louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01521247: Implementation of a Pediatric-to-adult Asthma Transition Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Education
Keywords: Asthma
Transition program
Pediatric
Adult
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Despite the clear and often stated need, a formal transition program does not exist for asthma patients as they move from pediatric to adult care in Western Canada. This population is not having their health care needs met. The investigators proposed study would evaluate a well structured transition program designed to facilitate continuity of care for this at risk patient population.

Primary hypothesis: A pediatric-to-adult asthma transition program will improve the asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year period.

Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma control, decrease asthma exacerbations, and reduce health care utilization in young asthma patients in the Calgary area over a 1 year period.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of asthma (as confirmed by a pediatric respirologist or pediatrician with asthma expertise, and including evidence of variable airflow obstruction, bronchial hyperresponsiveness, airway inflammation, and/or response to therapy)

Exclusion Criteria:

* patients who are known to be non-adherent within the Calgary Regional Pediatric Asthma Clinic (defined as \>50% missed appointments over a 2 year period)
* patients unable to complete pulmonary function testing
* patients with a history of significant respiratory comorbid conditions (including history of cystic fibrosis, alpha-1 antitrypsin deficiency, and lung transplant - rhinosinusitis patients will not be excluded)
* patients unable to provide consent.

Primary outcomes:
measure: Asthma Quality of Life Questionnaire with Standardized Activities [AQLQ(S)]
timeFrame: 12 months
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ)
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Regional Pediatric Asthma Clinic
state: Alberta
Study officials:
affiliation: Alberta Children's Hospital
name: Mary Noseworthy, MD
role: STUDY_DIRECTOR
name: Rodel Padua, RRT
role: STUDY_DIRECTOR
affiliation: Alberta Children's Hospital
name: Sheldon Spier, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Ward Flemons, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Warren Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416647: SMAS: a Prospective Study in a Single Institution
Official title: Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superior Mesenteric Artery Syndrome
Keywords: Superior Mesenteric Artery Syndrome
Chronic duodenal obstruction
Duodenojejunostomy
Wilkie's syndrome
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008 and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of SMAS were prospectively included in the study, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.


Eligibility criteria: Inclusion Criteria (at least 2 of the following):

* severe and frequent upper digestive symptoms (occurring at least once a week), associated to poor quality of life and refractory response to medical treatment;
* a condition of underweight (BMI \<18.5 kg/m2) associated with difficulty eating;
* severe complications of SMAS (e.g. gastric perforation, acute pancreatitis, aspiration pneumonia);
* suggestive findings of SMAS at barium swallow;
* diagnostic aortomesenteric angle and distance at CT/MR angiography.

Exclusion Criteria:

* inability to provide the informed consent;
* malignancies;
* bowel motility disorders;
* severe psychiatric illness;
* pregnancy;
* impossibility to perform the required diagnostic workup.

Primary outcomes:
measure: Symptom score
timeFrame: 47 months (IQR 34-72)
measure: BMI
timeFrame: 47 months (IQR 34-72)
measure: Need for medical treatment
timeFrame: 47 months (IQR 34-72)
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: General Surgery Unit
state: PD
Study officials:
affiliation: General Surgery Unit
name: Angelica Ganss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganss A, Rampado S, Savarino E, Bardini R. Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution. J Gastrointest Surg. 2019 May;23(5):997-1005. doi: 10.1007/s11605-018-3984-6. Epub 2018 Oct 5.
Clinical trial NCT01776047: A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
Official title: A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteer
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-01-25
Enrollment: 51
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study Design : randomized, open label, single-dose, 2-way cross-over design

Phase : Phase I


Eligibility criteria: Inclusion Criteria:

* healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
* having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
* doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion Criteria:

* Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan
* Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
* Gastrointestinal diseases or surgeries that affect absorption of drug
* Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
* Smoking over 10 cigarettes per day

Primary outcomes:
measure: AUClast, Cmax
timeFrame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
Secondary outcomes:
measure: AUCinf, Tmax, t1/2, % AUCextra
timeFrame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
Other outcomes:
Locations:
Study officials:
affiliation: Head of Clinical Development, Clinical Trials Center Severance Hospital
name: K S Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04132947: Validity of the MET-REPAIR Questionnaire
Official title: MET-REPAIR CONVAL: Concurrent Validity of the MET-REPAIR Questionnaire in German and of the Duke Activity Scale Index for Estimating Exercise Capacity Measured Using Exercise Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 140
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients admitted to the ambulatory cardiology ward

Brief summary: MET-REPAIR CONVAL is an international cohort study to examine the ability of self-reported exercise capacity to predict perioperative cardiovascular events correcting for preoperative risk factors.


Eligibility criteria: Inclusion Criteria:

* over 45 years of age
* clinically indicated exercise testing
* signed written informed consent

Exclusion Criteria:

* unable to complete the questionnaire
* unable to consent or unwilling to participate
* cancelled exercise

Primary outcomes:
measure: Metabolic equivalents (METs)
timeFrame: at Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital Basel, Dep. of Anesthesia
name: Eckhard Mauermann, Dr. med. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03313947: Airway Ultrasound Prediction and Correlation
Official title: Airway Ultrasound to Predict Obstructive Sleep Apnea Syndrome in Children and Its Correlation With Clinical Signs and Symptoms of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Difficult Airway
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. The investigators hope to determine if a combination of simple bedside clinical tests can be used to identify OSAS in patients who present for surgery with clinical signs of OSAS but without a formal polysomnography.


Eligibility criteria: Inclusion Criteria:

* All children presenting for surgery at NCH ranging in age from 3-12 years

Exclusion Criteria:

* Parent/ patient refusal to participate in study

Primary outcomes:
measure: Hyo-mental distance
timeFrame: 5 minutes before surgery starts
Secondary outcomes:
measure: Tongue width
timeFrame: 5 minutes after being intubated in surgery
measure: Tonsil size
timeFrame: 5 minutes after being intubated in surgery
measure: Questionnaire
timeFrame: 30 minutes before surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03676647: Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
Official title: Retrospective-Prospective Collection of Thyroid Specimens After FNA
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Thyroid Gland Nodule
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People undergoing fine needle aspiration.

Brief summary: This trial studies how well the diagnostic deoxyribonucleic acid (DNA) methylation signature works in detecting thyroid cancer in patients with thyroid nodules. Using diagnostic testing, such as the diagnostic DNA methylation signature, may be a less invasive way to check for thyroid cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To validate a novel epigenetic thyroid nodule diagnostic test, diagnostic DNA methylation signature (DDMS) in a retrospective-prospective study with leftover of fine needle aspiration biopsies.

OUTLINE:

Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay.

After completion of study, patients are followed up yearly for 5 years.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing FNA for thyroid nodule diagnosis.
* Any race and ethnicity are eligible for the study.
* Patient should have thyroid nodule(s) with indeterminate diagnosis after FNA (Bethesda category of indeterminate FNA \[III-V\]).

Primary outcomes:
measure: Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)
timeFrame: Up to 5 years
measure: Specificity of DDMS
timeFrame: Up to 5 years
measure: Positive predictive value (PPV)
timeFrame: Up to 5 years
measure: Negative predictive value (NPV)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Maria Hahn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02787447: Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy
Official title: A Phase II Trial of Hypofractionated Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Adenocarcinoma
Keywords: Hypofractionated Radiotherapy
Thymosin Alpha 1
Lung Adenocarcinoma
Tyrosine Kinase Inhibitors
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is also planned.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and showed stable disease after 3 months TKI, evaluated twice by PET/CT scan, brain MRI, and abdomen ultrasound (≥3 measurable lesions, and these lesions haven't received local therapy)
* Age 18 years or older
* ECOG Performance Status 0-2
* Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal
* For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
* Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
* Patients and their family signed the informed consents

Exclusion Criteria:

* Received chemotherapy before TKI therapy
* Brain parenchyma or leptomeningeal disease
* Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment
* Any medical co-morbidities that would preclude radiation therapy.

Primary outcomes:
measure: The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy
timeFrame: 1-6 months
Secondary outcomes:
measure: To assess the short-term quality of life (QOL)
timeFrame: 4 months
measure: Rate of CTCAE grade 2 or higher radiation pneumonitis
timeFrame: 1 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05919147: The Neuroendocrine Effects of Pioglitazone in Patients with Cancer and Cachexia
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Neuroendocrine Effects of Pioglitazone in Patients with Cancer and Cachexia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is evaluate the effect of pioglitazone compared with placebo on skeletal muscle insulin sensitivity in subjects with cancer and cachexia.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Documented histologic or cytologic diagnosis of non-small-cell lung cancer or gastrointestinal cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs)
* Cachexia defined by Fearon criteria
* Insulin resistance syndrome, defined with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
* Ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures
* Provide written approval by a qualified healthcare professional
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

* Prior diagnosis of type 2 diabetes
* Prior or current thiazolidinedione (TZD) therapy
* Known hypersensitivity to TZD
* New York Heart Association (NYHA) class I-IV heart failure
* History of or actively treated bladder cancer
* Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin)
* Inadequate hepatic function
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks
* Contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant)
* Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

Primary outcomes:
measure: Change in skeletal muscle insulin sensitivity
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT00333047: Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy
Official title: A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
Aromatase inhibitor
Letrozole
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.


Eligibility criteria: Inclusion criteria

* Histologically proven metastatic breast cancer
* Measurable disease, patients with bone only disease are not eligible
* Age ≥ 65 years
* Performance status ≤ 2 (World Health Organization)
* Estimated life expectancy under therapy of at least 3 months
* Estrogen-/progesterone-receptor status positive or unknown
* Signed informed consent

Exclusion criteria

* Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting
* Disease-free interval after adjuvant therapy \< 1 year
* Clinical signs of central nervous system metastases
* Renal, bone marrow, or liver insufficiency
* Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases
* Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression
Secondary outcomes:
measure: Time to progression and safety and toxicity during treatment
Other outcomes:
Locations:
city: Kiel
country: Germany
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT02747147: Multi-Day Evaluation of the TIVA Device
Official title: Multi-Day Evaluation of the TIVA Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Collections Via Peripheral IV Catheter
Lead sponsor: Velano Vascular, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay.


Eligibility criteria: Inclusion Criteria:

* Patient will be admitted to the BWH unit 15 for post-surgical care
* Patient is at least 18 years old
* Patient is willing and physically / cognitively able to sign a written consent form
* Patient is willing and able to complete study questionnaires
* Patient is NOT a prisoner

Exclusion Criteria:

* Active hemodialysis
* Hemolytic disorders (e.g., sickle cell disease)
* Pregnancy

Primary outcomes:
measure: % Aspiration reliability
timeFrame: up to 4 days after PIV placement
measure: % of Specimen hemolyzed
timeFrame: up to 4 days
Secondary outcomes:
measure: Avg PIV dwell - hours, mean, range
timeFrame: 1, 2, 3, and 4 calendar days after PIV placement
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Deborah F Mulloy, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: