louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02053623: Evaluation of a Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor
Official title: Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension
Atrial Fibrillation
Obesity
Heart Failure
Atherosclerosis
Lead sponsor: Health Parametrics Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 3
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: We will recruit a minimum of 20 qualified adult patients who come to the catheterization lab at the University of Ottawa Heart Institute for an angiography. The patients will have at least one of the following chronic conditions: atrial fibrillation, obesity, atherosclerosis, and heart failure.

Brief summary: Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Personal interaction with medical practitioners (doctors) and review of published clinical research confirms that current non-invasive automatic blood pressure (BP) monitors that rely on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP estimation can lead to wrong diagnoses and hence to complications such as stokes and heart attacks.

The Sponsor is developing a novel non-invasive BP monitor that is similar to existing automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in conjunction with BP pulse data to provide better and more accurate measurements in the above chronic conditions.

The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP monitor against invasive BP measurements in a small group of patients who suffer from the above conditions.


Eligibility criteria: Inclusion:

1. Patients undergoing an angiography in the catheterization lab who also suffer from at least one of the following chronic conditions:

   * Established diagnosis of AF.
   * Obesity characterized by a BMI \> 40 (extremely high, Class III).
   * Established diagnosis of AS.
   * Established diagnosis of HF.
2. Age ≥ 18 years.

Exclusion:

1. Patients unwilling or unable to comply with study requirements.
2. Failure to sign the informed consent form.
3. Age \< 18 years.

Primary outcomes:
measure: Accurate and Consistent Blood Pressure Measurement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
References:
Clinical trial NCT00001123: A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
Official title: A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hantavirus Pulmonary Syndrome
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread through the air into the lungs when dry rodent feces are moved or disturbed. It is characterized by fever and bleeding.

Detailed description: Patients are randomized to receive either ribavirin or a placebo for 7 days. At the completion of therapy, patients will be seen on follow-up visits on days 14, 28, and 84.

Eligibility criteria: Inclusion Criteria:

You may be eligible for this study if you:

* Are 12 years of age or older.
* Are not pregnant.
* Agree to practice sexual abstinence or use accepted barrier methods of birth control/contraception.
* Are not breast-feeding.
* Have a positive blood test for hantavirus.
* Have symptoms suggestive of hantavirus illness.

Exclusion Criteria:

You will not be eligible for this study if you:

* Have severe low blood count (anemia).
* Have a diagnosis of other respiratory viruses (influenza, RSV, etc.).
* Have group A Streptococcus with symptoms of streptococcal pharyngitis, a positive culture from a normally sterile site, or symptoms of bacterial pneumonia.
* Are HIV positive.
* Have cancer.
* Have had any period of irregular heartbeat.
* Have had chemotherapy or other drugs that suppress the immune system within 30 days.
* Have taken by mouth or injection any antiviral drug (other than acyclovir, famciclovir, amantadine or rimantadine.)
* Have taken by mouth or injection corticosteroids equivalent to approximately 0.5 mg/kg prednisone.
* Have taken any experimental drug within 30 days prior to enrollment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: NIAID/DMID/CASG Central Unit
state: Alabama
Study officials:
References:
Clinical trial NCT00574223: A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Official title: Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perennial Allergic Rhinoconjunctivitis
House Dust Mite Allergy
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2007-12-17
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 purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting


Eligibility criteria: Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

* Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
* Use of any concomitant medication that could affect the patient's study treatment response or assessment results

Primary outcomes:
measure: Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
timeFrame: about 1.5 hours on 4 occasions over 1 year
Secondary outcomes:
measure: Safety and tolerability of the study treatment by collection of adverse events
timeFrame: about 30 min. at each visit
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Cytos Biotechnology (Sponsor's Headquarter)
Study officials:
affiliation: Cytos Biotechnology
name: Philipp Mueller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00114023: 1-Year Follow up to the 1473-IMIQ Study
Official title: A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1473-IMIQ Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratosis
Keywords: AK
Imiquimod 5% cream
3M Pharmaceuticals
Aldara
Actinic Keratosis
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-06-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.


Eligibility criteria: Inclusion Criteria:

* Subject had to participate in the 1473-IMIQ Study AND have had 100% clearance of AK lesions

Exclusion Criteria:

* Did not use any topical preparations in the previous treatment area within 24-hours of the scheduled visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
Study officials:
References:
Clinical trial NCT04816123: The Mass Balance and Biotransformation of [14C]Donafenib in Healthy Adult Man
Official title: The Mass Balance and Biotransformation Study of [14C] Donafenib in Chinese Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Adult
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm with single dose of 300mg Donafenib, containing about 120μCi \[14C\]Donafenib
Primary purpose: OTHER

Brief summary: This study was designed to evaluate the mass balance and biotransformation after single-dose of \[14C\]Donafenib orally in Chinese healthy adult male volunteers, revealing the overall pharmacokinetic characteristics of Donafenib in humans, and providing a reference for the rational administration.


Eligibility criteria: Inclusion Criteria:

* A healthy male adult.
* Age is between 18 and 45, inclusive.
* Body mass index is between 19 and 26, inclusive.
* Voluntarily to provide informed consent form.
* Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.

Exclusion Criteria:

* Any abnormal and clinical significant findings.
* A positive examination result of HBsAg/HBeAg, HIV antibody and treponema pallidum antibody.
* Volunteers who had participated in a radiolabeled clinical study or were exposed to significant levels of radiation for any reasons within the 12 months prior to the study.
* Volunteers who had used of prescription or herbal products that may affect the drug metabolism within 30 days before the study.
* Volunteers who had blood loss/donation up to 400 mL within 3 months before the screening, or received blood transfusion within 1 month.

Primary outcomes:
measure: Quantitive analysis of whole radioactivity of excrement of orally administered [14]Donafenib in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body
timeFrame: from 0 hour to 240 hours after administration
measure: Identification of the main metabolite and biotransformation pathway of Donafenib and investigation of metabolite in plasma by LC-RAM/HRMS
timeFrame: from 0 hour to 240 hours after administration
measure: Quantitive analysis of the concentrations of Donafenib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
timeFrame: from 0 hour to 240 hours after administration
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 7 days (approx) from the start of administration
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Suzhou Medical College
name: Liyan Miao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00973323: BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Official title: BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: BAY59-7939
Rivaroxaban
Non-valvular atrial fibrillation
Japanese Patients
Phase II
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).


Eligibility criteria: Inclusion Criteria:

* Japanese subjects with non-valvular AF who met all of the following criteria:

  * Persistent or paroxysmal non-valvular AF with \>/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
  * Male subjects aged 20 years or older and postmenopausal female subjects
  * Subjects with at least one risk factor for thromboembolism or aged 60 years or older (Risk factor for thromboembolism: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).

Exclusion Criteria:

* History or presence of stroke or transient ischemic attack.
* History of intracerebral hemorrhage.
* History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.

Primary outcomes:
measure: (Safety) Incidence of bleeding
timeFrame: Throughout treatment and followup period
measure: (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
timeFrame: Day 14 and Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Kurume
country: Japan
state: Fukuoka
city: Maebaru
country: Japan
state: Fukuoka
city: Kitahiroshima
country: Japan
state: Hokkaido
city: Kushiro
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Nomi
country: Japan
state: Ishikawa
city: Yokohama
country: Japan
state: Kanagawa
city: Tokorozawa
country: Japan
state: Saitama
city: Fukui
country: Japan
city: Oita
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06872723: CPRIT: Patient Adherence to Lung Cancer Screening
Official title: CPRIT: Patient Adherence to Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Screening
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 340
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To understand participants' barriers to lung cancer screening and their experience with scheduling lung cancer screening.

Detailed description: Primary Objectives/Aims

1. Determine rates of lung cancer scheduling and screening at the UTMB and UT Tyler LCS programs.
2. Using state-of-the-art machine learning (ML) approaches, develop prediction models for adherence to screening guidelines for newly eligible and established patients. Investigators will leverage data from BRFSS, UT Tyler and UTMB to develop and validate the prediction model, ensuring its generalizability and accuracy.
3. Survey participants in the LCS programs about their impressions and experience with the scheduling and completing screening; conduct interviews with participants who receive an order for LCS but do not complete screening by their due date.
4. Interview LCS program directors and staff about barriers and facilitators of increasing screening rates in their programs.

Eligibility criteria: Inclusion Criteria:

* Current smoker or quit within the past 15 years
* A 20+ pack-year smoking history
* Healthy enough for treatment

Exclusion Criteria:

* Not applicable as our focus is on patients with an order for screening at the UTMB or UT Tyler

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01291823: Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer
Official title: A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: gefitinib
radiation
esophageal cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.

Detailed description: Purpose: to evaluate the efficacy and toxicity of a concomitant treatment using EGFR-TKI and thoracic radiation in elderly patients with esophageal Cancer.

Methods:Patients(\>70 years old) with esophageal Cancer will receive thoracic radiation therapy 54-60 Gy over 30 fractions and concurrent with gefitinib 250mg/day.

Eligibility criteria: Inclusion Criteria:

* Histologically documented diagnosis of esophageal Cancer
* Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible
* age:70-85 years
* Written informed consent.
* Performance status of 0 to 2
* Neutrophil count \>1.5 x 10 to the 9th power/L and platelets \> 100 x 10 to the 9th power/L.
* Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement
* Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)

Exclusion Criteria:

* Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
* Prior systemic chemotherapy or radiation therapy for esophageal cancer

Primary outcomes:
measure: Tumor response rate
timeFrame: 1 month after the thoracic radiotherapy and concurrent gefitinib treatment
Secondary outcomes:
measure: The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
timeFrame: 1 month after treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Mao Weimin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 0086-571-88122082
name: Xu yaping, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404923: Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Official title: Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Lead sponsor: Laboratoires Mayoly Spindler
Sponsor class: INDUSTRY
First posted: 2011-07-28
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:

* Strategy A = MeteoSpasmyl®, on-demand therapy
* Strategy B = standard of care chosen by the physician


Eligibility criteria: Inclusion Criteria:

* male or female ambulatory patients, aged \>= 18 years
* with IBS as defined by Rome III criteria for more than 1 year and less than 10 years
* with a IBS-SSS between 175 and 400

Exclusion Criteria:

* Acute diarrhea, bowel disorders due to an underlying cause
* Patient treated with MeteoSpasmyl® within the past 6 months
* Recent history of gastro intestinal surgery

Primary outcomes:
measure: Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
timeFrame: Baseline and 6 months
measure: Percentage of Improvement of the Total IBSQoL Scores
timeFrame: Baseline and 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ducrotte P, Grimaud JC, Dapoigny M, Personnic S, O'Mahony V, Andro-Delestrain MC. On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014 Feb;68(2):245-54. doi: 10.1111/ijcp.12333. Epub 2013 Oct 21.
Clinical trial NCT02876523: Biliary Hilar Drainage Managed by Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hilar Biliary Strictures
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a hilar biliary strictures requiring a drainage

Brief summary: The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. There is controversy as to whether partial or complete liver drainage should be done. Furthermore there are no standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a multistage procedure can be required.

This study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Biliary strictures requiring a drainage

Exclusion Criteria:

* Contraindication to hilar biliary drainage

Primary outcomes:
measure: Efficacy evaluated by the need for re-interventions
timeFrame: up to 2 years
measure: Efficacy evaluated by the need for re-hospitalization
timeFrame: up to 2 years
measure: Efficacy evaluated by complete or partial liver drainage
timeFrame: up to 2 years
Secondary outcomes:
measure: Toxicity: Occurrence of drainage complications (sepsis, hemorrhage)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches du Rhone
Study officials:
References: