louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01847859: Pocket-size Ultrasound by Nurses in Cardiothoracic Post-operative Patients
Official title: Feasibility and Reliability of Routine Ultrasound Examination Performed by Nurses in Cardiothoracic Post-operative Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiothoracic Surgery
Keywords: Cardiothoracic surgery
Post-operative
Nurses
Cardiac
Echocardiography
Pocket-size
Hand-held
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2013-05-07
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators aim to study the feasibility and reliability of pocket-size diagnostic ultrasound examinations performed by nurses of postoperative patients who have underwent cardiothoracic surgery in a cardiac unit.

Detailed description: Patient inclusion: Post-operative cardiothoracic surgery patients transferred to a cardiac unit. All such patients are eligible for inclusion if they consent to participate in the study. No other exclusion criteria other than not willing/able to give their consent. Only postoperative patients will be included.

Study population: Approximately 50 patients

Intervention: All participants will undergo careful medical history, physical examination and blood tests led by residents. All patients will routinely be examined with ultrasound by nurses trained in ultrasound examinations of the pleural space and the pericardium and a complete high-end echocardiography including assessment of both pleural cavities and the pericardial space will be performed in all by cardiologists.

Statistics and results: Feasibility and reliability will be studied.

Eligibility criteria: Inclusion Criteria:

* Post-operative cardiothoracic patients admitted to the cardiac unit at the local hospital

Exclusion Criteria:

* Not able or not willing to consent

Primary outcomes:
measure: Feasibility and reliability
timeFrame: 0 days
measure: Reliability
timeFrame: 0 days
Secondary outcomes:
measure: Time use
timeFrame: 0 days
Other outcomes:
measure: Clinical impact
timeFrame: 0 days and 30 days
Locations:
city: Levanger
country: Norway
facility: Department of medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Study officials:
References:
citation: Graven T, Wahba A, Hammer AM, Sagen O, Olsen O, Skjetne K, Kleinau JO, Dalen H. Focused ultrasound of the pleural cavities and the pericardium by nurses after cardiac surgery. Scand Cardiovasc J. 2015 Feb;49(1):56-63. doi: 10.3109/14017431.2015.1009383. Epub 2015 Feb 6.
Clinical trial NCT03942159: Modification of the Human Colon and Oral Microbiome by Allogenic HSCT
Official title: Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Microbiome
HSCT
Keywords: Microbiome
stem cell transplantation
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 15
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric recipients and their donors receiving treatment in the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology, and Immunology

Brief summary: Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Aim of the study is to investigate the composition of the microbiota in both recipient and nursing relative donor, reveal changes in biodiversity after HSCT via 3-time points V3V4 16S rRNA and NGS sequencing of the colon and oral swabs, 3-indoxyl-sulfate measurement in the urine.


Eligibility criteria: Inclusion Criteria:

* indications to alloHSCT
* nursing healthy donors 3-55 y.o.

Exclusion Criteria:

* unable to give samples for the test
* graft rejection
* previous HSCT

Primary outcomes:
measure: beta-index dynamics
timeFrame: 7 days before HSCT
measure: beta-index dynamics
timeFrame: 7 days after HSCT
measure: beta-index dynamics
timeFrame: 60 days after HSCT
Secondary outcomes:
measure: Proportion of patients with microbial domination after HSCT
timeFrame: 7 days after HSCT
measure: Proportion of patients with microbial domination after HSCT
timeFrame: 60 days after HSCT
measure: Shannon-index dynamics
timeFrame: 7 days before HSCT
measure: Shannon-index dynamics
timeFrame: 7 days after HSCT
measure: Shannon-index dynamics
timeFrame: 60 days after HSCT
measure: ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
timeFrame: 7 days before HSCT
measure: ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
timeFrame: 7 days after HSCT
measure: ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
timeFrame: 60 days after HSCT
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Study officials:
affiliation: National Research Center for Pediatric Hematology , Moscow, Russian Federation
name: Michael Maschan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058759: Taxotere-Enoxaparin-(ENOXA)-Study
Official title: Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as Single Therapy or in Combination With Enoxaparin in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, a Phase III Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
NSCLC
Enoxaparin
Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 14
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: Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Men and women aged 18 and older
* Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy
* Life expectancy at least 12 weeks
* EOCG performance \< 1
* Appropriate renal and hepatic function
* Appropriate Hematology
* No bleeding events within 4 weeks prior to randomization
* No indication for prophylactic or therapeutic anticoagulation therapy
* Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
* Capability for s.c. injection of Enoxaparin every 24 hrs

Exclusion Criteria:

* History of cancer other than NSCLC
* Known contraindication for Enoxaparin e.g. HIT,
* Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication
* Participation in any other clinical trials within 30 days prior to randomization
* Any known medical condition that does not allow therapy according to study protocol
* Seizure disorder

Primary outcomes:
measure: Progressive free survival
timeFrame: monthly
Secondary outcomes:
measure: Overall survival
timeFrame: monthly
measure: RECIST
timeFrame: monthly
measure: Quality of life
timeFrame: every three months
measure: thromboembolic complications
timeFrame: monthly
measure: safety of long term application of Enoxaparin
timeFrame: monthly
measure: overall toxicity
timeFrame: monthly
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Pneumology
state: Lower Saxonia
Study officials:
affiliation: Hannover Medical School
name: Nicolas Dickgreber, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01144559: Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function
Official title: Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nerve Block
Keywords: Femoral
Nerve Block
Bolus
Continuous Infusion
UCSD
Perineural Catheter
Volunteer
lower extremity nerve blocks
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 15
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: This is a research study to determine if the way local anesthetic- or numbing medication- is delivered through a tiny tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.

Detailed description: Specific Aim: Research study to test the null hypothesis that differing the delivery method (continuous basal infusion vs. repeated bolus doses) but providing an equal total dose of Ropivacaine has no impact on quadriceps muscle strength. These results will help define the optimal delivery method of local anesthetic used for continuous peripheral nerve blocks and help guide future research in this clinically relevant area.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* willing to have bilateral femoral perineural catheters place with a subsequent ropivacaine infusion and motor/sensory testing for 9 hours
* willing to stay overnight in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning.

Exclusion Criteria:

* current daily analgesic use
* opioid use with in the previous 4 weeks
* any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
* pregnancy
* incarceration

Primary outcomes:
measure: Quadriceps Femoris Muscle Strength
timeFrame: Every Hour for 14 hours
measure: Quadriceps Femoris Muscle Strength
timeFrame: Hour 22
Secondary outcomes:
measure: Muscle Strength
timeFrame: Every Hour for 14 hours
measure: Sensory Level
timeFrame: Every Hour for 14 hours
measure: Muscle Strength
timeFrame: Hour 22
measure: Sensory Level
timeFrame: Hour 22
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center, Hillcrest
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279459: Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas
Official title: Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas: Assessing Tumor Perfusion and Prediction of Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2014-10-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, aged 18 years and older with untreated, histologically confirmed head and neck squamous cell carcinoma

Brief summary: The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the added benefit of providing functional information that would only be possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission tomography (PET) imaging techniques.

Detailed description: Patients with head and/or neck tumors routinely have head and neck imaging completed with a computerized tomography scan, commonly called a CT scan. A CT scan combines a series of x-ray views that are taken from many different angles and uses computer processing to create cross-sectional images inside your body. These cross-sectional images are very thin slices, often less than 1 mm thick and allow the radiologist to examine parts of your tissue very closely.

Dual energy computed tomography (DECT) is a fairly new technology that uses both the normal x-ray and also a second less powerful x-ray to make the images. The Ottawa Hospital has scanners in use that are able to take the images that oncologists typically order for patients and can also be set to obtain DECT images at the same time.

The purpose of this study is to investigate whether DECT images can provide helpful information to better predict how the tumor will respond to treatment and the likely course of head and neck tumors.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* untreated, histologically confirmed head and neck squamous cell carcinoma

Exclusion Criteria:

* paranasal sinus involvement of head and neck squamous cell carcinoma

Primary outcomes:
measure: Correlate iodine quantification with the microvascular density in the biopsy specimen
timeFrame: up to 18 months
Secondary outcomes:
measure: Utility of dual-energy computerized tomography obtained during chemoradiation therapy to predict treatment response.
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Santanu Chakraborty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05229159: Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery
Official title: Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Care After Cardiac Surgery With Cardio Pulmonary Bypass
Keywords: phase angle
cardiac surgery
cardiopulmonary bypass
risk stratification
outcomes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients admitted in intensive care unit for postoperative care after cardiac surgery with cardiopulmonary bypass.

Brief summary: Phase angle determined by bioelectrical impedance analysis is a strong prognostic factor in several medical areas as clinical nutrition, nephrology, infectious disease, oncology. Inflammation, frailty status and fluid overload can lead to a phase angle decreased. Some studies support its use for risk stratification in intensive care unit and other in preoperative for cardiac surgery. The investigators would like to evaluate its relevance for risk stratification at intensive care unit admission in the context of postoperative cardiac surgery with cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* Age higher than 18
* Cardiac surgery with cardiopulmonary bypass
* Bioelectrical impedance analysis the day of the admission in intensive care unit

Exclusion Criteria:

* Left ventricular assist device
* Limitations des thérapeutiques actives en place pour le patient
* Patient opposition to the use of his health data
* Invalid bioelectrical impedance analysis
* Advanced directives to withhold or withdraw life-sustaining treatment

Primary outcomes:
measure: Area under the receiver operating characteristic curve to predict a composite criterion including in-hospital mortality or prolonged hospital length of stay.
timeFrame: at 6 months after the cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
state: Rhône
Study officials:
References:
Clinical trial NCT00314600: Treatment of Non-Dislocated Midshaft Both-Bone Fractures
Official title: Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Keywords: Fracture
Forearm
Midshaft
Child
Cast
Lead sponsor: Colaris, Joost, M.D.
Sponsor class: INDIV
First posted: 2006-04-14
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.

Detailed description: Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.

Eligibility criteria: Inclusion Criteria:

* Both-bone midshaft forearm fracture
* Age \< 16 years old

Exclusion Criteria:

* Dislocation
* Fracture older than 1 week
* No informed consent
* Refracture
* Open fracture (Gustillo 2 and 3)
* Torus fractures of both ulna and radius

Primary outcomes:
measure: pronation and supination
Secondary outcomes:
measure: complications, function, esthetics, complaints in daily living, X-rays
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HAGA, Juliana Children's Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre, Sophia Children's Hospital
state: Zuid Holland
Study officials:
affiliation: HAGA/Erasmus Medical Centre
name: Joost W Colaris, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colaris JW, Reijman M, Allema JH, Biter LU, Bloem RM, van de Ven CP, de Vries MR, Kerver AJ, Verhaar JA. Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial. Arch Orthop Trauma Surg. 2013 Oct;133(10):1407-14. doi: 10.1007/s00402-013-1812-8. Epub 2013 Jul 17.
Clinical trial NCT01518400: LIFE Cancer Survivorship Database for Pediatric Cancer
Official title: A Research Database for Survivors of Childhood Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Cancer
Keywords: Pediatric Cancer
Cancer Late Effects
Cancer Survivor
Cancer Survivorship
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 5000
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: Population diagnosed with cancer at 21 years of age or younger

Brief summary: The purpose of this study is to develop a mechanism for utilizing the comprehensive clinical database of childhood cancer survivors at Childrens Hospital Los Angeles (CHLA) for research purposes. Using clinical information obtained from follow-up visits of childhood cancer survivors, the database will focus on interventions to improve health status and health-related quality of life in childhood cancer survivors. This study allows for establishment and analyses of a research database for LIFE survivors by the investigators listed herein. Over the last three decades, there has been marked improvement in survival following childhood cancer, with 5-year survival rates now approaching 80%. However, the use of cancer therapy at an early age can result in complications that may not be apparent until years later as the child matures. These resulting complications, called late effects, are principally related to the specific therapy employed and the age of the child at the time the therapy was administered. Late effects may affect virtually every body system and substantially impair quality of life. As many as two-thirds of childhood cancer survivors develop at least one late effect as a result of treatment, and approximately one-third have a late effect classified as severe or life threatening.

Detailed description: Eligibility Criteria: Eligibility criteria include (1) a history of cancer or similar illness diagnosed before 22 years of age; (2) cancer in remission. Methods: For subjects enrolled on this study, clinical data will be entered into the LIFE database as routinely done for all survivors, but tagged so that research analyses may be carried out and limited only to those who are enrolled on this study.

Eligibility criteria: Inclusion Criteria:

1. Been diagnosed with cancer or similar disease
2. Been diagnosed with cancer at 21 years of age or younger
3. Be currently off treatment and disease free

Primary outcomes:
measure: create a database of Cancer Survivors
timeFrame: Annual (up to 40 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: David Freyer, DO, MS
role: PRINCIPAL_INVESTIGATOR
References: