louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01138722: Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial
Official title: Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Early Stage Non-small Cell Lung Cancer
Keywords: early stage non-small cell lung cancer
hypofractionated radiation therapy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Nationaal Kankerplan
First posted: 2010-06-07
Enrollment: 1
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: Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival.

The current trial addresses the relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.


Eligibility criteria: Inclusion Criteria:

* Proof of cT1a/b - 2a/b N0M0 NSCLC
* Informed Consent signed
* Resectable tumour
* Operable patient
* \> 18 years old
* men and women

Primary outcomes:
measure: pathological effects of hypofractionated radiation therapy
timeFrame: at 2 years
Secondary outcomes:
measure: clinical response rate
timeFrame: from 2 to 5 years
measure: the accuracy of clinical mediastinal staging
timeFrame: from 2 to 5 years
measure: the complication rate
timeFrame: from 2 to 5 years
measure: local, regional or distant failure
timeFrame: from 2 to 5 years
measure: progression free survival
timeFrame: from 2 to 5 years
measure: disease specific overall survival
timeFrame: from 2 to 5 years
measure: overall survival
timeFrame: from 2 to 5 years
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Jan Van Meerbeeck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230022: Pilot Clinical Trial of Computer-based Motivational Intervention - 1
Official title: Pilot Clinical Trial of Computer-based Motivational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance-Related Disorders
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.

Detailed description: Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.

Eligibility criteria: Woman in immediate post-partum period

Inclusion Criteria:

Self-report of drug use prior to pregnancy

Exclusion Criteria:

Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant

Primary outcomes:
measure: Motivation to Change Substance Use
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: ACT
name: Steven J Ondersma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. doi: 10.1016/j.jsat.2005.02.004.
Clinical trial NCT01081522: A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
Official title: A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilonidal Sinus
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: secondary care clinics

Brief summary: As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent.


Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years, willing and able to provide written informed consent.
* Subjects who have an excised pilonidal sinus wound left to heal by secondary intent.
* Subjects who are willing to commit to having two biopsies being taken during the study.

Exclusion Criteria:

* Subjects with a history of skin sensitivity to any of the components of the study product
* Subjects whose wound is infected
* Subjects who have participated in a previous clinical study within the past 3 months
* Subjects' with a known history of poor compliance with medical treatments
* Subjects who are pregnant (where pregnancy is a possibility, a pregnancy testing kit will be provided)
* Necrotic/sloughy wounds unless surgically debrided prior to enrolment
* Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator
* Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
* Subjects with impaired renal function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerod
country: Denmark
facility: Hillerod Hospital
state: Dk 3400
city: Heath Park
country: United Kingdom
facility: Wound Healing Research Unit
state: Cardiff
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
state: North Lincolnshire
Study officials:
affiliation: ConvaTec Inc.
name: Dheerendra Kommala, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00946439: Wheel Assisted Running Training (WART) in Children With Cerebral Palsy
Official title: Wheel Assisted Running Training in Children With Cerebral Palsy: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: training exercise gait
Lead sponsor: Israel Sport Center for the Disabled
Sponsor class: OTHER
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2009-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to a conventional mixed physical activity training (CT) program on walking and gross motor function in trained children with cerebral palsy (CP).

Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age 11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM), self-selected and fast walking velocity (SSV and FV, respectively), and cadence are administered by a trained physical therapist. The intervention period is six months, with two sessions per week.


Eligibility criteria: Inclusion Criteria:

* (a) medical diagnosis of cerebral palsy;
* (b) ability to comprehend instructions in a group setting;
* (c) no medical procedures involving the lower limbs (including casting and Botox injections) during the last six months prior to pre-testing;
* (d) able to walk three minutes at a self paced speed;
* (e) no seizures during the last year, and (f) functional performance levels between II-IV of the gross motor functional classification system (GMFCS)

Exclusion Criteria:

* (a) GMFCS I or V;
* (b) Not being able to comprehend or comply with instructions.

Primary outcomes:
measure: walking velocity
timeFrame: six months
Secondary outcomes:
measure: Energy expenditure index
timeFrame: six months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Israel Sport Center for the Disabled
Study officials:
affiliation: Israel Sport Center for the Disabled
name: Yeshayahu Hutzler, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01285739: Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation
Official title: Eight-year Follow up in Tracheostomized COPD Patients Undergoing Domiciliary Non Invasive Mechanical Ventilation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Pulmonary Disease, Chronic Obstructive.
Tracheostomy.
Invasive Mechanical Ventilation.
Non-Invasive Mechanical Ventilation.
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2011-01-28
Enrollment: 247
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort was selected from patients admitted to Weaning Center. Patients weaned from invasive mechanical ventilation but who needed to keep endotracheal canula were enrolled for the study. Patients with COPD, tracheostomized and in domiciliary invasive mechanical ventilation was the control group.

Brief summary: The purpose of this study was to determine occurrence of ventilator associated pneumonia (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive mechanical ventilation (NIMV).

Detailed description: Acute respiratory failure due to COPD is often treated with invasive mechanical ventilation through endotracheal intubation, followed by placement of a endotracheal canula. However, invasive ventilation is at risk of infective complications and is difficult to manage at home. In particular, invasive mechanical ventilation may be associated with ventilator associated pneumonia (VAP). VAP is usually suspected when the individual develops a new or progressive infiltrate on chest radiograph, leukocytosis, and purulent tracheobronchial secretions. When possible, we tried to put these tracheotomized patients in non invasive mechanical ventilation (NIMV)to avoid VAP. This population was followed for eight consecutive years and compared with patients in invasive home mechanical ventilation (IMV).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD
* Tracheostomy
* Need of domiciliary invasive / non invasive ventilation

Exclusion Criteria:

* Patients with COPD weaned from invasive / non invasive mechanical ventilation
* Lack of tracheostomy

Primary outcomes:
measure: ventilator associated pneumonia (VAP)
timeFrame: six months
Secondary outcomes:
measure: Blood gas analysis
timeFrame: Six months
measure: Care givers involvement
timeFrame: Six months
Other outcomes:
Locations:
city: Montescano
country: Italy
facility: Weaning Center - Fondazione Salvatore Maugeri IRCCS
state: Pavia
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Ercole Zanotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806039: Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure
Official title: Impact of EArly Renal Involvement on the Developement of Severe In-hospital Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Failure, Acute
Renal Insufficiency, Acute
Kidney Failure
Renal Insufficiency
Keywords: Kidney Failure, Acute
Renal Insufficiency, Acute
Kidney Failure
Renal Insufficiency
Lead sponsor: Saint Louis VA Medical Center
Sponsor class: FED
First posted: 2008-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes.


Eligibility criteria: Inclusion Criteria:

* Hospitalized, elevation in creatinine meeting definition

Exclusion Criteria:

* CDK5, ESRD,solid organ transplant

Primary outcomes:
measure: Severe renal Failure
timeFrame: 10 days
Secondary outcomes:
measure: Composite outcome morbidity mortality
timeFrame: hospitalization
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis VA Medical Center
state: Missouri
Study officials:
affiliation: Saint Louis VA Medical Center
name: Tarek M El-Achkar, MD
role: STUDY_DIRECTOR
References:
citation: Balasubramanian G, Al-Aly Z, Moiz A, Rauchman M, Zhang Z, Gopalakrishnan R, Balasubramanian S, El-Achkar TM. Early nephrologist involvement in hospital-acquired acute kidney injury: a pilot study. Am J Kidney Dis. 2011 Feb;57(2):228-34. doi: 10.1053/j.ajkd.2010.08.026. Epub 2010 Dec 31.
Clinical trial NCT02939625: NIV Application in the Treatment of Asthmatic Children
Official title: Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Child
Bronchial Spasm
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 68
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.

Detailed description: Pharmacologic therapy has clinical efficacy in the control, but the patient often does not adhere adequately.

There is need for further research into non-pharmacological therapies for clinical asthma control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that these therapies also have effects on the BIE.The aim of this study is to evaluate the effect of these non-pharmacological therapies in several variables and especially the BIE.

Eligibility criteria: Inclusion Criteria:

* Age between 5:11 years;
* Both sexes;
* Do not be included in any regular physical activity program;
* Having a diagnosis of asthma, according to the Global Initiative for Asthma (GINA);
* Not having received Theophylline or aminophylline and oral corticosteroids in the last 30 days;
* not have presented respiratory infection in the last two months;
* Signature of IC

Exclusion Criteria:

* Have done inhaled bronchodilator in less than 12 hours before the assessment;
* Inability to understand or perform any of the tests, due to physical and mental limitations;
* Intolerance proposed activities;
* Have heart disease inflammatory, congenital or ischemic origin;
* Being in the presence of any infectious process with fever.

Primary outcomes:
measure: Exhaled nitric oxide (part per billion)
timeFrame: 5 minutes
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: 20 minutes
measure: manovacuometry
timeFrame: 10 minutes
measure: Pulmonary function test
timeFrame: 20 minutes
measure: bioelectrical impedance
timeFrame: 10 minutes
measure: Bronchoconstriction induced by stress
timeFrame: 30 minutes
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Maisi David Cabral
Study officials:
References:
citation: David MMC, Gomes ELFD, Mello MC, Costa D. Noninvasive ventilation and respiratory physical therapy reduce exercise-induced bronchospasm and pulmonary inflammation in children with asthma: randomized clinical trial. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618777723. doi: 10.1177/1753466618777723.
Clinical trial NCT02274025: NovellusDx Functional Profiling of Oncogenic Mutations in Lung Cancer Patients
Official title: Collection of Lung Malignant Tissue for the Validation of a Novel Technology to Identify Oncogenic Mutations and Personalized Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Patient diagnosed with lung cancer
Lead sponsor: Fore Biotherapeutics
Sponsor class: INDUSTRY
Collaborators: name: Rabin Medical Center
First posted: 2014-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that are suspected to have lung cancer and are eligible for biopsy, surgical intervention or pleural fluid suction.

Brief summary: NovellusDx technology identifies tumor-specific driver mutations, but unlike sequencing-based tests, NovellusDx has a functional assay that detects dis-regulated translocation of mutated signaling proteins to the nucleus. This allows NovellusDx to identify functionally-impactful driver mutations regardless of whether the mutation has previously been described or linked to a tumor type.


Eligibility criteria: Inclusion Criteria:

* Patients that are suspected to have lung cancer and are eligible for biopsy, surgical intervention or pleural fluid suction

Exclusion Criteria:

* Patients without lung cancer

Primary outcomes:
measure: Correct identification of tumor mutant genes
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson
Study officials:
affiliation: Rabin Medical Center, Beilinson
name: Mordechai Kremer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712525: Gut Recovery In Patients Following Surgery
Official title: Gut Recovery In Patients Following Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Diseases
Ileus
Lead sponsor: G-Tech Corporation
Sponsor class: INDUSTRY
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2023-02-03
Enrollment: 150
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 who will undergo a colectomy

Brief summary: The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them..

Detailed description: Measure myoelectric signals with the G-Tech WPS and determine if a correlation exists between signal strength and the rate of gastrointestinal recovery following surgery. Determine the relationship between gastrointestinal myoelectrical signal strength and clinical markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.

Eligibility criteria: Inclusion Criteria:

* Willing and able to follow all study requirements
* Eighteen (18) years of age or older
* Subject is willing and able to follow all study requirements
* Subject will undergo a colectomy

Exclusion Criteria:

* Subject is pregnant or suspects pregnancy
* Known allergy to medical grade adhesive

Primary outcomes:
measure: GI Functional Recovery
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Adverse Events
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Kristen Crowell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469625: A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
Official title: A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Proteinuric Renal Disease
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2007-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the United States. The degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early in CKD, and is undertreated. Vitamin D may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.

Detailed description: Objectives:

1. To determine the effect of oral paricalcitol on protein excretion in patients with proteinuric renal diseases
2. To determine the effect of oral paricalcitol on renal disease progression in patients with proteinuric renal diseases Hypothesis: Oral paricalcitol will reduce protein excretion in proteinuric kidney disease Study Design: Prospective, randomized, placebo controlled, double blind, trial of paricalcitol compared to placebo.

Sample Size: 60 patients, 30 in each group Summary of Patient Eligibility Criteria: Subjects with proteinuric renal disease (\>400 mg/24 hours)

Randomization and Dosage: Patients will be randomized to treatment with oral paricalcitol (initial dose 1 mcg orally per day) compared to placebo Duration : 6 Months

Eligibility criteria: Inclusion Criteria:

1. Stable chronic kidney disease
2. Urine protein : Creatinine ratio \> 0.4
3. Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min
4. PTH (intact) \>20 pg/ml and \<250 pg/ml
5. Age 18-85
6. If on ACEI/ARB, then dose optimized (BP, K)

Exclusion Criteria:

1. Failure to provide informed consent
2. Glomerunephritis requiring active treatment with immunosuppresive therapy
3. Serum phosphorus \> 5.2
4. Serum calcium (adjusted for albumin)\> 10.0
5. Active malignancy
6. Likelihood of requiring renal replacement therapy within 1 year
7. Uncontrolled hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop Univ. Hospital
state: New York
Study officials:
References:
citation: Fishbane S, Chittineni H, Packman M, Dutka P, Ali N, Durie N. Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial. Am J Kidney Dis. 2009 Oct;54(4):647-52. doi: 10.1053/j.ajkd.2009.04.036. Epub 2009 Jul 12.