cyrilzakka/clinical-trials huggingface dataset:
Expanding Phase III Study of Tyroserleutide for Injection

This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions 21 days after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or placebo

* The first stage includes evaluation of subjects, to assess the inclusion criteria and exclusion criteria, based on the patients' preoperative imaging results, including tumor size, tumor characteristics, etc.
* In the second stage, subjects will return to the hospital 21 days following the baseline examination.The investigator will determine whether the subject satisfies all inclusion/exclusion criteria. If all requirements are satisfied, then randomization will occur 21 days after surgery
* The day of randomization will be defined as Day 0. Randomized subjects will return to the hospital and begin cycle 1 on the day of randomization (Day 0). and the relevant laboratory tests will be performed within 3 days after the end the study drug infusion.
* Cycles will occur as follows: cycles 2, 3, 4, 5, and n will begin on days 42±3, 70±3, 98±3, 126±3, and 14+28（n-1)± 3, respectively.
* Based therapeutic drugs are Gan Fu Le
* the participant will receive medical inspection so as to observe and ensure drug safety.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Aged ≥ 18 years and ≤ 75 years old, male or female
* Subject underwent resection of hepatocellular carcinoma (confirmed by pathology)
* The tumor characteristics must meet the following:A single tumor with a maximum diameter \>5cm ,Preoperative imaging, or Intraoperative visual observation.;

Exclusion Criteria:

* Concomitant malignant tumor(s) in other systems is/are present
* Tumor thrombosis in the branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery
* The subject received any previous systemic anti-HCC therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC therapy
* The subject took Sorafenib prior to randomization
* The subject took other study/investigational drugs 7 days prior to randomization
* The subject took Kang Laike injection/soft capsule，or Jinke Huaier granule 7 days prior to randomization
* The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases
* The subject has history of investigational drug or similar drug allergy
* The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present
* The subject is pregnant, lactating, or urine pregnancy test result is positive
* Baseline (post-resection) examination exist tumor recurrence or metastasis;
Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol

The purpose of this study is to review patients with E. coli infections at UPMC from September 1, 2008 to August 31, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes and determine their clinical outcomes.

The specific aims of this study are to:

1. Review whether cephalosporin-resistant E. coli infections are hospital-acquired, healthcare-associated or community-associated.
2. Determine the clinical outcome of the patients according to the antibiotics given.

De-identified data will be obtained by the honest broker for the requested time period. In addtion, the honest broker will work with the microbiology laboratory to collect the isolates associated with the de-identified data. All data and samples will be de-identified. De-identified data will be given to the nurse coordinator to complete the case report forms and enter the data into the password protected database and the de-identified isolates will be stored and analyzed on the 8th floor Scaife in Dr. Yohie Doi's laboratory.

Eligibility Criteria:
Inclusion Criteria:

* patients with E. coli infections at UPMC

Exclusion Criteria:

* not meeting entry criteria
Mirogabalin for Total Hip Arthroplasty

The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. American Society of Anesthesiologists class 1-3

Exclusion Criteria:

1. Major prior ipsilateral open hip surgery
2. Allergies to drugs used in research
3. Difficult to manage diabetes mellitus (including insulin dependence)
4. Chronic use of gabapentin or pregabalin (regular use for more than 3 months)
5. Patients taking cimetidine, probenecid, or lorazepam
6. Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal)
7. Estimated glomerular filtration rate \< 60 mL/min/1.73m2
8. Dependence on opioids
9. In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)
The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

This study tests the hypothesis that repeated inflation of a blood pressure cuff on the arm will improve results of coronary stent implantation by:

* reducing chest pain and electrocardiogram changes during balloon inflation to place the stent
* reducing leakage of heart muscle protein(troponin) into the blood stream after stent placement, indicated reduced damage to heart muscle during stent implantation
* increases in molecules in the blood that promote dilation of arteries
* reduced evidence of heart muscle damage on MRI immediately after stenting
* improved patient outcomes over six months with fewer adverse cardiovascular events(heart attack, acute coronary syndrome,renarrowing of the stented artery, heart failure, death, stroke, transient ischemic attack)
* improved heart structure and function at 6 months after stenting


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.

Exclusion Criteria:

* Recent (1 month) myocardial infarction
* Acute coronary syndrome
* Chest pain at res
* Estimated glomerular filtration rate(GFR)\<45 mL/min/1.73 m2
* Frequent premature atrial or ventricular contractions or atrial fibrillation
* Any contraindication to MRI including implanted non MRI compatible medical devices or ferromagnetic materials such as shrapnel
* Inability to breath-hold
* Severe claustrophobia
* Deafness
* Persistent tremor
* Inability to follow instructions.
Guided Biopsy for Mapping Prostate Cancer

Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy.

The objective of this study is to determine the accuracy of HIT (Hybrid Imaging Technology) guided biopsies for mapping tumor foci with men undergoing prostatectomy. Using a prostate hybrid imaging technology (HIT) which fuses a previously obtained endorectal MR image to transrectal ultrasound (TRUS) image to allow identification and biopsy of tumors by MR imaging in real time. We hypothesis that HIT guided biopsies will accurately localize the foci of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed diagnosis of prostate cancer
* Patients must have elected to undergo radical prostatectomy using an open, laparoscopic or robotic approach
* Patients must be at least 18 years of age and able to provide written informed consent.
* No history of radiotherapy, chemotherapy or hormone therapy within 6 months of surgery
* Primary tumor must be amenable to surgical removal for curative intent
* Patients must have ECOG-performance status 0 or 1 (appendix II)
* Patients must have no history of rectal or anal disease.
* Patients must have adequate organ function as defined by the following criteria:

  * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\])≤2.5x local laboratory upper limit of normal (ULN), or AST and ALT ≤5x ULN if liver function abnormalities are due to underlying malignancy
  * Total serum bilirubin ≤1.5 x ULN
  * Absolute neutrophil count(ANC)≥1,500/microL
  * Platelets≥lOO,OOO/microL
  * Hemoglobin≥9.0 g/dL
  * Serum calcium≤10.2mg/dL (correct for low albumin if necessary; calcium + (normal albumin - serum albumin)x 0.8)
  * Patients must have serum creatinine\<2 mg/dL or serum creatinine clearance (CrCl)\>40ml/min(CrCl= Wt(kg)x(140-age)\*/72xCr. level,\*female x 0.85)

Inclusion of minorities:

* Members of all races and ethnic groups are eligible for this trial. Women and children are not eligible since prostate cancer is not diagnosed in these groups.
Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation

The use of steroids after kidney transplantation has been challenged because of variable adverse effects which may increase the patient morbidity and mortality. The aim of this study was to compare the safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients.

131 patients were randomized to CsA (n = 63) or TAC (n = 68). Of 118 patients who did not have a biopsy-proven rejection episode and who had a serum creatinine level \< 2.0 mg/dL 6 months after transplantation, 55 were of the CsA group and 63 were of the TAC group. We assessed patient and graft survival, acute rejection episodes, and adverse events 5 years after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* older than 15 years
* first living donor kidney transplantation

Exclusion Criteria:

* congestive heart failure (ejection fraction \< 35%)
* chronic liver disease
* underlying diabetes mellitus
* evidence of systemic infection at screening time
* history of malignant disease
* multiple organ transplantation
* positive serologic evidence of human immunodeficiency virus
Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.

To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

-
XLIF Decade Plate System Study

The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.

This study is a prospective, single-arm, multicenter study to evaluate the safety and performance of the XLIF Decade Plate in patients undergoing a thoracic and/or lumbar interbody fusion, at one or two levels, with supplemental fixation using a lateral plate. Consecutive patients at a given site who meet all eligibility requirements will be asked to consent to participate in the study. Eligible patients include those with degenerative conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo XLIF surgery with lateral plating using the Decade Plate. At least 75 subjects will be enrolled and will be followed for 24 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are ≥18 years of age at the time of consent
2. Planned interbody fusion surgery using the Decade Plate System in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for

   1. degenerative disc disease
   2. spondylolisthesis
   3. scoliosis, kyphosis, lordosis
   4. spinal stenosis
   5. spondylolysis
   6. pseudoarthrosis or failed previous spine surgery
3. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
4. Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study

Exclusion Criteria:

1. Use of posterior fixation for the scheduled surgery Note: Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study
2. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
3. Use of bone growth stimulators postoperatively
4. Active smoking within 6 weeks before surgery
5. Patient has known sensitivity to materials implanted
6. Systemic or local infection (latent or active) or signs of local inflammation
7. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
8. Pregnant, or plans to become pregnant during the study
9. Patient is a prisoner
10. Patient is participating in another clinical study that would confound study data
Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

This study aims to evaluate the effect of bone marrow concentration on union of femoral shaft fracture by comparing clinical and imaging outcomes between patients receiving Intramedullary nail fixation with intraoperative bone marrow concentration and those receiving Intramedullary nail fixation only.

Femoral shaft fracture is a common orthopaedic injury. Intramedullary nail is one of the standard treatments. Its primary goal is to develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain, and facilitate bone union. Delayed union or nonunion is common in femoral shaft fracture. Risk factors include comminuted fracture, open fracture, smoking, diabetes and open reduction of fracture fixation. Mesenchymal stem cells are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve bone healing. Therefore, the goal of this study was to evaluate the effect of bone marrow concentration on union of femoral shaft fracture.

Eligibility Criteria:
Inclusion Criteria:

* With recent diagnosis of femoral shaft fracture
* Treated with intramedullary nail fixation
* With one or more risk factors of non-union: comminuted fracture, open fracture, smoking, obesity, diabetes, open reduction,
* Age between 20 and 80 years

Exclusion Criteria:

* Old femoral shaft fracture
* With concurrent major trauma, ex. intracranial hemorrhage, pneumothorax, hemothorax, internal bleeding.
* With prior history of femoral surgery
* With current or prior history of trauma or infection at femur
* With current diagnosis of coagulopathy
* With current or prior history of cancer
* With current or prior history of hematological disease
* Pregnancy
* Patients who will not cooperate with one-year followup
SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

Stroke is the first most common cause of death in China and one of the major causes of functional disability in the adult population.The burden of stoke is significantly increased in China in recent years.

In order to investigate the prognosis of stroke, with diagnostic and treatment information of traditional Chinese medicine (TCM), and assess the effectiveness and safety of TCM for stroke in southern China, the investigators will conduct this multicenter prospective registry study in southern China. This study will recruit 10,000 consecutive eligible patients with acute stroke from more than 50 hospitals. 24 months follow-up will be carried out on-site in hospitals and by telephone to track endpoint (including all-cause mortality, composite cerebrovascular and cardiovascular events at one and two year follow up, and neurological and functional assessments).


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years.
2. Patients within 14 days of onset of acute stroke (including acute cerebral infarction, transient ischemic attack, acute cerebral hemorrhage, acute subarachnoid hemorrhage).
3. The patient and/or guardian agree to participate in this study.

Exclusion Criteria:

1. Patients with silent cerebrovascular disease.
2. Patients with non-cerebrovascular disease events.
Implementation of Bedside Pediatric Early Warning Systems (PEWS)

Timely identification, referral and treatment of children who are clinically deteriorating while admitted to hospital wards is a fundamental element of inpatient care. In community hospitals, advantages including greater continuity of inpatient-outpatient care, improved geographic access for families, and lower healthcare system costs, may be undermined if children with evolving critical illness are not recognized and transferred in a timely manner. The Bedside Paediatric Early Warning System (Bedside PEWS) is a system of care designed to augment existing expertise and to provide a safety net for children who are clinically deteriorating while admitted to hospital wards. The Bedside PEWS is comprised of 4 components; \[1\] an expert derived, multi-centre validated severity of illness score, \[2\] an inter-professionally developed documentation record into which the severity of illness score is embedded, \[3\] a series of score-matched care recommendations based on the opinions of over 280 paediatric health care professionals, and \[4\] an educator-developed education-implementation program.

We will be performing a prospective observational study of care outcomes, physician workload and frontline staff perceptions before and after the implementation of Bedside PEWS in a community paediatric hospital. We plan to evaluate the outcomes of patients who were admitted to the 22-bed paediatric inpatient unit and were less than 18 years of age at hospital admission, and the healthcare professionals caring for them during their inpatient stay.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the paediatric inpatient unit at Credit Valley Hospital from June 2008-December 2008

Exclusion Criteria:

* Patients over 18 years of age
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

This is a open label, prospective, pair comparison, randomised, multi-centre trial. The primary aim of this study to is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for identifying Influenza A infection Polymerase Chain Reaction (PCR).

The secondary aim is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged between 7 and 80 years (inclusive);
2. Fever \> 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
3. Cough or sore throat;
4. Rhinorrhea or nasal congestion;
5. ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
6. Subject (or parent/guardian) capable and willing to give informed consent;
7. Subject provides written assent according to his/her age, if applicable.

Exclusion Criteria:

1. Recent craniofacial abnormality or injury (last 3 months);
2. Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
3. Craniofacial abnormality, such as severe deviation of the nasal septum;
4. Onset of clinical Influenza - Like Illness (ILI) symptoms \> 5 days;
5. Know history of allergic reaction to plastics or adhesives;
6. Subject (or parent/guardian) unwilling or unable to give informed consent.
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma

This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded to standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Waldenstroms Macroglobulinemia
* Relapsed or refractory after at least one prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
* Prior autologous stem cell transplant within 6 months of study entry
In-stent Restenosis and Pericoronary Fat Attenuation Index

This study aims to investigate the predictive value of fat attenuation index (FAI) and related radiomics characteristics of pericoronary fat in patients after percutaneous coronary intervention (PCI) for the occurrence of in-stent restenosis (ISR) during the follow-up period (9 to 24 months). The results of this study are expected to provide an early assessment of the inflammation around the coronary lesion segment in patients after PCI, and provide a basis for early targeted intensive drug therapy in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary heart disease who have undergone PCI;
* Patients followed up coronary angiography 9 to 24 months after PCI;
* Patients received chest CT examination during inpatient/outpatient follow-up;

Exclusion Criteria:

* Patients with diseases of the immune system;
* Patients with history of tumor diseases;
* Patients with chronic/acute infectious diseases;
* Image quality is not sufficient for analysis;
Construction of a Database for TTP

Information about patients was collected by reviewing the Hitech case system and telephone and outpatient follow-up, and the case database was constructed by Epidata software. The sample size is expected to be 200 cases, the participating hospital is the First Affiliated Hospital of Soochow University, and the study time frame is from Oct 20, 2022, to Oct 20, 2027. The observation indexes of the study include the basic information of patients' age and gender and the clinical related data of thrombotic thrombocytopenic purpura.


Eligibility Criteria:
Inclusion Criteria:

- Subjects diagnosed with severe ADAMTS13 deficiency, defined as ADAMTS13 activity \<10%, documented in the patient's medical history or at screening.

Exclusion Criteria:

- The investigator considers the subject unable or unwilling to cooperate with the study procedures.
GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
* hypersensitivity to any of the test substances