louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02513862: Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery
Official title: Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: C.Surgical Procedure; Cardiac
Keywords: autologous platelet rich plasma
deep hypothermic circulatory arrest
transfusion
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、
* preoperative platelet counts\>150000000000/L、
* preoperative hematocrit\>33%、
* without recent anticoagulants less than 5 days

Exclusion Criteria:

* preoperative coagulation disorder
* severe renal and liver dysfunction
* preoperative hemodynamic instability

Primary outcomes:
measure: total perioperative allogenic transfusions of platelet and fresh frozen plasma
timeFrame: on the 7th day postoperatively
Secondary outcomes:
measure: postoperative blood loss
timeFrame: on the 7th day postoperatively
measure: rate of reexploration for bleeding
timeFrame: on the 7th day postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
state: Beijing
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Hongwen Ji, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Yongyuan Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05368662: Quality of Life and Quality of Sleep Studies in Children with Home Care Ventilation in the West of France
Official title: Quality of Life and Quality of Sleep Studies in Children with Home Care Ventilation in Two Regions of France Pays De Loire and Bretagne
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Non Invasive Ventilation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-05-10
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Home ventilation in children, invasive or non invasiv,e is an interesting treatment for different disease which cause chronic respiratory impairement. The aim of this treatment is to support alveolar hypoventilation. Concerned diseases are : neuro-muscular disease, upper airways pathologies, whest wall or lung pathologies, central control ventilation disease. Prevalence of home children ventilation is in augmentation in France. The last national study in 2021 about infants show a prevalence of 9.3/100 000. Advantages with home children ventilation in addition of improvement of survey, it can observe improvement of quality of life and improvement of the quality of their sleep. Quality of life is a thematic less studying. Last studies show an impairment of quality of life in all thematics compare to children with no disease but also with infants whith chronic diseases. This study were about few numbers of patients. The aim of this study is to evaluate the quality of life and the quality of sleep in children with home ventilation to complete the actual littérature to improve the respiratory care of this population.


Eligibility criteria: Inclusion Criteria:

* Child aged 6 months to 17 years treated with non-invasive ventilation at home for at least 1 month
* Follow-up in one of the five centers participating in the study (Angers, Nantes, Le Mans, Rennes and Brest)
* Informed consent form signed by both parents, or holder of parental authority, for the participation of their child
* To be affiliated or beneficiary of social security

Exclusion Criteria:

* Parents with poor command of the French language, implying not being able to complete the various questionnaires
* Refusal of the child to participate in the study

Primary outcomes:
measure: Quality of life in children with home care ventilation
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
state: Maine et Loire
Study officials:
References:
Clinical trial NCT06711562: Model-informed Individualized Treatment of Anti-infective Drugs
Official title: Model-informed Individualized Treatment of Anti-infective Drugs in Patients With Osteoarticular Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarticular Infections
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected/confirmed osteoarticular infections who are undergoing anti-infective drug therapy.

Brief summary: The study aims to optimize individualized treatment of anti-infective drugs in osteoarticular infections by analyzing drug exposure in patients blood and/or tissues using population pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected/confirmed osteoarticular infections who are undergoing anti-infective drug therapy.

Exclusion Criteria:

* Pregnant/lactating women.
* There are other factors that the researchers think are not suitable for inclusion.

Primary outcomes:
measure: Clearance (L/h)
timeFrame: Through study completion, an average of 30 days
measure: Volume of Distribution (L)
timeFrame: Through study completion, an average of 30 days
Secondary outcomes:
measure: ratio of the area under the concentration-time curve from 0 to 24 hours
timeFrame: Through study completion, an average of 30 days
measure: erythrocyte sedimentation rate
timeFrame: Through study completion, an average of 30 days
measure: Adverse events
timeFrame: Through study completion, an average of 30 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02464462: The Role of Vitamin D3 and Calcium Supplementation in Attenuating T2DM Severity
Official title: The Role of Vitamin D and Calcium Supplementation in the Pathogenesis of Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: serum calcidiol
T2DM
vitamin D3 supplementation
post-menopausal women
ethnic diverse
calcium supplementation
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Women's Health in Women's Hands Community Health Center
First posted: 2015-06-08
Enrollment: 11
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.

Detailed description: Subjects of this study received a total of 1800 IU vitamin D3 and 720 mg of calcium per day for 3 years. The study was conducted in Toronto, Ontario, Canada.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Non-white, post menopausal female
* Have access to Community Health Center

Exclusion Criteria:

* neurodegenerative disease
* kideny disease
* gluten allergy

Primary outcomes:
measure: Serum calcidiol
timeFrame: 3 years
Secondary outcomes:
measure: Fasting insulin
timeFrame: 3 years
measure: Parathyroid Hormone
timeFrame: 3 years
measure: Fasting blood glucose
timeFrame: 3 years
measure: Glycated Hemoglobin
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00392262: A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients
Official title: An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-week Treatment With Amlo 5mg or Felodipine 5mg in Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Moderate essential hypertension (WHO grade II)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients (18 years)
2. Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and \<180 mmHg at Visit 1, treated must have MSSBP \<180 mmHg at Visit 1) (WHO grade II)

Exclusion Criteria:

1. Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
2. Pregnant or nursing women
3. Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP \< 90 mmHg and systolic BP \< 140 mmHg)
4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg
Secondary outcomes:
measure: Mean sitting diastolic blood pressure (analogously & explorative)
measure: Normalization (analogously & explorative)
measure: Responder rate. (analogously & explorative)
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis +41 61 324 1111
role: STUDY_DIRECTOR
References:
citation: Brachmann J, Ansari A, Mahla G, Handrock R, Klebs S. Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy. Adv Ther. 2008 May;25(5):399-411. doi: 10.1007/s12325-008-0054-6.
Clinical trial NCT02430662: Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Neoplasms
Keywords: irreversible electroporation
Unresectable Gallbladder Neoplasms
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.

Detailed description: By enrolling patients with unresectable Gallbladder Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Gallbladder Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Gallbladder Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: A minimum and maximum range of voltage for safe and effective IRE
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00696462: The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
Official title: The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cesarean Section
Keywords: forced-air warming
Bair Hugger
cesarean section
postoperative infection
surgical site infections
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.

Detailed description: Given the physiologic and experimental evidence regarding temperature regulation; it remains convincing that forced air warming is protective against the development of SSI. We will set out to prospectively study the effect of forced air warming on patients undergoing cesarean section.

Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years old) female subjects who will undergo cesarean delivery regardless of indication.
* Subjects who have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Patients scheduled to receive prophylactic antibiotic therapy.

Exclusion Criteria:

* Patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices.
* Patients undergoing general anesthesia.

Primary outcomes:
measure: treatment effects on wound infection
timeFrame: As is current standard of care post procedure
Secondary outcomes:
measure: treatment effects on endometritis
timeFrame: as is current standard of care post procedure
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Curtis L Baysinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02171091: Intubated ICU Patients
Official title: Impact of the Endotracheal Tube on Airway Inflammation: Prospective Analysis in Intubated ICU Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patients Requiring Endotracheal Intubation
Keywords: endotracheal
intubation
airway
inflammation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving endotracheal intubation in the ICU

Brief summary: The purpose of this research study is to determine how cell changes during endotracheal intubation and artificial lung ventilation affect lung inflammation.

Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic (lung) samples will be collected at the same time intervals when possible and if they are done as standard of care.

Blood samples will be obtained simultaneous with the collection of the trachael (windpipe) specimens.


Eligibility criteria: Inclusion Criteria

1. Ages 18 to 85
2. Required to have endotracheal intubation
3. Admitted to an intensive care unit

Exclusion Criteria

1. On immunosuppressive medications
2. Previous tracheal surgery
3. On azithromycin
4. Pregnancy
5. Cancer

Primary outcomes:
measure: Neutrophil changes
timeFrame: 72 hours
Secondary outcomes:
measure: analyze neutrophil activation
timeFrame: 72 hours
measure: correlate tracheal and lung neutrophil activation
timeFrame: 72 hours
measure: determine the impact of airway (tracheal, lung) inflammation
timeFrame: 72 hours
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Carlos Puyo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01781091: S4 :Trial Of Fully Closed-Loop Ventilation In ICU.
Official title: S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intensive Care Patients Invasively Ventilated
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to extubation or death in ICU patients requiring mechanical ventilation measuring duration of mechanical ventilation in order to design a multicenter large trial.


Eligibility criteria: Inclusion criteria:

- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.

Exclusion criteria:

* broncho-pleural fistula
* dyshemoglobulinémia
* moribund patient
* do-not-resuscitate order
* chronic respiratory failure requiring long term ventilation,
* patient ventilated more than 24 hours before admission,
* pregnancy,
* age below 18 years,
* protected patients,
* patient already participating in the study,
* Cheynes-Stockes breathing.
* Included patients with a treatment withdrawal decision within 24 hours after inclusion will be excluded,
* patients transferred to another ICU,
* patients needing ECMO, patients randomized to IntelliVent having less than 20% of time in IntelliVent-ASV.

Primary outcomes:
measure: Numbers of manual adjustments
timeFrame: participants are followed until they no longer need ventilation, up to 10 days
Secondary outcomes:
measure: sedation duration,
timeFrame: participants are followed until they no longer need ventilation, up to 10 days
measure: ventilation parameters
timeFrame: participants are followed until they no longer need ventilation, up to 10 days
measure: Sedation doses
timeFrame: participants are followed until they no longer need ventilation, up to 10 days
measure: Duration of invasive ventilation
timeFrame: participants are followed until they no longer need ventilation, up to 10 days
measure: ICU Mortality
timeFrame: participants are followed until they no longer need ventilation, up to 10 days
measure: 28 days mortality
timeFrame: participants are followed until they no longer need ventilation, up to 10 days
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
state: Paca
city: Pavia
country: Italy
facility: Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo
state: Lombardia
Study officials:
References:
Clinical trial NCT00691691: Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
Official title: A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Tumors
Keywords: Liver malignancy
Stereotactic Body Radiation Therapy
Efficacy of SBRT in liver tumors
Hepatic toxicity with SBRT
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 71
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: Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation


Eligibility criteria: Inclusion Criteria:

* Histologically conformation of liver malignancy
* Solitary or multiple liver tumors amenable to SBRT
* No jaundice or liver dysfunction
* For metastases, the primary tumor site has been adequately treated.
* For primary hepatoma, no extra-hepatic disease
* Karnofsky \> 70

Exclusion Criteria:

* no extra-hepatic disease
* Liver failure or inadequate liver function
* Ascites
* Previous radiation therapy to the liver
* lesions invading major blood vessels in the porta region
* Contraindication to receive radiation therapy in the liver

Primary outcomes:
measure: Response rate to SBRT
timeFrame: 3-6 Months
Secondary outcomes:
measure: Treatment Related Toxicity
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Tom Baker Cancer Centre
name: Robert Nordal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: