louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04104633: Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA
Official title: Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Colo-rectal Cancer
Keywords: ctDNA
Molecular karyotype
Lead sponsor: Centre Hospitalier Henri Duffaut - Avignon
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: There are several types of circulating DNA: DNA from patient's existing cells, foetal DNA in the case of pregnant woman, and tumoral DNA in the case of patients with cancer. These circulating tumoral DNA (ctDNA) can be obtained from a blood test called liquid biopsy and be detected by the latest generation of very high throughput sequencers with the Massive Parallel Sequencing technique (MPS).

This study focus on using this technique on breast and colorectal cancers in which no analysis of CNV (tumor origin marker) with this technique has been performed yet. It is a prospective, pilot, monocentric, feasibility study on genomic profile. The study aim is to show the possibility to realize in a reproductive way a molecular karyotype on ctDNA with the MPS approach from a liquid biopsy taken from patients with cancer and to compare this profile with the one obtained by CGH array (Comparative Genomic Hybridization) from primitive tumor.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Signed consent
* Women with invasive breast carcinoma, NOS, with a radiologically measurable tumor of more than 10 mm (stade I to III)
* Patients with invasive colorectal adenocarcinoma with a radiologically measurable tumor of more than 10 mm (stade I to III)
* Patients who primary surgery is planned

Exclusion Criteria:

* Neoadjuvant chemotherapy or neoadjuvant radiotherapy
* Other cancer
* BMI \> 30
* Pregnant woman
* Patients under protective administration or deprived of liberty

Primary outcomes:
measure: Feasibility of molecular karyotype performed from liquid biopsy: copies number variations (CNV)
timeFrame: Up to surgery
Secondary outcomes:
measure: Identification of patient's tumor genomic profile with blood sample
timeFrame: Up to surgery
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
Study officials:
affiliation: Centre Hospitalier Henri Duffaut
name: Guillaume GRANIER, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01565733: Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes
Official title: Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 2223
Sex: ALL
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 type 2 diabetes requiring treatment with NovoMix® 30 insulin on admission who before hospitalisation had been treated with oral antidiabetics and/or human insulin

Brief summary: This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Treated with oral anti-diabetics and/or human insulin

Exclusion Criteria:

* Persons previously included in the trial
* Hypersensitive to biphasic insulin aspart or any of the excipients
* Pregnant or lactating women, or those who plan to get pregnant within the next 12 months

Primary outcomes:
measure: Frequency of severe hypoglycaemic episodes
Secondary outcomes:
measure: Number of severe hypoglycaemic episodes
measure: Number of mild hypoglycaemic episodes
measure: Postprandial glucose concentration after breakfast, lunch, and dinner
measure: Average fasting glucose concentration after waking and before main meals
measure: Average plasma glucose level at bedtime and at night
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00521833: Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surrgical Induced Astigmatism
Keywords: Kataract
Astigmatism
phacoemulsification
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-08-28
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.

Detailed description: In a clinical trial, consecutive eyes with senile cataract underwent phacoemulsification with implantation of a 6.0 mm foldable hydrophobic acrylic intraocular lens through a 3.2 mm horizontal clear cornea incision at 180 degrees (temporal incision in right eyes, nasal incision in left eyes). Keratometric astigmatism was measured preoperatively and one and four weeks and 6 months after surgery. Surgically induced astigmatism (SIA) was calculated by the vector analysis method using the Holladay-Cravy-Koch formula. Patients with history of diabetes mellitus, connective tissue disorders, steroid use, previous ocular surgery, with the rule astigmatism \>1D, pseudoexfoliation and any corneal pathology were excluded.

Eligibility criteria: Inclusion Criteria:

* All the patients with senile cataract

Exclusion Criteria:

* Previously operated eyes
* Presence of corneal pathology
* Pseudo exfoliation
* With-the-rule (WTR) astigmatism \>1 D
* Presence of diabetes mellitus
* History of connective tissue disease
* Consumption of systemic steroids

Primary outcomes:
measure: Total and Surgical Induced Astigmatism
timeFrame: At 1 and 4 weeks and 6 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic research center
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammad Pakravan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03931733: The Impact of Receptive Music Therapy in the ICU
Official title: The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether Music Therapy has an effect on pain, agitation, and vital signs of patients in the Intensive Care Unit (ICU) when compared to usual care. Music Therapy is an intervention provided to patients after a referral by a nurse or attending physician. Patients will be assigned to two groups. The intervention group will receive 1 30 minute music therapy intervention provided by a Board Certified Music Therapist (MT-BC). The music therapy intervention will consist of a relaxation experience with live music presented by the MT-BC on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. Vital signs, pain, and agitation are collected pre and post. Patients assigned to the control group will receive usual care for a patient in the ICU. Vital signs, pain, and agitation will be collected.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* On a Mechanical Ventilator

Exclusion Criteria:

* Airborne and Special Contact Isolation
* Non English or Spanish Speaking LARs
* Pregnant
* Prisoners
* Brain Dead
* Unstable bradycardia or hypotension
* Patients who have been referred to music therapy with a goal of stimulation.

Primary outcomes:
measure: Change in heart rate
timeFrame: 30 minutes
measure: Change in respiratory rate
timeFrame: 30 minutes
measure: Change in Oxygenation
timeFrame: 30 minutes
Secondary outcomes:
measure: Critical Care Pain Observation Tool (CPOT): Range of 0-8 Includes 2 points for: Facial expression, body movements, muscle tension, compliance with the ventilator/vocalization. Intent is decrease in pain level.
timeFrame: 30 minutes
measure: RASS: The Richmond Agitation and Sedation Scale (RASS) 0 (Alert and Calm) -1 -5: Drowsy/Unarousable +1-+4 Agitated/Combative Intent is decrease in agitation level
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Leesburg
country: United States
facility: Inova Loudoun Hospital
state: Virginia
Study officials:
References:
Clinical trial NCT00848133: A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty
Official title: A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Lead sponsor: Sinai Hospital of Baltimore
Sponsor class: OTHER
Collaborators: name: Bonutti Clinic
First posted: 2009-02-20
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* patients with advanced bilateral osteoarthritis of the knee for treatment with total knee arthroplasty
* patients who wish to undergo bilateral total knee arthroplasty as part of a single surgical procedure

Exclusion Criteria:

* patients who were previously treated with knee arthroplasty

Primary outcomes:
measure: Knee Society Score
timeFrame: Final follow-up (minimum 24 months)
Secondary outcomes:
measure: Radiographic alignment and fixation
timeFrame: Final follow-up (minimum 24 months)
Other outcomes:
Locations:
city: Effingham
country: United States
facility: Bonutti Clinic
state: Illinois
Study officials:
affiliation: Sinai Hospital of Baltimore
name: Michael A Mont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00176033: Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra
Official title: Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra (Lopinavir/Ritonavir) and on the Concentration Relations Between Plasma, Blood Cells, Saliva and Urine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Pharmacokinetics
Keywords: ritonavir
lopinavir
HIV Infections
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the two protease inhibitors. The latter will be studied by comparing intracellular concentrations of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in healthy individuals. These effects will be studied after single dose (day 1), during steady state (day 3), and during chronic treatment (day 14).

Detailed description: Objective:

Measurement of AUC, Cmax, tmax, t1/2 and clearance (Cl) of the protease inhibitor Kaletra™ (lopinavir and ritonavir) each in the plasma of healthy individuals

* establish free and total plasma - blood cell concentration-relationship
* establish free and total plasma - saliva concentration-relationship
* establish blood cell concentration - drug transporter expression-relationship

Eligibility criteria: Inclusion Criteria:

* Good state of health

Exclusion Criteria:

* Drug treatment with known inhibitors or inducers of cytochrome P450 isozymes or ABC-transporters within the preceding 2 months
* Any acute or chronic illness
* Smoking
* Pregnancy
* Alcohol or drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Clinical Research Center, Department of Internal Medicine VI
Study officials:
affiliation: Department of Internal Medicine VI
name: Gerd Mikus, MD, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03149133: Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle
Official title: Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle, An Ultrasound-Based Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tightness
Hypertrophy
Occlusion Vein
Keywords: Biomechanics
Strength training
Elastography
Ultrasound
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SCREENING

Brief summary: Occlusive or ischemic training is a type of strength training which is becoming more and more popular every day. The safety, efficacy and detailed description about the use of occlusive training is well documented in the literature. However, the effects on hypertrophy and the stiffness of the muscle tissue are not studied. We aimed to measure these changes by ultrasound technology in a randomized controlled design.

Detailed description: Patients were randomized into classical hypertrophy and occlusive hypertrophy groups. The participants are free from any systemic disease, infection or recent injury. Both groups perform hypertrophy training with different intensities. The outcome measures are; thickness determined by B-mode ultrasound and stiffness by shear-wave elastography. Comparison of both groups will be made.

Eligibility criteria: Inclusion Criteria:

* Healthy recreational athletes

Exclusion Criteria:

* Any kind of systemic disorder
* Active or chronic infection
* Recent (last 6 months) musculoskeletal injury
* Performed strength training at last 72 hours

Primary outcomes:
measure: Thickness
timeFrame: 6 weeks
measure: Stiffness
timeFrame: 6 weeks
Secondary outcomes:
measure: Strength change
timeFrame: 6 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University
Study officials:
References:
Clinical trial NCT06241833: Emulation of Randomized Clinical Trial in Cardiovascular Disease
Official title: Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Coronary Artery Disease
Keywords: Percutaneous coronary intervention
Cardiovascular Pharmacotherapy
Proton pump inhibitor
Dual antiplatelet therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 118420
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AMI undergoing PCI

Brief summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Detailed description: This is a non-randomized, non-interventional study from Korean National Health Insurance Service database. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.

Eligibility criteria: Inclusion Criteria:

* - PCI with MI (I21) admission
* Age more than 40 or less than 80 years old
* Aspirin and Clopidogrel/Prasugrel/Ticagrelor prescription with more than 2 days at discharge

Exclusion Criteria:

* - Previous use of a PPI, an H2-receptor antagonist, sucralfate, or misoprostol within 30 days before admission
* Preexisting cancer within a year before admission
* History of RBC transfusion
* RBC transfusion in admission
* Cardiogenic Shock
* Length of stay more than 14 days
* OAC prescription with more than 2 days at discharge
* H2 prescription with more than 2 days at discharge

Primary outcomes:
measure: Rates of Major GI bleeding requiring transfusion
timeFrame: 1-year follow-up
measure: Rates of Major adverse cardiac event
timeFrame: 1-year follow-up
Secondary outcomes:
measure: Rates of Major or Minor GI bleeding with hospitalization
timeFrame: 1-year follow-up
measure: Rates of Cardiac death
timeFrame: 1-year follow-up
measure: Rates of Spontaneous MI
timeFrame: 1-year follow-up
measure: Rates of Ischemic stroke
timeFrame: 1-year follow-up
measure: Rates of Repeat revascularization
timeFrame: 1-year follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ki Hong Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02772133: Circulating PRCP in STEMI Patients Undergoing Primary PCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Percutaneous Coronary Intervention
PRCP
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects, consecutive patients with unstable angina, and those undergoing primary PCI for STEMI

Brief summary: Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on circulating prolylcarboxypeptidase (PRCP) level and activity.


Eligibility criteria: Inclusion Criteria:

* Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
* Age ≥18 years;
* Informed consent from subject or next of kin.

Exclusion Criteria:

* Nonischaemic Cardiomyopathy;
* Cardiac surgery planed in the 6 months;
* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
* Renal or hepatic failure;
* Malignancy, HIV, or central nervous system disorder;
* Cardiopulmonary resuscitation \>15 min and compromised level of consciousness;
* Cardiogenic shock;
* Current participation in any research study involving investigational drugs or devices;
* No written consensus;
* Previous myocardial infarction.

Primary outcomes:
measure: Circulating PRCP level
timeFrame: 1 month
measure: Circulating PRCP activity
timeFrame: 1 month
Secondary outcomes:
measure: Circulating Ang II level
timeFrame: 1 month
measure: Circulating Ang-(1-7) level
timeFrame: 1 month
measure: Circulating BK-(1-9) level
timeFrame: 1 month
measure: Circulating KBK-(1-9) level
timeFrame: 1 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong University Qilu Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT05451433: The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS
Official title: The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome

Detailed description: This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome within timeframe of study 28 days and then will be examined the outcome as the improvement quality of life

Eligibility criteria: Inclusion Criterias:

* 18 years or older
* diagnosed with IBS based on ROME IV criteria
* agree to be participant by signing inform consent

Exclusion Criteria:

* patient who does not want to sign the inform consent

Primary outcomes:
measure: Clinical improvement quality of life within 29 days
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: