cyrilzakka/clinical-trials huggingface dataset:
Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users

This study assessed the effect of one month of use of preservative-free artificial tears (Systane Ultra UD, Alcon) on symptomatology related to digital eye strain (DES), visual task performance, and tear film stability in visual display terminal users.

Visual display terminal users (\>4h/day) with DES (CVSS17 score: ranged 29 to 42) and dryness (OSDI score: ranged 13 to 24) symptomatology were prescribed with preservative-free artificial tears (Systane Ultra UD, Alcon) four times a day for one month collecting OSDI and CVSS17 questionnaires in four visits \[screening (Day -7), initial (Day 0), one week (Day 7) and one month (Day 30)\].

Blink rate and number of eye fixations (collected with eye-tracker) in six simple computer tasks and out-loud reading speed were determined before and after performing all tasks on the computer. Tear film stability and ocular parameters were also measured.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher, receiving the information sheet and signing the informed consent.
* Eye discomfort related to dryness (OSDI score ranged from 13 to 24)
* Symptomatic digital device users (CVSS17 score ranged from 29 to 42 points - stages 3 and 4)
* Use of computer continuously for at least 4 hours per day (work week)
* Good best-corrected visual acuity (Visual acuity LogMar ≤ 0.00 for distance, intermediate (60cm) and near (40cm))

Exclusion Criteria:

* Systemic administration of drugs with a possible effect on the ocular surface.
* Topical administration of any drugs that can alter the ocular surface.
* Use of contact lenses
* Use of artificial tears or lubricants at least 7 days before inclusion in the study (recruitment visit).
* Any other ocular pathology or binocular conditions which may cause discomfort (e.g. heterophoric, accommodative, and eye movement disorders)
Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct

Exclusion Criteria:

* Patients with left ventricular ejection fraction (LVEF) \< 45%
* Patients with thrombocytopenia, platelet count \< 50 x109/L (50 x 103/µL).
* Patients with uncontrolled systemic arterial hypertension, systolic pressure \> 160 mmHg or diastolic pressure \> 90 mmHg.
* Patients with a QTcF \> 450 ms for males and \> 470 ms for females in the absence of right bundle branch block.

Other protocol-defined inclusion/exclusion criteria may apply
Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis

Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 years , no gender restriction.
* Clinical diagnosis of resectable HCC.
* Preoperative liver function test showed Child-Pugh Class A or B.
* Indocyanine green retention at 15 minutes (ICG-15) of \<30%.
* Acceptable clotting profile :platelet count \> 50 x 109/L and a prolonged prothrombin time of \< 5 seconds.
* Enough relative residual liver volume (%RLV) ≥ 40%.
* No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
* No other anti-tumor therapy received before the treatment.
* No metastasis in lymphnode or other organs.
* Written consent inform assigned.

Exclusion Criteria:

* Pregnancy.
* Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis.
* Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
Phase IIA Study in Patients With Schizophrenia

This study is designed to assess the effects of AZD 2624 in patients with schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential
* Diagnosis of Schizophrenia

Exclusion Criteria:

* Clinically relevant disease and /or abnormalities.
* Alcohol or substance abuse not in remission
* Enrollment in another investigational study within 30 days
Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC

Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.

Exclusion Criteria:

* Patients with records unavailable (lost, empty or not recoverable).
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function

The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.

The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.


Eligibility Criteria:
Inclusion criteria:

* Subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
* Subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 mL/min by Cockcroft-Gault formula,
* Male and female patients, age =18 years at entry

Exclusion criteria:

* Contraindications to Pradaxa (history of a serious hypersensitivity reaction to Pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
* Creatinine clearance \<15ml/min or patients with End Stage Renal Disease on dialysis,
* Creatinine clearance \>30 ml/min,
* Pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
* Patients who are participating in another drug study,
* Patients who have participated in another drug study within 6 weeks,
* Patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview,
* Any condition the investigator believes would not allow safe participation in the study,
Sweet Taste Receptors and the Secretion of Glucagon-like Peptide-1 and Peptide YY

The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of GI satiety peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gut.

There is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled receptors have been identified in the human gut, including the sweet taste responsive T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for unsaturated long-chain free fatty acids.The functional significance of sweet taste receptors in glucose stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion of 75 g glucose with different concentrations of lactisole (150 ppm, 300 ppm and 450 ppm)in a double blind, 4-way crossover trial including 16 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* BMI of 19.0-24.5
* Age 18-40
* stable body weight for at least 3 month

Exclusion Criteria:

* smoking
* substance abuse
* regular intake of medication
* medical or psychiatric illness
* gastrointestinal disorders or food allergies
Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair

Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal and central nervous system, and mortality ranging up to 5%. In our study, we tested the hypothesis that intraoperative and postoperative intravenous restrictive fluid regime reduces postoperative morbidity and mortality and improves the outcome of the treatment of minilaparotomy AAA repair.

We investigate effects of a restricted fluid regime versus standard regimen on complications and hospital stay after minilaparatomy aortic aneurysm repair.

Eligibility Criteria:
Inclusion Criteria:

* AAA more than 5,5 cm in diameter tube graft

Exclusion Criteria:

* emargency comorbidity maligancy
Cultural and Linguistic Adaptation and Normative Study of the Turkish Version of the Free and Cued Selective Reminding Test: 16-Word Version (FCSRT-T)

An Adaptation Study of Free and Cued Selective Reminding Test in Turkish

As very commonly used for objectifying Alzheimer Disease memory deficits, an adaptive selection of word choices are done for the use of free and cued selective reminding test (FCSRT) procedure in Turkish population. In this study the validity and reliability of the test to measure memory deficits in persons with memory complaints will be discussed.

Eligibility Criteria:
Inclusion Criteria:

* having memory complaints
* demanding clinical consultation for the memory complaint

Exclusion Criteria:

* vascular pathology
* extrapyramidal findings
* psychiatric illness
* epilepsy
* cognition affecting drug use
Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital

Acute necrotizing encephalopathy of childhood (ANEC) is a fulminant type of encephalopathy. Most reported cases occur in Asian children with the highest prevalence among patients between the age of 6 and 18 months. The most common clinical presentations are fever, rapid alteration in the level of consciousness, and seizures, in addition to characteristic findings in brain imaging that include, but are not limited to, bilateral thalamic lesions with supra and infra-tentorial lesions of variable dimensions.

The diagnosis of ANEC was determined by specific diagnostic criteria as described by Mizuguchi \[1\] which consist of

1. Encephalopathy preceded by viral febrile illness with rapid deterioration in the level of consciousness and convulsions.
2. Absent cerebrospinal fluid (CSF) pleocytosis.
3. Symmetric multifocal brain lesions.
4. Elevation in serum aminotransferase levels.
5. Exclusion of similar diseases. The ANE severity score was used to assess the severity of illness after admission for shock (3 points), brainstem lesions (2 points), age \>4 years (2 points), platelet (PLT) count \< 100,000 (1 point), and elevated CSF protein (1 point) was observed. \[3\] A total score of 9


Eligibility Criteria:
Inclusion Criteria:

- Children aged from 2months up to 12 years admitted to the pediatric emergency department or pediatric ICU presented with Acute encephalopathy \& meet diagnostic criteria of acute necrotizing encephalopathy or come for follow up in our outpatient clinic.

Exclusion Criteria:

* Children known to have metabolic disease. Children who have picture of CNS infection \& confirmed by CSF analysis.
Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI and/or endorectal ultrasound
* Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy a
* ECOG performance status 0-2
* At least 18 years of age
* Adequate bone marrow function defined as:

  * ANC \> 1,500 cells/mm3
  * Hgb \> 8 g/dl
  * platelets \>100,000 cells/mm3
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* No clinically detectable (MR, endoscopy or DRE) tumor present
* Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
* Any evidence of disease from another malignancy or history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix). Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible.
* Currently receiving any investigational agents.
* A history of allergic reaction attributed to compounds of similar chemical or biologic composition to 5FU, oxaliplatin, or leucovorin.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
* Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Training of Eccentric Lower Extremity Function After SCI

This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at moderate speeds - targeted to rehabilitation eccentric function of the knee or hip.

Lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with SCI. This proposal aims to characterize eccentric motor control of the muscles about the knee or hip during locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an intervention to improve eccentric function of the knee joint or hip joint during walking.

Eligibility Criteria:
Individuals with SCI:

Inclusion Criteria:

* medically approved
* discharged from outpatient rehabilitation for 6 months
* incomplete SCI based on ASIA impairment score (AIS C or D) at neurologic level C1-T10
* ability to take some steps overground and on the treadmill
* 18-90 years old.
* ability to speak English. Note: the quality of life measures have not been validated yet in non-English speaking populations.

Exclusion Criteria:

* evidence of lower motor neuron injury in the legs
* use of botox in the past 3 months
* pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, HIV)
* acute deep vein thrombosis
* skin wounds in regions where harness or hands provide support
* pregnancy. Note: Persons who are pregnant will not be enrolled as exercise tolerance is unknown in these women with SCI.
* cognitive conditions that preclude providing informed consent
* ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment
* persistent orthostatic hypotension (drop of BP \>30mmHg in treadmill and harness equipment)
* hospitalization for myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study
* participation in any other concurrent exercise programs.

Note: Use of anti-spasticity and other medications (dose, frequency) will be monitored throughout training and used as a confounding variable in the analyses.
Retrospective Review on Patients With Culture Negative Empyema

Empyema is associated with a wide range of complication and mortality. It is defined by either a positive pleural fluid culture or grossly pus appearance. However, little is known about the differences in aetiology and outcome between culture-positive empyema (CPE) and culture-negative empyema (CNE). The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE.

Pneumonia is a common disease and it ranked second as the leading cause of death in Hong Kong in 2016. Among patients suffering from acute pneumonia, up to 57% of them would develop parapneumonic effusion. Without proper treatment, parapneumonic effusion would progress into empyema, which is a clinical emergency. Empyema leads to a longer length of hospital stay, a higher rate of complication and mortality than uncomplicated parapneumonic effusion.

The mainstay of treatment for empyema is antibiotics and drainage. Therefore, identification of causative microorganism is important in guiding the choice of antibiotics. The common bacterial culprits, for community acquired and hospital acquired, were identified by various local and international studies. However, the aetiological agents were still unknown in up to 40% of cases. In addition, the clinical outcomes between culture negative empyema (CNE) and culture positive empyema (CPE) are largely unknown. Data from one Taiwanese study suggested that patients with CPE had a higher in-hospital mortality than those with CNE. However, the primary objective of this study was not putting on the importance of CNE. Therefore, data on outcome of CNE patients remain largely uncertain, either worldwide and local population.

The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE. Through more understanding of CNE, the clinical management of this patient group may be altered and a better patient outcome is anticipated.

Eligibility Criteria:
Inclusion Criteria:

i. All patients hospitalized for empyema, defined by the presence of purulent pleural fluid or positive culture result from pleural fluid ii. Age greater than 18 years old

Exclusion Criteria:

i. Inappropriate diagnosis of empyema after evaluation ii. Tuberculous pleuritis, defined by presence of Mycobacterium tuberculosis culture from pleural fluid or granulomatous inflammation on pleural biopsy histology
Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease.

This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.

Eligibility Criteria:
Inclusion Criteria:

1. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
3. Subject meets the NINCDS/ADRDA criteria for probable AD.
4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
6. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and 12-lead ECG.
7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
9. Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
10. Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficient visual, hearing and graphomotor skills to complete procedures.

Exclusion Criteria:

1. Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
2. Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
3. Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to Screening Visit 1.
4. In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
5. The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.