cyrilzakka/clinical-trials huggingface dataset:
Factors Related to Truth Telling in Primary Caregivers

The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.

Background: Over the last 50 years, telling truth in adult with cancer was direct. However, studies of truth telling in newly diagnosed children with cancer were seldom. Explore the factors and experiences related to truth telling in primary caregivers of children newly diagnosis with cancer were seldom too. Therefore, we could not estimate the current status of truth telling in primary caregivers of newly diagnosed children with cancer.

Purpose: The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.

Method: Purposive sampling structured questionnaire, used longitudinal resistance, repeated measurements, correlational design. SAS 9.3 for Windows was used for data entry and analyze. By using the frequency, percentage, mean, and standard deviation to describe demographic information and current status of truth telling. By using the mean, standard deviation, maximum and minimum to analyze hope, care burden, and quality of life. Demographic information, medical information data, truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Pearson correlation coefficients; the change and predictors about truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Generalized estimating equation.

Limitation: Studying in one medical center in Taipei, it could not estimate the country's primary caregivers of newly diagnosed children with cancer in conclusions. Because of the limitation of the manpower, time and case numbers, study tracked only six month, could not be assessed the long-term change of the Herth Hope Index, caregiver burden scale, truth telling and quality of life in primary caregivers of newly diagnosed children with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregivers of children newly diagnosed with cancer must be aged 20 years or older.
* Who can communicate in Chinese and Taiwanese.
* Consciousness clear.
* Normal cognitive function.
* After the explanation, agreed to participate in the study and signed a consent form.
* The age of children newly diagnosed with cancer is between 0 and 18 years old, who are newly diagnosed with cancer, before determined treatment plan.
* The physician of children newly diagnosed with cancer, who were willing to participate this study and signed a consent form.

Exclusion Criteria:

* Primary caregivers of children newly diagnosed with cancer, who have been diagnosed mental illness.
* The children were cancer recurrence.
* The physician of children newly diagnosed with cancer, who were not willing to participate this study.
Annexin Imaging in Dissection of the Descending Aorta

The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported. The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection. The innovative character is based on the use of annexin scintigraphy.

To establish the proof of concept in humans of the link between the intensity of 99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic diameter in patients with type B aortic dissection.

Eligibility Criteria:
Inclusion Criteria:

* patient whose age is ≥ 18 years old
* any patient seen more than 6 months and less than 5 years after a dissection involving the descending aorta at Bichat Hospital, whether it is a dissection of the descending aorta alone or a dissection of the ascending aorta extended to the descending aorta
* dissection of the uncomplicated descending thoracic aorta: not requiring surgery or stent implantation within the first 6 months after acute dissection
* effective contraception for women of childbearing age

Exclusion Criteria:

* scheduled procedure for dissection of the descending aorta
* contraindication to aortic CT with injection of contrast media: renal failure with creatinine clearance \<30 ml/min or creatinine \>200 µmol/l; allergy to contrast media
* history of surgery or stent implantation in the descending thoracic aorta
* pregnant or breastfeeding women
* patient under guardianship or trusteeship
* non affiliation to social security or CMU (beneficiary or assignee)
* patient refusal to participate in the study
Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block

1. Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
2. Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy

Scalp nerve block for supratentorial craniotomy patients can effectively reduce the consumption of perioperative analgesic drugs, avoid the occurrence of hypertension and tachycardia, relieve postoperative pain, improve postoperative recovery quality of patients. Scalp nerve block is safe and has fewer complications due to the small amount of local anesthetic. For auriculotemporal nerve block, temporary block of adjacent facial nerve is one of the most likely complications, with an incidence of 8.6%, and usually can be recovered within 24 hours, since the facial nerve was located in the anterior and lower part of the tragus, 1 cm deep in the skin. Therefore, improving nerve block methods and reducing the dosage of local anesthetics may reduce the risk of facial nerve block. The investigators proposed helix feet in front of the zygomatic arch as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. The study intends to compare a modified auriculotemporal nerve block method with the traditional way, reflecting on perioperative hemodynamical fluctuation, postoperative analgesia effect and incidence of facial nerve paralysis. This will verify the safety and analgesic efficacy of the modified nerve block method proposed in this study, and then provide a basis for improving the quality of perioperative management during neurosurgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing supratentorial craniotomy under general anesthesia;
2. 18-65 years old;
3. ASA I or II.

Exclusion Criteria:

1. Emergency surgery;
2. Be allergic to ropivacaine;
3. Participating in other clinical investigation within 30 days;
4. Skin infection at the puncture site;
5. Patients taking analgesic drugs before surgery;
6. Persons addicted to alcohol or drugs;
7. Patients with severe liver and kidney dysfunction;
8. Patients with coagulation disorder;
9. Pregnant and lactating women;
10. Patients with consciousness disorder before surgery;
11. Those who have undergone neurosurgery within the last 6 months;
12. Patients who were unable to understand the NRS before surgery.
PD-1 Knockout Engineered T Cells for Muscle-invasive Bladder Cancer

This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic advanced bladder cancer. Blood samples will also be collected for research purposes.

This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically verified stage IV muscle-invasive bladder cancer with measurable lesions (On CT: longest diameter of tumoral lesion \>=10 mm, shorted diameter of lymph node \>=15 mm; measurable lesions should not have been irradiated)
* Progressed after all standard treatment
* Performance score: 0-1
* Expected life span: \>= 6 months
* Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
* Major organs function normally
* Women at pregnant ages should be under contraception
* Willing and able to provide informed consent

Exclusion Criteria:

* Pathology is mixed type
* Emergent treatment of tumor emergency is needed
* Poor vasculature
* Coagulopathy, or ongoing thrombolytics and/or anticoagulation
* Blood-borne infectious disease, e.g. hepatitis B
* History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
* With other immune diseases, or chronic use of immunosuppressants or steroids
* Compliance cannot be expected
* Other conditions requiring exclusion deemed by physician
Alternative Doffing Strategies to Prevent Healthcare Worker Self-Contamination When Using Personal Protective Equipment (PPE)

Alternative doffing strategies may help prevent self-contamination of staff members when using PPE. The study aims to determine which among the suggested methods in the literature that have been proposed as alternatives to the traditional CDC recommended doffing protocol, would be most beneficial to reduce healthcare worker self-contamination.

A randomized controlled trial of doffing procedures will be conducted by healthcare worker volunteers who participate in direct patient care. However, doffing simulations will be conducted outside of patient care areas and will not involve patients. Staff participants PPE techniques will be evaluated in the controlled environment of the simulation center of the Unique Pathogens Unit. The comparison groups will be the Centers for Disease Control (CDC) procedure with the addition of a second layer of gloves (double gloving procedure), the CDC procedure with additional hand hygiene performed on gloves at key steps (intensified hand hygiene procedure), and the one-step roll off of gown and gloves (one-step procedure), with the CDC procedure as the control. Participants will be assigned to a doffing protocol chronologically starting with the double glove and ending with the control until 100 volunteers have participated. Additional PPE such as masks and goggles will be removed as part of each of the four protocols. Healthcare workers will receive a demonstration of the donning/doffing from the study coordinator, and perform a practice donn/doff prior to the observed simulation. Only one volunteer with participate in each simulation session. Glogerm (TM) will be applied to PPE in a thin stripe and smoothed to evenly with gloved hands to cover arms, trunk, and gown hem. S. epidermidis will be applied using colonies diluted in solution and spread over gloves, arms, trunk, hem with a swab.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Providers at VCU Medical Center, including medical degree holding trainees who are medical housestaff Adults \> or =18 years of age

Exclusion Criteria:

students pregnant or breastfeeding healthcare workers non-clinical providers children/teens \<18 years of age open skin lesions or dermatitis presence of prosthetic materials such as prosthetic joints, heart valves
Prevalence and Risk Factors of Pressure Ulcers in Beni Suef Governorate of Egypt

the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt

pressure ulcers are defined as localized damage to the skin as well as underlying soft tissue, usually occuring over a bony prominence or to medical devices.

immobility and friction are important risk factors for pressure ulcers, Malnutrition and body mass index are associated with pressure injury prevalence, the days in hospital, skin moisture and other neurological factors are significant risk factors for pressure ulcer development.

Beni-Suef is one of the upper Egypt governorates located about 120 Km south of cairo, according to population estimates from 2019, the majority of residents in the governorate live in rural areas, with an urbanization rate of only 23.2%, Due to greater reliance on federal and state payers, low volume and complxity of services provided, rural residents often encounter barriers to healthcare that limit their ability to obtain the care they need

Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients will be selected from ICU and CCU
* both sexes males and females
* their age ranges between 25-65 years old
* patients who have peripheral arterial disease
* their body mass index (class II and class III obesity)
* diabetic patients more than 5 years old

Exclusion Criteria:

* medically unstable patients
* un cooperative patients
* semi- conscious or unconscious patients according to glascow coma scale
Medication Adherence in Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic multisystemic disease requiring ordinary doctor visits and an adherence to medication. Evaluating the parameters affecting the medication adherence is essential for the efficacy of the treatment. To our knowledge no study has ever evaluated the factors affecting the medication adherence in patients with PsA so far.

Psoriatic arthritis (PsA) is a multisystemic disease requiring ordinary doctor visits and an adherence to medication. Due to its chronic nature treatment regimens lasts for the lifetime and that may affect the efficacy of the treatment. Although treatment with drugs is a biological intervention, medication adherence and eliminating the factors affecting it seems essential for treatment efficacy. To our knowledge no study has ever evaluated the factors affecting the medication adherence in patients with PsA so far. Our aim in this study is to evaluate the factors affecting the medication adherence in patients with PsA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PsA according to CASPAR criteria
* Administering PsA medication for at least 6 moths
* Aged ≥18

Exclusion Criteria:

* Not having enough cognitive functions to understand and answer the questionnaires
* Having a psychiatric disorder
* Having a severe comorbidity (e.g. malignancy, stroke)
Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal Fluid

Therapeutic drug monitoring of antibiotics in critically ill patients is a present research topic of the last ten years. Research results have shown subtherapeutic blood concentrations in those patients. However, the amount of antibiotics in the cerebrospinal fluid (CSF) in patients with ventriculitis or meningitis is still unclear. This study is a prospective study to evaluate the concentration of different antibiotics in the CSF in patients with an external ventricular drainage compared to antibiotic blood concentration.

Bacterial infections are still associated with a high mortality in intensive care unit patients. Especially patients diagnosed with ventriculitis caused by a bacterial infection have a bad outcome. Therefore, antibiotic therapy is the only causal opportunity to treat those infections. However, there are many chances in pharmacokinetic and -dynamic in critically ill patients with unpredictable antibiotic concentrations. Furthermore, it is important that the concentration in the blood as well as in the effect-compartment "CSF" is sufficient. Less data of the last years describe antibiotic concentrations in the CSF and show subtherapeutic levels, which is endangering for the therapeutic success. The introduced study is a prospective, observational study that analyses antibiotic concentrations in CSF in critically ill patients. The distribution between CSF and blood will be evaluated by comparing these two compartments.

Eligibility Criteria:
Inclusion Criteria:

* written approval of the legal guardian
* external ventricular drainage
* antibiotic therapy

Exclusion Criteria:

* no approval
* no antibiotic therapy or no external ventricular drainage
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exlcusion criteria as specified in the study protocol
The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers

Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.

Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.

Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, aged between 19 and 40 years
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination
* Drug free for 1 week prior to the study day

Exclusion Criteria:

* Regular use of medication especially analgesics
* Abuse of alcoholic beverages, drug abuse
* History of asthma
* Participation in a clinical trial in the 2 weeks preceding the study
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Resting systolic blood pressure \> 135 mmHg or diastolic blood pressure \> 85 mmHg
* Acute skin diseases like sunburn on the relevant areas or skin lesions
* Pregnancy or breast feeding
* Regular consumption of very spicy (capsaicin containing) food
* Allergy against any medication used in the study protocol
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (Europe)

This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post-implementation of an "Alarm Advisor software".

In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded.

In an interim period an Alarm Advisor software will be introduced to the unit.

In a second phase (post-implementation) the same set of alarm data will be recorded.

The "Alarm Advisor" Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits).

The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care unit during the study period

Exclusion Criteria:

* none
Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.

In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21-65 years inclusive;
2. Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
3. By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
4. Provides a urine drug screen positive for methamphetamine;
5. Able to provide informed consent;
6. No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
7. Adequate English proficiency for study consent, and completion of the study instruments.

Exclusion Criteria:

1. Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
2. Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
3. Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
4. Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;
5. Presence of a clinically significant abnormality on baseline MRI;
6. Inability to have an MRI;
7. Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);
8. Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
9. History of head injury with loss of consciousness for more than 15 minutes;
10. Diagnosis of dementia;
11. Prescribed benzodiazepines or anticonvulsants;
12. Currently enrolled in formal substance use disorder treatment;
13. Metal implants or non-removable metal objects above the waist;
14. Lifetime history of prior clinical treatment with TMS;
15. Serious risk of suicide or homicide;
16. Unable/unwilling to follow the study procedures;
17. History of intractable migraine;
18. Assessed to be at risk for alcohol or opioid withdrawal.