cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study

The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Eligibility Criteria:
Inclusion Criteria:

-patients with primary or recurrent NMIBC for whom complete TURBT was done

Exclusion Criteria:

-Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).
Optimizing PrEP Uptake and Adherence Among Male Sex Workers

"PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)

A theory-based, manualized intervention -called "PrEPare for Work"-includes two separate but complementary interventions that address MSW-specific behavioral, economic, interpersonal \& structural-level barriers to accessing and adhering to PrEP: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a technology and counseling intervention to optimize PrEP adherence (once they have access to PrEP). This research will test the PrEPare for Work intervention in a fully-powered RCT to assess efficacy and cost-effectiveness.

Eligibility Criteria:
Inclusion

* Age: 18 years or older
* Assigned male sex at birth
* Identifies as male at enrollment
* Report having engaged in condomless anal sex with another man in the past 3 months
* Report having exchanged sex for money, drugs, items of value, or a place to stay with another man in the past 3 months
* Report HIV status as negative or unsure
* Not currently on PrEP
* Able to understand and speak English or Spanish

Exclusion

* Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview (will use an adapted version of the Evaluation to Sign Consent Form65 to assess capacity)
* Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance)
* Participated in the pilot RCT and initiated PrEP during study participation
Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction

Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine receptor up-regulation through an observational study using nicotine replacement therapy for two weeks and no intervention for two weeks.

Studies have shown that prolonged exposure to nicotine reinforces addiction. The act of smoking delivers nicotine through lungs into the blood stream. As a result, during smoking nicotine levels peak and then when smoking stops levels progressively diminish to a base (trough) level. At the peak level a smoker feels rewarded, but at the trough level a smoker starts to experience negative withdrawal affects and a desire to smoke. Nicotine Gum and Inhalers mimic this smoking behaviour maintaining a peak and trough regime, but nicotine patches do not. Instead, nicotine patches deliver a constant base dose considered to be either above that of the smokers trough level or at a level where negative withdrawal effects are reduced.

The question arises as to if nicotine levels delivered by a patch are constant and potentially above that of the baseline smokers level, does this reinforce the addiction and therefore contribute to the high long term relapse rate? To answer this question the investigators will be looking at metabolites which the body uses to breakdown nicotine and several other enzymes. These metabolites respond to the levels of nicotine in the blood stream by increasing or decreasing over time. By testing blood flow, blood and urine the investigators are able to gain an insight into how the body is dealing with a constant stable dose of nicotine rather than a peak and trough dose. In combination with the questionnaires the investigators will be able to determine the level of affect.

Eligibility Criteria:
Inclusion Criteria:

* Smokers who currently smoke at least 10 cigarettes per day
* Aged between 18 and 75
* Informed consent
* Willingness to attempt to quit smoking for the period specified, initially with a transdermal patch for 14 days and then without any smoking cessation aids for a further 14 days.

Exclusion Criteria:

* Use of bupropion, champix or nicotine containing products other than cigarettes in the last 2 months
* previous reactions to NRT
* Pregnancy / Breast Feeding
* Uncontrolled hypertension
* Unstable angina
* Heart attack or stroke within the previous 6 months
* Severe Obesity as indicated by Body Mass Index (BMI) ≥35 (potential for slow release of nicotine from tissues)
* acute psychiatric illness, past history psychosis, suicidal ideation or current diminished capacity.
* Current treatment or recent diagnosis of cancer
* Current use of Phenobarbital or other anticonvulsant drugs (induction of metabolism of nicotine to cotinine)
* Renal failure (creatinine clearance\<30ml/min - reduces metabolic clearance of cotinine and nicotine)
A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant

The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation.

Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that eculizumab, an antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. To test this hypothesis, this study is a pilot prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation in preventing delayed graft function in first adult recipients of deceased donor kidneys.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Weight \> 40 kg
* Male or Female
* Recipients of first deceased donor kidneys
* Able to provide written informed consent
* Transplant candidate as per site specific guidelines
* Dialysis dependent renal failure (initiated more than 2 months prior to transplant)
* Novartis Delayed Graft Function Score 3-8
* Extended criteria donor with brain death, or standard criteria donor with cold ischemic time \< 24 hours

Exclusion Criteria:

* Planned to receive multi-organ transplant
* Kidneys from donors \< 6 years of age
* Dual kidney transplant (from same donor, including en bloc)
* Living donor kidney
* Highly sensitized recipients (PRA \> 50%)
* Previous transplant
* Participation in another investigational trial
* Recipient BMI \> 40
* ABO incompatible
* DCD Donor
* Preemptive kidney transplant
* Recipients with DGF scores \< 3 or \> 8
* Women who are pregnant or breast feeding
* Women of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
* Patients infected with HIV, HCV or HBV
* Active bacterial or other infection which is clinically significant in the opinion of the investigator
* Patients with history of splenectomy
* Patients with history of meningococcal disease
* Patients with known or suspected hereditary complement deficiency
* Patients with history of cancer (other than non-melanoma skin cancers) within the last 5 years
Unmet Needs, Barriers and Facilitators to Vision Services for Children and Adolescents With Special Vision Care Needs: A Mixed-Model Design Study

Children and adolescents with special needs, compared to those with general development, have a much higher incidence of visual impairments (10.5% vs. 0.16%). This project will focus on "children and adolescents with special visual care needs", comprehensively exploring their unmet needs in ophthalmology and visual care, as well as the obstacles and facilitators they may encounter in the process of seeking ophthalmic services.

The purposes of this study will investigate the current needs of children and adolescents with special visual care needs in ophthalmology and visual medical services, and the obstacles and potential facilitators encountered by children and adolescents with special visual care needs in the process of obtaining ophthalmology and visual medical services.

The research will center on children and adolescents with special visual needs and explore the research questions from various stakeholders' perspectives, including parents, special education teachers and experts, healthcare professionals, workers from related NGOs and government units. A mixed-methods research approach will be used to gather both quantitative and qualitative data. After data analysis, a comparison and interpretation between the two results will be conducted to obtain the final research outcomes.

1. Quantitative research: Two-part questionnaire. The first part collects background information, and the second part is a "Needs and Difficulties Survey", framed by Levesque et al.'s conceptual framework of access to healthcare.
2. Qualitative research: The first part consists of semi-structured in-depth interviews, and the second part uses the focus group method. Both parts will use a common interview guideline and the International Classification of Functioning, Disability and Health, Child \& Youth Version (ICF-CY) as the theoretical framework.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand, and fill out questionnaires in Chinese
2. Able to conduct interviews in Chinese

Exclusion Criteria:

1. The special needs children or adolescents they have taught do not have specific visual needs, hence they cannot provide relevant information.
Improving Cognitive Function of Aripiprazole in Treating Adolescents and Young Adults With Psychotic Disorder

This is a 24-week, observational, prospective study to evaluate the effectiveness of improving cognitive function of aripiprazole in treating adolescents and young adults with psychotic disorder in Taiwan. Approximately 120 qualified patients who have clinical diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not otherwise specified.) will be recruited to achieve at least 100 evaluable subjects. After signing the informed consent form, the demographics, medical history and concomitant medication will be recorded. Besides, physical examination, vital sign, BMI, DSM-IV multiaxial examination, CGI-S and menstrual history will be conducted. Laboratory tests and pregnancy test will be optionally conducted. After evaluating all variables obtained, the eligible patients will be enrolled into study. Patients who fulfill the inclusion / exclusion criteria will be performed the CPT, WCST, BPRS and WHOQOL. Afterwards, patients will be given their first medication at this visit (5 mg \~ 30 mg daily by subject). Besides, the switching period is maximum 8 weeks and is depended upon the clinical judgment of investigator. Efficacy will be evaluated by the change from baseline in Continuous Performance Test (CPT), Wisconsin Card Sorting Test (WCST), Clinical Global Impression Scale (CGI), Brief Psychiatric Rating Scale (BPRS) and The World Health Organization Quality of Life questionnaire (WHOQOL). Safety will be evaluated by the frequency of adverse events, abnormal laboratory results, physical examination, vital sign, BMI and menstrual history for female subgroup analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female in age between 12 and 25 years old.
2. Clinical diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not otherwise specified.).
3. CGI-S ≧ 3 at screening visit.
4. Informed Consent was obtained from the subject (and legal guardian as if necessary).

Exclusion Criteria:

1. Pregnant or breast feeding women or planning a pregnancy.
2. Patient received electroconvulsive therapy within 4 weeks before the screening visit.
3. Patient has a history of hypersensitivity or allergy to investigated drug.
4. A known severe adverse event related to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
5. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.

The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.


