louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00728533: Open-Label, Randomised Parallel-Group Study
Official title: The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer requiring Androgen Ablation Therapy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.


Eligibility criteria: Inclusion Criteria:

* Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
* Screening testosterone level above the lower limit of normal range, globally defined as \> 2.2 ng/mL.
* Screening PSA level of =2 ng/mL. ECOG score of =2.
* Life expectancy of at least one year.

CRITERIA FOR EVALUATION:

Primary endpoint:

* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.

Secondary endpoints:

* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
* Serum levels of testosterone, LH, FSH, and PSA over time.
* Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
* Plasma levels of degarelix over time.
* Frequency and severity of adverse events.
* Clinically significant changes in laboratory safety parameters.
* Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.

Primary outcomes:
measure: To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
timeFrame: 3-month
Secondary outcomes:
measure: To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
timeFrame: 3-month
measure: To evaluate pharmacokinetic response.
timeFrame: 3-month
measure: To compare safety and tolerability profiles of different degarelix three-month dosing regimens.
timeFrame: 3-month
Other outcomes:
Locations:
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT05755451: Natural History of SMA
Official title: Natural History of SMA: Long Term Longitudinal Study and Development of a Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Muscular Atrophy, Spinal
Keywords: natural history
spinal muscular atrophy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: University of Milan
name: Istituto Giannina Gaslini
name: Ospedale Pediatrico Bambin Gesù
name: University of Messina
First posted: 2023-03-06
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all pèatients with mutations in the SMN1 gene

Brief summary: This is an investigator initiated observational study with the aim to record several aspects of function, care and adverse events in a large cohort of SMA patients followed longitudinally by using a structured academic disease registry.

Detailed description: This is an observational multicenter retrospective and prospective study involving high quality data collected in 5 academic centers in Italy, the registry aims to

* better understand the natural history of the disease in untreated patients identifying factors that can influence disease progression by combining retrospective and prospective data.
* Describe the patterns of disease progression (in terms of functional measure, adverse events, levels of care, and hospitalization) in treated and untreated patients
* Identify all the patients treated with the available therapies in Italy, providing first line details on epidemiological data in a wider network including all centers recognized as centers for spinal muscular atrophy (SMA) in each region.

As part of the activity clinical evaluators, data manager and sub-investigators are also trained and use common manuals of operation to ensure reliability across the participating centers. The registry provides accurate and reliable information on natural history including results from currently used functional measures. The registry also includes information on supportive care, hospitalization and adverse events.

Details of the electronic clinical file record including data assembly and the platform used are available as part of a peer reviewed paper

Eligibility criteria: Inclusion Criteria:

all patients

Exclusion Criteria:

if enrolled in clinical trials

Primary outcomes:
measure: motor function
timeFrame: 15 years
Secondary outcomes:
measure: respiratory function
timeFrame: 15 years
measure: nutrition
timeFrame: 15 years
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Istituto Gaslini
city: Messina
country: Italy
facility: Nemo Sud
city: Milano
country: Italy
facility: Centro Clinico nemo
city: Rome
country: Italy
facility: Ospedale Bambino gesu
city: Rome
country: Italy
facility: Policlinico gemelli
Study officials:
affiliation: F Policlinico Gemelli IRCCS
name: Eugenio Mercuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02134054: Stavanger IBD Study - Cross Sectional
Official title: Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Bowel Disease
Keywords: Therapeutic drug monitoring
Biological treatment
IBD
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Rikshospitalet University Hospital
name: Oslo University Hospital
First posted: 2014-05-08
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab

Brief summary: In this cross sectional and longitudinal study, patients with inflammatory bowel disease on biological treatment with infliximab or adalimumab will be included.

After inclusion, the dosage of their existing biological therapy will be adjusted following regular trough-level and antibody-level monitoring, according to a treatment algorithm.

Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis is that therapeutic drug monitoring may improve clinical disease outcome after one year of follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)

Exclusion Criteria:

* Inability to consent
* Inability to adhere to treatment protocol.

Primary outcomes:
measure: Clinical remission rate
timeFrame: One Year
Secondary outcomes:
measure: Symptom scoring
timeFrame: One Year
measure: Inflammatory markers
timeFrame: One year
measure: Fatigue scoring
timeFrame: One Year
Other outcomes:
measure: Healthcare resource utilization
timeFrame: One year
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Stavanger University Hospital, Department of Medicine
name: Tore B Grimstad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlsen A, Omdal R, Leitao KO, Isaksen K, Hetta AK, Karlsen LN, Aabakken L, Bolstad N, Warren D, Lundin KEA, Grimstad T. Subtherapeutic concentrations of infliximab and adalimumab are associated with increased disease activity in Crohn's disease. Therap Adv Gastroenterol. 2018 Mar 14;11:1756284818759930. doi: 10.1177/1756284818759930. eCollection 2018.
Clinical trial NCT03644654: Perioperative Fluid Therapy Optimization in Spinal Surgery
Official title: Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovolemia
Hypervolemia
Keywords: fluid responsiveness, haemodynamical monitoring, ClearSight
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 100
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 decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.

Detailed description: The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.

Eligibility criteria: Inclusion Criteria:

* Glasgow Coma scale 15
* ASA Physical Status Classification System I-III
* planed spinal surgery to 3 hours
* postoperative awakening
* sinus rhythm

Exclusion Criteria:

* NYHA III, IV
* BMI over 40 in females and over 35 in men
* awake operation
* postoperative artificial ventilation

Primary outcomes:
measure: intraoperative fluid balance
timeFrame: 5 hours
Secondary outcomes:
measure: mean dose of norepinephrine
timeFrame: 5 hours
measure: level of creatinine
timeFrame: 24 hours
measure: pooperative lung dysfunction
timeFrame: 24 hours
measure: the length of postoperative stay
timeFrame: till 2 months after surgery
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Pavel Dostal, MD, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Kukralova L, Dostalova V, Cihlo M, Kraus J, Dostal P. The Impact of Individualized Hemodynamic Management on Intraoperative Fluid Balance and Hemodynamic Interventions during Spine Surgery in the Prone Position: A Prospective Randomized Trial. Medicina (Kaunas). 2022 Nov 20;58(11):1683. doi: 10.3390/medicina58111683.
Clinical trial NCT05931354: Longitudinal HPV Pap in CIN and VAIN
Official title: Longitudinal Study of Human Papillomavirus (HPV) Genotyping and Pap Smear in Patients With Antecedent Cervical Intraepithelial Neoplasia (CIN) and Association With Vaginal Intraepithelial Neoplasia (VAIN)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Intraepithelial Neoplasia
Hysterectomy
Human Papillomavirus
Vaginal Intraepithelial Neoplasia
Keywords: Cervical Intraepithelial Neoplasia
hysterectomy
human papillomavirus
vaginal intraepithelial neoplasia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 600
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with a previous history of cervical cancer or CIN before incident VaIN and those with VaIN detected concomitantly with cervical cancer or CIN for whom both vaginal biopsy and cervical specimens

Brief summary: This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+. The study will include three arms to complete the follow-up data for the previous cohort constructed, and prospectively recruit new subjects with the appropriate inclusion/excluding criteria in order to increase sample size of this study.

Detailed description: The long-term outcomes of patients with antecedent cervical intraepithelial neoplasia (CIN) were lacking. A systematic review published in 2008 identified no studies that met the review eligibility criteria for the prevalence of HPV types among vaginal precursors and cancers. Two sporadic studies containing 16 and 81 cases were reported in that review. Given that vaginal intraepithelial neoplasia (VAIN) post-hysterectomy for CIN is an uncommon disease which has a prevalence of being 1 to 6 %; it has the potential to progress to malignancy. Although the etiology of VAIN has not been as thoroughly investigated as that of CIN, evidence implicates that the human papillomavirus (HPV) as the probable carcinogenic agent for the onset and evolution of some VAIN and vaginal cancers.

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+.

Eligibility criteria: Inclusion Criteria:

1. Age \>= 20 years
2. Those with a previous history of CIN+

Primary outcomes:
measure: progression rate of CIN+ or VaIN+
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation
Study officials:
References:
Clinical trial NCT03189654: Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure
Official title: Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Heart Failure
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
Collaborators: name: ResMed GmbH & Co KG
First posted: 2017-06-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with decompensated heart failure and pleural effusion

Brief summary: There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement.

The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to our hospital on a routine or emergency basis
* Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis
* Non-invasively determined cardiac index of \< 2.5 l/min/m²
* BNP \> 300 pg/ml
* Transudative pleural effusion according to Light criteria
* Effective pleurocentesis with residual effusion on the side affected of \< 500 ml
* Tolerance of non-invasive ventilation without subjective or objective hemodynamic impairment as verified during a test ventilation
* No change in drug or other therapy for the duration of the study (5 days)

Exclusion Criteria:

* Psychological or neurological concomitant disease making an informed consent impossible
* Pregnancy
* Pneumothorax or pneumomediastinum
* Pathologically low blood pressure, particularly associated with intravascular volume depletion
* Liquor discharge, recent head surgery or trauma
* Severe bullous lung disease
* Dehydration
* Current ventilation therapy
* Bilateral pleural effusion \> 500 ml at the time of enrolment
* Exudative pleural effusion

Primary outcomes:
measure: Amount of pleural effusion
timeFrame: 5 days
Secondary outcomes:
measure: nt-Pro-BNP
timeFrame: 5 days
measure: Cardiac output
timeFrame: 5 days
measure: NYHA class
timeFrame: 5 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Study officials:
affiliation: Heart and Diabetes Center North Rhine-Westphalia
name: Thomas Bitter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04662554: Study of a 1-Millimeter Resolution Clinical Positron Emission Tomography (PET) System in Head and Neck Cancer Imaging
Official title: Pilot Study of a 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Goldman Sachs Foundation
name: Wallace H. Coulter Foundation
name: Emerson Collective
First posted: 2020-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to gain initial experience imaging HNC patient using a new PET camera, a 1mm spacial resolution. The goal is to understand image quality of the system and to see how it works in a clinical environment.

Detailed description: PRIMARY OBJECTIVE(S): Gain initial experience imaging head/neck cancer patients using a novel PET camera comprising two opposing panels with 1 millimeter spatial resolution.

SECONDARY OBJECTIVE(S):

1. Determine the radioactive dose and scan time required for this novel 1 millimeter (mm) resolution clinical PET camera.
2. Images obtained with the 1 mm resolution PET camera will be compared to conventional PET imaging (which will serve as gold standard) for image quality and lesion/node visualization.

Eligibility criteria: Inclusion Criteria:

1. Biopsy-confirmed diagnosis of HNC
2. Patient scheduled to undergo surgery for HNC
3. Scheduled to have a PET/CT study on a conventional PET/CT system
4. Age greater than or equal to 19 years of age.

Exclusion Criteria:

1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.

Primary outcomes:
measure: Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.
timeFrame: Day 1
Secondary outcomes:
measure: Measure image quality of the 1 mm resolution PET imaging device
timeFrame: Day 1
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Universiy
name: Eben Rosenthal, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02271854: A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness
Official title: A Randomized, Double-blind, Placebo-controlled, Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness (DOMS) of the Lower Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Muscle Soreness
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-10-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18-35 years
* Not engaged in regular lower extremity fitness activities in the past 6 months prior to screening
* Willing to refrain from use of ice, heat and massage during the study
* DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with moderate or severe on categorical scale

Exclusion Criteria:

* Pain medication \& corticosteroids prior to randomization
* Topical analgesic or anti-inflammatory treatment over the previous month
* Body mass index of \>32 kg/m2

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.
timeFrame: 24 hours
Secondary outcomes:
measure: Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Pasadena,
country: United States
facility: Lotus Clinical Research, 100 W California Blvd,
state: California
Study officials:
References:
Clinical trial NCT01459354: The Effects of Bimanual Laryngoscopy on Post-Operative Sore Throat in Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Sorethroat
Bimanual Laryngoscopy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 490
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20-70 yrs patient receive elective surgery with general anesthesia without position change or any influence on sorethroat

Brief summary: Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable, distressing sequelae after tracheal intubation. It was postulated that these effects are because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to improve visual field during intubation. This procedure might reduce laryngeal trauma during intubation and therefore reduce the incidence or degree of post-operative sore throat. This is the first prospective, double-blinded, controlled study, which is focused on the effects of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).


Eligibility criteria: Inclusion Criteria:

1. ASA I or II
2. 20-70 y/o
3. GAET for A. Breast op B. GYN op C. Upper/lower extremities op D. Ophthalmology op E. GU op F. minor surgery

Exclusion Criteria:

1. emergency surgery
2. head and neck surgery
3. recent URI symptom in last one weeks with medication
4. post op PCA use
5. on NG/OG
6. perioperative bucking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: taiwan ROC
Study officials:
References: