cyrilzakka/clinical-trials huggingface dataset:
The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU

The aim of this study is to determine the effective nalbuphine dose in 90% of intubated patients in the ICU, including the continuous infusion dose and a bolus dose during moving to the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS) requiring a score of 3-4.

The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4, the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not, increased by 20 ug/kg/h.

The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at 0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS score of 3-4 is obtained.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical invasive ventilation
* Sedated only with nalbuphine

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Age below 18 or over 80 years
* An indication for deep sedation (e.g.the initial stage of septic shock, acute brain injury or acute respiratory distress syndrome)
* Renal dialysis
* The inability to assess pain by the BPS scale (e.g. paralysis)
* BMI less than 18 or more than 35
* Preadmission use of opioid analgesic for chronic pain
* Severe hepatic failure
* State of consciousness with impossibility to use self-assessment scale; monoamine oxidase inhibitors
Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps

Analysis of cell and protein deposits on the Impella Heart Pump.

The Impella heart pump supports patients in cardiogenic shock for various reasons and has passed safety and biocompatibility evaluations. The planned investigation aims to further analyze cell and protein adhesion on these pumps and the effects of their prolonged use, especially in scenarios like bridge-to-transplant, recognizing preclinical testing limitations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Impella 5.5 therapy and duration of support for ≥ 25 days OR Patients with Impella CP therapy and duration of support for \> 4 days
* Use of Sodium Bicarbonate as a purge additive as permitted by the IFU

Exclusion Criteria:

* Age \< 18 years
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Achalasia
* Age 16-80
* ASA Class 1-3

Exclusion Criteria:

* Pregnancy
* Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.

After eight subjects have been treated as part of this study, this exclusion criteria no longer applies

* Patients who are taking immunosuppressive medications or are immunocompromised
* Patients on anticoagulant medications or abnormal coagulation tests
* Patients with severe medical comorbidities, in the judgment of the treating surgeon
Statin-Intolerance Registry

The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention.

Patients will be systematically and prospectively included and followed by the registry.

This non-interventional registry based on routine clinical practice will collect data under real-life conditions. The treatment of patients will not be changed by this study.

Data on patient characteristics and the treatment history will be collected via questionnaires at study entree. Yearly follow up visits will re-assess the baseline parameters and document cardiovascular events.

The data will be analyzed using descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with dyslipidemia and statin intolerance, defined as:

   Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued
2. Participants are ≧ 18 years old
3. Written declaration of consent is available
4. The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely.

Exclusion Criteria:

1. Use of any experimental or investigational drugs within 30 days prior to screening.
2. An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.
PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases

To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Male or female, age ≥ 18 years;
3. Solid tumors confirmed by histological or cytological examination;
4. At least 1 bone metastasis from a documented tertiary A hospital during the screening period;
5. Worst pain score NRS ≥5 points when treated with a stable analgesic regimen during the baseline assessment period;
6. Received a stable anti-tumor regimen within 28 days prior to the baseline assessment period
7. During the screening period, the physical status score of the Eastern Cooperative Oncology Group (ECOG) was 0-2 points;
8. Life expectancy judged by the investigator to be at least 6 months
9. Good organ function during the screening period (repeated testing can be confirmed if necessary);
10. Female subjects of childbearing potential with negative blood pregnancy test results within 7 days prior to the first dose of study drug and not lactating.

Exclusion Criteria:

1. Previous occurrence or concomitant osteomyelitis of the jaw or osteonecrosis of the jaw, dental disease or jaw disease that is active, requiring oral surgery, dental surgery or oral surgery wound that has not fully healed, or has planned invasive dental procedures during the study;
2. History of major joint trauma or surgery within 1 year prior to enrollment
3. Cardiac dysfunction Within 6 months before enrollment;
4. Resting tachycardia or resting bradycardia on ECG at screening；
5. Subjects who have evidence of orthostatic hypotension at screening；
6. Hepatitis B surface antigen (HBSAG), hepatitis C antibody (HCVAB), human immune defect antivirus (HIV) antibody, syphilis antibody;
7. The pain of the subjects not predominantly related to a bone metastasis;
8. The subject with neurological diseases and/or mental illness and/or cognitive dysfunction ；
9. Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 1 month of the treatment period, and the subject who received the radiotherapy within one month before the first research drug administration
10. Subject has a history of allergic or anaphylactic reaction to mammalian -based drugs, or allergies to supplements (calcium or vitamin D supplements), or have a history of allergens of opioids, or past history of treatment or diagnostic monoclonal antibody, Or other allergies;
11. The subject participated in the treatment of other clinical trials within one month before receiving the experimental drug (except for participating in other clinical trial screening losers);
12. In the judgment of the investigator, would make the subject inappropriate for entry into this study;
Cancer Symptom Management in Nursing Students

Ensuring that nursing students learn the symptoms seen in cancer.

Nursing education plays an important role in providing the knowledge, skills and critical thinking abilities needed to provide quality care. Innovative teaching strategies provide quality education. These methods, such as cooperative learning and concept maps, help them to criticize and apply their knowledge. It is important to integrate these strategies in oncology nursing education, which involves complex treatment processes and symptom management. Collaborative learning with concept maps can contribute to the development of a more holistic understanding of oncology care. This study was planned to examine the effect of collaborative learning approach with concept maps on nursing students' knowledge learning about symptom management of oncologic patients.

Eligibility Criteria:
Inclusion Criteria:

* The sample of the study will consist of students who were attending the course on the date the research data were collected,
* who had not received education for oncology patients before and
* who agreed to participate in the study.
* It will be aimed to include all students who meet the inclusion criteria.

Exclusion Criteria:

* Students who were absent from the course and
* did not participate in the pre-test, post-test and follow-up test will be excluded from the study.
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System

The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.

The IRRAflow system offers automated irrigation, controlled drainage, and ICP monitoring all in one system for the treatment of intracranial hemorrhage - \[Intracerebral hemorrhage (ICH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hematoma (SDH)\], intracranial abscess, and ventriculitis.

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care. Such treatment includes but is not limited to neurointensive care, neuromonitoring, and surgical or endovascular occlusion of identified sources of intracranial hemorrhage (e.g. vascular anomalies, aneurysms, etc.).

Eligibility Criteria:
Inclusion criteria:

* Age \>=18 years of age
* Intracranial hemorrhage documented on head CT or MRI scan.
* Indication for active fluid exchange evaluated by treating physician.
* Signed informed consent obtained by patient or Legal Authorized Representative
* Scheduled enrollment and treatment within 72 hours of last known well (LKW)

Exclusion criteria:

* GCS ≤ 5
* Pregnancy
* Fixed and dilated pupil
* Life-threatening medical condition
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.


Eligibility Criteria:
Disease Characteristics:

* Patients with documented histologic and cytologic diagnosis of colon or rectal malignancy
* Patients with documented status post surgical resection of primary cancer or metastases
* Limited residual disease (i.e., CEA serum levels \< 15 ng/mL and negative baseline CT scans, or no lesion \> 1 cm)

Prior/Concurrent Therapy:

* Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy, other investigational therapy for cancer, or surgical procedures at least six weeks prior to study entry.
* Patients must have recuperated from surgery and toxicities (as a result of previous therapy) sufficiently prior to study entry
* Biologic Therapy: Patients who have received a murine, chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA)
* Radiotherapy: No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys)

Patient Characteristics/Inclusion Criteria:

* Performance Status: Patients with Karnofsky performance status \> 70%
* Hematopoietic: ANC \>/= 1.5 x 10/L; Hemoglobin \>/= 10 g/dL; Platelets \>/= 100 x 10/L
* Renal: Serum Creatinine \</= 1.5 x ULN
* Hepatic: Serum Bilirubin \</= 1.5 ULN; AST and ALT \</= 2.5 x ULN; Alk Phosphatase \</= 2.5 x ULN
* Cardiovascular: Patients with LVEF \>/= 50% by required MUGA/2D-ECHO tests
* Pulmonary: Patients with DF and FEV1 \>/= 60% by required Pulmonary Function Tests
* Central Nervous System: Patients with known metastatic disease to the CNS are excluded.
* Other: Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into study. Patients must understand and give written informed consent.
Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of 18 years or older able to sign informed consent
2. A previous diagnosis of low grade bladder cancer
3. A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
4. Serum creatinine levels ≤ 2.0 mg/dl
5. Serum sodium levels \<146 mg/ml
6. Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months
7. Patient is candidate for TURBT

Exclusion Criteria:

1. Previous history of high grade bladder cancer including carcinoma in situ
2. Presence of upper urinary tract tumor on imaging
3. Renal failure with serum creatinine \>2.0 mg/dl prior to inclusion
4. Hypernatremia \>146 mg/dl prior to inclusion
5. Contra-indication to undergo TURBT
Low Intensity Training Combined With KAATSU on Muscle Vasodilatation and Arterial Stiffness in the Elderly Population

The purpose of the present study is to evaluate the acute and chronic effect of low intensity strength training with or without moderate blood flow restriction on muscle vasodilation and arterial stiffness in elders with low gait speed. In addition, the responses of prothrombotic factors in blood coagulation, the impact on heart rate and arterial pressure will be assessed.

The investigators propose a study of 26 sedentary elders with low speed gait, supervised by the Hospital Israelita Albert Einstein - Vila Mariana ambulatory. This will be an open clinical trial, prospective, single center, randomized and controlled study. It will be divided into two parts: acute and chronic phases. After signing an informed consent, the participants will be separated in two groups:

Group 1. Resistance exercise with low intensity combined with partial blood flow restriction Group 2. Conventional resistance exercise with low intensity

All of participants will be submitted to interventions tests before and after the period of training which are:

1. Laboratory Tests: Blood tests
2. Plethysmography
3. Handgrip
4. Quality of life questionaire
5. FMD tests
6. Vasodilation capacity

Eligibility Criteria:
Inclusion Criteria:

* Elderly people aged 60 to 85 years, with walking speed \<0.8m / s (Guralnik, 1994).

Exclusion Criteria:

* Elderly patients with uncontrolled diabetes mellitus or peripheral neuropathy;
* Symptomatic peripheral obstructive arterial disease or brachial ankle index \<0.9;
* Uncontrolled arterial hypertension (BP\> 160 / 100mmHg);
* Uncontrolled dyslipidemia (total colostrum\> 220mg / dL);
* Infectious with less than 1 month;
* Osteoarticular or neurological problems that prevent training;
* History of anemia, cerebrovascular disease, myocardial infarction in the last 6 months;
* Pior deep venous thrombosis;
* Use of oral anticoagulant;
* Smoking \<6 months;
* Use of antiplatelet agents and anticoagulants;
* Cognitive dysfunctions: Mini-mental \<24. (Brucki, 2003).
LSI (Lesion Index) Workflow Observational Study

This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.

The primary objective of this study is to characterize LSI achieved values for durable lesion formation using the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF)

Secondary objectives of this study are as follows:

* To characterize the use of EnSite Automap and AutoMark module software settings, including LSI threshold (OUS), contact force, time, power, flow, and AutoMark spacing using the TactiCath SE catheter for RF ablation for the treatment of drug-refractory PAF.
* To characterize LSI achieved values for lesions that reconnected versus those that were durable, both in an acute procedural setting as well as in patients who undergo additional ablations during the 12-month follow-up period after an index RF ablation procedure for the treatment of drug-refractory PAF.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation related procedure.
2. Subject is at least 18 years of age.
3. Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.
4. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.
5. Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug.

   * For the purposes of this study, "intolerant" includes either:

     1. Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.
     2. Subject was offered the drug and refused to take for any reason.

Exclusion Criteria:

1. Previous ablation or surgery in the left atria.
2. Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
3. Participation in another clinical investigation that may confound the results of this study.
4. Pregnant or nursing.
5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
6. Life expectancy less than 12 months.
Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III

The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.

It is a prospective observational cross-sectional European multi-centre study collecting health-related patient data on anaesthetic airway management over three months. This detects the incidence and nature of local airway management problems and assesses how they are solved. This will enable the investigators to identify generalisable interventions and recommendations to further improve patients' airway management to improve patient safety. During the observational period, the anaesthesia staff in charge will fill out a screening questionnaire for airway management for every patient undergoing anaesthesia care with airway management. The investigators will extract the characteristics from the local anaesthesia record system for all patients. If no event arises, there are no further requirements. If an event occurs, the anaesthesia provider will fill out an additional form asking for more details on what happened.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients requiring airway management under anaesthesia care for elective, semi-elective, urgent or emergency diagnostic procedures or interventions. Airway management includes awake and asleep tracheal intubation, insertion of supraglottic airway devices, and face mask ventilation.
* Patients older than 18 years of age
* Informed consent given or general consent in place, according to local ethics committee requirements.

Exclusion Criteria:

* Refusal to give consent or withdrawal of consent.
* Patients \<18 years.
Fatigue Management in HIV

This randomized clinical trial (RCT) pilot study as two main objectives:

* determine the overall feasibility of a behavioral intervention for managing fatigue among older adults with HIV infection.
* to estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions of fatigue.

The investigators hypothesize that adherence, satisfaction, and attrition will be similar for the active intervention group and the attention control group. The investigators also hypothesize that all five dimensions will improve in the intervention group compared to controls over time, and that Cohen's d (Standard Deviation units) will be greater than 0.5 SD units for all five fatigue dimensions at all three post-intervention time points.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of HIV infection
* Be at least 50 years of age
* Have a Fatigue Severity Score13 \> 4.0
* Be retired or on disability
* Be willing to wear a FitBit One Tracker and keep a 7-day diary at 4 time points (electronic, paper, or other convenient format)
* Be able to speak, understand, and read English
* Have a telephone, cell phone, computer access, or other means of communication

Exclusion Criteria:

* Current temporary, part-time, or full-time employment
* Planning to travel or be away from home during the 3-month study time frame
* Being pre- or peri-menopausal because of fluctuations in vasomotor symptoms over time
* Taking hormones to treat symptoms of menopause
* Brief Interview for Mental Status score \< 13
* AIDS dementia diagnosis
* Diagnosed sleep disorder that would not be responsive to behavioral interventions (sleep apnea, restless legs, etc.).