louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06556498: Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair
Official title: Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial: The ProPro Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Hernia, Inguinal
Laparoscopic Surgery
Keywords: hernia surgery
inguinal hernia
fixation free repair
TAPP
laparoscopic surgery
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: we use progrip mesh and proflor mesh in different arms of patients
Primary purpose: TREATMENT

Brief summary: there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. The Progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. In contrast, the ProFlor concept introduces a 3D dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. This report presents the outcomes of laparoscopic techniques employing Progrip and ProFlor in randomized clinical trial. The results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.


Eligibility criteria: Inclusion Criteria:

* bilateral inguinal hernia

Exclusion Criteria:

* Recurrent inguinal hernia
* Incarcerated inguinal hernia
* Hernia not in the inguinal area
* Signs of obvious local or systemic infection
* ASA score \> 4
* Presenting with unstable angina or NYHA class of IV
* Pregnant
* Active drug user
* Immunosuppression, chemotherapy
* Chronic renal insufficiency
* Abdominal ascites
* Infection in area of the surgical field
* BMI \>34

Primary outcomes:
measure: postoperative adverse events
timeFrame: 30-postoperative days
Secondary outcomes:
measure: Visual analogue score (VAS)
timeFrame: 1 - 6- 12 and 24 months
measure: Carolinas Comfort Scale (CCS)
timeFrame: 1 - 6- 12 and 24 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Italy
Study officials:
affiliation: University of Palermo
name: Giuseppe Di Buono
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Palermo
name: Antoninoq Agrusa
role: STUDY_DIRECTOR
References:
Clinical trial NCT04297098: Pain Sensitivity Evaluation in Respiratory Patients
Official title: Pain Sensitivity Evaluation in Respiratory Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Pain, Chronic
Allergy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were between 18 and 65 years of age, accepted to sign the informed consent and presented a diagnosis of persistent asthma, in a well-controlled phase, were recruited from the Pneumology Service of the "Complejo Hospitalario Universitario" (Granada).

Brief summary: Previous studies have reported that asthmatic or chronic pulmonary obstructive disease patients have an increased response to pain stimulus. However, this aspect has not been evaluated in allergic patients. Additionally, the difference in pain sensitivity between asymptomatic period crisis have not been evaluated yet.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 65 years of age.
* Accepted to sign the informed consent.
* Diagnosis of asthma or allergy.

Exclusion Criteria:

* Cognitive impairment.
* Orthopedic pathologies limiting test performance.
* Active smokers.
* Neurologic pathologies limiting voluntary mobility.

Primary outcomes:
measure: Pressure pain threslhold
timeFrame: Baseline
measure: Pressure pain threslhold
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Leicester Cough Questionnaire
timeFrame: Baseline
measure: Leicester Cough Questionnaire
timeFrame: Up to 24 weeks
measure: Borg scale
timeFrame: Baseline
measure: Borg scale
timeFrame: Up to 24 weeks
measure: Catastrophizing about Asthma Scale
timeFrame: Baseline
measure: Catastrophizing about Asthma Scale
timeFrame: Up to 24 weeks
measure: Latency and summation
timeFrame: Baseline
measure: Latency and summation
timeFrame: Up to 24 weeks
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: Up to 24 weeks
measure: Health status
timeFrame: Baseline
measure: Health status
timeFrame: Up to 24 weeks
measure: Exercise capacity
timeFrame: Baseline
measure: Exercise capacity
timeFrame: Up to 24 weeks
measure: Kinesiophobia
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01158898: Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
Official title: A Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Mild to moderate asthma
Allergen inhalation challenge
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2010-07-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.

Detailed description: Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.

Eligibility criteria: Inclusion Criteria:

* Mild asthma, male and female aged 18-55 y.old
* Steroid-naive, non-smoker
* Dual responders

Exclusion Criteria:

* Any chronic disease(unstable)
* Immunosuppressed, recent or ongoing steroid intake
* Methacholine PC 20 \> 16 mg/mL

Primary outcomes:
measure: Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
timeFrame: Day 14 (Between 3-7 hr post-AIC)
Secondary outcomes:
measure: Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment
timeFrame: Day 14
measure: Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge
timeFrame: Day 13 and Day 15 (Pre & post AIC)
measure: Effect of ASM8 on mast cells (as measured by specific biomarkers)
timeFrame: Day 14 (pre, post and and peri-AIC)
measure: Sputum inflammation indicators (Eos, neutrophils, etc.)
timeFrame: Day 14 and Day 15
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Health Research Innovation Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Quebec
country: Canada
facility: Laval Centre de Pneumologie Chest Division
Study officials:
affiliation: McMaster University
name: Paul O'Byrne, MD
role: STUDY_CHAIR
affiliation: Pharmaxis Ltd
name: Rene Pageau, M.Sc Pharm
role: STUDY_DIRECTOR
affiliation: Hopital Laval, Quebec
name: Louis-Philippe Boulet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Richard Leigh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Gail M Gauveau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vancouver Coastal Health Research Institute
name: Mark Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06026098: Evaluation of Impact of AI Assistance on Workload Associated w Preparation of Rare Tumor Case Repts
Official title: A Prospective Evaluation of Impact of AI Assistance on Workload Associated With Preparation of Rare Tumor Case Reports
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Burden
Cognitive Symptom
Keywords: artificial intelligence
case report
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this study is to explore cognitive burden perceptions among physicians in relation to case report writing. Furthermore, this study evaluates the use of artificial intelligence (AI) assistance as a tool to reduce cognitive burden among providers preparing and submitting case reports. If an AI-tool is helpful in this setting, it may potentially help increase reporting of rare medical events and thereby improve the evidence base for care of these patient populations. This study will occur at a single time point which is expected to last approximately 2 hours. This session will include reviewing two rare tumor cases and then writing a clinical vignette with and without AI assistance.


Eligibility criteria: Inclusion Criteria:

1. The subject is a physician, medical student, or postdoctoral student.

Exclusion Criteria:

Primary outcomes:
measure: Subjective Cognitive workload (CWL)
timeFrame: Baseline to 2 hours
measure: Perceived cognitive load
timeFrame: Baseline to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Shivani Sud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724698: Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Official title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Tablet Among Filipino Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Urticaria
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 3011
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Filipino patients diagnosed to have Allergic Rhinitis or Chronic Idiopathic Urticaria

Brief summary: Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.


Eligibility criteria: Inclusion Criteria:

* Outpatient men or women, age 12 years and above.
* Diagnosis of Allergic Rhinitis or Chronic Idiopathic Urticaria

Exclusion Criteria:

* Known hypersensitivity to Desloratadine.
* Pregnancy or lactation

Primary outcomes:
measure: Adverse Events
timeFrame: Final Visit (Day 15)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02101398: Study of the Effect of Transcranial Stimulations in Aphasic Subject Within a Year of Their Stroke
Official title: Etude de l'Effet de Stimulations transcrâniennes en Courant Continu (tDCS) Sur Les Performances en dénomination Chez le Sujet Aphasique à Moins d'un an de Son Accident Vasculaire cérébral : Comparaison de 5 Configurations de Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Keywords: tDCS
Stroke
Aphasia
Naming
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-04-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this work is to study the effect of transcranial direct current stimulation combined with naming therapy in acute and post-acute stroke comparing four bihemispheric positioning electrodes to a sham condition.

Detailed description: TDCS have shown a positive effect on clinical outcome in naming treatment in aphasic subjects however some aspects as the positioning of the electrodes on the head are still unclear. That is why we compare the effects of four different positionings of the electrodes (two anterior over Broca's area and its homologue and two posterior over Wernicke's area and its homologue) to a sham stimulation in order to observe if a more important effect of one or another positioning could be found.

Eligibility criteria: Inclusion Criteria:

* man or woman of 18 years and older
* aphasic patient following a first left hemispheric stroke
* BDAE 3.0 aphasia score \> or = to 1
* stroke within 3 to 12 months before inclusion in the study
* mother tongue = French
* right handedness
* signed informed consent

Exclusion Criteria:

* history of other neurologic pathologies
* epileptic seizure within 2 months before inclusion
* dementia
* bilingual patient (2 mother tongues)
* history of cranial surgery
* presence of intracerebral metallic material
* unauthorized molecules at inclusion : sulpiride, rivastigmine, dextromethorphan, carbamazepine, flunarizine, levodopa
* pregnant, parturient or lactating woman

Primary outcomes:
measure: Percentage of improvement of picture naming
timeFrame: Before stimulation and immediately after stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
affiliation: Hôpital Raymond Poincaré
name: Nicolas ROCHE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406198: Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis
Official title: Phase 4 Randomized Multicentric Controlled Study on Impact of Continuous Venovenous Hemofiltration on Organ Failure at the Early Phase of Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacteremia
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Pneumonia, Bacterial
Shock, Septic
Sepsis
Keywords: Sepsis syndrom
severe sepsis
septic shock
hemofiltration
multiple organ failure
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2006-12-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The impact of continuous veno-venous haemofiltration (CVVH) on sepsis-induced multiple organ failure severity is controversial. We thus sought to assess the effect of early application of haemofiltration on the degree of organ dysfunction and plasma cytokine levels in patients with severe sepsis or septic shock.

Detailed description: prospective, randomized, open, multicentre study was performed between 1997 and 1999 in 16 French intensive care units. Patients were enrolled within 24 hours of development of the first organ failure related to a new septic insult. They were randomized to group 1 (HF), who received haemofiltration for a 96 hr period, or group 2 (C) who were managed conventionally. The primary end-point was the number, severity and duration of organ failures at 14 days, as evaluated by the SOFA score, on an intention-to-treat analysis. Strict guidelines were provided to perform continuous haemofiltration under the same conditions and objectives in all centres.

Eligibility criteria: Inclusion Criteria:

* clinically identified focus of infection associated with at least 2 SIRS criteria and one or more sepsis-induced organ failures within the 24 hours prior to inclusion, plus a SAPS II score between 35-63

Exclusion Criteria:

* Patients were excluded if pregnant, younger than 18 years, in a moribund state, in chronic renal failure, or receiving immunosuppressive therapy.

Primary outcomes:
measure: The primary end-point was the number, severity and duration of organ failures at 14 days, as evaluated by the SOFA score, on an intention-to-treat analysis
Secondary outcomes:
measure: Secondary end point : safety, ventilation and hemodynamic support weaning
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisiere University Hospital
Study officials:
affiliation: Hpopital Lariboisiere
name: Didier Payen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02827097: The Effect of Rectus Sheath Block on the Postoperative Analgesia in the Patients Undergoing Robotic Single Port Cholecystectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gallbladder Diseases
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy.

The secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery.


Eligibility criteria: Inclusion Criteria:

* robotic single Port cholecystectomy for gallbladder disease

Exclusion Criteria:

* Allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30

Primary outcomes:
measure: Abdominal pain score after surgery
timeFrame: Change from baseline abdominal pain score up to 24 hours
Secondary outcomes:
measure: Fentanyl consumption in recovery room
timeFrame: Up to 1 hours
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoum
Study officials:
References:
Clinical trial NCT02816697: Implementation of a System-level Tobacco Treatment Intervention
Official title: Implementation of a System-level Tobacco Treatment Intervention in Thoracic Oncology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lung Cancer
Keywords: Smoking Habits
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2016-06-28
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods.

Detailed description: In particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. Findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients.

* Adaption of CEASE will entail exit interviews with patients and individual interviews with clinical staff to identify and address facilitators and barriers to the implementation process.
* Effectiveness of CEASE will be measured through questionnaires \& biochemical verification of smoking status using a pre-test/post-test study design before (usual care)and after implementation (CEASE)

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Have an actual or potential diagnosis of thoracic malignancy
* Able to read and write in English.
* Current or recent former smoker (defined as having smoked within past 6 months)
* Must have an active telephone number.

Exclusion Criteria:

* Former smoker greater than 6 months.
* Have any of the below conditions needing immediate medical intervention

  * Hypercalcemia causing lethargy and confusion,
  * Acute respiratory distress
  * Dehydration
  * Hypotension

Primary outcomes:
measure: Smoking cessation Rate
timeFrame: 6 Months
Secondary outcomes:
measure: Documentation of tobacco treatment
timeFrame: 2 months after CEASE
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary E Cooley, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06915597: Drug-Coated Coronary Balloons in Different Clinical Scenarios
Official title: Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Keywords: drug coted balloons
coronary artery disease
chronic total occlusions
de novo lesions
small vessel disease
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2025-04-08
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease treated with drug coated balloons

Brief summary: Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.


Eligibility criteria: Inclusion Criteria:

* Patients treated with drug coated balloons

Exclusion Criteria:

* Patients treated with other than DCBs

Primary outcomes:
measure: Death, target lesion revascularization, target vessel revascularization, myocardial infarction
timeFrame: 12 months
Secondary outcomes:
measure: Angina, target vessel revascularization
timeFrame: 12 months
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: