cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Music Intervention on Postictal Agitation in Electroconvulsive Therapy Patients

This study will investigate the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.

Postictal agitation (PIA) is a fairly common adverse effect after electroconvulsive therapy (ECT) treatment that, when present, predicts other complications such as retrograde amnesia. Multiple studies have suggested that a music intervention in the context of surgery significantly reduces pre-operative anxiety, as well as the need for sedatives and analgesic medication. Pretreatment anxiety is common for ECT patients and is a known predictor of PIA. Currently, there is no preventative treatment for PIA. Given the beneficial effects of music demonstrated in similar hospital settings combined with its easy implementation and lack of side effects, the investigators hypothesize that music listening can lower the incidence and severity of PIA among patients undergoing ECT therapy, thereby also reducing post-treatment cognitive impairment. Therefore, the objective of the study is to assess the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ECT treatment for depression (including depression as part of bipolar disorder)
* Adult patients (≥18 years)
* Hypnotic agent used is etomidate
* Sufficient understanding of the Dutch language (in judgement of the attending physician or researcher)
* Written informed consent by patient or legal representative

Exclusion Criteria:

* Significant impaired hearing (defined as unable to communicate verbally or listen to music)
* Severe neurological condition (defined as interfering with the ability to process music)
* Patients receiving ECT for treatment of schizophrenic disorders
Clinical Characteristics and Subgroups in Greater Trochanteric Pain Syndrome

This cross-sectional study will gather participant data from clinical assessment and questionnaires for individuals with a clinical diagnosis of Greater Trochanteric Pain Syndrome.

Greater trochanteric pain syndrome (GTPS) is characterised by pain over and around the greater trochanter and is primarily due to gluteal tendinopathy. Pain associated with GTPS can affect an individual's ability to perform daily activities while also having a negative impact on sleep, work and participation in sport. Quality of life is often impaired and comparable to severe hip osteoarthritis. A significant number report chronic pain and disability with 29% and 45% of individuals continuing to experience pain at five and 11-year follow-up respectively.

Exercise programmes which specifically target the gluteal muscles and tendons are normally the first-line treatment for GTPS, however 20-50% of individuals do not fully recover within 12 months with this intervention. The reasons for this poor response remain unclear but may be associated with the presence of certain clinical characteristics. Diabetes, obesity, co-existing musculoskeletal disorders, psychological factors and physical activity level may affect prognosis and treatment outcome in GTPS. Co-existing low back and/or hip joint pain is common in this population and a higher number of pain sites has been associated with poorer outcome in other musculoskeletal conditions. In clinical trials, participants with GTPS are often grouped together regardless of individual clinical characteristics. Current treatment strategies appear inadequate for a proportion of patients with this condition meaning alternative options are required to achieve a positive clinical outcome.

Subgroups of patients within the same condition have been identified in low back pain, osteoarthritis and patellofemoral pain. Thus, it is important to look for subgroups within the clinically diagnosed GTPS population.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged \> 18 years who currently reside within Greater Glasgow and Clyde
* Lateral hip pain of any duration
* Able to give written informed consent
* Pain on direct palpation of the gluteal tendon insertion on the greater trochanter and additionally at least one of the following pain provocation tests must also be positive:

  1. FABER (Flexion, Abduction, External Rotation of the hip)
  2. FADER (Flexion, Adduction, External Rotation of the hip)
  3. FADER and resisted Internal Rotation (IR) (FADER position plus resisted IR of the hip)
  4. Single leg stand for 30 seconds
  5. Resisted hip abduction at end-range adduction

Exclusion Criteria:

* Lateral hip pain secondary to another source e.g. hip joint pathology or lumbar referred pain
* Inflammatory joint conditions
* Neurological conditions
* Pregnancy
* Unable or unwilling to give informed consent
* Unable to write, read or comprehend English
Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)

Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

Quantitative analysis of the ultrasound exam with doppler of those masses could identify diagnostic criteria, especially for the lacrimal gland, easily explorable.


Eligibility Criteria:
Inclusion Criteria:

* patient aged 18 years or more
* with an orbital mass for which a biopsy and/or a surgical removal is planned
* before surgery or biopsy

Exclusion Criteria:

* pregnancy
* breast feeding
* patient under a legal protection procedure
* patient denying to participate to the study
* lack of affiliation to a social security system
Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Elderly Over 80 Years

The purpose of this study is to compare the effects of different trainings on cognition and physical performances in elderly over 80 years.

Purpose: To compare the effects of 16-week multicomponent and resistance trainings on cognition and physical performances related to falls in oldest old people living in community; to analyze the same variables after 6-week detraining. Method: We conducted a randomized controlled trial with 69 community elderly over 80 years, sedentary and without cognitive disorder. Participants were allocated to control, multicomponent training or resistance training group. The multicomponent group performed a protocol involving warm-up, aerobic, strength, balance and cool-down exercises. The resistance group underwent to strength exercises using six machines: leg press, chest press, calf, back extension, abdominal and rowing. The control group did not perform any intervention. The trainings had progressive intensity, lasted 16 weeks and included three 1-hour sessions per week. The participants were evaluated at baseline, at the end of 16-week training and at 6-week detraining. The assessment consisted of anamnesis, depression (Geriatric Depression Scale), cognition (Montreal cognitive assessment), dual task walking (associated to cognitive and motor tasks), balance (unipedal and tandem tests), strength of lower limbs (sit-to-stand test) and history of falls. For statistical analysis by intention to treat, we adopted a significance level of α=0.05.

Eligibility Criteria:
Inclusion Criteria:

* age between 80 and 95 years old
* live in community
* sedentary lifestyle
* ability to walk without help from another person with/without aid walking

Exclusion Criteria:

* any cardiovascular or infectious comorbidity described in the absolute contraindications of the Physical Activity Readiness Medical Examination
* Relative contraindications of cognitive, neurological and/or musculoskeletal comorbidities which make participation in protocols impossible
* Score in mini-state examination mental below the cutoff score designated by education level.
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

Two cervical immobilization devices will be used in this study named cervical neck collar and head blocks strapped on the backboard and optic nerve diameter will be measured using point of care ultrasound and compare the effect of each type of cervical immobilisation on optic nerve sheath diameter.

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers aged more than 18 years

Exclusion Criteria:

* Hx of stroke

  * Inability to consent,
  * Inability to lay flat on a bed or table for 15 min in duration,
  * History of glaucoma, globe injury, lens implant,
  * Recent refractive surgery (within the past 60 days).
  * Uncontrolled hypertension
Does Olfactory Training Improve Olfaction in a Population With Normal Sense of Smell?

Awareness of the sense of smell in the western population has been low. Most people do not think about the consequences of absence of smell (anosmia). Reduction in sense of smell (hyposmia) can influence everyday life. In situations of stress anosmia can be life threatening for example when there is a fire. Cooks may lose their job. Not being able to enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of the nose and sinuses or head injuries. OD may be congenital, age related or associated with neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the first symptom of both Parkinson's and Alzheimer's disease several years before the mental changes occur.

Knowledge and focus on OD has until recently been low among most physicians and treatment options have often not been available. Different approaches to improve OD have been tried with variable effect depending on the cause of OD. There are studies on corticosteroids, zinc gluconate and vitamin A. In recent years, olfactory training has been launched as a promising treatment option. Most studies with olfactory training are done with patients with OD. A recently published review describes 10 studies with olfactory training among 639 patients and concludes that daily stimulation with odorants (odor concentrate) over a limited period time is a promising treatment. The suggested duration of olfactory training varies from 3 to 14 months. Different intensities of olfactory training were compared in patients with post-viral OD. Olfaction was more improved by the high concentration of odorant than by the low concentration.

A small number of studies have shown that the olfactory nerve to some extent can be trained in persons with normal sense of smell, but we need more experience and structured studies to be able to conclude with greater certainty about the effect of olfactory training in this population.

This study examines whether intensive olfactory training improves the sense of smell more than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines self-evaluation of olfactory function.

Sub-study: Part of the participants (45/200) will be included in a pilot study which will be an analytical observational study to compare olfactory bulb volume measured on MRI three times during a year, while at the same time resting state fMRI will be measured before and after olfactory training. There is not sufficient data in the literature for power calculations and this sub-study is therefore a pilot study.

Eligibility Criteria:
Inclusion Criteria:

* TDI score \> 30.5 measured by Sniffin'Sticks

Exclusion Criteria:

* Not able to follow the olfactory training or follow-up (language, practical implementation, mental condition)
* Disease affecting olfaction (sinusitis, pronounced allergies, recent nasal surgery, Alzheimer's, Parkinson, MS, COPD)
Multifocal Contact Lenses Fitting Methods Comparison

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.

Eligibility Criteria:
Inclusion Criteria:

* At least 40 years old;
* Have read and understood the Participant Information Sheet;
* Have read, signed and dated the Informed Consent;
* Best corrected visual acuity of at least 20/25 in each eye;
* Have normal eyes with the exception of the need for visual correction;
* Current multifocal contact lens wearer;
* Spectacle refraction:

Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D \& +1.75D

* Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular participants (only one eye with functional vision) or participants fit with only one lens;
* Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Known pregnancy or lactation during the study period;
* Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study

Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population.

Study design Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.

Sample size The estimated sample size will be n=156. Duration of study 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) Safety Assessment: Patient will be monitored for Hypoglycemia, Dehydration, Hypotension, Urinary Tract Infections, Fungal Infections, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion and Other side effects (if any).

Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups.

Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy.

LABORATORY TESTING:

Reputable Lab is considered for laboratory testing of diabetes patients i.e. HbA1C%, FBG, RFT and urine R/E. The certified clinical lab will be responsible for receiving and analyzing clinical sample. Patients will have special discount of upto 50% for study related laboratory investigations.

Where in Urine Routine Examination (Urine R/E), we consider as follows:

* Visual Examination:

  * Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other.
  * Urine clarity: Clear, slightly Cloudy, cloudy or turbidity
* Chemical Examination:

  * Specific gravity
  * pH
  * Bilirubin
  * Urobilinogen
  * Protein
  * Ketone
  * Leukocyte Esterase
* Microscopic Examination:

  * Red Blood Cells:
  * Epithelial Cells:
  * Amorphous:
  * Pus Cells
  * Bacteria
  * Yeast
  * Casts
  * Crystals

Where in Renal Function Test (RFT), we consider as follows:

* Blood Urea Nitrogen (BUN): mg/dL
* Serum Creatinine: mg/dL
* Estimated Glomerular Filtration Rate (eGFR): mL/min/1.73 m2


Eligibility Criteria:
Inclusion Criteria:

Patient with T2DM between 18 to 65 years with HbA1C 7% - 10%, who can give informed consent. Patient uncontrolled on oral antidiabetics and lifestyle modification for at least 3 months. Patient who are empagliflozin naive. eGFR ˃60 mL/min/1.73m2.

Exclusion Criteria:

Type 1 diabetes, History of recurrent urinary tract infection (UTI), fungal infection, renal and/or hepatic dysfunctions, where RFT and Urine R/E is abnormal, Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state, severe hypoglycemia, Pregnant or lactating women, Pancreatitis, any serious complications or hypersensitivity.
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm surgery and stenting, allowing the surgeon or interventional radiologist to take action quickly, while the colon ischemia is still treatable.

This purpose of this study is to establish how T-Stat can best be used to prevent deaths.


Eligibility Criteria:
Inclusion Criteria:

* Aortic Aneurysm, intact or ruptured
* Repair by catheter based stent or by open surgery during monitoring
* Patent rectum
* Absence of rectal bleeding

Exclusion Criteria:

* Lack of informed consent
* Rectal bleeding
* Obstructed rectum
Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2

The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.

This is an evaluation of the implementation of the Salud en Mis Manos program. The investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and HPV vaccination using a one-group pre-post study design (2022-2024). The investigators also describe the implementation of the program during a longer time period (2020-.2024).

Eligibility Criteria:
Inclusion Criteria:

* Primarily residing in the Gulf Coast \& Lower Rio Grande Valley county areas (or other counties in Texas)
* Women 40 years of age and older with no mammogram in the past 2 years
* Women 21-65 years, with no Pap test in the past 3 years
* Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals.

Exclusion Criteria:

* Current pregnancy
* Have a current or prior cancer diagnosis
Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease

This study investigates the feasibility of a cognitive strategy training intervention for people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire study duration per participant = 8 weeks). We will measure participant responsiveness and the overall efficiency of the intervention process.

Cognitive impairment is common in Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Existing rehabilitative interventions, which focus on cognitive process training, have not been successful in mitigating its negative functional consequences. We have developed a client-centered cognitive strategy training intervention to enable people with PD to work around their cognitive deficits and maintain their functional performance. This study is an exploratory case series to assess aspects of its feasibility. Specifically, we will assess participant responsiveness to the intervention (acceptance, engagement, adherence), and we will track logistical information (e.g., scheduling). We will also administer an exploratory outcome measure of treatment effect to gain preliminary evidence on the effect of the intervention on self-identified cognitive performance problems. This information will guide modifications and enhancements in preparation for future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn \& Yahr stage I-III (mild to moderate disease; Hoehn \& Yahr, 1967) and are treated with levodopa/carbidopa. For this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it.

Exclusion Criteria:

* Possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., STN DBS), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-English speaking). Participants taking benzos will be excluded.