cyrilzakka/clinical-trials huggingface dataset:
Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Atrial or ventricular septum defect patients requiring cardiac surgery with CPB
* Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB
* Coronary artery disease patients requiring coronary revascularization surgery with CPB

Exclusion Criteria:

* Non-primary cardiac surgery
* Definite liver or renal dysfunction
* Disorder in coagulation function
* Allergy
* Pregnancy or lactation
* Disabled in spirit or law
* Fatal conditions such as tumour
Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Who are able and willing to give signed informed consent
* Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
* Who have up to 20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

* Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
* Who have been treated with systemic therapy within 30days of randomization.
* Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
* Who have been treated with topical therapy within 14days before the day of randomization.
Effects of Footstrike Transition on Tibial Stress Fracture Risk

Biomechanical literature suggests that runners who utilize a mid or forefoot strike pattern may suffer from a reduced incidence of chronic injuries compared to a rearfoot strike. This investigation examined the effects of a 10-week footstrike transition intervention on tibial stress fracture risk in runners.


Eligibility Criteria:
Inclusion Criteria:

* Recreational runner
* 3-years minimum of running experience
* Injury free for 12-months

Exclusion Criteria:

* Injury at baseline
Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality

The study will enhance the theory in the frame of reference on the efficacy of Ulinastatin while managing sepsis and subsequent morbidity and mortality. Moreover, the present study will explore Ulinastatin's prophylactic role in progression of multiple organ dysfunctions. Furthermore, the study will have the clinical implications in predicting the ICU admitted patient's stay and related cost in the context of new drug. Current researches will explore the new dimensions in Pakistan's healthcare facilities, paving the way of future academics to analyze it in order to enhance healthcare outcomes.

The current study is a randomised clinical trial with the aim of exploring the following objectives in the context of Pakistan:

* To determine the efficacy of Ulinastatin in preventing the progression of Sepsis to Severe Sepsis and septic shock.
* To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients.
* To investigate the impact of Ulinastatin on sepsis associated mortality and morbidity.
* To explore the role of Ulinastatin in reducing ICU stays and associated costs in defined patients.
* To provides a condensed basis to understand ULINASTATIN as a sepsis management drug.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 or \<60
* Sepsis, and severe sepsis, as defined in operational definitions
* Patients voluntarily agreed to participate in the study after informed consent

Exclusion Criteria:

* Fulminant hepatic failure
* Acute cerebrovascular accidents
* Acute poisoning
* Chronic Kidney Disease stage 5
* Diagnosed case of immune thrombocytopenia
* Low output cardiac failure, with left ventricular ejection fraction \<20%
* Advance chronic obstructive pulmonary disease on long term oxygen therapy
* Lactation or pregnancy
A Study of Overall Survival in Participants With Metastatic Colorectal Cancer (mCRC)

The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined by:
* Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x)
* Pathology consistent with CRC
* At least two documented clinical visits on or after January 1, 2013
* Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013
* Participants with high levels of microsatellite instability (MSI-H) and/or mismatch repair (MMR) protein deficiency (dMMR)
* Participants who received 2L therapy of interest on or after the initial mCRC diagnosis date
* Participants who had at least 1 month medical data during the prior to and post periods; however, participants who died within 1 month after the index date will not be excluded from the study

Exclusion Criteria:

* Participants \<18 years of age at index date
* Participants who received clinical trial drug during the prior or post periods
Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

300 IgG4-RD patients, 200 other autoimmune diseases, 60 IgG4-RD mimickers and 100 healthy controls were enrolled. Circulating plasmablast/plasma cells were detected of all patients at baseline and healthy controls. IgG4-RD patients were followed up every 3-6 months. Circulating plasmablast/plasma cells were also detected at disease remission and relapse. IgG4-RD patients' clinical data and laboratory parameters were collected.

300 IgG4-RD patients, 200 other autoimmune diseases, 60 IgG4-RD mimickers (pancreatic cancer, cholangiocarcinoma, vasculitis, lymphoproliferative diseases, inflammatory bowel disease, kimura disease) and 100 healthy controls were enrolled. Peripheral blood samples of 5-10 ml were collected from all patients and healthy controls. Serum was separated for ELISA detection. Circulating plasmablast/plasma cells were detected of all patients at baseline and healthy controls. IgG4-RD patients were followed up every 3-6 months. Circulating plasmablast/plasma cells were also detected at disease remission and relapse. IgG4-RD patients' clinical data and laboratory parameters were collected. Data were analyzed to evaluate plasmablast/plasma cells in diagnosis and relapse prediction of IgG4-RD.

Eligibility Criteria:
Inclusion Criteria:

* IgG4-RD patients fulfilled the 2011 comprehensive diagnostic criteria of IgG4-RD (2011). Other autoimmune disease and IgG4-RD mimickers fulfilled the corresponding diagnostic criteria.

Exclusion Criteria:

* Patients in pregnancy or preparing to pregnancy, patients with active infection, including HIV, HCV, HBV, TB, et al.
Validation of the Prostate Cancer Assay - Beta+Pivotal

The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device.


Eligibility Criteria:
Inclusion Criteria:

* • Male aged 18 years and above

  * Be willing to sign an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
  * Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  * Eastern cooperative group (ECOG) performance status ≤2
  * Documented histologically confirmed adenocarcinoma of the prostate
  * Metastatic prostate cancer to the bone as documented by positive bone scan imaging
  * CRPC patient being considered for systemic therapy or in between lines of therapies (\>= 14 days from prior treatment) for metastatic disease. Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 \[PCWG2\] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl).

Exclusion Criteria:

* • Subjects actively receiving systemic therapy regimens, or between lines of therapies (\< 14 days from prior treatment)

  * Have any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
  * Active infection or other medical condition that would make corticosteroids (i.e. prednisone) use contraindicated
  * Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
  * Severe hepatic impairment (Child-Pugh Class C)
  * History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
  * Have poorly controlled diabetes (HgB A1C ≥ 8%)
  * Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  * Abnormal bone marrow function (absolute neutrophil count \[ANC\] \< 1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL)
  * Abnormal liver function (bilirubin \> upper limit of normal \[ULN\]; AST and/or ALT \> 1.5 x ULN concomitant with alkaline phosphatase \> 2.5 x ULN)
  * Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, unstable atrial fibrillation, or New York Heart Association (NYHA) Class III-IV heart disease
  * History of ventricular tachyarrhythmia within the past 5 years
Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow

Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.


Eligibility Criteria:
Inclusion Criteria:

* Patients, with primary breast cancer who had undergone complete primary tumor resection and axillary lymph node dissection
* Evidence of minimal residual disease (disseminated tumor cells in bone marrow)
* Patients had to receive one of the following adjuvant therapy categories: chemotherapy ± hormonal therapy or hormonal therapy alone

Exclusion Criteria:

* Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer prior to the currently diagnosed case
* Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant radiotherapy
* Prior stem cell rescue/bone marrow transplant
* History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix

Additional protocol-defined inclusion / exclusion criteria may apply
Selegiline for Smoking Cessation - 1

The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Be in good general health
* Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
* Be currently smoking \> 15 cigarettes/day, and have smoked cigarettes for the past 5 years
* Subjects must be motivated to quite smoking
* If female and of child bearing potential, agrees to use birth control and subject
* Subject must be able to understand and provide written informed consent.

Exclusion

Criteria:

* Please contact site for more information
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients

This is a drug study that will examine if inhaled tranexamic acid can improve mortality in patients with cancer-related pulmonary hemorrhage and respiratory failure as compared to usual care.

Primary Objective: To assess the benefit of using nebulized tranexamic acid versus the standard of care on 30 day mortality.

Secondary Objectives: To assess the following outcomes when using nebulized tranexamic acid versus the standard of care:

1. 100 day, ICU and hospital mortality rate
2. Ventilator days at day 30
3. ICU and Hospital Length of Stay
4. PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days
5. Time to resolution of pulmonary hemorrhage
6. Rate of recurrence of pulmonary hemorrhage
7. Rate of invasive procedures required to control pulmonary hemorrhage

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Have a diagnosed hematological malignancy
3. Are actively receiving mechanical ventilation
4. Have evidence of pulmonary hemorrhage as defined by either

   1. Persistently bloody secretions upon endotracheal tube suctioning, or
   2. Evidence of diffuse alveolar hemorrhage by bronchoscopic examination
5. Signed informed consent by patient or if the subject lacks decision-making capacity, the subject's legally authorized representative

2.3.2 Exclusion Criteria

Patients excluded from participation in the study if any of the following criteria are met:

1. Presence of a Do Not Resuscitate (DNR), no escalation of care or comfort care order at the time of screening
2. Expected survival \< 48 hours
3. Evidence of nasal or oral spillage likely to be the cause of bloody secretions
4. Patients requiring 100% FIO2
5. Known hypersensitivity to tranexamic acid
6. Treatment with inhaled tranexamic acid prior to screening
7. Acquired defective color vision
8. Subarachnoid hemorrhage
9. Deep Venous or arterial thrombus diagnosed within the previous 3 months
10. Seizure disorder on active anti-epileptic therapies
11. Hypersensitivity to tranexamic acid or any of the ingredients
12. Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
13. Patient receiving concurrent anti-fibrinolytic therapy
14. Confirmed active COVID-19 infection
Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years with ocular hypertension or open-angle glaucoma
* Subjects who have a best-corrected visual acuity of 20/100 or better

Exclusion Criteria:

* Subjects who wear contact lenses
* Uncontrolled medical conditions
* Subjects with a known sensitivity to latanoprost, BAK, or any other products required for the study
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
Augmented Reality Enhanced Surgery: Use of Holographic Technology in Cranial and Spinal Surgery

* To demonstrate the feasibility of integrating holographic technology as a heads-up display for navigated cranial and spinal neurosurgical procedures. This entails simply displaying the navigation screen currently used by Medtronic Stealth or Brainlab systems as a holographic image that can be positioned closer to the operative field.
* To develop a systematic, efficient communication and registration process allowing holographic technology to be potentially utilized as a navigation tool in cranial and spinal neurosurgery. This entails developing software, optimizing connection parameters, and devising registration techniques incorporating line-of-sight fiducial markers to allow the holographic device to function as a navigation instrument.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* must be able to read and understand English, and sign the informed consent form

Exclusion Criteria:

* emergent/emergency procedures
* pediatric patients
* pregnant patients
* vulnerable populations
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)

Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric, non randomized and with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter, randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Age : from 18 to 70 years
* Neurological signs evoking cerebral ischemia

Exclusion Criteria:

* Severe hypoxemia (PaO2/FiO2 \< 200) with controlled ventilation (FiO2: 100%)
* Hypothermia \< 36°C
* Obesity (BMI ≥ 40) with documented hypopnoea
* Intractable hypotension despite optimal filling and catecholamine doses \> 1µg.Kg.min
* Patients with contraindication for organs harvesting.
* Documented chronic respiratory failure
* Progressive infectious acute respiratory disease
* Family opposition to subject's participation in the study
Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illness in Turkey

It is predicted that the number of Pediatric Chronic Critical Illness increases similar to adult all over the world. The prevalence of Pediatric Chronic Critical Illness in Turkey is unknown. The investigators aimed to evaluate the etiology, comorbid conditions, demographic data, prevalence, mortality and costs of these patient in intensive care units in Turkey. In this multi-centered study, The investigators will retrospectively review the last 3 year of patients receiving treatment at the Intensive Care Unit.

Patients receiving acute critical cause of ICU in the Intensive Care Unit (ICU) may be hospitalized for longer periods of time due to accompanying diseases or iatrogenic causes. This disease is called "Chronic Critical Illness" (CCI). CCI is associated with prolonged acute mechanical ventilation, but there is no definition in the literature for newborns. Pediatric CCI is estimated to be similar to adults. In the United States, the number of CCI is around 250,000, which is estimated to have doubled in the last 10 years. 50% of patients die in one year and much less than 12% recover. The estimated annual cost for the CCI in the United States is over $ 20 billion. The prevalence of Pediatric CCI in Turkey is unknown. In this study, it was aimed to investigate risk factors, mortality and cost of children with chronic critically ill and newborn patients in intensive care units in Turkey.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Critical IIlness
* The patients who are younger than 18 years old and staying in ICU for at least 14 days.

(The patients who is newborn and stay in the intensive care unit for 30 days in addition to prematurity).

At least one of the additional criteria;

* Prolonged acute mechanical ventilation
* Tracheostomy
* Sepsis
* Severe wound (burn) or trauma
* Encephalopathy (Post resuscitation syndrome, Asphyxia, Intra-cranial hemorrhage, Metabolic disease, etc.)
* Traumatic brain injury
* Status epilepticus
* Post operative (Cardiac and noncardiac)
* Neuromuscular disease (Spinal Muscular Dystrophy, Cerebral Palsy, Muscular Dystrophy)

Exclusion Criteria:

* Patients with a disease other than a chronic critical disease
* Patients older than 18 years
The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors

The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well.

This study is a multicenter, open label, phase Ⅰb/Ⅱ clinical study conducted in unresectable patients with advanced or recurrent metastatic Claudin18.2 positive (medium and high expression) and HER-2 negative primary gastric adenocarcinoma or gastric esophageal junction adenocarcinoma. The Phase Ib dose escalation study included two dose groups each combined with the XELOX standard treatment regimen. Perform dose escalation to obtain MTD and/or RP2D doses for combined administration. The Phase II study adopted an open label parallel randomized controlled design. Further observe the efficacy and safety of Q-1802 combined with XELOX regimen in treating patients with moderate to high expression of Claudin 18.2, and compare and analyze the efficacy and safety of Q-1802 combined with XELOX regimen and XELOX regimen alone.

Eligibility Criteria:
Inclusion criteria：

Patients with at least one measurable lesion per RECIST (v1.1);

Patients with medium or high expression of Claudin18.2 in tumor tissue samples tested by immunohistochemistry in central laboratory were included;

Patients with untreated, unresectable advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with negative HER-2 immunohistochemistry or FISH test (HER-2 immunohistochemistry 0/1+ confirmed by a qualified local or central laboratory, or 2+ confirmed negative by FISH test) were included;

Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening and no deterioration occurs within two weeks before enrollment;

Life expectancy period ≥ 12 weeks;

Patients who have sufficient baseline organ function.

Exclusion Criteria:

Receive anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the treatment drug, whichever is shorter;

Patients who have previously used Claudin 18.2 products for treatment;

With uncontrolled diseases;

Who are allergic to the study drug or any of its components;

Patients with a history of other primary malignant tumors at the time of screening, except for cured skin Basal-cell carcinoma or Cutaneous squamous-cell carcinoma or cervical Carcinoma in situ.