louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01623050: Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
Official title: SinuSys Patency of Maxillary Sinus Ostia Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sinusitis
Lead sponsor: SinuSys Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-19
Enrollment: 36
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 purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

Detailed description: A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis

Eligibility criteria: Inclusion Criteria:

-Diagnosis of chronic maxillary sinusitis

Exclusion Criteria:

* Previous antrostomy
* Sinonasal tumours
* Cystic fibrosis
* History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
* Pregnant or breastfeeding females
* Currently participating in another drug or device study

Primary outcomes:
measure: Patency of Treated Area
timeFrame: Immediately post procedure
Secondary outcomes:
measure: Patency of Treated Area
timeFrame: 3 months
measure: Number of Participants With Device-related Adverse Events as a Measure of Safety
timeFrame: 3 months
measure: Patency of Treated Area
timeFrame: 6 months
measure: Patency of Treated Area
timeFrame: 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Valley ENT
state: Arizona
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Boston
country: United States
facility: St. Elizabeth Medical Center
state: Massachusetts
city: Vancouver
country: Canada
facility: St. Paul's Hospital, ENT Department
state: British Columbia
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: St Elizabeth Medical Center
name: Peter Catalano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Paul's Hospital
name: Amin Javer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802750: Study Where Healthy Volunteers Evaluate LoFric Catheters
Official title: A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day.

The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Healthy volunteers
* Males age 18 years and over

Exclusion Criteria:

* Known or suspected, current impairment of and/or decreased urethral sensibility
* History of urethral disease
* History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
* Use of medications that may affect the urethra's dryness (e. g. anti-cholinergic drugs or cortisone)
* Current drug, alcohol or other substance abuse
* Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation
* Allergy to Trimethoprim
* Suspected poor compliance with the protocol during the complete study period.

Primary outcomes:
measure: Healthy volunteers perception of catheterization
timeFrame: At each catheterization (three times during one day)
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Clinical Research and Trial Centre, Lund University Hospital
Study officials:
affiliation: Clinical Research and Trial Centre, Lund University Hospital
name: Ulf Malmqvist, MD, PhD, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03211650: Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis
Official title: Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Regen Lab SA
First posted: 2017-07-07
Enrollment: 174
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
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 evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.


Eligibility criteria: Inclusion criteria:

* Knee pain for 4 months;
* Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;
* Patients able to understand the study conditions and willing to participate for its entire duration;
* Patients who signed written informed consent.

Exclusion criteria:

* Severe knee osteoarthritis of grade 4;
* Diabetes mellitus;
* Rheumatoid arthritis;
* Ongoing malignancies;
* Certified allergic reactions towards the administered drugs ;
* Malalignment of mechanical axis of the lower limb (varus \> 10 °, valgus \> 10 °);
* Coagulopathies;
* Severe cardiovascular diseases;
* Ongoing infections;
* Immunodepression;
* Anticoagulants or anti-platelet agents;
* Haemoglobin \< 11 g/dl;
* Platelet count \< 150,000/mm\^3
* Drug addiction;
* Alcoholism;
* Psychiatric disease;
* Pregnancy or breastfeeding.

Primary outcomes:
measure: WOMAC score
timeFrame: 6 months after the first intra-articular injection
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
state: Milan
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
affiliation: Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
name: Pietro Randelli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05367050: Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
Official title: Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Dependence
Opioid Use
Pain, Joint
Lead sponsor: Lucid Lane, Inc
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
name: VA Palo Alto Health Care System
First posted: 2022-05-10
Enrollment: 103
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female patients between the ages of 21-90 years old
* Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
* Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
* Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
* Patient is willing to sign a Lucid Lane Client Agreement.
* Patient is willing to sign an informed consent form

Exclusion Criteria:

* Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
* Active suicidal ideations
* Patient is on methadone or buprenorphine for treatment of opioid use disorder(i.e. for treatment of addiction, and not for treatment of pain)
* Patient unwilling to use or not possessing access to a device that allows for video visits(e.g. a smart phone, tablet, or computer)
* Patients who are in palliative care
* Unable to use English to participate in the consent process, the intervention or study assessments.
* Unable to provide informed consent to participate

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
timeFrame: Up to 4 months
measure: Change in Pain Catastrophizing scale
timeFrame: Up to 4 months
measure: Change in Depression Scores
timeFrame: Up to 4 months
measure: Change in Anxiety Scores
timeFrame: Up to 4 months
Secondary outcomes:
measure: Percent tapered off opioid (50% MME)
timeFrame: 4 weeks after surgery
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Division - VA Palo Alto Health Care System
state: California
Study officials:
References:
Clinical trial NCT04052750: SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs
Official title: Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients With Functional Gastrointestinal Disorders: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Patient Compliance
Keywords: Functional Gastrointestinal Disorders, Adherence
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of SMS follow-up on drug compliance and efficacy in patients with FGIDs has not been reported in the literature. We, therefore, conducted a prospective randomized controlled trial to investigate whether SMS follow-up could improve treatment adherence in patients with FGIDs, which in turn would help symptom relief and improve treatment outcomes.

Detailed description: The irritable bowel syndrome (IBS) and other functional gastrointestinal disorders (FGIDs) are common and pose significant burdens to patients. Although regular medications have substantial benefits for disease remission, many patients do not follow the recommendations of standard medication regimens given by physicians at the time of the visit, so how to improve patient compliance becomes even more important. Many factors can affect drug compliance. Forgetting seems to be one of the important reasons for poor compliance. In order to solve this problem, many studies such as drug charts/calendars, mini kits, etc. have been conducted in previous studies. At present, with the popularization of mobile phones, SMS-based interventions are gradually being applied to various medical environments. Compared with the phone, SMS consumes less time and can be easily integrated into the patient's daily life. Therefore, short messages may be more suitable for follow-up of patients outside hospital.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed FGIDs according to Rome-IV
* Aged 18-70 years
* With no obvious organic abnormalities

Exclusion Criteria:

* With organic gastrointestinal diseases
* With psychiatric diseases or are taking psychotropic agents
* With severe cardiopulmonary or other organ diseases
* Pregnant women

Primary outcomes:
measure: Treatment compliance in outpatients with FGIDs
timeFrame: week2
Secondary outcomes:
measure: Improvement of abdominal pain in outpatients with FGIDs
timeFrame: week2
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJiH
Study officials:
References:
citation: Wang B, Luo QQ, Li Q, Cheng L, Chen SL. Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients with Functional Dyspepsia: a Prospective Randomized Controlled Trial. J Gen Intern Med. 2020 Oct;35(10):2925-2931. doi: 10.1007/s11606-020-06088-3. Epub 2020 Aug 10.
Clinical trial NCT06592950: Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin
Official title: Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type-2 Diabetes Mellitus (T2DM)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 513
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: Type-2 diabetes mellitus (T2DM) patients

Brief summary: The primary objective of this research is to assess T2DM patient preferences for a once weekly insulin treatment. The study involves a qualitative interview phase and quantitative survey phase with a Discrete Choice Experiment (DCE).


Eligibility criteria: Inclusion Criteria:

* Patient is an adult aged 18 years or over
* Patient was diagnosed with type-2 diabetes mellitus (T2DM) greater than or equal to 180 days prior to the day of screening
* Patient is currently prescribed a diabetes treatment (e.g., Metformin/Sus, DPP4i, SGLT2i, GLP-1 RA and/or basal insulin)
* Patient is willing and able to provide written informed consent to participate

For qualitative interviews:

* Patient is a fluent speaker of English and is able to read, write, and fully understand the English language
* Patient is a resident in Canada

For quantitative online survey:

* Patient is a fluent speaker of the local language (English/French/Spanish or Japanese) and is able to read, write and fully understand the local language
* Patient is a resident of either Canada, France, Spain or Japan

Exclusion Criteria:

* Patient is currently employing a basal-bolus insulin treatment regimen to manage their diabetes
* Patient is unwilling or unable to comply with the needs of the study or has a physical, behavioural or mental condition that, in the opinion of the recruiter may affect the patient's ability to take part in the study, understand the nature, scope and possible consequences of the study, or the responses they might provide.

