louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01725386: An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer
Official title: Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-11-12
Enrollment: 274
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with metastatic breast cancer initiated on therapy with capecitabine

Brief summary: This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.


Eligibility criteria: Inclusion Criteria:

* Adult female participants, \>/= 18 years of age
* Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer
* Prescribed capecitabine as in routine clinical practice
* Informed consent signed

Exclusion Criteria:

* Participation in any other clinical trial
* History of severe and unexpected reactions to fluoropyrimidine therapy
* Hypersensitivity to capecitabine or to any of the excipients of fluorouracil
* Known dihydropyrimidine dehydrogenase (DPD) deficiency
* Pregnant or lactating women
* Severe leucopenia, neutropenia, or thrombocytopenia
* Severe hepatic impairment
* Severe renal impairment (creatinine clearance below 30 ml/min)
* Treatment with sorivudine or its chemically related analogues, such as brivudine
* Refusal to give consent

Primary outcomes:
measure: Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
timeFrame: Up to approximately 4 years
measure: Percentage of Participants Receiving Concomitant Medications During the Study
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Percentage of Participants With Relevant Medical History Assessed at Baseline
timeFrame: Day 1
measure: Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
timeFrame: Day 1
measure: Mean Survival Time
timeFrame: Up to approximately 4 years
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
city: Faisalabad
country: Pakistan
city: Gujranwala
country: Pakistan
city: Hyderabad
country: Pakistan
city: Islamabad
country: Pakistan
city: Islamabad
country: Pakistan
city: Karachi
country: Pakistan
city: Karachi
country: Pakistan
city: Karachi
country: Pakistan
city: Lahore
country: Pakistan
city: Lahore
country: Pakistan
city: Multan
country: Pakistan
city: Peshwar
country: Pakistan
city: Rawalpindi
country: Pakistan
city: Rawalpindi
country: Pakistan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02487186: Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
Official title: Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Disease
Keywords: Chronic periodontitis
Local doxycycline
Ultrasonic debridement
PLGA microspheres
Microbiologic assessment
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment.

Detailed description: Thirty patients with chronic periodontitis and a minimum of seven pockets (\>5

mm) in non-molars teeth that bled on probing will be selected. Patients will be randomly

assigned to ultrasonic periodontal debridement followed by local application of doxycycline

by PLGA microspheres (DB+DOX) and periodontal debridement followed by administration

of void PLGA microspheres (DB). Plaque, bleeding on probe, clinical attachment level

(CAL), and probing depth (PD) will be recorded at baseline, 3 and 6 months. Subgingival

biofilm samples will be collected from initially moderate (5 to 6 mm) and deep (≥7 mm)

pockets at baseline, 1, 3 and 6 months. Polimerase chain reaction (PCR) analysis will be

used to detect the frequency of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf),

Treponema denticola (Td), Aggregatibacter actinomycetemcomitans (Aa), and Prevotella

intermedia (Pi).

Eligibility criteria: Inclusion Criteria:

* Chronic generalized periodontitis (AAP,1999);
* At least 7 sites with probing depths \>5mm, and 2 sites with probing depth \>7mm;
* At least 20 teeth present;
* Systemically healthy.

Exclusion Criteria:

* Had received periodontal care 6 months prior to the study;
* Had taken medications known to interfere with periodontal health and healing 6 months prior to the study;
* Pregnants or lactants;
* Smokers;
* Sensitive to doxycycline.

Primary outcomes:
measure: Probing depht (PD)
timeFrame: 6 months
Secondary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: 6 months
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Enilson A Sallum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02817386: Study of Postoperative Delirium in Elderly People After Orthopedic Surgery
Official title: microRNA and Delirium After Hip and Knee Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: postoperative delirium
microRNA
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 60 adults who were scheduled to have elective total hip or knee replacement surgery at the Zhongnan Hospital were asked to participate in this study.

Brief summary: The purpose of this study is to investigate the possible relationship of microRNA and postoperative delirium.

Detailed description: Postoperative delirium is one of the most common postoperative complications in elderly patients.It has been shown that postoperative delirium has independent adverse effects on short and long-term mortality and morbidity, including poor functional recovery, postoperative cognitive dysfunction, deterioration in quality of life, and increased costs. However, at the present time, postoperative delirium is a clinical phenomenon, and its neuropathogenesis remains unknown. This gap in knowledge has become a barrier that limits further studies, including the development of potential interventions for postoperative delirium.

Eligibility criteria: Inclusion Criteria:

1. 65 years old or older
2. candidates for spinal anesthesia
3. Non language communication barriers

Exclusion Criteria:

1. past medical history of neurological and psychiatric diseases including AD, other forms of dementia, stroke, or psychosis;
2. severe visual or hearing impairment;
3. unwillingness to comply with the protocol or procedures.

Primary outcomes:
measure: The level of microRNA in cerebrospinal fluid and serum
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhongnan Hospital
name: Mian Peng, MD
role: STUDY_DIRECTOR
References:
citation: Xie Z, Swain CA, Ward SA, Zheng H, Dong Y, Sunder N, Burke DW, Escobar D, Zhang Y, Marcantonio ER. Preoperative cerebrospinal fluid beta-Amyloid/Tau ratio and postoperative delirium. Ann Clin Transl Neurol. 2014 May 1;1(5):319-328. doi: 10.1002/acn3.58.
citation: Dong R, Sun L, Lu Y, Yang X, Peng M, Zhang Z. NeurimmiRs and Postoperative Delirium in Elderly Patients Undergoing Total Hip/Knee Replacement: A Pilot Study. Front Aging Neurosci. 2017 Jun 23;9:200. doi: 10.3389/fnagi.2017.00200. eCollection 2017.
Clinical trial NCT06567886: Fibromyalgia Sleep A to ZZZ Study
Official title: At Home Morning Bright Light Treatment for Chronic Nociplastic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Sleep timing stabilization
Morning light therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-08-23
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

Detailed description: This study will test a consumer health light therapy device (Re-Timer)

Eligibility criteria: Inclusion Criteria:

1. Meets 2016 revised diagnostic criteria for fibromyalgia (FM)
2. Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.

Exclusion Criteria:

1. Significant chronic disease
2. Severe hearing or memory problems
3. Pending medical leave applications at workplace
4. Current pregnancy, breastfeeding, or actively trying to get pregnant
5. Night work or travel outside the eastern time zone within 1 month of the study
6. Other research participation
7. Frequent number of special events during study period (weddings, concerts, exams, etc).

Primary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score
timeFrame: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Secondary outcomes:
measure: Change in Brief Pain Inventory (BPI) score
timeFrame: baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Afton Hassett
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901286: The Environment's Impact on Thinking When Added to Leg Cycling in People With TBI: VITAL
Official title: The Effects of a Single Bout of Moderate Intensity Aerobic Exercise Combined With Different Environments on Executive Function and Processing Speed in Individuals With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Brain Injuries, Traumatic
Aerobic Exercise
Leg Cycling
Virtual Reality
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aerobic exercise is a promising treatment modality for cognition in persons with TBI, but effects are consistently small. This study aims to investigate the effect of difference environments during moderate intensity cycling sessions on cognition.

Detailed description: The proposed research study would be the first to investigate the acute effects of aerobic exercise with different environments relative to control and comparison conditions on several domains of cognition in people with TBI. This critical investigation will be a first step toward systematically identifying an optimal exercise training intervention for managing common cognitive consequences of TBI.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age and younger than 59 years of age
* Speak English as their primary language
* Have had a previous TBI at least one year prior\\

Exclusion Criteria:

* Have contraindications to moderate or high intensity physical activity, based on the Physical Activity Readiness Questionnaire (PAR-Q)
* Have a history of psychiatric illness (ex: major depression, bipolar disorder, schizophrenia), neurological disorders beyond TBI (ex: stroke, seizure disorder), or substance abuse
* Currently use medications that might impact cognition (ex: steroids, benzodiazepines, neuroleptics)
* Be currently pregnant
* Have visual impairments not otherwise corrected by contact lenses (ex: stereo blindness, colorblindness)
* Have a high likelihood of motion sickness

Primary outcomes:
measure: Change on Walking While Talking Test (WWT)
timeFrame: 30 minutes (before and after the acute exercise intervention)
measure: Change on N-Back Test (N-back)
timeFrame: 30 minutes (before and after the acute exercise intervention)
measure: Change on the Modified Flanker Test (MFT)
timeFrame: 30 minutes (before and after the acute exercise intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT01089686: Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
Official title: Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Chronic Cerebrospinal Venous Insufficiency
Lead sponsor: The Vascular Group, PLLC
Sponsor class: OTHER
Collaborators: name: Center for Vascular Awareness, Albany, New York
First posted: 2010-03-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been found to have chronic cerebrospinal venous insufficiency (CCSVI).


Eligibility criteria: Inclusion Criteria:

* Must be 18 years old or greater and less than or equal to 65 years of age
* Score of 0 to 7 on the EDSS scale
* Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
* Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
* Informed consent signed by patient

Exclusion Criteria:

* Patient is unwilling to comply with the follow up
* Patient is pregnant
* Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
* Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
* Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
* Life expectancy is less than one year
* Lack of mental capacity to consent
* Creatinine level of greater than 2.5 or is dialysis dependant
* Enrollment in another clinical study

Primary outcomes:
measure: Incidence of major adverse events
timeFrame: 30 days
measure: Neurological assessment of MS
timeFrame: 1 year
measure: MRI/MRA evaluation of MS lesions, recommended
timeFrame: 1 year
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
measure: Major adverse events
timeFrame: 1 year
measure: Identification of central venous stenosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Albany
country: United States
facility: The Vascular Group, PLLC, The Vascular Health Pavillion
state: New York
Study officials:
affiliation: The Vascular Group, PLLC
name: Manish Mehta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03347786: Verapamil for Neuroprotection in Stroke
Official title: Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Lead sponsor: Global Neurosciences Institute
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each trial participant is randomly assigned to one of two total intervention groups. The first intervention group will receive a dose of 10mg Verapamil, while the second intervention group will receive a dose of 20mg Verapamil. Both treatment groups will have Verapamil administered intra-arterially following mechanical thrombectomy.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* 18 years of age and over
* Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
* Candidate for mechanical thrombectomy procedure
* Onset of symptoms less than 8 hours
* Measurable neurologic deficit (NIHSS ≥4)
* Willingness to follow up with rehabilitation therapy
* Anticipated life expectancy of at least 3 months

Exclusion Criteria:

* Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
* Hepatic and/or renal insufficiency (LFT's\>3× upper limit of normal; CrCl \< 30ml/min)
* Thrombocytopenia (platelet count \<75,000/mm3)
* History of intolerance to verapamil
* Previous functional disability (modified Rankin \> 1)
* Severe stroke (NIHSS\>22)
* Stuporous or comatose
* Unlikely to be available for 90 day follow-up

Primary outcomes:
measure: Number of Participants with Bleeding Complications
timeFrame: 3 months
measure: Number of Participants with a Serious Adverse Event of Death
timeFrame: 3 months
Secondary outcomes:
measure: Functional Outcomes
timeFrame: 30-days and 90-days
measure: Functional Outcomes
timeFrame: 30-days and 90-days
measure: Neuroimaging
timeFrame: 180 Days, 365 Days
Other outcomes:
Locations:
city: Atlantic City
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Langhorne
country: United States
facility: St Mary Medical Center
state: Pennsylvania
city: Upland
country: United States
facility: Crozer Chester Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06771986: Soluble Advanced Glycation End Product (sRAGE) Levels
Official title: Soluble Advanced Glycation End Product (sRAGE) Levels in Childhood Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese Patients
Keywords: Children, obesity, sRAGE
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-13
Enrollment: 88
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese and Healthy children who admitted to Kayseri City Hospital

Brief summary: The aim of this study is to evaluate sRAGE levels in children with obesity and to determine the relationship between metabolic status and sRAGE levels in childhood obesity


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Obesity BMI over 95th percentile BMI z-score over 2

Exclusion Criteria:

Primary hyperlipidemia Primary liver disease Hypothyroidism Diabetes

Primary outcomes:
measure: Evaluation of sRAGE levels in obese and healthy participants
timeFrame: From enrollment to the end of at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri City Hospital
Study officials:
References:
Clinical trial NCT01478386: Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
Official title: Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: OAD Orthopaedics
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone

Detailed description: A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.

Eligibility criteria: Inclusion criteria:

* Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs.
* Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment.
* Subjects will also have a documented varus deformity.

Exclusion criteria:

* Subjects with severe arthritis as demonstrated by radiographs.
* In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded.
* Female patients who are pregnant or breast feeding will also be excluded.

Primary outcomes:
measure: Reduction in knee pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Warrenville
country: United States
facility: OAD Orthopaedics
state: Illinois
Study officials:
affiliation: OAD Orthopaedics
name: William R Sterba, MD
role: PRINCIPAL_INVESTIGATOR
References: