louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03245957: HDL Dysfunction During the Acute Stage of Stroke
Official title: HDL Dysfunction During the Acute Stage of Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Acute
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-08-10
Enrollment: 112
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: Adult patients with clinical picture of early stage of stroke with the first signed lasting for less than 12 hours

Brief summary: The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes.

Detailed description: MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.

Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3 cases.

The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent marker of early stage of ischemic stroke.

Plasma MPO levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture.

Eligibility criteria: Inclusion Criteria:

Patients with less than 12 hours stroke clinical signs:

* hemiparesis or hemiplegia
* unilateral sensitivity disorder
* language impairment
* balance disorder
* dizziness, bilateral or monocular vision totally or partially lost

Exclusion Criteria:

* Pregnancy
* head trauma since the last 3 months
* stroke since the last 3 months
* myocardial infarction since the last 3 months
* patient disagrees to be enrolled in the study

Primary outcomes:
measure: Plasma MPO concentrations
timeFrame: Through study completion, an average of 6 hours
Secondary outcomes:
measure: HDL-MPO concentrations
timeFrame: Through study completion, an average of 6 hours
Other outcomes:
measure: HDL dysfunction
timeFrame: Through study completion, an average of 6 hours
Locations:
city: Saint-Pierre
country: Réunion
facility: Chu Reunion Island
state: Reunion Island
Study officials:
affiliation: Centre Hpospitalier Universitaire de La REUNION
name: David COURET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712257: Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis
Official title: A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Restenosis
Keywords: treatment of superficial femoral artery instent restenosis
Lead sponsor: VIVA Physicians
Sponsor class: OTHER
Collaborators: name: W.L.Gore & Associates
name: Spectranetics Corporation
First posted: 2008-07-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis


Eligibility criteria: Inclusion Criteria:

* Subject or subject's legal representative informed of the study nature.
* Subject understands the duration of the study and its follow up visit requirements.
* Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
* Subject able to walk unassisted.
* Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.

Exclusion Criteria:

* Life expectancy less than 12 months
* Myocardial infarction less than 3 months prior to procedure
* Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
* Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
* Uncontrolled hypercoagulability

Primary outcomes:
measure: 12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis.
timeFrame: 12 months
Secondary outcomes:
measure: Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure.
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Gary Ansel, MD
state: Ohio
Study officials:
affiliation: Presbyterian Heart Institute
name: Tony Das, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05112757: Effective Conversion of Individuals at Risk
Official title: Effective Conversion of Individuals at Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Atrial Fibrillation
Keywords: OSA
AFib
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
Collaborators: name: Sanford Health
First posted: 2021-11-09
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis

Detailed description: The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.

Eligibility criteria: Inclusion Criteria:

* High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health
* 18 years or older, with sufficient English language skills
* Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11\<)
* Able to download and handle an app on a smartphone
* Willing and able to give informed consent

Exclusion criteria:

* Diagnosed with OSA and/or AFib
* Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)
* Pregnancy/breast feeding

Primary outcomes:
measure: Effective conversion
timeFrame: 6 months after consent
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sandford Health
state: South Dakota
Study officials:
affiliation: Philips Healthcare
name: Tim Weysen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01449357: Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors
Official title: A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Zalutumumab
Efficacy
Safety
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.


Eligibility criteria: Inclusion Criteria:

* Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).

Exclusion Criteria:

* Estimated life expectancy of less than 3 months.
* Received the following treatments within 2 weeks prior to Visit 2:

  * Cytotoxic or cytostatic anti-cancer chemotherapy
  * Total resection or irradiation of the target lesion
  * Any investigational agent

Primary outcomes:
measure: Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.
timeFrame: within 6 months
Secondary outcomes:
measure: Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months.
timeFrame: within 6 months
Other outcomes:
Locations:
Study officials:
affiliation: H. Lee Moffitt Cancer Center, Tampa, Florida, USA
name: Not applicable, Study cancelled
role: STUDY_CHAIR
References:
Clinical trial NCT00193557: Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
Official title: Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2005-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib

Detailed description: Upon determination of eligibility, patients will be receive:

* Bortezomib

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Multiple Myeloma
* Received no more than 2 previous treatment regimens for multiple Myeloma
* ECOG performance status 0, 1, or 2
* Serum creatinine \< 2.0mg/dL
* calculated or measured creatinine clearance \> 30ml/minute
* Measurable or evaluable disease
* Provide written informed consent prior to receiving protocol therapy.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Moderate or severe peripheral neuropathy
* Other serious medical conditions
* Other active malignancies
* history of treatment for other invasive cancers
* Women who are pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: objective response rate
Secondary outcomes:
measure: progression-free survival
measure: overall survival
measure: Safety
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hainsworth JD, Spigel DR, Barton J, Farley C, Schreeder M, Hon J, Greco FA. Weekly treatment with bortezomib for patients with recurrent or refractory multiple myeloma: a phase 2 trial of the Minnie Pearl Cancer Research Network. Cancer. 2008 Aug 15;113(4):765-71. doi: 10.1002/cncr.23606.
Clinical trial NCT03483857: Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
Official title: Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: Peer Navigation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: ANOVA Health Institute
name: National Institutes of Health (NIH)
First posted: 2018-03-30
Enrollment: 103
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm study assessing to determine feasibility and acceptability of a pilot PN intervention among 100 HIV-positive MSM. We will explore associations between PN participation and continuum of care outcomes in a cohort of 55 HIV-positive MSM receiving PN, as compared to a cohort of 48 HIV-positive MSM receiving standard-of-care clinical referral, in preparation for a full-scale multi-site behavioral efficacy trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been implemented among HIV-positive men and women in the general population in North West province, South Africa, by members of this research team.


Eligibility criteria: Inclusion Criteria:

* Biological male;
* Age \>=18 years;
* Self-identify as a gay or bisexual man, or a transgender woman;
* Have male sexual partners within the prior six months
* Resident in the Ehlanzeni District Municipality for at least six months of the year;
* Be physically present in Ehlanzeni for at least two weeks per month
* Self-disclosed receiving an HIV-positive diagnosis in the last 5 years;
* Consent to all serological testing for HIV antibodies, ART analytes, and HIV RNA
* Consent for study staff to review participants' clinical records;
* Consent to the randomization process.

Exclusion Criteria:

* Inability to provide written informed consent for participation, including being under the influence of alcohol or drugs.
* Inability to provide laboratory or documentary evidence of HIV diagnosis.

Primary outcomes:
measure: Viral Suppression
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nelspruit
country: South Africa
facility: Anova Health Institute
state: Mpumalanga
Study officials:
affiliation: University of California, San Francsico
name: Sheri Lippman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04933357: Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy ￼
Official title: Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Head and Neck Cancer
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.


Eligibility criteria: Inclusion Criteria:

* More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx.

Clinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT).

Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.

Primary outcomes:
measure: Loco-regional control of HNSCC patients.
timeFrame: 2 years loco-regional control.
Secondary outcomes:
measure: Acute radiation toxicity
timeFrame: During treatment and up to 6 months post treatment.
measure: Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.
timeFrame: 2-4 weeks after start of treatment
measure: Overall survival
timeFrame: 2 years overall survival
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Tarek Shouman
role: STUDY_DIRECTOR
References:
Clinical trial NCT01009957: Everolimus on CKD Progression in ADPKD Patients
Official title: Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Polycystic Kidney Diseases
Keywords: ADPKD
CKD
Renal disease progression
Everolimus
Lead sponsor: A. Manzoni Hospital
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 71
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: The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.

Detailed description: Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts.

Eligibility criteria: Inclusion Criteria:

1. Subjects over 18 years of both genders
2. Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
3. GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
4. Previous follow up of two years, with a creatinine evaluation at least once a year
5. GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)

Exclusion Criteria:

1. Pregnancy, lactating, males and females without adequate contraception
2. Leucopenia (\< 3,000 leucocytes/mm3) or thrombocytopenia (\< 100,000 platelets/mm3)
3. Dyslipidemia (cholesterol or triglycerides \> 260 mg/dl with treatment)
4. Urinary tract infection
5. Patients who cannot undergoing NMR

Primary outcomes:
measure: Reduction of GFR (according to MDRD formula) during a two-year follow up
timeFrame: Two year-followup
Secondary outcomes:
measure: reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
timeFrame: Two year-followup
measure: changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study
timeFrame: Two year-followup
measure: safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events
timeFrame: Two year-followup
measure: evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point
timeFrame: Two year-followup
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: A.O. Spedali Civili Di Brescia
city: Lecco
country: Italy
facility: Alessandro Manzoni Hospital, Nephrology and Dialysis Department
city: Modena
country: Italy
facility: Modena Hospital
city: Napoli
country: Italy
facility: Dipartimento di Patologia Sistematica - Università Federico 2°
city: Piacenza
country: Italy
facility: Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department
city: Torino
country: Italy
facility: C.M.I.D. - Presidi Ospedalieri ASL 4
city: Vicenza
country: Italy
facility: Ospedale Civile San Bortolo Vicenza
Study officials:
affiliation: Nephrology and Dialysis Department - A. Manzoni Hospital
name: Francesco Locatelli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05991557: Peroneus Longus Graft :Effect in Foot and Ankle Function
Official title: Peroneus Longus Autograft Use in Knee, Shoulder, Elbow Ligaments Reconstruction Surgery : Effect On Ankle And Foot Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ligament Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to report the ankle and foot functions via American orthopedic foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments reconstruction.

Detailed description: Using a Peroneus longus tendon (PLT) as an autograft is a common procedure and has been used previously for deltoid ligament reconstruction in flatfoot deformity correction . Recently, (PLT) is gaining popularity as a graft option in primary anterior cruciate ligament (ACL) reconstruction surgeries with biomechanical studies showing tensile strength and clinical outcomes comparable to quadrupled hamstring grafts.

In addition to using PLT for isolated (ACL), it is also used in posterior cruciate ligament (PCL) reconstruction, medial collateral ligament reconstruction, posterolateral corner reconstruction of the knee, or knee multiple ligament injuries . The partial-thickness of the tendon has been used variably in knee ligament surgery..

Being a powerful muscle in plantar flexion and eversion of the foot, there might be associated ankle functional impairment. To the authors knowledge, there is a gap in science evaluating donor site morbidity. The aim of this study is to report the clinical and functional outcome of the donor site for better explanation of the cons and pros of using PLT as a graft in joint ligamentous injury .

Eligibility criteria: Inclusion Criteria:

1. clinical and radiological diaginsis of joint ligament injury and needs to ligament reconstruction .
2. people with asymptomatic ankle and foot pre and post injury

Exclusion Criteria:

1. Associated ankle and/or foot fractures.
2. Associated hip or pelvic fractures
3. Abnormal ankle function pre-injury.
4. Contralateral limb fractures
5. Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
6. Presence of neurological condition that result in spasticity or any abnormal lower limb muscles tone.
7. Any condition that would preclude the ability to comply with post-operative guidelines.

Primary outcomes:
measure: peronei muscle strength testing using handheld dynamometer
timeFrame: preoperative, three months postoperative and six months postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: