louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01657383: Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery
Official title: Surgical Outcomes Database for Faculty of Hepatopancreatico Biliary Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Liver
Pancreatic Cancer
Biliary Tract Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatopancreatico Biliary surgical patients.

Brief summary: The collection of data regarding patient outcomes after surgical intervention creates imperative knowledge to include surgeon performance, cost analysis, base for surgical research and publication, which in turn assist surgeons to improve the standard of care utilizing evidence-based practice.

Detailed description: The concept of disease management stems from a logical evolution in the field of outcomes applications by healthcare provides is the concept of disease management. The basic premise of disease management is that there is a more optimal way to manage patients in order to reduce costs and improve health outcomes. The data collected from patient-reported outcomes allows the physician and staff to screen for specific health conditions, monitor patients individually, evaluate outcomes for specific groups, assess quality of care, determine impact of intervention and predict outcomes. Most of the follow-up results from this study will be obtained directly from the patient during follow-up visits, but other information may be obtained from medical records.

Evaluation of the surgical database Application will identify both patient and procedural variables that can predict adverse outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients that are Hepatopancreatico Biliary surgical patients.

Exclusion Criteria:

* Patients that are not Hepatopancreatico Biliary surgical patients.

Primary outcomes:
measure: Surgical Outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Health System
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David A Iannitti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02399683: Immune Modulation From Trichuris Trichiura
Official title: Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Colitis, Ulcerative
Intestinal Helminthiasis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A single healthy volunteer

Brief summary: Mucosal immunology during helminth infection

Detailed description: The present study investigates the effects of Trichuris trichiura on human mucosal and systemic immunity in a single self-infected individual.

Eligibility criteria: Inclusion Criteria:

* The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his inclusion in the study was that he was healthy.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Faecal egg excretion
timeFrame: 30 weeks
Secondary outcomes:
measure: Mucosal T cell associated cytokines
timeFrame: Week 15
measure: Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)
timeFrame: 30 weeks
measure: Adverse events
timeFrame: 30 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Jens F Dahlerup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02321683: Evaluation of a New Coating in Cement Less Femoral Stems
Official title: No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Osteoarthritis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2014-12-22
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.

Detailed description: 60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.

Eligibility criteria: Inclusion Criteria:

* non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants

Exclusion Criteria:

* infection, revision surgery, severe morbidity and obvious bone loss

Primary outcomes:
measure: Early and intermediate periprosthetic bone remodeling
timeFrame: 5 years
measure: Early and intermediate femoral stem stability
timeFrame: 5 years
Secondary outcomes:
measure: Clinical function
timeFrame: 5 years
measure: Radiographic signs of loosening
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Flatoy B, Rohrl SM, Boe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016 Feb;87(1):42-7. doi: 10.3109/17453674.2015.1084768. Epub 2015 Sep 12.
Clinical trial NCT05731583: Telemonitoraggio Domiciliare Della Saturazione Arteriosa di Ossigeno in Pazienti COVID-19
Official title: Telemonitoraggio Domiciliare Della Saturazione Arteriosa di Ossigeno in Pazienti COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients of any gender, with confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)

Brief summary: The COVID-19 pandemic created an urgent need to implement digital health solutions for remote clinical management of infected patients who could be monitored at home. The Gemelli Polyclinic in Rome provided a digital health program (SATCOV) to monitor at home newly diagnosed COVID-19 patient, or after an early discharge from the COVID units.

A digital application and a wireless oximeter were provided to patients. Oxygen saturation, heart rate and body temperature were monitored. The aim is to evaluate the feasibility and safety of the oxygen saturation telemonitoring in COVID-19 patients.

Clinicians personalized their remote assistance defining specific alerts for each patient and/or required a timely hospitalization in a dedicated COVID unit if necessary.


Eligibility criteria: Inclusion Criteria:

* adult patients (age\>18)
* confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)
* clinical condition compatible with hospital discharge (for recoving COVID group) or home management (for ongoing COVID group)

Exclusion Criteria:

* non-autonomous patients
* patients without a smartphone and home internet connection
* patients unable to refer to emergency room in less than 2 hours or unable to observe home isolation
* the presence of severe comorbidities that could compromise the safety of telemonitoring

Primary outcomes:
measure: Number of patients without missing days of telemonitoring/total patients
timeFrame: 14 days
Secondary outcomes:
measure: Oxygen saturation measurements
timeFrame: 14 days
measure: Number of subject hospitalized/total patients
timeFrame: 3 yars
measure: Descriptive statistics
timeFrame: 14 days
measure: Correlation between the number of comorbidities and smoking status and SpO2 nadir
timeFrame: 14 days
measure: Cost efficacy
timeFrame: 14 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
state: Roma
Study officials:
References:
Clinical trial NCT01185483: Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife
Official title: Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopy, Digestive System
Esophageal Neoplasms
Stomach Neoplasms
Keywords: Endoscopic submucosal dissection
Submucosal tumor
Minimal invasive
Gastroscopy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Endoscopic Section at the Department of Surgery, Odense University Hospital, with a mucosal or submucosal tumor in the esophagus or stomach.

Brief summary: Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.

New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.

The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.


Eligibility criteria: Inclusion Criteria:

* Submucosal tumor (\< 4 cm)
* Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion Criteria:

* Endoscopic ultrasound (EUS) or CT signs of metastasis
* Insufficient access to tumor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT01045083: A Study of the Ability of Functional Magnetic Resonance Imaging (fMRI) to Detect and Characterize the Effects of Two Marketed Centrally Active Drugs, Placebo, and RO4917523 in Healthy Volunteers
Official title: Randomized, Observer-blind, Placebo-controlled, Four-way Cross-over Study to Study the Ability of Functional Magnetic Resonance Imaging (fMRI) of the Brain to Detect and Characterize the Effects of Single Doses of a Selective Serotonin Reuptake Inhibitor (Escitalopram [Lexapro&#61650;]), a Dopamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to characterize the response to three centrally active drugs and placebo.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 to 45 years of age
* In good general health
* Weight of \&#x2265;120 lbs (55 kg) and a body mass index (BMI) between 18 to 30kg/m²
* Males and females with reproductive potential: willing to use a reliable method of contraception

Exclusion Criteria:

* Evidence of clinically significant disease
* Medical or surgical condition that could alter the absorption, metabolism, or elimination of drugs
* Family history of sudden death or ventricular arrhythmia
* History of any psychiatric disorder and/or marked anxiety
* History of glaucoma
* History (including family) of motor tic or diagnosis of Tourette's syndrome
* Active suicide ideation
* Contraindication to MRI

Primary outcomes:
measure: To evaluate the ability of fMRI to detect and characterize the effect of the three drugs on brain activity at rest and during emotional stimuli
timeFrame: 8 weeks
Secondary outcomes:
measure: To evaluate the ability of other behavioural paradigms/scales to detect drug effects
timeFrame: 8 weeks
measure: To correlate the fMRI measures with the clinical/behavioral measures
timeFrame: 8 weeks
measure: To investigate the safety of single doses of RO4917523 in healthy volunteers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02285283: Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
Official title: Randomized Double-Blinded Controlled Trial of Oral Antifungal for the Treatment of Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Chronic Rhinosinusitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled double-blinded trial is to determine if the addition of an oral antifungal to typical post-operative medical therapy can prevent or reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Detailed description: CRSwNP patients scheduled for medically-indicated sinus surgery will undergo screening ELIspot assay to identify patients with fungal sensitivity based on positive fungal induced interleukin 4 (IL-4) ELIspot. Enrolled fungal sensitive CRSwNP patients will undergo their sinus surgery and randomized into either placebo or itraconazole 200 mg taken by mouth twice a day (PO BID) for 24 weeks in addition to standardized post-surgical regimen (9 days of perioperative prednisone, saline irrigations and pain medication as needed). Patients will be followed as outpatient in rhinology clinic for 48 weeks total. During these post-op visits, compliance with medications will be determined. Patients will be questioned about any possible side effects or adverse events to post-operative medications. Then, the patients will be evaluated by 2 nasal specific quality of life questionnaires and nasal endoscopy. The goals of the nasal endoscopy are to evaluate the state of the sinus mucosa and to determine recurrence of nasal polyps.

Eligibility criteria: Inclusion Criteria:

* Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery

Exclusion Criteria:

* cystic fibrosis
* aspirin exacerbated respiratory disease
* uncontrolled or unstable chronic diseases such as uncontrolled diabetes
* active or history of cancer
* HIV positive
* history of liver or kidney disease
* history of disease with effects on immune system
* pregnant
* allergy to triazole antifungals

Primary outcomes:
measure: Number of Participants With Recurrence of Nasal Polyps Requiring Intervention
timeFrame: 48 weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical School at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Amber Luong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610883: LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Official title: LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 17
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. To aggressively treat this cancer this study uses effective drugs in three parts:

* Induction ends on day 19
* Consolidation ends on day 38 or 42
* Maintenance may include up to 6 cycles


Eligibility criteria: Inclusion Criteria:

* Non-Hodgkin's Lymphoma stages III, IV, IVA with

  1. T cell lymphomas, any primary site irrespective of LDH level
  2. large cell lymphomas, any primary site irrespective of LDH level
  3. B cell lymphomas, any primary site with initial LDH of less than 500

Exclusion Criteria:

* B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS or bone involvement

Primary outcomes:
measure: Complete Remission
timeFrame: 330 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tanya Trippett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01813383: Clinical Relevance of Typing HLA-DR7-DQ2
Official title: Clinical Relevance of Typing HLA-DR7-DQ2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease Patients Following Recommendations of ESPGHAN
HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes
Keywords: Celiac disease
HLA-DQ2.2
HLA-DQ2.5
HLA-DR7-DQ2
HLA-DR3-DQ2
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 92
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Celiac disease patients who have been diagnosed in a Hospital by a Pediatrician.

Brief summary: Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical and clinical behaviour as patients with HLA-DR3-DQ2 haplotype.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of celiac disease following ESPGHAN recommendations
* HLA-DQ2 typing including HLA-DR3-DQ2 and HLA-DR7-DQ2 haplotypes

Exclusion Criteria:

* Patients who have not been diagnosed for celiac disease
* HLA-DQ2 typing that not include HLA-DR7-DQ2 haplotype

Primary outcomes:
measure: Anti-tissue transglutaminase
timeFrame: Up to 1 month after diagnosis
Secondary outcomes:
measure: Anti-Endomysium autoantibodies
timeFrame: Up to 1 month after diagnosis
Other outcomes:
measure: Oberhuber histological damage classification
timeFrame: Up to 1 month after diagnosis
measure: Clinical characteristics of celiac disease
timeFrame: Up to 1 month after diagnosis
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària i Universitària Parc Taulí
state: Barcelona
Study officials:
affiliation: Immunology Section, Laboratori. UDIAT-CD. Corporació Sanitària i Universitària Parc Taulí
name: Juan Francisco Delgado de la Poza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03729583: The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases
Official title: The Effects of Breathing Retraining on Dyspnoea Measures and the Six-Minute Walking Distance in Patients With Interstitial Lung Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: University of Malta
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (COPD) patients. Evidence regarding the effects of such an intervention in ILD patients is though lacking. In view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ILD patients.

Detailed description: One of the commonest symptoms experienced in patients with a diagnosis of interstitial lung disease (ILD) is shortness of breath, a symptom which greatly affects their abilities to carry out activities of daily living. Breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (COPD) patients. Evidence regarding the effects of such an intervention in ILD patients is though lacking. In view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ILD patients. Twenty Seven ILD patients were randomly distributed to either the control group (n=15) which received a 12-week Pulmonary Rehabilitation (PR) programme without breathing retraining or the active group (n=12) which received a 12-week PR programme with breathing retraining. All patients had both the 6-minute walk test and their level of breathlessness assessed using the Dyspnoea Borg scale assessed at baseline and at 4 weekly intervals for a 12-week period throughout the programme.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of ILD and who were referred for PR

Exclusion Criteria:

* Patients who had musculoskeletal or neurological conditions affecting the outcome measures
* Patients who required oxygen therapy and did not accept administration
* Patients with unstable cardiovascular conditions
* Patients who were not willing to participate

Primary outcomes:
measure: 6 minute walk test
timeFrame: Change in walking distance from baseline to 12weeks
Secondary outcomes:
measure: Dyspnoea score
timeFrame: Change in dyspnoea measures from baseline to 12weeks
Other outcomes:
Locations:
city: Mosta
country: Malta
facility: Melanie Axiak
Study officials:
affiliation: University of Malta
name: Melanie Axiak, BSc
role: PRINCIPAL_INVESTIGATOR
References: