louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05919706: Mobile Technology and Motivational Interviewing in Type 2 Diabetes Patients
Official title: The Effect of Motivational Interview Empowered by Mobile Technology on Self Management, Quality of Life and Satisfaction Level in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Gaming
Motivational Interviewing
Self-Management
Quality of Life
Mobile Technology
Keywords: Type 2 Diabetes
Self-Management
Quality of Life
Satisfaction
Nursing
Mobile Technology
Gaming
Motivational Interviewing
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted as a randomized controlled experimental study with pretest-posttest-follow-up test.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Type 2 diabetes patients were divided into experimental and control groups. Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology. Pre-test, post-test and follow-up test self-management, quality of life and satisfaction levels scores were determined.

Detailed description: A randomized controlled and experimental study design was used to conduct this research on 64 patients with Type 2 DM. Purpose of this study was to explore how motivational interviewing powered by game-based mobile technology affected self-management, quality of life, and satisfaction in Type 2 diabetes patients.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older,
* Having a diagnosis of Type 2 Diabetes Mellitus according to the ADA diagnostic criteria,
* Being on oral antidiabetic and/or insulin therapy,
* Having a smart phone and knowing how to use it,
* Internet connection (to install mobile technology application),
* Not having participated in motivational interviewing (MG) training before,
* Not having vision and hearing problems,
* Not having a communication problem,
* To be able to read, write and speak Turkish,
* Volunteering to participate in the study and continue the study process.

Exclusion Criteria:

* Having a diagnosis of Type 1 and/or Gestational Diabetes Mellitus,
* Having serious health problems that prevent participation in motivational interviewing,
* Using steroid therapy,
* Having complications that may develop in the long term due to diabetes and having advanced retinopathy, neuropathy, amputation history or active foot wound,
* Having mental confusion, having any psychiatric problems and/or using a psychiatric drug,
* Being unwilling to participate in the study and/or not wanting to continue the study process.

Primary outcomes:
measure: DSMQ
timeFrame: Last 8 weeks
measure: SF-36
timeFrame: Last 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bingöl
country: Turkey
facility: Bingol State Hospital
state: Centrer
Study officials:
References:
Clinical trial NCT05338606: Expanded Access to Bimatoprost (Durysta)
Official title: Expanded Access to Bimatoprost
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Open-angle Glaucoma
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-04-21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Durysta (Bimatoprost) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* The participant must not be eligible for bimatoprost implant (Durysta) clinical trial.
* Eligibility for this program is limited to patients with moderate or worse glaucoma who are at risk of severe visual impairment based on physician assessment of risk factors associated with visual field progression as defined by the respective country/regional glaucoma clinical practice guidelines (eg, Canadian Ophthalmological Society guidelines, European Glaucoma Society guidelines, etc.), and who have exhausted all the appropriate pharmaceutical treatment options and are contraindicated for surgery, which may include:

  * Patients with ocular comorbidities such as severely scarred conjunctiva (eg, chemical burns, Stevens-Johnson Syndrome), scleral thinning.
  * Patients who are intolerant to any pre- , intra-, or post-op treatments (e.g allergy/intolerance to medical treatments or to anesthesia).
  * Patients with systemic comorbidities (e.g cardiovascular conditions) in which any surgery is not recommended

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04582006: Changes of Oral and Intestinal Microbiota After Bariatric Surgery
Official title: Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators included patients undergoing surgical treatment for morbid obesity.

Brief summary: Purpose

The aim of this study was to analyze the changes of microbiota among patients undergoing LSG or LRYGB on two levels of gastrointestinal tract (using oral swab and stool sample). We compared samples from patients before and after bariatric operation.

Materials and methods This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2.

Analysis and endpoints

Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients before and after bariatric surgery. Secondary endpoint was to compare the difference in microbiota changes between patients undergoing LSG and LRYGB


Eligibility criteria: Inclusion Criteria:

* informed consent to participate in the study
* meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).

Exclusion Criteria:

* treatment with antibiotics within 30 days prior to gathering microbiological material
* gastrointestinal infections
* inflammatory bowel disease
* thyroid diseases
* cancer (especially the digestive tract)
* immunodeficiency.

Primary outcomes:
measure: Change of microbiota in oral cavity
timeFrame: 6 months
measure: Change of microbiota in large intestine
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University Medical College
state: Małopolska
Study officials:
References:
citation: Stefura T, Zapala B, Gosiewski T, Skomarovska O, Pedziwiatr M, Major P. Changes in the Composition of Oral and Intestinal Microbiota After Sleeve Gastrectomy and Roux-En-Y Gastric Bypass and Their Impact on Outcomes of Bariatric Surgery. Obes Surg. 2022 May;32(5):1439-1450. doi: 10.1007/s11695-022-05954-9. Epub 2022 Feb 21.
Clinical trial NCT03426306: A Novel Lung Function Imaging Modality As a Preoperative Evaluation Tool (LIME)
Official title: A Novel Lung Function Imaging Modality As a Preoperative Evaluation Tool (LIME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: 4-Dimensional Computed Tomography
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function.

Detailed description: To evaluate the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT-ventilation) imaging and post-surgical lung function. To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using pulmonary function tests (PFTs). To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using quality of life (QOL) questionnaires. Evaluate cost-effectiveness of using 4DCT-ventialtion and VQ scans for pre-surgical assessment. To use longitudinal (pre and post-surgical) 4DCT-ventilation imaging to derive novel post-surgical prediction formulas.

Eligibility criteria: Inclusion Criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study.
3. Be a male or female aged 18 to 100.
4. Patient with lung cancer (presumed or biopsy proven) currently undergoing or having undergone evaluation for resection.
5. Lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon.
6. Life expectancy greater than 3 months.

Exclusion Criteria:

1. Patients getting a planned wedge resection as the only thoracic resectional procedure.

Primary outcomes:
measure: Pre-Surgical Imaging and Post-Surgical Lung Function
timeFrame: Baseline visit to follow up visit, up to 9 months.
Secondary outcomes:
measure: Ability of %PPO PFTs
timeFrame: Start of study to end of study, up to 2 years
measure: Quality of Life (QOL)
timeFrame: Start of study to end of study, up to 2 years
measure: Cost-Effectiveness
timeFrame: Start of study to end of study, up to 2 years
measure: Longitudinal Imaging Changes
timeFrame: Start of study to end of study, up to 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Bernard Jones
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008306: Cardiovascular Risk Factors After Renal Transplantation in Children and Adults
Official title: Outcome After Pediatric Renal Transplantation: Cardiorespiratory Fitness, Cardiovascular Risk Factors and Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exercise Capacity
Physical Activity
Hypertension
Overweight and Obesity
Metabolic Syndrome
Keywords: Cardiorespiratory fitness
physical activity
hypertension
overweight and obesity
metabolic syndrome
Body composition
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Red Cross
First posted: 2009-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplanted children, adolescents and young adults transplanted in the period 1983-2006 in the same center (Oslo University Hospital, Rikshospitalet)

Brief summary: Renal transplantation of children started in Norway in 1970.Since the beginning, \>80% of renal transplants are provided from Living Donors(mainly parents), short pre-transplant dialysis time( median 4 months) and 50% of transplantations are performed before dialysis is needed.This gives good premises for graft survival and avoidance of detrimental effects of dialysis. However, renal transplanted children are subjected to an increased cardiovascular morbidity and mortality in adulthood due to consequences of chronic renal failure and immunosuppressive treatment.Cardiovascular death comprises 30-40% of death causes. In this cross-sectional study we evaluate cardiovascular risk factors in childhood- and also in young adults renal transplanted in childhood.

Focus is cardiorespiratory fitness using treadmill testing,24h BP measurements, anthropometrics including waist circumference,echocardiography,intima media thickness of carotids, glucose intolerance test.Participants are also requested to fill out physical activity recalls and Quality of life questionnaires.


Eligibility criteria: Inclusion Criteria:

* Transplanted after 1983, functioning graft

Exclusion Criteria:

* Patients in dialysis
* In part of the study concerning treadmill testing: Age\<8 years, orthopedic limitations

Primary outcomes:
Secondary outcomes:
measure: other cardiovascular risk factors
timeFrame: 2007-2010
measure: hypertension
timeFrame: 2007-2010
measure: impaired glucose intolerance
timeFrame: 2007-2010
measure: left ventricular hypertrophy,
timeFrame: 2007-2010
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet HF, Division of Pediatrics
Study officials:
References:
citation: Sitek JC, Tangeraas T, Bjerre A, Helsing P. The prevalence of skin disorders in Norwegian paediatric renal transplant recipients. Acta Derm Venereol. 2014 Jul;94(4):421-4. doi: 10.2340/00015555-1741.
Clinical trial NCT02052206: Reconstruction of Complex Proximal Humeral Fractures.
Official title: Reconstruction of Complex Proximal Humeral Fractures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Shoulder
Complexe Proximal Humeral Fractures
Keywords: osteoarthritis
complexe proximal humeral fracture
shoulder
shoulder replacement
accuracy
computer-assisted
3D
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 20
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: The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.


Eligibility criteria: Inclusion Criteria:

* osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty
* patients \> 18years

Exclusion Criteria:

* contraindication for computertomography
* pregnancy
* previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture

Primary outcomes:
measure: Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: Balgrist University Hospital
name: Lazaros Vlachopoulos, MD
role: STUDY_CHAIR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Clinical trial NCT01598506: Intrathecal Hydromorphone for Labor Analgesia
Official title: Determination of the ED50 of Intrathecal Hydromorphone in Laboring Women Using the Up-and-down Sequential Allocation Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Labor Pain
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

After the intrathecal injection is given and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy patients
* Labor
* Desires pain relief

Exclusion Criteria:

* Any comorbidities other than obesity

Primary outcomes:
measure: Pain Score, Visual Analogue Pain Scores
timeFrame: 30 minutes after intrathecal injection
Secondary outcomes:
measure: Pain Scores, Visual Analogue Pain Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Grant C Lynde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Reilly-Shah V, Lynde GC. Determination of ED50 and time to effectiveness for intrathecal hydromorphone in laboring patients using Dixon's up-and-down sequential allocation method. BMC Anesthesiol. 2018 Oct 5;18(1):140. doi: 10.1186/s12871-018-0603-8.
Clinical trial NCT05807906: The Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients
Official title: The Effect of Virtual Reality Application on Fistula Puncture Associated Pain in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients.

Hypotheses of the Research:

H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients.

H1-2: Virtual reality application has no effect on fistula puncture-related pain in HD patients.

In the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.

Detailed description: * Demographic/medical data will initially be recorded prior to fistula puncture.
* The patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position.
* Virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started.
* The patient will continue to monitor the virtual reality application during the fistula puncture procedure. It will be ensured that no communication with the patient is made until the application is finished.
* The application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.

Eligibility criteria: Inclusion Criteria:

* No diagnosis of neuropathic pain
* No sedatives, analgesics and sedatives are applied 3 hours before the application.
* Not taking recently taken antipsychotic drugs and tranquilizers,
* Deaf and visually impaired (to mark VAS pain)
* Without cognitive and psychiatric diagnosis
* Open to communication and cooperation
* Patients who agreed to participate in the study

Exclusion Criteria:

* Kidney transplant
* Discomfort due to virtual reality glasses
* Suspected/diagnosed COVID-19
* Patients who want to leave the study voluntarily
* Death
* Multiple fistula puncture attempts

Primary outcomes:
measure: Pain-VAS Scale
timeFrame: Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain scale score will measure fifth week.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
Clinical trial NCT07016906: MRI Assessment of Knee Kinematics From Extension to Flexion - Exploratory Study
Official title: MRI Assessment of Knee Kinematics From Extension to Flexion - Exploratory Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Volunteer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: During flexion of the knee, internal rotation of the tibia associated with translation of the tibial plateaus in relation to the femoral condyles is automatically induced. This mechanism combines a sliding phenomenon and a rolling phenomenon of the condyles on the plate, the latter being known as 'roll-back'. In 2024, imaging analyses of the knee, and in particular MRI, are carried out with the leg in extension.

MRI of the knee at different degrees of flexion would enable to assess the sliding and roll-back phenomena, in order to gain a better understanding of knee kinematics.

However, MRI of the knee at different degrees of flexion is limited by the size of the MRI machines and especially by the knee antennae, which are narrow and do not allow flexion beyond 30°. In this context, the only solution for carrying out an MRI study on knees in flexion would be to carry out this examination with an antenna that allows the knee to be positioned at different angles of flexion. This particular type of antenna only exists in veterinary schools, where they are used in particular for horses.

Consequently, this study is based on the assumption that the kinematics of the knee can be assessed using MRI with an antenna for veterinary use.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (no damage to either knee)
* Male or female, aged between 18 and 40
* Healthy volunteer affiliated to or benefiting from a social security scheme
* A healthy French-speaking volunteer who has signed an informed consent form.

Exclusion Criteria:

* Contraindication to MRI
* Joint osteoarthritis
* BMI \> 30
* Previous trauma or surgery to the knee
* Recurrence of sprains
* Knee trauma other than sprain
* Protected person: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant or breast-feeding woman

Primary outcomes:
measure: femorotibial knee kinematics
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Marcy L'étoile
country: France
facility: Hawkcell
Study officials:
References: