cyrilzakka/clinical-trials huggingface dataset:
Ate-Bev Early Response Prediction Model in Advanced HCC

The prognosis of hepatocellular carcinoma is poor compared to other carcinomas. Many drugs have recently been developed, and recently, atezolizumab-bevacizumab treatment was superior to sorafenib, the conventional treatment for advanced hepatocellular carcinoma. However, there is no information on the evaluation on the evaluation of treatment response for atezolizumab-bevacizumab combination therapy compared to atezolizumab alone or bevacizumab alone. Therefore, this study aimed to create a predictive model that can detect treatment response at an early stage.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with advanced hepatocellular carcinoma and who were scheduled to receive atezolizumab-bevacizumab as the first-line therapy
* Patients willing to participate in this study

Exclusion Criteria:

* Individuals with a history of severe contrast allergy
* Individuals with severe comorbidities (according to the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction.)
Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery; however, hypotension might impair perfusion of vital organs. The aim of this work is to compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for induction of deliberate hypotension

Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the status of peripheral perfusion under this target is not well investigated. Nitroglycerin and Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a direct vasodilator and its main action is through venodilation, while labetalol combines a selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously compared during deliberate hypotension with regard to surgical field quality and blood loss. No study to date compared the effects of both drugs on peripheral perfusion when used for induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin and labetalol on tissue perfusion when used for induction of deliberate hypotension during FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of peripheral and global tissue perfusion respectively.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients
* 18-45 years
* ASA physical status I-II
* scheduled for FESS operations

Exclusion Criteria:

* uncontrolled hypertension
* cerebrovascular disorders
* coagulation disorders
* cardiovascular diseases
* renal impairment
* liver impairment
* history of allergic reaction to any of the study medications
Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.


Eligibility Criteria:
Inclusion Criteria:

* Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA

Exclusion Criteria:

* recent history of active bleeding or VTE
* known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding
* persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline
* myocardial infarction or cerebrovascular accident within three months of the scheduled surgery
* major surgery in the prior three months
* renal insufficiency with a creatinine clearance \<60mL/min , hepatic failure combined with coagulopathy, or thrombocytopenia (platelets \< 100,000/mm³), or planned indwelling epidural catheter for \> 6 hours after the end of surgery
Treatment of Acute, Unstable Chest Wall Injuries

Unstable chest injuries are common in poly trauma patients. They can lead to severe pulmonary restriction, loss of lung volume, difficulty with ventilation and can render the patient to require intubation and mechanical ventilation. Traditionally these injuries have been treated non-operatively, however in the past decade there has been numerous studies suggesting improved outcomes with surgical fixation. Surgical fixation can significantly decrease time spent in ICU as well as day on mechanical ventilation. The investigators aim is to conduct a randomized control trial of these injuries, to compare non-operative treatment with surgical fixation. The investigators' hypothesis is that surgically treated patient will have significantly improved outcomes compared to those treated non-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Age \>16 or skeletal maturity
* Meeting one of the two indication for surgical fixation of chest wall injury:

  1. Flail chest, defined as follows:

     * 3 unilateral segmental rib fractures; OR
     * 3 bilateral rib fractures; OR
     * 3 unilateral fractures combined with sternum fracture/dissociation Note: at least 3 of the rib fractures involved in the flail segment must demonstrate displacement.
  2. Severe deformity of the chest wall (Diagnosed by CT scan). Defined as follows:

     * Severe (100%) displacement of 3 or more ribs OR
     * Marked loss thoracic volume/caved in chest (\>25% volume loss in involved lobe(s)); OR
     * Overriding of 3 or more rib fractures (by minimum 15mm each); OR
     * Two or more rib fractures associated with intra-parenchymal injury - ie ribs in the lung, in the parenchyma

Exclusion Criteria:

* Anatomic location of rib fractures are not amenable to surgical fixation (eg fractures directly adjacent to spinal column)
* Rib fractures primarily involving floating ribs (ribs 10-12)
* Home Oxygen (O2) requirement
* Other significant injuries that may require long term intubation:
* Severe pulmonary contusion (Defined as PaO2/FIO2 ratio \<200 with radiological evidence of pulmonary infiltrates WITHIN 24 hours of THORACIC TRAUMA)
* Severe head injury/Traumatic brain injury - (GCS ≤ 8 at 48 hrs post injury. If unable to assess full GCS due to intubation or other causes, GCS motor ≤4 at 48 hrs post injury)
* Upper airway injury requiring long term intubation and mechanical ventilation (e.g. tracheal disruption)
* Acute quadriplegia/quadraparesis
* Head and neck burn injuries, or inhalation burn injuries
* Dementia or other inability to complete follow-up questionnaires
* Medically unstable for OR (e.g. haemodynamic instability, acidosis, coagulopathy, etc.)\* or unlikely to survive 1 year follow-up, in the opinion of the attending physician
* Lack of informed consent from patient or substitute decision maker
* Randomization \> 72 hours from injury
* ORIF \> 96 hours from injury (if randomized to surgical fixation group)
* Age \> 85
A Study of LY3841136 in Japanese Participants With Obesity or Overweight

The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants who agree to contraception requirements
* Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive
* Have had a stable weight for the 3 months

Exclusion Criteria:

* Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years
* Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
* Have a history of chronic medical conditions involving the heart, liver, or kidneys
* Have a history of any malignancy within the past 5 years
* Have a history or presence of a GI disorder
* Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity
* Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening
* For participants in Part B, have previously received tirzepatide within 6 months prior to screening
* For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2
Sequence and Time-of-day Infusion of immunoCHemotherapy Affect Response in Oesophageal Cancer in the NeOadjuvant Setting

It is reported that compared to chemotherapy alone, immunochemotherapy has significantly improved the overall survival of patients with advanced metastatic ESCC. However, there are still more than 30% of patients who cannot benefit from this treatment modality. In addition to these factors, the time-of-day infusion and administration sequence of immunochemotherapy have been reported to be associated with tumor responses and overall survival. In this study, The investigators aimed to explore the roles of infusion time and administration sequence of immunochemotherapy in predicting tumor responses and overall survival in patients with advanced ESCC.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as esophageal squamous cell carcinoma
* KPS≥80
* Adequate organ function
* No distant metastasis
* The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist

Exclusion Criteria:

* incomplete medical record which affects statistical analysis
* have participated in previous interventional clinical trials
* other situations evaluated by investigators not meet the enrollment
ADJUST: A Study on MDT Prognostication

This study investigates how clinicians form intuitive judgements about the prognoses of palliative care patients after receiving advice perceived as coming from either a team member or an algorithm.

Using the Judge-Advisor System, the investigators will recruit clinicians working in palliative care for adults. Participants will be asked to complete an online survey and review five patient summaries ("vignettes") based on real cases derived from a previous study. Clinicians will be presented with key prognostic information and will be asked to provide an estimate of the probability that the patient will survive for two weeks (0-100%). After providing this initial estimate, participants will receive prognostic advice. While in reality all participants will receive the same advice, participants will be randomised into two groups and these groups will be informed that the advice is either: (1) provided by an algorithm; or (2) provided by a team colleague. Participants will then be given the opportunity to give a second, possibly revised estimate in the light of the advice received.

Eligibility Criteria:
Inclusion Criteria:

* Clinicians working in an adult palliative care service
* Willing and able to provide written informed consent

Exclusion Criteria:

* None
Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing

The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.

Recently, as genome technology such as next-generation sequencing has progressed, precision medicine using genetic analysis in lung cancer, colorectal cancer, and melanoma has been actively studied. The need for such precision medicine is also increasing in biliary tract cancer patients. Although whole genome sequencing is relatively costly, it is known to provide more accurate information than other methods such as exome analysis and RNA sequencing in identifying promoter mutations, regulatory regions, and structural variants. Pancreatic cancer and melanoma have been studied by whole genome sequencing, but there is no previous study using whole genome sequencing method in biliary tract cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram

Exclusion Criteria:

* Pregnancy
* Other active tumors within 5 years
* Coagulopathy
* Severe mental illness
Vibration in Boys With a History of Fracture

Boys aged 9-12 years, with a history of facture will be asked to stand on one of two vibrating platforms for 10 minutes on 5 consecutive days. The investigators will take blood samples before and after the vibration to measure changes in the bone cells.

Fractures in children are common, accounting for 10% of attendances in Accident and Emergency Departments. Research into risk factors for fracture has found that children who have narrower bones and a low bone mass are more likely to fracture than children with larger bones. Studies in postmenopausal women, young women with low bone mass and children with disabling conditions such as cerebral palsy, have shown that up to 10 minutes a day stood on a vibrating platform can significantly increase bone mass.

However little is known of the immediate response of bone to whole body vibration (WBV). The investigators previously investigated the acute bone response in healthy pre-pubertal boys to standing on one of two vibrating platforms for 10 minutes on 1, 3 or 5 consecutive days. This showed a platform dependent reduction in the bone resorption marker CTx pre to post vibration, with an increase in the bone formation marker P1NP over the 8 day study. The investigators would like to look at the response of bone to WBV in pre-pubertal boys who have a history of fracture(s). The investigators will compare this to the investigator's previous data to determine if bone in boys who have previously fractured responds in the same way as bone in boys who have not.

The investigators plan to recruit 24 boys aged 9-12 years who have had a previous fracture to stand on one of two vibrating platforms for 10 minutes on 5 consecutive days. Before and after the period of vibration on days 1, 3, 5, and on days 8 and 12 the investigators will take a blood sample to measure changes in the bone cells. The boys will be asked about the amount of exercise they have participated in over the previous seven days. The findings of this study will be used to direct further research.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Aged 7-13yrs (pre-pubertal)
* First language English
* History of one or more fracture(s)

Exclusion Criteria:

* Pre-existing chronic illness
* Known bone disease
* Current or healing fracture
* Recent (last 12 months) or current treatment likely to affect bone - this does not include inhaled or intermittent oral therapy with steroids for asthma
* Balance problems
* Continuing involvement in more than one other research study
Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)

The purpose of the study is to determine the safety and the efficacy of Tretinoin and Pioglitazone HCL in patients with ALS who are currently on Riluzole.

Physicians at Phoenix Neurological Associates (PNA) are looking for individuals diagnosed with ALS to participate in a double-blind, placebo controlled study of Tretinoin and Pioglitazone HCL, used in combination with Riluzole, for treating ALS. This investigator initiated trial conducted by Dr. Todd Levine and Dr. David Saperstein will help determine whether Tretinoin and Pioglitazone HCL, in combination, can slow the progression of ALS.

At present, there is little to no effective therapy for ALS, nor is there a known cause. Therefore there is a tremendous unmet need for more effective therapy for this disease and that is why the physicians at PNA have been very interested in the role of developing a more active anti-excitotoxic cocktail for patients with ALS. Since recent data have suggested that inflammatory mechanisms may interact with and promote neurodegeneration (where cells in the spinal cord and brain are lost), there have been a number of anti-inflammatory treatment strategies that have been evaluated in animal models. Some studies have shown that mice that were given Pioglitazone HCL demonstrated improved muscle strength and body weight, exhibited a delayed disease onset as well as had a longer survival rate compared to non treated mice.

In addition to these studies, retinoic acids have been studied extensively in various models of the injured nervous system. These studies have shown that retinoic acids, such as Tretinoin may be neuroprotective and support axonal growth, which could in turn slow disease progression.

The purpose of this study is to determine if such a drug "cocktail" could offer the best chance of attaining a significant reduction in disease progression by utilizing currently available FDA-approved agents

Eligibility Criteria:
Inclusion Criteria:

* El Escorial Classification of laboratory supported probable, probable, or definite ALS
* Age 18 - 85 years
* Male or female
* FVC greater than or equal to 70% predicted

Exclusion Criteria:

* Patients with FVC below 1.5 L or below 70% predicted
* History of liver disease
* Severe renal failure (CrCl\<30)
* History of coronary artery disease requiring placement of stents, bypass surgery or previous myocardial infarction
* EKG at baseline with evidence for previous myocardial infarction, cardiomyopathy, or arrhythmia
* History of intolerance to Riluzole, Tretinoin, or Pioglitazone HCL
* History of diabetes
* Any other comorbid condition which would make completion of trial unlikely
Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections

Streptococcus pneumoniae is a gram-positive (GP) bacteria responsible for common infections such as community-acquired pneumonia (CAP), as well as complicated infections such as bacteremia, infective endocarditis and meningitis. S. pneumoniae bacteremia ranks among the top 10 most common pathogens associated with bloodstream infections and correlates with high morbidity and mortality worldwide.

The Infectious Diseases Society of America (IDSA) guidelines for CAP management advocate for short courses of antibiotics for CAP treatment. However, it does not address duration of therapy for common CAP pathogens such as S. pneumoniae when associated with blood stream infections (BSI). 3

Currently, GP bacteremia duration of therapy typically ranges from 7 to 14 days based on IDSA guideline recommendations for Staphylococcus aureus bacteremia with no further definitive consensus.4 Additionally, lack of data and randomized clinical trials on the efficacy and safety of short compared to long treatment duration have led to variability in practice. Most randomized clinical trials as well as retrospective studies on treatment duration, have been conducted mainly in gram-negative BSI

Eligibility Criteria:
Inclusion Criteria:

* • ≥18 years of age

  * S. pneumoniae isolated from ≥1 blood cultures
  * Active IV antibiotic therapy within 48 hours of the first positive blood culture(7,8)
  * Clinical stability by day 10 of therapy

Exclusion Criteria:

* • Treatment duration \<5 days or \>16 days

  * Death before completion of therapy (\<10 days vs. ≥ 10 days )
  * Polymicrobial BSI
  * Invasive infection caused by S. pneumoniae (endocarditis, meningitis, and lung abscess)
Oxytocin in MRI-HIFU

Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing MRI-HIFU -treatment
* Patients assessed for suitability to MRI-HIFU treatment
* willingness to participate in trial

Exclusion Criteria:

* Known allergy to Syntocinon/oxytocin
* Elevated blood pressure
* ischemic heart disease
* Long QT- interval
Boluses of Ringer's in Surgical Kids (BRiSK Study)

Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.

Recent studies have questioned the validity of each of these tenets. Maintenance rate as defined by Holliday \& Segar is postulated to be in excess of pediatric patients' post-surgical fluid needs. The investigators propose a novel protocol for the administration of IV fluids to children after major abdominal or thoracic surgery that includes: (1) Intermittent boluses; (2) Total volume administered in 24 hours closer to 2/3 of the traditional maintenance fluid requirements; and (3) Use of a balanced salt solution (Lactated Ringer).

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 12 months to 21 years.
2. Weight \>= 8 kg.
3. Patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days.
4. Patients admitted to a regular bed following surgery.
5. Patients who will be inpatient for approximately 4-8 days postoperatively.
6. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.
2. Patients prescribed insulin.
3. Patients receiving parenteral nutrition.
4. Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
5. Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
6. Patients with any form of hypersensitivity to the study fluids.
7. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:

   * Serum Sodium \<130 or \>145 mmol/L
   * Serum Potassium \<3.0 or \>5.0 mEq/L
   * Serum Chloride \<90 or \>110 mEq/L
   * Serum Creatinine ≥ 1.6 mg/dL
   * Serum Glucose \<60 or \>180 mg/dL
   * Alanine Aminotransferase \>200 U/L
   * Total Bilirubin \>12.0 mg/dL
8. Pregnant or lactating females.
9. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis

This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>=18 years of age
* Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 \>=5.1
* Inadequate responder to at least 2 non-biological DMARDs
* Absence of documented erosions at start of RoActemra/Actemra treatment
* Received RoActemra/Actemra treatment for at least 6 months
* Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

Exclusion Criteria:

* Contraindications for treatment with RoActemra/Actemra