cyrilzakka/clinical-trials huggingface dataset:
Influence of Lachrymal Substitute Gels on Tear Film Thickness in Patients With Moderate to Severe Dry Eye Syndrome

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, exact information about the tear film thickness and the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.

Recently a new method for assessment of tear film thickness based on ultra high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess tear film thickness and corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane® Gel Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged over 18 years
2. Signed and dated written informed consent
3. History of dry eye syndrome for at least 3 months
4. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
5. OSDI ≥ 22
6. Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
7. No administration of topical lubricants 12-24 hours before the screening examination

Exclusion Criteria:

1. Presence of an ocular pathology judged by the investigator as incompatible with the study.
2. Any other clinical relevant ocular abnormality except DES.
3. History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.
4. History of known clinically relevant allergy.
5. Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplastic, haematological disease; severe psychiatric illness, etc.).
6. History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
7. Pregnancy, lactation.
8. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
9. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
10. Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
11. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
12. Subject is a ward of court.
The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

The investigators hypothesize that partial robotic tongue base resection surgery and / or soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to characterize the dysphagia The investigators will locate participants undergoing this surgery more than six months ago.The investigators will test their swallowing by fiberoptic endoscopic evaluation of swallowing (FEES) and let participants fill out a questionnaire regarding swallowing disorders swallowing dysfunction questionnaire (SDQ). Also the investigators will use data collected from participants who have undergone this surgery and already had these tests due to swallowing complaints.

first step: The investigators will review the operating room reports, identify participants who underwent trans-oral robotic surgery for base of tongue and/ or soft palate surgery more than six months ago.

second step:

1. The investigators will locate and conclude data of participants who already underwent assessment of postoperative swallowing function (FEES test and SDQ).The investigators will review the summary of their meeting.
2. The investigators will Call participants who have not yet done swallowing assessment and invite them to a clinic appointment.

third step- participants come to the clinic. Receive an explanation, sign a consent form. Then the participants fulfill the SDQ questionnaire (patient self- filling questionnaire) in which the participants assess the quality swallowing.

Then the investigators will conduct the swallowing test - FEES test. During This test fiber optic fiber is inserted through the participants nose for the purpose of observing the pharyngeal and laryngeal areas.The participants eat and drink food and with different textures while looking for their swallowing mechanism via the optical fiber in order to identify swallowing problems.

forth step- Two laryngologists and a speech therapists will go over the recorded swallowing tests, filling out the two questionnaires:Swallowing performance status scale (SPSS) and Penetration- aspiration scale (PAS).

With these scales every participant receives a score that reflects the quality of swallowing. A higher score indicates a more severe swallowing disorder.

Eligibility Criteria:
Inclusion Criteria:

* participants above 18 years who had Robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea.

Exclusion Criteria:

* participants who previously underwent surgery or treatments known to be hazardous for swallowing.
* participants suffering from a neurological problem that affects the quality of swallowing.
* Tracheostomized participants.
Students and Trainers' Evaluations Correlation

The delegation of procedures within the medical competence to the nurses can increase the effectiveness of the healthcare provided. The objectives of the study are (1) to assess the quality of training courses for delegated surgical procedures through implementation for graduate scrub nursing ("students") (2) and to evaluate the correlation between the evaluation of this training carried out by students and the self-assessment conducted by the faculty ("trainers").


Eligibility Criteria:
Inclusion Criteria:

* scrub nurses already in practice
* professional trainer, specialist in the field of the proposed course subject
Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma

Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma

Data collection (electronic case report forms), Data dictionary (MedDRA)

Eligibility Criteria:
Inclusion Criteria:

* 19 years and older, female and male
* IOP ≤21 mmHg
* Subject showing open angle finding, glaucomatous optic nerve damage and visual field defects
* BCVA ≥+0.2

Exclusion Criteria:

* Subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc)
* Subject who can't discontinue contact lenses
* Subject who can't discontinue topical/systemic IOP lowering medication
Studying Chromosomes in Samples From Younger Patients With Neuroblastoma

This research studies chromosomes in samples from younger patients with neuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

OBJECTIVES:

I. Determine the impact on overall survival of patients with non-MYCN neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age.

OUTLINE:

Archived DNA samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (MLPA), a polymerase chain reaction (PCR)-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.

Eligibility Criteria:
Inclusion Criteria:

* Samples from neuroblastoma patients who, according to risk stratification, did not receive cytotoxic treatment and did never receive chemotherapy and are in complete response (CR) OR patients who, according to risk stratification, did not receive cytotoxic treatment initially, but had a localized or a systemic (stage Ms or M) relapse with or without following chemotherapy

  * Low-risk Children Oncology Group (COG) designation: no initial cytotoxic treatment, any stage, any age, any outcome
* DNA from untreated neuroblastoma tumor samples (from patients in the age group below and from patients in the age group above 1.5 years of age) available from the COG, Europe, Israel, and Japan
* No MYCN amplification
* No Schwann cell stroma-rich tumors
* No tumor cell content below 60%
* No DOT
* No patients diagnosed before 1997 and after 2005
* No lack of follow-up data
* See Disease Characteristics
* No initial cytotoxic treatment
Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.


Eligibility Criteria:
Inclusion Criteria:

* male
* acute watery diarrhoea defined as at least 3 watery stools per 24 hours
* duration of watery diarrhoea of less than 72 hours and with at least one watery stool during the last 12 hours
* dehydration signs requiring oral rehydration according to current WHO guidelines

Exclusion Criteria:

* severe dehydration that needs IV therapy
* presence of gross blood in stools
* fever \> 39 degrees Celsius
* current treatment by an antidiarrheal medication
MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP

The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years of age(male or female).
2. Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
3. Platelet counts at Screening of 30 billion/L or less for subjects not on ITP medication, or 50 billion/L or less for subjects receiving stable background ITP medication.

Exclusion Criteria:

1. Subjects who have had a splenectomy for any reason.
2. Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
3. Nursing or pregnant.
4. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
5. Any known history of bone marrow stem cell disorder.
6. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
7. Liver disease.
8. Malignancy within the past 5 years.
9. History of active tuberculosis (TB) or history of TB infection.
10. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
11. History of congenital immunodeficiency.
Efficacy of Remifentanil in Preventing Emergence Agitation

The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. The secondary aim of the study was to compare the demographic data, intraoperative and postoperative hemodynamic data, surgical time and modified Aldrete score of patients who received different intraoperative analgesia methods.


Eligibility Criteria:
Inclusion Criteria:

The study included patients over the age of 18, planned to undergo rhinoplasty by the plastic and reconstructive surgery department, and American Society of Anesthesiologist (ASA) I-II.

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Exclusion Criteria:

* Patients with a known history of allergy to the drugs to be administered in the study, ASA III and above, body mass index (BMI) 35\>kg/m2, younger than 18 years of age, any problems that would prevent general anesthesia in the preoperative evaluation (upper respiratory tract infection, etc.), and those who did not agree to participate in the study were excluded from the study.
Multimodal Imaging Analysis of Spinal Tumors

In this study, we retrospectively analyzed the imaging data of spinal tumors to find out more imaging features of spinal tumors, in order to provide more accurate reference for the diagnosis of spinal tumors.

Bone tumors account for 1-2% of total body tumors, and spinal tumors only account for 6.5% of total body tumors. Because of the low incidence rate, the number of patients and the attention in this field are far lower than other tumors, so far, all the researches on spinal tumors are relatively lacking. Because the diagnosis of bone tumor needs the combination of clinical, imaging and pathological to make a more accurate diagnosis, so the imaging diagnosis of spinal tumor is very important. In this study, through retrospective analysis of a variety of imaging data of patients with spinal tumor, measurement and recording of spinal tumor image related parameters, and statistical analysis, in order to find out more imaging characteristics of patients with spinal tumor, more accurate diagnosis of lesions, and provide more help for clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Complete and accurate clinical and pathological data are available；Imaging examination was performed in our hospital

Exclusion Criteria:

* Patients with missing image data and unclear image
Reading Together: How to Promote Children's Language Development Using Family-based Shared Book Reading

The aim of this project is to determine how shared reading promotes child language development, and to use this knowledge to make it an effective language-boosting tool for children from all social and economic backgrounds.

Two interventions will be created which are intended to boost children's vocabulary and grammar abilities, and will be assessed on how they are implemented by caregivers across different socio economic groups, and how they affect children's development of these language skills. Previous research has found dialogic reading interventions to be less effective for children from low socio-economic backgrounds. This project will investigate whether a shared reading intervention, designed to require less of a behaviour change from caregivers than dialogic reading, can be used to effectively boost vocabulary and grammar development in children across the whole socio-economic spectrum.

Eligibility Criteria:
Inclusion Criteria:

* All families will be included unless they fit the exclusion criteria.

Exclusion Criteria:

* Children born before 37 weeks gestation (premature)
* Children who weighed less than 5lb 9oz at birth (low birth weight)
* Children who have had an ear infection/glue ear for longer than 3 months, 4-6 ear infections within a 6 month period or another identified hearing problem (e.g. at newborn hearing screening)
* Children with an identified developmental disability (e.g. Cerebral Palsy, Autism Spectrum Disorder, Fragile X syndrome, Muscular dystrophy, Di George syndrome, Down's syndrome, Williams syndrome)
* Children with a hearing or visual impairment
* Children who hear another language (not English) for 1 day or more in a typical week (please note that this also excludes children of parents who do not speak English)
* Children whose parents have a learning disability which puts their children at risk of language delay and excludes the parents from giving informed consent on their own and on their children's behalf.
Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia

The purpose of this study is to pilot a mobile health intervention, originally designed for HIV retention in care, for use in aiding patients with medication refills. The study will implement the PositiveLinks Rx app with the Henrico Health department. The study will assess user engagement and satisfaction with the app as well as preliminary impact on patient refill compliance.

The study will enrolled provider and patient participants at the Henrico Health Department in Virginia who either receive or provide medication refills through the AIDS Drug Assistance Program (ADAP). Patient participants will be provided access to a mobile app that allows them to track their mood, stress, and medication adherence, access an anonymous online community, securely message providers, and receive medication refill alerts. Provider participants will be able to view the information entered by enrolled clients, securely message clients, and track medication refill processes. Study participants will be asked to provide feedback on usability, utility, impact, and effectiveness of the program. Additional assessments will evaluate for impact on medication refill adherence and patient-provider communication.

Eligibility Criteria:
Patient Inclusion Criteria:

* Currently picking up of receiving medications through ADAP from the Henrico Health Department; Able to read in English; Able to speak English; Able to sign informed consent

Provider Inclusion Criteria:

* Current Henrico Health Department employee working with the ADAP pharmacy; Able to read in English; Able to speak English; Able to sign informed consent

Exclusion Criteria:

* Severe cognitive impairment that interferes with a subjects ability to consent; non-English speaking; Prisoners
The Affecting Factors on Airway Temperature and Moisture

There is no literature information about the flow rate of fresh gas mixture (air+O2) in the patients who underwent general anesthesia. Different flow rates of fresh gas mixture are used in both the investigator's hospital and the experiences of the anesthesiologists. It is aimed to study the effects of different fresh gas flow rates on the rate of temperature and moisture of the airway of patients who underwent general anesthesia.

Under physiological conditions, inhaled air is heated and humidified as it passes through the nose and upper airways until reaching the alveoli. This mechanism is bypassed by endotracheal intubation. Ventilation with dry and cold compressed gases leads to loss of water and heat from the respiratory tract. Drying of the respiratory tract can lead to destruction of the cilia and mucous membranes, resulting in decreased mucociliary transport and increased concentration of secretions.There is no definitive literature on fresh gas mix (oxygen + air) flow rates in patients under general anesthesia. This study aimed to investigate whether two fresh gas flow rates routinely employed in the authors' practice affected airway temperature and humidity.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-65 years underwent general anesthesia -

Exclusion Criteria:admitted to emergency and trauma, history of advanced cardiac disease, cigarette use ≥ 3 packet/day, pulmonary parenchymal disease such as malignancy or chronic obstructive pulmonary disease (COPD), history of thyroid disease, body mass index (BMI) greater than 30 kg/m2, alcohol and substance addiction, mentally deficiency, pregnancy or postpartum, fever and infection, drug use such that would influence thermoregulation such as vasodilators, hemorrhage \> 5 mL/kg, and patients who declined to participate.

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Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD


Eligibility Criteria:
Inclusion Criteria:

* SCD with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users

Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.

100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT.

Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams.

Eligibility Criteria:
Inclusion Criteria:

* Long-term, daily NRT users (except nicotine patch) (\>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
* More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
* more than 10 puffs of nasal spray per day.

Exclusion Criteria:

* Age \< 18 years,
* CO Smokers,
* Pregnant and lactating women,
* Used varenicline before,
* Not able to cooperate,
* Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air \> 7 ppm.
The Effect of Traditional Mat Exercises Versus Reformer Pilates and Hammock Yoga on Chronic Back Pain

The purpose of the present study was to examine the effects of traditional mat exercises, Reformer Pilates and Hammock Yoga approaches on pain, endurance, balance, disability, and quality of life of individuals who had Chronic Back Pain.

Low back pain is among the leading musculoskeletal problems worldwide causing serious health expenditures. It can affect people of all ages in the community, but it is common in individuals between the fourth and fifth decades of life. Low back pain is divided into 3 subclasses according to the duration of the symptoms as Acute (lasting only a few weeks), Subacute (lasting about 6 to 12 weeks), and Chronic (lasting more than 12 weeks).Traditional exercise approaches are frequently used modalities in the treatment of Chronic Back Pain as an extremely valuable approach to preventing movement limitation, controlling existing pain, and regaining motor functions. Pilates exercises are very valuable for the treatment of low back pain because they provide stabilization. Pilates activates the lumbopelvic muscles and supports functional movement as an effective factor in reducing pain. Yoga is also a mind-body exercise discipline that includes both physical and mental aspects of pain with core strengthening, flexibility, relaxation, and breathing modalities.When the literature was reviewed, no study was detected examining the effectiveness of Hammock Yoga and Reformer Pilates in people who have Chronic Back Pain and compares it with traditional mat exercises.

Eligibility Criteria:
Inclusion Criteria:

* Being within the 25-60 age range
* Having low back pain in the last 6 months .

Exclusion Criteria:

* The history of surgery in the lumbar region in the last 1 year,
* Diagnosed radiculopathy,
* Systemic diseases
* Malignancy,
* Performed regular physical activity,
* Using steroids and anti-inflammatory drugs in the physiotherapy program