cyrilzakka/clinical-trials huggingface dataset:
Impact of Red Light Therapy on Alleviating Visual Fatigue in Presbyopes

Visual fatigue, or asthenopia, occurs when visual demands exceed the capacity of the visual system, leading to various ocular discomfort and systemic symptoms. This condition can negatively affect personal activities, quality of life, and work productivity. Given the high prevalence of asthenopia in presbyopic population, finding effective methods to alleviate these symptoms is crucial. This study aims to evaluate the effects of repeated low-level red-light (RLRL) therapy on alleviating visual fatigue in individuals with presbyopia over a one-month period. Additionally, we will assess the potential benefits on accommodation function, cognition, and emotional effects of RLRL in this population.

Interested individuals will be invited to the PolyU Optometry Clinic to undergo an eligibility examination. An estimated sample size of 66 participants will be recruited. The inclusion criteria specify individuals aged 40 years or older who self-report visual fatigue symptoms and require near correction in daily life. Exclusion criteria include those with ocular disease, systemic diseases, illiteracy, or an afterimage duration longer than 6 minutes.

Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Each participant in the intervention group will be provided an RLRL therapy device, which they are required to use twice daily for 3 minutes per session, with a minimum interval of 4 hours between sessions, 7 days a week for one month. Participants in the control group will receive a sham device, following the same usage schedule. The study will evaluate changes in asthenopia questionnaire scores, CFF scores, other objective asthenopia indicators (i.e., eye movement, pupil parameters, and blink patterns), accommodation function, cognitive function, and emotional states at 2 weeks and 1 month compared to baseline. Statistical analysis will be conducted to explore evaluate within-subject changes over time and between-group differences in visual fatigue metrics, accommodation metrics, cognitive metrics, and emotional metrics.

The findings will contribute to evaluating the effectiveness of RLRL therapy in reducing asthenopia and presbyopia symptoms, as well as its impact on cognitive function and emotional well-being.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged over 40 years old.
* Self-reported visual fatigue symptoms.
* Distance best-corrected visual acuity (BCVA) of 0.5 LogMAR or better, and near visual acuity worse than N8 (20/50) at 40 cm with the subject's habitual distance correction.
* Require near correction in daily life.
* No light therapy received in the past six months.
* Giving informed written consent.

Exclusion Criteria:

* Presence of diseases that can cause eye pain or headaches, such as strabismus, glaucoma, ocular trauma, conjunctivitis, migraines, keratitis, iridocyclitis, or other self-reported diseases.
* Systemic diseases (e.g., epilepsy, photosensitivity, seizure) or illiteracy.
* Afterimage time longer than 6 minutes.
Emerging Adults Who Use Alcohol and Marijuana

The purpose of this study is to if a brief motivational intervention, compared to health education sessions, reduces alcohol and marijuana use and is related to fewer sexually transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 25
* Binge drink (5 or more drinks in a 2-hour period for men, 4 or more for women) at least monthly
* Use marijuana at least weekly
* Have been heterosexually active in the past six months
* Are not married
* Have not been living with a sexual or romantic partner for more than 6 months
* Be English speaking
* Reside within 20 miles of Providence, RI and plans to stay in the geographic area for the next 15 months
* Provide contact information for at least two verifiable locator persons

Exclusion Criteria:

* Have DSM-IV diagnosis of drug abuse or dependence (other than nicotine, marijuana)
* Have DSM-IV diagnosis of alcohol dependence
Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.

This is a prospective investigation of the effects of Laughter therapy (LT) on perceived stress, self-efficacy, mood and other wellness measures in people with the following neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord injury.

Laughter therapy (LT) has potential benefits in treating illness. It combines laughter with breathing and body exercises to stimulate laughter, both real and artificial, in a group setting. Laughter therapy may help treating illness by strengthening breathing muscles, improving mood, and providing pain and stress relief. EvergreenHealth has presented laughter therapy classes to patients with Parkinson's disease and Multiple sclerosis and other neurological conditions. The therapy will be led by a certified laughter therapist and mental health professional.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis based on medical record review of one of the following neurological diseases: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease, Post-Stroke, Spinal Cord Injury.
* Medically stable for at least 2 months.
* Not participating in Laughter therapy for 30 days prior to screening.

Exclusion Criteria:

* Females who are pregnant
* Any unstable medical condition
* Severe cognitive deficits that would interfere with participation (e.g. unable to follow commands).
* Severe abdominal pain, chest pain or back pain.
* Abdominal, chest or back surgery within 90 days.
* Psychosis or severe mental illness.
* Untreated hernia.
* Persistent cough.
* Advanced hemorrhoids.
* Epilepsy.
* Uncontrolled Hypertension - SBP \>170 or DBP \>105.
The EASYTRAK EPI Clinical Investigation

The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.

This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the EASYTRAK EPI indications
* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
* Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
* Patients who meet any one of the following three conditions:

  * Meet current indications for cardiac resynchronization therapy (CRT) and epicardial placement of a pace/sense lead on the left ventricle is preferred over an endocardial lead
  * Meet current indications for a cardiac pacing system and have documented evidence that an endocardial lead cannot be used
  * Meet current indications for a cardiac pacing system and a concurrent cardiac surgical procedure is taking place where no additional surgical procedures are required to provide access to the epicardial surface of the heart

Exclusion Criteria:

* Patients who meet the EASYTRAK EPI contraindications
* Patients who have had a myocardial infarct, unstable angina, or percutaneous coronary intervention during the preceding 30 days prior to enrollment
* Patients with a documented life expectancy of less than 6 months or expected to undergo heart transplant within the next 6 months
* Patients enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study
* Women who are pregnant or plan to become pregnant
Uterine Artery Diastolic Notching & Apelin-13 and 36

This study was conducted to investigate the relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and 36 concentrations between 11 and 14 weeks of gestation.

Apelin-13 and apelin-36, which provide vasodilatation through a nitric oxide-dependent mechanism, also play a role in trophoblasts' survival, proliferation, and migration.

Based on this, we aimed to investigate serum apelin-13 and apelin-36 concentrations in pregnant women with and without diastolic notch on uterine artery Doppler between the 11th and 14th weeks of pregnancy.

We hypothesized that apelin-13 and apelin-36 might be associated with the formation of diastolic notch in uterine artery Doppler and serum apelin-13 and apelin-36 concentrations would be lower in the group with a notch in the uterine artery Doppler than in the group without a notch.

Eligibility Criteria:
Inclusion Criteria:

1. Nonsmokers,
2. Singleton pregnancies between 11 and 14 weeks of gestation
3. Pregnant women who did not conceive with assisted reproductive methods

Exclusion Criteria:

1. Smokers
2. Pregnant women who conceived with assisted reproductive techniques
3. Pregnant women with multiple pregnancies
4. Pregnant women who started with multiples and continued with singletons
5. Pregnant women with any pregestational disease, thrombophilia
6. Pregnant women with any congenital uterine anomaly
7. Pregnant women with a history of recurrent pregnancy loss
8. Pregnant women using aspirin or heparin
Saliva Levels of S100A12, CRP, Fetuin-A in Periodontal Disease Patients

Hs-CRP, Fetuin-A and S100A12 are acute phase proteins associated with many systemic diseases and conditions. The aim of this study was to determine the clinical parameters and salivary Hs-CRP, Fetuin-A and S100A12 levels before and after non-surgical periodontal treatments in the patients with periodontal diseases.

A total of 54 subjects were divided in to three groups; periodontally healthy (n: 18), gingivitis (n: 18), chronic periodontitis (n: 18). Clinical periodontal parameters, salivary Hs-CRP, Fetuin-A and S100A12 levels and salivary flow rates were evaluated at baseline and a month after the treatments. Salivary Hs-CRP, Fetuin-A and S100A12 levels were assayed by ELISA.


Eligibility Criteria:
Inclusion Criteria:

never-smokers no history of systemic disease no patients had been under periodontal therapy and medicine for at least 6 months before the study no pregnancy or lactation no alcohol or antioxidant vitamin consumption.

Exclusion Criteria:

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Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

A Phase II, single-center, randomized study of albumin-bound paclitaxel combination with capecitabine versus capecitabine monotherapy in paclitaxel/docetaxel-resistant advanced breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 70 years old
2. Histological proven unresectable recurrent or advanced breast cancer
3. Negative for human epithelial receptor-2 (HER2) by immunohistochemistry. A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
4. Patients who developed disease progression within 12 months of previous paclitaxel-containing chemotherapy regimens.
5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
6. Performance status no more than 1
7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
8. Life expectancy longer than 12 weeks
9. No serious medical history of heart, lung, liver and kidney
10. Be able to understand the study procedures and sign informed consent.
11. Patients with good compliance.

Exclusion Criteria:

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
4. Treatment with an investigational product within 4 weeks before the first treatment
5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
7. Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
8. Uncontrolled serious infection
Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation

In patients undergoing coronary bypass surgery; 10% topical lidocaine administered endotracheally before intubation is to investigate the effect of hemodynamic response and EKG paramater after intubation.

This prospective randomized double-blind study consisted of 60 volunteers undergoing coronary artery bypass surgery. Patients will be randomized and divided into two groups as control (Group C) = 30) and topical lidocaine group (Group L) = 30). Two intravenous 18-gauge (G) cannula will be inserted to all patients. Premedication will be provided with 0.03 mg/kg intravenous (iv) midazolam (Dormicum 1 mg/ml, Roche preparations Inc., Istanbul Turkey) and 50 mcg fentanyl and patients will be given 2 L / min O2 via nasal cannula. Radial artery cannulation will be performed by applying an Allen Test with 20G cannula under topical anesthesia. heart rate (HR), mean arterial pressure (MAB), peripheral oxygen saturation (SpO2) will be recorded. Induction of group C will be performed after preoperative preparation. No intervention will be made in group c and standard anesthesia protocol will be applied.

Group L (intervention group) Oral-tracheal lidocaine spray will be applied. The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine pump spray 10% 50 ml) 160 mg (16 puffs) . After pre-oxygenation, anesthesia induction will be performed with intravenous administration of 2 μg / kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium bromide (Esmeron 5 mg vial, Organon Oss Holanda). Tracheal intubation of all patients will be performed by an experienced anesthesiologist after providing adequate relaxation. Anesthesia will be maintained with sevoflurane(Forane, Abbott, İstanbul Türkiye) % 2 in a 50% Air +50% O2 mixture. ECG recording of participants will be performed before (baseline) and after one minute from induction and at the first and third minutes following intubation. Hemodynamic measurements and record (MAB, HR, SpO2) will be performed at baseline one minute after the induction of anesthesia as well as at 1,3,5,10 min after tracheal intubation. Before the ECG analysis, all participants will be blinded by closing their group names on the ECG recording. QTc (corrected QT,), QT intarvale dispersion (QTd), P wave dispersion will calculated by a blind researcher within a 12-lead ECG recording (velocity: 25 mm / sec, Amplitude: 10 mm / mV). QTd , was the difference between the longest QT intervale(QT max.) durations and shortest QT intervale(QT min.) durations(msec); P wave dispersion, was the difference between the longest and shortest P-wave durations(msec); QTc interval was calculated using Bazett's formula (QTc = QT/√RR).)

Eligibility Criteria:
Inclusion Criteria:

* 50-75 between age patients
* ASA status III patients
* patients undergoing coronary artery bypass graft operation

Exclusion Criteria:

* cardiomyopathy,
* arrhythmia,
* valvular disease,
* electrolyte disorders
* chronic liver and kidney diseases
* use of medication that led to extended QT intervals
Non-invasive Molecular Imaging of Muscle Structure (MSOT_muscles)

This study aims to determine hemoglobin and collagen levels in muscles before and after exercise, and over time, using Multispectral Optoacoustic Tomography (MSOT). During MSOT, a transducer is placed on the skin similar to a conventional sonography and instead of sound, energy is supplied to the tissue by means of light flashes. This leads to a constant change of minimal expansions and contractions (thermoelastic expansion) of individual tissue constituents or molecules. The resulting sound waves can then be detected by the same examination unit.

Duchenne muscular dystrophy (DMD) is one of the most common progressive childhood muscle diseases with an incidence of 1 in 3500 male newborns and is associated primarily with decreased life expectancy. Pathogenetically, there is a deficiency of dystrophin, a structural protein of the sarcolemma, which is caused by mutations (usually deletions) of the dystrophin gene (Xp21.3-p21.2). The result of dystrophin deficiency is a necrosis of muscle cells that are replaced by connective tissue and adipose tissue. Clinical scores (6-minute walk test, 6MWT) and MRI studies to characterize the degenerative changes of skeletal muscle in the early stages are available for the quantitative assessment of the disease progression as well as therapy effects, the significance of which is controversially discussed. However, the highly sensitive assessment of gene therapy effects will become increasingly important in the future. Sensitive, non-invasive methods for the detection of early muscle degeneration and muscle function in the course are of great clinical and scientific importance.

MSOT has already been demonstrated to be a potential monitoring tool in different diseases. However, it has not yet been investigated to what extent 1) previous physical activity 2) different measuring ranges at the muscle, 3) longitudinal measurements and 4) intra- and interoperative variability influences the measured results. In particular, molecular changes immediately after the 6-MWT are relevant for studies in patients with DMD.

In this first pilot study, the investigators want to investigate in healthy adults, whether increased exercise changes the hemoglobin values, whether the collagen content remains constant and whether repeated measurements at different muscle positions by different investigators provide consistent results over time. This information is indispensable for future studies of children with muscular diseases in order to be able to make statements about disease progression or even therapy response.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age

Exclusion Criteria:

* any reference to a myopathy
* pregnancy
* tattoo in the scanning region
Perioperative Lung Function Monitoring After Anatomic Lung Resections

Aim of this study was to prospectively investigate the correlation between postoperative spirometry values and pulmonary complications after anatomic lung resections. In addition, the investigators compared postoperative pulmonary function changes between open and minimally invasive approaches.

All patients undergoing an anatomical lung resection at the investigators' institution were evaluated for this study. Underage patients and those undergoing extended resections (including resection of the chest wall and/or diaphragm) and/or bronchoplastic procedures were excluded.

In every eligible patient undergoing an anatomic lung resection, preoperative spirometry was performed using a handheld spirometer on the day before surgery and on every second day after surgery was performed until patient discharge. The absolute values of FEV1 were recorded by an independent study nurse and noted on a separate sheet not available to the treating doctors.

At the end of the study period FEV1 values were evaluated especially with focus on their correlation with postoperative pulmonary complications (i.e. pneumonia, acute exacerbation of COPD, air leak and atelectasis). Furthermore lung function values of patients undergoing 'open' resections were compared with patients undergoing minimally invasive resections.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing anatomical lung resection
* Written informed consent

Exclusion Criteria:

* Underage patients
* Extended resections including resection of chest wall or diaphragm
* Bronchoplastic resections
Midodrine Effect on the Mortality Rates in Septic Shock Patients

Assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18 years or older diagnosed with septic shock.
* Hypotensive and require IV vasopressor for more than 24 hours.

Exclusion Criteria:

* Hypovolemic shock.
* Severe organic heart disease (ejection fraction \<30 percent).
* Bradycardia (HR\<50 b/m).
* Chronic kidney disease (serum creatinine \>2mg/dl).
* Thyrotoxicosis.
* Pheochromocytoma.
* Known allergy to midodrine.
* Unable to administer an oral medication.
Treatment Monitoring of Advanced Colorectal Cancer With 18F-FDG PET/CT

Measuring tumor response to treatment based on computed tomography (CT) and/or magnetic resonance imaging (MRI) has been a widely debated issue (response criteria in solid tumors \[RECIST\] and World Health Organization criteria). Furthermore, early identification of nonresponding patients is of great importance because the rates of response of common malignant solid tumors to chemotherapy are in the range of only 20-30%. Therefore, quantitative imaging of tumor metabolism with 18F-FDG PET/CT may provide important advantages and thus reduce side effects and costs of ineffective therapy. However, the evidence to date for the use of 18F-FDG-PET/CT with this indication is limited.

The purpose of the present trial is to determine the impact of 18F-FDG PET/CT in the management of advanced colorectal cancer. The aim is also to confirm whether a metabolic response can be used as a surrogate end point in monitoring treatment response in this cancer type.

The study consists of 40 patients with advanced colorectal cancer patients. All patients will be studied with 18F-FDG PET/CT combined with diagnostic contrast enhanced abdominal CT before the start of chemotherapy and re-evaluated 4-5 weeks after the initiation of therapy. Effect of this metabolic and anatomic change in therapy are evaluated and correlated to survival, morbidity, and treatment -related costs. Histopathologic confirmation of response is evaluated whenever possible. The data will be collected between 2008 and 2012.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 80 years old
* Language spoken: Finnish or Swedish
* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
* earlier diagnosed (histologically confirmed) colorectal cancer with discovered metastases at operation
* Earlier diagnosed and treated colorectal cancer with discovered recurrence in the follow up
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
* Vulnerable study subjects such as described in Finnish law concerning clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.