cyrilzakka/clinical-trials huggingface dataset:
Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance

Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Subjects who currently have mild to moderate symptoms of dry eye as defined by a screening SANDE score of 20-55 inclusive (equivalent to OSDI score of 12 -32).2
* Subjects between the ages of 18-65.
* Subjects willing to comply with the prescribed regimen and schedule of eye drops.
* Subjects willing to attend all study visits.
* Subjects willing to discontinue any current artificial tear use 24 hours prior to the baseline study visit.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Ocular anterior segment infection, inflammation, abnormality, or active disease.
* History of herpetic keratitis or ocular surgery.
* Recent (within 1 year) thermal meibomian gland expression procedure including Lipiflow, iLux, or TearCare.
* Recent (within 1 year) blepharitis debridement procedure including BlephEx.
* Screening SANDE score \> 55 (equivalent to OSDI score of \>32).2 This is indicative of a severe dry eye.
* Screening SANDE score \< 20 (equivalent to OSDI score of \<12).2 This is indicative of a clinically normal eye.
* Screening non-invasive TBUT \< 2 seconds, or \> 10 seconds.3
* Screening NaFl score \< 3 (clinically normal eye) or \> 10 (severe dry eye).4
* Pregnant or lactating.
* Current use of contact lenses.
* Any change in eye drop regimen, whether OTC or RX in the last 90 days.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country.

The main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation.

The aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.

24 healthy volunteers will be randomized and will start the study. The study will last 12 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 3 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Body mass index 20 \<= BMI \<= 30 kg/m2
* Affiliated to French National Health Insurance
* Subject giving his written informed consent
* Subject considered as normal after clinical examination and medical questionnaire

Exclusion Criteria:

* Previous medical and/or surgery judged by the investigator as incompatible with this study
* Previous familial of colon, ovarian or breast cancer
* Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
* Dislike ham or red meat
* Heavy consumer of alcohol
* Practising intensive physical exercise (\> 5 hours)
* Being under someone's supervision
* Refusal to be registered on the National Volunteers Data file
* Dietary habits unreliable to controlled food intake
* Being in exclusion on the National Volunteers Data file
Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure

To evaluate the effects on heart function of ivabradine administered to patients with severe chronic heart failure


Eligibility Criteria:
Inclusion Criteria:

* systolic congestive heart failure
* sinus rhythm, HR \>= 80bpm

Exclusion Criteria:

* unstable cardiovascular condition
Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential benefits in trials of magnesium. This is a single center, prospective, randomized, double blind, placebo controlled clinical trial that aims to investigate the effect of treatment with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide \& Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the number and severity of NLC; an improvement in the quality of life and quality of sleep may ensue.

Ads in the local media and pharmacies will invite individuals afflicted by NLC to participate in the study. Each participating individual will undergo two weeks of eligibility screening followed by 4-week double-blind treatment. The number, severity and duration of NLC will be measured daily as documented in a designated, structured sleep dairy. Quality of life and quality of sleep will be assessed by SF-36 and PSQI questionnaires, respectively, to be completed twice - at enrollment and within one week of the end of the treatment period.

Eligibility Criteria:
Inclusion Criteria:

Signed informed consent before any procedure or assessment is done. Age over 21 years old. Over 4 episodes of documented NLC during 2 weeks of eligibility screening (for the treatment phase).

Insured by Clalit Health Services (CHS). Hebrew speaking

Exclusion Criteria:

Pregnancy Currently taking Quinidine or Magnesium additive Renal failure - serum creatinine more than 2 mg/DL or estimated glomerular filtration rate (eGFR) less than 60 ml/min (the worst, ascertained by the participant electronic records in the last 6 months). If the result is near these limits (i.e. serum creatinin 1.5-2) a second analysis will be done near the study enrollment.

Major neurological disease- ALS, MS, Paraplegia or Quadriplegia.
Prophylaxis of Venous Thromboembolism After Bariatric Surgery

This study is a prospective evaluation of the relationship between lean body weight and anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery.

There is no guideline for postoperative thromboembolic prevention in morbidly obese patients.

The investigators goal is to examine which dose of nadroparin is effective.

Eligibility Criteria:
Inclusion Criteria:

* Approval for Roux-en-Y gastric bypass
* Total body weight \> 140 kg

Exclusion Criteria:

* Renal impairment (GFR \< 30ml/min and/ or serum creatinin \> 150 micromol/ml)
* Coagulation disorders
* Use of vitamin K antagonists (such as acenocoumarol) pregnancy
Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. CXL is thought to augment the tectonic strength of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. All excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with FDA approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. This can result in ectasia even in patients without pre-existing risk factors.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Up to 4 potential risk factors for ectasia
* A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
* B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
* C. Age 18 to 25
* D. Planned Residual stromal bed between 250 and 300 microns
* Ability to provide written informed consent
* Likely to complete all study visits
* Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye
* Patients with and without previous laser vision correction are eligible for participation.

Exclusion Criteria:

* Frank keratoconus, Pellucid, or Post-LASIK ectasia
* Less than 20/30 BSCVA in either eye
* Corneal scarring that markedly affects vision
* Contraindications to any study medications or their components
* Pregnancy or breast feeding
* Active Herpes Corneal Disease
Ketamine and Magnesium in Post-operative Pain Control in Patients Treated With Opioids

The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain.

In this randomized control trial, patients' postoperative pain scores will be assessed as scored by the Numeric Rating Score (NRS) system. Intraoperative and postoperative narcotic usage, nausea scores and patients' perception of their quality of recovery via the QoR-40 survey will also be assessed.

The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects undergoing elective laparoscopic gynecologic surgery
2. Patients with chronic pelvic pain defined as pain that has persisted for more than 6 months in duration which is localized to the pelvis, anterior abdominal wall, lower back or buttocks and has leads to functional disability or medical care1
3. Patients requiring opioids daily for \>1 month
4. Consenting adults age 18-80
5. American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III

Exclusion Criteria:

1. Patient refusal
2. Chronic Kidney disease (Creatinine\>2)
3. Patients treated with methadone
4. Known allergy or adverse effect of ketamine or magnesium
5. Patient unable to give informed consent
6. Patient with limited or no English fluency
7. Uncontrolled hypertension
Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)

The investigators developed a protocol utilizing once-daily intravenous busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Treatment:

busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Eligibility Criteria:
Inclusion criteria

1. Histologically confirmed aggressive NHL
2. Mantle cell lymphoma
3. salvage chemotherapy sensitive relapse/refractory NHL
4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
5. Age; 18-65
6. Adequate renal function: serum creatinine ≤ 1.5mg/dL
7. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value

Exclusion criteria

1. low grade NHL
2. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
3. Other serious illness or medical conditions

   * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
   * History of significant neurological or psychiatric disorders
   * Active uncontrolled infection (viral, bacterial or fungal infection)
4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
5. HIV (+)
6. Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period
BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 12 to 70 years
* Subjects with severe hemophilia A (\< 1% factor VIII \[FVIII\]:C)
* Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
* Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
* Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
* Subjects with no measurable inhibitor activity
* Subjects with no history of FVIII inhibitor antibody formation
* Written informed consent by subject and parent / legal representative, if \< 18 years

Exclusion Criteria:

* Subjects who are receiving primary prophylaxis
* Subjects on prophylaxis with documented requirements of \> 75 IU/kg/week
* Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
* Subjects with abnormal renal function
* Subjects with elevated hepatic transaminases
* Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
* Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
* Subjects who require any pre-medication for FVIII injections
Two Versus Four Implant-supported Fixed Full-arch Prosthesis

The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.

* Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department
* All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.

The patients will be divided into 2 groups

1. Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
2. Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Eligibility Criteria:
Inclusion Criteria:

* • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I

Exclusion Criteria:

* systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.
Coroflex ISAR 2000 Registry

Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries

The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.

Eligibility Criteria:
Inclusion Criteria:

* patients suitable for percutaneous coronary intervention with proof of ischemia
* at least 18 years of age

Exclusion Criteria:

* Intolerance to sirolimus and/or probucol
* Allergy to components of the coating
* Pregnancy and lactation
* Complete occlusion of the treatment vessel
* Severely calcified stenosis
* Cardiogenic shock
* Risk of an intraluminal thrombus
* Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
* Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
* Severe allergy to contrast media
* Lesions which are untreatable with PTCA or other interventional techniques
* Patients with an ejection fraction of \< 30 %
* Vascular reference diameter \< 2.00 mm
* Treatment of the left stem (first section of the left coronary artery)
* Indication for a bypass surgery
* Contraindication for whichever accompanying medication is necessary
EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 75 years old
* Informed consent available
* Suffering from chronic hepatitis induced cirrhosis
* Suffering from oesophageal varices and received EVL as a result of

  1. Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or
  2. Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding
* Or bleeding gastric varices that have received endoscopic canoacrylate injection

Exclusion Criteria:

* Medical Child-Pugh Class C Uncorrected platelet count \<50,000 INR \> 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma
* Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure).

Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation

- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.

Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
Validation of the Occupational Sitting and Physical Activity Questionnaire for E-Sports Players

Electronic sports (Esports) has become a branch that started to gain popularity in the gaming community in the early 2000s and that more and more individuals are interested in. Esports players are often called sedentary athletes because gaming requires prolonged sedentary activity. The aim of this study is to adapt the Occupational Sitting and Physical Activity Questionnaire to individuals playing Esports and to validate it in Turkish.

Electronic sports (Esports) has become a branch that started to gain popularity in the gaming community in the early 2000s and that more and more individuals are interested in. Esports players are often called sedentary athletes because gaming requires prolonged sedentary activity. Although studies have examined the physical activity levels of Esports players with questionnaires, they emphasize that the results may be more variable because they do not control for potential confounding factors such as gender, age, game type, and performance level. Among the questionnaires used in the studies, there was no study evaluating the player-specific physical activity level. Therefore, the aim of this study is to validate the Occupational Sitting and Physical Activity Questionnaire in individuals playing Esports. Individuals aged 12-24, who play computer games 3-4 times a week for 2-4 hours professionally or 7-14 hours a week as an amateur, and have the ability to read and understand Turkish will be included in the study. Individuals with severe physical limitations that prevent physical activity and individuals with cognitive impairment will be excluded from the study. Correlation of the scale with Visual Analogue Scale (VAS), International Physical Activity Questionnaire-Short Form for construct validity, Young Internet Addiction Test-Short Form (YİBT-SF) and Buss-Perry Aggression Scale will be tested, respectively. In order to determine the test-retest reliability of the Turkish version of the scale, individuals will be asked to fill in the scale again 7-14 days after they first filled out the scale.

Eligibility Criteria:
Inclusion Criteria:

ESports Players:

* Volunteer to participate in the study
* Age between of 12-24
* Training for 2-4 hours 3-4 times a week
* Playing e-sports for at least 1 year
* Play and be licensed as an active esports player in an official esports tournament or league

Amateur Recreational players:

* Not having an e-athlete license
* Age between of 12-24
* Playing games 7-14 hours a week
* Have an active game account in any region

Exclusion Criteria:

ESports Players:

* Having had a head injury accident within the last week
* No e-sports license
* Having a congenital disease or deformity
* Having a diagnosis of psychiatric and neurological disease
* Having a diagnosis of musculoskeletal disease

Amateur Recreational players:

* Having a systemic or congenital disease
* Having a diagnosis of neurological and psychiatric disease
* Having a disorder that affects the musculoskeletal system