cyrilzakka/clinical-trials huggingface dataset:
Management of Signs and Symptoms Associated With Dry Eye Disease

A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate dry eye defined as corneal fluorescein staining score of ≥ 3
* Age ≥ 18 years
* Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
* Willing to sign a written informed consent to participate
* Able to follow study instructions, with the intention of completing all required visits

Exclusion Criteria:

* Presence of persistent corneal epithelial defect or ulcer in either eye
* Presence of active ocular infection in either eye
* Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
* Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
* Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
* Contact lens wear
* History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
* Presence of cicatricial ocular surface diseases
* A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
* Any scheduled or planned ocular or systemic surgery or procedure during the study
* Pregnancy and women who are expecting to be pregnant.
* Current enrolment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption

This study was designed for exploring the association of cytochrome P450 3A4 rs2242480 polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal surgery，to provide evidence for genetic prediction of personalized medication.Methods:60 patients who prepared for elective upper abdominal surgery under general anesthesia were recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480 genotyping was carried out by direct sequencing. The blood samples were drawn before anesthesia，30 min and 45min after anesthesia respectively，used for plasma sufentanil concentration detection with high performance liquid chromatography-mass spectrometry (HPLC-MS). After surgery，the patients received patient-controlled intravenous sufentanil immediately. And postoperative pain at rest，sufentanil consumption，side effects and rescue analgesic requirements were recorded at the 6th，12th，24th hour. The plasma sufentanil concentration and PCA sufentanil consumption were analyzed to investigate the differences among rs2242480 three genotypes.

The study consisted of healthy men and women between 18 to 65 years of age.

Participants were screened and stratified according to cytochrome P450 3A4 rs2242480 genotype:

* 1/\*1 Grouped by rs2242480 polymorphism, wild-type homozygote
* 1/\*1G Grouped by rs2242480 polymorphism,\*1/\*1G: mutant heterozygote
* 1G/\*1G Grouped by rs2242480 polymorphism,\*1G/\*1G: mutant homozygote

Eligibility Criteria:
Inclusion Criteria:

* 1.American Society of Anesthesiologists (ASA) physical status I or II 2.age from 18 to 65 years old 3.BMI of 19～26kg/m2

Exclusion Criteria:

* 1.known history of chronic pain, psychiatric diseases, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function 2.alcohol or drug abuse (according to the criteria of Diagnostic and Statistical Manual of Mental Disorders-IV) 3.pregnancy or at lactation period 4.Patients who consumed drugs (1 week) or foods (3 days) known to inhibit or induce the expression of cytochrome P450 3A4 enzymes prior to surgery were also excluded. The following drugs or foods included but were not limited to erythromycin, clarithromycin, alcohol, chocolate, coffee, grapefruit juice, verapamil, rifampicin, HIV protease inhibitors, phenytoin,itraconazole, dexamethasone, phenobarbital, and carbamazepine.
To Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma

The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.

This study will be conducted in a randomized, open-label, multi-center design. On Day 1 of chemotherapy, approximately 90 subjects screened and determined eligible will be randomized to either Group A or Group B in a 1:1 manner for study participation.

* Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 6 months (24 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.
* Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 12 months (48 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age of ≥ 18 (Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy. / A woman of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of tenofovir. / If the Investigator obtains information concerning the pregnancy of a female patient, the Investigator must terminate the study drug immediately in that patient, and report the information to IRB in the same manner as for SAE reporting)
2. CD 20 positive patients with Non-Hodgkin's lymphoma who are planned to receive anticancer treatment with rituximab based chemotherapy and A. ECOG performance status 0-2 B. Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L) C. Adequate hematological function: hemoglobin ≥ 9g/dL, absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma D. Expected residual life ≥ 6 months
3. Serum HBsAg negative, anti-HCV negative, but anti-HBc positive
4. ALT \< 80IU/mL, serum bilirubin \< 3.0mg/dL, unless abnormalities are due to liver involvement by lymphoma or tumor lysis syndrome
5. Individuals who were given and understood detailed explanations about this study, voluntarily decided to participate in the study, and provided written informed consent

Exclusion Criteria:

1. Child-Pugh class C
2. Other chronic liver diseases such as autoimmune hepatitis or Wilson's disease
3. Patient who has hypersensitivity to study drug
4. Patient who has galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
5. Patient who is pregnant or on lactating. Or who has plans for pregnant or lactation during study period even the partner of the male patient
A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
* Predominant negative symptoms
* With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

* Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
* Body Mass Index (BMI) of less than (\<) 17 or greater than (\>) 40 kilograms per meter square (kg/m\^2)
* Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
* A severity score of 3 or greater on the Parkinsonism item of the Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)
Improving Food Security and Nutrition to Promote ART Adherence in Latin America

The purpose of this three-year study is to develop, implement, and pilot test a culturally appropriate, multi-component nutrition intervention for people living with HIV and food insecurity in Honduras, which is among the Latin America nations with the highest HIV prevalence rates. The investigators specific aims are to:

1. Explore the relationships between food security, nutrition, and HIV treatment access, utilization, and adherence, and examine key mediators and moderators of these relationships.
2. Develop a multi-component nutrition intervention to address food insecurity among Honduran HIV+ individuals and their families.
3. Evaluate the preliminary effectiveness of the intervention on (1) food security and nutritional status; (2) HIV care retention (clinic attendance), uptake of ART when recommended, and ART adherence; and (3) clinical outcomes (CD4 count, ART side effects, and opportunistic infections).
4. Examine key mediators and moderators of the intervention effects from among characteristics of the patient, household, and contextual setting.

The project will be conducted in two phases. Phase 1 involves qualitative, formative research methods to (1) gain understanding of availability and cost of the local foods and the regular diet, (2) evaluate the level of food security among people living with HIV, including intra-household food distribution patterns, and assess the nutritional status of HIV affected individuals, and (3) examine the role that food security and nutrition play in HIV treatment access, utilization and adherence. Phase 2 consists of developing and pilot-testing a multi-component nutrition intervention through a randomized, controlled trial conducted at 4 HIV clinics in Honduras, with two clinics randomly assigned to receive the intervention and two clinics to serve as the comparison group. Patients at each of the 4 sites will receive nutrition counseling, following the guidelines currently proposed by the World Health Organization (WHO) as the standard of care for HIV-infected individuals. In addition, clients at the intervention sites will receive food assistance in the form of a food-aid basket, designed ad hoc to address their macro and micronutrient needs.

Eligibility Criteria:
Inclusion Criteria:

* Registered at the clinic
* Age 18 or older
* If not on ART, CD4 \< 350\*
* Living in the area for the past year.

Exclusion Criteria:

* Deterioration of clinical status such that requires diet or nutrition therapy
* Cannot understand or speak Spanish
Paternal Psychosis After Baby Born

A large number of studies have investigated the psychological disorders occurred in postpartum women, and found that postpartum psychosis is common in new mothers.

However, the situation of paternal psychological status after they had their first baby is not assessed. The investigators hypothesized that they had a high occurrence of paternal psychosis after first baby born. In addition, different factors might influence its onset and development in new fathers.


Eligibility Criteria:
Inclusion Criteria:

* Men will be the would-be fathers
* Chinese

Exclusion Criteria:

* Age \< 18 years or \> 50years
* Not willing to participating or completing the whole study at any time
HES and NICOR Data Linkage for Cardiac Failure Population Analysis

This study is a population-based, patient-level analysis of heart failure in England over a 5-year period using a dataset created by linking HES and NICOR databases. Our analyses will look into the re-occurrence of hospitalisation after the initial diagnosis of heart failure, the influence of population factors on risk of re-hospitalisation, and the resultant cost implications in an NHS environment.

Data from the National Heart Failure Audit (NICOR) and Hospital Episodes Statistics (NHS Digital) will be linked, by NHS Digital, using fields that are recorded in both databases (for example, NHS number). We will receive de-anonymised data that has been pseudo-anonymised, allowing for patient-level analyses but without identifying individual patients.

Eligibility Criteria:
Inclusion Criteria:

* patients \>17 years old
* individual patient data appears on both HES and NICOR databases
* 4-character primary diagnosis codes I50.0-I50.9

Exclusion Criteria:

* patient requests withdrawal from analyses
NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.

The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Gefitinib has shown great efficacy in NSCLC patients with EGFR mutations. This study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable EGFR mutant stage III NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR activating mutation in exon 19 or 21
* Written informed consent provided
* Aged 18-75 years
* Able to comply with the required protocol and follow-up procedures
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Had a life expectancy of 12 weeks or more
* Adequate hematological function, liver function and renal function
* Female participants should not be pregnant or breast-feeding

Exclusion Criteria:

* Known severe hypersensitivity to gefitinib or any of the excipients of this product
* Inability to comply with protocol or study procedures
* Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab)
* Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder
* Interstitial pneumonia
* Eye inflammation not fully controlled or conditions predisposing the subject to this
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
* Known human immunodeficiency virus (HIV) infection
* Pregnancy or breast-feeding women
* History of neurologic or psychiatric disorders
* Ingredients mixed with small cell lung cancer patients
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.

Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with benign bile duct stricture

Exclusion Criteria:

* No written informed consent
* Malignant biliary obstruction
* Patients with uncorrectable severe coagulopathy
* Patients with severe cardiopulmonary disease precluding sedation
Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations

The aim of this study was to assess the impact of flat occlusal preparation design (FOD) of endodontically treated molars on the fracture resistance and distribution of stresses among a ceramic crown-molar structure when compared to two planes occlusal preparation design (TOD).


Eligibility Criteria:
Inclusion Criteria:

* Patients with posterior root canal treated teeth that require full coverage restoration.
* 20 - 50 years old.
* Males or Females.
* Good oral hygiene.
* Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth.
* Patients agreed to return to follow-up evaluation.

Exclusion Criteria:

* Active periodontal or pulpal diseases.
* Lack of opposing dentition.
* Severe medical complications.
* Pregnancy.
* Lack of compliance.
* Evidence of parafunctional habits
* Temporomandibular joint disorders
Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting

The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.

Additional objectives of this research study are:

* To evaluate healing of pressure ulcers already present or pressure ulcers that develop during the study.
* To evaluate the effectiveness of DermaTherapy® bedding and alternative diapers to reduce the potential for bacterial contamination associated with patients' bed linens, underpads, gowns and pajamas, and thereby help reduce the incidence of facility-acquired infections.

Study nurses will assess the skin of the subjects once or twice a week for the presence of pressure ulcers and measure the size of the pressure ulcers if they are present. Study nurses will also obtain bacterial culture swabs of the bedding weekly for the first eight weeks of the study from five participants in each group.

Eligibility Criteria:
Inclusion Criteria:

* Residents admitted for long term care.
* Residents admitted for Hospice Care with an expected length of stay greater than one week.
* Residents with an expected length of stay equal to or greater than 90 days.
Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery

A longitudinal observational study examining preoperative, intraoperative and postoperative factors associated with Postoperative Cognitive Dysfunction in patients older than the age of 50.

A longitudinal observational study examining factors associated with Postoperative Cognitive Dysfunction (POCD) utilizing a computerized neurocognitive battery. In addition, investigators seek to assess the presence of pre-existing psychiatric disorders and chronic pain to determine their relationship with POCD. The study will seek to compare the rates of POCD in previously published literature with performance on a computerized neurocognitive battery. In addition, the study will seek to determine preoperative, intraoperative and postoperative factors associated with POCD by comparing these variables to performance on a computerized neurocognitive battery.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to perform informed consent
2. Age greater than 50 years old
3. Ability to read and understand English
4. Undergoing elective surgery with general or neuraxial anesthesia

Exclusion Criteria:

1. Patients who do not meet above defined criteria, patients from vulnerable populations (adults unable to consent, pregnant women, prisoners), patients refusing informed consent and participation in the study.
2. A previous history of the following medical conditions: dementia of any kind (vascular dementia, Alzheimer's disease, organic brain disease with documented cognitive deficits, severe traumatic brain injury, Parkinson's disease, senility)
3. Physical impairment impairing their ability to perform neurocognitive testing incl. essential tremor, loss of upper extremity motor function, blindness, or severe hearing loss)
Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.

A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.

Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Laparoscopic cholecystectomy
* Emergent/elective
* ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement

Exclusion Criteria:

* Conversion to laparotomy
* Emergent re intervention
* Immunosuppression
* Umbilical hernia
Papillary Thyroid Cancer and Central Lymp Node Dissection

Papillary cancer is a disease that spreads through lymphatic ways and its treatment is surgery. We performed prophylactic central dissection in addition to bilateral total thyroidectomy in patients with bethesda 5 and bethesda 6 biopsy results. We evaluated the pathology results retrospectively.


Eligibility Criteria:
Inclusion Criteria:

- B5 and B6 biopsy results

Exclusion Criteria:

- lobectomy