cyrilzakka/clinical-trials huggingface dataset:
Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes

After focusing many years only on intraocular pressure (IOP) as the primary risk factor, recently the impact of ocular blood flow is getting more consideration for the pathophysiology of glaucoma. The circadian change of intraocular pressure (IOP) is well investigated, but diurnal variations in ocular blood flow are yet to be evaluated, especially in glaucomatous eyes.

This study is performed to investigate circadian variation of ocular blood flow assessed by laser interferometric fundus pulsation amplitude (FPA) and laser Doppler flowmetry (LDF) in glaucomatous eyes during topical antiglaucoma therapy at 8:00, 12:00, 17:00 and 21:00, to compare these circadian variation of ocular blood flow in glaucomatous eyes with variations in healthy eyes and to relate blood flow variations with IOP variations.


Eligibility Criteria:
Inclusion Criteria:

For the glaucoma patients:

* Medical controlled Primary Open Angle Glaucoma with a history of more than 2 years
* Topical medication with beta-blockers (timolol, betaxolol, levobunol)
* IOP with medication \< 22 mmHg (with a medical history of IOP \> 22 mmHg)
* Visual field testing: mild glaucomatous defects (Humphrey 30-2 with MD\>10)
* Optic nerve head: C/D-ratio between 0.4 and 0.9
* ametropy \< 3 dpt
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

For the age matched control subjects:

* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 dpt.

Exclusion Criteria:

For the glaucoma patients:

* History of trabeculectomy or laser trabeculoplasty
* Any other ocular disease with possible vascular involvement such as diabetic retinopathy, age related macular disease, retinal vein or artery occlusion.
* Uncontrolled systemic hypertension (defined as systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 100 mmHg)
* Diabetes mellitus

For the age matched control subjects:

* abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease
* Ametropy \> 3 dpt
Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia

The aim of this study is to compare the effect of listening to music, to a control group (no music), on peri-operative anxiety using the validated VAS-A, in patients undergoing lower limb arthroplasty procedures under spinal anaesthesia.

Music is becoming an increasingly popular adjunct to traditional medical therapies. International studies have shown the numerous benefits of music in a medical setting. Music has been used effectively to decrease patients' anxiety under neuraxial anaesthesia for caesarean section. There is currently a lack of evidence supporting the use of music to reduce patients' anxiety under neuraxial anaesthesia for lower limb arthroplasty procedures. The worldwide growth of the ageing population has led to an increased demand for arthroplasty. It is imperative that the anaesthetic technique used for this procedure is both safe and is associated with high levels of patient satisfaction. The purpose of this study is to compare the effect of music, to a control, on peri-operative anxiety in patients undergoing lower limb arthroplasty procedures under spinal anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* all patients, aged 18 years and older,
* American Society of Anaesthesiologists (ASA) class I, II or III,
* patients undergoing primary hip or knee arthroplasty surgery under spinal anaesthesia,
* patients with the mental capacity to consent to the study.

Exclusion Criteria:

* patients with significant visual or hearing loss,
* patients with any contra-indications to spinal anaesthesia,
* patients with any contra-indications to moderate sedation including moderate to severe obstructive sleep apnoea (indicated by a "STOPBANG" score of 5-8) (46),
* patients with pre-existing diagnosed anxiety disorders or other serious mental disturbances,
* revision arthroplasty (this may require deviation from the standardised anaesthetic technique used for this trial),
* anxious patients who cannot be reassured and require additional anxiolytic agents.
HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's)

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD)

The main questions it aims to answer are:

1. Can the current HOBSCOTCH program be adapted for people with PD?
2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?

Participants will be asked to:

* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach
* complete a brief clinical questionnaire about their diagnosis of PD
* complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes
* keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program
* complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program


Eligibility Criteria:
Inclusion Criteria:

* Age 30 - 75 years
* Diagnosis of Parkinson's Disease per participant's provider
* Literate, English-speaking with grade 12 or equivalent in education
* Self-reported cognitive/memory difficulties
* Telephone and internet access

Exclusion Criteria:

* Cognitive dysfunction that precludes participation in giving informed consent
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

This is a prospective, descriptive, single site, observational study in subjects receiving alpelisib for treatment of metastatic breast cancer. The purpose of the study is to characterize the impact of alpelisib on glucose control in patients with breast cancer using continuous glucose monitoring to measure glucose levels throughout the day and night. Patients will follow a hyperglycemia prevention and management regimen aimed to diminish hyperglycemia known to occur in most oncology patients starting alpelisib.

All patients will wear an Abbott FreeStyle Libre 2 system to obtain continuous glucose monitor (CGM) data (glucose measured every minute for 14 days). CGM will be placed at least 10 days prior to starting alpelisib and continue for at least 3 months while taking alpelisib.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 or older with a diagnosis of metastatic breast cancer that are initiating treatment with alpelisib.
2. Must be willing and able to comply with study visits and procedures.
3. Must meet standard clinical criteria for utilization of alpelisib including hormone-receptor positive/HER2 negative cancer with the presence of a PIK3CA mutation.
4. Oncologist plans to use alpelisib until progression of disease or unacceptable toxicity.
5. Patients must receive cancer care during alpelisib treatment phase with a HealthPartners oncologist and be willing to see IDC/HealthPartners Diabetes Education for diabetes management.
6. Must have a compatible smartphone, access to a compatible smartphone, or the ability to upload CGM reader from home or bring the reader in to a medical visit at least once a month for uploading, to allow for remote management of diabetes and data collection.
7. Life expectancy of at least 3 months

Exclusion Criteria:

1. Known history of serious allergy to skin-adhesive material or previous cutaneous reaction to a continuous glucose monitor.
2. Known currently uncontrolled diabetes, defined as the most recent HbA1c over 10% or history of DKA within 6 months prior to enrollment.
3. Concurrent use of high-dose vitamin C, defined as ≥ 1g of oral vitamin C daily, or intravenous Vitamin C infusions.
4. Any other concurrent severe and/or uncontrolled medical condition that, in the opinion of the investigator, would cause unacceptable safety risk, compromise compliance with the protocol, or contraindicate participation in the study. One example being known requirement for high dose steroids at the time of possible enrollment into the study.
Stress Balls in Gynecologic Exams: A Patient Comfort Trial

Women's anxiety about gynecological examinations causes them to skip examinations during this process. Research shows that women with high levels of anxiety are more likely to feel pain. Women who can manage their anxiety can increase their satisfaction by reducing pain levels during the examination . The stress ball has the potential to improve the patient experience by reducing these anxieties. This will positively affect women's willingness to participate in gynecological examinations and follow-up processes.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-35,
* Being literate, knowing and understanding Turkish,
* Don't have a pap-smear test for the first time,

Exclusion Criteria:

* Presence of chronic pain in the pelvic region,
* Presence of a condition in the wrists that prevents squeezing the stress ball,
* Congenital malformation of the cervix, .Having a known diagnosis of a serious psychiatric illness.
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis

The purpose of the study was to assess preliminary efficacy, safety, and tolerability of LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate clinical profile for further development in this indication.

This was a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis. This study consisted of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. The maximum study duration for each participant including the 4 week screening period was 16 weeks.

At the beginning of the treatment period, subjects were randomized to one of the two following treatment groups in 2:1 ratio

* LYS006
* matching placebo

Eligibility Criteria:
Key Inclusion Criteria:

* Male and female subjects 18-75 years of age with an established diagnosis of ulcerative colitis at least 3 months prior to screening are eligible for the study.
* Patients must have active disease with a full Mayo Score between 5 and 10 (inclusive) with an endoscopy score of 2 or 3; rectal bleeding and stool frequency scores 1 to 3 and a physician's global assessment of 1 or 2.
* Patients must have responded inadequately to conventional therapy with oral 5-ASA prior to screening.

Key Exclusion Criteria:

* Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history.
* History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at risk of colectomy.
* Treatment with biologics within 3 months or 5 half-lives (whichever is longer) prior to screening endoscopy, non-biologics advanced therapies within 4 weeks prior to screening endoscopy, systemic immunosuppressant or immunomodulator within 6 week, topical treatment with 5-ASA or steroids within 2 weeks prior to screening endoscopy
Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology

Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic.

After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.

Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate hearing loss
* New hearing aid users with no previous hearing aid experience interested in trying Lyric devices
* Must meet Lyric candidacy (see exclusion criteria)

Exclusion Criteria:

* middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes
* radiation therapy to head or neck area
* participants who need regular MRI testing
* participants who regularly scuba dive or swim underwater
A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle

Caudal epidural injection (CEI) is effective for spinal pain. However, intravascular injection may occur during CEI, which can lead to hematoma, neurologic deficit and local anesthetics systemic toxicity. Whitacre type needle has been reported to be effective for reducing intravascular injection during transforaminal epidural injection. In this study, we compared the Chiba needle and Whitacre needle on incidence of intravascular injection during CEI.

A total of 164 caudal epidural injections were performed in patients with disc herniation or spinal stenosis on lumbosacral region. Patients were randomly allocated to Group Whitacre (n=82) and Group Chiba (n=82). Patients in Group Whitacre received caudal epidural injection using Whitacre type needle and those in Group Chiba received the procedure using Chiba type needle. Intravascular injection was assessed with blood aspiration and angiography during real-time fluoroscopy.

Eligibility Criteria:
Inclusion Criteria:

* patients with low back pain and/or leg radicular pain under diagnoses as disc herniation or spinal stenosis

Exclusion Criteria:

* allergy to local anesthetics or contrast medium, coagulopathy, local infection at the injection site, and systemic infection
Prognosis of Very Low Dose SPECT

Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a nuclear isotope during a stress on the heart that permits taking pictures of the heart muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of the nuclear isotope than standard protocols, by utilizing a new, more efficient camera (called an Alcyone camera) which could decrease radiation dose to patients while still providing excellent clinical information. Subjects will undergo imaging under the Alcyone camera after undergoing stress testing with exercise or a standard medication simulating exercise, and then at rest if needed. Subjects will have follow-up to measure events occurring after the test, such as death, heart attack, unstable angina, repeat emergency department visit for chest pain evaluation, or repeat imaging needed to evaluation for coronary artery disease. Radiation doses and quality of the images from the imaging with the new protocol will be recorded to compare to those used in standard nuclear imaging protocols. The primary study hypothesis is that greater than 90% of patients who have a normal very low dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3 months after study of death, nonfatal myocardial infarction, unstable angina, and repeat emergency department visit for chest pain evaluation or repeat anatomical or functional cardiac imaging.

See brief summary above.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponin levels taken 4 or more hours apart.
* Age greater than 18 years.
* Written informed consent is obtained by a study investigator.

Exclusion Criteria:

* Previous Myocardial perfusion scintigraphy (MPS) with evidence of scar
* Previous MPS with evidence of ischemia and no subsequent revascularization
* Known dilated left ventricle
* Known cardiomyopathy
* High pre-test probability of a perfusion defect on MPS
* Body mass index greater than 35
* Prisoner status
Effects of IASTM Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome.

This study will see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. In the reference study only male population was targeted which did not show effects of both techniques on the female population though females have high stress levels which may alter results.

The upper cross syndrome involves stiffness of levator scapulae, pectoralis major and upper trapezius muscles and serratus anterior, deep neck flexors, rhomboids, middle and lower trapezius and scalene muscles weakness. Numerous bodily abnormalities such as headache, early deterioration of cervical spine and loss of cervical spine curve can be brought on by this syndrome. This syndrome can also result in thoracic spine abnormality and impaired glenohumeral joint biomechanics. Upper cross syndrome develops abnormality in head, neck and shoulder and develops in upper 1⁄4 of the trunk. The underlying causative agents of Upper cross syndrome are long surgeries, weakness, female gender, disability and poor posture. It was a randomized, controlled trial, conducted among patient with upper cross syndrome with Sample size was 44 by using G- Power software. Group A will be given IASTM with Graston's tool and comprehensive corrective exercise program and Group B will receive only comprehensive corrective exercise program. The protocol will consist of 12 sessions in total with 3 sessions a week 45 minutes / session for both groups. Assessment will be at baseline then after 2 weeks after that 2 weeks home plan for exercises and then after 4 weeks assessment will be done. Only pain will be assessed on alternative days

Eligibility Criteria:
Inclusion Criteria:

Age 18-40 years.

* Diagnosed patients with the upper crossed syndrome who have chronic neck
* pain for more than 3 months.
* Having neck pain scoring more than 3 on the Numeric Pain Scale were included
* in this study.
* Any abnormality in the position and rhythm of the scapula, as measured by the Scapular dyskinesis test, having postural changes such as excessive thoracic kyphosis (≥42°), forward head (≥44°) or round shoulder (≥49°) as measured by Flexicurve and photogrammetry.
* Both male and female population will be included

Exclusion Criteria:

The subjects with any previous surgery, any type of Infection Hypersensitive skin Diabetes Mellitus type II Having Traumatic Injury Psychological disorder Manual Therapy contraindication like osteoporosis, infection, Disc- Herniation acute Inflammation, burn scars, closed /non-complicated fractures and open wound.
BMS-986012 in Relapsed/Refractory SCLC

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histological or cytological confirmed small cell lung cancer (SCLC)
* Performance Status 0-1
* Adequate organ function
* Measurable disease

Exclusion Criteria:

* Known or suspected brain metastasis
* Small cell cancer not lung in origin
* Significant or acute medical illness
* Uncontrolled or significant cardiac disease
* Infection
* ≥ Grade 2 peripheral neuropathy
* Concomitant malignancies
* HIV related disease or known or suspected HIV+
* Hepatitis B or C infection
* ECG abnormalities as defined by the protocol
* Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine and Nivolumab

Other protocol defined inclusion/exclusion criteria could apply
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine whether whole body exercise training alters the immunity in the lungs of people with COPD and reduces the incidence of chest infections over the longer term.

Patients will undertake an 8 weeks pulmonary rehabilitation program of exercise and education. Those who decline to take part in pulmonary rehabilitation will have the same outcome measures collected at the same timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (FEV1/FVC \< 70), smoking Hx of minimum of 10 pack years

Exclusion Criteria:

* Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks
Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma

Pelvic girdle pain (PGP) related to pregnancy is a common reason to sick leave during pregnancy. Low back pain and PGP affects about 50% of women during pregnancy. Most of the women recover, however about 10% of the women still have complaints after birth. Most patients have positive effect from conservative treatment, but unfortunately some do still have much pain despite intensive conservative rehabilitation. Surgery has been tried on these women with various results. Surgical treatment is controversial and there is a lack of documentation. The investigators will operate 20 patients with arthrodesis to the sacroiliac joint and symphysis. Radiostereometric analysis (RSA) will be used to evaluate the joint movement in different part of the process.

Hypothesis: Severe pelvic girdle pain is caused by pelvic joint instability in some cases and surgically fixation of the affected joints can help these women to get back to a normal life.


Eligibility Criteria:
Inclusion Criteria:

* Pain in one or more pelvic joints.
* Minimum 2 positive clinical tests.
* High pain and disability score
* Tried adequate physiotherapy without effect.

Exclusion Criteria:

* Known psychiatric diagnosis
* Other spine pathology
* CT verified ankylosis
* BMI\>30