louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00618202: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two Period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So Ran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04263402: The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia
Official title: An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: 2019-nCoV Severe Pneumonia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 100
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: At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.


Eligibility criteria: Inclusion Criteria:

1.Meet the definition of severe pneumonia(Comply with any of the followings):

1. Shortness of breath,RR≥30 bpm;
2. In a resting state:SPO2≤93%;
3. PaO2/FiO2≤300mmHg.

2.2019-nCoV nucleic acid test was positive.

3.CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria:

1. dying state (i.e. survival time is less than 24 hours);
2. progressive malignant tumor with life expectancy less than 6 months;
3. immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
4. underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
5. pregnancy
6. patients with glucocorticoid taboos

Primary outcomes:
measure: Rate of disease remission
timeFrame: day 7
measure: Rate and time of entering the critical stage
timeFrame: day 7
Secondary outcomes:
measure: Rate of normal tempreture
timeFrame: day 7
measure: Rate of respiratory symptom remission
timeFrame: day 7
measure: Rate of lung imaging recovery
timeFrame: day 7
measure: Rate of laboratory indicator recovery
timeFrame: day 7
measure: Rate of undetectable viral RNA
timeFrame: day 7
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department and Institute of Infectious Disease
state: Hubei
Study officials:
References:
Clinical trial NCT03764202: Determination of Sufentanil in Breast Milk of Puerpera
Official title: Determination of Sufentanil in Breast Milk of Puerpera During Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determination of sufentanil in human breast milk during the administration of the sufentanil via the analgesic infusion pump and after the administration, to determine whether the breastfeeding after clinical anesthetic or analgesic administration has an effect on the infant and provide a reference for the security issues.

Detailed description: The concentration of sufentanil in milk was determined by LC-MS /MS method( liquid chromatography mass spectrometry).The separation was carried on Agilent ZORBAX Eclipse Plus C18 column(2.1×50 mm, 3.5 μm)with a mobile phase of 10 mmol ammonium formate(A)and methanol(B), and the elution conditions were optimized as follows：linear gradient 0→0.30 min, A:B=50:50; 0.30→0.31 min, A:B=50:50→10:90; 3.00→3.10 min, A:B=10:90→50:50; 3.1→6.5min, A:B=50:50; The flowing rate was 0.2 mL•min-1, column temperature was 30 ℃, injection volume was 5 μL. ESI source was applied and operated in positive ion mode. Quantitative determination was performed using multiple reaction monitoring (MRM) of m/z 387.2 → m/z 238.2 for sufentanil, and m/z 337.2 → m/z 158.2 for fentanyl.

Eligibility criteria: Inclusion Criteria:

* Aged 20yr to 38yr
* Height 155\~170 cm
* Weight 65\~85 Kg
* American Society of Anesthesiologists statuses I or II
* Normal cardiac and pulmonary function
* Undergoing elective Cesarean section
* Willing to provide breast milk

Exclusion Criteria:

* pregnancy induced hypertension
* gestational diabetes
* gestational heart disease

Primary outcomes:
measure: The concentration of sufentanil in human breast milk
timeFrame: 1 year
measure: The volume of human breast milk
timeFrame: 1 year
measure: The dose of sufentanil in human breast milk
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Zhang liangcheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01685502: Special Drug Use Investigation of Glucobay OD
Official title: Special Drug Use Investigation of Glucobay OD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Glucobay OD
Diabetes Mellitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-09-14
Enrollment: 2289
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glucobay OD naive diabetics. Patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

Brief summary: The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.


Eligibility criteria: Inclusion Criteria:

* Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)
timeFrame: Up to 1 year
measure: Decrease rate of HbA1c
timeFrame: Up to 1 year
Secondary outcomes:
measure: Body weight
timeFrame: up to1 year
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05477602: The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System
Official title: The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: electrophysiology
cardiac ablation
persistent atrial fibrillation
cycle length
Lead sponsor: CathVision ApS
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for a cardiac ablation for the treatment of persistent atrial fibrillation

Brief summary: Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.

Detailed description: A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.

Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.

The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
* Male or non-pregnant female aged ≥ 21 years.
* Able and willing to provide written informed consent prior to any clinical investigation related procedure.

Exclusion Criteria:

* Current participation in another investigational drug or device study that interferes with this study.
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
* Life expectancy less than 12 month, in the opinion of the Investigator.
* Subjects who, in the opinion of the investigator, are not candidates for this study.
* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Primary outcomes:
measure: Physician feedback on algorithm performance
timeFrame: One day - day of procedure
Secondary outcomes:
measure: Measurement of AF Cycle Length
timeFrame: One day - day of procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
Study officials:
References:
Clinical trial NCT01729702: Neurohormonal Parameters in Hypertrophic Cardiomyopathies
Official title: Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy
2- Obstructive Hypertrophic Cardiomyopathy
3- Non Obstructive Hypertrophic Cardiomyopathy
Keywords: 1- Hypertrophic cardiomyopathy
2- BNP
3- NT-proBNP
4- Neurohormons
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)

Detailed description: The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of MRI myocardial fibrosis with the degree of exercise functional limitation.

Eligibility criteria: Inclusion Criteria:

* - Age 18 to 75 years
* Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac MRI with gadolinium late-enhancement
* Informed consent
* Patient with a social insurance Patient at rest
* - Age 18 to 75 years
* Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive
* Informed consent
* Patient with a social insurance

Exclusion Criteria:

* - Insufficient echogenicity
* Permanent atrial fibrillation
* Complete BBB on the ECG
* LVEF \< 35 %
* Previous septal ablation (surgical or percutaneous)
* Simultaneous participation to another biomedical research

If exercise needed:

* contraindication to exercise : hemodynamic instability, uncontrolled high blood pressure (\>220/120 mmHg), severe aortic stenosis
* Inability to exercise (muscular, pulmonary, elderly patient)

Primary outcomes:
measure: Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
timeFrame: Day 1 at rest and during exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: HEGP - Paris
name: Albert Hagège, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01424202: Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation
Official title: Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-extubation Failure
Persistent Weaning Failure
Secretion Encumbrance
Weak Cough
Ventilatory Failure
Keywords: Post extubation failure
Mechanical Insufflation-Exsufflation
Noninvasive Ventilation
Weaning
Lead sponsor: Hospital Sao Joao
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.

In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.

Detailed description: Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.

Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology

Exclusion Criteria:

* facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.

Primary outcomes:
measure: re-intubation rates
timeFrame: 48 hours
Secondary outcomes:
measure: NIV failure rates
timeFrame: 48 hours
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João
Study officials:
References:
citation: Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
Clinical trial NCT00869102: Characterization of Beta Cell Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Metabolic Syndrome
Keywords: IGT
IFG
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to characterise beta cell function in subjects who despite taking part in a diabetes prevention program (life style intervention with diet and exercise) exhibit impaired glucose tolerance and beta cell dysfunction.

Detailed description: We have identified a subgroup of individuals with a good compliance to lifestyle intervention to prevent diabetes who lose body weight and increase insulin sensitivity, however they remain impaired glucose tolerant. These individuals show a deterioration in insulin secretory function.

We will identify a highly selected group of subjects with prediabetes that displays a large defect in insulin secretory function.We will study 50 individuals who display these characteristics and 50 subjects who do not display these characteristics. Their insulin secretion capacity in response to different secretagogues (glucose, GLP-1, arginine) will be studied. We expect to detect new pathophysiologic aspects that lead to beta cell failure particularly in this group.

Eligibility criteria: Inclusion Criteria:

* Impaired glucose tolerance
* BMI 16-40 kg/m²

Exclusion Criteria:

* chronic disease
* anemia
* therapy with insulin or cortisone

Primary outcomes:
measure: Insulin secretion
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen
Study officials:
References:
Clinical trial NCT05476302: Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic
Official title: Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
COVID-19
Mild Cognitive Impairment
Keywords: COVID-19
cognitive telerehabilitation
Parkinson's disease
Cognition
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease that, after eight months of COVID-19 lockdown when all interventions were suspended, received an intensive digital cognitive rehabilitation treatment.

Brief summary: Retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the Covid outbreak in subjects with Parkinson's disease.

Detailed description: Mild cognitive impairment is frequent among people with Parkinson's disease. Cognitive training seems effective on cognitive status and for mitigating anxiety and depression. With COVID-19 outbreak, such therapeutic interventions were delivered online. This retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in COVID times and based on the Parkinson's-Adapted Cognitive Stimulation Therapy, on cognitive domains and mood in 18 older people with Parkinson's disease.

Eligibility criteria: Inclusion Criteria:

* Parkinson disease: Hoehn \& Yahr's scale: 1-3 based on the UK PD Society Brain Bank
* mild cognitive impairment
* no cognitive training between March and October 2020
* presence of a family caregiver to access and use the online platform

Exclusion Criteria:

* other neurological diseases
* deep brain stimulation
* schizophrenia
* depression
* sensory deprivations that could interfere with the treatment

Primary outcomes:
measure: changes in cognitive status
timeFrame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
Secondary outcomes:
measure: changes in cognitive domains
timeFrame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
measure: changes in thymic state
timeFrame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
References: