cyrilzakka/clinical-trials huggingface dataset:
Lidocaine Infusion in Pancreatic Cancer

This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer.

A prospective randomized controlled double blinded trial design will be used for the proposed study.

The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is expected that by downregulating the pathways by lidocaine might affect the enzymatic activity in those CTCs as well as the number of CTCs in the circulation.

A prospective randomized controlled double blinded trial design will be used for the proposed study.

Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is considered resectable as well as other types of pancreatic cancer (malignant endocrine and exocrine tumors)
2. Has measurable disease, defined as at least 1 tumor that fulfills the criteria
3. Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease
4. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC)
5. Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.

Exclusion Criteria:

1. Has American Society of Anesthesiologists (ASA) physical status \> 3
2. Has hypersensitivity or allergy to amide-linked local anesthetics
3. Has a second or third degree heart block
4. Has severe sinoatrial block
5. Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide
6. Has been treated with amiodarone in the past
7. Has Adams-Stoke syndrome
8. Has Wolff-Parkinson-White syndrome
9. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment
10. Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)

The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. Part 2 compares healthy volunteers with participants with moderate hepatic impairment. Healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval \[0.50, 2.00\].


Eligibility Criteria:
Key Inclusion Criteria for Healthy Participants Groups:

* Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.

Key Inclusion Criteria for Hepatic Impaired Groups:

* Must have mild or moderate hepatic impairment.
* Must have a diagnosis of chronic liver disease for \>6 months.
* Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
* Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.

Key Exclusion Criteria

* Must not be on any prohibited medications for entry into the trial.
Antidepressant Treatment in Older Adults With Schizophrenia

The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa) for the treatment of depressive symptoms in middle-aged and elderly patients with schizophrenia.

Older people with schizophrenia suffer from greater physical comorbidity, cognitive impairment, and medication side effects compared to their younger counterparts. Unfortunately, little research is available to guide the treatment of subsyndromal depressive symptoms in older adults. This study will compare the antidepressant citalopram to placebo to determine the most effective treatment for reducing depressive symptoms in older patients with schizophrenia

After patients have been on stable treatment with antipsychotic medication for at least 4 weeks, they are randomly assigned to receive antipsychotic medication plus either citalopram or placebo for 3 months. Depressive symptoms and side effects are assessed weekly for the first month, biweekly for the second month, and again at the end of the third month. Cognition, motor and daily functioning, quality of life, and medication adherence are assessed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* HAM-D score of 8 or above
* Antipsychotic medication treatment
Intercare, Mindfulness and Compassion Based Intervention for Parental Burnout

The goal of this clinical trial is to test the effectiveness of an adapted mindfulness and compassion-based intervention (IBAP) in reducing parental burnout in Chilean mothers who telework while living with children under 18 years old. The main questions it aims to answer are:

* Can the intervention reduce symptoms of parental burnout in the short term (3 months) and medium-term (6 and 9 months) compared to the control group?
* Can the intervention improve work engagement in the intervention group compared to the control group?

Participants will be randomly assigned to either the intervention group or the active control group. The intervention group will receive the IBAP program while the active control group will receive a relaxation audio guide. Both group will receive parental burnout educational material, invitation to a Whatsapp group and a weekly email reminders. Parental Burnout (PBA) will be measured at baseline, 3, 6, and 9 months, and work engagement will be measured at the same time points.

Researchers will compare the intervention group to the active control group to see if the IBM program is more effective in reducing parental burnout and improving work engagement,


Eligibility Criteria:
Inclusion Criteria:

* Mother living with at leat one child over the same roof
* Telework at leat one day per week
* Work at leat three days per week

Exclusion Criteria:

* Self reported acute severe depression
* Self reported psychotic disorder
* Self reported substance abuse
Evaluating the Reach of Clinical Decision Support for Patients With Heart Failure

To work best, clinical decision support tools (CDS) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). Unfortunately, most CDS tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of physical assessments and labs, different workflows), which could generate new inequities for patients more likely to use virtual visits. The objective of this study is to test the reach, feasibility and acceptability of a new CDS tool for heart failure with reduced ejection fraction (HFrEF) during virtual visits. This new CDS tool was developed through an iterative design process, and will be compared to an existing HFrEF CDS tool in a randomized pilot study at outpatient cardiology clinics throughout the UCHealth system.


Eligibility Criteria:
Inclusion Criteria:

* The study subjects are potential users of the CDS, specifically clinicians with prescribing privileges who practice at one of the health system's (UCHealth) outpatient cardiology clinics. Because we are observing their prescribing behaviors in a virtual care setting (phone or video), we are also evaluating patient characteristics which could influence their prescribing decisions.

Exclusion Criteria:

* Clinicians who do not practice in a UCHealth cardiology clinic.
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.

The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.

* double-blind, superiority, parallel group trial.
* Experiment duration: 05 days.
* 03 visits (days 0, 5 and 28).
* Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score
* Adverse events evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree for all the purposes of the test, signing and dating the Term of Free and Informed Assent (TALE), signed by the Free and Informed Consent Form (TCLE) by responsible;
* Age ≥ 6 years and ≤ 11 years on the day of signing the TALE and the TCLE by the person responsible;
* Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA);
* Presence of sensitization to aeroallergens confirmed by positive result to the immediate reading skin test (PRICK test) and/or the presence of specific IgE to the test radioallergoabsorbent (RAST);
* Symptom intensity score "nasal obstruction" ≥ 2 points.
* Total nasal symptoms score (TNSS) ≥ 8 points.

Exclusion Criteria:

* Use of prednisolone or other oral or parenteral corticosteroid in the seven (07) days prior to inclusion;
* Use of H1 antihistamine, anti-leukotriene and decongestant topic in the seven (07) days prior to inclusion;
* Use or indication for the use of antibiotics at the screening visit and randomization;
* Presence of adenoid hypertrophy or anatomical disorders known obstructive disorders (e.g. septal deviation) that may be held responsible for nasal obstruction, at the discretion of the investigator;
* Diagnosis of severe or uncontrolled asthma;
* Allergy to desloratadine, prednisolone or any other component of the formulation of investigational products (PSIs);
* Presence of systemic fungal infection;
* Presence of any uncontrolled infection;
* Presence of any clinical observation finding (evaluation clinical/physical) or laboratory condition that is interpreted by the investigator physician as a risk to participation in the trial clinical or presence of serious uncontrolled disease(s);
* Participants who are pregnant or breastfeeding;
* Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be direct benefit to the participant.
Intergenerational Transmission & IGD

This study aims to test the longitudinal association between parental IGD and adolescent IGD, after controlling for covariates at personal, interpersonal and familial levels and the mediation effects of parenting on the intergenerational transmission.

This study is a two-year 3-wave longitudinal study. Students and parents will complete questionnaires at Time1, Time2, and Time3.

Introduction Adolescent Internet Gaming Disorder (IGD) causes severe physical, psychological, and social harms. Family and parents play critical roles in adolescent IGD. Based on the socially-based intergenerational transmission theories, parental IGD may increase the risk of adolescent IGD directly and indirectly.

Objectives The primary objective is to test the longitudinal association between parental IGD and adolescent IGD, after controlling for covariates at personal, interpersonal and familial levels

Subjects and methods This study is a two-year 3-wave longitudinal study. Adolescents will be recruited from Secondary schools using stratified random sampling method. One parent of each adolescent will be invited. Students will finish a set of validated psychological scales in class-room settings, while parents will finish their questionnaires through telephone interviews at Time1, Time2, and Time3.

Outcomes and measures The primary outcome is adolescent IGD symptoms based on DSM-5 IGD symptoms checklist. The secondary outcomes include time spent on Internet-related activities including gaming and gaming attitudes of adolescents.

Data analysis Univariate and multivariate linear/logistic regression analyses will be conducted to test the associations between parental factors (including parental IGD, parental modeling, and parenting practices) and adolescent IGD.

Implications This study will clarify the level of adolescent IGD in Hong Kong to inform policy and planning. It delineates mechanisms concerning intergenerational transmission of adolescent IGD, and shed light on the development of timely and innovative prevention programs based on a family approach and evidence-informed parental training.

Eligibility Criteria:
Inclusion Criteria (adolescent sample):

* Secondary 1-3 students (grade 7-9)
* willingness to finish the study
* Chinese speaking
* living with parent(s)

Inclusion Criteria (parent sample):

* Father or mother of participating child
* living with the participating child
* willingness to finish the study
* Chinese speaking

Exclusion Criteria (adolescent sample):

* receiving treatment for mental disorders
* intellectually disabled

Exclusion Criteria (parent sample):

* lack of competence in the Chinese language
* receiving treatment for mental disorders
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

Exclusion Criteria:

* Undergoing procedure in addition to the sling
* Not competent to give consent
* Using intermittent self catheterization pre-operatively
* Known allergy to local anesthetic
* Undergoing spinal anesthesia for the procedure
* Prisoners
* Non-English speaker
* Under 18 years of age
* Has a condition that would contra-indicate the use of local anesthetic or epinephrine
Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients

Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguately from acute respiratory failure.

If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia, cardiac-associated morbility, and death. On the other hand, weaning too soon often results in reintubation, which is associated with complications similar to those of prolonged ventilation.

The aim of this trial is to establish an evidence-based approach to weaning and to determine when a patient is ready to be weaned from mechanical ventilation, and what is the best weaning technique.


Eligibility Criteria:
Inclusion Criteria:

1. Age higher than 18 yrs
2. PaO2/FiO2 greater or equal than 150 with PEEP equal or lower than 10, and minute ventilation lower than 15 l/min
3. Temperature lower than 38,5°C
4. Stable hemodynamics: HR 60-125 b/min, SBP 90-160 mmHg without or with dopamine lower than 10 gamma/Kg/min or dobutamine lower than 10 gamma/Kg/min, no acute arrythmias
5. Hb higher than 8 g/dl
6. GCS higher or equal than 9
7. The attending physician has to agree that the patient is in stable conditions and ready to be weaned from the ventilator

Exclusion Criteria:

1. presence of chronic neuromuscular diseases
2. need of surgical intervention within the next 72 hours
3. difficult tracheal intubation
4. tracheostomized patients
Intrauterine Insemination and Luteal Fase Support

The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients with an indication for IUI:

* unexplained infertility
* mild male factor infertility
* minimal-mild endometriosis

Women:

* first IUI cycle ever
* normal ovulatory cycles (26-32d)
* age\<43,BMI≤30
* presence of at least one patent tube on hysterosalpingography and/or laparoscopy
* normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)

Men: Total motile count ≥ 5 Million/ml after capacitation

Exclusion Criteria:

* Patients with contra-indication for pregnancy , infertility or progesterone use.
A Family-based Intervention for Drug-abusing Adults in Hong Kong

To develop a family-based intervention with components of engagement, family roles, affection, and competence and verify its effectiveness on drug abstinence and family functioning for drug-abusing adults in Hong Kong; To compare the difference between family-based intervention and routine care which mainly consists of individual counselling services for drug abusers.

This is a quasi-experimental trial examining the effects of a proposed family-based intervention for drug abusers on motivating them to stay drug abstinence and improve family functioning, in which 40 drug abusers with focal families (including spouses and/or children) will be recruited for intervention group receiving both family-based intervention and routine care and 40 drug abusers without involving family will be recruited for comparison group receiving routine care. In the in-take, drug-abusing subjects will be given a brief introduction and invited to provide basic background information about themselves and families. After filling the informed consent, participants will be assigned to intervention group or comparison group according to whether their family will join sessions together. After drug abusers and families fill in the online questionnaire at the baseline (T0), the intervention group will receive family-based intervention and routine care in one month, while the comparison group will receive only routine care in one month. Both groups will be assessed at two time points after intervention period (T1 = 1-month after baseline; T2 = 2-month after baseline). As hypothesized, the intervention group will show a greater reduction in the primary outcomes of drug use and greater increase in the secondary outcomes of family functioning than the comparison group. A repeated-measures analysis of covariance will be conducted to assess the effects of family-based intervention.

Eligibility Criteria:
Inclusion criteria for intervention group:

1. Adults aged 18 to 55
2. Have used drugs in the past 90 days
3. At the time of case recruitment, the subject is engaged in an intimate relationship with a spouse/partner, or having a child/children
4. Understand oral and written Chinese

Exclusion criteria for intervention group:

1. Taking other treatments during intervention
2. The spouse or child of DA are not available to participate in the program

Inclusion criteria for comparison group:

1. Adults aged 18 to 55
2. Have used drugs in the past 90 days
3. Understand oral and written Chinese

Exclusion criteria for comparison group:

1. Taking other treatments during intervention
Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices

This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.

In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.

Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs.

This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.

Eligibility Criteria:
Inclusion Criteria:

1. Adult males and females who are 18 years of age or older.
2. Evidence or suspicion of upper gastrointestinal bleed (GIB)
3. Patient with known or suspected cirrhosis
4. Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation
5. Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so

Exclusion Criteria:

1. Known upper gastrointestinal malignancy
2. Bleeding from gastric varices, with or without esophageal varices
3. Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation
4. Variceal bleeding in the last 90 days
5. History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
6. Pregnant females
7. Incarcerated individuals
8. Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks
9. Non-cirrhotic portal hypertension causing esophageal varices
10. Known or suspected allergy to octreotide