louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00783250: Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Respiratory Mechanics
Bronchodilators
COPD patients with poor reversibility
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effects on respiratory mechanics of one "classical" short-term bronchodilator (i.e., salbutamol) versus placebo, and to verify the hypothesis that the addition of another bronchodilator (i.e., anticholinergic) may induce a further improvement on the work of breathing of stable COPD patients.

Detailed description: Studies with long-acting b2-agonists in COPD patients who poorly respond to routine airways obstruction reversibility tests with forced expiratory manoeuvres, such as forced expiratory volume in one second (FEV1), are scarce. Such studies, however, seem to show favourable effects on clinical parameters.

This may explain the subjective improvements and changes in quality of life with long-acting b2-agonists in patients with COPD. The lack of effect on forced expiration tests may be due to early airway collapse and subsequent airflow decline causing underestimation of the existing bronchodilatory effects located more peripherally in the respiratory tract, where the major site of resistance is located in obstructive lung disease.

We therefore design a study aimed to assess the short term effects of one short-acting beta2-agonist vs placebo, and the effects of an additional and sequential administration of a different bronchodilator, like tiotropium bromide (anticholinergic agent) on the work of breathing, and its components (i.e., lung resistances and compliance) of COPD patients with poor reversibility assessed using the classical Pulmonary Function Tests.

Eligibility criteria: Inclusion Criteria:

* COPD patient with a Tiffenau ratio \<55% and \>25% predicted
* Poor reversibility to an acute bronchodilator test (i.e. FEV1 changes\<10% from baseline)

Exclusion Criteria:

* Lack of informed consent
* Cancer
* Concomitant lung and airways diseases

Primary outcomes:
measure: Recordings of respiratory mechanics
timeFrame: 90 minutes
Secondary outcomes:
measure: Dyspnea score
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Respiratory Unit Fondazione S.Maugeri
state: PV
Study officials:
References:
Clinical trial NCT06355050: Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer
Official title: Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Adaptive Radiotherapy
Quality of Life
Keywords: Adaptive Radiotherapy
Quality of Life
Ultra-hypofractionation
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
name: Klinikum Stuttgart
name: University Medical Center Göttingen
First posted: 2024-04-09
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * low / intermediate risk prostate cancer
* prostate volume \< 100 ccm

Brief summary: In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.


Eligibility criteria: Inclusion Criteria:

* no androgen deprivation therapy within the last 2 months prior to RT
* good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)
* no secondary malignancy

Primary outcomes:
measure: Quality of Life (EPIC 26)
timeFrame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Secondary outcomes:
measure: Toxicity (CTCAE v5.0)
timeFrame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
measure: Planning parameters
timeFrame: for every fraction, total: 5x (1 week)
measure: Dose constraints
timeFrame: for every fraction, total: 5x (1 week)
measure: Conformity indices
timeFrame: for every fraction, total: 5x (1 week)
measure: Quality of adaptive planning
timeFrame: for every fraction, total: 5x (1 week)
measure: PSA-value
timeFrame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
measure: Overall survival
timeFrame: 5 Years
measure: Recurrence free survival
timeFrame: 5 Years
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Department of Radiotherapy and Radiation Oncology, Jena University Hospital
Study officials:
References:
Clinical trial NCT05911750: Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
Official title: Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV Infection
Dysplasia Anus
Oral Cavity Disease
Keywords: HPV, oral swab, anal swab
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 384
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau

Brief summary: The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.

Detailed description: Male IBD patients attending the IBD Clinic of Hospital de la Santa Creu i Sant Pau will be screened for eligibility. Informed consent will be obtained from all eligible patients. An anal and oral swab will be performed on all patients to look for HPV infection (HPV DNA test) and cytologic alterations. Patients will be inspected to rule out the presence of HPV-related lesions. Moreover, a self-administered questionnaire will be completed by all enrolled patients. Information regarding IBD characteristics and treatment will be obtained.

According to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
* Male
* Age from 18 to 79 years

Exclusion Criteria:

* Unclassified Inflammatory Bowel Disease
* Diarrhea (\> 3 bowel movements/day) with rectal bleeding at enrollment
* Prior full proctectomy
* Inability to collect the biological samples
* Inability to complete the questionnaire
* Refusal to sign the informed consent

Primary outcomes:
measure: Prevalence (number/percentage) of HPV infection in oral and anal samples
timeFrame: Up to 12 months
measure: Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples
timeFrame: Up to 12 months
Secondary outcomes:
measure: Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: dr.antoniogiordano@gmail.com
name: Antonio Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03049150: PREdicting RENAL Injury In Patient After Hip Fracture Surgery
Official title: The Use of Urinary MALDI-MS in Predicting Post-Operative Acute Kidney Injury in Patients After Fixation of Fractured Neck of Femur.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Urine
Mass Spectometry
Observational
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 50 years old who have suffered fractured neck of the femur

Brief summary: To determine whether MALDI, a type of Mass-Spectometry, can use protein pattern detection within urine to predict postoperative (after an operation) kidney damage in adults who have undergone emergency hip fracture surgery?

Detailed description: The PRE-RENAL study is a prognostic accuracy study testing the ability of the MALDI-MS assay to predict incident acute kidney injury after fractured neck of femur surgery. The study aims to validate the findings of a urinary peptide panel previously developed and validated on a cohort of septic patients.

Kidney injury following surgery or as a part of severe illness is an important complication, because it can delay and reduce the chances of recovery. A reliable early test for kidney injury would be useful so that treatments to prevent or minimise it can be started as early as possible. This study, based with a group of medical researchers working with chemists, will analyse clinical urine specimens from patients undergoing major orthopaedic (bone) surgery. We will explore whether patterns of proteins in the urine could be used as an early warning that kidney injury is present before existing tests demonstrate it.

Eligibility criteria: Inclusion Criteria:

* Fractured Neck of Femur
* Age \>50
* Informed consent

Exclusion Criteria:

* Refusal of Consent

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: Within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
References:
Clinical trial NCT01018550: AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
Official title: A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.


Eligibility criteria: Inclusion Criteria:

* Males or females 18 to 65 years of age
* Percent of predicted FEV1 ≥ 50% and ≤ 80%
* At least 12% reversibility over pre-bronchodilator FEV1
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
* Ongoing asthma symptoms with ACQ score ≥ 1.5 points

Exclusion Criteria:

* History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
* Any uncontrolled, clinically significant systemic disease
* Respiratory infection within 4 weeks of the screening visit

Primary outcomes:
measure: The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
timeFrame: Baseline to Week 12
measure: Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)
timeFrame: Baseline to Week 12
measure: Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline to Week 12
measure: Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)
timeFrame: Baseline to Week 12
measure: Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Busse WW, Wenzel SE, Meltzer EO, Kerwin EM, Liu MC, Zhang N, Chon Y, Budelsky AL, Lin J, Lin SL. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients. J Allergy Clin Immunol. 2013 Feb;131(2):339-45. doi: 10.1016/j.jaci.2012.10.013. Epub 2012 Nov 20.
Clinical trial NCT04229550: Metabolic Effects of One-weak Heavy Drinking
Official title: Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disturbance
Alcohol; Harmful Use
Glucose Intolerance
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Detailed description: Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Festival participants were studied before and after participation (one week) in Roskilde Festival 2016 and matched with controls who lead a normal life for an equivalent period of time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for liver stiffness were performed together with a bioimpedance scan and cognitive tests.

Eligibility criteria: Inclusion Criteria:

* BMI of 18,5-25 kg/m2
* Normal liver function (assessed by ASAT, ALAT, GGT, alkaline phosphatase, albumin and bilirubin, coagulation factors II, VII and X, INR and platelets)

Exclusion Criteria:

* Planning alcohol withdrawal or dieting/a special low-fat diet during Roskilde Festival
* Diabetes or pre-diabetes
* First degree relatives with diabetes
* Kidney disease (eGFT\<60 ml/min and/or albuminuria)
* Chronic diseases (in addition to those already mentioned) that could affect participation in festival activities (concerts and parties)
* Any condition in which the investigator believed would make it impossible to participate

Primary outcomes:
measure: Impairment of glucose tolerance
timeFrame: First day after intervention week
Secondary outcomes:
measure: Hepatic steatosis
timeFrame: First day after intervention week
Other outcomes:
measure: Altered cognitive function
timeFrame: First day after intervention week
Locations:
Study officials:
affiliation: University of Copenhagen
name: Filip K Knop, Prof,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04174950: Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients
Official title: Effect of Perioperative ERAS Based Nursing Intervention on Hope Level of Patients With Laryngeal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Cancer
Nursing
Keywords: Laryngeal cancer
enhanced recovery after surgery
hope level
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were allocated into two groups randomly.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To explore the effect of perioperative ERAS based nursing model on the hope level and recovery of patients with laryngeal cancer.

Detailed description: 200 patients who were diagnosed with laryngeal cancer and received total or partial laryngectomy were included. They were allocated into experimental and control group. Patients in experimental group were given ERAS based nursing intervention. Control group were given routine nursing intervention. Compare hope level, postoperative recovery, complication between two groups.

Eligibility criteria: Inclusion Criteria:

* Patients were confirmed as laryngeal cancer by CT scan.
* Patients were given total or partial laryngectomy.

Exclusion Criteria:

* Unconscious or psychiatric patients.
* Patients with distant metastasis or recurrence of cancer
* Patients with coagulation dysfunction
* Patients with severe cardiac, hepatic or renal dysfunction.

Primary outcomes:
measure: Hope level
timeFrame: the day before surgery
measure: Hope level
timeFrame: Day 10 after surgery
Secondary outcomes:
measure: Ambulation time
timeFrame: Day 3 after surgery
measure: Level of Pain
timeFrame: Day 3 after surgery
measure: Postoperative complication
timeFrame: Day 30 after surgery
measure: Length of stay
timeFrame: Day 30 after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Xuefei Yu, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02746250: Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
Official title: Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-type Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare the results with healthy individuals.

Detailed description: The muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m. sternocleidomastoid and m. Trapezius.

The muscle soreness is measured by palpation of the muscles aided by a so called palpometer.

Eligibility criteria: Inclusion Criteria:

* Chronic Tension type headache or frequent episodic tension type headache with at least ten episodes or more per month throughout three months or more.
* Pericranial muscle tenderness

Exclusion Criteria:

* Other primary headache disorder (with the exception of episodic migraine.)
* Pregnancy or ongoing breastfeeding
* Heart disease that contradicts treatment with amitriptyline
* Drug or substance abuse

Primary outcomes:
measure: Change in Total Tenderness Score
timeFrame: March 2016 to march 2018. Up to 4 months.
measure: Change in muscle stiffness
timeFrame: March 2016 to march 2018. Up to 4 months.
measure: Change in Local Tenderness Score
timeFrame: March 2016 to march 2018. Up to 4 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache center
Study officials:
affiliation: Danish Headache Center, Department of neurology, Rigshospitalet Glostrup
name: Henrik W Schytz, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00888550: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
Official title: A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibia Fracture
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience.

The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.


Eligibility criteria: Inclusion Criteria:

* Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail

Exclusion Criteria:

* Pregnant Women
* Prisoners

Primary outcomes:
measure: Differences across time and between groups for pain and range of motion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
References: