louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03189693: Paravertebral Block for Pain Management After Appendectomy
Official title: Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reduce Pain After Appendectomy
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to examine the analgesic effect of PVB on appendectomy in adult patients.

Detailed description: Patients undergoing appendectomy will be randomly allocated into two equal groups using the sealed envelope technique. All patients will receive general anesthesia (GA). Patients in group I will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture, while patients in Group II will receive placebo.

Paravertebral Block Technique Unilateral right side nerve stimulator-guided PVB is performed while patients are in the left lateral decubitis position. The appropriate levels for the PVB are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline. After aseptic preparation of the skin, 1 mL 1% lidocaine is infiltrated at the injection sites. A 21-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to maintain muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA.

4 mL of the local anaesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Scheduled to undergo appendectomy

Exclusion Criteria:

* cardiac disease,
* developmental delay,
* neurologic deficit,
* allergies to any of the drugs routinely used in anesthesia management.

Primary outcomes:
measure: Analgesic consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: hemodynamic stability measured through mean arterial pressure (MAP).
timeFrame: Approximately 1 hour
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
References:
Clinical trial NCT02095093: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
Official title: Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Leg Length Discrepancy
Dislocation
Keywords: Total Hip Arthroplasty
Navigation
Imageless
THA
Computer navigated
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Leg length discrepancies following total hip arthroplasty have been associated with nerve palsies, gait abnormalities, and lower back pain. Leg length discrepancies are related to poorer functional outcomes and patient dissatisfaction. Failure to restore femoral offset following total hip arthroplasty has been linked to decreased range of motion and abductor muscle strength, impingement, limping, higher dislocation rates, increased polyethylene wear, and loosening of implants. Computer navigation has shown to improve the accuracy of leg length and hip offset during total hip arthroplasty. The investigators research objective is to prove the accuracy of the Intellijoint HIP™ system for determining leg length and hip offset. The investigators hypothesis was that Intellijoint HIP™, an imageless intraoperative intelligent instrument, could improve the accuracy of leg length and hip offset during primary total hip arthroplasty. The investigators plan to study this hypothesis in humans by comparing the leg length and hip offset discrepancies produced with Intellijoint HIP™ to the standard at the investigators institution, which is a pin and outrigger system.


Eligibility criteria: Inclusion Criteria:

* Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital.

Exclusion Criteria:

* Pre-operative flexion contracture \>30°, infection, or inability to achieve rigid fixation of instruments intra-operatively.

Primary outcomes:
measure: Accuracy of leg length
timeFrame: 6 weeks post-op
measure: Accuracy of Hip Offset
timeFrame: 6 weeks post-op
Secondary outcomes:
measure: Time of surgery
timeFrame: Measured at the time of surgery
measure: Harris Hip Score
timeFrame: 1 year
measure: Dislocation Rates
timeFrame: 1 Year
measure: Oxford Hip Scores
timeFrame: 6 weeks and 1 year post-op
Other outcomes:
Locations:
city: Torono
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Division of Orthopedic Surgery
name: Paul Kuzyk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457893: THE EFFECT OF THE EDUCATION PROGRAM BASED ON THE HEALTH BELIEF MODEL ON THE PHYSICAL ACTIVITY BELIEFS AND BEHAVIOR OF FIRST YEAR STUDENTS OF THE FACULTY OF NURSING
Official title: THE EFFECT OF THE EDUCATION PROGRAM BASED ON THE HEALTH BELIEF MODEL ON THE PHYSICAL ACTIVITY BELIEFS AND BEHAVIOR OF FIRST YEAR STUDENTS OF THE FACULTY OF NURSING
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: THE HEALTH BELIEF MODEL ON THE PHYSICAL ACTIVITY BELIEFS
Keywords: Youth
Exercise Training
Exercise
Physical Inactivity
Physical Activity
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Structured education and physical activity.
Primary purpose: OTHER

Brief summary: The aim of the study is to examine the effect of the Health Belief Model-Based Education Program on the Physical Activity Beliefs and Behaviors of First Year Students of the Faculty of Nursing using a randomized controlled experimental research method.

Detailed description: The research was conducted in a randomized controlled manner between December 2022 and October 2023, among first-year students of the faculty of nursing who wanted to participate in an education program based on the health belief model. The study was completed with a total of 121 students, 60 in the experimental group and 61 in the control group. The health belief model-based exercise training program was implemented with the students in the experimental group for 5 weeks and follow-ups were made at the 3rd and 6th months. No intervention was made to the students in the control group. Experimental and control group data were collected with the Student Personal Information Form, Exercise Health Belief Model Scale and International Physical Activity Short Survey Form. Data were evaluated with descriptive statistics, Mann Whitney-U, Chi-square, Independent Sample T Test, Paired Sample Test and ANOVA analysis.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age
* No language barrier in communication.
* Not having any disease or illness (arrhythmia, heart disease, bronchitis, chronic herniated disc pain, chronic neck herniated pain) that would prevent participation in the study.
* Not having received structured training for physical activity.

Exclusion Criteria:

* Foreign students
* Students who fill out any of the forms related to the study incompletely (experiment, control)

Primary outcomes:
measure: Health Belief Model Scale Scores
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Aydin Adnan Menderes University
Study officials:
affiliation: Aydin Adnan Menderes University
name: AYLA AYKAC KOCAK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706193: HXLPE Vs CPE Cups Under 50 Years
Official title: Wear Resistance of Highly Crosslinked Cemented Polyethylene Cups in Young Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 59
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After obtaining informed consent, the participants were randomized to a surgical intervention with the use of 60 sealed envelopes which were opened by the surgeon in theatre just before surgery.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial evaluated the long-term wear of cemented highly cross-linked polyethylene (HXLPE) versus conventional polyethylene (CPE) acetabular cups in patients under 50 years undergoing primary total hip arthroplasty (THA).

All surgeries were performed at Radboud University Medical Center by three surgeons using a posterolateral approach. Acetabular components included either highly cross-linked polyethylene (HXLPE) cups (X3 RimFit) or conventional polyethylene (CPE) cups (Exeter Contemporary Flanged). Both were implanted with bone cement, and femoral components consisted of Exeter V40 stems with 28 mm cobalt-chromium heads. Impaction bone grafting (IBG) was routinely used, with mesh applied in cases of acetabular bone defects.

Radiographs were taken preoperatively and at 10-year follow-up using standardized protocols. Polyethylene wear was assessed with PolyWare software, creating 3D models from baseline and 10-year radiographs to calculate linear and volumetric wear. Cup inclination and osteolysis were evaluated in three acetabular zones (DeLee and Charnley classification).


Eligibility criteria: Inclusion Criteria:

* primary THA
* age under 50 years

Exclusion Criteria:

* THA due to an oncological condition

Primary outcomes:
measure: Linear wear (mm/y)
timeFrame: 10 years
measure: Volumetric wear (mm3/y)
timeFrame: 10 years
Secondary outcomes:
measure: Cup survival (%)
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02485093: To Pace or Not to Pace in Sinus Node Disease
Official title: Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Node Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 215
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: Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.

The aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.


Eligibility criteria: Inclusion Criteria:

* Patients with sinus node disease

Exclusion Criteria:

* Complete or high degree AV block
* Permanent atrial fibrillation

Primary outcomes:
measure: Left Ventricular Endsystolic Diameter (LVED)
timeFrame: 18 months
Secondary outcomes:
measure: AF incidence
timeFrame: 18 months
measure: Hospitalizations
timeFrame: 18 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Pontchaillou - CCP
Study officials:
References:
Clinical trial NCT04704193: Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Official title: Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Testing
Keywords: Decision Aid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: National Cancer Institute (NCI)
First posted: 2021-01-11
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or older)
* Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma

Exclusion Criteria:

* Children (\<18 years of age)
* Unable to complete surveys
* Previous germline genetic testing

Primary outcomes:
measure: Participant Satisfaction With How Educational Information is Presented in the Decision Aid
timeFrame: This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.
Secondary outcomes:
measure: Total Time Spent on Decision Aid
timeFrame: From the start of the decision aid to the completion of the decision aid
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel C Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05948293: FSH Doser for Controlled Ovarian Stimulation
Official title: Randomized Investigation With an AI Powered Medical Device to Select the First Dose of FSH for Controlled Ovarian Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Keywords: controlled ovarian stimulation
Follicle Stimulating Hormone
AI
Lead sponsor: Clínica EUGIN
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effectiveness of an individualized FSH dosing model called IDoser in controlled ovarian stimulation (COS) for assisted reproduction. The randomized, controlled, multicenter trial involves 236 first cycle IVF patients, who will be assigned to either the intervention arm (using the IDoser model) or the control arm (standard clinician-determined dosing). The primary outcome is the number of mature oocytes retrieved, with the hypothesis of non-inferiority for the intervention arm. Secondary outcomes include cycle cancellations, risk of ovarian hyperstimulation syndrome (OHSS), and pregnancy and live birth rates.


Eligibility criteria: Inclusion Criteria:

* First IVF cycles
* Use of autologous oocytes
* Use of FSH on the first day of stimulation (which can be combined with luteinizing hormone, LH).

Exclusion Criteria:

* Natural ovarian stimulation cycles (without Controlled ovarian stimulation)
* Cycles where FSH is not measured in International Units (IU).

Primary outcomes:
measure: Number of MII oocytes
timeFrame: 3 weeks (from enrollment to oocyte pick-up)
Secondary outcomes:
measure: Cycle cancellation rate
timeFrame: 3 weeks (from enrollment to oocyte pick-up)
measure: OHSS risk
timeFrame: 3 weeks (from enrollment to oocyte pick-up)
measure: Clinical pregnancy rate
timeFrame: 10 weeks (from enrollment to detection of fetal heart beat)
measure: Live birth rate
timeFrame: 44 weeks (from enrollment to baby delivery)
Other outcomes:
Locations:
Study officials:
affiliation: Eugin Group
name: Mina Popovic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05436093: CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
Official title: CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.


Eligibility criteria: Inclusion Criteria:

* 1. Aged \>18 years old; ECOG 0 or 1;
* 2. Patients with solid tumors;
* 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
* 4. life expectancy \>=12 weeks.

Exclusion Criteria:

* 1. Significant hepatic or renal dysfunction;
* 2. Is pregnant or ready to pregnant;
* 3. Cannot keep their states for half an hour;
* 4. Refusal to join the clinical study;
* 5. Suffering from claustrophobia or other mental diseases;
* 6. Any other situation that researchers think it is not suitable to participate in the experiment.

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing cancer hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Hua Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04071093: Home Telemonitoring System for Patients With Heart Failure
Official title: Trial Clínico. Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Universidad Nacional de Tucuman
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 30
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: This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.


Eligibility criteria: Inclusion Criteria:

* were over 18 years with a primary diagnosis of HF,
* had been hospitalized at least once time as a consequence of a HF decompensation,
* had a Smartphone,
* had access to WiFi,
* had access to a weight scale and to a blood-pressure monitor

Exclusion Criteria:

* illiterate patients,
* had learning difficulties,
* had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.

Primary outcomes:
measure: Changes in self-care
timeFrame: 3-month
measure: Changes in treatment adherence
timeFrame: 3-month
Secondary outcomes:
measure: Rate of Rehospitalizations
timeFrame: 3-month
Other outcomes:
Locations:
city: San Miguel de Tucuman
country: Argentina
facility: Zenón Santillán Health Center Hospital
state: Tucuman
Study officials:
affiliation: Universidad Nacional de Tucumán
name: Lucia M Yanicelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yanicelli LM, Goy CB, Gonzalez VDC, Palacios GN, Martinez EC, Herrera MC. Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial. J Telemed Telecare. 2021 Oct;27(9):553-561. doi: 10.1177/1357633X19899261. Epub 2020 Jan 23.
Clinical trial NCT05566093: EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors
Official title: Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonfunctional Pancreatic Neuroendocrine Tumor
Pancreatic Neuroendocrine Tumor
Endoscopic Ultrasound
Keywords: Nonfunctional Pancreatic Neuroendocrine Tumor
Endoscopic ultrasonography-guided fine-needle injection
Ablation
Endoscopic ultrasonography
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs

Detailed description: The management of nonfunctional pancreatic neuroendocrine tumors (NF-pNETs) remains controversial. In general, surgical resection is the standard treatment for NF-pNETs. However, the incidence of postoperative adverse events of surgical resection is relatively high. Recently, several studies have revealed that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may offer an effective treatment for pNETs. Therefore, a multicenter prospective study is being conducted to further identify the efficacy and safety of EUS-FNI for NF-pNETs.

Eligibility criteria: Inclusion Criteria:

1. Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
2. Patients who refuse surgery or observation.
3. Patients who have given their fully informed consent.

Exclusion Criteria:

1. Patients who are not suitable for EUS-FNI.
2. Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.

Primary outcomes:
measure: The rate of complete ablation
timeFrame: At 24 months after treatment
measure: The Chang The change of tumor size
timeFrame: From baseline to 24 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Within 3 month after treatment
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Shanyu Qin, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: