cyrilzakka/clinical-trials huggingface dataset:
Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)

Hypothermia amongst trauma patients is a persistent problem that increases the relative risk of transfusion as well as morbidity and mortality. The investigators propose to conduct a single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF) temperature monitor can reduce the incidence of hypothermia amongst trauma patients discharged from the trauma bay (TB). All eligible trauma patients will be randomized to either a standard of care group or an active temperature monitoring group. In the active temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to continuously record their temperatures after they enter the TB at a large tertiary trauma centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will determine if early continuous temperature monitoring can reduce the incidence of hypothermia upon discharge from the TB. Should early monitoring of severely injured trauma patients within the hospital improves discharge temperature, the foundation for two additional research studies will be laid. Firstly, the investigators will enter a vanguard phase of this trial and assess if early warming patients can improve morbidity and mortality in this patient population utilizing a multi-centered randomized controlled trial design. This will be further extended to test whether early monitoring can be applied in a pre-hospital setting (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Severely injured trauma patients with a Revised Trauma Score (RTS) ≤ 11 brought into the SHSC TB.

Exclusion Criteria:

* Patients with blast injuries to the face or severe facial trauma will be excluded.
* Major burn patients - as they follow a separate care pathway at SHSC
Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin

The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy has been previously described in mice and in neuronal cell cultures (Massicot 2013); clinical manifestations and pathophysiological mechanisms potentially involved have also been described in humans (Andreas 2007) (Attal 2009).

The investigators team plans to conduct a translational clinicobiological research to explain the nature of the biochemical and molecular mechanisms of the development of oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose to realize a pilot study in patients newly treated with oxaliplatin. This will be conducted in the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion of 20 patients.

The main objective of this pilot study is to evaluate the occurrence of acute and chronic neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization of this pain is based on validated tests (Cruccu 2010).

Moreover, the biochemical changes related to oxidative stress and those related to cellular lipid composition are characterized in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient newly traeted with oxaliplatin
* Patient suffering from any type of cancer treated with oxaliplatin
* Man or Woman over 18

Exclusion Criteria:

* Patient with brain or leptomeningeal metastases
* Patient previously treated with cisplatin
* Patient addicted to alcohol
* Diabetic patient with peripheral neurological disorders
* Patient receiving calcium or magnesium salts intravenously
* Patient suffering from peripheral neuropathy
* Patient suffering from psychiatric disorders
* Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.
Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES: I. Determine the response to docetaxel and vinorelbine with filgrastim (G-CSF) support in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival and time to tumor progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes and docetaxel IV over 1 hour on day 1 and filgrastim (G-CSF) subcutaneously daily on days 2-12 or until blood counts recover. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer Bidimensionally measurable or evaluable disease No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: Greater than 2 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and ALT no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension, unstable angina, congestive heart failure, or atrial or ventricular arrhythmias At least 6 months since prior myocardial infarction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No poorly controlled diabetes No known allergy to E. coli derivatives or any products to be administered No other prior malignancy within the past 5 years except surgically cured basal cell skin cancer or carcinoma in situ of the cervix No active infection or fever Not previously entered in this study

PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent hematopoietic growth factors Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior major thoracic or abdominal surgery and recovered At least 6 months since prior coronary angioplasty Other: At least 30 days since prior investigational agents No other concurrent investigational agent No prophylactic acetaminophen for fever
TXA in Anticoagulated Patients Study

This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA). Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.


Eligibility Criteria:
Inclusion Criteria

* Patients older than 18 years old
* Patients undergoing scheduled primary anatomic total shoulder arthroplasty
* Patients undergoing scheduled primary reverse total shoulder arthroplasty
* Patients who consent to be randomized
* Preoperative use of anticoagulant or antiplatelet therapy within 10 days prior to surgery:

  * Coumadin (Warfarin)
  * Heparin
  * Low molecular weight heparin
  * Factor Xa inhibitors
  * Apixaban (Eliquis)
  * Rivarixaban (Xatelto)
  * Edoxaban (Savaysa)
  * Dabigatran (Pradaxa)
  * Clopidogrel (Plavix)
  * Prasugrel (Effient)
  * Ticagrelor (Brilinta)

Exclusion Criteria

* Patients younger than 18
* Patients who are pregnant\* or breast-feeding women
* Patients who are allergic to tranexamic acid
* Patients scheduled for revision total shoulder arthroplasty
* Patients with proximal humerus fracture or fracture sequelae
* Patients who use estrogen containing medications (i.e. oral contraceptive pills)
* Patients who have acquired disturbances of color vision
* Patients with a history of any of the following diagnosis: '

  * Subarachnoid hemorrhage
  * Active intravascular clotting
  * Severe pulmonary disease (FEV \<50% normal)
  * Plasma creatinine \> 115 μmol/L in males, \> 100 μmol/L in females, or hepatic failure)
  * (Renal impairment serum creatinine \> 1.5 times the upper limit of normal NYU)
  * Preoperative anemia \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
* Patients who refuse blood products
* Patients undergoing hormone replacement therapy
* Patients with diagnosed or self-reported cognitive dysfunction;
* Patients who are unable to understand or follow instructions;
* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
* Patients with BMI over 50
* Any patient that the investigators feel cannot comply with all study related procedures.
Nasogastric Tube After Laparoscopic Heller-Dor Myotomy

The goal of this prospective observational study is to evaluate the role of nasogastric tube (NGT) in patients with achalasia underwent to Heller-Dor laparoscopic. The main question it aims to answer are:

• If it is possible to remove NGT at the end of surgery. Participants will be dived in two groups: the first one with NGT after surgery and second one without NGT (noNGT).

If there is a comparison group: Researchers will compare group NGT and group noNGT to see if routine placement of NGT is useless.

Achalasia is a rare disease characterized by dysfunction of low oesophageal sphincter. This disease is divided according to Chicago classification into three subtypes.

Laparoscopic Heller - Dor is a important treatment of types I and II Achalasia. There are several studies evaluating the NGT in colorectal, hepatic, urologic, thoracic, otorhinolaryngology, gastric and esophageal surgery. Its use in postoperative period in achalasic patients is not yet clear.

Historically, NGT has been used to reduce gastric distention, nausea, vomiting and chest pain.

The aim of our study is to value the role of NGT for this surgery. We prospectively enrolled achalasic patients undergoing laparoscopic Heller -Dor .

The NGT group and noNGT were compared in terms of perioperative outcomes.

Eligibility Criteria:
Inclusion Criteria:

* patients with achalasia of type I and II
* patients undergoing laparoscopic Heller-Dor
* patients older than 18 years
* both sexes

Exclusion Criteria:

* pregnant patients;
* patients a history of abdominal surgery;
* body mass index (BMI) \>40;
* American Society of Anesthesiology (ASA) score \>4;
* megaesophagus;
* III type Achalasia;
* previously treated for this disease.
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)

A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication


Eligibility Criteria:
Inclusion Criteria :

* Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis
* A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)
* Smokes less than 10 cigarettes/day

Exclusion Criteria :

* Patients with uncontrolled diabetes or uncontrolled congestive heart failure
* Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts
* Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg
* Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg
A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer

This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer using an imaging test called positron emission tomography (PET). Hypoxia can influence how pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic cancer. Also as part of the study, a blood sample will be taken to study biomarkers (substances in the body that may be important indicators of hypoxia and/or pancreatic cancer) that may be useful in studying pancreatic cancer and hypoxia.

This is a single centre, single arm hypoxia study of pancreatic cancer with PET FAZA imaging.

PET-CT imaging of tumor hypoxia with FAZA will be done prior to the start of standard treatment for pancreatic cancer with chemotherapy. The FAZA PET-CT imaging session will last approximately 2.5 hours and include an initial dynamic scan to completely characterize the initial rapid phase of FAZA uptake, followed by a later static scan.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years old
* Histologic diagnosis of pancreatic adenocarcinoma
* TNM (7th edition) cT1-4, N0-1, M0-1
* No cytotoxic anti-cancer therapy for advanced / metastatic pancreatic cancer prior to study entry
* Ability to provide written informed consent to participate in the study
* ECOG performance status 0, 1 or 2.
* Patient should have the following blood counts at baseline: ANC equal or greater to 1.5 x 109/L; Platelets equal or greater to 100 x 109/L; Hgb equal or greater to 9g/Dl
* Patient should have the following blood chemistry levels at baseline: AST (SGOT), ALT (SGPT) equal or less than 5 x upper limit of normal range (ULN) is allowed
* Patient has an identifiable tumor (pancreatic tumor and/or metastasis) by imaging (CT scan and/or MR)
* Patient must agree to use contraception considered adequate and appropriate by the investigator and if the patient is female of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (B-hCG)

Exclusion Criteria:

* Inability to lie supine for more than 30 minutes
* Any other type of primary cancer
* Life expectancy of less than 12 weeks
* Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart)
* Patient has serious medical risk factors involving any of the major organ systems
Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding

In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent/assent will be obtained before any study-related activities
* PTPs with hemophilia A assigned to Jivi prophylaxis treatment
* Negative FVIII inhibitor test before study entry
* Decision to initiate treatment with commercially available Jivi has been made by the treating physician before and independently from the decision to include the patient in this study

Exclusion Criteria:

* Known or suspected contraindications to Jivi or related products
* Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation
* Participation in an investigational program with interventions outside of routine clinical practice
Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study

The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female
2. Between 18 to 50 years old
3. Body mass index of 18 to 30 kg/m2

Exclusion Criteria:

1. Acute or chronic medical illness
2. Abnormal lung function Positive for HIV, Hepatitis B or C
3. Any significant abnormality of the nose or nasopharynx
Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes

1. To explore the pathology of nerve, vascular, and skin in the amputated leg
2. To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention
3. To search for (1) mechanisms of amputation and (2) prevention measures for further amputation in the currently healthy-looking limb

Diabetic foot occurs in 15% of diabetic population (3) and 15% of the diabetic foot patients end up with lower limb amputation. Peripheral neuropathy (sensory, motor and autonomic), peripheral vascular disease, trauma, infection and poor wound healing all contribute to diabetic foot problem.

Peripheral neuropathy could be evaluated in a variety of ways, including vibratory thresholds, thermal thresholds, pressure perception thresholds, muscle strength. All these predict foot ulceration to some degree(1). Motor nerve conduction velocity is an independent predictor for the development of new foot ulcer in diabetic population.

For more detailed structural study of neuropathy in diabetic patient, we could use skin biopsy method. Skin biopsy with PGP9.5 immunohistochemistry has been demonstrated by ultrastructural studies to label the terminal portions of both small myelinated and unmyelinated nerve in the epidermis . Intra-epidermal nerve fiber (IENF) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes . Previous IENF density study was performed in diabetic patients with sensory symptom but no foot ulcer. Now we tried to evaluate IENF density in severe diabetic foot patient who received below knee amputation. Skin biopsy willl be performed at amputated leg. The skin biopsy area will be located at lateral side of distal leg, 10 cm above the lateral malleolus as previous protocol of our group . Underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study. The result will be compared to the control group which were recruited from a previously described cohort matched by gender and age.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic foot wound patient who underwent below-knee amputation

Exclusion Criteria:

* Diabetic foot wound patient who couldn't receive below-knee amputation due to severe heart disease, high anesthetic risk.
Surgery or Chemoradiation for Esophageal Cancer

The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients had mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable.

Exclusion Criteria:

* The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
* Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.
Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion

The observational study is to compare vitamin D deficiency and related indicators among different spontaneous abortions in describe female reproductive health.The main question aim to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin D.

Participants, who visit the RSA specialty clinic, will provide medical history information, regularly exam based on the condition, following up on pregnancy status.Participants will be asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect after treatment.

Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes tested voluntarily, plasma VD content and the level of anticardiolipin antibody.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of patients without spontaneous abortion;
* Clinical diagnosis of patients with a spontaneous abortion;
* Clinical diagnosis of patients with recurrent pontaneous abortions;

Exclusion Criteria:

* Patients with chromosomal abnormalities in RSA couples, such as balanced translocation;
* Patients who take VD preparations or related VD supplements within 3 months before treatment;
* Patients with a combination of certain malignant tumors and severe mental illness.