Eligibility Criteria:
Inclusion Criteria:

* Have been receiving liver transplant two years ago.
* Be 18 years or older.
* Treatment with immunosuppression including cyclosporine or tacrolimus.
* Having a normal liver function in the last year
* Not have suffered acute rejection in the last year and have no chronic rejection
* Submit any significant side effects from medication immunosuppressive (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity novo malignancy, etc.)
* Etiology of underlying disease: alcoholic cirrhosis with or without hepatocarcinoma, metabolic diseases, amyloidotic polyneuropathy family, biliary atresia, fulminant hepatitis non-A, non-B, non-C, cirrhosis cryptogenic and generally causes no viral or autoimmune.
* Patients offering sufficient guarantees of adherence to protocol
* Patients who give written informed consent for participate in the study.
* It is necessary that the patient meets all inclusion criteria.

Exclusion Criteria:

* Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) or epatocarcinoma about cirrhosis of viral or autoimmune.
* Patients with chronic rejection, or acute rejection in the last year.
* Patients with liver retransplantation.
* patients with history of hypersensitivity or idiosyncratic reactions to methoxsalen, psoralen the compounds or any of the excipients.
* patients with melanoma, cutaneous basal cell carcinoma or squamous cell coexistent.
* Patients with aphakia.
* Patients taking Oxoralen.
* Pregnant women or nursing mothers, or adults of childbearing age not using effective contraception.
* Participation in another clinical trial.
* Inability to understand informed consent.
Emotion and Craving Regulation Among Individuals With Internet Gaming Disorders

To investigate the potential deficits in emotion and craving regulation capacities of drug-naïve young adults with Internet gaming disorder as compared with healthy controls.

The purpose of this study is to examine the differences in young adults' capacities of utilizing cognitive appraisal versus mindfulness to regulate negative emotions and/or craving in response to negative affective stimuli or gaming cues, respectively. This project will be conducted in Beijing, China.

Eligibility Criteria:
Inclusion Criteria:

Internet gaming disorders (IGD):

1, DSM-5 recommended diagnosis of Internet gaming disorder :

1. the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.
2. engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.

2, the scores of the Y-IAT(Young-Internet addiction Test) ≥ 50

Healthy controls (HCs): DSM-5 scores less than 5 and less than 20 hours gaming time per week.

Exclusion Criteria:

current or history of use of illegal substances and gambling; current or history of psychiatric or neurological illness; current use of psychotropic medications; being left-handed.
Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient

role of RDW as anon invasive method for predicting liver cell failure \& portal hypertension in cirrhotic patient

Red blood cell distribution width (RDW) is a measure of the range of variation of red blood cell (RBC) volume. The RDW-SD (Standard deviation ) is an actual measure of size. Normal reference range of RDW-SD in adult human is 39-46 fL .Liver plays an important role in removing body toxins which affects RBCs ,so liver cirrhosis may affects the RDW. Cirrhosis is a chronic degenerative disease in which irreversible scarring of the liver occurs. It leads to liver failure. Child's score is used as an indicator for liver cell function Portal hypertension is an increase in the blood pressure within the portal venous system .Obstruction to blood flow that occurs in liver due to fibrosis and regenerating nodules reduce flow from the portal veins into the hepatic veins. It also impedes hepatic artery flow from the branches that feed into the sinusoids. This increase in arterial resistance leads to an increase in arterial flow into the portal vein via producing a new anastamosis. The net result of that is an increase in portal vein pressure and dilatation of portal vein. Direct measurement of portal pressure is invasive, inconvenient, and clinically impractical. The Hepatic Venous Pressure Gradient (HVPG) is used to measure portal pressure .Recently, portal vein diameter is used as indicator for portal hypertension .

Eligibility Criteria:
Inclusion Criteria:

The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US. They will be divided into 3 groups according to Child's score (A,B,C)

Exclusion Criteria:

* Evidence of iron deficiency anaemia
* Patients within one month of hematemesis
* Thalassaemia
Radiofrequency Ablation Using Cooled-Wet Electrode

To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.

To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.

Eligibility Criteria:
Inclusion Criteria: all conditions have to be fulfilled.

* Diagnosed with HCC (1\~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
* liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
* signed informed consent
* treatment naive index tumor (no history of local treatment for an index tumor)

Exclusion Criteria:

* more than three tumors in a patients
* tumor size larger than 5cm
* tumor attaches to central portal vein or hepatic vein
* Child-Pugh classification C
* uncorrected coagulopathy
* presence of extrahepatic metastases
Buffered Local Anesthetic

The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children or children with mild controlled systemic illness
* Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration

Exclusion Criteria:

* Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
* Antibiotic premedication requirement
* History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
* Has signs of dental pain, odontogenic abscess or facial cellulitis
* Allergy to local anesthetics or sulfites