louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00117039: A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia
Official title: SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Neoplasms
Keywords: anemia
fatigue
Aranesp®
clinical trial
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
Enrollment: 1500
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: The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).


Eligibility criteria: Inclusion Criteria: - Subjects with non-myeloid malignancy - Anemia (Hgb less than 11.0 g/dL) due to cancer chemotherapy - Receiving chemotherapy and expected to receive at least 8 additional weeks of chemotherapy - Adequate renal function - Adequate liver function Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Unstable cardiac disease - Active bleeding - Active systemic or chronic infection - Severe active chronic inflammatory disease - Other hematologic disorder associated with anemia - Uncontrolled hypertension - Known iron or nutritional deficiency - Known positive test for human immunodeficiency virus (HIV) infection - History of pure red cell aplasia - History of positive antibody response to any erythropoietic agent - Erythropoietin therapy within 4 weeks before screening - RBC transfusions within 2 weeks prior to screening

Primary outcomes:
measure: Hemoglobin maintenance
Secondary outcomes:
measure: Quality of Life
measure: Changes in measures of work productivity and anemia treatment convenience
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Boccia R, Lillie T, Tomita D, Balducci L. The effectiveness of darbepoetin alfa administered every 3 weeks on hematologic outcomes and quality of life in older patients with chemotherapy-induced anemia. Oncologist. 2007 May;12(5):584-93. doi: 10.1634/theoncologist.12-5-584.
citation: Boccia R, Malik IA, Raja V, Kahanic S, Liu R, Lillie T, Tomita D, Clowney B, Silberstein P. Darbepoetin alfa administered every three weeks is effective for the treatment of chemotherapy-induced anemia. Oncologist. 2006 Apr;11(4):409-17. doi: 10.1634/theoncologist.11-4-409.
Clinical trial NCT02650739: Optical Coherence Tomography-based Positioning for Macular Hole Surgery
Official title: Duration of Prone Positioning After Macular Hole Surgery Determined by Swept Source Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole Surgery
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images in 60 eyes was compared with the 69 eyes with same surgical procedure but the prone position determined by the surgeon's decision.

Brief summary: The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared.

Detailed description: The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual outcome were compared.

Eligibility criteria: Inclusion Criteria:

* The patients were followed more than 2 months.

Exclusion Criteria:

* Eye with axial length more than 26.0 mm

Primary outcomes:
measure: Macular hole closure
timeFrame: Changes from baseline to 1, 2 months
Secondary outcomes:
measure: Visual acuity before and after surgery
timeFrame: Changes from baseline to 1, 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774939: EVLA and Optimal Timing of Sclerotherapy
Official title: FinnTrunk, EVLA and Optimal Timing of Sclerotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Venous Reflux
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Helsinki University Central Hospital
name: Oulu University Hospital
name: Tampere University Hospital
name: Päijänne Tavastia Central Hospital
name: Satasairaala
name: Vaasa Central Hospital, Vaasa, Finland
First posted: 2021-03-01
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

Detailed description: The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.

Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.

Eligibility criteria: Inclusion Criteria:

* Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.

Exclusion Criteria:

* No severe comorbidities. Previous DVT.

Primary outcomes:
measure: re-intervention
timeFrame: 3 months
measure: Pain after procedure
timeFrame: up to 3 months after the treatment
measure: Quality of life before after procedure
timeFrame: up to 5 years
measure: Recur
timeFrame: up to 5 years
Secondary outcomes:
measure: Surgical complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: University of Turku
name: Harri Hakovirta, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02460939: The Study on the Pulmonary Vessel Disease and Its Changes in Metabolism of Small Molecules
Official title: The Study on the Pulmonary Vessel Disease and Its Its Changes in Metabolism of Small Molecules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Vessel Disease
Keywords: Pulmonary Vessel Disease
metabolism of small molecules
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ARDS and sepsis or only sepsis aged between 45 and 85

Brief summary: The purpose of this study is to investigate the changes of the pulmonary vessel disease and its metabolism of small molecules.

Detailed description: The patient with acute respiratory distress syndrome and sepsis come to hospital ,the investigators will blood them to study the changes in metabolism of small molecules.

Eligibility criteria: Inclusion Criteria:the aged between 18 and 85;Patients with ARDS and sepsis;Patients with only sepsis;normal

-

Exclusion Criteria:Age \<18 or \>85, pregnancy, diabetes mellitus, cardiac pulmonary edema, can lead to other conditions of ARDS: severe trauma, a large number of blood transfusions, severe acute pancreatitis, etc., end-stage tumor.

Primary outcomes:
measure: The changes of patients'metabolism of small molecules
timeFrame: about 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liu Sijie
state: Beijing
Study officials:
affiliation: Vice President of the Beijing chaoyang hospital
name: yingmin ma
role: STUDY_DIRECTOR
References:
Clinical trial NCT02826239: Evaluation of Postural Effects on Multiple-breath-washout Derived Lung Function Parameters
Official title: Evaluation of Postural Effects on Multiple-breath-washout Derived Lung Function Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Healthy Controls
Pulmonary Disease
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with and without known pulmonary disease

Brief summary: The investigators aim to evaluated the effect of postural changes on novel lung function parameters derived from multiple-breath-washout.


Eligibility criteria: Inclusion Criteria:

* patients with and without known pulmonary disease

Exclusion Criteria:

* pregnancy
* inability to participate

Primary outcomes:
measure: change of lung clearance index (LCI) as determined by multiple breath washout
timeFrame: 60 minutes
Secondary outcomes:
measure: repeatability of lung clearance index (LCI)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
Study officials:
References:
Clinical trial NCT01146639: DynaCT in Preoperative Imaging Before Insertion of Stentgraft
Official title: Usefulness of DynaCT Compared to Multidetector CT as Preoperative Imaging Before Insertion of Aortic Stentgraft.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: EVAR DynaCT
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Endovascular therapy of Aortic Aneurysms depends on good imaging facilities. A relatively new kind of x-ray equipment makes it possible to create computer tomography (CT) - like slice images in the operating room. The purpose of this study is to verify the clinical usefulness of DynaCT in a preoperative setting. To do so we compare aortic measurements in DynaCT to the same measurements in ordinary CT-images which are regarded the gold standard.


Eligibility criteria: Inclusion Criteria:

* Not inserted stent graft before.
* Patiens over 60 Years old.
* Able to give informed consent.

Exclusion Criteria: Not

-

Primary outcomes:
measure: Verify clinical usefulness of DynaCT images in preoperative imaging.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Operating Room of the Future.
Study officials:
References:
citation: Eide KR, Odegard A, Myhre HO, Hatlinghus S, Haraldseth O. DynaCT in pre-treatment evaluation of aortic aneurysm before EVAR. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):332-9. doi: 10.1016/j.ejvs.2011.05.014. Epub 2011 Jul 22.
Clinical trial NCT04947839: Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients
Official title: Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resting Energy Expenditure
Peritoneal Dialysis
Equation
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center

Brief summary: The energy and nutrition states are closely associated with dialysis patients' complications and outcomes. To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations do not focus on and applicable to peritoneal dialysis patients, so we aim to develop and validate an equation for estimating resting energy expenditure in peritoneal patients.


Eligibility criteria: Inclusion Criteria:

* Peritoneal dialysis patients and hemodialysis patients
* Dialysis length \>3 months
* \>18 years old
* Consented to participate in all aspects of the study

Exclusion Criteria:

* Acute complications to hospitalization 1 month prior to the study;
* Acute or chronic infections, cancer, and other wasting diseases in the past year;
* Thyroid dysfunction;
* Acute onset of podagra; Musculoskeletal diseases;
* Respiratory diseases (asthma, pleural effusion, pneumothorax, COPD);
* History of hormonal drug use;
* During pregnancy or lactation;
* Can not maintain posture and complete the REE test.

Primary outcomes:
measure: Novel equation development
timeFrame: March 18, 2021 to October 30, 2021
measure: Novel equation validation
timeFrame: October 30, 2021 to December 30, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Haidian Hospital
Study officials:
References:
Clinical trial NCT00408239: Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
Official title: Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thromboembolism
Keywords: Factor Xa inhibitor
Thromboembolism
Arthroplasty
Knee Replacement
Prevention and Control
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-12-06
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective primary total knee replacement surgery
* Legal minimum age requirement ( country-specific)
* Written informed consent has been obtained

Exclusion Criteria:

* Documented history or considered to be at increased risk of venous thromboembolism
* Subjects considered to be at increased risk of bleeding:

  * Known hemorrhagic disorder and/or coagulation disorder
  * Thrombocytopenia
  * Clinically important bleeding occurred within 3 months prior to the screening visit
* Acute bacterial endocarditis
* Severe hypertension
* Retinopathy
* Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.

Primary outcomes:
measure: All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment
timeFrame: 2 Weeks
Secondary outcomes:
measure: Venous thromboembolism and/or bleeds
timeFrame: 2 Weeks
measure: Other safety assessments
timeFrame: 2 Weeks
measure: PK, PD variables
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
city: Chubu region
country: Japan
city: Chugoku region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushyu region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
city: In Cheon
country: Korea, Republic of
city: Jeonnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kelantan
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: Singapore
country: Singapore
city: Kaohsiung
country: Taiwan
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03832439: Probiotic Supplementation on Weight Loss
Official title: The Effect of Probiotic Supplementation on Weight Loss, and Its Association With the Gut Microbiome After Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Probiotic
Microbiome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are trying to better understand how bariatric surgery leads to weight loss, and the role of bacteria that live in the gut in making this happen.

Detailed description: The investigators are interested in seeing how a probiotic, which is a dietary supplement containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial population and what effect it has on weight loss and loss of fat. Before undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be asked to provide a stool sample to assess the make-up of their gut bacterial population. They will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount of fat present inside the body.

After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be given either a probiotic supplement or dummy pill (placebo) for 3 months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and stool sample will be repeated at the end of the 3 month period and analyzed for changes.

Eligibility criteria: Inclusion Criteria:

1. All subjects who are \> 18 and \< 65 years of age recruited from the Mayo Clinic bariatric surgery clinic
2. Will also meet one of the National Institute of Health's criteria for bariatric surgery, i.e. body mass index (BMI) \> 40 kg/m2 or BMI \> 35 kg/m2 with significant weight-related comorbidities.
3. Patients will be eligible if they are not on chronic antibiotic therapy and without active systemic illness.

Exclusion Criteria:

1. Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population. All patients will not have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks.
2. Patients with allergy to antibiotics precluding the use of standard peri-operative antibiotics (cefazolin and metronidazole) will be excluded.

Primary outcomes:
measure: Weight loss
timeFrame: 3 months
measure: Visceral fat loss
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Meera Shah, M.B., Ch.B
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02899039: Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
Official title: Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IgG4-related Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.

The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.

These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.

The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +\> 50% on tissue immunostaining.

The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.


Eligibility criteria: Inclusion Criteria:

* IgG4-related disease patients or
* Sjogren syndrome patients or
* Healthy subjects

Exclusion Criteria:

* Presence of autoimmune or inflammatory associated disease
* Age less than 18 years

Primary outcomes:
measure: Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References: