louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00691951: Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
Official title: Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-06-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to non-smoking asthmatic patients. However, the comparative response to other currently prescribed medications such as combination therapy of long-acting beta agonists and ICS remain to be further evaluated.

No significant differences were found between our group of subjects in regard to changes in asthma control pulmonary function and airway inflammation following budesonide or the association of budesonide with formoterol for a period of 2 months. This should be further explored in larger groups of subjects.


Eligibility criteria: Inclusion Criteria:

* Asthmatic non-smokers or ex-smokers (less than 10 pack/years)
* Asthmatic smokers (more than 5 cigarettes a day and more than 5 pack/years
* FEV1 greater than 70%
* No more than 3 doses of rescue medication (bronchodilator) per day

Exclusion Criteria:

* Mentally or legally incapacitated thus preventing informed consent from being obtained
* Other pulmonary disorder
* History of upper respiratory tract infection in the last month
* Pregnant or lactating women

Primary outcomes:
measure: Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
Secondary outcomes:
measure: Other control scores (ACSS score) and rescue B2 agonist need
measure: Comparative changes in FEV1
measure: Quality of life questionnaire
measure: Morning and evening PEF
measure: Total and differential cell counts in induced sputum and ECP and MPO
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montreal
state: Quebec
city: Quebec
country: Canada
facility: Laval Hospital
Study officials:
References:
Clinical trial NCT06170151: Role of18F-FDG PET-CT for Assessing and Predicting Response to Daratumumab and for Prognosis With Multiple Myeloma
Official title: Role of18F-FDG PET-CT for Assessing and Predicting Response to Daratumumab and for Prognosis With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with refractory multiple myeloma who relapsed after therapy with daratumumab in combination with dexamethasone + bortezomib or dexamethasone + lenalidomide.

Brief summary: Positron Emission Tomography - Computed Tomography (PET-CT) using fluorine-18 fluorodeoxyglucose is a functional imaging diagnostic tool which is widely used In several neoplastic conditions, at initial staging, for restaging in suspected disease relapse and for assessing the response to treatment. Most patients with multiple myeloma (MM) exhibit a high-glycolytic activity rate and therefore they are FOG-avid, especially at the disease relapse. The priceless value of 18F-FOG PET-CT in the therapeutic assessment for several treatment schemes, including aSCT, has been highlighted by several studies: particularly, the occurrence of negative PET-CT after a double aSCT in MM patients with clinical complete response or very good partial response positively correlates with favourable PFS and overall survival (OS). likewise, persistence of 18F-FDG avid disease in MM patients achieving a clinical complete response constitutes a poor prognostic factor. Primary objective of this prospective, observational, non-pharmacological, multicentric study is to evaluate the role of 18F-FDG PET-CT for assessing early response after 6 months of treatment with daratumumab in patients with .relapsed/refractory MM.


Eligibility criteria: Inclusion Criteria:

* patients with refractory multiple myeloma who relapsed after therapy with daratumumab in combination with dexamethasone + bortezomib or dexamethasone + lenalidomide;
* patients capable of expressing informed consent.

Exclusion Criteria:

* patients with clinical contraindications to the administration of daratumumab;
* patients with coexisting non-hematological neoplastic condition;
* patients\< 18 years;
* patients uncapable of expressing informed consent.

Primary outcomes:
measure: 18F-FDG PET-CT to predicting response to treatment and to predicting prognosis in patients with relapsed/refractory multiple myeloma.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
state: Italia
Study officials:
References:
Clinical trial NCT03379051: Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Official title: Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: James P. Wilmot Cancer Center
First posted: 2017-12-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Known histological transformation from CLL to an aggressive lymphoma (Richter's)

Primary outcomes:
measure: Determine Acceptable Adverse Events That Are Related to Treatment
timeFrame: 12 months
Secondary outcomes:
measure: Overall Response and Complete Remission Rate
timeFrame: 12 months
measure: Minimum Residual Disease (MRD)
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Rochester
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Cleveland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
Study officials:
affiliation: Wilmot Cancer Institute - University of Rochester
name: Paul Barr, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01588951: Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Official title: Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Acute Myeloid Leukemia
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Able to give informed consent
3. New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion criteria:

1. Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
2. Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
3. Pregnancy: Women of childbearing potential who are β- HCG+

Primary outcomes:
measure: Relapse Free Survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: JHU
name: Margaret Showel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01936051: Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
Official title: Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OCD
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OCD patients

Brief summary: To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma concentration and the transporter occupancy from OCD patients treated with escitalopram.

To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the PK-PD modeling in OCD patients treated with escitalopram.

Detailed description: To measure plasma concentration of escitalopram in OCD patients treated with escitalopram.

To measure serotonin transporter occupancy by escitalopram in OCD patients treated with escitalopram.

To genotype G2677T/A SNP of ABCB1 gene in OCD patients treated with escitalopram.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of OCD based on Diagnostic and Statistical Manual(DSM)-IV criteria
* no change of escitalopram dosage in 6 weeks

Exclusion Criteria:

* psychiatric comorbidity other than OCD
* History of head injury, epilepsy, other general medical disorder

Primary outcomes:
measure: serotonin transporter occupancy
timeFrame: 72hr after oral administration of escitalopram
Secondary outcomes:
measure: genotype
timeFrame: baseline
measure: Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score
timeFrame: baseline
measure: serotonin transporter occupancy
timeFrame: within the first 24hrs after oral administration of escitalopram
measure: escitalopram plasma concentration
timeFrame: within 72 hours after oral administration of escitalopram
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jun Soo Kwon, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01122251: Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension
Official title: A Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy Phase II Trial to Evaluate the Efficacy and Safety of the Combinations of Lercanidipine and Valsartan in Comparison to Each Component Administered Alone and to Determine the Optimal Dose Combinations in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Keywords: hypertension
lercanidipine
valsartan
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 441
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 20 and 75
* Essential hypertension at screening (-3 week)

Randomization Criteria:

* Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)

Exclusion Criteria:

* Mean sitDBP≥110mmHg or sitSBP≥180
* Secondary hypertension or suspected secondary hypertension
* Uncontrolled diabetes
* Severe heart disease or severe cerebrovascular disease
* clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
* History of malignant disease
* Autoimmune disease
* Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial

Primary outcomes:
measure: sitDBP
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: sitDBP
timeFrame: Week 4, 8
measure: sitDBP
timeFrame: Week 4
measure: sitSBP
timeFrame: Week 4, 8
Other outcomes:
Locations:
city: Seoul, Busan etc.
country: Korea, Republic of
facility: 23 sites in Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02729454: Mental Practice in Parkinson's Disease
Official title: Effects of Mental Practice on the March and the Risk of Falls in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 18
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: Introduction Although drug therapy is the mainstay of treatment for Parkinson's disease, the therapy also has its importance by means of exercises which maintains the muscular activity and preserve mobility. One of the techniques that has been used for physical therapy is the mental practice of the mental simulation of movement, aiming at learning or improvement of motor skills through the cortex areas of activation responsible for the movement of preparation before it is executed. In patients with Parkinson's disease motor anticipation this system is compromised, culminating in the march changes and increased risk of falls. Objective: To evaluate the effects of mental practice on physical therapy on the march and the risk of falls in people with Parkinson's disease. Method: The study is defined as a randomized clinical trial with systematic recruitment. Recruitment will be conducted at the Clinic of Neurology, Hospital das clinics Federal University of Pernambuco (Pro-Parkinson Project: Neurology) and the intervention will be held at the same hospital physiotherapy clinic. Both the control group and the trial will be subjected to 15 therapy sessions twice a week, lasting 40 minutes for physical therapy and 15 for mental practice.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of idiopathic Parkinson's disease
* Male and female
* Stage 1-3 of the Hoehn and Yahr scale.

Exclusion Criteria:

* Have other neurological diseases
* They have decompensated systemic diseases
* Musculoskeletal changes that prevent the achievement of movements
* With lowering of the cognitive level assessed using the Mini-Mental State Examination with cutoff point according to education
* With respiratory impairment
* With medical restrictions for performing exercises
* Do not get hold motor imagination during the application of Visual and Kinesthetic Imagery Questionnaire-10
* In physical therapy, occupational therapy service for 3 months or more;
* Patients with moderate to severe depression assessed by inventory Beck Depression Inventory

Primary outcomes:
measure: Dynamic Gait Index test to evaluate gait and risk of falls
timeFrame: two months
measure: Timed up and go Test to evaluate risk of falls
timeFrame: two months
measure: Walk Test of 10 meters to evaluate gait
timeFrame: two months
measure: history questionnaire falls to evaluate risk of falls
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital Das Clinicas - Ufpe
state: Pernambuco
Study officials:
References:
Clinical trial NCT02920554: The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer
Official title: The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gallbladder Cancer
Keywords: gallbladder cancer
bisegmentectomy
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.

Detailed description: The extent of hepatic resection for gallbladder cancer has a wide range. A partial hepatectomy involving the gallbladder fossa is a critical part of the resection but can range from a wedge resection to an anatomic resection of segments 4b and 5 to an extended right hepatectomy. This study enrolls Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy. Eighty eight patients are randomized to wedge resection group or bisegmentectomy group. Except the extent of hepatic resection, all the procedures including hepatoduodenal,common hepatic, posterior pancreatic lymph node dissection are same.

Primary endpoint is recurrence-free-survival rates and overall survival rates.

Eligibility criteria: Inclusion Criteria:

* Patients with T2 or T3 gallbladder cancer on preoperative CT exam
* Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy

Exclusion Criteria:

* Peritoneal seeding or distant metastasis
* Impossible to resect the cancer radically
* Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.
* R1 or R2 resection were pathologically diagnosed.

Primary outcomes:
measure: Survival rates
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: the Catholic University of Korea St. Vincent's Hospital
Study officials:
affiliation: the Catholic Universityof Korea St. Vincent's Hospital
name: Dong Do You, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06932354: Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy
Official title: Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 16
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Detailed description: In the UK approximately 1200 babies per year undergo 'cooling' for the treatment of 'birth asphyxia' or hypoxic ischaemic encephalopathy (HIE). HIE not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. The clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. Clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. We have used continuous glucose monitoring (CGM) to help target glucose control in extremely preterm infants who require intensive care. CGM however has not been used in babies who are being cooled. This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Eligibility criteria: Inclusion Criteria:

* Hypoxic ischaemic encephalopathy Informed parental consent

Exclusion Criteria:

* Known significant congenital malformation

Primary outcomes:
measure: Percent of time glucose levels measured on CGM are in target
timeFrame: From sensor insertion for up to the first 7 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Addenbrookes Hospital Trust
Study officials:
References: