louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05676125: Trunk Muscle Strength and Endurance in Chronic Ankle Instability
Official title: Trunk Muscle Strength and Endurance in Chronic Ankle Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Ankle Instability
Keywords: CAI
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: faculty of physical therapy outpatient clinic

Brief summary: Evaluation of trunk muscle strength in patients of chronic ankle instability

Detailed description: This study will be conducted in the Isokinetic Laboratory. Sixty females with CAI will participate in this study. Their age will range from 18-30 years. They will be divided into two groups; the experimental and the control group. The experimental group will involve 30 females with CAI and the control group will involve 30 healthy females. The isokinetic strength of trunk muscles will be evaluated in a concentric mode of muscle contraction at an angular velocity 60°/sec. McGill test will be used to assess trunk muscle endurance.

Eligibility criteria: Inclusion Criteria:

* The initial sprain must have occurred at least 12 months prior to study enrollment.
* The most recent injury must have occurred more than three months prior to study enrollment (unassisted walking without limping for at least three months after injury).
* A history of the previously injured ankle joint giving way, recurrent sprain and/or feelings of instability.
* The injured/unstable ankle functionally weaker, more painful, looser, and less functional than the uninvolved ankle.
* The Oswesty Disability Index (ODI) score for both groups is from 0 to 20% (minimal disability) (Fairbank and Pynsent, 2000).

6- The Identification of Functional Ankle Instability questionnaire (IdFAI) score is less than 10 for the experimental group and 11 or more for the control group (Simon et al., 2012).

Exclusion Criteria:

* 1-A history of previous surgeries or fractures in either limb of lower extremity.

  2-Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.

  3-Any positive ﬁndings of the anterior drawer or talar tilt test (Hubbard and Kaminski, 2002).

  4-Any shoulder (Kibler et al., 2006) or elbow injuries (Ben Kibler and Sciascia, 2004).

Primary outcomes:
measure: trunk muscles strength
timeFrame: this will be evaluated on day one
measure: core muscle endurance
timeFrame: this will be evaluated on day one
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
state: Dokki
Study officials:
affiliation: Cairo University
name: salam M Elhafez, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05305625: Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke
Official title: Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aimed to investigate the changes of glymphatic function after remote ischemic postcondioning treatment in acute ischemic stroke .


Eligibility criteria: Inclusion Criteria:

* The patient was 18-80 years old;
* The NIHSS score was ≤ 25 and NIHSS \> 5，Glasgow coma score ≥ 8;
* The patients were diagnosed as anterior circulation cerebral infarction and could start remote ischemic postcondioning within 24 hours after onset
* Normal to random time within 24 hours
* Written informed consent signed by patients or their families

Exclusion criteria:

* patients receiving thrombolysis or endovascular therapy;
* modified Rankin scale (mRS) score ≥ 2 before this attack;
* other intracranial lesions, such as cerebral hemorrhage, cerebral venous disease, severe subclavian artery stenosis and other diseases involving the brain;
* Arterial blood pressure ≤ 90/60mmHg or ≥ 180/100mmHg after treatment.

Primary outcomes:
measure: Changes of glial lymphatic system
timeFrame: from baseline to 3 day
Secondary outcomes:
measure: Differential expression pattern of differential proteins
timeFrame: from baseline to 3 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00170625: Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
Official title: Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Keywords: platin-resistant
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compatibility of the topotecan therapy in combination with carboplatin.

Detailed description: The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* patient with ovarian cancer after primary therapy
* bone marrow function leukocytes \>= 4,0 x 109/ l, platelets \>= 100 109/l, hemoglobin \>= 9 g/dl
* renal function creatinin \<= 1,5 mg% or creatinin clearance \>= 60 ml/min
* liver function bilirubin \<= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
* ECOG \<= 2
* Intention of regular follow-up visits for the duration of the study
* written informed consent

Exclusion Criteria:

* any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
* ECOG \> 2
* patients with radiotherapy within the last 4 weeks

Primary outcomes:
measure: Occurrence of a DLT (Dose Limiting Toxicity)
timeFrame: after each cycle for up to one year
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: after every third cycle, for up to one year
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jalid Sehouli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. doi: 10.1016/j.thromres.2009.03.013. Epub 2009 May 8.
Clinical trial NCT05689125: Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions
Official title: Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions by Anesthesia Residents: a Randomized Crossover Simulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Cardiopulmonary Resuscitation
Simulation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will perform endotracheal intubation by four methods in a randomized order. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trials is to analyze the effects of using bougies as adjuncts on the performance of endotracheal intubation via video laryngoscopy during cardiopulmonary resuscitation in anesthesia residents. The main question it aims to answer is whether bougie use has a significant effect on first-attempt failure of endotracheal intubation via video laryngoscopy during continuous chest compressions. Participants will perform endotracheal intubation via video laryngoscopy by four methods in a randomized order in a simulated cardiopulmonary resuscitation scenario on a manikin. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance. Researchers will compare the first-attempt failure rate of the four methods to see if a railroaded bougie method has a significant different first-attempt failure from that of the other three methods.


Eligibility criteria: Inclusion Criteria:

* Residents who are enrolled in the three-year standardized residency training program in the Department of Anesthesiology, Peking Union Medical College Hospital in February, 2023.

Exclusion Criteria:

* Residents who refuse to participate and residents who fail the pre-test.

Primary outcomes:
measure: Failure on the first attempt
timeFrame: At the completion of the intubation
Secondary outcomes:
measure: Failure on two attempts
timeFrame: At the completion of the intubation
measure: Duration of the first attempt
timeFrame: At the completion of the intubation
measure: Overall intubation duration
timeFrame: At the completion of the intubation
measure: Self-reported intubation difficulty
timeFrame: At the completion of the intubation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xu Li, MD
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Yuguang Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03954925: Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique
Official title: Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique: Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: ACL
short hamstring graft
standard hamstring graft
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Thammasat University
First posted: 2019-05-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study was to evaluate the functional outcome of quadruple hamstring graft in femoral tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and clinical evaluation between short and normal femoral tunnel graft length of hamstring tendon ACL reconstruction.

Detailed description: The patient recruitment (N=29) and baseline data collection were done at our institute between March2014-September 2015. The inclusion criteria were patients with anterior cruciate ligamentous injury who needed ligamentous reconstruction, closed growth plates and younger than 60 years old, absence of ligament injury to the opposite knee. The exclusion criteria are patients who did not want to participate in this study or patient with failed anterior cruciate ligamentous reconstruction.

All the procedure of anterior cruciate ligament reconstructions were performed by the senior authors (B.C). Semitendinosus and gracilis tendons were harvested through an oblique approach medial to the tibial tubercle in all patients. Complete anterior cruciate ligament was confirmed at arthroscopy. Associated intra-articular injuries such as meniscus tear and cartilage lesions were fixed at of the index operation .The femoral tunnel were drilled though the AM portal.

Eligibility criteria: Inclusion Criteria:

* Patients with anterior cruciate ligamentous injury with the diagnosis of injured ligaments was made based on a detailed history of the knee injury, physical examination on pathologic status and abnormal laxity, routinely performed plain radiographs and MRI scans, and the findings at surgery.
* Patients who have closed growth plates.
* Patients who younger than 60 years old.
* Patients who absence of ligament injury to the opposite knee.

Exclusion Criteria:

* Patients with a combined ligament injury as folling:

  1. Posterior cruciate ligament
  2. The lateral collateral ligament
  3. The posterolateral corner structures of the knee
  4. Medial collateral ligament.

Primary outcomes:
measure: Visual analog score
timeFrame: 18 months
Secondary outcomes:
measure: range of motion
timeFrame: 18 months
measure: complication
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06071325: Green Digital Diabetes Waste Project
Official title: Green Digital Diabetes Waste Project: Quantifying the Amount of Environmental Waste Associated With Devices and Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: Continuous glucose monitor
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Multiple daily injection
Insulin pump
Diabetes waste
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Diabetes Technology Society
First posted: 2023-10-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with diagnosed diabetes mellitus (either Type 1 or Type 2) at least 6 months earlier, and treated with insulin and a continuous glucose monitor (CGM).

Brief summary: The purpose of this study is to determine how people with diabetes are disposing of various products and devices and at what rates so that better devices with less waste can be designed in the future.

Detailed description: The study aims to compare the amount of environmental waste that is generated during the management of diabetes of participants who are using a CGM and on multiple daily injection (MDI) or using an AID (automated insulin delivery) system. This study is expected to demonstrate which devices create the most waste and where opportunities exist to decrease diabetes device waste. We will collect data to describe both quantitatively (via daily survey) and qualitatively (via photography) the types of waste that are generated during the management of diabetes.

Eligibility criteria: Inclusion Criteria:

* Person with diabetes (self-identified), either type 1 or type 2, who has been diagnosed at least 6 months earlier
* Age 18 years and above
* Use of a CGM
* Use of an insulin pump or on MDI
* Access to the Internet and e-mail
* Access to a smartphone with photographic capability
* Able and willing to provide informed consent

Exclusion Criteria:

* Failure to meet any of the inclusion criteria
* Any condition which, in the opinion of an investigator, would make the subject not qualified to participate in the study.
* Adults unable to consent
* Adults unable to speak English
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Cognitively impaired adults

Primary outcomes:
measure: Types and Amount of Diabetes Waste
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Diabetes Technology Society
state: California
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Dean & Prof. of FSU College of Nursing
name: Jing Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: President of Diabetes Technology Society and Clinical Professor of UCSF Medicine
name: David C Klonoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01570725: Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations
Official title: A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Keywords: Immersive virtual reality
e-health
surgery
anxiety
relaxation
Patients who undergo ambulatory surgical operations
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background. Preoperative anxiety is a common problem for patients who undergo surgical operations, being often associated with a number of negative behaviours during and after the surgical experience. Since drug treatments alone have frequently proved to be inadequate to reduce stress and anxiety in surgical contexts, in the last decades there has been an increased interest in non invasive complementary and alternative medical therapies (CAM), including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension during pre and post operative phases. Virtual reality can be considered an innovative form of e-health-based CAM therapy having gained recognition as a means of attenuating pain during medical procedures. VR reduces distress and pain perception by providing a particularly intense form of immersive distraction that taxes the patient's limited attention capacity, resulting in the withdrawal of attention from the real, noxious, external stimulus with a subsequent reduction in pain and stress.

Objective. The aim of this study is to test the efficacy of a small, portable and immersive virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory surgical operations under local or regional anaesthesia.


Eligibility criteria: Inclusion Criteria:

* all patients who undergo ambulatory surgical operations and sign informed consent

Exclusion Criteria:

* death or blind patients

Primary outcomes:
measure: Psychological measure of anxiety (VAS-A)
timeFrame: One day before operation; one hour after operation; one week after operation
Secondary outcomes:
measure: Physiological parameter (heart rate)
timeFrame: One day before operation; one hour after operation; one week after operation
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Regional Hospital No. 25 of the IMSS
Study officials:
affiliation: Istituto Auxologico Italiano
name: Giuseppe Riva, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00903825: Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization
Official title: Optimization of Local Anesthetic Effect With Duplex Ultrasound Guided Injection of Lidocaine Before Femoral Artery Catheterization: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Local Anesthetics
Ultrasound Guidance
Catheterization
Keywords: femoral artery puncture
local anesthesia
ultrasound guided
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2009-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the optimization of local anesthetic effect with duplex ultrasound-guided injection of lidocaine before femoral artery puncture during diagnostic or therapeutic interventional procedures.

In total, 200 patients scheduled for various diagnostic or therapeutic interventional radiology procedures requiring femoral artery puncture, will be randomized in two groups after informed consent. Patients will be randomized to undergo groin local anesthesia with the proposed method of duplex ultrasound guided injection of lidocaine versus standard injection of lidocaine with manual palpation (control group).

The protocol includes the registration of patients' demographics (age, gender, risk factors for peripheral arterial disease), arterial morphological characteristics (calcifications and presence of atheromatous disease), as well as technical details of the procedure (total puncture duration, sheath size, antegrade/retrograde puncture, etc.)

Primary study endpoint will be peri-procedural pain that will be assessed with the use of a visual analog scale (VAS) completed by the patient at the end of the procedure. Secondary study endpoints will evaluate procedural safety and complications during the immediate post-procedural period (up to 7 days).


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for diagnostic intra-arterial procedures
* Patient scheduled for therapeutic intra-arterial procedures
* At least 1 palpable femoral artery
* Patient informed consent

Exclusion Criteria:

* Allergic reaction to iodine contrast media
* Allergic reaction to lidocaine
* Bilateral obstruction of femoral arteries
* Impaired or lost vision

Primary outcomes:
measure: visual analog scale (VAS) for pain evaluation
timeFrame: immediatelly after sheath placement, days 0-7
Secondary outcomes:
measure: major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding)
timeFrame: immediate, up to 7 days
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Department of Radiology, Angiography Suite, Patras University Hospital
state: Achaia
Study officials:
affiliation: Department of Radiology, Patras University Hospital
name: Dimitris Siablis, Professor
role: STUDY_DIRECTOR
References: