louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02134574: Prospective Cohort With Hemopathy in Languedoc-Roussillon
Official title: Prospective Cohort Study of Clinical and Laboratory Data of Patients With Hemopathy in Languedoc-Roussillon
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Malignancy
Keywords: Lymphoma,
leukemia,
multiple myeloma,
hodgkin disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 500
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: patient for suspected haematological disease and justifying further exploration

Brief summary: Prospective Cohort Study of clinical and laboratory data of patients with hemopathy.

Detailed description: Prospective Cohort Study of clinical and laboratory data of patients with hemopathy in LR.

Eligibility criteria: Inclusion criteria:

* Age over 18
* Consultant or hospitalized patient for suspected malignant hemopathy and justifying further exploration or patient with a diagnosis of malignant hemopathy less than 6 months old at the time of signing the consent
* Having signed an informed consent
* Affiliated with a social security scheme

Exclusion criteria:

* Minor or major protected
* Patients who have received treatment for hematological pathology

Primary outcomes:
measure: Survival with 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Survival with 5 years
timeFrame: 5 years
measure: Survival with 10 years
timeFrame: 10 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hematology department - UHMontpellier Saint éloi
Study officials:
affiliation: University Hospital, Montpellier
name: GUILLAUME CARTRON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012674: Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Official title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Arterial Diseases
Keywords: carotid or vertebral artery disease
Contrast agent
MRA
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed description: Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA

Eligibility criteria: Inclusion Criteria:

* Male or female, aged more than 18 years
* Strongly suspected of having carotid or vertebral arterial disease
* Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination

Exclusion Criteria:

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²)
* Contraindication to MRI
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Primary outcomes:
measure: Technical Failure Rate
timeFrame: 2 - 28 days
measure: Sensitivity
timeFrame: 2-42 days
measure: Specificity
timeFrame: 2 - 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Guerbet LLC
state: Indiana
Study officials:
affiliation: Guerbet
name: Pierre DESCHE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01463774: A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
Official title: Pivotal BE CANA/MET IR FDC - Low Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Bioequivalence
Canagliflozin (JNJ-28431754)
Metformin
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-11-02
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

Detailed description: This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 30 kg/m² inclusive and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator

Primary outcomes:
measure: Canagliflozin plasma concentrations
timeFrame: Up to 72 hours
measure: Metformin plasma concentrations
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Adverse events
timeFrame: Up to approxmately 23 days
measure: Changes from baseline in clinical laboratory test results
timeFrame: Up to approximately 23 days
measure: Vital Signs
timeFrame: Up to approximately 23 days
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC L.LC. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02858674: Health Information Technology in Heart Failure Care
Official title: Health Information Technology in Heart Failure Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 958
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this proposal is to develop, implement, and test the effectiveness of a computerized clinical decision support system for hospitalized patients with heart failure.

Aim 1: Develop an electronic health record (EHR) based search method that uses both structured data and natural language processing of unstructured text to identify hospitalized patients with heart failure while they are still in the hospital.

Aim 2: Develop and test the usability of an electronic health record (EHR) based clinical decision support system (CDSS) to support delivery of evidence-based care to hospitalized heart failure patients using human computer interaction methods.

Aim 3: Assess the effect of an electronic health record (EHR) based clinical decision support system (CDSS) on processes of care for heart failure patients who are hospitalized for other causes. As part of the evaluation, we will test two implementation strategies, one of which will introduce the CDSS as an interruptive alert to providers, the second of which will introduce the CDSS as part of a provider checklist that exists on the side of the screen for each patient.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized 2 years prior and 18 months after the time of implementation of the Computerized clinical decision support systems (CDSS) in the (Electronic Health Record (EHR).

Exclusion Criteria:

* Patients on the obstetrical service, who died during hospitalization, or on hospice care.

Primary outcomes:
measure: Percent of Patients with a Secondary Diagnoses of Heart Failure
timeFrame: 90 Days
measure: Percentage of patients with a secondary diagnosis of heart failure and LV systolic dysfunction who have been prescribed an Angiotensin-converting enzyme (ACE) inhibitor or Angiotensin II receptor blockers (ARB)
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Saul Blecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blecker S, Austrian JS, Horwitz LI, Kuperman G, Shelley D, Ferrauiola M, Katz SD. Interrupting providers with clinical decision support to improve care for heart failure. Int J Med Inform. 2019 Nov;131:103956. doi: 10.1016/j.ijmedinf.2019.103956. Epub 2019 Sep 4.
Clinical trial NCT04397874: Maternal Perception of Fetal Movements Evaluation Using and Analyzing the Variables of Antepartum Computerized Cardiotocography: An Exploratory Study.
Official title: Maternal Perception of Fetal Movements Evaluation Using and Analyzing the Variables of Antepartum Computerized Cardiotocography: An Exploratory Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fetal Movement
Keywords: Fetal movement
Fetal activity
fetal assessment
fetal well-being
Computerized cardiotocography (cCTG)
Fetal heart rate (FHR)
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physiological nonlaboring term singleton pregnancies

Brief summary: Several studies analysed the association of fetal movement counting with perinatal mortality and fetal outcomes. However, no one examined the relationship of the maternal perception of fetal movement with the fetal wellbeing quantifies through computerised cardiotocography.

Our study evaluates the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.


Eligibility criteria: Inclusion Criteria:

* nonlaboring term singleton pregnancies (37 0/7 - 41 6/7 weeks of gestation)

Exclusion Criteria:

* fetal malformations, stillbirths, preterm deliveries

Primary outcomes:
measure: To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.
timeFrame: External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
state: Italia
Study officials:
References:
Clinical trial NCT05738174: High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction
Official title: Theta Burst Zur Behandlung Der Alkoholabhängigkeit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Dependence
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 72
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 is a two-arm randomized placebo-controlled trial in which 72 patients with alcohol addiction are treated with high-dose accelerated intermittent theta burst stimulation (TBS).


Eligibility criteria: Inclusion Criteria:

* alchohol dependence according to ICD-10 (F10.2)
* desire to reduce or abstain from alcohol drinking
* male or female
* 18-65 years
* residency in Germany, German speaking
* written informed consent

Exclusion Criteria:

* contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker)
* relevant neurological or internistic diseases according to study investigator
* treatment with TMS in the past
* participation in other trials during treatment
* pregnancy or breatfeeding
* positive breath test for alcohol
* legal care and placement in a psychiatric hospital
* co-medication with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefene
* acute psychiatric comorbidity that requires inpatient treatment or medication readjustment (\<1 month)
* severe chronic psychiatric illness (schizophrenia, schizoaffective disorder, bipolar disorder)
* patients who are unable to complete study questionnaires or follow-up questionnaires (in the opinion of the investigators)

Primary outcomes:
measure: Craving visual analoge scale
timeFrame: one week
Secondary outcomes:
measure: Craving visual analoge scale
timeFrame: 13 weeks
measure: relapse (number of patients with alcohol relapse)
timeFrame: 13 weeks
measure: heavy drinking days
timeFrame: 13 weeks
measure: abstinence confidence
timeFrame: 13 weeks
measure: degree of dependence
timeFrame: 13 weeks
measure: Fagerström Test for Nicotine Dependence
timeFrame: 13 weeks
measure: major depression inventory
timeFrame: 13 weeks
measure: World Health Organisation quality of life bref
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Regensburg
Study officials:
affiliation: University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
name: Berthold Langguth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575874: Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose and Active Comparator-Controlled Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: rivoglitazone HCl
pioglitazone HCl
thiazolidinedione
peroxisome proliferator-activated receptor gamma (PPAR gamma)
type 2 diabetes mellitus
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-12-18
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* HbA1c \>6.5% and \<10.0%
* FPG \>126 mg/dL (7 mmol/L) and \< 270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of type 1 diabetes
* History of ketoacidosis
* Current insulin therapy
* C-peptide \<0.5ng/mL
* Imparied hepatic function
* NYHA Class II-IV cardiac status or hospitalization for CHF or EF\<40%
* uncontrolled hypertension

Primary outcomes:
measure: Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to that for placebo. Change in HbA1c from baseline compared to that for pioglitazone HCl
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
Study officials:
References:
Clinical trial NCT03911674: Effects of Oral Stimulation in Preterm Infants
Official title: Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premature Infant
Eating Disorder
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 48
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention.

The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.


Eligibility criteria: Inclusion Criteria:

* Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria:

* Instability caused by respiratory, cardiac or gastrointestinal issues
* Orofacial malformations.

Primary outcomes:
measure: Gestational age at the initiation of oral feeding
timeFrame: Up to 46 weeks
measure: Weight at discharge (g)
timeFrame: Up to 46 weeks
measure: Height at discharge (cm)
timeFrame: Up to 46 weeks
measure: Head circumference at discharge (cm)
timeFrame: Up to 46 weeks
measure: Days of enteral nutrition
timeFrame: Up to 46 weeks
measure: Gestational age at discharge (weeks)
timeFrame: Up to 46 weeks
measure: Total length of hospitalization
timeFrame: Up to 46 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CEU San Pablo University
state: Comunidad De Madrid
Study officials:
References:
Clinical trial NCT02756065: Connectomics in Psychiatric Classification of Bipolar Disorder and Schizophrenia
Official title: Connectomics in Psychiatric Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Schizophrenia
Keywords: Bipolar
schizophrenia
schizoaffective
Lead sponsor: Washington University Early Recognition Center
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals between the ages of 18-30 with a diagnosis of Bipolar Disorder or Schizophrenia

Brief summary: Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with bipolar disorder and schizophrenia.

Detailed description: This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 18-40 years who have a diagnosis of either schizophrenia/schizoaffective disorder or bipolar disorder, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Eligibility criteria: Inclusion Criteria:

* Between ages 18-30

Exclusion Criteria:

* Head Injury
* Unstable Medical Condition

Primary outcomes:
measure: MRI Brain Imaging
timeFrame: within one month of study enrollment
Secondary outcomes:
measure: DNA testing through saliva
timeFrame: within one month of study enrollment
measure: Hair sample for cortisol measurement
timeFrame: within one month of study enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Daniel Mamah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01593865: The Catholic University BIMA Grafting Study
Official title: Observational, Case-Control, Propensity-Matched Study of Bilateral Versus Monolateral Internal Mammary Artery Grafting for Severe Coronary Artery Disease. Assessment of Feasibility of Systematic Bilateral Mammary Artery Grafting and Early/Late Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multivessel Coronary Artery Disease
Keywords: Coronary Artery Bypass Grafting
Mammary Artery Grafts
Bilateral Mammary Artery Grafting
Clinical Outcomes
Lead sponsor: Catholic University, Italy
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target study population consists of 1,000 patients undergoing isolated coronary surgery for multivessel disease within a Cardiac Surgery University Department.

Brief summary: The present study hypothesizes that the systematic use of bilateral internal mammary artery (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for the treatment of multivessel coronary artery disease (primary hypothesis). The secondary study hypothesis is that the BIMA grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.


Eligibility criteria: Inclusion Criteria:

* Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery

Exclusion Criteria:

* Emergency status
* Previous cardiac operation
* Any associated cardiac procedure other than CABG Surgery
* Left Ventricular Ejection Fraction \<20%

Primary outcomes:
measure: Feasibility of systematic BIMA grafting
timeFrame: 2012-2014 (2 years)
Secondary outcomes:
measure: Clinical results at follow-up
timeFrame: 2012-2016 (4 years)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario "A. Gemelli"
Study officials:
affiliation: Division of Cardiac Surgery, Catholic University
name: Massimo Massetti, MD
role: STUDY_DIRECTOR
References: