cyrilzakka/clinical-trials huggingface dataset:
Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer

Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with metastatic Colorectal Cancer.

In addition investigators propose to assess the compliance of patients to treatment and the efficacy of treatment. That means percentage of objective responses, duration of response, frequency of curative liver resection after the administration of treatment, progression free survival and estimation of overall survival

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histologically confirmed metastatic or locally advanced non-operable colorectal cancer
* No prior first line treatment for metastatic colorectal cancer
* Age ≥18 years
* One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
* ECOG performance status ≤2
* Adequate haematological, renal and hepatic function
* Urine protein \<2+ (dipstick)
* Life expectancy of ≥12 weeks

Exclusion Criteria:

* Previous first line treatment for metastatic colorectal cancer(progression \>6 months after the end of adjuvant treatment)
* Previous radiotherapy to target lesions
* Patients with brain metastases and/or cancerous meningitis
* Metastatic infiltration \>50% of the liver parenchyma
* Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
* Patients participating in interventional clinical trial
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation

The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.

There is no consensus on the need for antibiotic treatment for ventilator-associated tracheobronchitis (VAT). There's a lack of high-quality clinical data on this subject, and although some observational studies recommend antibiotic treatment for VAT, some guidelines do not. The VATICAN is a prospective, randomized, single-blinded (analysis), non-inferiority trial evaluating antibiotic treatment for patients with ventilator-associated tracheobronchitis. Patients with clinically diagnosed tracheobronchitis will be randomized to receive antibiotics for 7 days versus clinical observation without antibiotic treatment for VAT. The primary hypothesis is that clinical observation without antibiotic treatment is noninferior to 7-day antibiotic course.

Eligibility Criteria:
Inclusion Criteria:

* Admission to one of the participating ICUs
* Invasive Mechanical ventilation ≥ 48 hours
* Available chest imaging of screening day
* Clinical diagnosis of VAT, defined by the presence of:

  1. Temperature \>38.0°C or \<36°C OR leukocytes \>12000/mL or \<4000/mL or presence \>10% of immature forms, AND
  2. Onset of purulent tracheal secretion, or change in characteristics of the secretion, or increase in the amount of respiratory secretion, or increased need for aspiration
* Culture of tracheal secretion from the day of screening under analysis or collected for analysis

Exclusion Criteria:

* Pregnant or lactating women
* Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening
* Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose \> 0.1mcg/kg/min of noradrenaline or equivalent in the past 6 hours
* Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days
* Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more
* Presence of pulmonary radiological image suggestive of new infectious infiltrate
* Previous lung disease that makes radiological interpretation for the diagnosis of VAP difficult
* Previous diagnosis of ventilator associates pneumonia (VAP) during hospitalization
* Neutropenic patients (neutrophils \<1000/mL)
* Known severe immunosuppression
* Tracheostomized patients at the time of screening
* Inclusion in the study in the past 30 days
* Expected limitation of care or early withdrawal of supportive therapies (\< 7 days)
* Patients with a survival expectancy of less than 48 hours
* Refusal of consent to participate in the study
Arthroscopic Treatment for Femoral Acetabular Impingement Syndrome With Gluteus Medius Lesions.

To evaluate the prognosis of femoral acetabular impingement syndrome (FAIS) patients with gluteus medius lesions after hip arthroscopy.

The data of FAIS patients with gluteus medius lesions were retrospectively extracted pre- and postoperatively after hip arthroscopy. The prognosis of the surgery was evaluated through MRI images.

Eligibility Criteria:
Inclusion Criteria

* Diagnosed FAIS
* Ineffective conservative treatment
* Available pre- and postoperative images

Exclusion Criteria

* Revision arthroscopy
* Osteoarthritis
* History of hip joint disease or surgery
* Sacroiliac joint disease
* Loss of follow-up
Physiological Response of Cortisol to Cardiac Catheterization

Cortisol is essential for survival. The importance of cortisol response is most apparent in patients with partial or complete deficiency of glucocorticoids during stressful events such as illness or surgery.

It is known that cortisol and other stress hormones increase during acute myocardial infarction as well (9-11). Cardiac catheterization is an essential tool for the management of acute coronary syndrome, and for the evaluation of the burden of coronary artery disease in cardiac patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cardiac catheterization, who are willing and able to give consent.

Exclusion Criteria:

* • Patients with .primary or secondary adrenal insufficiency.

  * Patients taking steroids in the doses equivalent of at least 5 mg of prednisone daily for more than 3 weeks in the previous year.
  * Patients undergoing cardiac catheterization in the setting of acute coronary syndrome, eg. STEMI, NSTEMI and unstable angina.
  * Patients with low albumin level (\<3.5 g/dL)
Acute Normovolemic Hemodilution in Off-pump CABG

To study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery

Off-pump coronary artery bypass surgery is an alternative to conventional coronary artery bypass grafting using cardiopulmonary bypass (CPB). It avoids adverse effects of CPB such as systemic inflammatory response, impaired myocardial protection, and air or plaque embolism. However, OPCAB surgery involves displacement and manipulation of the heart to expose target coronary arteries. These manipulations cause hemodynamic instability as a result of transient annulo-mitral distortion and acute mitral regurgitation, compression of the right ventricle, and impaired cardiac contractility due to epicardial stabilizers. signs of impaired perfusion such as metabolic acidosis, increased serum lactate and decreased urine output are commonly seen intraoperatively

Excessive surgical bleeding causes hypovolemia and hemodynamic instability, anemia, and reduced oxygen delivery to tissues

Acute normovolemic hemodilution (ANH) is an alternative method of management of intraoperative blood loss, in which a certain volume of blood is collected from the patient, stored at room temperature and replaced by an equal volume of colloid solution. By the end of surgery, this blood is returned to the patient, usually within eight hours of collection, with little deterioration of platelets or coagulation factors

This work aims to study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for off- pump CABG surgery

Exclusion Criteria:

* Ejection fraction less than 40%
* Hematocrit less than 11 g/dl
* patients with severe renal impairment
ED Treatment of Suicidal Patients With Ketamine Infusion

This study aims to determine if a single intravenous (IV) dose of ketamine given in the emergency department (ED) can provide a long term reduction in suicidal ideation, lower time to ED discharge, and increase discharge to home or voluntary treatment facilities all while being safe.

Suicide has risen to the 2nd leading cause of death in Americans aged 10 to 34, and is the10th leading cause of death overall. Globally, the World Health Organization estimates one person dies of suicide every 40 seconds. Despite its lethality, no recognized acute treatments for suicidality exist. Recently, ketamine, an N-methyl-D-aspartate (NMDA) receptor agonist, has been shown to rapidly reduce suicidality in small studies in psychiatric settings. However, most patients with acute suicidal thoughts are treated initially in Emergency Departments (EDs). Delays in treatment have both short and long term impacts on recovery as patients spend longer time frames in an actively suicidal state.

Identifying a rapid and effective treatment for suicidal ideation that can be administered in the ED would have a profound impact on the emergent management of patients with suicidal thoughts. Ketamine is an FDA approved medication that is commonly used in EDs for multiple indications. EDs have the familiarity, facilities and personnel to safely administer IV ketamine.

Ketamine is regularly used in EDs in high doses for procedural sedation in adults and children. It is also used in high doses as a sedative for acutely agitated patients. In low-doses ketamine is frequently used for its analgesic properties and is considered safe.

Ketamine has also been safely used in the pre-hospital setting. In a recent joint policy statement of the American College of Emergency Physicians recommended the use of low-dose ketamine for pain in control with a safety profile comparable to other intravenous analgesia such as morphine.

Use of Ketamine to rapidly reduce suicidality may facilitate a safe and faster transition of acutely suicidal patients to outpatient treatment. Such treatment potentially shortens these patients' ED and hospital lengths of stay.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Chief complaint of suicidal thoughts with a MADRS-SI score \> 3
* Major depressive episode with MADRS \> 19 (moderate to severe)

Exclusion Criteria:

* Pregnancy
* Psychosis
* Acute intoxication with alcohol or illicit drugs
* Acute withdrawal from alcohol or illicit drugs
* Adults otherwise unable to consent
* Concurrent, active medical illness requiring medical hospitalization
* Inability to follow-up including no permanent address or valid telephone number
* Patients unable to attend outpatient follow-up (no medical insurance, refusal to follow-up, no established care provider)
* Specific contraindication to the use of ketamine (concern for increased intracranial or intraocular pressure, known allergy to ketamine)
* Greater than 12 hours from time of ED presentation
* Prisoners
Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients

The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life.

The aim of the Serious Illness Care Program (SICP) is to provide clinicians with an evidence-based structure for eliciting and documenting vital information about preferences for patient driven care of their serious illness. It is designed to help open the door for patients, families, and clinicians to talk and reflect on end-of-life issues in an ongoing way. The hypothesis of the Serious Illness Care Program is that adherence to the conversation guide portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life. For this protocol specifically, the investigators are testing a pilot intervention of a quality improvement project; the investigators plan to train clinicians and assess the feasibility and impact of the Serious Illness Care Program, which includes patient identification, clinician training, "triggering" of clinicians to conduct the SICG conversation, and documentation, in the iCMP at the Brigham and Women's Hospital.

Eligibility Criteria:
Clinician Inclusion Criteria:

1. Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham \& Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner
2. Care for patients enrolled in Brigham and Women's Hospital integrated Care Management Program (iCMP)

Clinician Exclusion Criteria:

1. Resident in Training
2. Non-English Speaking Clinic (e.g. Spanish Clinic)

Patient Inclusion Criteria:

1. Over 18 years of age
2. English Speaker
3. Patient at Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham \& Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner
4. Enrolled in Brigham and Women's Hospital integrated Care Management Program

Patient Exclusion Criteria:

1. Patient at Dana-Farber Cancer Institute
Effect of Metformin in Patients With Type-1 Diabetes With Inadequate Glycaemic Control by Insulin and Diet

Ninety percent of patients with type-1-diabetes will develop late-diabetic complications in the eyes, kidneys, nervous- or cardiovascular-system. Poor glycaemic control is an important risk-factor for development of these late-diabetic complications. The Diabetes Control and Complications Trial (DCCT)-study showed, that improved glycaemic control can prevent the development and progression of these late-diabetic complications. Until now treatment with insulin- and diet-therapy has been the only treatment-modalities available to improve the glycaemic control in patients with type-1-diabetes. A substantial number of these patients still have long-standing poor glycaemic control despite intensive treatment with insulin- and diet-therapy.

The antidiabetic drug metformin has shown to be able to improve the glycaemic control in combination with insulin and furthermore reduce both mortality and the risk of developing cardiovascular disease in patients with type-2-diabetes.

Only few small studies have investigated the effect of treatment with metformin in patients with type-1-diabetes. These studies have suggested a positive effect of metformin in these patients too.

Method:

100 patients with type-1-diabetes with persistent poor glycaemic control i.e. HbA1c \> 8.5% during the last 12 months are eligible. Patients are treated for one month with placebo. Hereafter half of the patients will be treated with metformin and the other half continues with placebo for 12 months both as add-on therapy. All patients are continuing ongoing treatment with insulin throughout the study. Before and after the start of treatment with metformin the effect on glycaemic control and other known risk-factors for development of cardiovascular disease i. e. blood-pressure, fasting lipids, urine-albumine-excretion, endothelial dysfunction, inflammation, fibrinolysis etc. is assessed.

This study will show if treatment with metformin can improve the glycaemic control and hereby the prognosis of patients with type-1-diabetes with persistent poor glycaemic control despite intensive treatment with insulin- and diet-therapy. This group of patients suffers the highest risk of developing late-diabetic complications with reduced quality of life and life-expectancy as a consequence.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c \> 8.5% for more than one year prior to enrolment.
* Diabetes-duration \> 5 years.
* Age at onset of diabetes \< 35 years
* Fasting C-peptide \< 300 pmol/l
* Age \> 18 years at enrolment.

Exclusion Criteria:

* Clinical or biochemical signs of kidney-, liver- or heart-failure.
* Other coexisting serious morbidity, which will affect the study-participation or outcome of the study i.e. cancer.
* Known abuse of any medication or alcohol
* Hypoglycaemia unawareness.
* Pregnancy or planned pregnancy in the study-period.
Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography

The purpose of this study is to use a new imaging drug called 11C-choline that is used with a PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as bone scans, CT or MRI.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have biopsy-proven adenocarcinoma of the prostate initially treated with curative intent (surgery and radiation therapy are most common treatments but other treatments are also eligible).
* Biochemical recurrence defined as any of the following:

  1. PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery.
  2. PSA ≥ 0.2 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
  3. PSA ≥ 0.2 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting
* Patient must have undergone standard-of-care restaging that does not clearly identify site(s) of active disease, or such prior studies must show equivocal findings for which further work-up is considered necessary to make clinical decision. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy MDP or F-18 sodium fluoride PET), FDG PET, or In-111 capromab pendetide scintigraphy no older than 3 months of consent date.
* Age ≥ 18 years.
* Patient must be able to tolerate PET/CT imaging.
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.
Treatment of Periodontitis With Er:YAG Laser

The purpose of this research project is to gain information on the best and most comfortable way to treat the periodontal disease. The main objective is to compare the efficacy of conventional scaling and root planning compared to laser scaling for the non-surgical treatment of periodontal disease. Both therapies have shown to be effective and are regularly used in the dental clinic.

The study has been designed as a single blinded split-mouth randomized controlled clinical trial. Patients will be randomized prior to treatment, to which the examiner will be blinded. Clinical parameters will be recorded at baseline and 3 months after treatment has been completed. At the time of recruitment, inclusion/exclusion criteria checklist, informed consent and baseline measurements will be obtained and recorded. Medical history will be updated and radiographs will be reviewed or taken. During the second appointment, conventional scaling and root planing will be performed in the corresponding quadrant; during the third appointment, laser therapy will be conducted, 1 month after, during the forth appointment, a follow up (no measurements) will be scheduled with provider, and 3 months after scaling completion, measurements will be taken and periodontal maintenance performed. Patient will receive home care instructions at every visit and will fill out a visual analogue scale at baseline, 1 month and 3 month visit.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated Informed Consent
* Good general health
* Participants \> 18 years of age
* Participants with \> 20 teeth with 5 teeth, including at least 1 molar, in each quadrant of the mouth
* Participants with \> 30% of the present teeth with Probing depths of \> 4mm and Bleeding on Probing
* Non-smoker and former smokers (stopped smoking \> 1 year)
* Participants that have not received any periodontal treatment in the past 3 months

Exclusion Criteria:

* Participants with uncontrolled systemic diseases that could affect the treatment outcome such as Diabetes with HbA1c \> 7.0 percent, rheumatoid arthritis, immunosuppression, HIV with detectable viral loads
* Participants requiring antibiotic prophylaxis for any cardiovascular conditions or after any transplant and/or replacement procedures
* Pregnant women
* Patients treated with systemic antibiotic therapy of periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration
* Patients being chronically (two weeks or more) treated with any NSAIDs, steroids or any medications known to affect soft tissue condition (excluding treatment with Acetylsalicylic acid \< 100 mg/day)
* Presence of orthodontic appliances, or any removable appliances that impinges on the tissues being assessed.
* Presence of soft or hard tissue tumors of the oral cavity
* The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study
Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors.

This study aim to investigate whether the prognosis of eyelid malignant tumor is better treated with Mohs surgery combind with cryotherapy than Mohs surgery only.

This study is a randomized perspective study. American Joint Committee on Cancer was applied to define the cancer stage of patients recruited. Patients with Tis to T3cN0M0 will be randomized to receive Mohs surgery or Mohs suregery conbind cryotherapy. Patients will be followed for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of this study.
* Definite pathology signs of eyelid basal cell carcinoma, squamous cell carcinoma and sebacous carcinoma, Stage Tis to T3CN0M0 based on American Joint Committee on Cancer.
* Pathological examination showed the primary tumor was compeletely resected

Exclusion Criteria:

* Any previous treatment in the study eye
* Tumor complicated with infection
* Any other tumors of the paticipants
* Intolerate of surgery or anesthesia