louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05207683: Pulmonary Hypertension in Patients Attending Sohag University Hospital: A Focus on The Etiology
Official title: Pulmonary Hypertension in Patients Attending Sohag University Hospital: A Focus on The Etiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Pulmonary Hypertension
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pulmonary hypertension patients attending Sohag university hospital (either admitted in the hospital or attending the out patient clinics)

Brief summary: Assessment of pulmonary hypertension in patients attending Sohag university hospital ( in out patient clinic or in patient) focusing on the etiology of pulmonary hypertension


Eligibility criteria: Inclusion Criteria:

* patients who are 18 years old or more
* patients with pulmonary hypertension diagnosed with echocardiography

Exclusion Criteria:

* patient who are less than 18 years old

Primary outcomes:
measure: Detection of the causes of pulmonary hypertension in patients attending Sohag university hospital
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Prins KW, Thenappan T. World Health Organization Group I Pulmonary Hypertension: Epidemiology and Pathophysiology. Cardiol Clin. 2016 Aug;34(3):363-74. doi: 10.1016/j.ccl.2016.04.001.
citation: Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
citation: Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
Clinical trial NCT02885883: Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
Official title: Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Three groups of patients will be considered: a control group (n = 10); a group of patients with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will replace CT-scan usually performed in routine before the procedure (n = 15); a group of patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution 2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA relaxation times. Argus software will be used for post-treatment imaging. Quantitative data will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed between the three groups. Statistics will be performed with SPSS software in bilateral analysis and a value of p \< 0.05 will be considered as significant.


Eligibility criteria: Inclusion Criteria:

All persons \> 18 years, which have:

gp paroxysmal or persistant FA

1. paroxysmal or persistent FA (under one year),
2. refractory to at least one antiarrhythmic drug therapy
3. eligible for an ablation procedure with cryotherapy
4. the patient may benefit from surveillance. gp permanent FA permanent AF ( defined as chronic arrhythmia after 2 failed attempts to electrical cardioversion and / or more than one year old) , and hospitalized for cardiac reasons or not in different cardiology Timone .

Exclusion Criteria:

* age \< 18 years,
* cons -indications to MRI ( claustrophobia, pacemakers and implantable cardiac defibrillators , metal chips intra ocular , valvular mechanical prosthesis ) , allergy to gadolinium ,
* renal impairment ( creatinine clearance \<60 mL / min)
* pregnant or nursing ( a pregnancy test must be performed for women of childbearing age at the time of inclusion , the result of this test will be communicated to them .
* the MRI examination takes place three months after the inclusion women of childbearing potential should be placed under effective contraception)

Primary outcomes:
measure: quantitative measure of atrial fibrosis
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP HM
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT01740583: Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
Official title: A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: mitral valve, regurgitation, annuloplasty
Lead sponsor: Mitralign, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 50
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: The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

Detailed description: The ALIGN study is a single arm, prospective study. The objective of the study is to investigate the safety and performance of a catheter-based plication device intended to reduce the circumference of the dilated mitral valve. The study will enroll up to 50 subjects from up to 5 sites (Paraguay, Columbia, Dominican Republic, Brazil, and India) who will be followed for 36 months post index procedure. Enrollment is defined at the time the study device is inserted into the body and patients will be followed at 30 days, and Months 6, 12, 24 and 36 post index procedure.

Eligibility criteria: Inclusion Criteria:

* NYHA II-IV
* Structurally normal mitral valve
* At least Grade 2 mitral regurgitation
* Left ventricular ejection fraction not less than 20% and not greater than 45%
* Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm

Exclusion Criteria:

* Pregnant or lactating female
* Mitral stenosis
* Mod/severe aortic stenosis or regurgitation
* Mod/severe tricuspid stenosis or regurgitation
* Endocarditis
* Previous mitral valve repair or MV replacement
* Bioprosthetic or mechanical aortic valve
* Known unstable angina or MI within 30 days prior to procedure
* CVA within past 6 months
* Known contraindications to blood transfusion, contrast dye, DAPT

Primary outcomes:
measure: Major Adverse Events (MAE)
timeFrame: within 30 days post procedure
Secondary outcomes:
measure: Echocardiographic Outcomes
timeFrame: at 6 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Clinica CardioVID
state: Antioquia
city: Valle del Cauca
country: Colombia
facility: Antonio Dager, MD
state: Cali
city: Bordeaux-Pessac
country: France
facility: Bordeaux Heart University Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
city: Asuncion
country: Paraguay
facility: Sanatorio Italiano
city: Bielsko-Biala
country: Poland
facility: American Heart of Poland S.A.
city: Poznan
country: Poland
facility: Centrum Medyczne HZP
city: Warsaw
country: Poland
facility: Instytutem Kardiologii
Study officials:
affiliation: Sanatorio Italiano (The Italian Hospital)
name: Adrian Ebner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00853983: Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers
Official title: An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
ADME
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to show how the body absorbs, metabolises and excretes the drug \[14C\]AZD0530. As for all clinical trials, safety and tolerability of the drug will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Regular Daily Bowel movements
* Veins suitable for cannulation or repeated venepuncture

Exclusion Criteria:

* Presence of any clinically significant illness
* Abnormal vital signs
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Primary outcomes:
measure: To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530
timeFrame: Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose
Secondary outcomes:
measure: To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG
timeFrame: From time of consent to last visit
Other outcomes:
Locations:
city: Alderley Park
country: United Kingdom
facility: Research Site
state: Cheshire
Study officials:
affiliation: AstraZeneca, Clinical Pharamcology Unit, Alderley Park
name: Raj Chetty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Parklands, Alderley Park
name: Mary Stuart, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02503683: A Study of an Investigational Drug, ALN-AAT, in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease
Official title: A Phase 1/2, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Antitrypsin Deficiency Liver Disease
Keywords: RNAi therapeutic
AAT
Alpha-1 Antitrypsin Deficiency
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.


Eligibility criteria: Inclusion Criteria:

* Adequate complete blood counts, liver and renal function.
* 12-lead electrocardiogram (ECG) within normal limits
* Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization
* Male subjects agree to use appropriate contraception
* Willing to provide written informed consent and willing to comply with study requirements
* Nonsmokers for at least 5 years before screening

Exclusion Criteria:

* Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
* Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
* Active serious mental illness or psychiatric disorder requiring current pharmacological intervention
* History or evidence of alcohol or drug abuse within 12 months before screening.
* History of intolerance to SC injection

Primary outcomes:
measure: The safety of ALN-AAT evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation
timeFrame: Part A (SAD phase): through day 70; Part B (MAD) phase: through Day 154; Part C: through Day 224
Secondary outcomes:
measure: Profile of Pharmacokinetics (PK) of ALN-AAT
timeFrame: Part A (SAD) phase: up to 21 days; Part B (MAD) phase: up to 105 days; Part C: up to 161 days
measure: The effect of ALN-AAT on serum levels of AAT protein
timeFrame: Part A (SAD) phase: through day 70; Part B (MAD) phase: through Day 154; Part C: through Day 224
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology, Ltd.
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Patrick Haslett, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06169683: Lyric4 Outcomes Evaluation
Official title: Evaluation of Daily- and Extended-wear Hearing Instruments
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: hearing loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 28
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: The goal of this clinical investigation is to obtain feedback on Lyric4 device updates within a cohort of experienced adult Lyric hearing instrument users. The main question it aims to answer is:

• Do device updates cause a change in Lyric patient experience?

Participants will be asked to complete questionnaires about their past experience with Lyric, as well as their experience with Lyric during the study period. They will also be asked to undergo aided audiometric testing with Lyric devices.


Eligibility criteria: Inclusion Criteria:

* Experience with Lyric hearing instruments
* Willingness to travel to the study site and complete study procedures
* Adults, age 18 or older
* Fluency with English (written/spoken)

Exclusion Criteria:

* No Lyric hearing instrument experience
* Ear health issues preventing Lyric fitting or requiring medical clearance prior to fitting
* Difficulty reading when corrected for vision loss

Primary outcomes:
measure: Aided Audiometric Testing
timeFrame: From enrollment to the end of the study period, approximately one month.
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Sonova Silicon Valley
state: California
city: Cary
country: United States
facility: Triangle Hearing Services
state: North Carolina
Study officials:
References:
Clinical trial NCT06329583: Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry
Official title: Establishing Pressures at the Esophagogastric Junction During Diaphragmatic Breathing Using High-resolution Esophageal Manometry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux
Dysphagia
Esophageal Motility Disorders
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm.

Detailed description: This is a prospective, single-center study of adult (age ≥18 years) participants undergoing high-resolution esophageal manometry to assess the optimal method of diaphragmatic breathing. Included patients will complete two validated surveys, the Brief Esophageal Dysphagia Questionnaire (BEDQ) and the Gastroesophageal Reflux Disease Questionnaire (GERDQ). Patients will then undergo a standard protocol of supine and upright swallows with high-resolution manometry analyzed according to the Chicago Classification v4.0. After completion of the standard manometry protocol, participants will then perform a protocol assessing different techniques and positions for diaphragmatic breathing.

Eligibility criteria: Inclusion Criteria:

* patients undergoing high-resolution esophageal manometry

Exclusion Criteria:

* prior esophageal or gastric surgery
* chest tube
* major concomitant illness
* sinus disease precluding manometry placement
* history of heavy alcohol or tobacco use
* poor comprehension and/or fluency of English language
* inability or unwillingness of individual to give written informed consent

Primary outcomes:
measure: Pressure at the esophagogastric junction
timeFrame: Measured for each participant during high-resolution esophageal manometry. Data will be collected over the enrollment period of one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Andree Koop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00262483: Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C
Official title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Infected with hepatitis C virus

Exclusion Criteria:

* Contraindications to peginterferon or ribavirin therapy.

Primary outcomes:
measure: Safety of triple combination therapy.
timeFrame: retrospective and prospective
Secondary outcomes:
measure: Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.
timeFrame: retrospective and prospective
measure: Plasma HCV RNA levels
timeFrame: retrospective and prospective
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Call for information
state: Texas
city: Santurce
country: Puerto Rico
facility: Call for information
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00735683: A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety
Official title: Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Obesity
Keywords: Weight loss
Weight-loss drugs
Obesity
Overweight
Body weight
Diet
Metabolic Disorder
Nutrition Disorder
Lead sponsor: Healios K.K.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2008-08-15
Enrollment: 0
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 primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.

Detailed description: The rate of obesity in adults continues to increase. Obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. To date, the medication options to treat obesity have been limited.

This study will examine if a new investigational drug, ATHX-105 phosphate, may cause weight loss in humans over a 12-week period.

Eligibility criteria: Inclusion Criteria:

* Obese adults with a body mass index of 30-45 kg/m2

Exclusion Criteria:

* Pregnancy
* Diabetes
* Adults with serious or unstable current or past medical conditions

Primary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
Secondary outcomes:
measure: vital signs, lipids/glucose, waist circumference
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: