louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04057651: Hip and Knee Scores
Official title: Study of Self-assessment Questionnaires Used in Hip and Knee Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 800
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: Hip and knee patients waiting for hip and knee arthroplasty

Brief summary: Patient-reported outcome measures (PROMs) are currently used for evaluating orthopaedic procedures. Nevertheless, there is no consensus in the different studies, making them difficult to compare . The score mapping (or cross walk) is a statistical model for estimating a score associated with an unmeasured score.

Moreover , Minimal clinically important differences (MCID) is the smallest change in a treatment outcome that a patient would identify as important. The MCID is also not clearly identified for the French population for the hip and knee orthopaedic scores.


Eligibility criteria: Inclusion Criteria:

* Hip osteoarthritis (certified by standard radiographs)
* Knee osteoarthritis ( certified by standard radiographs)

Exclusion Criteria:

* BMI ≥ 40
* Systemic inflammatory disease
* Pregnant
* Surgery revision

Primary outcomes:
measure: Oxford Hip Score
timeFrame: The day Before surgery
measure: HOOS Score
timeFrame: The day Before surgery
measure: KOOS score
timeFrame: The day Before surgery
measure: Oxford knee score
timeFrame: The day Before surgery
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: an average between 6 to 9 months after surgery
measure: HOOS Score
timeFrame: an average between 6 to 9 months after surgery
measure: KOOS score
timeFrame: an average between 6 to 9 months after surgery
measure: Oxford knee Score
timeFrame: an average between 6 to 9 months after surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Sophie Putman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Putman S, Preda C, Girard J, Duhamel A, Migaud H. Mapping and Crosswalk of the Oxford Hip Score and Different Versions of the Hip Disability and Osteoarthritis Outcome Score. Clin Orthop Relat Res. 2021 Jul 1;479(7):1534-1544. doi: 10.1097/CORR.0000000000001675.
citation: Putman S, Dartus J, Migaud H, Pasquier G, Girard J, Preda C, Duhamel A. Can the minimal clinically important difference be determined in a French-speaking population with primary hip replacement using one PROM item and the Anchor strategy? Orthop Traumatol Surg Res. 2021 May;107(3):102830. doi: 10.1016/j.otsr.2021.102830. Epub 2021 Jan 29.
Clinical trial NCT06279351: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Official title: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: Chongqing Medical University
First posted: 2024-02-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.
2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies.


Eligibility criteria: Inclusion Criteria:

1. Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing;
2. Physical state is good: PS 0-2;
3. Expected survival of more than 3 months;
4. Aged 18-75 years old;
5. Have not received systematic chemotherapy before;
6. Did not receive cetuximab treatment;
7. Liver, kidney and bone marrow functions are basically normal;
8. The clearance period of chemotherapy and molecular targeted therapy is more than 4 weeks;
9. Voluntary participation in the group, good compliance, can cooperate with the experiment observation, and sign the written informed consent.

Exclusion Criteria:

1. Patients with severe dysfunction of vital organs (heart, liver, kidney);
2. Patients with other malignant tumors;
3. Patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test);
4. In the active phase of acute or chronic infectious diseases;
5. People with a clear history of drug allergy or allergic constitution;
6. Patients participating in other clinical trials;
7. Other conditions in which the patient was considered inappropriate to participate in the study.

Primary outcomes:
measure: ETS
timeFrame: 8 weeks
Secondary outcomes:
measure: ORR
timeFrame: 8 weeks
measure: DCR
timeFrame: 8 weeks
measure: PFS
timeFrame: 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the second affiliated hospital of Army medical university
state: Chongqing
Study officials:
affiliation: Chongqing Medical University
name: rui kong, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02167451: Maraviroc as GVHD Prophylaxis in Transplant Recipients
Official title: Maraviroc as Graft Versus Host Disease Prophylaxis in Pediatric and Adult Stem Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diagnoses That Require Stem Cell Transplant
Graft Versus Host Disease (GVHD)
Keywords: stem cell transplant
GVHD prevention
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 31
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose is to determine if the addition of Maraviroc to a standard transplant regimen will reduce the incidence of graft versus host disease in children and young adults after a stem cell transplant.

Detailed description: In the first stage, drug levels will be obtained to establish appropriate dosing. In the second stage of the study the investigators will study the effects of using Maraviroc in these patients.

Eligibility criteria: Inclusion Criteria:

* Ages 5 years and \</= 40 years
* All diagnoses
* Peripheral blood stem cells, marrow or cord blood
* All conditioning regimens
* Patient must be planned to receive a calcineurin inhibitor (cyclosporine or tacrolimus) together with steroid, methotrexate or mycophenolate mofetil as GVHD prophylaxis.

Exclusion Criteria:

* Documented anaphylaxis to Maraviroc
* Ex vivo T-cell (type of white blood cell) depleted grafts
* Abnormal Alanine Aminotransferase (ALT) (\>/=10X ULN) on day -3. (Assessed at study enrollment and confirmed again prior to the first dose of maraviroc.)

Primary outcomes:
measure: Feasibility of Maraviroc
timeFrame: Up to day +100
measure: GVHD Incidence
timeFrame: By day +100
measure: Area Under The Concentration-Time Curve (AUC) of Maraviroc
timeFrame: Day 0
measure: Incidence of Visceral GVHD
timeFrame: day+100
measure: Area Under The Concentration-Time Curve (AUC) of Maraviroc
timeFrame: Day 10
Secondary outcomes:
measure: Overall Survival
timeFrame: By day +100
measure: Graft Failure
timeFrame: By day +100
measure: Primary Disease Relapse
timeFrame: By day +100
measure: Toxicities
timeFrame: Up to day +100
measure: Infectious Complications
timeFrame: Up to day +100
measure: Time to Neutrophil
timeFrame: Up to day +100
measure: Time to Platelet Engraftment
timeFrame: days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Pooja Khandelwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01089751: Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 322
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.


Eligibility criteria: Inclusion Criteria:

* Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
* Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
* Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).

Exclusion Criteria:

* Predominant stress or insensate incontinence
* History of neurogenic bladder
* Two urinary tract infections in the last six months
* Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
* Donated \>500mL blood in the 30 days prior to the screening visit

Primary outcomes:
measure: Percentage of Patients Continent (PPC)
timeFrame: Week 14
Secondary outcomes:
measure: Change From Baseline in Continent Days Per Week (CDW)
timeFrame: Baseline, Week 14
measure: Change From Baseline in Nocturic Toilet Voids
timeFrame: Baseline, Week 14
measure: Change From Baseline in Urgency-Related Toilet Voids
timeFrame: Baseline, Week 14
measure: Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)
timeFrame: Baseline, Week 14
measure: Change From Baseline in Voided Volume
timeFrame: Baseline, Week 14
measure: Change From Baseline in Urgency Severity
timeFrame: Baseline, Week 14
measure: Change From Baseline in Urgency Urinary Incontinence (UUI)
timeFrame: Baseline, Week 14
Other outcomes:
Locations:
city: La Mesa
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03460353: Bariatric Surgery and Pharmacokinetics of Dexamphetamine
Official title: Bariatric Surgery and Pharmacokinetics Dexamphetamine: BAR-MEDS Dexamphetamine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Dextroamphetamine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-09
Enrollment: 12
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: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on dexamphetamine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Dexamphetamine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00716053: Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema
Official title: Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Advanced Upper Lobe Predominant Emphysema
Keywords: emphysema
chronic obstructive pulmonary disease
COPD
lung volume reduction
LVRS
BLVR
Aeris
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 225
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in treating patients with advanced upper lobe predominant emphysema.

Detailed description: Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications,which often provide little or no benefit.

In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System to achieve lung volume reduction without surgery and its attendant risks. With BLVR, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient's lungs. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a bioabsorbable gel. The gel is comprised of clotting proteins that deliver the treatment, an antibiotic to prevent infection and drugs designed to remodel damaged areas of the lungs-actually using the body's natural scar formation response to permanently collapse the diseased areas. This reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively.


Primary outcomes:
measure: Improvement in pulmonary function and respiratory symptoms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
citation: Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.
Clinical trial NCT01718951: Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
Official title: Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondyloarthropathy
Keywords: spondyloarthropathy
ankylosing spondylitis
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2012-11-01
Enrollment: 30
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: To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy

Detailed description: To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy

Eligibility criteria: Inclusion Criteria:

1. Subjects greater than 18 years of age
2. Fulfilling the latest classification criteria for axial spondyloarthropathy
3. Active spondylitis as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of more than 4 despite treatment with non-steroid anti-inflammatory drugs for more than 3 months

Exclusion Criteria:

1. Major surgery (including joint surgery) within 8 weeks prior to study entry
2. History of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry
3. Immunization with a live/attenuated vaccine within 4 weeks prior to study entry
4. Active current bacterial, viral, fungal, mycobacterial or other infections at study entry
5. Chronic hepatitis B or hepatitis C carriers
6. History of malignancies, including solid tumors and hemic malignancies
7. History of congestive heart failure
8. History of demyelinating disorders
9. History of peripheral neuropathy
10. Pregnant women or lactating mothers
11. Baseline liver parenchymal enzymes elevated to more than 2 times normal
12. Absolute lymphocyte count less than 500/mm3
13. Serum creatinine level of more than 200umol/L

Primary outcomes:
measure: Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response
timeFrame: week 48
Secondary outcomes:
measure: Changes in MRI spinal inflammation scores
timeFrame: week 24 and 48
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
Study officials:
References:
Clinical trial NCT05914051: PRELOAD-TAVI Trial
Official title: PRELOAD TAVI Trial: Prospective Randomized Trial of Volume Preload Optimization in Patients With Severe Aortic Stenosis Treated on Spontaneous Breathing With Transfemoral TAVI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TAVI
Lead sponsor: Fundación de investigación HM
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.

Detailed description: Patients with severe aortic stenosis present a maintained overload pressure of the left ventricle that can lead to a progressive hypertrophy. This results in elevated left-sided filling pressures and impaired diastolic function.In this context, paradoxical changes in left ventricular function after aortic valve replacement have been described, with acute decrease of the afterload condition that can result in the development of a dynamic intraventricular gradient, especially in the presence of small ventricles with severe hypertrophy, resulting in hemodynamic collapse.

In this setting, it is particularly important to ensure accurate left ventricular preload to optimize myocardial contractility and guarantee an adequate hemodynamic response to valve implantation.

Patients with severe aortic stenosis submitted for transfemoral TAVI on spontaneous breathing will be randomly assigned 1:1 to standard care vs volume preload optimization. Non-invasive continuous monitoring (Clear Sight System, Edwards Lifesciences) will be used to evaluate the cardiac output and the stroke volume in both groups, comparing the hemodynamics before and after valve implant.

Eligibility criteria: Inclusion Criteria:

* Aortic valve stenosis with echocardiographic derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2

Exclusion Criteria:

* Cardiogenic shock.
* Life expectancy \< 1 year.
* Need of mechanic ventilation.

Primary outcomes:
measure: Cardiac output after valve implant
timeFrame: "1 year"
Secondary outcomes:
measure: Stroke volume after valve implant
timeFrame: "1 year"
Other outcomes:
measure: Need of inotropes
timeFrame: "1 year"
measure: HR after TAVI
timeFrame: "1 year"
Locations:
Study officials:
References:
Clinical trial NCT02036151: Impact of Maternal Xylitol Consumption on Mutans Sterptococci
Official title: Impact of Maternal Xylitol Consumption on Mutans Sterptococci ,Plaque and Caries Levels in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries and Streptococcus Mutans Count
Keywords: Xylitol
prevention
Mutans streptococci
caries
plaque
children
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was designed to determine whether maternal xylitol consumption through regular chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and dental plaque levels of their children.

Detailed description: Method: Study sample included 60 mother and child pairs with high salivary mutans streptococcus (MS) levels. Samples were randomly divided into experimental group (30 pairs) and control group (30 pairs). Mothers in the experimental group received xylitol chewing gum treatment three times/day for three months, whereas the controls received fluoride varnish. Both groups received oral hygiene instructions, dietary counseling and restorative treatment. All children were examined after 6, 12 and 18 months from the initiation of the study to assess caries, plaque and salivary mutans streptococcus (MS) levels.

Eligibility criteria: Inclusion Criteria:

* mothers with high salivary counts (≥ 105)
* mothers having children at least 10 months of age (10-36months) or having a minimal of 8 primary teeth.

Exclusion Criteria:

* subjects with systemic disorders or on regular medications

Primary outcomes:
measure: Assesment of mutans streptococci count in off-spring
timeFrame: 24 month
Secondary outcomes:
measure: Assesment of Caries level in off-spring
timeFrame: 24 month
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King abulaziz University, Dental University Hospital
state: P.O Box 80209
Study officials:
References:
citation: Alamoudi NM, Hanno AG, Sabbagh HJ, Masoud MI, Almushayt AS, El Derwi DA. Impact of maternal xylitol consumption on mutans streptococci, plaque and caries levels in children. J Clin Pediatr Dent. 2012 Winter;37(2):163-6. doi: 10.17796/jcpd.37.2.261782tq73k4414x.