louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00293709: Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists
Official title: Prospective Post Marketing Surveillance To Evaluate The Safety And Efficacy Of Etanercept Under Usual Care Settings In Patients With Psoriatic Arthritis (Psa) Treated By Dermatologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous
Keywords: Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 129
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: Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis.

Brief summary: The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists.

Detailed description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Psoriatic Arthritis

Exclusion Criteria:

* Sepsis or risk for sepsis,
* Acute infection,
* Hypersensitive against Etanercept

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Ritchie Index at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
timeFrame: Baseline, Week 52
measure: Number of Participants With Nail Involvement
timeFrame: Baseline, Week 12, 52
measure: Change From Baseline in C-reactive Protein (CRP) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient Assessment of Itching at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient Assessment of Pain at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00600509: Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
Official title: Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: UCB Japan Co. Ltd.
First posted: 2008-01-25
Enrollment: 216
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.


Eligibility criteria: Inclusion Criteria:

* simple and/or complex partial seizures with or without secondary generalization, and first partial seizure \>= 2 years before selection visit;
* seizures classifiable according to the ILAE classification;
* minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
* exposed to two or more standard AEDs;
* taking up to three of the standard AEDs, at the initiation of the trial.

Exclusion Criteria:

* medication influencing the CNS, except for medication taken for antiepileptic treatment;
* partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
* history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
* presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Primary outcomes:
measure: partial onset seizure frequency per week
timeFrame: collection of seizure count throughout the whole study (baseline and treatment periods)
Secondary outcomes:
measure: safety and tolerability
timeFrame: safety and tolerability data were collected throughout the study period
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02844309: The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM
Official title: The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Waldenström Macroglobulinemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.

Detailed description: Enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone. if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.

Eligibility criteria: Inclusion Criteria:

1. Aged \>=18 years
2. diagnosed with WM
3. Untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
4. symptom patients
5. with life-expectancy more than 3 months.

Exclusion Criteria:

1. diagnosed with other malignancies outside B-NHL within one year(including active centre neural system lymphoma)
2. Transformed lymphoma
3. liver or renal function lesion unrelated to lymphoma
4. serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician
5. HIV positive or active HBV infection or other uncontrolled systematic infection
6. clinical central nervous dysfunction
7. serious surgery within 30 days
8. pregnancy or baby nursing period or un-contracepted child-bearing period woman;
9. allergy to the trail drugs.

Primary outcomes:
measure: Overall response rate
timeFrame: up to 12 months
Secondary outcomes:
measure: progress-free survival
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Shuhua Yi
Study officials:
affiliation: institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Shuhua Yi, Doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03356509: Effect of Exercise on Chocolate Addiction
Official title: The Effect of a High Intensity Interval Exercise Bout on Addictive Behaviors in Overweight/Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Exercise and Addictive Behavior
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will use stress inducing tasks to determine if there are significant improvements in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate abusers following rest and a bout of high intensity interval exercise.

Detailed description: The purpose of this research study is to investigate whether a single high intensity interval exercise (HIIE) bout, following two stress-inducing tasks, reduces addictive behavior to chocolate. Volunteers must complete the consent form before being able to participate in two days of testing (exercise day and control day) which will be presented in randomized order. The two days will be separated by a one to 7 day washout period. Subjects will be required to submit a three day chocolate diary then abstain from chocolate on the 4th day. They will also be asked to record everything they eat and drink on the day before and the morning of the study and list three types of chocolate they crave most. Two stress-inducing tasks will be performed on both days followed by completion of either 26 minutes of HIIE or seated resting condition followed by the completion of two mood and craving questionnaires. They will finally be asked to complete a task that measures the amount of attention they pay to chocolate. Statistical analyses will be conducted to determine the effect of either exercising or not on addictive behaviors to chocolate.

Eligibility criteria: Inclusion Criteria:

* BMI equal or greater than 25
* Eat at least 3.5 oz of chocolate per day
* Scorer at least 33 out of a possible 36 on the Handedness Questionnaire
* Ability to provide informed consent
* No medical contraindications to exercise
* Premenopausal

Exclusion Criteria:

* PMS
* Pregnancy
* Prisoners
* Risk factors for heart disease as determined by physician
* Medication that interferes with capacity to exercise
* Answer "Yes" to PAR-Q

Primary outcomes:
measure: Attentional Bias (AB) to chocolate using a modified visual dot probe task (Kemps et al, 2009)
timeFrame: 15 minutes
Secondary outcomes:
measure: Affective Valence measured by The Feeling Scale (Hardy & Rejeski, 1989)
timeFrame: 1 minute
measure: Affective Activation measured by the Felt Arousal Scale (Svebak & Murgatroyd, 1985)
timeFrame: 1 minute
measure: Cravings for chocolate using the State Food Cravings Questionnaire (Cepeda-Benito et al, 2000)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Laboratory of Clinical and Applied Physiology
state: Florida
Study officials:
References:
Clinical trial NCT01930409: Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture
Official title: A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Keywords: Femoral Fractures
Hip Fractures
Frail older adults
Quality of Life
Feasibility Studies
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
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 determine whether is is feasible and acceptable to deliver a telephone based coaching intervention compared with education alone in community dwelling older adults (age 60 and older) after a fall related hip fracture.

Detailed description: The investigators propose a randomized controlled trial design to inform the development of a larger scale study to test effectiveness of a clinician supported telephonic self management intervention for older adults after hip fracture. The primary aim is to determine feasibility and acceptability of the intervention, and the secondary aim is to measure statistical trends on quality of life at 4 months after fracture in community dwelling older adults. In parallel, we will conduct a process evaluation to ascertain key features of the intervention via qualitative interviews of participants and health care professionals involved in delivery of the intervention.

Eligibility criteria: Inclusion Criteria:

* Adults (men and women) over 60 years of age
* Fall related hip fracture
* Community dwelling
* English speaking

Exclusion Criteria:

* Dementia
* Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
* Profound hearing loss

Primary outcomes:
measure: Feasibility of study recruitment and retention
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life EQ5D-5L
timeFrame: 4 months
Other outcomes:
measure: Quality of Life ICECAP-O
timeFrame: 4 months
measure: de Morton Mobility Index (DEMMI)
timeFrame: 4 months
measure: Gait (Walking) speed
timeFrame: 4 months
measure: Falls FES-1
timeFrame: 4 months
measure: Pain: Visual Analogue Scale (VAS)
timeFrame: 4 months
measure: Falls self report diary
timeFrame: 4 months
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 months
Locations:
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
Study officials:
affiliation: Vancouver Coastal Health
name: Dolores P Langford, Msc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Hip Health and Mobility
name: Maureen C Ashe, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04286009: Pathogenesis and Mechanisms of Mitral Annular Calcification
Official title: Pathogenesis and Mechanisms of Mitral Annular Calcification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Annulus Calcification
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to the Mayo Clinic valve clinic, with or without MAC. Also, subjects undergoing surgery, either standard surgical MVR or trans-atrial TMVR.

Brief summary: Researchers are testing blood or mitral valve tissue to better understand the reasons why Mitral Annular Calcification (MAC) develops in patients with heart disease.

Detailed description: The aim is to test the hypothesis that Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) play a significant role in the process of Mitral Annular Calcification (MAC) as prognostic markers of calcific cardiac valves.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of MAC and patients coming to the Valve Clinic without MAC diagnosis Patients who will undergo surgery, either standard surgical MVR or trans-atrial TMVR, with diagnosis of MAC or without diagnosis of MAC

Exclusion Criteria:

* Subjects unwilling to participate or to provide consent

Primary outcomes:
measure: Prognostic markers of calcific cardiac valves
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517309: Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)
Official title: Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Genital Warts
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-16
Enrollment: 1877
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of the study is to test the safety of HPV Vaccine in Women


Eligibility criteria: Inclusion Criteria:

* Females age 16 to 23 years old
* Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

Exclusion Criteria:

* History of vaccination with an HPV vaccine
* History of hepatitis B infection
* History of vaccination with hepatitis B vaccine
* History of genital warts or treatment for genital warts

Primary outcomes:
measure: Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
Secondary outcomes:
measure: HPV vaccine is well tolerated in 16-23 year old females.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5.
citation: Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
Clinical trial NCT04900909: Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)
Official title: Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Landesklinikum Sankt Polten
name: Sicknessfund Burgenland (BGKK)
name: A.ö. Krankenhaus St. Josef Braunau GmbH
First posted: 2021-05-25
Enrollment: 13993
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years of age with no other concomitant heart surgery were included.

Brief summary: The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2018.

Detailed description: The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency (secondary outcomes) after aortic valve replacement. We aim to compare those outcomes between mechanical valves and bioprostheses.

Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2018.

Eligibility criteria: Inclusion Criteria:

* isolated surgical aortic valve replacement in Austria

Exclusion Criteria:

* below 18 years of age
* concomitant heart surgery

Primary outcomes:
measure: Overall mortality
timeFrame: 8 years
Secondary outcomes:
measure: reoperation
timeFrame: 8 years
measure: stroke
timeFrame: 8 years
measure: heart attack
timeFrame: 8 years
measure: heart insufficiency
timeFrame: 8 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03385109: The TransEnterix European Patient Registry
Official title: The TransEnterix European Patient Registry for Robotic Assisted Laparoscopic Procedures in Urology, Abdominal Surgery, Thoracic and Gynecologic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Keywords: Robotic
Laparoscopic
Lead sponsor: TransEnterix
Sponsor class: INDUSTRY
Collaborators: name: CRO Dr. med Kottmann GmbH & Co. KG
name: St. Marien-Krankenhays Siegen gem. GmbH Department of Surgery
First posted: 2017-12-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at a participating center who have had or are scheduled to have surgery using the Senhance system

Brief summary: An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.

Detailed description: This is a prospective multi-center registry in which sites may also choose to retrospectively enroll subjects meeting the inclusion criteria, but whom have already been treated using the Senhance system. The data collection includes baseline patient characteristics, surgical details, and adverse events. Patient follow-up time point is open to the clinical practice of each center and only adverse events are tracked post discharge.

Eligibility criteria: Inclusion Criteria:

* patients 18-80 years old
* Signed the informed consent
* life expectancy 12 months or more

Exclusion Criteria:

-

Primary outcomes:
measure: Adverse Event
timeFrame: Surgery to 30 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Siegen
country: Germany
facility: St. Marien-Krankenhaus
Study officials:
References: