louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04236726: Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure
Official title: Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Respiratory Failure
Neuromuscular Diseases
Ventilatory Failure
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic respiratory failure being treated with a form of ventilation of mechanical insufflation-exsufflation therapy.

Brief summary: To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Detailed description: To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

Eligibility criteria: Inclusion Criteria:

Diagnosed with chronic respiratory failure receiving any of:

* Non-invasive ventilation
* Prolonged mechanical ventilation
* Mechanical insufflation-exsufflation therapy

Exclusion Criteria:

* Aged \<18
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Primary outcomes:
measure: HRQoL score
timeFrame: Day 0: At the first outpatient clinical consultation with the clinical team
Secondary outcomes:
measure: Change in HRQoL score
timeFrame: 6 months following first assessment for Outcome 1
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St. Thomas NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Patrick Murphy, MBBS
role: STUDY_CHAIR
References:
Clinical trial NCT00106626: Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
Official title: Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Advanced solid tumors including MPM and NSCLC
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-03-29
Enrollment: 52
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 investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies
* Has at least 1 measurable lesion
* Has adequate blood, liver, and kidney functions
* Has not received any chemotherapy for at least 4 weeks prior to entry in this study
* Agrees to take adequate measures to prevent pregnancy as outlined in the protocol

Exclusion Criteria:

* Patient has been treated with other investigational agents with a similar anti-tumor mechanism
* Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months
* Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy
* Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs
* Patient has HIV, hepatitis B or hepatitis C infection
* Patient is pregnant or breast feeding
* Patient has allergy to any component of the study drugs
* Patient has history of GI (gastrointestinal) surgery or conditions

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level
timeFrame: Cycle 1 (21 days)
Secondary outcomes:
measure: Safety and Tolerability as Measured by the Number of Participants With Disease Progression
timeFrame: Any time during 8 cycle treatment period through 30 days after.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00479726: Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
Official title: Lilly's Emotional and Physical Symptoms of Depression Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 8000
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: To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting

Detailed description: To assess physical and emotional symptoms of depressed patients

Eligibility criteria: Inclusion criteria:

* Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria
* Outpatients at least 18 years of age
* Sign the informed consent
* All females must test negative for a urine pregnancy test at visit 1. Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
* Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study

Exclusion Criteria:

* Are investigator site personnel directly affiliated with the study or immediate family
* Are employed by Eli Lilly and Company
* Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
* Current substance dependence, excluding nicotine and caffeine
* Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug
* Acute liver injury or severe (Child-Pugh Class C) cirrhosis

Primary outcomes:
measure: Clinical Global Impression of Severity
measure: Somatic Symptom Inventory
measure: Depressive Symptomatology-Self Report
Secondary outcomes:
measure: Patient Global Impression of Improvement
measure: Mood and Physical Symptoms in Depression
measure: Quality of Life Enjoyment Satisfaction Questionnaire-Short form
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial,contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Wohlreich MM, Wiltse CG, Desaiah D, Ye W, Robinson RL, Kroenke K, Kornstein SG, Greist JH. Duloxetine in practice-based clinical settings: assessing effects on the emotional and physical symptoms of depression in an open-label, multicenter study. Prim Care Companion J Clin Psychiatry. 2007;9(4):271-9. doi: 10.4088/pcc.v09n0404.
Clinical trial NCT03090126: Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory Failure (QoVNI)
Official title: Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Alveolar Hypoventilation
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 0
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

Brief summary: The purpose of the study is to assess the therapeutic education of patients with chronic respiratory failure who start to be treated with non invasive ventilation and during the first six months of ventilation.

Detailed description: Therapeutic education about non invasive ventilation in patients with chronic respiratory failure and alveolar hypoventilation is assessed during the first six months of ventilation thanks to a questionnaire. Moreover, the impact of this therapeutic education on non invasive ventilation compliance, blood gas, dyspnea and nocturnal desaturation is assessed.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic respiratory failure
* with alveolar hypoventilation required non invasive ventilation
* Adults and non-vulnerable subject
* Fluency in French

Exclusion Criteria:

* Age under eighteen years old
* Patient with guardianship
* No french-speaking
* Severe cognitive abnormalities
* No criteria to introduce non invasive ventilation

Primary outcomes:
measure: Score efficacy of therapeutic education
timeFrame: 6 months
Secondary outcomes:
measure: Compliance with the non invasive ventilation
timeFrame: 6 months
measure: Dyspnea score
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière
Study officials:
References:
Clinical trial NCT00746226: Probiotics for Birch Pollen Allergy
Official title: Probiotic Intervention for Children With Birch Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rhinitis, Allergic, Seasonal
Keywords: birch pollen
Lead sponsor: Danisco
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 47
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic countries. Treatment consists of antihistamine use. Specific probiotic strains have been observed to modulate the immune system. Since the body has a common mucosal immune system; it was hypothesised that consumption of probiotics may affect also the respiratory mucosal immune response and hence affect respiratory allergy.

Earlier studies with probiotics had been unable to show improvements in adults with pollen allergy. It was therefore hypothesised that children, who's immune system is not yet fully developed, might be better targets.


Eligibility criteria: Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics

Primary outcomes:
measure: Birch pollen allergy symptoms
timeFrame: March/April and June
measure: Nasal Eosinophilia
timeFrame: April/May and June
Secondary outcomes:
measure: Change in microbiota composition
timeFrame: April/May and June
measure: Cytokine profile from serum
timeFrame: April/May and June
measure: Faecal recovery of administered probiotics
timeFrame: April/May and June
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Central Hospital
Study officials:
affiliation: Danisco
name: Arthur C Ouwehand, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01779726: Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis
Official title: Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Organization
of fast track
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 331
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. In denmark, as in many other countries, a fast track evaluation for lung cancer has been introduced in 2008.

When the general practitioners refer patients through the fast track, the majority of patients make their first visit to the Department of Pulmonary Medicine. After this visit, further investigation is initiated, which is often a CT scan of the chest and the upper abdomen. We dont know Whether this is the most appropriate organisation.

The aim of this project is to evaluate the way lung cancer patients are examined through the fast track and the impact of chest CT before an evaluation by a chest physician.

Investigators want to randomise all patients referred for the existing fast track to either direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order to test:

A) Fast track performance measured by number of CT scans and chest physician specialist time per diagnosis, and whether there is a difference between the intervention and the control group.


Eligibility criteria: Inclusion Criteria:

* All patients referred to fast track evaluation (lung department, Aarhus university hospital) from primary care.

Exclusion Criteria:

* Not referred from general practice

Primary outcomes:
measure: Chest physician time
timeFrame: 2013
Secondary outcomes:
measure: Satisfaction with new organisation
timeFrame: 2013
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
city: Aarhus
country: Denmark
facility: Department of lung medicine, Aarhus University Hospital
Study officials:
affiliation: The Research Unit for General Practice
name: Peter Vedsted, M.D., Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guldbrandt LM, Fenger-Gron M, Folkersen BH, Rasmussen TR, Vedsted P. Reduced specialist time with direct computed tomography for suspected lung cancer in primary care. Dan Med J. 2013 Dec;60(12):A4738.
Clinical trial NCT04560426: Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
Official title: Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parathyroid
Intraoperative Monitoring
Thyroid Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. This study will explore the protective effect of the parathyroid gland auxiliary recognition instrument on parathyroid function during thyroid malignant tumor surgery through reasonable grouping.


Eligibility criteria: Inclusion Criteria:

1. Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50.
2. No history of neck surgery and radiotherapy.
3. There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
4. No abnormal calcium metabolism disease.
5. No abnormalities in blood calcium and blood PTH before operation.
6. No allergy to contrast agents.
7. The patient or his agent signs an informed consent statement.

Exclusion Criteria:

1. Does not meet the entry criteria;
2. Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.

Primary outcomes:
measure: Serum Calcium level
timeFrame: 24 hours after surgery
measure: Serum Calcium level
timeFrame: 1 month after surgery
measure: PTH
timeFrame: 24 hours after surgery
measure: PTH
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT05881226: Application of Biomarkers in Neurological Diseases
Official title: Application of Biomarkers in Neurological Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biomarkers
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neurological diseases admitted to hospital/emergency department.

Brief summary: To explore the predictive and diagnostic role of biomarkers in patients with neurological diseases.

Detailed description: With the rise and continuous development of omics technology and bioinformatics technology, some scholars have applied proteomics technology and metabolomics technology to study the brain tissue, plasma and CSF of patients with nervous system diseases, so as to screen out potential biomarkers, with a view to providing new research ideas for pathogenesis and early diagnosis of neurological diseases. At present, the research on some novel biomarkers is still in its infancy, and many key problems remain to be solved. It is necessary to further determine the expression level of biomarkers in normal human body and the characteristics of biomarkers in patients with neurological diseases.

Eligibility criteria: Inclusion Criteria:

1. Patients with neurological diseases;
2. Subjects or legal agents agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Participating in other clinical investigators;
2. Unwilling to be followed up or poor treatment compliance;
3. Other conditions considered unsuitable for inclusion by the researchers.

Primary outcomes:
measure: mRS score in 90 days
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT04707326: Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study
Official title: Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hiv
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Maasstad Hospital
name: Haaglanden Medical Centre
name: Catharina Ziekenhuis Eindhoven
name: Elisabeth-TweeSteden Ziekenhuis
name: Rijnstate Hospital
name: Admiraal de Ruyter Hospital
name: Spaarne Gasthuis
name: Medisch Spectrum Twente
First posted: 2021-01-13
Enrollment: 2040
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: To be eligible as case in the study, plasma HIVRNA must be \<50c/mL on triple drug cART containing 2NRTI at switch to DTG/3TC and no key mutations associated with major 3TC (i.e. M184V/I only) or DTG resistance of at least low level according to the Stanford HIV drug resistance database should be present. Patients with no genotyping results available at baseline will be eligible for inclusion in this study. Cases should not have documented inadherence in the preceding 3 months or HepB coinfections. These data on adherence and HepB is routinely collected at switching to DTG/3TC. Controls are matched on predefined criteria.

Brief summary: This study aims to determine real-life clinical efficacy of virally suppressed patienst switching to DTG/3TC compared to DTG triple drug cART controls

Detailed description: Dolutegravir (DTG) based dual antiretroviral therapy constitutes a paradigm shift from triple drug based therapy. Data outside clinical trials are scarce. This study evaluates the value of DTG/3TC in real life.

Eligibility criteria: Inclusion Criteria:

Plasma HIVRNA \<50c/mL on triple drug cART regimen including 2NRTI In care in a HIV treatment center in the Netherlands Consented to ATHENA participation

Exclusion Criteria:

Documented mutations associated with 3TC or DTG resistance of at least low level Documented inadherence by the treating physician or HepB coinfection (cases only)

Primary outcomes:
measure: Efficacy On Treatment (OT)
timeFrame: 1 year
measure: Efficacy Intention to Treat (ITT)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: MC Haaglanden
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Tilburg
country: Netherlands
facility: Elisabeth Tweesteden Hospital
Study officials:
References: