cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression

This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.

The primary objective of this pilot study is to evaluate the safety of venlafaxine extended release formulation (XR) in the treatment of geriatric non-psychotic depression. This pilot study's specific aims are to assess the safety of venlafaxine XR in the geriatric population, to estimate the response rate of older depressed subjects treated under open conditions and to evaluate pharmacokinetic characteristics that may impact on safety and outcome.

Eligibility Criteria:
Inclusion Criteria:

* men and women of all races who are 60 years old or older;
* a DSM-IV diagnosis of major depressive episode without psychotic features;
* 17-item Ham-D score of \>15 for potential subjects who have not received any antidepressant treatment during this illness episode or HAM-D \> 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-XR) during this illness episode;
* a MMSE score of \>15.

Exclusion Criteria:

* history of meeting DSM-IV criteria for mania, schizophrenia or other psychotic disorder;
* history of substance abuse or dependence, including alcohol, within the last three months;
* current hyponatremia (as defined as a serum sodium level \< 130 meq/l);
* untreated or uncontrolled hypertension;
* a history of being unable to tolerate venlafaxine-XR or venlafaxine immediate release formulation;
* history of receiving venlafaxine-XR or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) EKG revealing QTc \> 480 msec;
* myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
* the presence of active suicidal ideation with intent.
DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess

The purpose of this study is to evaluate of the clinical efficacy and safety of DLAAG protocol in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome with blast excess


Eligibility Criteria:
Inclusion Criteria:

1. corresponding to the AML (except M3) or high-risk MDS diagnostic criteria, with any of the following circumstances:

   ①secondary AML patients (including AML secondary to MDS)

   ②corresponding to refractory AML diagnostic standard ( relapsed refractory acute myeloid leukemia Chinese guidelines(2017 Edition): Refractory AML diagnostic criteria: invalid after standard treatment 2 cycles of untreated cases; consolidation therapy after CR and then recurrence within 12 months; recurrence after 12 months and then invalid after conventional chemotherapy ; relapse of ≥ 2 times ; extramedullary leukemia continued existence.

   ③corresponding to recurrent AML diagnostic criteria (relapsed refractory acute myeloid leukemia China guidelines (2017 Edition): peripheral blood leukemia cells or bone marrow progenitor cells appear again \> 0.050 after CR (with the exception of bone marrow regeneration after consolidation chemotherapy and other reasons) or leukemia cells infiltration appear in extramedullary

   ④corresponding to MDS refractory anemia with blasts excess (RAEB) diagnosis standards
2. Age ≥18 years old
3. Eastern Cooperative Oncology Group(ECOG) score 0-3
4. Expected survival ≥8 weeks
5. Patients must be able to understand and be willing to participate in this study, and signed informed consent

Exclusion Criteria:

1. acute promyelocytic leukemia (M3 type)
2. Other types of MDS patients except RAEB
3. with other advanced malignant tumors
4. patients with uncontrolled severe infection, and can not tolerate chemotherapy with other serious underlying diseases
5. patients with heart failure: ejection fraction (EF) \< 30%, New York Heart Association(NYHA) standard, cardiac insufficiency in class II or above
Graded TTCE for Post-Embolization PAVM Monitoring

Current HHT guidelines recommend CT scan to detect new or recurrent PAVMs after embolotherapy. Recent studies using transthoracic contrast echocardiography (TTCE) shunt grade for PAVM screening suggest that graded TTCE can accurately predict the size of PAVMs on chest CT and their amenability to embolization. This study's purpose is to evaluate whether TTCE shunt grade can also accurately predict PAVM size and amenability to treatment in patients who are post-embolization.

Embolization is the standard of care for pulmonary arteriovenous malformations (PAVMs) in the Hereditary Hemorrhagic Telangiectasia (HHT) population. PAVMs are abnormal connections between the veins and arteries and result in right-to-left shunting of blood within the lungs. Successful embolization results in PAVM resolution and decreases the complications associated with right-to-left shunting. Current guidelines recommend follow-up with interval chest CT scan to determine treatment success and detect new or recurrent PAVMs after embolization. This results in significant radiation exposure to the relatively young HHT population. An alternative to chest CT is graded transthoracic contrast echocardiography (TTCE), which measures the amount of right-to-left shunting within the lung and assigns a grade based on this amount. TTCE has the advantage of being radiation free compared to chest CT. To date, graded TTCE has only been studied as a screening tool for PAVMs. These studies have shown that graded TTCE is highly sensitive in detecting PAVMs and is comparable to chest CT when screening for PAVMs. Results indicate that TTCE grade can accurately predict PAVM size on chest CT and predict whether PAVMs are amenable to embolization. However, no studies have compared graded TTCE and chest CT in patients who are post-embolization and it is therefore unknown whether graded TTCE can be used in patients who have undergone PAVM embolization. The current study seeks to correlate post-embolization TTCE grade with chest CT findings to determine whether TTCE can accurately predict PAVM size and amenability to treatment in the post-embolization population.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-89 years old
* Diagnosis of Hereditary Hemorrhagic Telangiectasia by the Curacao criteria
* Prior diagnosis of one or more PAVMs treated by embolotherapy
* Chest CT performed within the Penn system for surveillance of PAVMs after \\ embolotherapy

Exclusion Criteria:

* Known PAVM recurrence on most recent chest CT with feeding artery size amenable to repeat embolotherapy
* Known history of intracardiac shunt
* Discovery of intracardiac shunt during transthoracic contrast echocardiography
Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.

Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 or older
* Subject is willing and able to provide written consent

Exclusion Criteria:

* Severe contact allergies to standard adhesive materials
* Subjects with abnormalities that may prevent proper application of the device
* Women who are pregnant or lactating
* Subjects with significant Arrhythmias
A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy volunteers.
* Able to swallow pills.

Exclusion Criteria:

* Personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or GERD/reflux.
* History of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss.
* Celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection.
* Gelatin allergy.
* Use of a toothpaste containing SLS within 2 weeks of the study.
* Pregnancy.
Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study

This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. The hypothesis to be tested is that an increased number of circulating mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune process in islets causing progressive beta-cell death.


Eligibility Criteria:
Inclusion Criteria:

* fasting C-peptide \>0.12 nmol/l
* within three weeks of diagnosis of type 1 diabetes

Exclusion Criteria:

* body mass index (BMI) \>30
* unstable cardiovascular status incl. New York Heart Association (NYHA) class III/IV
* patients with known or previous malignancy
* active infections incl. serological evidence of infection with HIV, Treponema pallidum, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
* immune suppressive treatment
* women being pregnant or nursing, or women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

Upon determination of eligibility, patients will be receive:

* Pemetrexed + Gemcitabine

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologically confirmed non-small cell bronchogenic carcinoma
* Newly diagnosed or recurrent unresectable stage III or stage IV disease
* No mixed tumors with small cell anaplastic elements
* Measurable disease
* Must not have received any prior antineoplastic chemotherapy for lung cancer
* Age \> 18 years
* Able to perform activities of daily living with little or no assistance
* Adequate bone marrow, liver and kidney
* Understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Female patients who are pregnant or are lactating
* History of serious cardiovascular disease within the previous six months
* Serious active infection at the time of treatment
* Other serious underlying medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease

Parkinson's disease is a chronic progressive neurological disorder. Symptoms are tremor, slowness in movement, rigidity and postural instability. As the disease progresses and treatment with L-dopa is no longer sufficient, some patients may be treated with deep brain stimulation.

When treated with deep brain stimulation, electrodes are inserted in the affected area of the brain and through stimulation, motor symptoms of Parkinson's disease are significantly reduced.

During the first year of DBS treatment patients and spouses may experience changes in everyday life and illness trajectory posing new opportunities as well as new challenges.

The purpose of the study is to develop an individualised and targeted nursing program to support patients and relatives manage changes and challenges in life the first three months after Deep Brain Stimulation. The intervention is expected to generate important knowledge that will serve as a foundation for the further development of a future nursing program.

The intervention is designed as a psychosocial intervention, targeted both patients and spouses.

The intervention consists of individually targeted meetings with a specialized DBS nurse several times during the first six months og DBS. Patients and spouses likewise have to fill out a diary for use in the meetings.

All meetings have specific topics, addressing aspects of challenges in adjusting to DBS, and the aim is to off patients and spouses a tailored intervention, supporting each individual based on an individual assessment.

Eligibility Criteria:
Inclusion Criteria:

* eligible and offered treatment with DBS for PD
* married or cohabitant

Exclusion Criteria:

* living alone
Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial

Results after interventions on lifestyle in the secondary prevention of ischemic heart disease are not always consistent, and the Guidelines multidisciplinary measures aren't easily achievable.

Therefore, the purpose of this research project is the identification of an interventional approach to effective secondary prevention and realistic feasibility, in a field of multifactorial risk. The study is open to patients who totaled a double chronic disease, obesity/overweight and coronary heart disease, and who experienced a first event of ischemic cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational intervention in a sample of overweight and obese patients (BMI \> 24.9) incurred in a first episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic approach of prescriptive diet therapy.


Eligibility Criteria:
Inclusion Criteria:

Subjects of both sexes and age ≥ of 18 years consecutively admitted to the Coronary Unit of IRCCS Foundation Policlinico S. Matteo, at first episode of STEMI or non-STEMI AMI, with BMI greater than 24.9.

Exclusion Criteria:

Patients who can not provide informed consent (because illiterate or with significant language barrier or severe deficit/cognitive decays). Subjects with diseases and/or disabling organ damage. Subjects affected by active neoplasm. Individuals who have submitted arhythmic complications in acute and/or heart failure, or people referring to post-AMI residential rehabilitation. Subjects that are carriers of severe psychiatric disorders diagnosed by DSM-V -TR.
Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

To verify the association between respiratory system mechanical properties (ΔP, ΔPL,dyn, Pmus, Pplat and CRS and CL,dyn) assessed during assisted modes of ventilation (as average over the first three days since enrollment) and ICU mortality.


Eligibility Criteria:
Inclusion Criteria:

* Acute Hypoxaemic Respiratory Failure (defined as respiratory failure requiring invasive mechanical ventilation with a PaO2/FiO2\< 300 mmHg) during the course of ICU stay (including ARDS).
* Invasive mechanical ventilation in one of these modes: Pressure A/C, PRVC, SIMV PC, PSV, NAVA, PAV+, BiPAP
* Presence of spontaneous breathing activity (ventilator triggering), since 6 hours and no longer than 48 hours
* Patient for full active management at this point.

Exclusion Criteria:

* Age \<18 years old
* Pregnancy
* Active air leaks
* Moribund state
* High ICP
* Patient has passed a spontaneous breathing trial (if performed for clinical indication)
* Known COPD with history of home oxygen therapy and/or non invasive ventilation and/or GOLD III-IV. Non invasive ventilation for sleep apnea is NOT an exclusion criteria.
Dose for Deep Neuromuscular Blockade Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade

Find out the deciding factor(total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) of neuromuscular blocker dose for deep neuromuscular blockade.

Before the surgery, total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index were measured by height and weight and skeletal muscle mass and body fat were measured by Bioelectrical impedance analysis (InbodyH20N). Find the highest correlation between the 8 factors (total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) and the amount of rocuronium administered to deep neuromuscular blockade.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia

Exclusion Criteria:

* kidney disease (GFR\<60)
* allergy to study drugs
* decline participation
* side effect of propofol and remifentanil
* when anesthesia does not maintain the level of alertness (BIS) below 60 even when the anesthetic dose is increased, or when hemodynamic instability such as bradycardia and hypotension appears
SpyGlass Surgical Study

* To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study

This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:

* Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy
* Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy
* Treatment of hepatolithiasis
* Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses
* Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy
* Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy

Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* Written informed consent from patient or legally authorized representative of the patient

Exclusion Criteria:

* Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* \<18 years of age
* Potentially vulnerable subjects, including, but not limited to pregnant women
A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-\[18F\]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form(s)
* Histologically confirmed NSCLC
* Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Age ≥ 18 years
* Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy, radiotherapy, or investigational treatment) to NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 (excluding alopecia)
* Ability to comply with the study and follow-up procedures, including all specified imaging studies
* Ability to take oral medication
* Availability of archival diagnostic paraffin-embedded tumor tissue and willingness to provide sufficient tissue for testing for EGFR levels in tumor by both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)
* Life expectancy ≥ 3 months
* Measurable disease on computed tomography (CT)
* At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT
* Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility

Exclusion Criteria:

* Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib)
* Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered
* Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption
* Uncontrolled diabetes
* Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease)
* Pregnancy or lactation
* History of another malignancy in the past 2 years, unless the malignancy has been adequately treated, is currently not detectable, and is associated with a 5-year survival \> 90%
* Claustrophobia
* Any other disease, condition, physical examination finding, or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study