cyrilzakka/clinical-trials huggingface dataset:
Stem Cells Therapy for Corneal Blindness

This is a investigative initiated, comparative pilot clinical trial to ascertain the safety of application of ex-vivo cultivated limbal stem cells in human eyes for treating different superficial corneal pathologies. Pre-clinical work in murine models have already demonstrated efficacy of this technique in curing murine corneal pathologies.

In this prospective interventional study patients with superficial corneal pathologies like scars, ulcers and burns will undergo a surgical procedure. Limbal ring from a cadaveric donor tissue, which is therapeutically accepted and serologically tested, is collected. This tissue will then be cultivated in the stem cell biology laboratory using standardized culture technique. Briefly the limbal tissue will be cut up into small pieces and digested overnight using an enzyme (Collagenase L). The cells obtained from the digest will be cultured on a petri-dish using 2% serum and growth factors. The cultured cells will be passaged three times to remove all epithelial cells from the culture. In the second procedure, the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 5x10\^3 cells/uL diluted in the thrombin component of fibrin glue (TISEEL, Baxter) will be applied to the debrided corneal stroma. A soft bandage contact lens will be placed over the cornea at the end of the procedure. The patient will receive topical antibiotic and steroid eye drops in the post-operative period. Periodic comprehensive ophthalmic evaluation along with anterior segment optical coherence tomography (ASOCT) scanning and slit-lamp photography will be done at day 1, day 7, day 45 and day 90.

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female participants who are aged between 18-60 years.
2. Patients who are having with unilateral blindness due to superficial (defined as involving the anterior 200 microns of the corneal stroma on ASOCT imaging) corneal wounds, ulcers, burns and scars.
3. Eyes with otherwise normal.

Exclusion Criteria:

1. Active infection, proven by microbiology.
2. Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation.
3. Children (\<18 years of age).
4. Inability/refusal to give written informed consent or to undergo any of the anterior segment imaging tests.
Myotonometric Measurement of Myofascial Trigger Points: Reliability, Validity and Sensitivity

The aims of this study are:

* To examine the inter-rater reliability to assess myofascial trigger points using a myotonometer
* To determinate the strength of the correlation between myotonometric parameters and isokinetic parameters
* To evaluate the sensitivity of myotonometric measurements to detect the location of myofascial trigger points

Previous researches have used complicated and expensive methods to measure mechanical properties of muscle tone like isokinetic dynamometer.

The purpose of this investigation is to establish the reliability, validity and sensitivity of a myotonometer to assess myofascial trigger points. The results of this study will verify the inter-reliability of a myotonometer device in order to evaluate muscle tone, examine correlations and associations between myotonometric measurements and isokinetic measurements and provide a measurable understanding of the location of myofascial trigger points.

Assessment:

Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone.

Isokinetic dynamometric technique is considered a valid biomechanics method to measure muscle tone in non-injured subjects but isokinetic machine is a heavy and expensive equipment.

Outcome measures:

Myotonometric measures will include muscle frequency, decrement (elasticity) and stiffness.

Isokinetic measures will include passive resistive torque to ankle dorsiflexion and dorsiflexion passive range of motion (PROM)

All outcome measures will be evaluated once.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-55 years.
* Healthy volunteers.
* Presence of a latent medial MTrP of the soleus muscle.
* Being able to provide written informed consent.
* Being able to follow instructions and realize clinical tests.

Exclusion Criteria:

* Any history of ipsilateral lower limb severe injury or intervention (e.g. fracture, surgical intervention).
* Pain or musculoskeletal injury, ligament injury, tendonitis or plantar fasciitis in the ipsilateral leg for six months previous to the evaluation.
* Peripheral or central nervous system neurological disease.
* Altered sensitivity in the studied area.
* Treatment of a myofascial trigger point in the sural triceps in the six months previous to the evaluation.
Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole


Eligibility Criteria:
Inclusion Criteria:

* Clear diagnosis of macular hole;
* The minimum diameter of the macular hole is \>400 μm;
* Without serious systemic disease that make patients can not be operated;

Exclusion Criteria:

* suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
* opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
* eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
* traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
* having a history of vitrectomy surgery;
* glaucoma in stage of preclinical, severe stenosis or closure;
The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters

This randomized controlled study evaluate the effect of mindfulness-based structured nursing interventions on the mental health parameters of risky pregnant women. The hypothesis of this study is that mindfulness-based structured nursing interventions has an effect of the state-trait anxiety, perceived stress, depression on high risk pregnant women.

Methods: This study, was carried out in three phases. In the first phase, the views and experiences of high-risk pregnant women about being treated in the hospital and in the third phase, their views and experiences about the intervention were determined through individual in-depth interviews.In the second phase, 40 high risk pregnant women were randomly assigned to the study and control groups. The study group (n = 19) received 8 days of mindfulness-based structured nursing interventions. The control group (n = 21) did not receive any intervention. Results were collected through data collection forms before the mindfulness-based structured nursing interventions, after the mindfulness-based structured nursing interventions is completed.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65
* Able to read and understand Turkish
* Written informed consent was obtained before participation in the study
* Diagnosed with a risky pregnancy and treated in hospital
* Not receiving any other psychological therapy
* No prior meditation experience
* The participants do not have any physical/mental disability or limitation and disease that would prevent them from participating in the program

Exclusion Criteria:

* Under 18 years old
* Cant read and understand Turkish
* Pregnant women who have not been diagnosed a risky pregnancy or treated in hospital
* Meditation or psychological therapy experiences before the study
* The participants who left the program voluntarily or participating in less than 70% of the eight-day program
Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients

In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system reminding though telephone and message, group B with intelligent surveillance system reminding though message, group C with manual reminder, and group D with natural state. The surveillance among the four groups were compared.

The adherence of doctors to published colorectal post-polypectomy surveillance guidelines varies greatly, and patient follow-up is critical but time-consuming. Previous studies we developed an automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system reminding though telephone and message, group B with intelligent surveillance system reminding though message, group C with manual reminder, and group D with natural state. The surveillance among the four groups were compared.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older who undergo colonoscopy.

Exclusion Criteria:

* 1)No pathological result.
* 2) No or invalid contact information.
* 3) The surveillance interval cannot be determined according to the surveillance guidelines, including poor bowel preparation, colorectal cancer or suspicious malignance, surgery or colorectal ESD history, those who fail to complete colonoscopy due to unbearable, pathological indications of not polyps, hamartoma or lymphoma polyps, history of ulcerative colitis, and so on.
* 4) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
* 5) Have drug or alcohol abuse or psychological disorder in the past five years.
* 6）Pregnancy.
* 7）Not suitable for recruitment after investigator evaluation because of other high-risk conditions.
Project FACTS (Fidelity Accuracy: Comparing Three Strategies)

The objective is to compare the accuracy, costs, and cost-effectiveness of three fidelity measurement methods to assess fidelity to cognitive-behavioral therapy for youth. The investigators will randomize 135 therapists, implementing cognitive-behavioral therapy, to 3 conditions: self-report, chart stimulated recall, and behavioral rehearsal (N = 45 for each group). To calculate the outcomes of interest, each condition will be compared to the gold-standard fidelity measurement method, direct observation.

To achieve the primary objective, the investigators plan to (1) identify the most accurate fidelity measurement method; (2) estimate the economic costs and cost-effectiveness of the fidelity measurement methods; and (3) compare stakeholders' motivation to use each method, as well as identify their perceived barriers and facilitators to use of each method. This study will have a significant positive impact in two ways. First, it will validate fidelity measurement methods that can be used for research. Second, it will produce tools that can be used by community mental health clinics to monitor therapist fidelity, an indicator of therapy quality.

Eligibility Criteria:
Inclusion Criteria: Therapists

* they provide mental health treatment services in community mental health agencies in the City of Philadelphia participating in this study and

  * have been trained in cognitive-behavioral therapy (CBT) through the City-sponsored CBT evidence-based practice initiatives, and/or
  * respond to a brief screening survey that they use CBT; and/or
  * are nominated by a supervisor as a therapist who uses CBT.

Exclusion Criteria: Therapists

* n/a

Inclusion Criteria: Supervisors

* they are supervisors or administrators (i.e., they hold leadership positions) in community mental health agencies in the City of Philadelphia participating in this study.

Exclusion Criteria: Supervisors

* n/a

Inclusion Criteria: Youth and their Legal Guardians

* Youth and their legal guardians will be eligible to participate in this study if the youth

  * is 3-24 years old and
  * has completed at least one session with a therapist who has enrolled to participate in this study.

Exclusion Criteria: Youth and their Legal Guardians

* if the child does not have a legal guardian who is able to consent (e.g., the Department of Human Services (DHS) is the guardian).
Non-vitamin K Oral Anticoagulants in Cardioversion

Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. The aim of this study is to investigate the complications and the use of NOACs in AF patients undergoing cardioversion.


Eligibility Criteria:
Inclusion Criteria:

* AF patients undergoing cardioversion

Exclusion Criteria:

-
Zonulo-hyaloido-vitrectomy for Malignant Glaucoma

The purpose of this study is to assess the zonulo-hyaloido-vitrectomy for malignant glaucoma through an anterior approach.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent the zonulo-hyaloido-vitrectomy for malignant glaucoma through an anterior approach

Exclusion Criteria:

* systemic disease or inflammation
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT

1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;
2. To explore the impact of Cinacalcet HCL using on the combined use of drugs;
3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.


Eligibility Criteria:
Inclusion Criteria:

- Parents/guardians must sign informed consent;

Must be males or females whose age are 18 to 75 years old;

Clinical diagnosis of chronic kidney disease on maintenance hemodialysis with secondary hyperparathyroidism;

iPTH must be equal or higher than 300Pg/ml;

Must not have received Calcimimetics(for example, Cinacalcet) within 6 months prior to enrollment;

Must have been on maintenance hemodialysis 3 times weekly (TIW) for at least 3 months(12 weeks) prior to enrollment and must be expected to remain on hemodialysis for the duration of the study;

Over 2-year life expectancy.

Exclusion Criteria:

- Hypocalcemia \[Corrected serum calcium level less than 2.1mmol/L(8.4mg/dL);

History of gastrointestinal bleeding or peptic ulcer disease and possibility of deterioration or recurrence;

Severe heart disease;

Epilepsy risk or history of epilepsy;

Hypersensitivity to Cinacalcet;

Drug abuse/addiction;

Plan to receive renal transplantation within 52 weeks;

Pregnant or lactating women;

Pregnancy plan within 1 years, or no guarantee on taking effective contraceptive measures within 1 year after enrollment;

Participated in other clinical trials within 4 weeks prior to enrollment;

Received parathyroidectomy within 24 weeks prior to enrollment;

Investigator judgment that patients are not suitable to enroll.
Air Quality Check in Gastrointestinal Endoscopy Unit

Air pollution sources in indoor area are one of the main factors for reducing indoor air quality of locations. A gastrointestinal endoscopy unit consists of the following area: procedural, recovery areas, and area for a disinfection and cleaning for equipment. This area is frequently exposed to the gastrointestinal gas expelled from patients and gas from electrocoagulated tissue through carbonation or electrocoagulation of neoplasms. This can be potential harmful component for respiratory health not only to medical practitioners but also to the patients who undergo endoscopic examinations. However, there has been scare data for the air quality check in the endoscopic unit.

Air pollution sources in indoor area are one of the main factors for reducing indoor air quality of locations. A gastrointestinal endoscopy unit consists of the following area: procedural, recovery areas, and area for a disinfection and cleaning for equipment. This area is frequently exposed to the gastrointestinal gas expelled from patients and gas from electrocoagulated tissue through carbonation or electrocoagulation of neoplasms (procedure of endoscopic submucosal dissection, endoscopic mucosal resection, etc). This can be potential harmful component for respiratory health not only to medical practitioners but also to the patients who undergo endoscopic examinations. However, there has been scare data for the air quality check in the endoscopic unit. The aim of this study is to check the air quality using conventional portable passive air quality monitoring sensors in gastrointestinal endoscopy unit.

Eligibility Criteria:
Inclusion Criteria:

* This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.

Exclusion Criteria:

* This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.
Emergency Department Telephone Quitline

The purpose of this preliminary study was to evaluate the intervention completion rate among cigarette smokers enrolled through the Emergency Department (ED) in a tobacco quitline (QL) and to assess the feasibility of a randomized controlled trial assessing the efficacy of this intervention.

This pilot study was a prospective, randomized, controlled, un-blinded study using a convenience sample of cigarettes smokers recruited through the ED.

Utilizing a computerized block randomization schedule, subjects were randomized in blocks of four to receive a proactive QL intervention through an established QL or a United States Public Health Service (USPHS) self-help manual. Proactive telephone counseling describes counseling that is initiated by a counselor rather than the subject. Both groups received strong advice to quit from study personnel.

Names and telephone numbers of patients randomized to the QL group were faxed to the QL which then initiated contact with the patient. Multiple contact attempts were made over the following week by telephone. Patients in the QL were instructed to call the QL if they had not been reached in one week. QL counseling involved an initial 45-minute telephone session followed by up to four 10 to 15 minute follow-up sessions around their identified quit date. QL patients not successfully contacted within one week of enrollment were sent a letter inviting them to call as well as information on strategies to help them quit.

Eligibility Criteria:
Inclusion Criteria:

* We enrolled patients aged 18 or older who reported current daily cigarette smoking for at least one year and who indicated an interest in attempting to quit smoking.
Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness

Caregivers of patients with disorders of consciousness are highly prone to developing mental health issues. The aim of this study is to investigate the psychological symptoms and care burden of caregivers of patients with disorders of consciousness (DoC), and to examine which characteristics of patients were burden predictors to caregivers.

This is a multi-center cross-sectional study in China, from August 2021 to October 2022. Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety, depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison with patients' age and caregivers' age-matched subjects who were randomly selected and without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive statistics were used to illustrate the socio-demographics. One-sample t-test, independent sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to detect the difference between groups due to the distribution of each variable.

Eligibility Criteria:
Inclusion Criteria:

- (1) Family caregivers without neurological, mental health, or learning disability history.

(2) Family caregiver with consciousness and capability of independently completing questionnaires.

Exclusion criteria:

1. Caregivers unwilling to participate
2. Not the dominant caregivers
Effects of VR and MR Exergaming on Mood and Executive Function During Workplace Microbreaks

This study aims to evaluate the effects of virtual reality (VR) and mixed reality (MR) exergaming interventions during workplace microbreaks on mood and executive functions. A crossover experimental design will be implemented with desk-based administrative employees. Participants will be randomly assigned to three conditions: VR exergaming, MR exergaming, and passive rest. Executive functions will be assessed using the PEBL Victoria Stroop Test, and mood state will be evaluated with the Positive Affect Subscale of PANAS (PA-PANAS). Secondary measures include heart rate, perceived exertion, and exercise adherence intention.The study will address the following research questions:

How do VR and MR exergames influence executive functions compared to passive rest? How do VR and MR exergames affect mood states in workers compared to passive rest? How do VR and MR exergames compare in terms of heart rate response and perceived exertion during workplace microbreaks? How do VR and MR exergames impact exercise enjoyment and the intention to continue exergaming?


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* No regular physical exercise in the last three months (less than three days per week, less than 30 minutes per session)
* No prior experience with VR/MR technologies
* No history of neurological or cardiovascular disorders
* No epilepsy, vertigo, or inner ear conditions
* No use of medications affecting the central nervous system
* Low or moderate physical activity levels, as assessed by the International Physical Activity Questionnaire (IPAQ)
* Cleared for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion Criteria:

* High physical activity levels as indicated by the IPAQ
* Not meeting the safety criteria for physical activity according to the PAR-Q
* Individuals experiencing dizziness, nausea, or discomfort while using VR/MR
* Vision impairments that prevent the use of VR/MR headsets
* Pregnant individuals