louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06234553: Application of Radiomics in the Diagnosis and Treatment Prediction of Pituitary Adenoma
Official title: Radiomics-based Diagnosis, Treatment and Outcome Prediction for Pituitary Adenoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pituitary Adenoma
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants willing to receive brain imaging could be included in this study

Brief summary: The images of patients with Pituitary adenoma were collected and analyzed based on the methods of radiomics.

Detailed description: Inclusion of pituitary adenoma patients diagnosed clinically or pathologically

1. Clinical data and pre-treatment imaging data of included patients (DICOM format)
2. Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data
3. Collect relevant data of patients before and after treatment
4. Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas

Eligibility criteria: Inclusion Criteria:

1. Gender unlimited, 18-80 years old;
2. Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;
3. Received brain imaging;
4. informed consent signed

Exclusion Criteria:

1. Pregnant / lactating women
2. Contraindications of imaging examination
3. Lack of effective clinical data
4. MRI data before treatment cannot be obtained
5. Postoperative pathology not revealed pituitary adenoma

Primary outcomes:
measure: Recurrence rate of pituitary adenoma
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Pathological type of pituitary adenomas
timeFrame: 1 week after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tiantan hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yanghua Fan, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02055053: Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
Official title: A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain (Post Laparoscopic Hernia Repair)
Keywords: Post Operative Pain
hernia repair
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
* American Society of Anesthesiology (ASA) Class I and II

Exclusion Criteria:

* Conversion from laparoscopic to open surgery
* History of Chronic pain or ongoing treatment for chronic pain
* Age less than 18 yrs
* Allergy to local anesthetics

Primary outcomes:
measure: Visual Analog Scale Pain Score Assessment (VAS)
timeFrame: Post-operative period
measure: Visual Analog Scale Pain Score Assessment (VAS)
timeFrame: Pain scale 3 days after surgery
Secondary outcomes:
measure: Amount of Pain Medication Used in Oral Morphine Equivalents
timeFrame: 4 hours after surgery
measure: Duration of Narcotic Used to Control Pain
timeFrame: 4 weeks post-op
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
Study officials:
References:
citation: Rade M, Jayaram A, Birkett R, Ford H, Birkett D, Nepomnayshy D. A randomized, double-blinded, placebo-controlled trial of the effects of infusing local analgesia on post-operative pain during laparoscopic inguinal hernia repair. Surg Endosc. 2023 Mar;37(3):1970-1975. doi: 10.1007/s00464-022-09697-7. Epub 2022 Oct 20.
Clinical trial NCT01661153: An Observational Study of Avastin (Bevacizumab) in Combination With Paclitaxel in First-Line Treatment in Patients With HER2-Negative Metastatic Breast Cancer
Official title: A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 16
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: HER2-negative breast cancer patients in first-line treatment of metastatic disease

Brief summary: This prospective observational study will evaluate the use in clinical practice, efficacy and safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up to 2.5 years.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Locally recurrent or metastatic breast cancer
* No prior treatment for metastatic or locally recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* History or clinical evidence of brain metastases
* Pregnancy
* Uncontrolled hypertension ( systolic \> 150 mmHg and/or diastolic \> 100 mmHg) or clinically significant (i.e. active) cardiovascular disease
* Major surgical procedure or significant traumatic injury within 28 days prior to enrolment

Primary outcomes:
measure: Progression-free survival
timeFrame: approximately 2.5 years
Secondary outcomes:
measure: Dosage/schedule/number of cycles of Avastin treatment in clinical practice
timeFrame: approximately 2.5 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 2.5 years
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Uni Hospital Split; Oncology & Radiotherapy
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00310453: Tolerability of ALK Grass Tablet in Children
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years


Eligibility criteria: Inclusion Criteria:

* Grass pollen induced rhinoconjunctivitis
* Boys and girls, 5-12 years of age
* Positive skin prick test to grass pollen

Exclusion Criteria:

* Severe asthma
* Previous treatment with immunotherapy

Primary outcomes:
measure: Assessment of safety by recording of adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Alergia, Hospital del Niño Jesús
Study officials:
affiliation: ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark
name: Kim Simonsen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05407753: Effect of Exogenous Ketosis During Ultra-endurance Exercise
Official title: Effect of Oral Ketone Administration on Cognitive Function, Musculoskeletal Damage and Hormonal and Metabolic Dysregulations Induced by Ultra-endurance Running
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Exercise
Ultra-endurance Running
Ketosis
Skeletal Muscle
Cognitive Function
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the main focus. In this context, subjects (n=24) will perform a 100km ultrarunning trail, while receiving either ketone ester (KE, n =12) or placebo (CON, n=12). Experimental measurements will be performed immediately before and after the ultramarathon as well as 24h after the ultramarathon.


Eligibility criteria: Inclusion Criteria:

* Males between 18 and 55 years old
* Recreational or competitive runner having performed an ultramarathon (\>42km) during the last 2 years
* Good health status confirmed by a medical screening
* Body Mass Index (BMI) between 18 and 25

Exclusion Criteria:

* Any kind of injury/pathology that is a contra-indication to perform ultra-endurance exercise
* Intake of any medication or nutritional supplement that is known to affect exercise performance
* Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
* Blood donation within 3 months prior to the start of the study
* Smoking
* More than 3 alcoholic beverages per day
* Current participation in another research trial
* Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
* Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)

Primary outcomes:
measure: Reaction time
timeFrame: Before race - immediately after race
measure: Countermovent jump
timeFrame: Before race - immediately after race - 48 hours after start of race
measure: Exercise performance
timeFrame: Immediately after race
measure: Skeletal muscle inflammatory cell infiltration
timeFrame: Before race - 48 hours after start of race
Secondary outcomes:
measure: Catecholamines in blood
timeFrame: Before race - immediately after race - 48 hours after start of race
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Exercise Physiology Research Group
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT00272753: Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
Official title: A Randomized Double Blind Comparison Between Single Doses of Symbicort Turbuhaler (Budesonide/Formoterol Combination), Formoterol, Salbutamol and Placebo in Repeated AMP-challenges in Patients With Mild - to Moderate Asthma. Investigating the Supplementary Value of the Budesonide Component Within Symbicort When Tested in a Model of Slow Onset Acute Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day


Eligibility criteria: Inclusion Criteria:

* asthma diagnosis according to ATS criteria,
* lung function (FEV1) above 60% of predicted,
* AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation test

Exclusion Criteria:

* having smoked \> 10 Pack-years,
* hypersensitivity to one of the study drugs,
* significant co-morbidity, pregnancy or lactating

Primary outcomes:
measure: The decrease in lung function (FEV1) after the third AMP provocation test.
Secondary outcomes:
measure: Decrease in lung function (FEV1) after the second AMP provocation test,
measure: lung function and Borg Score over the test day,
measure: increase in FEV1 at three minutes after study drug inhalation,
measure: time course of recovery from the AMP-induced decrease in lung function
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Netherlands Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Aalbers R, Boorsma M, van der Woude HJ, Jonkers RE. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study. Respir Res. 2010 May 28;11(1):66. doi: 10.1186/1465-9921-11-66.
Clinical trial NCT06707753: Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD
Official title: An Open-label, Nonrandomized, Single-arm, Single Dose, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Wet Age-related Macular Degeneration (wAMD)
Lead sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will receive a single dose of AL-001 administered via suprachoroidal space injection.


Eligibility criteria: Inclusion Criteria:

1. Age≥ 50 and ≤ 80.
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
4. The subject or their legal representative agrees to participate in this study and signs a written ICF.

Exclusion Criteria:

1. Non-wAMD induced CNV or macular edema in the study eye.
2. Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
3. Uncontrolled glaucoma in the study eye.
4. History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
5. Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
6. Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
7. Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
8. None of intraocular inflammation in the study eye.
9. Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.

Primary outcomes:
measure: Safety and tolerability
timeFrame: Week 24
Secondary outcomes:
measure: Evaluate the effect of AL-001 on BCVA
timeFrame: Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Hospital
Study officials:
References:
Clinical trial NCT00523653: The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dilated Cardiomyopathy (DCM)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2007-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Dilated cardiomyopathy followed at the Heart Function Clinic and their families

Brief summary: Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases are of unclear cause, often occuring in families. We believe that mutations in specific already-identified genes contribute to DCM in Quebec and that certain mutations may account for a significant proportion of cases due to the well-documented "founder effect". Two hundred patients with DCM followed in our Heart Function Clinic will be approached for one blood sample at their routine clinic visit to test this hypothesis. The samples will be tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.


Eligibility criteria: Inclusion Criteria:

* Followed at MUHC Heart Function Centre
* Documented EF of less than or equal to 35% and an enlarged heart with a left ventricular end-diastolic size of greater than 6 cm.
* Patient's written consent

Exclusion Criteria:

* Patients with a known underlying condition that results in a weakened and enlarged heart
* Patients unable to read and understand the consent form
* Patients who do not wish to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Hospital Centre
name: Nadia S Giannetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Jamie Engert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03282253: Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity of Severe Acute Pancreatitis
Official title: Elevated Stearoyl-CoA Desaturase-1 Expression Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Organ Failure, Multiple
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with the diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission; we intended to include the severer cases (APACHEII score is more than 8 and Ranson score is greater than 3).

Brief summary: In this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.In this prospective study, participants were divided into two groups based on serum SCD-1 concentration on admission and prospectively observe the disease severity and clinical outcomes of them.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of acute pancreatitis (Atlanta standard), abdominal pain occurred within one week of admission;
2. APACHEII score is more than 8 and Ranson score is greater than 3;
3. Age 18-75;
4. Obtaining informed consent.

Exclusion Criteria:

1. Pregnancy pancreatitis;
2. Patients with the following disease history: severe cardiac, pulmonary, renal, liver function insufficiency or immunodeficiency disease.

Primary outcomes:
measure: the incidence rate of infected pancreatic necrosis
timeFrame: 2-4 week after disease onset
Secondary outcomes:
measure: the incidence rate of organ failure
timeFrame: 1-2 week after disease onset
measure: the incidence rate of local complications
timeFrame: 1-2 week after disease onset
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00573053: Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
Official title: Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Development of Control of Breathing
Keywords: hypercapneic response
hyperoxic response
breathing pattern
periodic breathing
sighs
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.

Detailed description: To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:

i) The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (\< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs

Eligibility criteria: Inclusion Criteria:

* Gestational age 23 0/7 - 27 6/7 weeks
* Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
* Postnatal age between 21 days and 70 days
* Informed written consent obtained from at least one of the parents.

Exclusion Criteria:

* Need for mechanical ventilation, NCPAP or O2
* Sepsis or other known causes of apnea.

Primary outcomes:
measure: Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
timeFrame: 3 months
Secondary outcomes:
measure: To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on the ventilatory response to CO2 and O2, the PCO2 apneic threshold, and the baseline breathing pattern
timeFrame: 3 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Science Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Ruben E Alvaro, MD
role: PRINCIPAL_INVESTIGATOR
References: