louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06234514: Manage Macular Cystoid Edema with Retinal Vein Obstruction Using Traditional Chinese Medicine and Ranibizumab
Official title: Traditional Chinese Medicine and Ranibizumab in the Treatment of Macular Cystoid Edema Associated with Retinal Vein Obstruction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Macular Cystoid Edema
Keywords: Traditional Chinese Medicine
Ranibizumab
Retinal Vein Obstruction
Lead sponsor: Dongyang People's Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-31
Enrollment: 100
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: The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.

Detailed description: Compared to the sole intravitreal injection of ranibizumab, the combined use of traditional Chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections.

Eligibility criteria: Inclusion Criteria:

* Foveal center-involved macular edema (ME) lasting less than 9 months
* Central Macular Thickness (CMT) greater than or equal to 250 μm
* Best-Corrected Visual Acuity (BCVA) of 24-73 letters (20/40 to 20/320) in the study eye
* Initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections

Exclusion Criteria:

* Presence of any additional macular pathology, such as age-related macular degeneration (AMD) or diabetic retinopathy (DR) affecting the macula
* Concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases
* Concerns or doubts regarding treatment
* Known allergies to the ingredients of the medication.

Primary outcomes:
measure: Mean number of injections
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in BCVA
timeFrame: 48 weeks
measure: The mean change of central retinal thickness (CRT).
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Dongyang
country: China
facility: Dongyang People's Hospital
state: Zhejiang
Study officials:
affiliation: Dongyang People's Hospital
name: Guangjin Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT02922114: Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients
Official title: Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: Ultrasonography
Clinical assesment
joint abnormalities
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.


Eligibility criteria: Inclusion Criteria:

* Systemic Lupus Erythematosus patients (with or without joint involvement).
* subjects will have to sign the inform consent before the beginning of the study

Exclusion Criteria:

* Current pregnancy or no effective contraception

Primary outcomes:
measure: Ultrasonography record (synovitis / tenosynovitis / effusion)
timeFrame: Day 0 (there is only one point measurement in the study)
measure: Clinical joint assessment (synovitis / tenosynovitis / effusion)
timeFrame: Day 0
measure: Evaluate SELENA SLEDAI (C-SLEDAI) score
timeFrame: Day 0
measure: Evaluate musculoskeletal BILAG score
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Brest
country: France
facility: Chu de Brest
city: Le Mans
country: France
facility: CH du MANS
city: Nantes
country: France
facility: CHU Hôtel Dieu
city: Orléans La Source
country: France
facility: CHR d'Orléans
city: Rennes
country: France
facility: Hopital Pontchaillon - Chu de Rennes
city: Tours
country: France
facility: Chru de Tours
Study officials:
affiliation: CHR ORLEANS
name: Carine SALLIOT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05964114: First Time Right of Vancomycin
Official title: Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vancomycin
Pharmacokinetics
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool.

In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department
* Patient or their legal representative is able and willing to sign the Informed Consent Form

Exclusion Criteria:

* Pregnant woman
* Children
* Patients with a transplantation history
* Patients on continuous renal replacement therapy (CRRT)
* Patients receiving extracorporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04918914: Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
Official title: Off Label Use of Dapsone in SARS-CoV-2 Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: SARS-CoV-2
Hypoxia
ARDS
Lead sponsor: Hunt Regional Medical Center
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Addition of dapsone to COVID19 patient treated with standard treatment
Primary purpose: TREATMENT

Brief summary: Abstract Background: Clinicians in pulmonary critical care medicine and critical care medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3 (NLRP3).

Objective: To study the targeting of NLRP3 itself or up-/downstream factors of the NLRP3 inflammasome by dapsone must be responsible for its observed preventive effects, functioning as a competitor.

Methods:

Patients who were on standard COVID-19 therapy are also after obtaining off label uses and explanation of side effects are started on dapsone 100-200 mg daily along with Cimetadine 400 mg three times daily.

Detailed description: We are investigating in prospective ongoing non-randomized case study effects of addition of dapsone 100-200 mg daily in addition to standardized recommended treatment versus a a cohort of patient admitted at our institution since October 2020 versus a group that only received standardized treatment. Our primary out comes are decrease in FIO2 requirement leading to discharge from hospital and decrease in over all mortality between group treated with only standardized recommended treat versus group with addition of dapsone and cimetadine.

An objective criteria of improvement, was used for effectiveness of therapy.

A. a reduction in the FIO2 requirement and

B. a decrease in the progression of hypoxia. We treated the patients with standard COVID-19 ARDS treatment with dapsone 100 mg to target NLRP3 inflammasomes.

Eligibility criteria: Inclusion Criteria:

1. All, PCR confirmed cases of COVID-19

Exclusion Criteria:

1. Only consenting consenting patients

-

Primary outcomes:
measure: Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Hunt Regional Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT00566514: The Role of Ribose in Patients Diagnosed With Fibromyalgia
Official title: The Role of D-RIbose in Patients Diagnosed With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
ribose
d-ribose
dextrose
Lead sponsor: Bioenergy Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purose of this research study is to determine the potential benefit of D-ribose, a nutritional supplement (a sugar), versus a placebo (another sugar) in people with fibromyalgia.

Detailed description: Two hundred to three hundred subjects (equally distribued between placebo and D-ribose) between 18-78 years of age will comprise this study. The final numbers enrolled will depend upon obtaining approximately 100 subjects that can display a high degree of compliance to TID dosing with approximately equal balance between the active and placebo arms.

Eligibility criteria: Inclusion Criteria:

* previous diagnosis of fibromomyalgia by a MD
* Has been diagnosed with fibromyalgia and are over 18 years of age
* Does live in the United States

Exclusion Criteria:

* does NOT have severe medication/chemical/supplement sensitivities
* does NOT have insulin dependent diabetes or other severe illnesses (cancer, hepatitis, congestive heart failure)
* does NOT have rheumatoid arthritis or gout
* previous use of ribose

Primary outcomes:
measure: Significant reduction in symptoms of pain and fatigue
timeFrame: 3 weeks
Secondary outcomes:
measure: Demonstrate an improvement in ones quality of life
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Bioenergy Life Science, Inc.
state: Minnesota
Study officials:
affiliation: The Annapolis Center for Effective CFS/Fibromyalgia Therapies
name: Jacob Teitelbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hormone and Longevity Medical Center
name: Kent Holtorf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teitelbaum JE, Johnson C, St Cyr J. The use of D-ribose in chronic fatigue syndrome and fibromyalgia: a pilot study. J Altern Complement Med. 2006 Nov;12(9):857-62. doi: 10.1089/acm.2006.12.857.
Clinical trial NCT00722514: Evaluation of a Patient Education Program for Ankylosing Spondylitis
Official title: Evaluation of a Patient Education Program for Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Spondyloarthritis
Lead sponsor: Rehazentrum Bad Eilsen
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
First posted: 2008-07-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic progressive systemic inflammatory disease of the axial skeleton. Extensive information about the disease is a necessary first step. An education program for AS was implemented to improve inpatient medical rehabilitation. In a controlled quasi-experimental multicentric study the efficacy of this program was analysed.


Eligibility criteria: Inclusion Criteria:

* Ankylosing Spondylitis (AS) according to modified New York Criteria
* Early diagnosis criteria for AS
* ESSG Criteria for Spondyloarthritis

Exclusion Criteria:

* History of malignant disease during past five years
* Secondary fibromyalgia syndrome
* Group integration deficiencies
* Seminar repeaters

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Eilsen
country: Germany
facility: Rehazentrum Bad Eilsen
state: Lower Saxony
Study officials:
affiliation: Rehazentrum Bad Eilsen
name: Inge Ehlebracht-Koenig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355614: A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
Official title: A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Fistula
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 10
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: This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* At least one draining enterocutaneous perianal fistula
* Diagnosis of Crohn's disease (CD) must have been established for at least 6 months
* At least one ineffective fistula treatment (but no previously failed anti-TNFα (tumour necrosis factor) antibody treatment)
* Patients should not suffer from any other health problems that may jeopardize their participation in the study.

Exclusion Criteria:

* Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFα antibody treatment
* Active Crohn's disease
* Recent or pending abdominal or ano-rectal surgery, particularly presence of stricture, or abscess, or retention for which surgery might be indicated
* Previously failed anti-TNFα antibody treatment
* Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation
timeFrame: 52 weeks
Secondary outcomes:
measure: Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01393314: A Trial of Telemonitoring in Adults With Heart Failure
Official title: A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 99
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial of telemonitoring vs usual care provided by home care agencies for patients with heart failure.

The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent care visits, unscheduled physician appointments, Emergency Room visits in patients with heart failure over the 60 day post hospitalization period.

Detailed description: A 60 day stratified, randomized clinical trial of a home-based telemonitoring system (TEP) vs. usual home-care with educational package (EP). Both Groups will receive intensive patient education and primary care physicians will be prompted to adhere to heart failure management guidelines. The study will be conducted on 100 patients receiving home care nursing services post-hospital discharge.

Each participant will be randomized in equal amounts to treatment (TEP) or no treatment (EP).

Eligibility criteria: Inclusion Criteria:

* Heart Failure (primary or secondary) diagnosis regardless of ejection fraction (EF) and New York Heart Association (NYHA) class II- IV at the time of Home Health Care (HHC) admission and HHC services initiated following a hospital stay

Exclusion Criteria:

* Inability to stand on a scale, weight over 500 pounds, unable to hear and/or see, or no working land line phone in the residence.
* Additional exclusion criteria were: patients with severe ischemic heart disease, Myocardial Infarction (MI) and/or Coronary artery bypass graft surgery(CABG) in the last 6 weeks, severe uncorrected valvular disease, home inotropic therapy, severe lung disease (oxygen dependent), active cancer, uncorrected thyroid disease, AIDS, or end stage renal disease on dialysis.

Primary outcomes:
measure: The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
timeFrame: Participants were followed for the duration of home care services up to 12 months
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionaire
timeFrame: Participants were followed for the duration of home care services up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve Univeristy
name: Rebecca Boxer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02879214: Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer
Official title: Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer (SIDE, Advanced Squamous Cervical Cancer Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Cervix
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
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 determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.

Detailed description: Concurrent radiation therapy and chemotherapy is the standard of care for locally advanced cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into minimal invasive surgical resection after maximal downstage. This protocol is designed to determine the dose escalation of both chemo and radiation for treating tumor bearing regions within the abdomen and pelvis, using an two drug chemotherapy in first cycle of mitomycin/cisplatin or taxol/cisplatin along with simultaneously integrated boost technique to Biological target area defined by PET scan. This dose escalation is to downstage disease for minimal invasive surgical resection.

Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed squamous cell carcinoma of cervix, able to receive chemotherapy and concurrent chemoradiotherapy.

Good performance status. Negative pregnancy test in women of child-bearing potential. Signed study-specific informed consent. Lab results within study specific limits

Exclusion Criteria:

* Prior radiation to the abdomen or pelvis. A history of Scleroderma or Inflammatory bowel disease. Contraindication to chemotherapy or radiation

Primary outcomes:
measure: To observe the efficacy from radiation therapy dose escalation
timeFrame: 4 year
Secondary outcomes:
measure: To evaluate the chemoradiation in Stage IIB~ III carcinoma cervix
timeFrame: 4 years
measure: Disease free survival(DFS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan PPH, Departmentn of Gynecology Oncology
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences
name: Ming Zeng, MD PhD
role: STUDY_CHAIR
References: