cyrilzakka/clinical-trials huggingface dataset:
Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

The objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.

The hypothesis is that the measured tear osmolarity from study participants decrease with sustained use of a over-the-counter artificial tears, TheraTears® lubricating drops, over an eight week period. Participant's dry eye symptoms would also improve with sustained use of TheraTears® lubricating drops.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 21 years of age and has full legal capacity to volunteer;
2. Has read and signed the information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
5. Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye.

Exclusion Criteria:

1. Has taken part in another research study within the last 30 days;
2. Planned contact lens wear during the course of the study;
3. Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
4. Any subject that violates the washout period by using eye drops during the 72hrs washout period;
5. Has any known ocular disease including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
6. Used Restasis (or similar topical medication) within the last 6 months;
7. Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable;
8. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
9. Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications;
10. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
11. Has undergone ocular surgery(LASIK, Cataract, etc)within the last year.
Study of the Diffusion of a Smoking Cessation Application Through an Online Network

Effective evidence-based interventions exist for smoking cessation delivered over the Internet, but consumer acceptance and adherence remains low. Scalable and efficient mechanisms to disseminate these interventions online are needed, and existing online social networks provide a potential mechanism. This is a proposal for a randomized, factorial trial of the dissemination of an evidence-based intervention through the massive Facebook social network, with the goal of determining intervention characteristics that drive viral spread.


Eligibility Criteria:
Inclusion Criteria:

* Facebook user
* Age 18 years or older
* Entered UbiQUITous Facebook Application
* Confirms smoker status
* U.S. resident

Exclusion Criteria:

* Non-smoker
* Under 18 years old
* Non-U.S. resident
* Non-Facebook advertisement point of entry
QOCA®-Image Medical Platform - Smart VCF Risk Management System

This project aims to develop and validate an automatic detection and classification system for vertebral compression fractures on computer tomography (CT) images using an artificial intelligence (AI) system (named Smart Bone) by Quanta.

A computer search of CT scans (2010.01.01-2018.09.30) was performed in Wan Fang Hospital. Those CT images that were retrospectively reviewed by experienced radiologists. The CT scans of 1000-1500 subjects aged 50 and above with and without thoracic or lumbar compression fractures were included in this project for machine learning and deep learning. The control group included those without compression fractures while the patient group were those with compression fractures. Subjects that did not meet the inclusion criteria were excluded.

The cortical layer of the T12-L5 spine images were manually labelled with the labeling software by the the technologists and confirmed the correctness of the image by an experienced radiologist. All the de-linked and completed images were provided to Quanta Computer Inc. for subsequent classification and analysis of AI machines for deep learning to facilitate the development of a system for automatic detection of pressure fractures by CT. This newly developed automatic system will be of valuable clinical impact in assisting radiologists to detect and classify vertebral compression fractures precisely and accurately.

Eligibility Criteria:
Inclusion Criteria:

* Cases with CT examinations acquired between 2010.01-2018.09
* Cases with CT examinations performed with one of the following protocol: whole body, abdomen, and spine
* Cases must be \>/= 50 years of age
* Cases with reports from CT examinations ditched as positive or negative compression fractures within a search range from T12 to L5 vertebrae.
* CT images with raw data that are allowed to be reconstructed in axial view with a slice thickness of 1.3 mm
* CT images with raw data that are allowed to be reconstructed in sagittal view with a slice thickness of 2.5 mm

Exclusion Criteria:

* CT images with imaging artifacts, foreign bodies, or implants
* Cases with comorbid conditions, such as infection, cancer metastasis, chronic osteomyelitis, or other nonosteoporotic compression fracture
Yoga on Stress Management in Adolescents

The World Health Organization (WHO, 2013) defined the 10-19 age group as "adolescent" and the 15-24 age group as "youth". Adolescence period; It is a period of rapid growth, development and maturation in terms of physical, mental, biochemical and social aspects.10-20% of children and adolescents living in the world have mental health diseases such as generalized anxiety disorders, depression, eating disorders, and post-traumatic stress disorders.In adolescents, yoga is practiced as a relaxing tool to reduce stress, especially for exam anxiety.In Turkey, there are no yoga-based experimental studies to prevent anxiety, stress and depression in adolescents.

The aim of the study is to examine the effect of the Yoga-Based Stress Management Program on the ability to cope with stress in adolescents.Stress management sessions of the Adolescent Health Promotion-Physical Activity, Nutrition, Stress Management (COPE HEALTH-TEEN) program will be used in the stress management training to be explained in the program. There will also be yin yoga exercises.

The general population of the research will be high school senior students in Safranbolu district of Karabük province in the 2021-2022 academic year. First of all, the stress, anxiety and depression levels of the adolescents will be calculated. The research will be carried out in a total of 14 high schools. Each school will be determined as a "cluster" and 7 experimental and 7 control schools will be randomly selected. Simple random draw method will be applied in the selection of experimental and control schools. Adolescents who meet the inclusion criteria will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* High school senior student

  * Those who volunteered to participate in the research and
  * Students who are allowed to participate in the research by their parents

Exclusion Criteria:

* Students with any physical or mental disability • Low levels of perceived stress, anxiety, depression
Effects of Virtual Reality in Pediatric Burn Patients

The aim of this randomized controlled trial is to find the effectiveness of Virtual reality as an adjunctive to transverse friction massage in pediatric burn patients for reducing pain, anxiety and enhancing elbow range of motion.

A burn injury is damage to the skin or other body parts caused by heat, chemicals, electricity, radiation, or friction.Pain or discomfort, redness and swelling, blistering, peeling skin, scarring , difficulty breathing, shock in cases of severe burn, fever as a complication of burn, anxiety and depression are some main signs and symptoms after burn injuries. Upper limb burn injuries are more common as compared to lower limb , trunk or head and neck. Physical therapy plays an important role in reducing pain and improving range of motion and prevention of contractures formation after burn injuries.

Virtual Reality training (VR) uses a computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real or physical way. In the context of burn injuries, VR can be used as a distraction technique during wound care procedures or as an adjunct to pain management, and reduction of anxiety level.

Transverse friction massage Therapy is a Cyriax technique , is applied by the fingers directly to the lesion and transverse to the direction of fibers.Pressure is applied with the ball of the practitioners thumb or fingers to the patient's skin or muscles. Friction massage applied correctly will quickly result in analgesic effect over the treated area. Friction prevents the adhesion formations as a result leads to improvement of range of motion , prevention of contractures formation as well as pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Willingly participated in the study.
* Age group:6-18.
* Gender: both Male and Female
* Acute burn injuries of elbow region (grade 2)
* Superficial wounds healing phase( 5-10) days
* TBSA is less than 20%

Exclusion Criteria

* Motion sickness
* History of seizure activity
* Burns on body region that impede use of VR equipment (ears, eyes, head)
* Deep burn (Grade 3,4)
* Fractures
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal pillows user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant
Intradialytic Parenteral Nutrition in Hemodialysis Patients

Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.

In cases where primary treatment of malnutrition is not effective, intradialytic parenteral nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids, carbohydrates and fatty acids as well as vitamins and trace elements can be given to the patients.

Effectiveness of IDPN has to be verified.

25% of hemodialysis patients who are treated for more than 5 years suffer from protein malnutrition. 7% have a protein catabolic rate less than 0,6 g/kgBW and day.

The conventional treatment of malnutrition include dietetic counseling, psychologic advice and giving additional oral nutrients.In many cases this kind of therapy is uneffective. If supplementary enteral nutrition is used, the additional intake of water has to be taken into consideration.

IDPN is a mode of treatment by which disadvantages of enteral nutrition and fluid overload of the patients can be avoided.During each dialysis session nutrients can be given and additional water simultaneously can be removed by ultrafiltration.

Some publications have shown that the catabolic state of the patients can be converted into an anabolic state. There are only small randomized studies showing the positive effect of IDPN.

In this german multicenter study malnourished hemodialysis patients are randomized into two groups. One group is treated with IDPN during each dialysis session for 16 weeks followed by 12 weeks of follow-up without IDPN. The control-group does not receive IDPN.

The parameters of metabolism are: Albumin, prealbumin, transferrin, phase angle alpha (bioimpedance), proteincatabolic rate (formal urea kinetics), BMI and subjective global assessment (SGA score).

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis therapy more than 6 months
* three times per week hemodialysis
* albumin \< 35 g/l
* prealbumin \< 250 mg/l
* phase angle \< 4,5°
* SGA score grade B or C
* informed consent

Exclusion Criteria:

* inadequate dialysis (Kt/V \< 1,2)
* chemotherapy or radiotherapy
* cardiac pacemaker
* acute bacterial infection
* acute immunological disease
* cancer disease
* severe hepatic insufficiency
* interferon therapy
* HIV disease
* severe diabetes mellitus
Free-Living Physical Activity and Energy Expenditure

We have recently validated a new device for measurement of physical activity and found it to detect type, duration and intensity of many types of physical activity at better than 98% accuracy. After further validating this device to determine if it can also accurately assess energy expenditure, we will use it to collect cross-sectional data on free-living physical activity and energy expenditure in adolescent girls.


Eligibility Criteria:
Study3: healthy lean and obese adults, at least 18 years of age.
Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity

This study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.

The investigators will collect safety information and evaluate effectiveness in patients who are prescribed with Lucentis® (Ranibizumab) injection in Retinopathy of Prematurity indication after receiving informed consent over a period of 4 weeks.

Subjects who received multiple doses, i.e., 2 or more doses, of Lucentis® injection will be defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks will be collected and analyzed separately.

Eligibility Criteria:
Inclusion Criteria:

1. Premature infants with retinopathy of prematurity (ROP)
2. Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea
3. In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study

Exclusion Criteria:

1. In the case that the legal guardian of the patient (infant) does not want participation in this study
2. In the case that it falls under any of the contraindications listed in local prescribing information of Lucentis® injection

   * Patients with hypersensitivity to the active substance or to any of the excipients
   * Patients with an active or suspected ocular or periocular infection.
   * Patients with active intraocular inflammation
Selective Manual Therapy Techniques in Chronic Obstructive Pulmonary Disease

Our study aiming for determining the combined effect of selective manual therapy techniques in chronic obstructive pulmonary disease patients

I will apply selective manual therapy techniques in form of mobilization techniques ,myofascial release techniques combined with traditional treatment to determine thier effect in chronic obstructive pulmonary disease patients

Eligibility Criteria:
Inclusion Criteria:

* All patients must diagnosed mild to moderate chronic obstructive pulmonary disease
* All patients should have foreward head and kyphosis

Exclusion Criteria:

* History of osteoporosis.
* Acute exacerbation.
* Presence of active hemoptysis
* Presence of malignant disease
Effect of Theophylline in Pseudohypoparathyroidism

The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.

It is an open label intervention study for the off-label use of theophylline in psuedohypoparathyroidism (PHP).Theophylline is a is non-specific phosphodiesterase inhibitor which increases the levels of secondary messenger,cAMP. PHP patients have end organ resistance to hormones involving cAMP signaling. Thus, theophylline has a potential to abrogate hormone resistance. Also, it may have a role in bone maturation, neurocognition and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with known diagnosis of PHP1A and PHP1B
* Age \>5 years

Exclusion Criteria:

* • Significant kidney disease, i.e. any CKD stage

  * Hypercalciuria
  * Kidney stones
  * Severe Heart disease
  * Uncontrolled seizure disorder
  * Peptic ulcer
  * Liver dysfunction
  * Bleeding disorder
  * Allergy to theophylline preparation
  * Muscle disorder
  * Infection
  * Any neurologic disease
  * Chronic drugs interacting with theophylline
Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

The purpose of this project is to study the presence of expression differences - at RNA and protein level - of different members of the tachykinin family and kisspeptin and their receptors, between fertile women and infertile patients with different etiologies.


Eligibility Criteria:
Two groups of subjects (each one with different criteria):

1. Oocyte donors

   Inclusion Criteria:
   * Age between 18 and 34 years
   * Normal caryotype
   * Normal psychological test

   Exclusion Criteria:
   * Presence of hereditary diseases
   * Beta-thalassemia
   * Cystic fibrosis
   * Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV)
2. Infertility patients

Inclusion Criteria:

* Age between 18 and 45 years
* One of the following etiologies:
* Patient with PCOS according to Rotterdam Criteria or
* Patients with endometriosis stage I-IV or
* Patients with low ovarian response according to Bologna criteria or
* Patients with advances maternal age (between 38 and 45 years)
Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function

This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.


Eligibility Criteria:
Inclusion Criteria:

* Non-surgical patients
* 70 years of age or older
* With renal impairment (creatinine clearance ≤35ml/min)
* Requiring pharmacological thromboprophylaxis

Exclusion Criteria:

* Indication for a treatment dose of anticoagulant treatment
* Knee surgery or hip surgery within 10 to 35 days, respectively
* Surgery, trauma, hemodialysis, peritoneal dialysis, or bleeding
* History of heparin-induced thrombocytopenia
* Known or suspected hypersensitivity to any component of study drug
* Patients with an excessive risk of bleeding and not eligible for pharmacological thromboprophylaxis based on physician assessment or due to any of the 3 major risk factors including active gastroduodenal ulcer, bleeding within the past three months prior to hospital admission, or a platelet count of \<50,000 platelets/ mm3
Immediate Implant Placement Using Xenograft Mixed with Vitamin D Versus Hyaluronic Acid.

Immediate implant placement using xenograft as space filling material mixed with vitamin D versus hyaluronic acid in posterior mandible region This study aims to evaluate implant stability and density after placement of immediate implant and Xenograft mixed with Hyaluronic acid or Vitamin D at posterior mandible region

Dental implants in fresh extraction sockets and healed sites have a erratic morphology, creating a wide space defect between the implant and buccal alveolar bone. This defect is critical for implant success, known as a jumping gap. Proper management of this space is essential for esthetic and functional success. Studies show adequate bone fill can be achieved in jumping gaps, but wider gaps increase implant body exposure risk.

The application of biological mediators embedded in the biomaterial can induce specific cell and tissue response, which can improve bone quality and quantity. Dental research has focused on improving bone substitutes by morphologic or bio- chemical modification.

Eligibility Criteria:
Inclusion Criteria:

Age: 18-60.

* Systemically healthy patients indicated for single or multiple immediate implants in posterior teeth region.
* Absence of any peri-apical pathosis.
* Patients with intact buccal plate of bone.
* Patients with adequate bone volume for the dental implant procedure.
* Patient with good oral hygrine

Exclusion Criteria:

* Heavy Smokers.
* Systemic disease that may affect the final outcome of the surgical procedure.
* No or poor patient's compliance.
* Patients with psychological problems.
* Pathology at the site of intervention.
* Patient with vit d deficiency
Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection

This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 - 65 years of age
* Recipients of deceased or living donors
* Patients who had undergone primary liver transplantation at least 6 months before enrolment
* Recurrent Hepatitis C viral infection and histologically confirmed liver fibrosis (stage I-IV in the Ishak-Knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment
* Patients receiving tacrolimus or cyclosporine micro-emulsion with or without - Mycophenolic acid (MPA), with or without steroids.
* Absence of acute rejection episodes within the previous 6 months to the date of enrolment
* Patient in whom an allograft biopsy will not be contraindicated
* Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months
* Patients with Hepatocellular carcinoma (HCC) within the University California, San Francisco (UCSF) Criteria and no recurrence for at least 18 months after OLT.

Exclusion Criteria:

* Recipients of multiple organ transplants or patients who have undergone retransplantation
* Current biliary complications
* History of drug or alcohol abuse within 1 year before enrolment
* Patients treated with anti-hepatitis C virus treatment at the time of enrollment or within the previous month to the date of enrolment
* Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
* Patients with Leukocyte count (WBC) \< 3000/mm3, platelet count \< 75000/mm3 or Hemoglobin (Hb) \< 8 g/dl
* Patients with proteinuria \>1g/24 hours
* Patient with a current severe systemic infection

Other protocol defined inclusion/exclusion criteria may apply.