louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00035867: Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Official title: Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2002-05-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of MDS
* Adequate liver and kidney function
* Ineligible for, or refusing, allogeneic bone marrow transplant
* At least 18 years of age
* Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry

Exclusion Criteria:

* Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
* Pregnant or lactating women
* History of allergy to eggs
* Other investigational drugs within 14 days of study entry
* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
* Concomitant steroids or hormones for the treatment of neoplasms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: The Angeles Clinic & Research Institute
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group
state: Illinois
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Cancer Associates
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References:
citation: Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.
Clinical trial NCT04515667: Mindfulness in the OR
Official title: Mindfulness in the OR: Can an Abbreviated Mindfulness Skill Improve a Surgeon's Focus, Anxiety and Performance in the OR?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Performance at Work
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to understand the effect of a short mindfulness video on self perceived performance in the OR. Specifically, assessing the effectiveness of brief mindfulness intervention on physician focus, anxiety and perceived performance at the time of a procedure through a survey containing a modified flow state scale and modified applied mindfulness process scale


Eligibility criteria: Inclusion Criteria:

* practicing physicians or medical trainees
* employed in a hospital setting
* providing surgeries in an operating room setting.

Exclusion Criteria:

• practitioners involved in counseling roles

Primary outcomes:
measure: Perceived flow
timeFrame: At the end of the procedure, up to 5 hours
Secondary outcomes:
measure: Perceived application of mindfulness
timeFrame: at the end of the procedure, up to 5 hours
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Frances Casey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03354767: The Role of Ischaemia-reperfusion Injury in the Pathogenesis of Muscle Wasting After Thoracic Aortic Surgery
Official title: Observational Study Into the Effect on Muscle Wasting and Multiple Organ Function of Ischaemia-reperfusion Injury After Major Aortic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Diseases
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing major aortic or aortic valve surgery requiring cardiopulmonary bypass and aortic cross-clamping

Brief summary: Single-centre observational study over one year investigating the mechanisms of muscle homeostasis in patients with acute skeletal muscle atrophy following major aortic surgery

Detailed description: Some patients who are critically ill develop a syndrome of muscle weakness called Intensive Care Unit Acquired Paresis. This syndrome involves the development of severe muscle wasting and weakness and affects all skeletal muscles including the muscles which help one breathe. Muscle wasting and weakness whilst critically ill cause prolongation of mechanical ventilation, longer stays on the ICU, reduced mobility and prolonged rehabilitation in survivors. It has also been shown to increase the risk of death on ICU, due to an inability to wean patients from mechanical ventilation. Most patients recover; however in some, the effects last for many years and patients may not recover fully.

Although there is some understanding of why this syndrome develops, the molecular processes underlying the muscle wasting are not well understood. From the current scientific evidence, the investigators have identified a group or family of proteins believed to be important in the development of this condition, the activity of which are regulated by disease processes thought to lead to Intensive Care Unit Acquired Paresis (e.g. infection, inflammation, oxidative stress, immobility).

This research aims to investigate the role of these proteins in human tissue from patients who are at risk of Intensive Care Unit Acquired paresis. Even patients who do not go on to develop the full syndrome, in the early stages of ICU care, show some signs of muscle changes and loss of strength.

Eligibility criteria: Inclusion Criteria:

* All adult (\>18) patients undergoing major aortic or aortic valve surgery

Exclusion Criteria:

* Pre-existing cause for neuromuscular weakness or severe wasting (such as previous stroke, neuromuscular disease or malignancy)

Primary outcomes:
measure: Change in Rectus Femoris muscle cross-sectional area (%)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00628667: Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
Official title: A Multicenter, Double -Blind, Placebo-controlled Study to Evaluate the Effects of Esomeprazole 40mg Bid on the Signs and Symptoms of Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Posterior Laryngitis (CPL)
Keywords: Chronic Posterior Laryngitis
CPL
Pharyngeal acid reflux
Esomeprazole
Nexium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 120
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: This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.


Eligibility criteria: Inclusion Criteria:

* One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness.
* Patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria.
* Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system.

Exclusion Criteria:

* A number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol.
* If the patient is on certain medications this will also preclude them from taking part.

Primary outcomes:
measure: Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid
timeFrame: Dialy diary cards, investigator assessments, laryngoscopy at week 16
Secondary outcomes:
measure: Daily diary cards and investigator symptom assessment throughout to evaluate the efficacy of acid suppression therapy on resolution of signs of CPL at weeks 8 and 16 in patients without documented pharyngeal acid reflux.
timeFrame: Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16
measure: Quality of life Questionnaire
timeFrame: Quality of life questionnaire completed at screening and week 16
measure: To evaluate the safety and tolerability by collecting an ongoing record of adverse events.
timeFrame: Ongoing to week 16.
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT00241267: Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease
Official title: Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Neoplasms
Keywords: Pulmonary
Neoplasms
Endobronchial
Ultrasonography
Primary
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. This allows targeted samples of the identified lesions.

A new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

Detailed description: The main objective of the study is to assess the ability of endobronchial ultrasonography to diagnose peripheral pulmonary lesions during the bronchoscopy and to correlate the abnormalities to computed tomography and/or histology.

The dedicated probe consist of a linear array of 2-3 mm in diameter connected to a commercial unit.

Eligibility criteria: Inclusion Criteria:

* Assumed proximal neoplastic pulmonary pathology
* Planned bronchoscopy and biopsy

Exclusion Criteria:

* Pregnancy
* Breastfeeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of TOURS
Study officials:
affiliation: Centre d'Innovation Technologique
name: François TRANQUART, PR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.
citation: Baba M, Sekine Y, Suzuki M, Yoshida S, Shibuya K, Iizasa T, Saitoh Y, Onuma EK, Ohwada H, Fujisawa T. Correlation between endobronchial ultrasonography (EBUS) images and histologic findings in normal and tumor-invaded bronchial wall. Lung Cancer. 2002 Jan;35(1):65-71. doi: 10.1016/s0169-5002(01)00284-7.
citation: Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. doi: 10.1159/000070066.
Clinical trial NCT00501267: A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
Official title: A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder
Keywords: solabegron,
oxybutynin,
healthy adults,
drug interaction
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together


Eligibility criteria: Inclusion Criteria:

* Healthy adult males \& females ages 18-65;
* Body weight \>50kg; BMI between 19-32;
* Signed and dated informed consent; QTc Interval \<450 msec;

Exclusion Criteria:

* Resting blood pressure \>140/90 mmHg or HR \>100 at screening;
* History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
* Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
* Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
* history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
* history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
* clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment

Primary outcomes:
measure: Absorption rate of solabegron and oxybutynin
timeFrame: as measured by multiple blood draws after repeat dosing
Secondary outcomes:
measure: To assess bladder function
timeFrame: prior to dosing Session 1 and post dose for each session
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02461667: Alendronate Compared to Metformin in Chronic Periodontitis
Official title: Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Keywords: alendronate, metformin
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 108
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.

Detailed description: ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.

Methods:

The study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months

Eligibility criteria: Inclusion Criteria:

* All the subjects were systemically healthy
* subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,
* vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and
* subjects with no history of periodontal intervention in the last 6 months.

Exclusion Criteria:

* patients with systemic diseases like cardiovascular disease
* diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
* pregnant/lactating females
* tobacco users
* alcoholics
* patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
* teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
* Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.

Primary outcomes:
measure: bone fill
timeFrame: baseline to 9 months
Secondary outcomes:
measure: Relative vertical clinical attachment level
timeFrame: baseline to 9 months
measure: probing depth
timeFrame: baseline to 9 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00147667: Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD
Official title: Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COPD
Keywords: COPD
EXACERBATIONS
AIRWAY INFLAMMATION
Lead sponsor: Royal Free and University College Medical School
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.

Detailed description: COPD is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling. Periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity, mortality and health care utilization. Currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations.

Macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD. We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD. If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of COPD
* Clinically stable for 6 weeks
* Able to Swallow Tablets

Exclusion Criteria:

* Clinically significant respiratory disease other than COPD
* Women of child bearing age
* Patients receiving existing Medication which may interact adversely with trial drug
* History of clinically significant liver disease

Primary outcomes:
measure: Exacerbation Frequency
measure: Airway Inflammation
Secondary outcomes:
measure: Lung Function
measure: Health Status
measure: Exacerbation Recovery Time
measure: Symptoms
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
state: England
Study officials:
affiliation: Royal Free and University College Medical School
name: Jadwiga A Wedzicha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seemungal TA, Wilkinson TM, Hurst JR, Perera WR, Sapsford RJ, Wedzicha JA. Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1139-47. doi: 10.1164/rccm.200801-145OC. Epub 2008 Aug 21.