
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ramathibodi hospital, Mahidol university
name: Arkom Nongnuch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02900417: Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes
Official title: Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
gut microbiota
sitagliptin
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the composition of gut microbiota before and after the therapy of sitagliptin.

Detailed description: The present study will included 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. These patients will receive 75g oral glucose tolerance test and fasting plasma glucose levels, lipids levels, fasting insulin levels and 2 hour post-load plasma glucose levels will be measured. Stool samples will be collected before the initiation of the use of sitagliptin. After 12 weeks, all patients will have fasting plasma glucose levels, lipids levels, fasting insulin levels tested. Stool samples will be collected again.

Eligibility criteria: Inclusion Criteria:

* Newly-diagnosed type 2 diabetic patients aged between 40-70 years

Exclusion Criteria:

* Any chronic disease (other than diabetes)
* Alcohol consumption/smoking
* Pregnancy/breastfeeding
* The use of antibiotics, pro-prebiotics within 3 months
* History of intestinal surgery

Primary outcomes:
measure: The changes of the composition of gut microbiota before and after the use of sitagliptin
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of HbA1c levels
timeFrame: 12 weeks
measure: Changes of fasting plasma glucose levels, lipids levels and insulin sensitivity
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02247817: A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Intraventricular Conduction Delay
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.


Eligibility criteria: Inclusion criteria

* NYHA class II-III.
* Left ventricular ejection fraction ≤ 35%.
* QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology.
* No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
* On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists.
* Age ≥ 18 years.
* Signed informed consent.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Coronary ischemia or a recent myocardial infarction (\< 6 months).
* Allready a CRT-device implanted.
* Venous thrombosis without options to reach the right heart.
* Presence of any other condition than HF with a life expectancy of \< 1 year.
* History of intrathoracic surgery.
* Presence or suspected presence of a noncompliant left lung.
* Participation in another intervention trial.
* Unable to understand Dutch language.
* Pregnant women.

Primary outcomes:
measure: Number of procedure related serious adverse events
timeFrame: 30 days after implantation of device
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03222817: HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
Official title: HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer Screening
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 10
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The proposed study will examine the implementation of a Human Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. The study will enroll participants to receive this cervical cancer screening intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.


Eligibility criteria: Inclusion Criteria:

* Self-identify as transgender male or as transmasculine

  * Assigned female sex at birth
  * English speaking
  * ages 25-65 years
  * report not having had a pap smear in the last three years
  * if age 30 and over, report not having a Pap smear/HPV co-test in the past 5 years

Exclusion Criteria:

* • Those who report having had a hysterectomy

  * Those who report having history of cervical cancer
  * Adults unable to consent
  * Those who are pregnant
  * Prisoners

Primary outcomes:
measure: Acceptability of HPV self-sampling Questionnaire
timeFrame: This questionnaire will be administered immediately after participants self-sample
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References:
Clinical trial NCT03436017: Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children
Official title: Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adhd
Keywords: adhd
metabolomics
child
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 89
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child or adolescent with symptoms of attention disorders and / or hyperactivity, aged from 6 to 15 years old, and consulting in current care in our university hospital

Brief summary: Attention-deficit with or without hyperactivity disorder (ADHD) is a real health public concern. No easy-use diagnosis tool are available. Metabolomic approaches has brought very usefull data in others neurological diseases like amyotrophic lateral sclerosis or autism spectrum disorder, as we had shown in previous studies. Targeting on neurotransmitter pathways involving in ADHD, metabolomic screening could help to enhance our diagnosis power to better help numerus of children. We propose to study the phenylalanine and the tyrosine pathways with a multimodal metabolomic approach, in easy-available biological fluid (blood and urine), in child or adolescent suspected of ADHD. Our objectives are: 1- to determine a specific metabolomic signature of ADHD 2- to compare the diagnostic value of this metabolomic signature with the reference methodology for ADHD diagnosis, as now practiced in our reference center for learning troubles.


Eligibility criteria: Inclusion Criteria:

* Child or adolescent with symptoms of attention disorders and / or hyperactivity
* aged from 6 to 15 years old

Exclusion Criteria:

* Failure or refusal of all or part of the multidisciplinary evaluation (medical and / or neuropsychological assessments and / or biological assessments)
* Identification of an intercurrent condition likely to have an impact on metabolomic analyzes (acute infection, fever, etc.)
* Parents or legal guardians opposed to data processing

Primary outcomes:
measure: ADHD metabolomic's signature of blood
timeFrame: At baseline
measure: ADHD metabolomic's signature of urine
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital TOURS
Study officials:
affiliation: CHU Tours
name: Pierre CASTELNAU, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05129917: Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise
Official title: The Anti-fatigue Effect of Gojinsen® Drink
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Addiction
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the present study is to determine the effects of acute and short-term (14 days) ginseng combined with branch chained amino acids supplementation on endurance exercise performance and the ability of anti-fatigue. In addition, this study also measured the performance of continuous attention during recovery period to examine the effect of supplementation on central fatigue.

Detailed description: Muscle fatigue was a common problem after exercise. When fatigue occured, body functions were affected and changed. Changbai Mountain ginseng had higher anti-fatigue substances than general commercial ginseng. And recent studies had showed that the supplementation of branched chain amino acids (BCAA), including leucine, isoleucine and valine, can increase attention and reduce fatigue. However, its effect on Changbai Mountain ginseng combined with BCAA was still unclear. Subjects were allocated to Gojinsen® drinks and placebo group (1:1 ratio) for 14 days, and then examined by maximal oxygen consumption, time to exhaustion, rating of perceived exertion (RPE), oxygen saturation (SPO2) , blood lactate concentration, and continuous attention performance test (CPT II). The Gojinsen® group significant increased maximal oxygen consumption, time to exhaustion, and attention compared to placebo group. Moreover, the Gojinsen® group significant decreased lactate concentration and fatigue compared to placebo group. By this study, Gojinsen® drinks did not showed absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for people suffering from exercise fatigue.

Eligibility criteria: Inclusion Criteria:

1. healthy male and female adults aged 20-25 years old .
2. without heart, liver, kidney, endocrine or other major organic diseases).
3. had at least 3 months experience in performing exercise

Exclusion Criteria:

1. BMI of the study subjects must be less than 25.

Primary outcomes:
measure: Endurance exercise performance testing
timeFrame: Execution on the 14th day
measure: rating of perceived exertion
timeFrame: Execution on the 14th day
measure: blood lactate
timeFrame: Execution on the 14th day
measure: Continuous attention performance test
timeFrame: Execution on the 14th day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pingtung University of Science and Technology
name: Bo han Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06883617: Neurostimulation for Sleep Disordered Breathing
Official title: The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disordered Breathing (SDB)
Sleep Apnea
Lead sponsor: Lunair Medical
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First-in-Human, prospective, multicenter, single arm, feasibility clinical study
Primary purpose: OTHER

Brief summary: This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.


Eligibility criteria: Inclusion Criteria:

* Subject does not tolerate, not compliant to or have access to alternative Sleep Disordered Breathing treatments
* Subject has moderate to severe sleep disordered breathing as diagnosed by PSG

Exclusion Criteria:

* Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
* Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate
* Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.
* Subject has a need for chronic supplemental oxygen therapy for any reason
* Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness
* Subject has severe chronic kidney disease
* Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study.
* Subject conducts work or regular activities requiring vigilance
* Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.
* Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices
* Subject has an active systemic infection at time of implant.
* Subject has clinical evidence of immunodeficiency.
* Any condition likely to require future MRI or diathermy
* Subject is pregnant
* Subject has a severe nasal obstruction that could restrict airflow
* Subject has any trauma to the upper airway
* Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.

Primary outcomes:
measure: Safety Endpoint - assessment of procedure or device related adverse events
timeFrame: enrollment to 12 months post-implant
Secondary outcomes:
measure: Improvement in sleep disordered breathing per sleep study
timeFrame: six months, 12 month and 24 months post implant
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Sanatorio Americano
Study officials:
References:
Clinical trial NCT02886117: Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative
Official title: Creation and Evaluation of a Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Assessment of Hemostasis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 2511
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: General population coming in programmed anesthesia consultation

Brief summary: The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.

Detailed description: Recent recommendations formalized by experts of the French society of anaesthesiology on systematic pre-interventional examinations recommend assessing the risk of bleeding from personal and family history of bleeding diathesis and after physical examination . They recommend not to prescribe a systematic hemostasis laboratory tests in patients with a history and physical examination do not suspect a disorder of hemostasis.

However, there is currently no validated questionnaire in the general population to assess the preoperative bleeding risk allowing a reliable assessment of the personal and family bleeding diathesis.

The establishment of a structured questionnaire, the patient could filled before surgery consultation to guide the possible prescription of a balance sheet, could meet the new recommendations.

It seems therefore important to establish this type of questionnaire in order to optimize the operation of the structure, and to limit the requirements of routine hemostasis balance sheets. To do this, the investigator wants to carry out a preliminary study to ensure the interest of the established questionnaire.

The questionnaire assessed in this study is drawn from existing specialized questionnaires, the description of hemostasis disorders described factor for deficits from the doctor in charge of hemophilia expertise center and expertise of a psychologist, to refine best.

Eligibility criteria: Inclusion Criteria:

* All adults addressed in programmed anesthesia consultation, regardless of whether surgery and consultation site

Exclusion Criteria:

* Patients minors
* Physical or mental disability in Patient to agree and complete the questionnaire
* Major patients undergoing a protective measure
* Refusal of participation

Primary outcomes:
measure: hemostasis tests (normal or abnormal)
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Yves Ozier, Professor
role: PRINCIPAL_INVESTIGATOR
References: