louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02974101: AdaptiveStim Objectifying Subjective Pain Questionnaires
Official title: AdaptiveStim Objectifying Subjective Pain Questionnaires
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Keywords: Spinal cord stimulation
AdaptiveStim
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-11-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, correlation study in which the investigators aim to explore the relationship between subjective pain questionnaires and the AdaptiveStim accelerometer output.

Detailed description: The aim of this research is to gather the necessary information relating to the patient his subjective self-report and the more objective information from the implanted IPG (RestoreSensor). Such subjective information can be gathered from the AdaptivStim output.

The main focus of this study is to explore the relationship between the subjective reporting of functional disability with the ODI, sleep quality with the Actiwatch and PSQI, pain intensity with the NRS-diary and the objective measurement of functional positions with the AdaptiveStim in patients receiving high density spinal cord stimulation.

Eligibility criteria: Inclusion Criteria:

* FBSS patients treated with SCS (IPG = RestoreSensor) who achieved a steady state (steady state is considered when the parameters didn't changed for at least one month)
* Age \> 18 years

Exclusion Criteria:

* Patients with Parkinson's disease
* Patients immobilised due to limb/pelvis/costal fractures
* Stroke patients with MRS\>3

Primary outcomes:
measure: AdaptiveStim output
timeFrame: The change between baseline (T1) and the second assessment 7 days later (T1+7days)
measure: Disability
timeFrame: Disability will be measured at the second assessment namely 7 days after the first assessment
Secondary outcomes:
measure: Numeric Rating Scale (NRS) pain diary
timeFrame: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
measure: Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
timeFrame: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
measure: Subjective sleep quality
timeFrame: Disability will be measured at the second assessment namely 7 days after the first assessment
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Oost-Vlaanderen
city: Brussels
country: Belgium
facility: UZ Brussel
state: Vlaams Brabant
Study officials:
References:
Clinical trial NCT07026201: Primary Anastomosis After Left Colectomy in Emergency Cases
Official title: Primary Anastomosis After Left Colectomy in Emergency Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Obstruction
Keywords: left colon mass
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 37
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to know the outcome of primary anastomosis after left colectomy in emergency cases regarding early post operative complication like surgical site infection , ileus, incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission within one month from the time of intervention.

Detailed description: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents\*

Eligibility criteria: Inclusion Criteria:

* Patients presenting to the emergency department with obstructed left colon
* Patients aged between 18 and 80 years old
* Decision of laparotomy is made
* Intraoperative conditions are favorable for anastomosis (e.g., good vascularity, no severe sepsis, no marked tissue edema, no thickened peritoneum)
* Patient agrees to participate in the study

Exclusion Criteria:

* Severe diffuse peritonitis (e.g., peritoneal thickening, thickened bowel loop, severe tissue edema, and pyogenic membrane)
* Marked decreased tissue vascularity due to distension
* Irresectable mass
* Rectal mass
* Patients refusing to participate in the study

Primary outcomes:
measure: Incidence of Anastomotic Leakage Within 30 Days Post-Operatively
timeFrame: 30 days after surgery
measure: Incidence of Surgical Site Infection
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Incidence of Postoperative Ileus
timeFrame: From date of surgery until first bowel movement, assessed up to 7 days post-surgery
measure: Time to Restoration of Bowel Movement
timeFrame: Assessed up to 7 days post-surgery
measure: Length of Hospital Stay
timeFrame: Assessed up to 14 days post-surgery
measure: Readmission Rate Within 30 Days
timeFrame: Time Frame: 30 days post-surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Ibrahim Magid, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594601: PEEP Titration and Lung Recruitment Potential Assessed by 3D EIT
Official title: PEEP Titration and Lung Recruitment Potential Assessment by 3D EIT in ARDS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ARDS
Respiratory Failure
Keywords: ARDS
EIT
3D-EIT
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ARDS on mechanical ventilation.

Brief summary: In a population of ARDS patients, we explore the influence of different PEEP levels on regional ventilation distribution, ventilation homogeneity, and the center of ventilation, optimal PEEP and lung recruitment potential as well as the extent of lung collapse and overdistension as detected by 3D-EIT.


Eligibility criteria: Inclusion Criteria:

* patients on mechanical ventilation.
* Diagnosis of ARDS was based on the Berlin definition
* lung recruitment potential assessment and PEEP titration was proper for the ARDS patients determined by the attending doctor

Exclusion Criteria:

* Under 18 years of age.
* Pregnant women;
* Ribcage malformation
* Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).
* Hemodynamic instability, unable to tolerate high PEEP;
* High-risk individuals with pneumothorax, mediastinal emphysema, etc.

Primary outcomes:
measure: OD/CL and optimal PEEP monitored by EIT
timeFrame: 5-10min
Secondary outcomes:
measure: ventilation distribution monitored by EIT
timeFrame: 5-10min
measure: GI monitored by EIT
timeFrame: 5-10min
measure: CoV monitored by EIT
timeFrame: 5-10min
measure: V/Q monitored by EIT
timeFrame: 5-10min
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
state: Beijing
Study officials:
affiliation: Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College Hospital
name: Huaiwu He, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College Hospital
name: Yun Long, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03837301: Non-exposure Simple Suturing EFTR (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)
Official title: Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Early Gastric Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2019-02-12
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing endoscopic full-thickness resection, NESS-EFTR) was recently developed.

This is the phase2 study to identify the efficacy of NESS-EFTR with sentinel node navigation in early gastric cancer patients.


Eligibility criteria: Inclusion Criteria:

* single lesion of adenocarcinoma in preoperative endoscopic biopsy
* clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
* tumor size: less than 3cm
* location: 3cm far from the pylorus or cardia
* aged 20 to 80
* ECOG 0 or 1
* patient who signed the agreement
* patient who is suspected to underwent laparoscopy assisted gastrectomy

Exclusion Criteria:

* absolute indication of endoscopic submucosal resection
* inoperable due to poor cardiac, pulmonary function
* pregnant
* having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
* diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Primary outcomes:
measure: complete resection rate (%) of tumor
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
Study officials:
affiliation: National Cancer Center
name: Chan G Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00947401: Fluid Management After Surgery in the Post-Anesthetic Care Unit (PACU)
Official title: The Practice of Fluid Management in the Post-anesthetic Care Unit (PACU) of Shaare Zedek Medical Center in Patients Undergoing Elective Surgery: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Keywords: Surgery, elective
Fluids
Post Anesthesia Care Unit
PACU
Fluid management
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 1000
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: Adult patients (age \> 18 yrs) after elective surgery

Brief summary: The objective of the present study is to describe the current practice of postoperative fluid management in the Post Anesthesia Care Unit (PACU) of the Shaare Zedek Medical Center, Jerusalem, Israel.

Detailed description: The aim of this study is to follow and present the current practice of fluid administration in the PACUof Shaare Zedek Medical Center for an extended period of time as a first step towards establishing guidelines for postoperative fluid management.

Eligibility criteria: Inclusion Criteria:

* age \> 18 yrs
* elective surgery
* ASA I-III

Exclusion Criteria:

* massive intraoperative blood loss
* non elective surgery
* pregnant women
* stay in the PACU \< 15 minutes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Yaacov Gozal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center
name: Sarah Shapira, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05830201: The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal
Official title: The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elbow Injury
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group or therapy group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow.

Detailed description: This procedure is done in an outpatient clinic 3-4 weeks after the pins are placed and can be uncomfortable and cause anxiety in some patients. Therapy dogs are trained to sit calmly with a patient on or near the exam table as a distraction from procedures.

Eligibility criteria: Inclusion Criteria:

* presenting to clinic for elbow pin removal post elbow fracture surgery

Exclusion Criteria:

* dog allergy
* fear of dogs

Primary outcomes:
measure: Pain Response
timeFrame: 1 year
Secondary outcomes:
measure: Anxiety Response
timeFrame: 1 year
measure: Anxiety Response
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael Conklin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060501: Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer
Official title: Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: rectal cancer
adjuvant chemoradiotherapy
5-FU, interferon-alpha
Locally advanced resectable rectal cancer (UICC stage II and III)
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Medac GmbH (Hamburg, Germany)
name: Roche (Grenzach-Wyhlen, Germany)
First posted: 2010-02-02
Enrollment: 796
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 primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or INF-alpha may increase overall survival.

Detailed description: Primary endpoint was overall survival (OS). For sample size estimation the following assumptions were made: The 5-year OS rate of 5-FU was estimated to be 58%. Our intention was to detect an increase in the 5-year OS rate by one of the additives of at least 10% with a power of 80% and a level of significance of 5% in comparison to 5-FU (one-sided). Hypotheses were analyzed as pair wise comparisons between the treatment options. This resulted in a target sample size of 280 patients per group and a total of 840 patients.

Eligibility criteria: Inclusion Criteria:

* Eligibility was defined as potentially curative en-bloc resection (R0) of an adenocarcinoma of the rectum with a lower tumor edge within 12 cm from the anal verge determined by rectoscopy, a pathologic UICC stage II (pT3/4pN0M0) or III (pT1-4pNposM0) with examination of at least 12 lymph nodes, a white blood count ≥ 3,500/µl, a platelet count ≥ 100,000/µl, a ECOG performance status of 0 or 1, and written informed consent.

Exclusion Criteria:

* Ineligible were patients not fulfilling these criteria or having a history of cancer except for adequately treated superficial basal or squamous cell skin cancer or in situ carcinoma of the cervix, getting previous radio- or chemotherapy, pregnant or nursing women, other having severe concomitant diseases limiting life expectancy or not allowing chemotherapy, and with social conditions not allowing a 5-year follow-up.

Primary outcomes:
measure: overall survival
timeFrame: 5-year
Secondary outcomes:
measure: recurrence-free survival
timeFrame: 5-year
measure: Toxicity (WHO)
timeFrame: 5-year
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of General, Visceral, and Transplantation Surgery, University of Ulm
Study officials:
References:
Clinical trial NCT03633201: Anatomic Congruent Prosthetic Knee Design
Official title: Anatomic Congruent Prosthetic Knee Design - a Kinematic and Kinetic Comparison With a Standard Prosthetic Knee Design and the Native Knee
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regional Hospital Holstebro
First posted: 2018-08-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double-blinded randomized control study will use kinematic and kinetic measures to compare an anatomical congruent prosthetic knee design to a standard prosthetic knee design. The patients will be measured pre- and post-operative and compared to a healthy non-osteoarthritis control group.


Eligibility criteria: Inclusion Criteria:

* Informed and written consent.
* Primary knee osteoarthritis in capable men and women.
* Indication for cruciate-retaining total knee arthroplasty.

Exclusion Criteria:

* Patients who do not speak and read Danish.
* Patients who are pregnant or at risk of becoming pregnant during the project.
* Patients with active cancer and/or radiation or chemotherapy.
* Patients who are alcoholics or have some form of abuse that impede information and follow-up.
* Patients with severe psychiatric disease that might complicate compliance with follow-up.
* Patients with surgically implants in the affected leg and/or pace maker.
* Patients with greater thigh circumference then 60 cm.
* Patients cannot perform the described exercises.
* Patients with knee instability due to multiligament injury.
* Patients with conditions that severely compromise their gait other than knee osteoarthritis in the affected knee.
* Patients with severe fracture sequelae or severe malalignment at knee level.
* Patients with osteosynthesised fractures using bone graft at knee level.
* Patients with need of an augmentation and/or stem-elongation.
* Patients with metabolic bone disease.
* Patients with rheumatoid arthritis.

Primary outcomes:
measure: Kinematics - knee joint movement
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Articular joint contact
timeFrame: 1 year follow-up
measure: Kinetic - knee joint contact force
timeFrame: 1 year follow-up
measure: Implant inducible micromotion
timeFrame: 1 year follow-up
measure: Static implant migration
timeFrame: 3, 12 and 24 month post operation using first operative day as baseline.
measure: Patient Reported Output Measure
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro
Study officials:
affiliation: University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University
name: Maiken T Stilling, maiken.stilling@clin.au.dk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05759767: The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
Official title: The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tamsulosin
Extracorporeal Shock Wave Lithotripsy
Stone, Kidney
Stone, Urinary
Pediatric Disorder
Keywords: Extracorporeal Shock Wave Lithotripsy
tamsulosin
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.


Eligibility criteria: Inclusion Criteria:

* Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
* Normal kidney function.

Exclusion Criteria:

* Bleeding diatheses
* Uncontrolled UTIs
* Severe skeletal malformations

Primary outcomes:
measure: assess the Stone-free rate (SFR) between groups
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
Study officials:
References: