louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00741533: Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital
Official title: Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Cervical Cancer
Cervical Intraepithelial Neoplasia
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-08-26
Enrollment: 172
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cervical intraepithelial neoplasia (CIN) or cervical cancer patients

Brief summary: To study the quality of life of patients earlier diagnosed for cervical cancer and cervical intraepithelial neoplasia (CIN).

Detailed description: In Thailand, age standardized incidence is 20.9 per 100,000 women-year. Treatment-related survival gain are experienced by side-effect that may reduce quality of life (QoL). We therefore, study the quality of life of patients earlier diagnosed for cervical cancer patients.

Eligibility criteria: Inclusion Criteria:

* Thai patients
* aged more than 15 years old.
* Diagnosed of cervical intraepithelial neoplasia (CIN) or cervical cancer with pathological confirmation. If she has more than one diseases, the most severe will be considered as diagnosis.
* Not suffered from confusion or reduced level of consciousness or unable to communicate.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: College of Public Health Sciences, Chulalongkorn University
name: Surasak Taneepanichskul, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076933: Transcranial Magnetic Stimulation for Borderline Personality Disorder
Official title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
Transcranial Magnetic Stimulation
Neuropsychological Test
Randomised Control Trial
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10 daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients.

Hypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the average number of move to achieve tasks of the Tower of London, than those receiving sham rTMS.


Eligibility criteria: Inclusion Criteria:

* 20 to 45 years old
* Borderline Personality Disorder (Diagnostic Interview for Borderline Personality Disorder \> 8)
* psychiatric follow-up
* righthander
* informed consent
* affiliated to medical insurance

Exclusion Criteria:

* bipolar disorder
* substance use disorder
* Major Depressive Disorder or Stress Post Traumatic Disorder
* history of epilepsy
* neurosurgery
* cardiac pacemaker
* lefthander
* involuntary admission
* participation in an other research
* legal guardianship
* poor mastery of french.

Primary outcomes:
measure: Tower of London
timeFrame: Inclusion, 15th day, 30th day and 3rd month
Secondary outcomes:
measure: Balloon Analog Risk Task
timeFrame: Inclusion, 15th day, 30th day and 3rd month
measure: Micro-World Test
timeFrame: Inclusion, 15th day and 3rd month
measure: Borderline Personality Disorder Severity Index
timeFrame: Pre-inclusion, 30th day and 3rd month
measure: Symptom Check List - 90
timeFrame: Inclusion, 15th day, 30th day and 3rd month
measure: Barratt Impulsivity Scale
timeFrame: Inclusion and 3rd month
measure: Global Assessment Scale
timeFrame: Inclusion and 3rd month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Lionel Cailhol
state: University Hospital Toulouse
Study officials:
affiliation: University Hospital Toulouse - 31059 Toulouse - France
name: Lionel Cailhol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cailhol L, Roussignol B, Klein R, Bousquet B, Simonetta-Moreau M, Schmitt L, Thalamas C, Tap G, Birmes P. Borderline personality disorder and rTMS: a pilot trial. Psychiatry Res. 2014 Apr 30;216(1):155-7. doi: 10.1016/j.psychres.2014.01.030. Epub 2014 Jan 30.
Clinical trial NCT00276133: Effects of Atorvastatin Versus Probucol on Small Dense LDL
Official title: Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Nephropathy
Keywords: small dense LDL
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular injury through conversion to an oxidatively modified form of LDL. However, few studies evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective actions in hyperlipidemic patients with non-diabetic nephropathy.

Detailed description: The study is a randomized crossover trial comparing the effect of atorvastatin (10 mg/day) and probucol (500 mg/day) for 24 weeks in 30 patients (urinary albumin excretion 0.3-2.0 g/day, and creatinine clearance \> 30 ml/min/1.73 m2 or serum creatinine concentration \< 2 mg/L). Lipid parameters, mean LDL particle diameter, creatinine clearance, and urinary albumin to creatinine excretion ratio are measured before and during treatment periods. It will be evaluated that, first, whether atorvastatin and probucol significantly reduce serum total cholesterol and LDL cholesterol concentrations, second, whether atorvastatin and probucol significantly increase the LDL particle size, third, whether significant differences in urinary albumin/creatinine excretion ratio and creatinine clearance are observed in both groups during treatment.

Eligibility criteria: Inclusion Criteria:

* Hyperlipidemic patients with non-diabetic nephropathy

Exclusion Criteria:

* Endocrinological, hematological or hepatic disease
* Cerebral infarction or hemorrhage
* Homozygous familial hypercholesterolemia
* Uncontrolled hypertension
* Myocardial infarction occurring within the previous 6 months
* Unstable angina
* Diabetic nephropathy
* Abnormal thyroid function
* Receiving steroids or immunosuppressive agents

Primary outcomes:
measure: Normalization of serum cholesterol concentrations
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University Center Hospital
state: Kanagawa
Study officials:
affiliation: Yokohama City University Center Hospital
name: Gen Yasuda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yasuda G, Kuji T, Hasegawa K, Ogawa N, Shimura G, Ando D, Umemura S. Safety and efficacy of fluvastatin in hyperlipidemic patients with chronic renal disease. Ren Fail. 2004 Jul;26(4):411-8. doi: 10.1081/jdi-120039826.
Clinical trial NCT00281333: The Influence of "Karate" on Bleeding in Hemophilic Patients.
Official title: The Influence of "Karate" on Bleeding in Hemophilic Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemophilia A
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-01-24
Enrollment: 12
Sex: MALE
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.

Detailed description: none - Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.

Eligibility criteria: Inclusion Criteria:

* Severe Hemophilia.

Exclusion Criteria:

* No Inhibitors.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Uri Martinowitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080933: ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS
Official title: Extracorporeal Membrane Oxygenation for COVID-19 and Influenza H1N1 Associated Acute Respiratory Distress Syndrome: a Multi-centre Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
COVID-19
H1N1 Influenza
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who required VV ECMO for COVID-19 and influenza A H1N1 associated ARDS

Brief summary: Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support.

Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS


Eligibility criteria: Inclusion Criteria:

* COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis
* Severe ARDS (according to Berlin Definition)
* VV ECMO
* Invasive mechanical ventilation through endotracheal tube or tracheostomy

Exclusion Criteria:

• Age\<18 years

Primary outcomes:
measure: All cause mortality on day 60 after ECMO initiation
timeFrame: 60 days
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 90 days
measure: ICU length of stay
timeFrame: 90 days
measure: Hospital mortality on day 90 after ECMO initiation
timeFrame: 90 days
measure: ECMO duration
timeFrame: 90 days
measure: ECMO associated hemorrhagic complications
timeFrame: 60 days
measure: ECMO associated mechanical complications
timeFrame: 60 days
measure: Invasive mechanical ventilation duration
timeFrame: 90 days
measure: ECMO related haemorrhagic complications
timeFrame: 90 days
measure: ECMO related mechanical complications
timeFrame: 90 days
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study officials:
References:
citation: Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.
Clinical trial NCT01604733: Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
Official title: Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Multi-Center Survey
patients currently on lipid-lowering pharmacological treatment
level of Control of Hypercholesterolemia in Egypt
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community patients

Brief summary: Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).

Detailed description: Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Eligibility criteria: Inclusion Criteria:

* 18 years and above on current lipid lowering drug for at least 3 months with no dose change for a minimum of 6 weeks
* Subject must provide informed consent and comply with the survey procedures

Exclusion Criteria:

* Less than 18 years less than 3 months on antidyslipidemic agent Subjects who are unwilling or unable to provide informed consent

Primary outcomes:
measure: The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country
timeFrame: 24 weeks
Secondary outcomes:
measure: The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes
timeFrame: 24 weeks
measure: The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes
timeFrame: 24 weeks
measure: Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia
timeFrame: 24 weeks
measure: Physician characteristics associated with the allocation of treatment regimen.
timeFrame: 24 weeks
measure: The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ethical committee, Faculty of medicine, Alexandria University
name: Mohie E Sherif, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03468933: Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Official title: Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pleural Infection
Empyema
Pleural Diseases
Parapneumonic Effusion
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 32
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 purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.

Detailed description: Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.

Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy

Methods: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients to either Medical Thoracoscopy group or Fibrinolytic Therapy group.

Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting

Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection

Eligibility criteria: Inclusion Criteria:

Subjects \>18 years old with:

Evidence of empyema or complex parapneumonic effusion

Exclusion Criteria:

Age \<18 years Pregnancy Inability to give informed written consent Previous thoracic surgery or thrombolytic therapy for pleural infection Medical thoracoscopy cannot be performed within 48 hours Hemodynamic instability or severe hypoxemia Non corrected coagulopathy Homogeneously echogenic effusion on pleural ultrasonography

Primary outcomes:
measure: Duration of Hospital Stay After Intervention
timeFrame: 12 week follow up period
Secondary outcomes:
measure: Total Length of Hospital Stay
timeFrame: 12 week follow up period
measure: Number of Participants Necessitating Intervention After the Assigned Treatment
timeFrame: 12 week follow up period
measure: Adverse Events
timeFrame: 12 week follow up period
measure: In Hospital and 30-day Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases
state: Louisiana
Study officials:
affiliation: Tulane University
name: Fayez Kheir, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905333: Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
Official title: Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
candesartan
felodipine
test formulations
Atacand®
Splendil®
healthy volunteers
blood samples
after meal intake interaction
Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Scentryphar Clinical Research
name: Cori Analyticals
name: Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
name: LabClin Laboratório Clínico
name: Laboratório de Patologia Clínica Dr. Franceschi Ltda.
name: Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
First posted: 2009-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI \> or = 19 and \< or = 28 (Dietary Guidelines Advisory Committee, 2005)

Exclusion Criteria:

* Not healthy
* Chronic drug intake

Primary outcomes:
measure: Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.
timeFrame: 76 blood samples per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Itatiba
country: Brazil
facility: Research Site
state: SP
city: Americana
country: Brazil
facility: Research Site
Study officials:
affiliation: Scentryphar Clinical Research
name: Eduardo Abib Junior, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scentryphar Clinical Research
name: Moises L. P Vanuncci, MD
role: STUDY_CHAIR
References: