cyrilzakka/clinical-trials huggingface dataset:
BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction

The aim of this observational study is to examine the connection between bone-tendinous defects after BTB graft harvest and the development of anterior knee pain.

The purpose of this study is to investigate the impact of bone-tendinous defects after ACL reconstruction on the development of anterior knee pain. We will assess the presence and extent of bone-tendinous defects using MRI scans, which will be conducted at two time points: 4 weeks and 1 year after ACL reconstruction surgery. Furthermore, we will compare the healing progress of the bone-tendinous defects observed on the MRI scans.

In addition, we will evaluate the correlation between the residual bone-tendinous defect and knee functionality by comparing the results with knee functional test (IKDC form, Lysholm score, Donor site morbidity score).

All individuals participating in the study have provided their informed consent by signing the necessary documents prior to their inclusion in the research.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients
* Diagnosed with ACL rupture based on medical history and clinical examination
* Confirmed ACL rupture on MRI scans
* A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

* Multiligament knee injuries
* Both knees injuries
* ACL re-rupture
* Postoperative complications in the form of infection
Statistical Analysis of Vlagtwedde-Vlaardingen Data Set

To determine the effects in early adulthood of asthma, increased bronchial responsiveness, markers of allergy and smoking on pulmonary function level and the effects of these same risk factors on subsequent decline in pulmonary function, because these early adult factors presumably profoundly influence the risk for chronic obstructive pulmonary disease.

DESIGN NARRATIVE:

The questions studied included whether the above named risk factors reduced the maximally attained level of pulmonary function in early adulthood, foreshortened the postulated stability of level of pulmonary function between age 18 and 35 and/or unfavorably affected subsequent decline in level of pulmonary function. FEV1/h2, VC/h2 and FEV1/IVC were studied, using graphic smooth techniques and regression analyses techniques on both cross-sectional and longitudinal datasets. In addition, the investigators tested the hypothesis stating that early adult symptoms of asthma, increased bronchial responsiveness, markers of allergy influenced who became a smoker, influenced the amount smoked and/or influenced who stopped smoking relatively early in adult life, using logistic regression analyses and survival analyses.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease

The purpose of this study is to evaluate the potential benefit of systematic preoperative coronary angiography followed by selective coronary artery revascularization on the incidence of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD) and undergoing carotid endarterectomy (CEA).

Patients candidates for CEA, with no history of CAD, a normal electrocardiogram (ECG), and a normal cardiac ultrasound were randomized in two groups. In group A (n = 216) all patients underwent coronary angiography before CEA +- coronary artery revascularization. In group B (n = 210) CEA was performed without coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* indication for carotid endarterectomy
* no clinical sign or history of ischemic heart disease
* no electrical signs of cardiac ischemia
* left ventricular ejection fraction \>50% at transthoracic echocardiogram.

Exclusion Criteria:

* disabling stroke (mRS ≥3)
* non atherosclerotic carotid disease
* severe intracranial carotid artery stenosis
* contra-indications to heparin, aspirin or clopidogrel.
Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures

Aim of the study is to analyze results of treatment of proximal humerus fractures with mini-invasive technique and plate fixation.

In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray results will be statistically analyzed to evidence any connection between clinical outcomes and osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Proximal humerus fracture

Exclusion Criteria:

* High risk to surgery (ASA 4 - 5)
Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique

Suture-bridge technique has been widely used for rotator cuff tears with many studies showing superior clinical results and lower failure rates compared to other techniques. This study aims to compare clinical outcomes and radiological integrity of arthroscopic rotator cuff repair between knot-tying and knotless suture-bridge techniques. The possibility of tendon strangulation and necrosis at the medial row when performing a suture-bridge technique may lead to retear and structural failure. In order to avoid this complication, the knots used at the medial row and their tension might be a factor to consider. Our hypothesis is that a knotless suture-bridge technique might avoid tendon strangulation thus might have lower retear rates.

This study has been planned as a prospective randomized clinical trial. We used a completely computer-generated list in order to randomize all participants to receive one of two treatments (https://www.random.org/sequences/).

Rotator cuff tear diagnosis will be made by physical examination and magnetic resonance imaging. Participants who agree to be enrolled to study will be examined one day prior to surgery. Half of the participants will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique, while the other half will receive a knotless suture-bridge technique. All the surgeries will be performed by the same senior surgeon experienced in shoulder surgery under general anesthesia with participant in beach-chair position.

All participants will receive a standard postoperative rehabilitation program starting immediately after surgery with active elbow and passive shoulder exercises. The operated upper extremity will be placed in a sling for 6 weeks. Active-assisted exercises will be started at 6 weeks postoperatively.

Postoperative evaluations will be performed regularly at 2 weeks, 6 weeks, 3 months, 6 months, 12 months postoperatively and each following year. The results of last follow-up will be analyzed. To assess repair integrity and tendon healing, a postoperative magnetic resonance imaging scan will be performed to all participants at 6 months postoperatively. The results of prospective clinical follow-up data and radiological evaluation will be analyzed in order to compare clinical outcomes, failure rates and patterns of knot-tying and knotless suture-bridge arthroscopic rotator cuff repair techniques.

Eligibility Criteria:
Inclusion Criteria:

* Full thickness rotator cuff tear repaired by arthroscopic suture-bridge technique

Exclusion Criteria:

* Partial thickness rotator cuff tear
* Presence of a full thickness subscapularis tear that requires a repair
* History of a neurological disease
* Presence of severe glenohumeral or acromioclavicular arthritis
* Presence of a metal implant which prevents magnetic resonance imaging scan
* Tears repaired with other techniques
* Revision surgeries
Effects of a Digital Diary on the Psychological Well-being of Former ICU Patients.

Previous research on the impact of a diary on mental symptoms of PICS, PICS-F, and quality of life in former ICU patients and their relatives has focused specifically on a paper diary. While there has been research on the experiences of former ICU patients, relatives, and ICU nurses regarding the use of a digital diary, it is not known whether this diary has an impact on the psychological well-being and quality of life of former ICU patients and their relatives. A successful implementation of \[the digital diary\] enables this research. The aim of this study is, therefore, to provide an initial impression of the health-related effects of a digital diary on former ICU patients and their relatives.

Objective: Exploring health-related effects of a digital ICU diary in former ICU patients and their relatives.

Research question 1: What is the effect of a digital ICU diary on the psychological well-being and quality of life in former ICU patients and their relatives? Research question 2: What is the effect of a digital ICU diary on the perceived quality of care and satisfaction with the ICU admission among relatives of former ICU patients?

Eligibility Criteria:
Inclusion criteria for former ICU patients and their relatives:

* Capacity to make decisions autonomously
* Proficiency in the Dutch language
* 18 years of age or older
* ICU length of stay \>48 hours
* No use of an ICU diary before (pre-measurement)
* Used the digital Post-IC diary for more than 1 day (post-measurement)

Exclusion criteria for former ICU patients and their relatives:

* Insufficient proficiency in the Dutch language to express themselves on the subject.
* Patients with a pre-admission diagnosis of psychosis or dementia.
* Use of a paper ICU diary.
Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software

Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but because of the high financial costs and technical complexity of the past generation of VR hardware, there has been no large-scale implementation of this promising treatment. The present study will investigate whether off-the-shelf, commercial VR hardware and software can be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The study will recruit n=25+25 participants from the general public suffering from substantial speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered VRET treatment program.


Eligibility Criteria:
Inclusion Criteria:

* Substantial public speaking anxiety
* Have access to VR-compatible smartphone (including Internet)
* Can travel to Stockholm University for treatment on one occasion
* Can speak and understand sufficient Swedish

Exclusion Criteria:

* Deficits in sight or balance impacting the VR-experience
* A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar
* Active psychopharmacological treatment, unless stable for last 3 months
* Other ongoing psychological treatment
The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin

The aim of this study is to investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone."

Hypothesis:

An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation.

0-hypothesis:

* TENS is not better than than placebo, medication or standard rehabilitation program.
* A neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.

Setting:

Skogli helse- og rehabiliteringssenter, Lillehammer, Norway. Center of Rehabilitation for chronic pain patients, rheumatic diseases and orthopedic postoperative patients.

Duration:

Until 18 months of intervention + 6 months of follow up and preparation.

Intervention:

Use of TENS during 3-4 weeks of hospitalization connected to multimodal rehabilitation (short-term efficacy). TENS or placebo-TENS is added to routine care.

Follow-up:

If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months. Questionnaires will be send at 2 and 4 months, both for the active group, the placebo group and for the group of patients who discontinued the use of TENS/placebo-TENS (long-term efficacy).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with chronic pain of predominantly neuropathic origin

Exclusion Criteria:

* Pain less than 3 months
* Surgery or lesion within 3 months
* Central neuropathic pain
* Fibromyalgia
* Primary headaches
* Primary psychiatric diagnosis
* Patients with pacemaker
* Formerly treated with TENS
EPAT: Estrogen in the Prevention of Atherosclerosis Trial

The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).

The primary goal of this randomized, controlled trial is to determine if ERT stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will further evaluate the association of lipid and non-lipid factors of ERT-mediated reduction in the progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. Blood samples will be used for measuring lipid and non-lipid mediators of ERT.

A total of 222 healthy postmenopausal women 46 to 80 years old without CVD symptoms will be randomized to receive either micronized 17B-estradiol (Estrace) 1mg/day, or a matching placebo tablet daily. All women will be on a low fat/low cholesterol diet, and will receive pravastatin if their LDL cholesterol level exceeds 160 mg/dL. Participants will undergo ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment. Measurements of lipid and non-lipid biochemical markers will also be done at baseline and every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female (serum estradiol less than 20 pg/ml)
* 46 to 80 years old
* Fasting LDL-C levels 130 to 210 mg/dL
* Triglyceride levels less than 400 mg/dL
* Current non-smoker

Exclusion Criteria:

* Clinical evidence of cardiovascular disease
* HDL-C level less than 30 mg/dL
* Fasting blood glucose greater than 200 mg/dL
* Previous hormonal replacement therapy (non-contraceptive) over 10 years duration and/or current use within 1 month
* Uncontrolled hypertension
* Untreated thyroid disease
* Renal insufficiency
* Clinical evidence of congestive heart failure
* Life threatening disease with prognosis less than 5 years
* Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)
* History of estrogen dependent cancer or detected at screening or any other disorder precluding use of ERT
* Hot flashes greater than 5 per day which interfere with daily activity and preclude randomization to placebo.
Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety in Children

The aim of the study was to observe the effect of the use of vibrating tourniquet and distraction card on the pain, fear and anxiety levels felt during the blood collection process in children. The study was conducted between July 2021 and March 2022 as a randomized controlled study with totally 120 children in three groups. The 'Child and Parent Identification Form' was used for socio-demographic data about the child and the parent before phlebotomy. The 'Visual Analog Scale (VAS)', 'Child Fear Scale (CFS)' and 'Child Anxiety Scale-State Scale (ÇAS-D)' were used before, during and after the phlebotomy. Vibrating Tourniquet Group (intervention group 1) consists of a total of 40 children. Distraction Cards Group (intervention group 2) consists of a total of 40 children. Control group consists of a total of 40 children.


Eligibility Criteria:
Inclusion Criteria:

* The child is between the ages of 6-10,
* The child has no pain just before the procedure,
* The child has not taken any analgesic-effective medication in the last 6 hours,
* The child does not have a hearing problem,
* The child and the parent can speak and understand Turkish
* The child has a sufficient level of mental development to understand speech -Parent and child are willing to participate in the research.

Exclusion Criteria:

* Children who cannot be successfully drawn in the first application
* Children with oncological disease, epilepsy, migraine, or vestibular disorder.
Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections

This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.

All patients enrolled in the study will already be undergoing lumbar epidural steroid injections for lumbar radicular pain as part of their clinical care. The epidural approach will either be transforaminal or interlaminar depending on clinical judgment (i.e. transforaminal ESI for unilateral pain, interlaminar ESI for bilateral pain). The study will consist of 3 groups: virtual reality, sedation, and a control group which receives no intervention (i.e. standard of care). The virtual reality group will receive virtual reality via a headset containing a menu of 6 programs that the subject can choose; the sedation group will receive from 1-5 mg of midazolam and up to 150 mcg of fentanyl as clinically indicated, and the control group will not receive an intervention (standard of care). All subjects will also receive 1% lidocaine local anesthetic through a 25-gauge needle for superficial anesthesia, which is standard of care. Subjects will be randomized to each of these groups, with sub-allocation being done stratified by the type of ESI (transforaminal vs. interlaminar).

A secondary pilot study will evaluate whether a processed electroencephalogram (pEEG) and continuous colored density spectral array monitored via a four-channel Masimo SEDLine frontal EEG sensor can serve as a biomarker for painful stimulation and the effectiveness of distraction and sedation to reduce acute pain.

Eligibility Criteria:
Inclusion Criteria:

* Males and females; ages 18-90 years
* Lumbosacral radicular pain with a baseline average of leg pain score of \> 4/10, MRI findings (if available) consistent with symptoms, duration of pain \> 6 weeks, and no previous lumbar spine surgery.
* Documented diagnosis of radicular pain caused by herniated disc, central stenosis, foraminal stenosis, degenerative disk disease
* Willingness to adhere to undergo ESI with either sedation (midazolam and or fentanyl) or with virtual reality
* Able to appear for a follow up visit between 24-40 days following the intervention

Exclusion Criteria:

* MRI findings discordant with symptoms (absence of herniated disc, spinal stenosis or severe disc degeneration without nerve root impingement (e.g. annular tears) that could explain symptoms)
* Previous lumbosacral spine surgery at the area affected
* Prior ESI within the past 6 months
* Allergy to contrast dye
* Poorly controlled psychiatric conditions that could affect outcomes (e.g. active substance abuse) or impose a barrier to participation (e.g. anxiety disorder requiring procedural sedation)
* Morbid obesity (BMI \>40)
Military Identity Project

The Military Identity Project is an exploration of military identity in Active Duty Service Members of the Army, Navy, Air Force \& Marine Corps. The purpose of this project is to discover common identity attributes shared by active duty members across Service branches and to see if specific traits are related to levels of well-being and resilience.

Rationale: Psychological health (PH) disorders continue to be the highest consumer of inpatient bed days and are in the top 10 diagnoses for Active Duty Service Members (ADSM) lost duty days and appointment utilization. Cognitive therapies (CT) are the evidence-based choice for PH conditions. Little is known about the cognitive contents of Military Identity (MI) and the potential for identifying specific cognitive vulnerabilities and resources common in ADSMs. Understanding the role of MI in common military PH conditions can inform the development of new military-specific clinical strategies for CTs.

Study Objective: To validate findings from a pilot Military Identity (MI) study utilizing a self-schema model to determine core cognitive contents of MI and to explore relationships between MI and psychological well-being (PWB).

Specific Aims:

Aim 1: Describe the core cognitive content of MI in active duty service members.

Aim 2: Examine the effect of MI on information processing response times.

Aim 3: Explore the relationship between MI and self-perceived psychological well-being scores.

Design: A descriptive cross-sectional mixed methods content analysis and a four-group information processing paradigm will be utilized to investigate a stratified sample of ADSMs across Joint Services (25% sample from each Army, Navy, Air Force, Marine).

Methods: Open-Ended and Closed-Ended Identity Attribute Tasks will be used to explore MI content as well as a 60 attribute response time task along with a demographic questionnaire, Inclusion of In-group in Self Scale, and Ryff's PWB Scales. All measures will be collected via computerized software program developed by Harvard's Project Implicit.

Dissemination of Results: Results from the study will be disseminated through publications, poster and/or podium presentations at professional annual conferences such as the American Psychological Association (APA), Military Health Systems Research Symposium, Association of Military Surgeons United States (AMSUS), and Tri-Service Nursing Research Program (TSNRP). Manuscripts will be submitted for publication to appropriate journals such as Military Psychology, Military Behavioral Health, and Military Medicine.

Eligibility Criteria:
Inclusion Criteria:

* An active duty member of the US Army, US Air Force, US Marine Corps, US Navy
* Willing to complete the online identity tasks requiring approximately 45 minutes

Exclusion Criteria:

* Civilian
* Guard or Reserve Service Members
* U.S. Public Health Service Member
* U.S. Coast Guard Service Member
Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 and older;
* Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).

Exclusion Criteria:

* Inability to comprehend and speak English;
* Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data;
* Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.