cyrilzakka/clinical-trials huggingface dataset:
Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip fracture and this complication is independently associated with increased morbidity, mortality, length of hospital stay, and placement in long-term care institutions. To date, the only intervention shown to be effective at minimizing postoperative delirium is a proactive geriatric consultation. This prospective randomized clinical trial will randomize 160 adults, aged 65 years or older, to either optimized general anesthesia or usual general anesthesia care for hip fracture surgery to determine if the optimized anesthesia management reduces the severity of postoperative delirium.

Subjects will be randomized to one of two intraoperative anesthesia treatment groups: 1.) Usual care - the anesthetic management will be at the discretion of the anesthesia provider; or 1.) Optimal care - the intraoperative depth of anesthesia will be directed using a BIS monitor, blood pressure will be maintained within 20% of preoperative levels, and cerebral oxygenation will be maintained \> 60% during anesthesia. Subjects will be evaluated using the Confusion Assessment Method (CAM) for the first 5 postoperative days to determine if they experience postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* Subject or legal representative has voluntarily signed the informed consent approved by the Institutional Review Board,
* Hip fracture surgery scheduled under general anesthesia
* Subject is 65 years or older on the day of surgery

Exclusion Criteria:

* Inability to follow directions or comprehend the English language
* Severe uncorrected visual or auditory handicaps
* Delirium at screening or baseline
* Emergency surgery
co2 Gap and co2/o2 Ratio in Liver Transplant Patients

finding surrogate to co to trace the effect of preload challenge would make the test more applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be used to detect FR after mini fluid challenge and fluid bolts .

use of carbon dioxide gap and arterio venous oxygen content to trace the effect of preload challenge by giving via a specific venous line , first 150 ml is infused over one minute, after stroke volume at one minute measure the remaining 350 ml is infused over 14 minutes at constant rate , the fluid challenge performed with albumin 5% , fluid responsiveness is an increase in stroke volume by 15% after infusion of 500ml albumin 5%.

Objectives is to investigate the ability of VA-co2 gap and gap/ ratio to predict the hemodynamic response to mini fluid challenge, and to compare the validity of VA-co2 gap and gap/ratio with svo2 for prediction of fluid responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* patients post liver transplantation
* serum lactate \>2mmol/L

Exclusion Criteria:

* age less than 18 years
* patients with fulminant liver failure.
Insulin Glargine in Type 2 Diabetes Mellitus

Primary objective:

To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).

Secondary objectives:

The secondary objectives are the assessment of: changes in glycaemic control (HbA1C), frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial weight, duration of diabetes mellitus, general education and diabetes education.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus for at least 5 years;
* Treatment with oral antidiabetic drugs in fixed combination (Combo, i.e. glibenclamide 2.5 mg + metformin 400 mg, 2 or 3 tablets, at stable dose in the last 3 months);
* HbA1c \>= 8% and \<= 11%;
* Body mass index (BMI) \> 27 and \< 35 kg/m2;
* Willingness and demonstrated ability to inject insulin;
* Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG);

Exclusion criteria:

* Patients diagnosed with type 1 insulin dependent diabetes;
* Patients with latent autoimmune diabetes of adults (LADA), defined as fasting C-peptide levels \< 1 ng/ml;
* Cardiac status NYHA III-IV;
* Impaired renal function as shown by (but not limited to) serum creatinine \>= 1.5 mg/dl for males or \>= 1.4 mg/dl for females;
* Planned pregnancy, pregnant or lactating females;
* Failure to use adequate contraception (women of current reproductive potential only);
* Any current malignancy, previous breast cancer, or malignant melanoma within the past 5 years;
* Diagnosis of dementia
* Hypersensitivity to insulin or any of their components or to metformin;
* Current or previous insulin therapy other than during hospitalisations;
* Inability or unwillingness to continue metformin at study dosages throughout the study;
* Treatment with intermittent doses of systemic steroids or large doses of inhaled steroids for the past one year (fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regime);
* Stroke, Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), or Angina Pectoris within the last 12 months;
* History of drug or alcohol abuse;
* Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal

The purpose of this study is to evaluate the efficacy and cost-effectiveness of Cone Beam Computed Tomography (CBCT) compared to panoramic radiography prior to removal of third molars in reducing patient's morbidity. Adults having a close relationship between the mandibular canal and one or both lower third molars, as diagnosed from digital panoramic radiographs will be recruited for this randomised controlled trial. In one trial arm, patients will receive the standard digital panoramic radiograph prior to third molar surgery. In the second arm, subjects will undergo an additional Cone Beam Computed Tomography (CBCT) prior to third molar surgery.

All patients require a postoperative visit one week after surgery to assess the outcome.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 year
* mandibular canal is superimposed more than one half by the roots of the third molar as assessed on panoramic radiograph.

Exclusion Criteria:

* pregnancy
* radiological evidence of cyst an tumors
* indication for removal under general anesthesia
* preoperative neurosensory alterations
* existence of an external CBCT
Pharmacogenetic Testing for Medication Management.

The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.

In this data collection only trial design, the PGx test is not a protocol-specified procedure. Rather, patients are eligible if they have undergone PGx testing within the last 90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical research initiative.

Eligibility Criteria:
Inclusion Criteria:

1. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");
2. Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;
3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;

5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.

Exclusion Criteria:

1. Patient is currently hospitalized;
2. Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;
3. Patient is unable to provide an accurate history due to mental incapacity;
4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.
Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

Uterine fibroids are benign tumors of the uterus made up of smooth muscle and the extracellular matrix proteins Collagen and Elastin. They are exceptionally common; the cumulative incidence of a diagnosis of fibroids in women aged 25 to 45 is approximately 30 percent.

Uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and non-cyclic pelvic pain. They also can contribute to symptoms related to an enlarging pelvic mass (e.g., urinary frequency or constipation).

Uterine fibroids are also associated with an increased risk of complications of pregnancy, and with infertility, although it is unclear whether this association is causative. Symptoms associated with uterine fibroids can have a significant impact on quality of life, with scores on standard measures that are comparable to those for other major chronic diseases

Eligibility Criteria:
Inclusion Criteria:

* Uninterested in fertility during the study.
* Premenopausal status.
* Active symptoms related to uterine fibroids.
* Subjects will be obligated to use non hormonal contraceptives during the study.

Exclusion Criteria:

* Abnormal liver and renal function
* Participants with significant increase in uterine fibroids size during a short time.
* Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.
* Current use of steroids, anticoagulants, herbals, or botanicals with possible hormonal effects.
Switching Medication to Treat Schizophrenia

This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.

Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.

Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.

Eligibility Criteria:
Inclusion criteria:

* SCID diagnosis of schizophrenia or schizoaffective disorder
* Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects
* Treatment with antipsychotic medications for at least 2 months
* Received at least 1 outpatient mental health service every 3 months for the past 6 months

Exclusion criteria:

* Severe symptoms or side effects that indicate the necessity for a medication change
* Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)
* Treatment with clozapine
* One or more nights spent in a psychiatric hospitalization within the past 3 months
* Received services from a crisis intervention program within the past 3 months
* Require placement in a skilled nursing facility as a result of a physical condition or disability
* Criminal charges pending (once charges clear, the person will be considered)
* Pregnant or breast feeding
* Contraindication to any of the medications to which the patient might be assigned
Erector Spinae Block Using a Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Bupivacaine

This prospective parallel group randomized study will be conducted over 52 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II undergoing lumbar spine surgery. The participants will be randomly allocated into 2 groups. Group BM (Bupivacaine + magnesium sulfate) will receive bilateral erector spinae block using bupivacaine and magnesium sulfate after induction of general anesthesia, while group BD (Bupivacaine + dexmedetomidine) will receive bilateral erector spinae block using bupivacaine and dexmedetomidine after induction of general anesthesia. Hemodynamic changes will be monitored intraoperatively, and postoperative pain will be assessed using the visual analogue scale in order to assess the need for postoperative analgesia.

This prospective parallel group randomized study will be conducted over 52 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II undergoing lumbar spine surgery. The participants will be randomly allocated into 2 groups.

General anesthesia will be induced using propofol 1-2mg/kg, fentanyl 2ug/kg, and atracurium 0.5mg/kg.

Both groups will receive bilateral erector spinae block Group BM will receive bilateral erector spinae block .A technique that will be performed ultrasound guided to identify the transverse process of T10, and an 18G (gauge) needle will be introduced in plane deep to the erector spinae muscle after which a combination of 20ml bupivacaine 0.25% and 2.5 ml magnesium sulfate.

While group BD will receive the same block with the with 20ml bupivacaine 0.25% and dexmedetomidine 1ug/kg.

Hemodynamic changes will be monitored intraoperatively, for detection of any variations.

Postoperative pain will be assessed every 2 hours following the surgery using the visual analog scale in order to assess the need for postoperative analgesia.

Analgesia will be given in the form of nalbuphine 10mg when the visual analog scale is above 4.

Patient satisfaction will be measured by a scale from 1-10 the next day. Any complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1, and 2

Exclusion Criteria:

* Patient refusal
* Spine deformities
* Coagulopathies
* Infection at the site of surgery
* Body weight above 100kg
* Known allergy to used drugs
* Psychiatric illness
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers

The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-05212365 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
* Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
Rapid Identification of MINOCA Based on Novel Biomarkers

Among the patients diagnosed as acute myocardial infarction by coronary angiography, 5%-25% of the patients did not find coronary artery obstructive lesions. These patients do not need PCI. The discovery and verification of clinical protocols for accurate identification of myocardial infarction in the absence of obstructive coronary artery disease（MINOCA）is a major issue that needs to be addressed.Novel biomarkers like grow stimulation expressed gene 2（ST2）can indicate the degree of coronary artery obstruction, copeptin is a biomarker of cardiac emergency state. No clinical studies have been conducted to evaluate whether the novel biomarkers combination regimen can diagnose or exclude MINOCA.

Our research aims to establish and validate a model for the recognition of MINOCA based on novel biomarkers (ST2, copeptin) and to evaluate the prognostic value of novel biomarkers among patients with acute chest pain.

A cross-sectional study design will be used to evaluate the correlation between baseline novel biomarkers（ST2 and copeptin）and MINOCA, and to establish a discriminant model for the identification of MINOCA, and to verify its discriminant efficacy. A cohort study design will be used to evaluate the prognostic role of novel biomarkers in patients with acute chest pain.

On the basis of precision cohort (BIPASS), the project team will adopt the method of cross-sectional diagnostic experimental study design. ①Blood samples of MINOCA and AMI were extracted. According to the new biomarkers（ST2 and copeptin）reported in literature, the team will detect and combine them with troponin, and correct the covariate. And then establish the multivariate joint discriminant model. ②At the same time, according to the propensity score, patients will be selected from UA in a 1:1 matching ratio for modeling. The discriminant model for rapid recognition of MINOCA will be verified by internal cross validation and external validation. Based on this discriminant model, whether the combined application of three biomarkers in MINOCA diagnosis is superior to that of a single biomarker will also be evaluated. Patients with acute chest pain from multi-center will be selected to verify the accuracy of the rapid discriminant model of MINOCA applied to patients with acute chest pain.

Eligibility Criteria:
Inclusion Criteria:

* The clear diagnosis of MINOCA, acute myocardial infarction（AMI) and unstable angina（UA) in BIpass
* The clear diagnosis of MINOCA from the multi-center cohort

Exclusion Criteria:

* Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)
* Patient with non-cardiac co-morbidities with life expectancy less than 12 months
* Patients unwilling or unable to comply with all clinical follow-up schedules
Mucin Levels in Dry Eye and Normal Populations

The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease.

It is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.

This is a single-center, two visit, pilot, drying environment study (CAE). There will be two different groups of subjects enrolled into this study: dry eye subjects and subjects with no prior diagnosis of dry eye.

All subjects will undergo safety and dry eye assessments as well as tear collection prior to and after being exposed to a dry environment. They will also return the following day to undergo dry eye assessments, tear collection, and safety procedures again.

Eligibility Criteria:
Inclusion Criteria:

* Be male or female of any race, at least 18 years of age at Visit 1.
* Have provided verbal and written informed consent.
* Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1, as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
* If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use a medically acceptable form of birth control throughout the study duration . \[Females are considered of childbearing potential unless they are surgically sterilized (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or post-menopausal (at least 12 months since last menses).\]
* Have previously completed a recent trial OR not completed a recent trial AND report no symptoms of dry eye disease.

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy or lactating
* Use of disallowed medications
* Have ocular infections, or ocular conditions that could affect study parameters
* Have used an investigational drug or device within 30 days of start of study
* Female that is currently pregnant, planning a pregnancy or lactating
Transfusion Requirements in Surgical Oncologic Patient

Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer after major abdominal surgery requiring post-operative ICU admission
* Adults patients

Exclusion Criteria:

* Age less than 18 year
* Hematologic Malignances
* Intensive care unit permanence lower than 24 hours
* Renal Chronic Failure in Renal Replacement Therapy
* Karnofsky Status \< 50
* Previous anemia (hemoglobin lower than 9 g/dL)
* Previous thrombocytopenia (platelet number lower than 50.000/mm3)
* Previous known coagulopathy
* Anticoagulation therapy
* Those unable to receive blood transfusion
* Patients who refused participation in the study