louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03532724: Clinical Outcomes From Patient Self-management of Antivitamin K Treatment
Official title: Retrospective Analysis of the Clinical Outcomes From Patient Self-management of Antivitamin K Treatment at the Hospitald de Sant Pau. ORION Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self Management of Oral Anticoagulation With VKA Therapy
Keywords: Patient Self-management, Acenocoumarol, Warfarin
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 927
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from atrial fibrillation, or carrying a cardiac mechanical valve prostheses, or suffering any other cardiac disease with risk of arterial embolism or with a previous venous thromboembolic event with high risk of recurrence, and receiving chronic oral anticoagulation (OA) with any VKA drug, and whom have been trained in our Unit by specialized nurses on self-management of their OA by using a portable coagulometer to weekly test the International Normalized Ratio (INR)

Brief summary: ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain)


Eligibility criteria: Inclusion Criteria:

1. Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation.
2. Signed informed consent

Exclusion Criteria:

1. Patients younger than 18 years old

Primary outcomes:
measure: Thromboembolic events
timeFrame: since 1 of july of 2002 to 30th of june of 2018
measure: Major hemorrhagic event
timeFrame: since 1 of july of 2002 to 30th of june of 2018
Secondary outcomes:
measure: Mortality
timeFrame: since 1 of july of 2002 to 30th of june of 2018
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hspital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
affiliation: Hospital de la Santa creu i Sant Pau - Barcelona
name: Juan C Souto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01130324: VIBATIV Pregnancy Registry
Official title: VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy
Keywords: VIBATIV
telavancin
Pregnancy
Registry
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women exposed to VIBATIV during pregnancy and where outcome of pregnancy is unknown at time of enrollment.

Brief summary: The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.


Eligibility criteria: Inclusion Criteria:

* Female patients who were exposed to VIBATIV at any time during pregnancy
* Outcome of pregnancy is unknown at the time of enrollment

Primary outcomes:
measure: Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy
timeFrame: Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date
Secondary outcomes:
measure: Effect of fetal exposure to VIBATIV on pregnancy outcomes
timeFrame: Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age.
measure: Fetal/neonatal outcomes
timeFrame: Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age.
measure: Infant development and milestones through 12 months of age
timeFrame: Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Cumberland Pharmaceuticals Inc.
state: Tennessee
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Adam Haberle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858624: Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
Official title: Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cough
Keywords: Cough
Cough reflex
NMDA receptor
central sensitisation
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. To develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing.

This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. The investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). The investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.


Eligibility criteria: Inclusion Criteria:

Healthy Volunteers:

* Over 18 years old
* Measurable cough reflex sensitivity
* No current or past history of chronic cough or chronic respiratory disease.
* No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip.

Chronic Cough Patients

* Over 18 years old
* Chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease.
* Normal CXR
* Normal lung function
* Measurable cough reflex sensitivity

Exclusion Criteria:

* Recent Upper Respiratory Tract Infection (4 weeks)
* Pregnancy/breast feeding
* Current smokers or ex-smokers with \< 6 months abstinence or cumulative history of \> 10 packyears
* Diabetes Mellitus
* Opiate or ACE Inhibitor use.
* Any centrally acting medication which has the potential to alter cough reflex sensitivity.
* Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness.
* Drug or alcohol abuse
* History of allergy or reaction to ketamine of other NMDA receptor antagonists.

Primary outcomes:
measure: Cough Reflex Sensitivity
timeFrame: 6 months
Secondary outcomes:
measure: Upper Oesophageal Pain Thresholds
timeFrame: 6 months
measure: Pain Thresholds Pharynx
timeFrame: 6 months
measure: Pain Thresholds Chest Wall
timeFrame: 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester, Education and Research Centre, Wythenshawe Hospital
Study officials:
References:
Clinical trial NCT04273724: Early Intervention for Impairments Identified During Comprehensive Geriatric Assessment in Patients With Bladder Cancer
Official title: A Pilot Study of Early Intervention for Impairments Identified During Comprehensive Geriatric Assessment in Patients With Muscle-invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Keywords: Geriatric oncology
Comprehensive geriatric assessment
Patient-reported outcomes
Muscle-invasive bladder cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 5
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A Comprehensive Geriatric Assessment (CGA) is a set of tests used to evaluate a patient's medical, social, and functional status, and can identify impairments in these domains that may not be noticed otherwise. Prior studies have shown that a CGA can accurately predict which patients are more likely to have serious side effects from cancer treatment. However, it is unknown whether interventions can be done to address the impairments found during a CGA in order to reduce the risk of these side effects. This pilot study will test the feasibility of targeted interventions for deficits identified during a CGA in patients 65 years or older with bladder cancer that have not yet started treatment.

Detailed description: This study will enroll patients with muscle-invasive bladder cancer that have not yet started systemic cancer treatment. The participants will complete a CGA and patient-reported outcome (PRO) measures at baseline. Based on any impairments found during the CGA, participants will be referred to specialists to help address these difficulties. Participants will complete the CGA and PRO measures again at 3 months and 1 year after the initial assessment. The goal of this study is to see if patients with advanced bladder cancer are interested in referrals to specialists to address their impairments, and whether participants attend those appointments.

Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* Confirmed diagnosis of muscle-invasive bladder cancer
* Plan to undergo systemic treatment but have not yet started therapy

Exclusion Criteria:

* Must be able to read English

Primary outcomes:
measure: Patient interest in impairment-directed interventions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Hyman Muss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02902224: Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery
Official title: Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exploratory Behavior
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI before and after bariatric surgery. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.


Eligibility criteria: Inclusion Criteria:

* right-handed
* morbidly obese patients
* scheduled for bariatric surgery

Exclusion Criteria:

* Diabetes mellitus
* cardiovascular disease
* neurologic or psychiatric disorder

Primary outcomes:
measure: Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow
timeFrame: changes from baseline to one hour after treatment
Secondary outcomes:
measure: Changes in plasma glucose
timeFrame: Changes from baseline to one hour after treatment
measure: Changes in plasma insulin
timeFrame: Changes from baseline to one hour after treatment
measure: Changes in Plasma GLP-1
timeFrame: Changes from baseline to one hour after treatment
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University of Basel
name: Christoph Beglinger, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03010124: Prognostic and Predictive Biomarkers in Ovarian Cancers
Official title: Prognostic and Predictive Biomarkers in Ovarian Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, vaginal smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.


Eligibility criteria: Inclusion Criteria:

1. New patient with a diagnosis of OC, or
2. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or
3. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.
4. Signed informed consent
5. Age ≥ 18
6. Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
2. Coagulation abnormalities that contra-indicates the biopsy

Primary outcomes:
measure: Progression Free Survival
timeFrame: Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT02421224: Social and Monetary Incentives for Smoking Cessation at Large Employers
Official title: Social and Monetary Incentives for Smoking Cessation at Large Employers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Smoking Cessation
Incentives
Health Behavior
Smoking
Work-site
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
name: Mahidol University
First posted: 2015-04-20
Enrollment: 4190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a cluster randomized controlled trial of several behavioral interventions for smoking cessation among a sample of employees at large workplaces in the Bangkok metropolitan area. The study aims to test the impacts of different incentive structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. The interventions are designed to elucidate certain principles from the field of behavioral economics.


Eligibility criteria: Inclusion Criteria:

* Current full-time employee of a participating company
* Smoker of 100+ cigarettes during lifetime
* Smoker of 10+ cigarettes per week
* Individual is aged 18+ years old
* Smoker wants to quit within the next 6 months

Exclusion Criteria:

* Expects to leave company within the next 12 months
* Is currently pregnant
* Are unable to provide informed consent

Primary outcomes:
measure: Proportion of Participants With Smoking Abstinence at 12 Months
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Proportion of Participants With Smoking Abstinence at 3 Months
timeFrame: 3 months after enrollment
measure: Program Acceptance
timeFrame: At 0 months (at enrollment)
measure: Proportion of Participants With Smoking Abstinence at 6 Months
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol University
Study officials:
affiliation: University of California, Berkeley
name: William H. Dow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: White JS, Lowenstein C, Srivirojana N, Jampaklay A, Dow WH. Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand. BMJ. 2020 Oct 14;371:m3797. doi: 10.1136/bmj.m3797.
Clinical trial NCT02074124: CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test
Official title: Abdominal Tissue Perfusion Changes in Esophageal and Gastric Cancer During Adenosine Vasodilation Measured With Computed Tomography (CT) Perfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Gastric Cancer
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy proven tumors in esophagus or stomach

Brief summary: The aim of this study was to investigate changes in abdominal tissue perfusion during adenosine vasodilation. Our hypotheses were that CT perfusion measurements are altered by changes in the circulatory system mediated by adenosine, and a more differentiated assessment of the circulatory capacity of abdominal tumours could be achieved by sequential rest and adenosine vasodilation CT perfusion measurements.


Eligibility criteria: Inclusion Criteria:

* Tumour larger than 1.5 cm on diagnostic CT
* Normal serum creatinine
* Age above 18
* Informed written and oral consent.

Exclusion Criteria:

* Contrast allergy or contrast induced nephropathy
* BMI \> 40
* Asthma or Chronic Obstructive Lung Disease
* Heart failure (NYHA III+)
* Heart conduction disorder
* Atrial fibrillation
* 2nd/3rd Heart block
* Long QT syndrome
* Wolf Parkinson White Syndrome
* Moderate / severe aortic stenosis
* Haemodynamic contraindications for adenosine, systolic pressure below 90

Primary outcomes:
measure: Change in arterial flow during adenosine vasodilation test (CT perfusion parameter)
timeFrame: 0 min and 15 min
Secondary outcomes:
measure: Change in Blood pressure during adenosine vasodilation test
timeFrame: 0 min and 15 min
measure: Change in Heart rate during adenosine vasodilation test
timeFrame: 0 min and 15 min
measure: Change in Area under arterial input curve during adenosine vasodilation test
timeFrame: 0 min and 15 min
measure: Change in Blood volume (CT perfusion parameter) during adenosine vasodilation test
timeFrame: 0 min and 15 min
measure: Change in Permeability (CT perfusion parameter) during adenosine vasodilation test.
timeFrame: 0 min and 15 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Martin L Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04511624: Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects

Detailed description: In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female 18 to 45 years of age at the time of consent
2. BMI of 19-26Kg/m2 and weight of 50-100kg
3. Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements

Exclusion Criteria:

1. Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine
2. Subjects who have a history of relapse or chronic infection, or a history of acute infection within 2 weeks;
3. Subjects who have previously used anti-IL-12 / 23 or anti-il-23 drugs;
4. Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
5. Subjects who are not suitable for this trial due to other reasons In the investigator' opinion

Primary outcomes:
measure: Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112
timeFrame: Day1 to Day 113 post dose
Secondary outcomes:
measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment
timeFrame: Day 113
measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
timeFrame: Day 113
measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment
timeFrame: Day 113
measure: Half-Life (t1/2) - Pharmacokinetic Assessment
timeFrame: Day 113
measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment
timeFrame: Day 113
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
References: