louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01658332: Circulating Tumor Cells in Lung Cancer
Official title: Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stage IIIB Non Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Keywords: lung cancer
circulating tumor cells
prospective
monocentrique trial
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2012-08-07
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: TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)

BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.

PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).

SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.

STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.

Duration of the inclusions: 54 months.

Duration of the study: 66 months.

PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.

SAMPLE SIZE : 200 patients

STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.


Eligibility criteria: Inclusion Criteria:

* Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.
* Age ≥ 18 years.
* Measurable or evaluable disease according to RECIST criteria.
* Ability to sign informed consent.

Exclusion Criteria:

* Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
* Prior chemotherapy, radiation or surgery for lung cancer.
* Inability to comply with study and/or follow-up procedures.

Primary outcomes:
measure: Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.
timeFrame: 18 months
Secondary outcomes:
measure: Identification of a cellular profile according to clinical factors (sex,histology, …).
timeFrame: 18 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Christelle Clement-Duchene
Study officials:
affiliation: CHU NANCY
name: Christelle CLEMENT-DUCHENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01000532: SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
Official title: Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Keywords: steroid, leads, threshold, pacemaker
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 88
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 with standard pacemaker indication who are refered to the hospital.

Brief summary: This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.


Eligibility criteria: Inclusion Criteria:

* Meet the indications for pacemaker therapy
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

* Meet none of the pacemaker indications
* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months
* Enrolled in another cardiac clinical investigation
* Have other medical devices that may interact with the implanted pacemaker

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
affiliation: Semmelweis University Heart Center, Budapest, Hungary
name: Béla Merkely, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kutyifa V, Zima E, Molnar L, Kuehne C, Theiss S, Herrmann G, Geller L, Merkely B. Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial. Cardiol J. 2013;20(4):431-8. doi: 10.5603/CJ.2013.0103.
Clinical trial NCT03491332: Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
Official title: Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Scheduled for Brain Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 117
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mechanical respiration during general anesthesia causes cold and dry gases to reach the lower airway, reduce the function of the airway mucosa, and cause accumulation of secretions. Inhaled dry gas is one of the causes of hypothermia during general anesthesia. To overcome this, the warm-humidifying breathing circuit uses warm, moisture-preserving gas to promote mucus mobility of the airway mucosal ciliate cells and prevents cold gases from evaporating from the mucosal surfaces which results lowering body temperature. We aimed to investigate the effect of newly developed Sohum warm humidifying respiration circuit (SH501) on the prevention of core body temperature reduction during surgery and systemic inflammation reaction.


Eligibility criteria: Inclusion Criteria:

1. age ≥ 19
2. scheduled for brain surgery

Exclusion Criteria:

1. age \< 19
2. patients with severe obstructive lung disease and/or restrictive lung disease patients
3. patients with infectious disease
4. surgery with prone position or lateral position
5. arrhythmia

Primary outcomes:
measure: core temperature
timeFrame: every 30 minute after induction of anesthesia until the end of anesthesia
measure: upper airway temperature
timeFrame: every 30 minute after induction of anesthesia until the end of anesthesia
measure: upper airway humidity
timeFrame: every 30 minute after induction of anesthesia until the end of anesthesia
Secondary outcomes:
measure: cytokine level
timeFrame: 1, 30, 60, 90, 120, 150, 180, 210, 240 minute after induction and 1 second after the operation
measure: dead space
timeFrame: every 30 minute after induction of anesthesia until the end of anesthesia
measure: intrapulmonary shunt
timeFrame: every 30 minute after induction of anesthesia until the end of anesthesia
measure: respiratory variables
timeFrame: every 30 minute after induction of anesthesia until the end of anesthesia
measure: compliance
timeFrame: every 30 minute after induction of anesthesia until the end of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT03759132: Effects of Transcranial Direct Current Stimulation on Postural Control
Official title: Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral excitability and movement control in neurological chronic conditions. However, few studies have investigated the effects of tDCS on postural control in patients with Parkinson's disease. This study aims to investigate the effect of bihemispheric tDCS on postural control in people with Parkinson's disease. Participants will be randomized to receive a single session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).

Primary clinical outcome (balance) will be collected before and immediately after tDCS. The data will be collected by a blind examiner to the treatment allocation.


Eligibility criteria: Inclusion Criteria:

Medical diagnosis of idiopathic Parkinson's disease present for at least 12 months

In clinical follow-up and pharmacological treatment by a responsible physician

Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale

Signing of the free and informed consent form-

Exclusion Criteria:

Use any associated orthopedic device to aid gait or balance control

Signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE)

Diagnosis of other neurological disorders (including those of central and peripheral nature)

Previous treatment with tDCS

Medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)

The use of pacemakers or other implanted devices.-

Primary outcomes:
measure: Change from COP - AP axis
timeFrame: Baseline and Post-tDCS (immediately after tDCS)
measure: Change from COP - ML axis
timeFrame: Baseline and Post-tDCS (immediately after tDCS)
measure: Change from COP - area
timeFrame: Baseline and Post-tDCS (immediately after tDCS)
Secondary outcomes:
Other outcomes:
measure: Adverse effects
timeFrame: Immediately after tDCS
Locations:
city: Parnaíba
country: Brazil
facility: Department of Physical Therapy. Federal University of Piaui
state: Piauí
Study officials:
References:
Clinical trial NCT00308932: Effect of Age and Device on Delivery of Fluticasone
Official title: Relative Amount of Fluticasone Delivered by HFA-MDI Through Chamber/Mask to Young Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: fluticasone
asthma therapy
spacer inhaler
HFA-134a
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in children of different ages. Hypothesis -- passive inhalation in younger children through a valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to airways.

Detailed description: The objective was to determine the effect of age and device on delivery of fluticasone propionate delivered by HFA-pMDI in children of different ages. The one-hour steady-state fluticasone plasma concentration which is an indirect measure of airway delivery and direct measure of systemic exposure, was determined. Sixty children with well-controlled persistent asthma received two actuations of 110 mcg twice daily for at least 3 days. A blood sample was collected one hour after the last dose when 100% adherence was documented by electronic monitor. Five groups of 12 each were studied: 1) 12-18 yr by actuator alone; 2) 5-9 yr by actuator alone; 3) 5-9 yr by antistatic VHC/mouthpiece; 4) 5-9 yr by antistatic VHC/mask and 5) 1-4 yr by antistatic VHC/mask. Fluticasone concentrations were measured by LC-MS/MS assay. Fluticasone plasma concentration between groups was compared using one way ANOVA.

Eligibility criteria: Inclusion Criteria:children 1-18 yr, adequately controlled persistent asthma, demonstrate effective administration technique in accordance with the group assigned -

Exclusion Criteria:inadequately controlled asthma: nocturnal awakening \>2 nights/month, prn albuterol use \>2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days

-

Primary outcomes:
measure: One-hour steady-state plasma concentration of fluticasone
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Asthma Research Lab
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie Hendeles, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856932: Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients
Official title: Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class I Cavities in High Caries Risk
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: PICOTS:

P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations.

T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer


Eligibility criteria: Inclusion Criteria:

* Bilateral class I carious lesions in their occlusal pits and fissures.
* High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA)
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Disabilities.
* Systemic diseases or severe medically compromised.
* Lack of compliance.
* Evidence of severe bruxism, clenching or temporomandibular joint disorders

Primary outcomes:
measure: Clinical performance using FDI criteria for dental restorations (functional properties and biological properties)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine, cairo university
Study officials:
References:
Clinical trial NCT00171132: VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women
Official title: A 26-week Double-blind, Randomized, Multicenter Parallel-group Trial to Compare the Effects of Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women With Impaired Exercise Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Postmenopausal
women
overweight
hypertension
impaired
exercise
capacity
valsartan
atenolol
hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (LVEF).


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) must be ≥ 27 and \< 35
* Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy
* LV ejection fraction must be \> 45% measured by echocardiography at Visit 2.
* Impaired exercise capacity measured by VO2max at Visit 4:

VO2max \>14 and \< 22 ml ⋅kg-1 ⋅min-1

Exclusion Criteria:

* Mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg
* LVEF ≤ 45 %
* Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study
* Heavy smokers (\>20 cigarettes/day)

Primary outcomes:
measure: Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks
Secondary outcomes:
measure: Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography
measure: Change from baseline in heart rate and blood pressure,
measure: during exercise testing after 26 weeks
measure: Change from baseline in heart size after 26 weeks, measured by echocardiography
measure: Change from baseline in quality of life measures after 26 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Dusing R, Handrock R, Klebs S, Tousset E, Vrijens B. Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE. J Hypertens. 2009 Apr;27(4):894-901. doi: 10.1097/HJH.0b013e328323f9be.
Clinical trial NCT00145132: Beta-CIT-SPECT and Neurophysiology in Depression
Official title: Serotonin and Dopamine Transporter (SERT, DAT) Availabilities as Assessed by b-CIT and SPECT, and Neurophysiological Measures of Central Serotonergic Activity in Patients With Depression Under Treatment With Escitalopram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: depression
β-CIT-SPECT
SERT
DAT
neurophysiology
LDAEP
escitalopram
SSRI
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2005-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression.


Eligibility criteria: Inclusion Criteria:

* Psychiatric in or outpatients with acute depressive episode
* Indication for pharmacological treatment

Exclusion Criteria:

* Acute suicidality
* Neurological or severe somatic disorders
* Occupational exposition to radiation \>15 mSv per year
* Women during pregnancy or lactation

Primary outcomes:
measure: changes in β-CIT/neurophysiological measurements from baseline to week 4
timeFrame: two assessments, at baseline and week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich
Study officials:
affiliation: Dept. of Psychiatry, University of Munich
name: Oliver Pogarell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01891032: Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Patients With Partial Nephrectomy
Keywords: acute kidney injury, partial nephrectomy, biomarker
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. the adult patients with open partial nephrectomy
2. the adult patients with laparoscopic partial nephrectomy
3. the adult patients with VAMS partial nephrectomy, 4: the adult patients with robotic partial nephrectomy

Brief summary: Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.


Eligibility criteria: Inclusion Criteria:

1. adults patient more than 20 years old with ASA score 1-3
2. the patients who undergoing partial nephrectomy for the renal mass less than 7 cm

Exclusion Criteria:

1. the patient with previous history with renal surgery
2. the patient with bilateral partial nephrectomy
3. the patient with synchronous operation for other intraperitoneal surgery
4. the renal mass more than 7 cm
5. previous kinds of surgery is changed into other kinds due to bleeding, etc
6. the patient with serum Cr level more than 1.4 mg/dl
7. the patient who does not understand the consent form

Primary outcomes:
measure: The level of urinary NGAL
timeFrame: changes from Preoperative, postop 3hr, 24hr, 48hrs after partial nephrectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Study officials:
References: