louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01501331: Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients
Official title: Multiparametric Evaluation of Heart Failure in Device-implanted Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Cardiac Resynchronization Therapy
Internal Cardioverter Defibrillators
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
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: Consecutive patients implanted with an Energen device or successor using the RRT diagnostic tool

Brief summary: The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. The study will assess the respiratory trends correlation with clinically relevant heart failure events.


Eligibility criteria: Inclusion Criteria:

* Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted within the past 45 days with a Energen device or successor
* Able to provide written informed consent

Exclusion Criteria:

* Life expectancy \<12 months
* Anticipated non-compliance with the follow-up scheme
* Moderate to severe Chronic Obstructive Pulmonary Disease
* Primary pulmonary hypertension

Primary outcomes:
measure: Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)
timeFrame: 24 months
measure: Correlation of RRT with appropriate ICD therapy (ATP or Shock)
timeFrame: 24 months
measure: Correlation of RRT with atrial and ventricular arrhythmias
timeFrame: 24 months
Other outcomes:
Locations:
city: Milan
country: Italy
city: Rome
country: Italy
Study officials:
affiliation: University of Rome Tor Vergata
name: Giovanni B Forleo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rome Tor Vergata
name: Luca Santini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806531: Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Enterovirus 71 Vaccine
Keywords: vaccine
safety
Lead sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 20000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.


Eligibility criteria: Inclusion Criteria:

* Infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. And The legal guardian are willing to vaccination at his own expense.

Exclusion Criteria:

* History of allergy to any vaccine ingredient or gentamycin;
* Fever, or acute disease, or acute stage of chronic disease;
* Having serious chronic diseases, or allergic constitution;
* Refusal of follow-up for safety concern.

Primary outcomes:
measure: The rate of adverse reactions of enterovirus 71 Vaccine
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00040131: Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bile Duct Diseases
Biliary Tract Diseases
Gallbladder Diseases
Pancreatitis
Pancreatic Diseases
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-06-21
Enrollment: 316
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: The purpose of this study is to determine if a single dose of IL-10 compared to placebo is safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects with increased risk.


Eligibility criteria: Inclusion criteria:

Adults weighing up to 125 kg who are undergoing ERCP for any of the following:

* Evaluate recurrent abdominal pain;
* Evaluate unexplained recurrent pancreatitis;
* Evaluate prior post-ERCP pancreatitis;
* Treatment of pancreatic disorders;
* Treatment of Common Bile Duct Stones (without jaundice)

Exclusion criteria:

* Active (acute) pancreatitis;
* Chronic pancreatitis (moderate and severe cases);
* ERCP to perform a second procedure on biliary tract;
* Patients who previously had pancreatic sphincterotomy;
* Known or suspected pancreatic cancer or cancer of Papilla of Vater;
* Known or suspected other malignancy;
* History of, or current clotting or bleeding problems;
* Moderate and severe Anemia;
* Low platelet counts

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01279031: Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
Official title: Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Astigmatism
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.


Eligibility criteria: Inclusion Criteria:

* Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs.
* Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of \<2.00D as well as similar globe axial length as measured by the IOL Master of \<0.5mm).
* Visual potential of UCVA 20/25/ or better.
* Clear intraocular media other than cataract.

Exclusion Criteria:

* Clinically relevant differences between eyes in ocular disease or pathology.
* Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree.
* Asymmetrical use of ocular medications.

Primary outcomes:
measure: Visual acuity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Kerry Assil
state: California
Study officials:
References:
Clinical trial NCT04735731: Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment
Official title: Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emphysema
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

Brief summary: Rationale:

The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. Reducing the lung hyperinflation could improve the diaphragm function mechanically. One of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. To our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated.

Objective:

To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).

Study design:

Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.

Main study parameters: Change in diaphragm function 6 week after EBV treatment measured by ultrasound. The main outcome will be diaphragm motion (difference between maximum in- and expiration).


Eligibility criteria: Inclusion Criteria:

1. Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
2. Patient read, understood and signed the Informed Consent Form

Exclusion Criteria:

There are no exclusion criteria for this study.

Primary outcomes:
measure: Change in diaphragm motion measured by ultrasound
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Dirk-Jan Slebos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742531: Does Induction Dosage in Latent Phase Affect Active Phase of Labor?
Official title: Does Induction Dosage in Latent Phase Affect Active Phase of Labor?A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oxytocin
Induction of Labor
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the need of oxytocin therapy in active phase of labor. there will be two groups treating with oxytocin in latent phase.One group will be treated with low dose oxytocin therapy and the other group will be treated with high dose oxytocin therapy. oxytocin treatment will be ceased at the beginning of the active phase of labor. the need of oxytocin treatment in active phase of labor will be compared between two groups.

Detailed description: Oxytocin treatment in active phase of labour is used with respect to clinicians preference and best approach has not been described. We want to investigate the effect of oxytocin treatment by using different regims in latent phase of labor when oxytocin treatment is ceased in active phase of labour. In our trial we discontinued oxytocin in active phase of labour and investigate which group needs oxytocin therapy due to inadequate uterine contractions and arrest of labor.

Eligibility criteria: Inclusion Criteria:

* Live fetus in cephalic presentation, sonographically estimated fetal weight less than 4200 g, undergoing induction of labor at 37-42 weeks of gestation, having indications of labor, no previous uterine surgery

Exclusion Criteria:

* malpresentation, placenta previa, previous uterine surgery, multiple gestation, active genital herpes, non-reassuring fetal heart rate pattern

Primary outcomes:
measure: need for oxytocin retreatment
timeFrame: an average of one year
Secondary outcomes:
measure: length of active phase
timeFrame: an average of one year
measure: ratio of caesarean section
timeFrame: an average of one year
measure: total oxytocin dose
timeFrame: an average of one year
measure: APGAR scores
timeFrame: an average of one year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Education and Research Hospital
Study officials:
affiliation: Zeynep Kamil Education and Research Hospital
name: ahmet eser
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04430231: Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.
Official title: Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.: A COHORT STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 602
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had American Joint Committee on Cancer (AJCC) stage I through III confirmed adenocarcinomas were selected, with "colon" or "upper rectum" as their primary site of malignancy according to International Classification of Diseases for Oncology, Third Edition topography code.

Brief summary: This work is an original clinical research article describing the relationship between wait list tome for colorectal cancer patients and long-term survival. These findings are particularly relevant for management of surgical wait lists during crisis such as the Covid-19 pandemic. The lack of a relationship between wait list time and disease free survival and tendency for improved survival in the 4-6 week imply some colorectal cancer operations can be safely delayed during times of limited resources.

Detailed description: Background Surgical wait list time is a major problem in many health-care systems and its influence on survival is unclear. The aim of this study is to assess the impact of the wait list time on long term disease-free survival in patients scheduled for colorectal cancer resection.

Materials and Methods A prospective, single center study was carried out in patients with stage I-III colorectal cancer scheduled for surgery between 2012-2017 at a Colorectal Surgery Unit of a tertiary care center. Wait list time was defined as the time from completion of diagnostic workup and definitive surgery and divided into 2-week intervals from 2 to 6 weeks. The outcome variables were 2- and 5-year disease free survival. Screening for disease progression was with carcinoembryonic antigen levels and chest/abdominal computed tomography scan. Data was collected prospectively and subsequently analyzed.

Eligibility criteria: Inclusion Criteria:

* American Joint Committee on Cancer (AJCC) stage I through III confirmed adenocarcinomas
* With "colon" or "upper rectum" as their primary site of malignancy according to International Classification of Diseases for Oncology, Third Edition topography code.

Exclusion Criteria:

* Emergency surgery,
* More than one primary site,
* Synchronous metastasis or peritoneal carcinomatosis at the time of surgery
* If they received neoadjuvant chemoradiotherapy
* If they had a local transanal excision.

Primary outcomes:
measure: Disease-free overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02857231: Bioimpedance Spectroscopy Compared to CardioMEMS™
Official title: Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NYHA Class III Heart Failure
Keywords: Bioimpedance spectroscopy
Lead sponsor: ImpediMed Limited
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients who have a CardioMEMS device

Brief summary: Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.

Detailed description: This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.

Eligibility criteria: Inclusion Criteria:

Patient:

1. has an CardioMEMs device implanted
2. has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
3. is able to give informed consent

Exclusion Criteria:

Patient:

1. has pacemaker/ICD
2. is pregnant or breastfeeding
3. is an amputee
4. has been diagnosed with multiple medical conditions that would make participation burdensome
5. not able to co-operate with impedance measurements

Primary outcomes:
measure: Change from baseline in bioimpedance measurement at 4 weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic, John R. Anderson V Medical Pavilion
state: California
Study officials:
affiliation: Scripps Clinic
name: James T Heywood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Accardi AJ, Matsubara BS, Gaw RL, Daleiden-Burns A, Heywood JT. Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy. Front Cardiovasc Med. 2021 Apr 7;8:636718. doi: 10.3389/fcvm.2021.636718. eCollection 2021.
Clinical trial NCT04483531: Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
Official title: Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Access Program)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Progressive Familial Intrahepatic Cholestasis
Keywords: PFIC
pediatric
Cholestasis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-07-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed

Detailed description: Eligible patients will be enrolled into this expanded-access program and treated with an oral dose of 120 μg/kg/day of odevixibat and evaluated on an ongoing basis.

Eligibility criteria: Inclusion Criteria:

1. A male or female patient of any age, with a clinical diagnosis of PFIC, and with a body weight ≥5 kg at Screening visit
2. Patient must have a clinical diagnosis of PFIC
3. Patient must have clinically confirmed pruritus
4. Patient must have elevated serum bile acid levels, specifically measured to be ≥2 × the upper limit of normal (ULN) prior to start of medication
5. Patient and/or legal guardian must sign informed consent (and assent) as appropriate. Patients who turn 18 years of age (or legal age per country) during

Exclusion Criteria:

1. Patient is expected to have a liver transplant within 6 months of Screening
2. Decompensated liver disease, coagulopathy, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy
3. International normalized ratio (INR) \>1.4 (the patient may be treated with Vitamin K intravenously, and if INR is ≤1.4 at resampling the patient may be started on program medication)
4. Serum ALT \>10 × ULN at Screening
5. Serum ALT \>15 × ULN at any time point during the last 6 months unless an alternate etiology was confirmed for the elevation
6. Total bilirubin \>10 × ULN at Screening
7. Any patient who is pregnant, lactating, or planning to get pregnant
8. Patients who qualify for enrollment in other Phase 2 or Phase 3 trials intended to support marketing approval in PFIC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Albireo Pharma Inc.
state: Massachusetts
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03682731: Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria
Official title: Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythropoietic Protoporphyria
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 14
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with erythropoietic protoporphyria.

Brief summary: Background: Erythropoietic protoporphyria (EPP) is characterized by development of painful skin symptoms upon exposure to visible light dye to accumulation of the photoactive substance protoporphyrin IX (PpIX) in the skin.This study aimed to quantify the actual light exposure of patients with EPP during everyday life. The investigators further aimed to establish the associations between symptoms and light exposure, use of protective clothes, and erythrocyte PpIX concentration.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with erythropoietic protoporphyria
* Informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Actual light exposure
timeFrame: from April through June 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References: