louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01116492: Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
Official title: Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Inflammatory Response
Keywords: SILS
Inflammatory reaction
a-defensins
SILS vs standard laparoscopic cholecystectomy
Lead sponsor: G. Hatzikosta General Hospital
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.

Detailed description: Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.

Eligibility criteria: Inclusion Criteria:

* Uncomplicated cholelithiasis
* American Society of Anesthesiologists (ASA) I or II
* No previous operations in upper abdomen
* Body mass index (BMI) \<30

Exclusion Criteria:

* Cholecystitis
* ASA \> II
* BMI\>30
* Previous operations in upper abdomen
* Previous operations in intestine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: "G. Hatzikosta" General Hospital of Ioannina
Study officials:
References:
Clinical trial NCT06781892: Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest
Official title: Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest (CA)
Keywords: Out-of-hospital cardiac arrest
Defibrillation
Double-sequential defibrillation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2025-01-17
Enrollment: 909
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 "Strategies for Defibrillation during Out-of-Hospital Cardiac Arrest" (STRAT-DEFI) trial is an investigator-initiated, individually randomized, 3-group clinical trial comparing standard anterior-lateral pad positioning with anterior-posterior positioning and double sequential defibrillation during adult out-of-hospital cardiac arrest.


Eligibility criteria: Inclusion Criteria:

1. Out-of-hospital cardiac arrest
2. Age ≥ 18 years
3. ≥ 1 manual defibrillation attempt by emergency medical services
4. Shockable rhythm as the last known rhythm
5. Two manual defibrillators present on-site

Exclusion Criteria:

1. Blunt trauma, penetrating trauma, or burn injury suspected to be the cause of the cardiac arrest
2. Prior enrollment in the trial
3. Posterior pad placement not deemed possible by on-site clinician

Primary outcomes:
measure: Survival at 30 days
timeFrame: 30 days after the cardiac arrest
Secondary outcomes:
measure: Survival at 90 days
timeFrame: 90 days after the cardiac arrest
measure: Favorable neurological outcome at 30 days
timeFrame: 30 days after the cardiac arrest
measure: Favorable neurological outcome at 90 days
timeFrame: 90 days after the cardiac arrest
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Emergency Medical Services, the North Denmark Region
city: Aarhus N
country: Denmark
facility: Danish Air Ambulance, Danish Regions
city: Aarhus N
country: Denmark
facility: Prehospital Emergency Medical Services, Central Denmark Region
city: Ballerup
country: Denmark
facility: Copenhagen Emergency Medical Services, the Capital Region of Denmark
city: Næstved
country: Denmark
facility: The Prehospital Center, Region Zealand
city: Vejle
country: Denmark
facility: Emergency Medical Services, the Region of Southern Denmark
Study officials:
References:
Clinical trial NCT04548492: The Validity of Modern Mobile Applications in Management of COVID-19 Home Isolation Patients: a Survey for Health Care Professionals
Official title: The Validity of Modern Mobile Applications in Management of COVID-19 Home Isolation Patients: a Randomized Survey for Health Care Professionals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the Use of Modern Technology Applications in Home Isolation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 175
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthcare professionals

Brief summary: In late 2019, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of a cluster of pneumonia cases (COVID-19) in Wuhan, China. Clinical symptoms of COVID-19 may be mild or severe. The location where a person will self-isolate will be determined by their healthcare provider and their health authority. When determining the location, several factors to determine the suitability of the home setting are described as the case should stay in a room of their own so that they can be isolated from other household members. The rapid increase and evolution of modern mobile applications for communication and messaging for personal purposes have proved great benefit in healthcare management


Eligibility criteria: Inclusion Criteria:

* healthcare professionals in Ain Shams University, Cairo, Egypt.

Exclusion Criteria:

* junior Staff

Primary outcomes:
measure: rate of reassurance delivered from doctors to patients through Whatsapp
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06088992: Leber Congenital Amaurosis Inherited Blindness of Gene Therapy Trial(LIGHT)
Official title: An Investigator-Initiated Open-Label, Multiple-Dose Clinical Study to Evaluate the Safety,Tolerability, and Efficacy of Gene Therapy for 2Leber&#39;s Congenital Amaurosis with RPE65 Mutation (LCA2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Leber Congenital Amaurosis
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: HuidaGene Therapeutics Co., Ltd.
First posted: 2023-10-18
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether HG004 as gene therapy is safe and effective for the treatment of Leber Congenital Amaurosis caused by mutationsin RPE65 gene.


Eligibility criteria: Inclusion Criteria:

* Male or females between 8 and 50 years of age at the time of signing theinformed consent form.
* Willing to adhere to protocol as evidenced by written informed consent orparental permission and subject assent.
* Clinical confirmed diagnosis of Leber congenital amaurosis (LCA) andmolecular diagnosis of LCA due to RPE65 mutations.
* Ability to perform tests of visual and retinal function.
* Visual acuity of ≤ 20/160 or visual field less than 20 degrees in the eye to beinjected.
* Acceptable hematology, clinical chemistry, and urine laboratory parameters.

Exclusion Criteria:

* OCT examination determined that the outer nuclear layer was not visible inthe planned injection area (Bleb) in the study eye.
* Presence of epiretinal membrane by OCT.
* Complicating systemic diseases or clinically significant abnormal baselinelaboratory values.
* Complicating systemic diseases would include those in which the diseaseitself, or the treatment for the disease, can alter ocular function.
* Prior ocular surgery within six months.
* Prior gene therapy or oligonucleotide therapy treatments.
* Any other condition that would not allow the potential subject to completefollow-up examinations during the study and would, in the opinion of theinvestigator, make the potential subject unsuitable for the study.

Primary outcomes:
measure: Incidence and severity of ocular and systemic adverse events
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital affiliated with Shanghai Jiao Tong UniversitySchool of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital affiliated with Shanghai Jiao Tong UniversitySchool of Medicine
name: Peiquan Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01983592: An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Official title: An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fatigue
Effects of Chemotherapy
Keywords: Homeopathy
Fatigue
Chemotherapy
Cancer
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Canadian CAM Research Fund
name: Ottawa Integrative Cancer Centre
First posted: 2013-11-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients and there are very few conventional therapies which can address the symptom of fatigue in patients who are undergoing cancer treatment.

This study will be testing whether the administration of a complementary therapy (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and whether this treatment can lessen the fatigue symptoms of adults. The study will also test whether the n-of-1 study design is feasible in this population.

Detailed description: This is an n-of-1 pilot trial of individualized homeopathic treatment of fatigue in a single adult who is undergoing any type of chemotherapy administered intermittently (i.e. not continuously). The participant will have a homeopathic consultation within 3 days of a round of chemotherapy ("treatment period") and will be administered either verum or placebo according to a binary randomization allocation sequence unknown to both the clinician and participant. During the subsequent treatment period the participant will be given the other allocation (verum or placebo). The following pairs of allocations will also be randomized with treatment continuing for as long as the participant is undergoing chemotherapy treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with any type of cancer. Patient may have newly diagnosed, relapsed or a second malignant disease.
* Receiving any type of cytotoxic chemotherapy with 6 or more cycles post study enrollment administered intermittently every two or three weeks with no planned radiation treatment.
* Is experiencing fatigue due to the chemotherapy treatments. (or has a score of 2 or higher on the fatigue item of the Symptom Distress Scale)
* Above 18 years of age.
* Able to ingest medications in lactose/sucrose globule or liquid form.

Exclusion Criteria:

* Previous history of allergy to the homeopathic products.
* Pregnant or lactating

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: 7 days
Secondary outcomes:
measure: EORTC-QLQ-C30
timeFrame: 7 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Integrative Cancer Centre
state: Ontario
Study officials:
affiliation: Canadian College of Naturopathic Medicine
name: Dugald Seely, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05635292: Addressing Disability Effectively With Psychosocial Telemedicine
Official title: Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2022-12-02
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with IBD to complete a baseline survey and enroll those with higher scores on a validated IBD-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with a licensed psychologist versus usual care. The investigators aim to lay the foundations that will shift the paradigm of IBD clinical practice towards a new horizon of holistic and equitable high-value care.


Eligibility criteria: Inclusion Criteria:

1. Adults ≥18 years old with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC)
2. Willingness to complete the baseline survey online. Participants in Aim 1 with moderate-to-severe disability based on the IBD Disability Index (IBD-DI) will be invited to the Aim 2 clinical trial
3. Able to consent and complete surveys in English.

Exclusion Criteria:

1. no/low disability (IBD-DI \<35) on the baseline survey
2. inability or unwillingness to participate in telemedicine with a therapist
3. Have an existing relationship with a mental health specialist within the past 3 months
4. Lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention

Primary outcomes:
measure: Change in the IBD Disability Index
timeFrame: 8 weeks
Secondary outcomes:
measure: Cost-benefits of telemedicine-delivered psychosocial care
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Chung Sang Tse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tse CS, Hunt MG, Brown LA, Lewis JD. Inflammatory Bowel Diseases-related Disability: Risk Factors, Outcomes, and Interventions. Inflamm Bowel Dis. 2024 Mar 1;30(3):501-507. doi: 10.1093/ibd/izad182.
Clinical trial NCT06053892: AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction
Official title: Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ultrasound
Interventions
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to prospectively evaluate the potential benefits of injections with Augmented Reality enhanced Ulrasound versus standard Ultrasound or fluoroscopy participants where assigend for fluoroscopic joint injections oder for Ultrasound guided injection.

The main question\[s\] it aims to answer are:

* The primary objective is to evaluate the duration of the different interventions
* the count of needle passes
* assess the reduction of radiation exposure using AR US rather than fluoroscopic guidance for joint injections

Detailed description: Patients assigned for standard Ultrasound or fluoroscopic joint injection are informed about the trial. Participants are randomly assigned to the study or control intervention. 1:1 randomization is used.

In both groups, data on duration of the intervention, count of needle passes, correctness of injection location and radiation exposure will be collected. The outcome measures will be compared between the groups.

Eligibility criteria: Inclusion Criteria:

* - Patients 18 to 99 years of age
* Patients assigned for fluoroscopic guided injections (including MR arthrographies)
* Patients assigned for US guided injections (including MR arthrographies)

Exclusion Criteria:

* - Patients who are not willing to be part of the study
* Contraindication against fluoroscopic guided injection
* Women who are pregnant or breast feeding (Pregnancy assessment is part of the routine prior to fluoroscopic joint injections. No pregnancy test will be done for this study.)

Primary outcomes:
measure: Augmented reality sonography is less time consuming
timeFrame: 10 minutes
Secondary outcomes:
measure: Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing
timeFrame: 10 minutes (ml aspirated) to 3 days (laboratory results)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02175992: Quality of Life After Surgery for Pancreatic Carcinoma
Official title: Quality of Life After Surgery for Pancreatic Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Suspected for a Pancreatic (Pre-)Malignancy
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a suspected pancreatic malignancy

Brief summary: Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured.


Eligibility criteria: Inclusion Criteria:

* patients with a suspected pancreatic malignancy
* eligible for surgery with curative intent
* being able to complete questionnaires in Dutch
* age \>=18 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Health-related quality of life
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Department of Surgery, University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Quintus Molenaar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heerkens HD, van Berkel L, Tseng DSJ, Monninkhof EM, van Santvoort HC, Hagendoorn J, Borel Rinkes IHM, Lips IM, Intven M, Molenaar IQ. Long-term health-related quality of life after pancreatic resection for malignancy in patients with and without severe postoperative complications. HPB (Oxford). 2018 Feb;20(2):188-195. doi: 10.1016/j.hpb.2017.09.003. Epub 2017 Oct 29.
Clinical trial NCT01247389: Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy
Official title: Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Colectomy
Keywords: laparoscopy
colon resection
incisional hernia
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 165
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: Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that laparoscopic colon resection would result in fewer incisional hernias, prospective studies demonstrate a similar incidence to open surgery. Observational studies suggest that the rate of incisional hernia after laparoscopic colon resection may be reduced with the use of a transverse compared to a midline extraction incision. However, no randomized trails are available, and a midline extraction incision for hemicolectomy remains the standard current approach. The investigators hypothesize that the use of a lower abdominal transverse muscle splitting incision for specimen extraction in laparoscopic colon surgery will result in fewer incisional hernias compared to a midline periumbilical extraction incision.


Eligibility criteria: Inclusion Criteria:

* scheduled laparoscopic partial colectomy where an abdominal extraction incision is planned

Exclusion Criteria:

* previous laparotomy
* rectal resection or anastamosis
* planned pfannenstiel extraction incision
* single site surgery
* planned or performed stoma
* BMI \>35 kg/m2
* ASA 4-5

Primary outcomes:
measure: Incisional hernia
timeFrame: one year
Secondary outcomes:
measure: surgical site infection
timeFrame: one month
measure: body image
timeFrame: one year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT06264089: Effects of Preservation Rhinoplasty Nasal Valve Angle and Area
Official title: Effects of Preservation Rhinoplasty Nasal Valve Angle and Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction, Bilateral
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery.

Detailed description: Nasal congestion is one of the most common complaints in Otorhinolaryngology medicine. One of the most common causes of this is the collapse or blockage of the Internal Nasal Valve (INV). The internal nasal valve is the narrowest part of the airway and creates the greatest resistance to airflow. Its most important function is to regulate the inspiratory airflow. It is determined by the angle formed between the caudal part of the upper lateral cartilage and the nasal septal cartilage. This angle normally varies between 9-15 degrees. The tip of the inferior turbinate and the tissues surrounding the piriform aperture may affect this area. When this angle is less than 9 degrees, the valve collapses in inspiration. The internal nasal valve region should be evaluated in every patient complaining of nasal congestion. the investigators planned to radiologically examine the improvement in the internal nasal valve angle of the patients we operated on.

Eligibility criteria: Inclusion Criteria:

* Preservation rhinoseptoplasty

Exclusion Criteria:

* Absence of nasal obstruction
* Previous nasosinusal surgery
* Cranio-facial anomalies
* Presence of nasosinusal tumors

Primary outcomes:
measure: Nasal Obstruction Symptom Evaluation Scale (NOSE)
timeFrame: 12 month
Secondary outcomes:
measure: Reformatted coronal Computed tomography
timeFrame: 12 month
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yaser Said Cetin
Study officials:
References: