cyrilzakka/clinical-trials huggingface dataset:
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

Primary Objective:

- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)

Secondary Objectives:

* To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409
* To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL
* To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

Eligibility Criteria:
Inclusion criteria:

* Tissue from an archived or fresh tumor sample
* A peripheral blood buffy coat sample is required for CLL/SLL.
* Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma
* Patient \> or = 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2. Patients with DLBCL will have ECOG \< or = 1
* Adequate white blood cells and hemoglobin
* Good kidney and liver function
* Fasting glucose \< 160 mg/dL
* No other malignancy
* Use of adequate birth control

Exclusion criteria:

* Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment
* Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment
* Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.
* Radiation therapy within 2 weeks of enrollment
* Autologous stem cell transplantation within 16 weeks of enrollment
* Prior allogeneic transplantation except for patients with R/R DLBCL who meet inclusion criteria
* Central nervous system (CNS) or leptomeningeal involvement. Patients with DLBCL may have active CNS or leptomeningeal involvement.
* Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology
* Primary CNS lymphoma
* Primary mediastinal B-lymphoma

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Acute and Persistent Pain in ICU Patients

Approximately 20,000 patients are treated in intensive care units (ICU) in Finland annually. During ICU stay many diagnostic and other procedures as well as immobilization and underlying diseases may cause pain. Therefore the incidence of pain in ICU patients can be high. Acute pain may cause several detrimental effects including respiratory distress, tissue hypoxia, immunosuppression and anxiety. After discharge many survivors of critical care have lower health-related quality of life, symptoms of post-traumatic stress disorder or persistent pain.

Only few studies with a focus on acute or persistent pain in ICU patients have been made, hence the incidence and risk factors for ICU-related pain is not very well known. Some of the identified risk factors for persisting pain may be increased age, sepsis or inadequate pain management during ICU stay. Opioids are most often used for analgesics in intensive care. Because they may have several adverse effects the use must be based on validated pain scales. Many factors such as sedation, relaxation or delirium of the patient complicates the management of the pain.

This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care.

This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care.

The recruitement process is finished, but the follow-up is on-going. Patients are followed-up by subsequent questionnaires until 5 years after admission to the ICU.

Eligibility Criteria:
Inclusion Criteria:

* not meeting the exclusion criteria

Exclusion Criteria:

* pregnant patients
* age under 18 years
* suffering from significant brain injury
* elective neurosurgical patients
* probable organ donors
* suffering from significant cognitive impairment
* presumed death under 48h
Pancreatic Anastomosis After Duodenopancreatectomy

A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).

Background: Postoperative pancreatic fistula is currently the most frequent complications after duodenopancreatectomy. There are currently no RCT comparing two of the most frequently used method of pancreato-enteric anastomosis (invaginating pancreatogastric anastomosis versus Blumgart anastomosis)

Hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a Blumgart (AB) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy decreases the rate of postoperative pancreatic fistula (PPF) compared to to pancreatogastric anastomosis.

Main goal: To comparatively evaluate the rate of PPF in patients with pancreatic and periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with Blumgart anastomosis or pancreatogastric anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy
* Signature of informed consent by the patient or his legal representative

Exclusion Criteria:

* Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
* Patients in whom tumor resection is ultimately not achieved due to intraoperative evidence that the tumor is locally advanced, unresectable.
* Patients with macroscopic residual tumor (R2).
* High risk patients with severe pathology (ASA IV) according to the American Association of Anesthetists.
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis

The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.

In this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and Mayo risk score in patients with PSC. The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. Each group will be treated for three months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PSC established by alkaline phosphatase \>1.5 times and/or two fold elevation of liver transaminases (AST and/or ALT) for at least 6 months duration.
* Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC.
* Both genders.
* Age ≥ 18 years old and \< than 75 years old.
* Patient's informed consent for study participation.

Exclusion Criteria:

* Treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding three months.
* Active drug or alcohol use.
* Prior history of allergic reactions to the antibiotics which will be used in the study.
* Any condition that, in the opinion of the investigator, would interfere with the patients' ability to complete the study safely or successfully.
* Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy.
* Anticipated need for transplantation in one year (Mayo survival model \<80% one-year survival without transplant).
* Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis.
* Pregnancy or current lactation. Subjects becoming pregnant during the study will be withdrawn.
The Effect of Early Use of Methylene Blue on Hemodynamics in Septic Shock

This study will include patients requiring high dose of norepinephrine (NA) to maintain blood pressure after fluid resuscitation. The patients will be randomized into two groups, the study protocol is early combined application of methylene blue. The primary outcome is Sequential Organ Failure Assessment (SOFA) score 72 hours after admission. Second outcome includes duration of shock, length of intensive care unit (ICU) hospitalization and so on. To explore the underlying mechanism, the changes of sublingual microcirculation before and after vasopressor combination will be collected, also is the global longitudinal strain of left ventricle.

Background: Decreased vascular tone is one of the main mechanisms leading to septic shock. The guidelines recommend NA as the first-line vasopressor. The benefits of early combination with other vasopressors are not yet known.

Methods:

1. Patients: Septic shock patients in need of high dose of NA (≥0.5ug/kg.min maintaining more than 2 hours) to maintain blood pressure after fluid resuscitation.
2. Intervention: The patients will be randomized into two groups. The study group will receive 2mg/kg methylene blue infusion with 15 minutes, 2 hours laters followed by 0.5mg/kg/h for 4 hours. The control group received conventional treatments, the attending physicians decide the protocol of vasopressors. The data including patients' characters, duration of shock and hospitalization, duration of mechanical ventilation, cumulative dose of vasopressors will be collected. Before and 6h after meeting the inclusion standard, sublingual microcirculation and automated function imaging of myocardium will be performed.
3. Outcome: The primary outcome is SOFA score 72 hours after admission. Second outcome includes duration of shock, length of ICU hospitalization and so on. the changes of sublingual microcirculation will be collected, also is the global longitudinal strain of left ventricle.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock, receive 0.5 ug/kg/min NA to maintain blood pressure for more than 2 hours after fluid resuscitation.

Exclusion Criteria:

* Pregnant women
* Without internal jugular vein or subclavian vein catheterization
* Child-Pugh grade C with liver cirrhosis
* Severe chronic obstructive pulmonary disease (severe acidosis caused by type II respiratory failure, PaCO2 ≥60mmHg and PH\<7.2 )
* End-stage of malignant tumors
* Glucose-6-phosphate dehydrogenase (G6PD enzyme) deficiency
* Positive end-respiratory pressure (PEEP) \>10mmHg, the oxygenation index \<150mmHg under mechanical ventilation
* Definitive pulmonary hypertension or chronic pulmonary heart disease.
* Oral use of 5-hydroxytryptamine in recent 3 months
MOTIV Study- Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting

The purpose of this study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting

Depression is known to have an adverse effect on post-operative mortality and morbidity after coronary artery bypass grafting. Cardiac surgery is known to cause transient depression in patients. The purpose of this double-blind, randomized study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting. Treatment is given from 21 to 15 days pre-operatively until the 6th post-operative month. Morbidity as defined by the STS database as well as mortality is checked during 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective coronary artery bypass surgery
* \> 30 years old

Exclusion Criteria:

* Contra-indication to antidepressive treatment
* Already treated by antidepressive treatment
* Concomitant cardiac surgery as valve replacement etc.
* Patients having anticoagulation therapy
* Pregnant women
* Hepatic insufficiency
Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography

This study aims to validate the possibility to track cardiac contractility changes with a new technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Adult between 18 and 50 years old.
* Healthy without medical cardiac conditions history.
* Non smoker.
* Does not take any drugs or medications.
* Does not participate in other clinical study or trial.
* BMI (Body Mass Index) in between 20 and 25 kg/m2.

Exclusion Criteria:

* Being younger than 18 or older than 50 years old.
* Having had previous cardiac conditions or present disease.
* Being a regular smoker.
* Taking any drugs or medications
* Taking part in another clinical study or trial.
* BMI (Body Mass Index) lower than 20 or higher than 25 kg/m2.
Anti-gingivitis Mouthrinse

The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
* Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
* Signed Informed Consent Form.

Exclusion Criteria:

* Presence of orthodontic bands.
* Malign tumor(s) of the soft or hard tissues of the oral cavity.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Self-reported pregnant or lactating subjects.
* Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
* Participants who require antibiotic treatments for dental appointments.
* Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index \[PSI\] \>2 in more than 2 sextants or PSI \>3).
* Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
* Smokers or/and users of tobacco products.
* Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)
Cone-beam CT Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)

The Guided Therapeutics (GTx) program at the University Health Network is a network of clinicians, scientists, and engineers focused on the development and translation of image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies developed within the GTx program include a portable intra-operative cone-beam CT (in collaboration with Siemens) that has been evaluated in clinical trials for head and neck surgery. The intraoperative imaging has been integrated with tracking and navigational tools and optical imaging to provide a general "surgical dashboard" that is used to improve the accuracy of surgical resection.

A recent addition to the GTx program is the development of the GTx OR, located within the general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy Somatom Flash provides a "gold-standard" in CT imaging, while the Zeego provides excellent 3D Cone-beam CT with robotic placement for flexible integration within the operating environment. Together, the integration of these 2 components into a single OR enables critical evaluation of the limits of CT imaging technology for surgical guidance.

This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous placement and localization of markers for resection of small pulmonary nodules during VATS.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient age 18 and older with lung nodules who are candidates for microcoil localization prior to VATS wedge resection

Exclusion Criteria:

* Patients that are unable to give informed consent
* Patients that are unable to tolerate general anesthesia
* Patients who are pregnant or patients that believe they are pregnant
* Patients with implantable devices susceptible to Radio Frequency (RF) fields
* Severely obese patients
DWP05195 in Healthy Adult Male Volunteers

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male subjects aged 20 to 45 years
* The subject has a Body weight ≥ 50 kg and \< 90 kg and Body Mass Index (BMI) ≥ 19.0 kg/m2 and \< 27.0 kg/m2
* A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
* A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)

Exclusion Criteria:

* A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
* A subject who had any allergic history to any drug (prescription drug or OTC medication etc.)
* A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication

  * Within last 1 month: drug or food known CYP1A2 inducer or inhibitor
  * Within 2 weeks: Prescribed or herbal or Non-prescribed medicine
  * Within 3 days: Consumption of grapefruit juice/grapefruit containing products or orange juice/orange containing products, garlic extracted functional foods
  * Within 3 days: Consumption of alcohol or caffeine
* A subject who had participated in any other clinical study within the last 12 weeks
* A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks
* A Subject with the known evidence of the following infections or drug abuse
* HIV, HBs, HCV
* cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine
* Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test
* AST or ALT greater than 1.5 times the upper limit of reference range or QTc \> 430 msec base on screening results
* Blood pressure: SBP ≥ 140 mmHg, DBP ≤ 85 mmHg
* A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

The investigators will directly compare the visual analog scale scores and narcotic pain medication requirements in the patients who have continuous passive motion (CPM) versus those who do not during the course of the hospital admission following an open reduction internal fixation surgery for acetabular fracture, supracondylar femur fracture, or a tibial plateau fracture.

This will be a prospective comparative cohort study analyzing the practices of three surgeons, one of whom routinely uses CPM following fixation of pelvic and acetabular fractures, and two surgeons who do not.

All patients, over the age of 18 years who have undergone open reduction and internal fixation (ORIF) of isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture will be asked to participate. Those who consent will be randomized into two groups. The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off, when not mobilizing with Physical Therapy (PT). The experimental group will also have traditional PT, including sessions 1 to 3 times a week. The control group will have typical care, including working with physical therapy 1 to 3 times a week. The investigators will directly compare the VAS scores and narcotic pain medication requirements in the patients who have CPM versus those who do not during the course of the hospital admission. VAS scores will be assessed throughout the day by RN and/or PT. Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12. Orthopedic Resident or Nurse Clinical will check the patient for incision integrity each day and each session of using the CPM, the patient will be monitored for adverse events. Data will be collected using Epic.

The investigators will record patient demographics including age, sex, and pre-existing narcotic usage. Fracture type according to the Orthopaedic Trauma Association will be recorded. VAS scores and pain medication requirements will be recorded from the first 48 hours during the patient's stay. Pain scores and CPM use will be obtained from Epic using the flowsheet.

Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture
* Have undergone operative intervention for fracture

Exclusion Criteria:

* Injury to either lower extremity that affects the patient's ability to weight bear
* Under the age of 18
* Pregnant
* A prisoner