louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03775837: Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults
Official title: Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults: a Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Panax Ginseng C.A. Mey Extract on liver function in adults for 8 weeks.

Detailed description: Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to improve liver function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Panax Ginseng C.A. Mey Extract on liver function in adults; the safety of the compound are also evaluate. The Investigators examine AST, ALT, GGT, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Panax Ginseng C.A. Mey Extract or a placebo each day for 8 weeks;

Eligibility criteria: Inclusion Criteria:

* ALT ranging from upper limit of reference to three times of upper limit

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks

Primary outcomes:
measure: Alanine aminotransferase
timeFrame: 8 weeks
Secondary outcomes:
measure: Aspartate aminotransferase
timeFrame: 8 weeks
measure: Gamma-glutamyl transferase
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Integrated Research Institute for Natural Ingredients and Functional Foods
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00317837: Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture
Official title: Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Fracture of Femoral Neck
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2006-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial femoral neck fracture. The study is prospective and randomised, and will be based on questionnaires, clinical examinations, registration of complications and radiographic evaluation at follow up at 3 months, 1 and 3 years postoperatively.


Eligibility criteria: Inclusion Criteria:

* Patients ages 70 years or above
* Dislocated medial femoral neck fracture (garden type 3-4)
* Residence in the county of Northern Jutland, Denmark

Exclusion Criteria:

* Pathologic fracture
* Failed formerly internally fixed fracture of the affected hip
* Degenerative joint disease of the affected hip or rheumatoid arthritis
* Dementia
* Terminal neoplastic disease
* No informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Klinik Aalborg
state: Northern Jutland
city: Farsoe
country: Denmark
facility: Northern Orthopaedic Division, Klinik Farsoe
state: Northern Jutland
city: Hjoerring
country: Denmark
facility: Northern Orthopaedic Division, Klinik Hjoerring
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Martin Lamm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06680037: A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
Official title: A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: B-cell Mediated Autoimmune Disorders
Keywords: Progressive forms of multiple sclerosis (PMS)
Primary Progressive MS (PPMS)
Secondary Progressive MS (SPMS)
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).


Eligibility criteria: Inclusion Criteria:

1. Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
2. Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.

Exclusion Criteria:

1. History of malignancy that has not been in remission for at least 2 years.
2. Viral Screening

   1. Evidence of chronic active or history of hepatitis B virus (HBV).
   2. Seropositive for human immunodeficiency virus (HIV) antibody.
3. History of bone marrow/hematopoietic stem cell or solid organ transplantation.
4. Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).

Note: Please note, other protocol specified Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with Dose-Limiting Toxicities (DLTs)
timeFrame: From Day 0 to Day 28
Secondary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
timeFrame: Up to Day 720
measure: Change From Baseline in CAR T-cell Toxicities
timeFrame: Baseline, up to Day 720
measure: Pharmacokinetics (PK) Plasma Concentrations of Azer-cel
timeFrame: Up to Day 720
measure: Pharmacodynamics (PD) Plasma Concentrations of Azer-cel
timeFrame: Up to Day 720
measure: Time to Confirmed Disability Progression (CDP)
timeFrame: Up to Day 720
measure: Time to Confirmed Disability Improvement (CDI)
timeFrame: Up to Day 720
measure: Change From Baseline in Brain MRI Gadolinium Enhancing T1, New or Enlarging Hyperintense T2
timeFrame: Baseline, up to Day 720
measure: Change From Baseline in Whole Brain Atrophy
timeFrame: Baseline, up to Day 720
Other outcomes:
Locations:
city: Lexington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Omaha
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nebraska
Study officials:
References:
Clinical trial NCT00157937: A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)
Official title: A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 18 and 60 with mild to moderate asthma

Primary outcomes:
measure: FEV1
Secondary outcomes:
measure: AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05724537: Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation
Official title: Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Disease
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by degenerative MR, due to prolapse/flail of the posterior leaflet, treated with quadrangular resection of the posterior leaflet and annular plication

Brief summary: Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Quadrangular resection combined with annular plication and annuloplasty, as originally described by Carpentier, has been the standard approach for many years, before sliding/folding plasty and artificial chordae gained larger popularity.However, very few studies have been published on thevery long-term results (up to 20 years) of quadrangular resection and annular plication, often reporting only freedom from reoperation rather than from recurrent MR. This study aims to evaluate the very long-term (20 years) clinical and echocardiographic results of this approach, which was used for many years at the beginning of our mitral repair program.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Affected by mitral valve posterior leaflet prolapse/flail causing severe mitral regurgitation
* Treated with quadrangular resection of the posterior leaflet and annulus plication

Exclusion Criteria:

* Other patients

Primary outcomes:
measure: Mortality
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT00880737: Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: Carlos III Health Institute
Sponsor class: OTHER_GOV
First posted: 2009-04-14
Enrollment: 850
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: Hemodynamically stable outpatients with suspicion of pulmonary embolism, confirmed by objective testing

Brief summary: The objectives of the PROTECT study are:

* To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).
* To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
* To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
* To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
* To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.


Eligibility criteria: Inclusion Criteria:

* Acute symptomatic Pulmonary Embolism (PE) confirmed by:

  * CT pulmonary angiography positive for PE
  * Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria)
  * V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis.

Exclusion Criteria:

* Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance \< 30 ml/min).
* Informed consent not obtained.
* Pregnancy.
* Life expectancy of less than 3 months.
* Hemodynamic unstability defined as SBP \< 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.
* Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode.
* Participation in another clinical trial for treatment of PE.

Primary outcomes:
measure: The primary outcome considered will be death by any cause in the month following diagnosis.
timeFrame: 30 days after PE diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramón y Cajal Hospital
Study officials:
References:
citation: Lankeit M, Jimenez D, Kostrubiec M, Dellas C, Kuhnert K, Hasenfuss G, Pruszczyk P, Konstantinides S. Validation of N-terminal pro-brain natriuretic peptide cut-off values for risk stratification of pulmonary embolism. Eur Respir J. 2014 Jun;43(6):1669-77. doi: 10.1183/09031936.00211613. Epub 2014 Mar 13.
Clinical trial NCT06326437: Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses
Official title: The Effect of Dyadic Intervention on Psychological Distress of Young and Middle-aged Patients With Colorectal Cancer and Their Spouses: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.


Eligibility criteria: Inclusion Criteria:

patients and spouses aged 18 years or older patients diagnosed with colorectal cancer Patients scored ≥ 22 points on the Kessler Psychological Distress Scale assessment patients and spouses able to read simplified Chinese

Exclusion Criteria:

psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials

Primary outcomes:
measure: the Kessler psychological distress scale-10
timeFrame: Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
Secondary outcomes:
measure: The Illness Cognition Questionnaire
timeFrame: Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
measure: Dyadic Coping Inventory
timeFrame: Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30
timeFrame: Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
measure: Locke-Wallace Marital Adjustment Scale
timeFrame: Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen Univesity
name: Qian Sun, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01513837: Rinitis y Sinusitis según la Gravedad Del Asma
Official title: PREVALENCIA, GRAVEDAD E IMPACTO DE LA RINITIS Y DE LA SINUSITIS SEGÚN EL NIVEL DE GRAVEDAD Y CONTROL DEL ASMA (PROYECTO IRIS-ASMA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2012-01-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitals in Spain and Latin America

Brief summary: Based on the evidence for the "common pathway" in asthma presentation, our working hypothesis is that asthma severity and lack of control are related to the prevalence and severity of nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal polyps.

Detailed description: Primary objective: To assess the prevalence and severity of rhinitis and rhinosinusitis, with or without nasal polyposis, in asthmatic patients depending on severity of their disease.

Secondary objectives:

To assess the impact of nasal and sinusal pathology on asthma control.

To correlate asthma severity to rhinitis and rhinosinusitis.

To compare the potential association between chronic rhinosinusitis, with and without nasal polyposis, and asthma severity, and to detect radiographic differences, markers of atopy, and pulmonary function.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes aged 18-70 years attending outpatient clinics diagnosed with asthma at least one year before. GINA/GEMA criteria will be used to diagnose asthma and to rate its severity.

Exclusion Criteria:

* Illiterate patients;
* very severe, disabling comorbidity;
* prior non-inflammatory nasosinusal disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sociedad Española de Neumología y Cirugía Torácica (SEPAR)
state: Catalonia
Study officials:
References:
Clinical trial NCT02117037: Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes
Official title: Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This prospective study aimed to validate a new prognostic approach of endothelial progenitor cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made prospectively by two centers of Inter -region South Mediterranean,


Eligibility criteria: Inclusion Criteria:

* acute coronary syndrome (ST + \< 12 hours and ST- high risk or intermediate risk ),which there is an indication of percutaneous coronary intervention.

Exclusion Criteria:

* Cancer
* Chronic inflammatory disease
* Infectious disease
* Erythrocyte \<4 G/l
* Thrombopénia less than 100 000/mm3 ;

Primary outcomes:
measure: evaluate the value of circulating endothelial progenitor cells quantification in the initial phase of ACS in predicting the occurrence of a major cardiovascular event (ECVM ) at 1 year.
timeFrame: one year
Secondary outcomes:
measure: determine the technical characteristics (sensitivity and specificity) and predictive value of the number of PEC
timeFrame: one day , one month , one year
Other outcomes:
measure: determine the technical characteristics (sensitivity and specificity) and performance (technical and predictive) of chemokines / receptors expression in the occurrence of ECVM
timeFrame: one day, one month ,one year
measure: Determine the above performance in the subgroup of patients defined as incompletely revascularized (at least a residual stenosis < 70%)
timeFrame: one year
Locations:
city: Marseille
country: France
facility: assistance Publique Hopitaux de Marseille
Study officials:
References:
Clinical trial NCT00840437: Quality of Life in Patients With Refractory Angina
Official title: Health Status of Patients Enrolled in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Ischemia
Keywords: angina
health related quality of life
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2009-02-10
Enrollment: 90
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: Sequential patients seen in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST)clinic with documented refractory angina and who have consented to participate in the OPTIMIST Long-term Follow-up Database

Brief summary: The health and well being of patients with refractory angina will be assessed using validated questionnaires (SF-36 and Seattle Angina Questionnaire \[SAQ\]) at baseline and one year.


Eligibility criteria: Inclusion Criteria:

* In the OPTIMIST clinic with documented refractory angina
* Have consented to participate in the OPTIMIST Long-term Follow-up Database

Exclusion Criteria:

* Decline to participate or are unwilling to give written consent

Primary outcomes:
measure: Health and anginal status of refractory angina patients
timeFrame: baseline and one year
Secondary outcomes:
measure: Change in Health Related Quality of Life (HRQL)
timeFrame: one year
measure: Association between MACE and changes in Health Related Quality of Life (HRQL)
timeFrame: one year
measure: Health Related Quality of Life (HRQL) and change in HRQL by subgroup
timeFrame: baseline and one year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Timothy D Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: