cyrilzakka/clinical-trials huggingface dataset:
Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling

The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors.

By retrospectively collecting patient data from a single centre of liver surgery at Tongji Hospital between February 2019 and February 2023, the study aimed to comprehensively evaluate patients' demographic characteristics, oncological parameters, surgical details and response to immunotherapy to identify the key factors affecting postoperative recurrence and survival.

Eligibility Criteria:
Inclusion Criteria:

* HCC confirmed by pathologists
* Undergone a curative resection (R0)
* Aged 18-75 years
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma or recurrent HCC
* Any preoperative treatment for HCC including local and systemic therapy
* Unable to receive adjuvant therapy due to surgery-related complications, acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* incomplete clinical data
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis

The aim of the project is to investigate effects of medical exercise therapy (MET) on patients with knee osteoarthritis. MET is a common physical therapy intervention, and the project aim to strengthen the evidence of this intervention. An experimental cohort design is chosen, and 20 participants will be followed for 6 months. Assessments will be clinical tests, questionnaires and accelerometer measurements before, during, and after a 3 month period of exercise (3 days per week) with a physical therapist. The project will answer if a 3 month physical therapy intervention using MET causes changes in pain level, function and activity level for patients with knee osteoarthritis. In addition, it will investigate whether a single global endurance workout for 30 minutes will have an effect on pain level for these patients


Eligibility Criteria:
Inclusion Criteria:

* x-ray verified knee osteoarthritis (Kellegren \& Lawrence grade I-III)
* Loss of function and withstanding pain \>3 months

Exclusion Criteria:

* physical therapy treatment during the last 3 months
* knee injury
* inflammatory arthritis
* symptoms from the hip joints greater than the knee pain
* planned knee surgery the next 6 months
* heart and lung disorders or other health issues affecting the ability to complete the intervention
Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan

The objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.


Eligibility Criteria:
Inclusion Criteria

· Patients with rheumatoid arthritis \[only those refractory to the previous treatment\]
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. In the present study, it was hypothesized that it was not necessary to prescribe amoxicillin for the children.

After inclusion of eligible children patients,one group was prescribed amoxicillin,and another not.

Eligibility Criteria:
Inclusion Criteria:

* Acute upper respiratory tract infection
* Fever
* Vomiting
* Increased white blood cell

Exclusion Criteria:

* 0ther symptoms of digestive system
* Headache
Phase 1 Trial of Oral Ixabepilone

This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 or older
* Histologically or cytologically confirmed diagnosis of solid tumor malignancy
* Measurable or non-measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
* Karnofsky Performance Status (KPS) of 70-100
* Recovered from toxicities resulting from previous therapies

Exclusion Criteria:

* More than 3 prior cytotoxic regimens in the metastatic setting
* Current or recent gastrointestinal (GI) disease that would impact the absorption of study drug
* Inability to swallow whole capsules
* Inadequate hepatic and renal function
* Function exposure to any epothilone
Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis

This study hypothesizes that the addition of a low-dose ketamine infusion to usual post-operative pain management will improve pain control as evidenced by an improvement in post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.

After consenting, patients will be randomized by the pharmacy. In the operating room patients will receive ketamine/placebo 0.5mg/kg bolus prior to the surgical incision, followed by ketamine/placebo 0.2mg/kg continuous infusion up to 48hours. All the patients will also receive 15mg/k IV acetaminophen at the end of the surgery, followed by every 6hr for 48hrs. Rest of the pain regimen will be the usual post-operative pain management for spinal fusion for idiopathic scoliosis, which includes morphine PCA, IV ketorolac from POD 1, and flexaril from POD 1.

All the patients and parents will fill out a survey at 0hr, 24hr and 48hr grading their level of satisfaction with the post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II, III
* Presenting for spinal fusion for idiopathic scoliosis
* English-speaking and able to give assent

Exclusion Criteria:

* Any contraindication to ketamine
* Previous spinal surgery
* Opioid dependence
* Chronic pain condition
* Significant developmental delay
* Pregnancy
Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay

The goal of this observational study is to learn the factors affecting the quality of life in children's development.

The main hypothesis for this study is:

If the level of well-being increases in age, could the quality of life be enhanced in terms of function and participation?

Participant will be given assessment every year for five years in total. No intervention will be given during the whole study period.


Eligibility Criteria:
Normal developing children

Inclusion Criteria:

* Agreeing in consent
* In the age range of 6-15 years old

Exclusion Criteria:

* Diseases of Central Nervous System
* Diseases of Neuromuscular
* Nature deficit disorder
* Genetic Disorder
* Sensory Integration disorder
* Auditory disorder

Development delay children

Inclusion Criteria:

* Agreeing in consent
* In the age range of 6-15 years old
* Diagnosed of Developmental Delay

Exclusion Criteria:

* Diseases of Central Nervous System
* Diseases of Neuromuscular
* Nature deficit disorder
* Genetic Disorder
* Sensory Integration disorder
* Auditory disorder
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)

This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.

Robotic assisted nipple sparing mastectomies with multi-port robots, like the Da Vinci Xi, have been described previously but pose significant hurdles due to the small area like the breast. The Single-Port da Vinci SP (Intuitive Surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. This is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy.

Subjects who undergo rNSM and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the UT Southwestern Breast Clinic. The patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both Breast and Plastics and Reconstructive Surgery (PRS) departments. Outcomes will be tracked in a prospectively kept electronic registry.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects age \>= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW

Exclusion Criteria:

1. Subjects who are \<18 years of age
2. Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
AL Amyloidosis and Anti-CD38-Daratunumab

AL Amyloidosis and anti-CD38

AL amyloidosis is a systemic disorder characterized by progressive multiorgan failure and premature death. While autologous stem cell transplantation (ASCT) is considered the standard therapy, eligibility is limited, and excludes a substantial proportion of patients. Recent guidelines recommend daratumumab-based regimens for these patients, but, particularly for cases with severe renal involvement, optimal treatment remains a challenge.

This study explore the efficacy of daratumumab monotherapy in patients with histologically proven severe renal involvement who are ineligible for ASCT

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by AL amyloidosis
* Patients who were ineligible for high dose therapy and bone marrow transplantation due to age and/or frailty score.

Exclusion criteria:

- Diagnosis of AL amyloidosis not biospy proven
Effectiveness of a Mobile Health Management Program for Colorectal Cancer Survivors with Chronic Conditions

The goal of this clinical trial is to evaluate if a mobile health management program can improve chronic disease management among colorectal cancer survivors with comorbid conditions such as hypertension, diabetes, and dyslipidemia. The main questions it aims to answer are:

Does the mobile health application improve clinical outcomes such as blood pressure, blood glucose levels, and lipid profiles? Does the application enhance participants' health behaviors and self-management capabilities? Researchers will compare the mobile health application group to the educational booklet group to see if the digital intervention leads to better health outcomes and adherence to lifestyle changes


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 19 years or older Colorectal cancer survivors (patients within 5 years of completion of curative treatments such as surgery, radiation therapy, or chemotherapy) who also have chronic conditions (hypertension, dyslipidemia, or diabetes)

Specific registration criteria:

Diabetes: Fasting blood sugar (FBS) ≥ 126 mg/dL or HbA1c ≥ 6.5% Dyslipidemia: Low-density lipoprotein cholesterol (LDL) ≥ 130 mg/dL Hypertension: Systolic blood pressure (SBP) ≥ 140 mmHg or Diastolic blood pressure (DBP) ≥ 90 mmHg Individuals who understand the purpose of this study and provide informed consent to participate Individuals who own and use a smartphone (able to use an ICT-based health management program)

Exclusion Criteria:

* Individuals who are unable to speak, listen, or read in Korean Individuals determined by a physician to be physically or mentally unfit (e.g., shortness of breath, severe depression) to participate in the study Individuals who are deemed unable to use the ICT-based program
3T MR Angiography of the Hepatic Vasculature

This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.

This study will use two Magnetic Resonance Angiography (MRA) techniques that will look at participants liver veins and arteries without giving a coloring matter (contrast) before taking the images. Investigators propose to evaluate the usefulness of these two new techniques, which do not involve exposing participants to radiation or contrast.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that fulfill the criteria for living liver donation and are evaluated for the procedure with CT and MR.

Exclusion Criteria:

* Unable to give informed consent
* Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MRI studies
* Not suitable to undergo MRI with a gadolinium-based contrast agent because of:

  * Claustrophobia, unless patient agrees to sedation measures per institutional standard practice during MR imaging
  * Presence of metallic objects or implanted medical devices in body per institutional safety standards
  * Weight greater than that allowable by the MR table
  * Renal failure, as determined by estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) model based on a serum creatinine level obtained within 28 days prior to enrollment
  * Known allergy-like reaction to contrast media (gadolinium) or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR), and unwillingness to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
  * Pregnancy (if a female is of childbearing potential --defined as a premenopausal female capable of becoming pregnant --a pregnancy test should be done)
Effect of High-intensity Intermittent Sprinting on Appetite Control on Obese Volunteers

Several studies have shown that high intensity intermittent sprints (HIIS) are more effective than moderate intensity continuous cycling (MICC) in reducing fat mass and improving insulin resistance in normal weight individuals. Changes in the appetite-regulatory system in response to exercise are likely to explain, at least partially, the better outcome observed after HIIS. Unfortunately, there are no studies comparing the impact of different types of acute aerobic exercise on the release of appetite-regulating hormones, subjective feelings of appetite and subsequent energy intake (EI).

The primary objective of this study is to investigate the effects of acute isocaloric bouts of HIIT and MICC or a short duration sprint, in comparison with a resting control condition, on the postprandial release of appetite-regulating hormones, subjective feelings of appetite and subsequent EI in obese individuals. The investigators hypothesize that an isocaloric session of HIIS will result in a better short-term appetite control compared with MICC, by reducing hunger feelings and subsequent food intake more than MICC and by inducing a larger increase in the release of satiety gut peptides compared with the MICC.

This will be a randomised cross-over study with four legs. Participants will act as their own controls and will be assigned to the four experimental conditions (resting, HIIS, MICC and SDS), 1 week apart, in a counter-balanced order.

Participants will be asked to come to the Unit five times: one preliminary session and four experimental conditions (resting, HIIS and MICC isocaloric sessions and SDS). In the preliminary session, anthropometric data (weight and height) will be collected and a maximal fitness test performed, using a cycle ergometer.

For the four experimental conditions, participants will be asked to arrive at approximately 8.00, having fasted for at least 10 hours, and a cannula will be inserted into an antecubital vein. Two fasting blood samples will be taken and a standard breakfast offered. After that, serial blood samples will be taken at regular intervals for a period of 3h.

Participants will be asked to rate their subjective feelings of hunger and fullness using visual analogue scales (VAS) throughout each study morning at different time points. Three hours after breakfast, participants will be placed in individual rooms, presented with a standardized lunch and instructed to rate the taste and palatability of the food presented.

Eligibility Criteria:
Inclusion Criteria:

* an inactive lifestyle,
* weight stable on the previous 3 months,
* not currently dieting to loose weight
* restraint score derived from the Three Factor Eating Behaviour Questionnaire ≤12

Exclusion Criteria:

* history of coronary heart disease,
* type 1 or type 2 diabetes,
* anaemia,
* gout,
* depression or other psychological disorders,
* eating disorders,
* drug or alcohol abuse within the last two years,
* current medication known to affect appetite or induce weight loss and hypertension.
PET Imaging of 68Ga-NOTA-H006 in Malignancy

5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Several antibody drug conjugates are currently under development for cancer therapy in preclinic and clinic stages.

Previously, investigators engineered a 5T4-specific biomolecule with nanomolar binding affinity. Radiolabeling with gallium-68 resulted in 68Ga-NOTA-H006 which showed 5T4 expression in a variety of xenograft models. Thus, the aims of current study are to evaluate the distribution and dosimetry of this novel tracer, and to explore the diagnostic values of 68Ga-NOTA-H006 in malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cancer clinical trial study subjects must meet all of the following criteria:

  1. Age between 18 and 65 years old.
  2. Pancreatic occupancy is found on imaging and combined with clinical judgment as a patient with pancreatic cancer.
  3. Written informed consent signed by the subject or his/her legal guardian or caregiver.
  4. Willingness and ability to cooperate with all programs of the study.

Lung cancer clinical trial study subjects must meet all of the following criteria:

1. Be between the ages of 18 and 65 years old.
2. Patients with CT findings of suspicious space on the lungs with a diameter of more than 1cm who have not undergone surgery.
3. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of the study.

Bowel cancer clinical trial study subjects must meet all of the following criteria:

1. Be between the ages of 18 and 65.
2. Have a clear histologic or pathologic diagnosis of colorectal cancer.
3. Written informed consent signed by the subject or legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

1. Severe hepatic or renal insufficiency;
2. Targeted therapy prior to radiotherapy or PET/CT scan. 5T4 expression in existing lesions assessed by immunohistochemistry using antibody clones.
3. History of serious surgery in the last month.
4. Those who have participated in other clinical trials during the same period.
Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

In patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. In this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. Neither the patients or their doctors knew what the patient was receiving.Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* be on mechanical ventilation greater than 3 days
* greater than or equal to 18 years of age survival greater than 14 days
* greater than 2 ccs of tracheal secretions/4 hours

Exclusion Criteria:

* allergy to drugs, pregnancy
An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects between 18 and 55 years, inclusive.
2. Good health
3. Body weight between 50 and 110 kg inclusive

Exclusion Criteria:

1. History of any drug allergy, hypersensitivity, or intolerance to any drug product that in the opinion of the Investigator would place the subject at particular risk and compromise the safety of the subject in the study.
2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, psychiatric disease, or any other condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
3. History or current diagnosis of substance dependence (except nicotine and caffeine) or alcohol abuse over the past 2 years, according to the criteria of DSM-IV-TR.
4. Smokes or has smoked more than 5 cigarettes per day in the last 90 days and is unable to stop smoking during in-patient observation period in clinic.
5. Unwillingness to abstain from alcohol for at least 24 hours prior to dosing with study medication until the time of discharge from the study unit and at least 24 hours prior to each ambulatory visit.
6. Plans to participate in another clinical trial while enrolled in this study and/or received an investigational drug and/or device within 60 days prior to admission.
7. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to admission.
8. History of splenectomy, asthma (with the exception of childhood asthma that has resolved), COPD, recurrent or current GI or respiratory infections.
9. On fluid restriction.
10. Systemic steroids within 3 months prior to the start of study drug administration, or any prescription medication(s) within 14 days of dose administration or any non-prescribed systemic or topical medication (including any herbal product) within 7 days prior to dose administration.
11. Vaccination within 1 month before dosing, or plans to receive vaccination during the study.
12. Any illness within 5 days, or clinically significant airway infections within 30 days, prior to first study drug dosing.
13. Positive urine drug screen (UDS) at screening.
14. Positivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at screening.