louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02844322: The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia
Official title: The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control 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: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.

Detailed description: Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.

Eligibility criteria: Inclusion Criteria:

1. aged \>=18 years
2. diagnosed with LPL/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 center 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 NCT04291222: Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
Official title: Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patent Ductus Arteriosus
Duct-dependent Cyanotic Congenital Heart Disease
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-02
Enrollment: 10
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the PDA as initial palliation of cyanotic CHD with duct-dependent PBF.

Detailed description: Study type: Interventional, prospective, single arm, investigator initiated Study population: 10 patients Primary purpose: Treatment Follow up: Review at 1 month and thereafter 3 monthly (clinical examination and echocardiography for stent patency, SaO2 measurement. Serum Iron and Ferritin levels will be measured before procedure and at follow ups. From 6 months onwards the patients will be assessed for the need of repeat catheterization with a view of surgery or for continued observation.

Study endpoints: 9 months post implant or the following: 1)Patients are subjected for surgical repair of CHD; 2)Death before surgical repair; 3)Unplanned re-intervention with additional stenting procedure.

Eligibility criteria: Inclusion Criteria:

* Weight \>3.0 kg
* Age \<3 months
* Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight

Exclusion Criteria:

* Weight \<3 kg, age \>3 months
* Angiographic criteria-tortuous PDA
* Family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis
* Other severe congenital anomalies with life expectancy \<12 months

Primary outcomes:
measure: Number of participants for surgical repair of CHD
timeFrame: 9 months
measure: Number of Unplanned re-intervention
timeFrame: 9 months
measure: Death
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
Study officials:
References:
Clinical trial NCT04494022: Role of CEUS as a Secondary Diagnostic Modality
Official title: Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.
Primary purpose: DIAGNOSTIC

Brief summary: To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.

Detailed description: The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.

Eligibility criteria: Inclusion Criteria:

* at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)
* at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI
* signed informed consent

Exclusion Criteria:

* congestive hepatopathies
* severe cardiovascular dysfunction
* no recent cross-sectional images within 4 weeks
* suboptimal cross-sectional images quality

Primary outcomes:
measure: Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation
timeFrame: 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.
measure: Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.
timeFrame: 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.
Secondary outcomes:
measure: Comparing image characters between two types of ultrasound contrast media
timeFrame: For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Jeong Min Lee, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06533722: Adaptive Therapy for Post-Second-Line Advanced Breast Cancer
Official title: A Phase II Study of the Efficacy and Safety of Adaptive Therapy for Metastatic Refractory Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HER2-negative Metastatic Breast Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 10
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 primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.

Detailed description: This is a phase II, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast cancer. The therapy regimen primarily including Gemcitabine, Vinorelbine, or Eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. This study plans to recruit 10 subjects.

Eligibility criteria: Inclusion Criteria:

* Understands and voluntarily signs the informed consent form.
* Minimum life expectancy 16 weeks.
* Histologically or cytologically confirmed advanced invasive breast cancer.
* Histological type: human epidermal growth factor receptor 2 (HER2) negative.
* Prior failure of at least first-line treatment for metastatic disease.
* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
* Premenopausal women must use medically acceptable contraception during the study.
* Compliance with the study protocol.

Exclusion Criteria:

* Pregnant or breast feeding.
* Uncontrolled medical problems.
* Evidence of active acute or chronic infection.
* Hepatic, renal, cardiac, or bone marrow dysfunction.
* Concurrent malignancy or history of other malignancy within the last five years.
* Patients were unable or unwilling to comply with program requirements.
* Concurrent use of any other anti-cancer therapy.

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: 12 months
Secondary outcomes:
measure: Occurrence and severity of adverse events (AEs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhongyu Yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06964022: Impact of Blood-Flow-Restriction Prehabilitation on Pre- and Postoperative Rehabilitation After Total Knee Arthroplasty
Official title: Impact of Blood-Flow-Restriction Prehabilitation on Pre- and Postoperative Rehabilitation After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 20
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: Degenerative and traumatic diseases of the musculoskeletal system lead to increased immobility of a patient, which in turn results in muscle atrophy. BFR training is a training method in which a blood pressure cuff partially blocks the arterial blood flow to the exercising limb and completely blocks the venous blood flow. During exercise, an externally induced venous occlusion occurs. This stimulus increases the metabolic stimulus in the occluded extremity - this means that strength can be increased even with low weights, which is why this training is also suitable for people who should not use high training loads due to injuries or operations.


Eligibility criteria: Inclusion Criteria:

* Indication for TKA Surgery
* Ability to perform prehabilitation exercise

Exclusion Criteria:

* Sickle Cell Anemia
* Iatrogenic changes in the vessels of the lower extremities (e.g. stents)
* Open wounds/Infection of the lower extremities

Primary outcomes:
measure: Subjective Pain Value
timeFrame: Pre- to 6 weeks Post Surgery
measure: Muscle Strength
timeFrame: Pre- to 6 weeks Post Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
state: NRW
Study officials:
References:
Clinical trial NCT01532622: Impact of Blueberries on Uric Acid and Quality of Life
Official title: Impact of Blueberries on Uric Acid and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperuricemia
Keywords: Blueberry
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: U.S. Highbush Blueberry Council
First posted: 2012-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of blueberries on uric acid in patients with hyperuricemia that are not receiving uric acid pharmacotherapy. The central hypothesis the investigators propose is that daily blueberries added to a pre-existing diet will promote uric acid lowering and improve quality of life without detriment to vital signs.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Uric acid \> 6.0 mg/dL

Exclusion Criteria:

* Current moderate-to-severe symptomatic gout
* Currently receiving gout pharmacotherapy
* Current participation in another clinical trial
* Documented non-compliance or consistent missed appointments
* Women who are pregnant or nursing

Primary outcomes:
measure: Change from Baseline and Placebo in Uric Acid Level in Patients Randomized to Treatment Group
timeFrame: Baseline, ~30 days later
Secondary outcomes:
measure: Blood Pressure
timeFrame: Baseline, ~30 days, ~45 days, ~75 days
measure: Body Weight
timeFrame: Baseline, ~30 days, ~45 days, ~75 days
measure: Quality of Life
timeFrame: Baseline, ~30 days, ~45 days, ~75 days
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Daniel Riche, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center
name: Marion Wofford, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04470622: Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Coronavirus
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 27
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 the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.


Eligibility criteria: Inclusion Criteria:

* Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain reaction (PCR), antigen or immunoglobulin M (IgM) antibody test.
* Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen saturation of \<94% by pulse oximetry on room air or requiring supplemental oxygen.
* Not anticipated to require mechanical ventilation within 48 hours.

Exclusion Criteria:

* Is taking high-dose hydroxychloroquine or chloroquine.
* Is taking pimozide or strong or moderate CYP3A4 inhibitors.
* Is currently receiving treatment with products intended to modify immune response to COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed), chemotherapy or on hemodialysis or peritoneal dialysis.
* Has known hypersensitivity to any components of aprepitant injectable emulsion.
* Has evidence of ARDS.
* Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask, noninvasive positive pressure ventilation, or ECMO.
* Has multiple organ failure.
* Has current confirmed Influenza A or B infection, or a a history of organ or hematologic transplant, HIV, or active hepatitis B or hepatitis C infection.

Primary outcomes:
measure: Proportion of Subjects Alive and Discharged From the Hospital.
timeFrame: 14 Days.
Secondary outcomes:
measure: Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO).
timeFrame: 56 Days.
measure: Time to Discharge From Hospital.
timeFrame: 56 Days.
measure: Change From Baseline in Interleukin 6 (IL-6).
timeFrame: Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo))
measure: Incidence of Treatment-emergent Adverse Events.
timeFrame: Through Day 56
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
References:
Clinical trial NCT01090622: Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
Official title: Phase 2a, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients With Inherited Erythromelalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Erythromelalgia
Inherited Erythromelalgia
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether XPF-001 is safe and effective in the treatment of pain caused by Inherited Erythromelalgia (IEM).


Eligibility criteria: Inclusion Criteria:

The study requires you to:

* Be18-75 years old
* Have inherited erythromelalgia
* Be experiencing pain caused by erythromelalgia (Moderate pain score 4/10)
* Be generally healthy (apart from your pain)
* Stop taking your usual pain medications for 9 days
* Not be pregnant or breast-feeding

Your role in the study includes:

* An out-patient screening visit
* 9-days/8 nights-in-patient treatment visit at Nijmegen Medical Center (where you will be closely monitored)
* A follow up phone call (after your return home)
* Taking the investigational medication daily
* Recording your pain levels daily during stay at the Medical Center.

Exclusion Criteria:

* Coexistent source of pain from other conditions
* Receiving professional psychological support for dealing with IEM
* Treatment for significant depression within 6 months of screening
* Active HIV, Hepatitis B or C
* Use of prescription or OTC medication between check-in and discharge
* Women who are pregnant, or lactating
* Not currently using adequate contraception
* Alcoholism or alcohol or substance abuse
* Presence or history of major psychiatric disturbance
* Unwilling or unable to comply with all dietary and activity restrictions
* Any other condition or finding that may pose undue risk for participation
* Use of any other investigational drug in the 60 days prior to dosing

Primary outcomes:
measure: Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine)
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Clinical Research Centre at Radboud University Nijmegen Medical Center
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Joost PH Drenth, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164422: Does Guanfacine Attenuate Stress-Induced Drinking?
Official title: Does Guanfacine Attenuate Stress-Induced Drinking?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Drinking
Keywords: Alcohol
Drinkers
Guanfacine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-06-16
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed) during the 2-hour self-administration period across two laboratory sessions.


Eligibility criteria: Inclusion Criteria:

* Age 21-65
* Able to read and write English
* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for current (past 6 months) alcohol abuse or alcohol dependence

Exclusion Criteria:

* Participants with any significant current medical conditions, seizures, delirium or hallucinations, or other unstable medical conditions including HIV
* Current DSM-IV abuse or dependence on substances, other than alcohol abuse, alcohol dependence, or nicotine dependence
* Women who are pregnant or nursing
* Suicidal, homicidal or evidence of current (past 6-month) mental illness
* Meet DSM-IV criteria for current (past-6 month) attention deficit hyperactivity disorder (ADHD)
* Specific exclusions for administration of guanfacine not already specified include: EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker; history of fainting, syncopal attacks, heart failure or myocardial infarction, or impaired liver as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3x normal or renal function (estimated creatinine clearance \<60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic blocker; use of any central nervous system (CNS) depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
* Subjects likely to exhibit clinically significant alcohol withdrawal during the study.
* Individuals who are seeking treatment for drinking

Primary outcomes:
measure: mL Per 15 Minutes
timeFrame: 2 hour self administration period during lab sessions held on days 22 and 25
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigations, Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References: