louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02461316: Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia
Official title: Open, Non-Interventional, Multicentre Trial of Rituximab in Combination With FC for the First-Line Therapy of Patients With Chronic Lymphocytic Leukaemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously untreated patients with Chronic Lymphocytic Leukemia (CLL)

Brief summary: Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
* CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment

Exclusion Criteria:

- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)

Primary outcomes:
measure: Percentage of Adverse Events (AEs)
timeFrame: From baseline to end of study up to 18 months
measure: Percentage of Serious Adverse Events (SAEs)
timeFrame: From baseline to end of study up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Novi Sad
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01947816: Special Investigation in Patients With Ulcerative Colitis
Official title: HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 1621
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for the first time receiving Humira for the treatment of Ulcerative Colitis

Brief summary: This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.

1. Unknown adverse reactions (in particular, clinically significant)
2. Incidence and conditions of occurrence of adverse reactions in clinical practice
3. Factors likely to affect the safety and effectiveness


Eligibility criteria: Inclusion Criteria:

* Patients receiving Humira for the first time for the treatment of Ulcerative Colitis

Exclusion Criteria:

Contraindications according to the Package Insert include patients who have any of the following:

* serious infections
* tuberculosis
* a history of hypersensitivity to any ingredient of Humira
* demyelinating disease or a history of demyelinating disease
* congestive cardiac failure

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
timeFrame: Up to Week 52
Secondary outcomes:
measure: Change From Baseline in CRP Levels Over Time
timeFrame: Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)
measure: Change From Baseline in Mayo Score Over Time
timeFrame: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
measure: Mayo Endoscopic Sub-Score Over Time
timeFrame: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
measure: Change From Baseline in Partial Mayo Score Over Time
timeFrame: Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00885716: A Shared Decision Making Training for Inpatients With Schizophrenia
Official title: Shared Decision Making: Ein Kommunikationstraining für Patienten Mit Schizophrenie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: The German-Israeli Foundation for Scientific Research and Development
First posted: 2009-04-22
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients suffering from schizophrenia who attend the communication skills program engage more deeply in therapeutic reasoning and treatment decisions. This results in stronger preferences to participate, greater perceived involvement and better long term adherence compared to patients who do not attend the training.


Eligibility criteria: Inclusion Criteria:

* Male and female inpatients with a diagnosis of schizophrenia/schizoaffective disorder according to ICD 10
* between 18 and 60 years of age are eligible for the study
* informed consent
* inpatients

Exclusion Criteria:

* poor German language skills

Primary outcomes:
measure: Decision Self Efficacy
timeFrame: post intervention
Secondary outcomes:
measure: Adherence to medication
timeFrame: 6 months post intervention
measure: Participation preferences
timeFrame: post intervention
measure: Treatment satisfaction
timeFrame: post intervention
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München
Study officials:
References:
citation: Hamann J, Mendel R, Meier A, Asani F, Pausch E, Leucht S, Kissling W. "How to speak to your psychiatrist": shared decision-making training for inpatients with schizophrenia. Psychiatr Serv. 2011 Oct;62(10):1218-21. doi: 10.1176/ps.62.10.pss6210_1218.
Clinical trial NCT02183116: A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee
Official title: Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 34
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days


Eligibility criteria: Inclusion Criteria:

- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

none

Primary outcomes:
measure: Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)
timeFrame: Baseline, 8 weeks after first drug administration
Secondary outcomes:
measure: Change from baseline in Lequesne index
timeFrame: Baseline, 8 weeks after first drug administration
measure: Change from baseline in physical examination (tenderness)
timeFrame: Baseline, 8 weeks after first drug administration
measure: Assessment of significant change from baseline in status according endoscopy
timeFrame: Baseline, 8 weeks after first drug administration
measure: Assessment of significant change from baseline in gastrointestinal (GI) symptoms score
timeFrame: Baseline, 8 weeks after first drug administration
measure: Assessment of significant change from baseline in laboratory values
timeFrame: Baseline, 8 weeks after first drug administration
measure: Number of Patients with Adverse Events
timeFrame: Up to 8 weeks after first drug administration
measure: Assessment of significant change from baseline in physical examination (swelling)
timeFrame: Baseline, 8 weeks after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01249196: A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-11-29
Enrollment: 256
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
* MRI within the last 12 months consistent with a diagnosis of AD
* MMSE score of 10 to 26 and CDR of 1 or 2
* AChEI or memantine was not taken at least 3 months prior to screening

Exclusion Criteria:

* Other central nervous disease
* Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
* T.I.A or Major infarction within the last 12 months
* Any serious disorder that could limit the ability of the patient to participate in the study
* COPD or asthma
* Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study

Primary outcomes:
measure: ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
timeFrame: 30 minutes
Secondary outcomes:
measure: CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)
timeFrame: 45 minutes
measure: MMSE (Mini Mental State Examination)
timeFrame: 10 minutes
measure: CDR-SB (Clinical Dementia Rating Sum of Box)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SKChemicals invetigational site
Study officials:
References:
Clinical trial NCT03047096: Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis
Official title: Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoarthritis
Pain Syndrome
Intra-articular Injection
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of present study is to to investigate whether the combined injection of HA and CS was superior than HA alone in the treatment of knee OA.

Detailed description: Intra-articular injection of hyaluronic acid (HA) or corticosteroids (CS) has been widely used with debate on its efficacy in osteoarthritis (OA). The aim of present study is to to investigate whether the combined injection of HA and CS is superior than HA alone in the treatment of knee OA.

Eligibility criteria: Inclusion Criteria:

According to radiographic findings, patients who are suffering from knee OA for over 3 months have to be stage II-IV according to the Kellgren-Lawrence (KL) grade by a senior radiologist. The diagnosis of symptomatic knee OA is based on American Rheumatism Association classification criteria for knee osteoarthritis.

Exclusion Criteria:

Exclusion criteria are the diagnosis of rheumatoid arthritis or other inflammatory OA, presence of trauma or pain-causing diseases, treatment with oral medications in recent 3 days, physiotherapy and intra-articular injection of HA or CS in the past 6 months. Participants who are allergic to any of the medications used in this study or diagnosed with current systemic infection are also excluded.

Primary outcomes:
measure: VAS
timeFrame: 6 months
Secondary outcomes:
measure: WOMAC
timeFrame: 6 months
measure: Knee flexion motion
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Shan-zheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05801796: Appraising Medical Trial Experiences of Ovarian Cancer Patients
Official title: Analyzing Factors of Patient Involvement in Ovarian Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Cancer
Keywords: ovarian cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-06
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ovarian cancer patients who are actively considering enrolling in a medical trial, but have not yet completed enrollment and randomization.

Brief summary: Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. Data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future ovarian cancer patients.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Patient has been diagnosed with ovarian cancer
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
* Pregnant, breastfeeding or expecting to conceive within the projected duration of the study

Primary outcomes:
measure: Patient decides to enroll in clinical trial
timeFrame: 3 Months
measure: Patient remains in clinical trial to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Cho KR, Shih IeM. Ovarian cancer. Annu Rev Pathol. 2009;4:287-313. doi: 10.1146/annurev.pathol.4.110807.092246.
citation: Eisenhauer EA. Real-world evidence in the treatment of ovarian cancer. Ann Oncol. 2017 Nov 1;28(suppl_8):viii61-viii65. doi: 10.1093/annonc/mdx443.
citation: Previs RA, Secord AA. Ovarian Cancer: Clinical Trial Breakthroughs and Impact on Management. Obstet Gynecol Clin North Am. 2019 Mar;46(1):67-88. doi: 10.1016/j.ogc.2018.09.005.
Clinical trial NCT05221996: Minimal-Dose Resistance Training for Improving sIgA and Cortisol
Official title: Minimal-Dose Resistance Training for Improving sIgA and Cortisol Among Young, Health and Sedentary People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Training
Immune System
Keywords: resistance training
immune system
cortisol
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Whereas the role of endurance training on immune function has been widely studied, little is known about the role of resistance training (RT). In this cross-over randomized controlled study, it will be analysed the effects of three RT protocols which only differs in volume in improving secretory immunoglobulin A (sIgA) and cortisol in saliva among young, health and sedentary people


Eligibility criteria: Inclusion Criteria:

* 18-30 years
* Sedentary

Exclusion Criteria:

* to have had COVID-19 during the last 3 months
* to have been vaccinated against COVID-19 during the last 3 months
* physical limitations or health problems

Primary outcomes:
measure: Concentration of secretory immunoglobulin A (sIgA)
timeFrame: 2 weeks
Secondary outcomes:
measure: Concentration of salivary cortisol (Scortisol)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Luis Berlanga
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785896: Analysis of the Effect oh the Carriere Motion 3D
Official title: Analysis of the Effect oh the Carriere Motion 3D on Patients With Class II Subdivision : a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angle Class II
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 25
Sex: ALL
Minimum age (years): 28
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consisted of patients treated by Dr. Romain de Papé at his practice in Strasbourg, within the established time frame.

Brief summary: Class II subdivision malocclusions are common and complex to treat due to their asymmetry. The range of orthodontic correction devices is expanding towards systems that are more comfortable for the patient but may not necessarily have scientific evidence to demonstrate their effectiveness. The aim of this study was therefore to evaluate, for the first time, the effect of a Class II correction device, namely the Carriere Motion 3D (CMA), on patients with a Class II subdivision malocclusion. Method:this retrospective observational study included all patients presenting with a Class II subdivision malocclusion and treated with CMA between July 2018 and November 2023. Before treatment (T0) and after treatment with CMA (T1), orthodontic data from dental molds and lateral cephalometric radiographs (Steiner analysis) were collected and statistically analyzed to assess dentoalveolar as well as skeletal effects of treatment using CMA."


Eligibility criteria: Inclusion Criteria:

* Patients who have completed their growth and present with a Class II subdivision malocclusion.
* Patients who underwent orthodontic treatment with CMA between 07/11/2018 and 11/22/2023.
* Patients who have a complete orthodontic record allowing for pre- and post-treatment measurements with CMA.

Exclusion Criteria: None

Primary outcomes:
measure: Molar Angle class II correction
timeFrame: Up to 6 months
Secondary outcomes:
measure: Canine Angle class II correction
timeFrame: Up to 6 months
measure: Extrusion or intrusion
timeFrame: Up to 6 months
measure: Correction of the Class II canine relationship
timeFrame: Up to 6 months
measure: Rotations
timeFrame: Up to 6 months
measure: Inter-incisal variations
timeFrame: Up to 6 months
measure: Arch depth
timeFrame: Up to 6 months
measure: Arch width
timeFrame: Up to 6 months
measure: Steiner analysis
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
References:
Clinical trial NCT00713596: Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty
Official title: The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Recovery Time
Bruising
Keywords: Nasal Surgery
Septorhinoplasty
fibrin glue
fibrinogen
Swelling
fibrin
tisseel
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.

Detailed description: Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. It has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. Homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. It has been shown to decrease bruising and swelling following surgery. This study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.

Eligibility criteria: Inclusion Criteria:

* Any patient over 18 years of age undergoing septorhinoplasty.

Exclusion Criteria:

* Any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)

Primary outcomes:
measure: Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity
timeFrame: 6 months post operative
Secondary outcomes:
measure: Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Oren Friedman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: