cyrilzakka/clinical-trials huggingface dataset:
Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

Despite improved assessment and pharmacologic management, cancer pain is still undertreated. Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs. However, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited. Patients want to know "How can I get the most pain relief with the fewest side effects?" This study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.

This study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. Study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination.

Participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. Patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers).

The study will be conducted as a pragmatic clinical trial at two hospitals to address these aims:

1. Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
2. Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
3. Examine stakeholder perspectives on non-pharmacologic approaches to pain management.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
2. Speak Cantonese, English, or Spanish
3. Have an anticipated stay of ≥ 48 hours
4. Be aged 21 or older
5. Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled

Exclusion Criteria:

1. Acupuncture contraindication
2. Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
3. Admission to the psychiatric ward (e.g., for severe depression)
4. Inability to consent (e.g., cognitive impairment)
5. Prior involvement with the study (e.g., readmissions)
6. Platelets \< 50,000 microliters
7. Absolute neutrophil count \< 500 microliters
8. C. difficile infection
Comparison of Ventilation Tubes Among Anesthetized Pediatrics

To discover whether different types of ventilation breathing tube influence ventilation effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon dioxide, compliance among children and neonate under general anesthesia. The study compares eight ventilator breathing tube of different length, diameter, material of the ventilator breathing tube. Besides, the investigators also make an approach verify the change of body temperate under different gas flow(2L, and 5L).

In previous research, initial mechanical ventilator settings about children were as following: 1.tidal volume 6 to 10 ml/kg of ideal body weight; 2.delta pressures of respiratory pressure should be \<10 cmH2O in healthy patients; 3. respiratory pressures could be kept less than 28 to 30 cmH2O in patient with lung injury; 4. positive end-expiratory pressure was necessary, although the optimal level is unknown.

However, few researches discussed about Influences of different types of ventilation breathing tube. The investigators want to clarify the character about length, diameter, and material of the ventilation breathing tube under the ventilation system in relation to tidal volume, end tidal carbon dioxide, compliance among children and neonate.

During this study, the participants will be 100 children who were ASA class1, 2 and performed non-emergency, non-cardiac surgery, who will receive general anesthesia . The participants will divide into three groups according to different body weights (Group N: \<4.5kg; Group T: 4.5\~20kg; Group C: \>20kg), and would receipt total eight type of ventilator breathing tube test. Primary outcome will be the difference of tidal volume, end tidal carbon dioxide and compliance. Besides, secondary outcome will be the change of body temperate under different gas flow (2L, and 5L).

Eligibility Criteria:
Inclusion Criteria:

* with American Society of Anesthesiologists (ASA) physical status classification 1\&2
* undergo elective surgery
* intubation

Exclusion Criteria:

* Cardiac-pulmonary surgery
* Had respiratory related disease
Efficacy and Safety Evaluation of BZ371B in ARDS Patients

The purpose of this study is to evaluate safety, tolerability and efficacy of BZ371B in intubated patients with severe Acute Respiratory Distress Syndrome.

Acute respiratory distress syndrome (ARDS) is a severe medical condition that is triggered by an alveolar capillary membrane damage resulted from several causes. Among these causes, respiratory viral infections such as SARS-CoV-2 can be responsible for the development of the disease. ARDS presents a high mortality rate, which may range from 33-52%. The main difficulty for the treatment of this disease is dealing with hypoxia.

Nitric Oxide inhalation therapy has proven to increase oxygenation and Ventilation/Perfusion by it's vasodilation property. However, there are several limitations for it's use, such as the need of a specialized equipment, systemic side effects, etc. The use of others vasodilation medications are not indicated due to their systemic systemic exposure and non-selective vasodilation.

BZ371B is a small peptide that acts as a NO synthase (NOS) enhancer, inducing local NO production, and is capable to present local vasodilation effect increasing blood flow regulation, by a new and innovative mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Men or Women
* In Mechanical Ventilation
* Diagnosed with Acute Respiratory Dystress Syndrome characterized by: acute beginning (less than one week from the beggining of the disease); bilateral opacity in the Torax X-Ray (not explained by stroke, atelectasis or nodules); respiratory failure not derived from cardiac failure and water overload.
* P/F lower or equal to 150 mmHg with FiO2 higher or equal to 70% and PEEP higher or or equal to 88 mmHg
* ALready executed first pronation, followed by supine position. One hour after returning from supine position.

Exclusion Criteria:

* Presence of pulmonary thromboembolism
* Presence of secondary bacterial pneumonia
* Severe Asthma
* Pregnant or lactanting women
Clinical Performance of a Chlorhexidine Antimicrobial Dressing

Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

Prospective, controlled, randomized, clinical trial comparing the 3M™ TegadermTM CHG (Chlorhexidine Gluconate) IV Securement Dressing (3M Healthcare, St Paul, MN) to a standard transparent dressing.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females over 18 years of age
* Patients with an existing, or newly inserted, central venous catheter
* Patients who require the catheter for at least 3 days

Exclusion Criteria:

* Sensitivity to chlorhexidine
MP-3 Biofeedback Training and Central Vision Loss

The objectives of this investigation are:

* evaluate the results of rehabilitation treatment using photostimulation with a structured stimulus in two different samples of low vision subjects with central vision loss who will be subjected to biofeedback at the MP3 microperimeter with different timing;
* compare the effectiveness of the rehabilitation treatments in the two groups to provide useful indications for proposing standardisation of the rehabilitation pathway focusing on photostimulation in subjects with central vision loss.


Eligibility Criteria:
Inclusion Criteria:

* Age related macular degeneration

Exclusion Criteria:

* Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days
A Study to Determine Optimal Absorption of Single Dose Omega-3

This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.


Eligibility Criteria:
Inclusion Criteria:

* Male and females over 19 years and otherwise healthy
* Healthy BMI \&gt;18.0 and \&lt;30.0
* Able to provide informed consent
* Agree to arrive fasted on the day of the trial
* Agree to participate in all arms of the study

Exclusion Criteria:

* Unstable or serious illness \[e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy\]\*
* Any treatment that included radiation or chemotherapy within the previous 2 years
* Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
* Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
* Active smokers, nicotine, alcohol, drug abuse
* Chronic past and/or current alcohol use (\&gt;14 alcoholic drinks week)
* Allergic to any of the ingredients (i.e., fish oil)
* Pregnant or lactating women
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

  * An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

    * Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.
Impact of Donor-Specific Antibodies in (Highly-) Immunized Living Donor Kidney Transplant Recipients

Kidney transplantation is the preferred treatment for end-stage renal disease. Alongside limited availability of donors, rejection and premature graft loss are main barriers to kidney transplantation. Donor-specific antibodies pre-transplantation may arise due to to prior solid organ transplantation, pregnancy or blood transfusions. Their presence is considered a risk of graft failure. The impact of DSA is differently reported in literature, also according to the technique by which DSA have been measured. Techniques such as the complement-dependent cytotoxicity crossmatch, the immunofluorescence crossmatch and the Luminex Single Antigen Bead have different sensitivities for detecting DSA.

Historically, our kidney transplant program has been advocating living donor transplantation and as a result the majority of transplantations are with a living donor. In this context and in the absence of a compatible living donor, pretransplant DSA have not been considered an absolute contra-indication for transplantation. The aim of the current study is to determine the effect of DSAs on rejection and death-censored graft survival in living donor kidney transplantation.

Participants are adults who underwent a living donor kidney transplantation between 2010 and 2019 in the presence of DSA. Control subjects are both immunized and non-immunized kidney transplant recipients in the same period.

This is a retrospective, case control study. Death-censored graft survival is analyzed for all patients and compared by presence of DSA and other predicting variables, such as immunization level, age, sex and HLA mismatches. Furthermore, biopsy proven rejection, patient survival, kidney function, length of hospital stay and proteinuria are analyzed.

Also, a predefined subgroup analysis is performed in the DSA positive patients. These are compared according to amount, strength and HLA-class of DSAs.


Eligibility Criteria:
Inclusion Criteria:

* Pre-transplantation donor-specific antibodies in Luminex Single Antigen Bead analysis.
* Age 18 years or older

Exclusion Criteria:

* Desensitization treatment for a current or historic positive CDC-crossamtch
Pacing in Left Ventricular Assist Device Recipients

Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the expected value. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance, to which heart rate may be a contributing factor.

The purpose of this study is to clarify the impact of heart rate (by means of pacing) on work capacity (measured as peak oxygen uptake) in LVAD recipients.

While implantation with left ventricular assist devices (LVADs) in patients with end-stage heart failure (HF) improve survival and quality of life, work capacity remains at a disappointing 50% of the expected value.

Due to the worldwide (increasing) shortage of donor hearts, LVADs are increasingly used as destination therapy which makes it crucial for physicians to persistently identify opportunities to improve management, lower the adverse events and maximize the benefits of this treatment option.

In recent years it was found that upregulation of device pump speed improves the maximal work capacity of LVAD recipients with no side effects. More recently it was found that the patients' heart rate reserve also was of importance in this regard, however, the latter was shown in a retrospective study and needs to be confirmed in a prospective randomized double-blinded intervention study. As a large portion of LVAD recipients are already implanted with a pacing device (and suffer from chronotropic incompetence) such a study is possible to conduct by controlling their heart rate during exercise by pacing (ie randomized crossover design).

Eligibility Criteria:
Inclusion Criteria:

* Implanted with a left ventricular assist device
* Implanted with a pace-device ensuring the possibility of pacing
* Age \> 18

Exclusion Criteria:

* Not able to undergo a peak oxygen uptake test
* No consent
DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY

To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels.

Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic.

For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level.

The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method "Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000)".

The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients,both male and female over the age of 18
* Patients with at least one year of follow-up

Exclusion Criteria:

* Combined liver-kidney or pancreas-kidney transplants
* Re-transplants
* Patients with follow-up less than one year
ERAS for Patients Received Neoadjuvant Chemotherapy

Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.

Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
2. Age older than 18 and younger than 75 years.
3. American Society of Anesthesiologists (ASA) class: I-III.
4. Participants can describe the symptom objectively and cooperate actively.
5. Written informed consent.

Exclusion Criteria:

1. Patients allergic to oxaliplatin, tegafur gimerac etc.
2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function \> II (NYHA)
3. Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
4. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr \< 25 ml/min).
5. Patients who require simultaneous surgery for other diseases.
6. Patients who received upper abdominal surgery previously.
7. Pregnant or breast-feeding women.
Treatment With AX200 for Acute Ischemic Stroke

The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Stroke onset within 12 hours prior to start of study agent administration
* Ischemic stroke in the middle cerebral artery (MCA) territory confirmed by magnetic resonance imaging (MRI)

Exclusion Criteria:

* Time interval since stroke onset impossible to determine
* Carotid T-occlusion (magnetic resonance angiography \[MRA\])
* Subarachnoid hemorrhages
* Several safety parameters
Supra-Pectineal QLS Plating Vs Infra-pectineal Plating in Management of Quadrilateral Plate Fractures

The investigators conducted such a prospective randomized controlled study aiming to reach a satisfactory outcome and to compare supra-pectineal QL buttress plating versus infra-pectineal for management of anterior column with or without posterior hemi-transverse component and quadrilateral plate involvement.

Our hypothesis was that supra-pectineal quadrilateral buttress plating provides much more rigid fixation and a strong buttress for medial wall migration, also it could correlate with a better functional and radiological outcome. However, there is a lack of knowledge in the prospective assessment of functional and radiological outcomes and follow up of postoperative complications of supra-pectineal quadrilateral buttress plating versus infra-pectineal plating in fixation of QLS and to our knowledge, it will be the first study to include such measures of outcome together in a prospective randomized fashion.

Eligibility Criteria:
Inclusion Criteria:

* Anterior column fracture acetabulum with QLS involvement
* Anterior column posterior hemi-transverse fracture acetabulum with QLS involvement
* Age between 16-60 years' old

Exclusion Criteria:

* Open fractures
* Associated pelvic ring injuries that require intervention
* Associated internal organ injuries that require intervention
* Age less than 14 years and older than 60 years
The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability

The goal of the Dortmund Vital Study is to validate previous hypotheses and to generate and validate new hypotheses about the relationship of ageing, working conditions, genetic makeup, stress, metabolic functions, cardiovascular system, immune system, and mental performance over the lifespan with a focus on healthy working adults. The Dortmund Vital Study is a multidisciplinary longitudinal study involving the Departments of Ergonomics, Immunology, Psychology and Neurosciences, and Toxicology of the Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo) in Dortmund, Germany, as well as several national and international cooperation partners.

The Dortmund Vital Study is designed as a combined cross-sectional and longitudinal study. About 600 subjects aged between 20 and 70 years will participate. A wide range of demographic, psychological, behavioral, sensory, cardiovascular, biochemical, immunological and biochemical data, a comprehensive EEG-based cognitive test battery as well as structural and functional magnetic resonance imaging (MRI) have been included in the study. Specifically, parameters obtained by MRI and EEG-related measures can be evaluated as a function of polygenic scores, metabolic products, concentration of immune cells, immune age and infections, such as Toxoplasmosis or COVID-19 that are largely unexplored. The same is true for environmental and lifestyle factors that impact on brain activity and behavior.

The initial testing has been conducted between 2016 and 2021 and will be repeated every five years (three follow-up measures until 2035).

The study will shed light on sources of large inter-individual differences in cognitive functioning with increasing age and reveal biological and lifestyle markers contributing to work ability, longevity and healthy aging on the one hand, and on risk factors for cognitive decline, mild cognitive impairment or even dementia on the other.

Eligibility Criteria:
Inclusion Criteria:

* Blood thinners
* Hormones
* Antihypertensives
* Cholesterol reducers
* Normal or corrected-to-normal vision and hearing
* Fulfill standard inclusion criteria for MRI measurements
* Sufficient language skills

Exclusion Criteria:

* Dementia
* Parkinsonism
* Stroke
* Cardiovascular diseases
* Bleeding tendency
* Oncological diseases
* Schizophrenia
* Obsessive-compulsive disorder
* Anxiety disorders
* Severe depression
* Head injuries
* Head surgery
* Head implants
* Eye diseases (cataract, glaucoma, blindness)
* Accidents that limit physical fitness and mobility
* Psychotropic drugs
* Neuroleptics