Primary outcomes:
measure: T2DM patient preferences for a once weekly insulin treatment
timeFrame: Day of interview/survey completion (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Novo Nordisk
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References:
Clinical trial NCT02894450: Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay Higher Among Those Aged Over 75 Years
Official title: Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay (Xaban) Higher Among Those Aged Over 75 Years, as AOD for Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
oral anticoagulant
bioassay
elderly subject
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 70
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients over 75 years under anticoagulant treatment 'xaban' (dabigatran, rivaroxaban, Apixaban) for atrial fibrillation, hospital unscheduled manner in Medicine and Geriatric services Versatile Service Home Emergency CHU Nantes and where a hemostatic balance is expected to be offered the study.

The recruitment will be made on a 6-month period (November 2014 - April 2015). Bioassay 'xaban' will be made from the remainder of the tube removed for hemostasis tests provided in the usual care of patients.

Brief summary: The objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 75 years
* Entering SAU or MPG (Nantes University Hospital) as part of an unscheduled hospitalization for acute or subacute disease (About MPG, will be included patients admitted to the department within 48 hours of calling the doctor)
* In xaban to entry (dabigatran, rivaroxaban, Apixaban) for non-valvular atrial fibrillation
* In whom hemostasis tests will be prescribed as part of usual care
* Patient has given its verbal agreement

Exclusion criteria

Patients with the following criteria may not be included:

* Patients refusing to participate in the study
* Patients under guardianship
* Inability to obtain the date and time of the last dose of xaban

Primary outcomes:
measure: bioassay direct oral anticoagulants
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Pascal Chevalet, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04471350: Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Official title: Post-market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Spine Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hemostasis
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 0
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: Subjects undergoing spine surgery that meet all of the inclusion criteria and none of the exclusion criteria

Brief summary: Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery

Detailed description: Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.

Eligibility criteria: Pre-operative Inclusion Criteria:

* Patient is undergoing a non-emergent spine surgery
* Patient is willing and able to give prior written informed consent for investigation participation;
* Patient is 18 years of age or older.

Intra-operative Inclusion Criteria

* Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.
* The TBS(s) has been treated with HEMOBLAST™ Bellows per instructions for use.

Exclusion Criteria:

* Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
* Patient has religious or other objections to porcine, bovine, or human components;
* Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
* Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator

Primary outcomes:
measure: Achievement of Hemostasis
timeFrame: Intraoperatively, expected within 3-10 minutes of application
Secondary outcomes:
measure: Incidence of Serious Adverse Device Effects (SADEs)
timeFrame: 4 weeks +/- 2 weeks
measure: Re-bleeding at Target Bleeding Site
timeFrame: Intraoperative, prior to surgical closure of the subject
measure: Re-operation due to bleeding
timeFrame: Post-operatively, expected within 1-28 days of the surgical procedure
Other outcomes:
Locations:
city: Nantes
country: France
facility: L'Hôpital privé du Confluent
Study officials:
affiliation: L'Hôpital privé du Confluent
name: Pierre-Marie Longis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04072250: Surgery for Recurrent Intrahepatic Cholangiocarcinoma
Official title: Surgery for Recurrent Intrahepatic Cholangiocarcinoma: a Promise or an Excess?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiocarcinoma, Intrahepatic
Recurrence Cholangiocarcinoma
Re-hepatectomy
Keywords: Recurrent intrahepatic cholangiocarcinoma
Intrahepatic cholangiocarcinoma
Repeat hepatectomy
Metastasectomy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between January 1977 and December 2014, 452 patients underwent curative-intent, different extent of hepatectomy for ICC in the Department of General Surgery, Chang Gung Memorial Hospital, Linkou branch, Taiwan. Only 216 patients fulfilled selection criteria aforementioned.

Brief summary: The investigators retrospectively reviewed the participants suffering from recurrent intrahepatic cholangiocarcinoma after curative resection and aimed to explore the predictive factors for recurrence and clarify the potential benefit of repeat hepatectomy or/with metastasectomy.


Eligibility criteria: Inclusion Criteria:

* R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis.

Exclusion Criteria:

* (1)Patient with R1 or R2 resection
* (2)Distant metastasis noted when laparotomy
* (3)Surgical mortality

Primary outcomes:
measure: Survival
timeFrame: 1977~2014
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
Study officials:
References: