louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00195416: Study Investigating Enbrel Treatment for Ankylosing Spondylitis
Official title: A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 526
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: Primary care clinic, secondary and tertiary medical centers

Brief summary: To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

1. Unknown adverse reactions, especially serious adverse reactions
2. Change of the incidences of adverse reactions under the routine drug uses
3. Factors that may affect the safety of the drug
4. Factors that may affect the effectiveness of the drug


Eligibility criteria: Inclusion Criteria:

* Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

Exclusion Criteria:

* Patients with known hypersensitivity to Enbrel or any component of the product
* Patients with sepsis or risk of sepsis
* Patients with active infections including chronic or localized infections such as tuberculosis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gyunggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02158416: Platelet Products Tested With the ThromboLUX® Platelet Quality Test
Official title: Blinded Study on Consecutive Transfusable Platelet Products Tested With the ThromboLUX® Platelet Quality Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poor Platelet Transfusion Outcome
Keywords: platelet
transfusion
ThromboLUX
corrected count increment
thrombocytopenic
Lead sponsor: LightIntegra Technology
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of adults who require treatment of a blood cancer with platelet transfusion(s). Patients will be stable and thrombocytopenic, however treatment center will intervene for bleeding. Adult hematology-oncology outpatients.

Brief summary: The planned minimal risk study is a blinded study on consecutive transfusable platelet products. The aim of the study is to evaluate the quality of platelet components sampled prior to transfusion.

The primary patient transfusion outcome in this study is the 1-hour corrected count increment (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be sampled for ThromboLUX testing before being sent from the blood bank to the treatment center. After receipt at the treatment center, the platelet products will be used as per regular clinical practice, and the outcome data from each patient will be collected. At the end of the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX Score is associated with a poor transfusion outcome.

During the course of the study, the TLX Score will not be known to the clinicians, or utilized in any way to decide if the platelet product should be transfused.


Eligibility criteria: Inclusion Criteria:

* adult hematology-oncology outpatients
* stable and thrombocytopenic

Exclusion Criteria:

* age \<18 yrs
* splenomegaly
* unable to provide informed consent
* pregnancy
* acute promyelocytic leukemia
* ITP (Idiopathic thrombocytopenic purpura)
* HUS

Primary outcomes:
measure: TLX Score Correlation with CCI
timeFrame: Patients are expected to be enrolled for an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Monter Center
state: New York
Study officials:
affiliation: Northwell Health
name: William A Heaton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04172116: Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass
Official title: Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass: Comparing Tissue Glucose Levels Between Two Surgical Bypass Methods - a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Continuous Glucose Monitoring
Roux-en-y Gastric Bypass
Hypoglycemia
Keywords: metabolic surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-11-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Of each bariatric-metabolic operation we plan to include 34 patients. Of these 34 patients we plan to include also patients in each group with a diagnosed Diabetes mellitus type II at the time of operation (defined by either HbA1c \>6.5 or any medication or impaired fasting blood glucose level)

1. Roux-en-y gastric bypass with long ang narrow pouch ("long pouch RYGB")
2. Roux-en-y gastric bypass with short and broad pouch ("short pouch RYGB")

Patients in the two RYGB groups will be matched for sex, age, comorbidities and BMI at the time of operation.

Brief summary: This study evaluates the difference in post prandial tissue glucose levels between two variation of Roux-en-Y Gastric bypass by continuous glucose monitoring.


Eligibility criteria: Inclusion Criteria:

1. Patients who underwent bariatric-metabolic surgery at the Medical University of Vienna in the years 2012-2016 for the "long and narrow" pouch group
2. Patients who underwent bariatric-metabolic surgery at the Clinic of Hollabrunn in the years 2010- 2012 for the "short and wide" pouch group
3. Patients on oral medication for diabetes mellitus (for subgroup assessment)
4. Stable weight (not more than + 15kg from lowest weight postoperatively)
5. Stable BMI

Exclusion Criteria:

1. Unable to give written informed consent
2. Patients with methods other than RYGB
3. Reoperation within the observed period
4. Any intervention changing pouch size or diameter of the anastomosis after the initial operation
5. Known allergy to oral contrast agent
6. Any regular intake of medication interfering with blood glucose levels

Primary outcomes:
measure: Tissue glucose levels
timeFrame: 6 days
Secondary outcomes:
measure: tissue vs. blood glucose levels
timeFrame: 1 day
Other outcomes:
Locations:
city: Hollabrunn
country: Austria
facility: Landesklinikum Weinviertel Hollabrunn
Study officials:
affiliation: Medical University of Vienna
name: Gerhard Prager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267916: Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity
Official title: Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity. Influence of Low Respiratory Rate With Unchanged Minute Volume.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Laparoscopic Cholecystectomy
Keywords: intrinsic positive end-expiratory pressure
obesity
ventilator setting
respiratory rate
Lead sponsor: Seoul Medical Center
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine position. The investigators tried to investigate the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

Detailed description: Impaired gas exchange is a common anesthetic problem in obese subjects. It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEPi) is present in grossly obese subjects especially in the supine position. It is known that there is a significant negative correlation between PEEPi present and PaO2. Therefore, the investigators postulated that if the reduce the PEEPi by reducing the respiratory rate in obese subjects, the impaired gas exchange might improve.

The investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

Eligibility criteria: Inclusion Criteria:

* ASA class I or II obesity, Body-mass index \> 27.5 undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* patients with severe cardiopulmonary disease peak inspiratory pressure \> 40 in the study setting

Primary outcomes:
measure: Gas change parameters
timeFrame: 15 minute interval
Secondary outcomes:
measure: intrinsic positive end-expiratory pressure
timeFrame: every 15 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
References:
Clinical trial NCT03857516: MultipOlar Left Ventricular Electrode Instability Trial
Official title: Multipolar Left Ventricular Electrode Instability Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pacemaker Electrode Lead Displacement
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving cardiac resynchronization therapy according to guidelines with the implantation of a multipolar left ventricular lead.

Brief summary: Characterization of pacing thresholds in available pacing vectors of quadripolar leads used for cardiac resynchronization therapy in a short term follow-up.

Detailed description: Multipolar left ventricular leads are increasingly used in cardiac resynchronization therapy. Lead dislodgment requiring re-intervention is rare. However, data on minor lead movements which may affect pacing capabilities and application of new pacing algorithms is scarce. Aim of the study is to characterize pacing thresholds of each of the implanted electrodes on quadripolar leads in a short term follow-up.

Eligibility criteria: Inclusion Criteria:

* De novo implantation of left ventricular multipolar leads.

Exclusion Criteria:

* Cardiogenic shock
* Device infection
* Revision for previously dislodged left ventricular lead
* Age below 18 years
* Pregnancy
* Patients under tutelage

Primary outcomes:
measure: Microdislodgement of leads
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Deutsches herzzentrum Muenchen
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Christof Kolb, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05842616: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:
Official title: Norepinephrine Titration In Patients With Sepsis Induced Encephalopathy: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Norepinephrine
Encephalopathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 112
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 aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.

Detailed description: Sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. It appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Must had clinical diagnosis of sepsis induced encephalopathy.

Exclusion Criteria:

* Refusal to participate in the study.
* Cerebral infection.
* Known cerebral lesions (Neoplasm, Traumatic brain injury, Stroke, Ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure).
* Known severe carotid stenosis (\>70％).
* Intoxication due to drugs.
* Pregnancy.
* Patients supported by intra-aortic balloon pumb (IABP).

Primary outcomes:
measure: Intensive care unit (ICU) mortality
timeFrame: 28 day or till death which earlier
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: 24 hours
measure: Norepinephrine titration
timeFrame: 24 hours
measure: Cerebral perfusion pressure
timeFrame: 24 hours
measure: Outcome of encephalopathy
timeFrame: 28 day
measure: SOFA score
timeFrame: Up to 4 weeks.
measure: Length of ICU stay
timeFrame: At least 28 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Elgharbia
Study officials:
affiliation: Assistant lecturer
name: Mai S Aboshaara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05226416: Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection
Official title: Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection (ACTIV4)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Chronic Heart Failure
Diabetes Mellitus
Chronic Kidney Diseases
Ischemic Heart Disease
Arrythmia
Hypertensive Heart Disease
Overweight and Obesity
Oncology
Ischemic Stroke
Myocardial Infarction
Atrial Fibrillation
DVT
Stroke
Copd
Asthma
Pulmonary Embolism
Anemia
Myocarditis
Keywords: covid-19
ACTIV
Chronic Heart Failure
Ischemic Heart Disease
Hypertensive Heart Disease
Chronic Kidney Diseases
Atrial Fibrillation
Myocarditis
Lead sponsor: Eurasian Association of Therapists
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 3554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anonymized male and female patients over 18 years hospitalized with COVID-19 during the fourth wave of novel coronavirus disease.

Brief summary: Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients.

Detailed description: Assessment of hospital course and health status during 3, 6, 12 months after discharge in COVID-19 patients in cohorts with comorbidities and without comorbidities. Evaluation of comorbidity impact to severity of novel coronavirus disease and comorbidity impact to demand for medical care.

Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed COVID-19

Exclusion Criteria:

* Age under 18 years.
* Refusal to be involved in study;

Primary outcomes:
measure: death for any cause
timeFrame: From date of hospitalization until the date of first documented date of death from any cause, assessed up to 12 months
measure: hospitalization for any cause
timeFrame: 12 months after discharge
Secondary outcomes:
measure: onset of any disease diagnosed 1 year after discharge
timeFrame: 1 year after discharge
measure: rate of demand for medical care
timeFrame: 1 year after discharge
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Eurasian Association of Therapists
Study officials:
affiliation: Eurasian Association of Therapists
name: Alexander Arutyunov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594016: Expanded Access to Fosigotifator
Official title: Expanded Access to Fosigotifator
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Vanishing White Matter
Cree Leukoencephalopathy
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Fosigotifator
FGT
ABBV-CLS-7262
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-09-19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Fosigotifator prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06258135: At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
Official title: At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: FrieslandCampina
First posted: 2024-02-14
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years).


Eligibility criteria: Inclusion Criteria:

* Typically developing, healthy male or female aged 6-14 years
* Access to home laptop/ personal computer

Exclusion Criteria:

* Current clinical levels of anxiety and/or co-morbid psychological diagnoses
* Neuro/developmental disorders
* Gastro-intestinal problems or disease
* Restrictive diets (e.g., lactose intolerance, gluten free)

Primary outcomes:
measure: Changes in trait anxiety.
timeFrame: End of treatment (4 weeks), Follow up (8 weeks).
measure: Changes in emotion processing.
timeFrame: End of treatment (4 weeks), Follow up (8 weeks).
Secondary outcomes:
measure: Changes in depression.
timeFrame: End of treatment (4 weeks), Follow up (8 weeks).
measure: Changes in attention networks.
timeFrame: End of treatment (4 weeks), Follow up (8 weeks).
measure: Changes in nutrient intake
timeFrame: End of treatment (4 weeks), Follow up (8 weeks).
Other outcomes:
measure: Parental anxiety: covariate of child outcome.
timeFrame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
measure: Parental emotion processing: covariate of child outcome.
timeFrame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
measure: Parent depression
timeFrame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
measure: Parent attention networks
timeFrame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
state: Surrey
Study officials:
References:
Clinical trial NCT01202435: An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule
Official title: An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 82.5 Mg Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 25 Mg Of The Immediate Release Formulation Administered Three Times Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 82.5 mg CR and 25 mg IR capsule given 3 times daily (total daily dose 75 mg)
timeFrame: 5 days
Secondary outcomes:
measure: Safety endpoints include evaluation of adverse events
timeFrame: 5 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2.