cyrilzakka/clinical-trials huggingface dataset:
Effects of Oculomotor Exercises on Volleyball Players

The researcher aimed to investigate the effects of oculo-motor exercises on dynamic visual acuity, balance and performance of volleyball players whose performance can be improved with visual skills training.

H0: Oculo-motor exercises applied to volleyball players are effective on dynamic visual acuity, balance and performance.

H1: Oculo-motor exercises have no effect on dynamic visual acuity, balance and performance in volleyball players.

This study on the Effect of Oculo-Motor Exercises on Dynamic Visual Acuity, Balance and Performance in Volleyball Players was ethically approved by the "Istanbul Medipol University Non-Invasive Ethics Committee" with file number 10840098-604.01.01-E.14171 on 16.04.2020. The study included 52 female volleyball players aged 16-26 who played participants for at least 3 years without interruption. Power analysis was performed using the 3.1.9.5 version of the G-Power program to determine the number of individuals to be included in the study. Type-1 was accepted as 0.05 and power ratio as 80%. Effect size 0.8 was taken. According to the results of the power analysis, the number of participants required to be included in the study was determined as 52.

Participants; Age, height, weight, gender, body mass index, dominant side, position played in volleyball, number of weekly training, daily training time, previous sports injuries, education status, smoking and alcohol use, accompanying illnesses were questioned. FBT and YBT were used for balance evaluations, and Nelson's Hand Reaction Test was used for reaction times. In addition, Dynamic Visual Acuity and Vertical Jumping distances were evaluated twice before and after treatment.

Participants included in the study, the control group continued their routine ball training after the evaluations, while the intervention group continued with the oculo-motor training for 4 weeks, 6 days a week, in the morning and evening, for 10 minutes, 2 times a day, in addition to normal ball training. they did the exercises. While doing the exercises, individuals were taught to focus on the purpose they held in their hands, move their head, and aim fast enough to see the image clearly. Two repetitions each week were added to the exercise numbers. Ten seconds rest between two sets and five seconds rest between movements.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 16-26
* Playing licensed volleyball for at least 3 years without interruption
* Have normal vision and hearing

Exclusion Criteria:

* Having a direct blow to the lower or upper extremity in the past month
* People with musculoskeletal disorders may experience balance (forward head posture).
* Refractive defects
* History of ankle fracture
* Double-sided ankle sprain
* Vision problems
* History of lower extremity surgery in the last 6 months
The Effectiveness of a Pressure Ulcer Prevention Programme for Older People in For-profit Private Nursing Homes

This study aims to evaluate the effectiveness of a PU prevention programme for for-profit private nursing homes

The study will be conducted as a two-arm cluster randomized controlled trial, which will compare the efficacy of a PU prevention programme versus usual PU prevention for older people in eight for-profit private nursing homes in Hong Kong. For-profit private NHs recruited will be randomly assigned as experimental or control groups. The nursing homes in the experimental group will be implemented a PU prevention programme. The programme includes a training course which was tailor-made for health workers(HWs) and persona care workers (PCWs) and also a 16-week PU prevention protocol. The outcome measures are incidence and prevalence rate of PUs as well as level of PU knowledge and skill among care staff in the nursing homes. In data analysis, survival analysis will be adopted for identifying PU incidence and prevalence rate. GEE will be used to analyze the time and effect differences of PU knowledge and skills among the care staff between two groups.

Eligibility Criteria:
Inclusion Criteria :

* For-profit private nursing homes having been classified as the category A2 homes in the Enhanced Bought Place Scheme and are eager to improve current pressure ulcer prevention care;
* For for-profit private nursing homes having a capacity of around 130-150 beds;
* For for-profit private nursing homes having no structured PU prevention protocol, and/or programmes in place;- Residents aged 60 or above
* Care staff including personal care workers, health workers and nurses who provide direct care to residents.

Exclusion Criteria:

* Care staffs who are not speak in Chinese.
South China Prospective Cohort Study of Chronic Disease

To investigate the risk factors and prediction biomarkers of chronic disease in adults aged 35-74 years.

To investigate the risk factors and prediction biomarkers of chronic disease within adults aged 35-74 years in South China. Following up the incidence of major chronic disease including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension.

Eligibility Criteria:
Inclusion Criteria:

aged 35-74 years local residents or lived in local for 5 years more

Exclusion Criteria:

Malignancy Cognitive impairment that can not cooperate with investigation
ACUpuncture in Diabetic Peripheral Neuropathy

Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.

The study will investigate the effect of a series of acupuncture treatments on subdimensions of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of the affected nerves are incorporated into the study as a possible morphological correlate of functional and clinical findings.

Eligibility Criteria:
Inclusion Criteria, among others:

* Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2
* Males and females aged \>18yrs \< 70yrs
* Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS)
* Completed titration of pain medication against diabetic peripheral neuropathy
* Pathological nerve conduction velocity and amplitude of N. suralis ( \<42meter/second and or \< 6 mikroVolt)

Exclusion Criteria, among others:

* Very severe diabetic peripheral neuropathy with muscular weakness of proximal leg muscles
* Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol toxic, or related to history of neurotoxic drugs.
* Severe peripheral artery disease Fontaine stage IV
* Ulcers or gangrenous lesions of the feet
Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it from other tissue types has been developed in a porcine model, by analysing a complex impedance dataset based on multiple measurement frequencies. It must now be confirm that the previous results are applicable in humans. Measurements from 24 predefined needle positions will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new algorithm to detect nerve tissue will be developed based on these measurement results. Further impedance algorithms will be developed for other tissue type. The efficacy of the algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers (part B).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* American society of anaesthesiologists score (ASA) 1 or 2
* Volunteers that have given informed written consent

Exclusion Criteria:

* Volunteers that cannot cooperate for the examination
* Volunteers with neurologic disease, nerve- or vascular impairment
* ASA \> 2
Neoadjuvant PSMA-RLT in Oligometastatic PCa

Prospective single-center phase II study to evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic radioligand therapy \[177Lu\]Lu-PSMAI\&T (PSMA-RLT) in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using \[68Ga\]Ga-PSMA-11 PET examination.

Ten patients with oligometastatic primary PCa diagnosed using \[68Ga\]Ga-PSMA-11 PET-CT/MRI imaging will be included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Oligometastatic PCa diagnosed using \[68Ga\]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.
* Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.
* Patients must be able to sign Informed Consent Form

Exclusion Criteria:

* Concomitant participation in any other interventional trial
* Concurrent severe oncologic and medical conditions that result in patients not having a life expectancy of longer than the duration of the trial.
* Nonmetastatic PCa on \[68Ga\]Ga-PSMA-11 imaging
* \>5 osseous metastases on \[68Ga\]Ga-PSMA-11 imaging
* Visceral metastases, apart from lungs
* Age \> 75 years.
* Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
* Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
* Complete urinary out-flow obstruction or severe unmanageable urinary incontinence
Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.

Implantation of bone marrow mononuclear cells, including endothelial progenitor cells and mesenchymal stromal cells, into leg ulcers has been shown to improve wound healing.

In the present study the safety and efficacy of autologous bone marrow mononuclear cells implantation will be investigated in patients with chronic leg ulcers. Forty cases will be enrolled. Improvement in the pain, rate and extent of leg ulcer wound healing as measured by change in wound surface area will be evaluated until one year.

Eligibility Criteria:
Inclusion Criteria:

* Stable sickle cell disease patients
* Patient hospitalized into the dermatology unit
* Patient with an evolutive leg ulcer since more than 1 year
* No infection at the time of surgery
* Patient competent to give informed consent

Exclusion Criteria:

* Patients with a history of corticosteroids or on active therapy
* infection at the limb affected by ulcer
* Recurrent painful crises,
* Immunosuppressive drug therapy,
* Pregnancy,
* Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer
Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.

PRIMARY OBJECTIVES:

I. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.

SECONDARY OBJECTIVES:

I. To confirm short-term safety within 1 month after bandage lenses.

II. To determine improvement in ophthalmologic examinations after bandage lenses.

III. To explore the use of optical coherence tomography as an objective measure of corneal inflammation.

OUTLINE:

Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic graft versus host disease (GVHD) as defined by the National Institutes of Health (NIH) criteria
* Ocular symptoms of NIH eye score 2 or greater:

  * Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops \> 3 x per day or punctal plugs), WITHOUT vision impairment
  * Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis
* No new systemic immunosuppressive medications within 1 month prior to enrollment
* Subject has the ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Absolute neutrophil count \< 1000/ul
* Known hypersensitivity or allergy to contact lenses
* Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment
* Treatment with contact lenses within the previous 3 months for any indication
* Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol
Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors

Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have solid organ tumors refractory to currently available treatments.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Have a life expectancy of 4 months
* Have normal organ and bone marrow function

Exclusion Criteria:

* Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to the 1st dose of the study drug or those who have not recovered from adverse events from agents administered more than 4 weeks earlier.
* Use of investigational agent in the 4 weeks prior to 1st dose of the study drug
* Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose
* Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
* Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
* Have a history of disease requiring ongoing steroid treatment
* Have a history of seizure disorders uncontrolled on medication
* Have a history of clinically significant coagulation or bleeding disorders or abnormalities
* Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.
* Are pregnant or lactating
Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.

To assess the prevalence and severity of frailty in patients undergoing LAAC, as well as its association to peri-procedural and long-term outcomes and quality of life.

Transcatheter left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with non-valvular atrial fibrillation and relative or absolute contraindications to oral anticoagulation (OAC).

Procedural safety and success are now excellent with approximately 98% of successful procedures without major complications. LAAC seems to offer persisting protection against ischemic events in long-term reports, while also decreasing bleeding risk by reducing antithrombotic treatment intensity. However, patients undergoing LAAC in real-world practice are a high-risk population with a high rate of adverse events, mainly not related to the LAAC device-procedure. As a prophylactic intervention, the beneficial effects of LAAC increase over time, as more potential adverse events (ischemic and haemorrhagic) are prevented. Thus, it took approximately 5 years to reach cost-effectiveness (favoring LAAC versus oral anticoagulation) in the pooled data from PROTECT-AF and PREVAIL randomized controlled trials. Patients that experience early death after LAAC do not fully benefit from the costly procedure - that can be therefore considered futile. In a recent study, close to 1 on 5 LAAC recipient had either died or suffered from a major ischemic event within the first year after the procedure highlighting the need for better patient selection before LAAC.

The definition of frailty is nonconsensual and has constantly evolved in the literature. Nonetheless, there is a general agreement that frailty is a multidimensional concept involving many domains (such as nutrition, mobility, strength and cognitive) and that frail patients are a high-risk population and vulnerable to stressors and adverse outcomes. Thus, considering this global definition, assessing frailty using multidomain scales is more appropriate to discriminate frail to non-frail patients.

Frailty and its association to adverse events are well-known in transcatheter aortic valve replacement (TAVR). Despite being performed in a high-risk population, frailty has not yet been studied in LAAC although it could be a potent indicator for futile or harmful procedures. The implementation of frailty assessment into the routine practice could help identify vulnerable patients who will most likely less benefit from the LAAC procedure. Therefore, in this prospective multicenter trial, the investigators seek to explore frailty and its consequences in LAAC recipients.

Eligibility Criteria:
Inclusion Criteria:

* Transcatheter LAAC with any approved device
* Age ≥18 years old

Exclusion Criteria:

* Unable to provide informed consent
* Severe neuropsychiatric impairment
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function.

The existence of coronary collateral vessels and their benefit against cardiac events have been recognized for many years, but their functional capacity in response to physical exercise has partially remained elusive. Via endothelial shear stress, the fundamental stimulus for collateral development, exercise theoretically leads to collateral vasodilation and recruitment by an increase in heart rate and blood pressure during exercise. Moreover, the phenomenon of "walking through angina" indicates that collateral function and physical activity are related and their interaction is of clinical relevance.

The purpose of the present study in humans with stable coronary artery disease was to assess the instantaneous response of coronary collateral function to dynamic physical exercise.

Eligibility Criteria:
Inclusion Criteria:

* Age more than or 18 years old
* 1- to 3-vessel coronary artery disease (CAD)
* Stable angina pectoris
* At least 1 stenotic lesion suitable for PCI
* Negative Allen-test
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients admitted as emergencies
* Acute myocardial infarction
* Unstable CAD
* Q-wave myocardial infarction in the area undergoing CFI measurement
* CAD treated best by CABG
* Severe valve disease
* Pregnancy
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask

Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask

1. Assess the process of scan, fit and print
2. Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and comfort
3. Ethnographic insights into the user experience of the scan, fit, print process.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Both genders
* Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA
* Currently CPAP pillows and nasal mask users
* Patients who are adherent as defined by conventional standards (i.e. 4 hours per night/70% of the nights)

Exclusion Criteria:

* Unwilling to wear the AVEERA
* Concern about privacy of data
* Pregnant
* Full face mask user
* Any medical condition deemed by the investigator to pose an issue with the subject's participation.
* Upper limit of CPAP pressure of ≥ to 15 cm H20 or APAP a upper limit pressure setting of ≥17cm H2O
* Requires the use of supplemental oxygen
PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action

Chronic dyspnea is the most characteristic symptom of patients with Chronic Obstructive Pulmonary Disease (COPD), with intermittent increases during exercise and other events.Despite optimal standard therapy, episodic dyspnea is a common occurrence in COPD. Recently, the PEP buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (PEP). Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. More research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. Therefore, the aim of our study is to explore the potential of this device for patients with COPD and episodic breathlessness.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥40 years
2. Read, understood and signed Informed Consent
3. COPD Gold class II-IV/ B or E (FEV1\<60% of predicted, CAT ≥10 points)

5. Optimized standard therapy according to the study physician 6. Episodic breathlessness requiring intervention (i.e. taking rest during physical activities, as needed inhalation medication, breathing techniques, as needed opioids) at least three days per week

Exclusion Criteria:

1. Other severe disease causing episodic breathlessness
2. Life expectancy ≤ 3 months
3. Exacerbation of COPD 4 weeks prior to inclusion
4. Change in COPD management targeted at breathlessness 8 weeks prior to inclusion
5. Inability to use the PEP buddy device
6. Currently participating in another interventional clinical study
7. Any other conditions, which, in the opinion of the investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.