cyrilzakka/clinical-trials huggingface dataset:
Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinson's Disease

OBJECTIVES: I. Determine the efficacy and tolerability of clozapine in ameliorating psychosis in patients with idiopathic Parkinson's disease (PD).

II. Determine the adverse effects of clozapine on motor function in this patient population.

III. Determine the safety of clozapine in psychotic PD patients taking multiple anti-PD medications.

IV. Describe the phenomenology of drug induced psychosis in PD.

PROTOCOL OUTLINE: This is a randomized, placebo controlled, double blind study, followed by an open label treatment of all patients. Patients are stratified according to the institutional investigator and age.

In the first phase of the study, patients receive either clozapine or placebo. The drug is taken orally at night, approximately 30 minutes before retiring. Therapy continues for 4 weeks unless psychosis becomes unmanageable without hospitalization, parkinsonism worsens, or other adverse effects occur. It is possible that the dose may be escalated.

In the second phase of the study, all patients are treated with open label clozapine. Therapy continues for 3 months unless psychiatric status or parkinsonism progress. Dose escalation is also possible during this phase.

Patients are followed weekly during the first phase of the study, and monthly during the second phase.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Presumed idiopathic Parkinson's disease Presence of three of the cardinal features: Rest tremor Rigidity Bradykinesias/akinesia Postural and balance abnormalities Absence of alternative explanations for the syndrome Absence of atypical features Psychosis of at least 4 weeks duration requiring treatment --Prior/Concurrent Therapy-- Chemotherapy: No concurrent chemotherapy Other: No use of any dopamine blocking drug within the past 3 months No use of depot neuroleptic within the past 12 months No change of antidepressant or anxiolytic dose within the past 1 month No prior clozapine for psychosis Anti-PD medications stable for at least 7 days before study entry --Patient Characteristics-- Hematopoietic: No history of leukopenia No active blood dyscrasia other than mild anemia Renal: No active problems with urinary retention Cardiovascular: No symptomatic orthostatic hypotension No uncontrolled angina No myocardial infarction within the past 3 months Other: Fertile patients must use effective contraception No uncontrolled seizures (i.e., 1 or more seizures per month over the past 6 months) No dementia precluding accurate assessment on psychiatric assessment battery No AIDS No other illness that would make use of clozapine potentially hazardous No narrow angle glaucoma No systemic factor contributing to the psychosis (e.g., urinary infection, liver disease, renal failure, anemia, infection, etc.)
OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis

This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 \& 4)
* Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)
* Life expectancy \> 10 months

Exclusion Criteria:

* Malignant disease
* Significant or acute bleeding
* Poorly controlled hypertension
* Blood transfusion during the previous 2 months
* Hypersensitivity to Mircera or any of its excipients
Smoking and Ventricular Repolarization

Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.

Non-user or chronic electronic cigarette (EC) users will use an EC or control on three occasions:1) EC with nicotine, 2) EC without nicotine, 3) empty EC (control).

Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw (control). The electrocardiogram will be recorded before and after acute exposures and analyzed for parameters representative of ventricular repolarization.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)

Exclusion Criteria:

* Cardiac disease, respiratory disease, diabetes
Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies

The investigators aim to examine the impact of changes in plasma lipoproteins induced by nutritional and pharmacological interventions on glucose homeostasis


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* both males and females

Exclusion Criteria:

* acute or chronic conditions influencing glucose and lipid metabolism
* pregnancy
An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

The phase II study of inactivated vaccine (vero cell) against EV71 has completed on Dec 2011 in China. The data from the phase I and II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. In order to evaluate the efficacy of the vaccine against Hand, Foot and Mouth disease caused by EV71, and to further explore the safety profile of this vaccine in expending infant population, a phase III clinical trial is planed to conduct.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
* Provided legal identification for the sake of recruitment
* Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents

Exclusion Criteria:

* History of Hand-foot-mouth Disease
* Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
* Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
* Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
* Epilepsy, seizures or convulsions history, or family history of mental illness
* Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
* History of asthma, angioedema, diabetes or malignancy
* History of thyroidectomy or thyroid disease that required medication within the past 12 months
* Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
* Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
* Acute illness or acute exacerbation of chronic disease within the past 7 days
* Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
* History of any blood products within 3 months
* Administration of any live attenuated vaccine within 14 days
* Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 days
* Axillary temperature \> 37.0 centigrade before vaccination
* Abnormal laboratory parameters before vaccination
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer

This clinical trial studies nanoscale artificial nose (NA-NOSE) in monitoring response and detecting recurrence after surgery or radiation therapy in patients with stage I or stage II non-small cell lung cancer (NSCLC). Using the NA-NOSE breath test may be an effective way to monitor response and detect recurrence of NSCLC after surgery or radiation therapy.

PRIMARY OBJECTIVES:

I. Determine if a suitable fraction of patients become NA-NOSE negative within three years post treatment. We will test the hypothesis that this fraction is at most 30% versus the alternative that it is at least 50%.

SECONDARY OBJECTIVES:

I. Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE positive prior to clinical recurrence.

II. Estimate the time post treatment needed to become NA-NOSE negative. III. Estimate the lead time gained between a negative to positive NA-NOSE transition and clinical recurrence.

OUTLINE:

Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2 pre-treatment samples), and post treatment samples at regularly scheduled follow up visits, for 2 years in the absence of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients must either have histologic or pathologically confirmed non-small cell lung cancer (NSCLC) or suspicious nodules/lesions which are going to be surgically resected before they are pathologically confirmed
* Patients must have stage I or II disease based on the parameters for staging NSCLC found in the American Joint Committee on Cancer (AJCC) cancer staging handbook seventh edition
* Patients must be deemed to be eligible candidates for either surgery or stereotactic radiation
* Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is allowed at the discretion of treating physician for the participating subject
* Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Ability to travel to appointments and willingness to participate in this study
* Ability to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form

Exclusion Criteria:

* Patients who have had a prior lung cancer within the last five years from the current diagnosis
* Patients having a prior malignancy within the past 3 years other than resected of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy
* Patients with any prior systemic therapy for the current diagnosis of lung cancer
* Patients with a diagnosis of advanced stage disease (stage III or IV)
* Patients who are unable to comply with study and/or follow up procedures
* Patients who have uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements
* Patients who are pregnant or are breast feeding
Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache

The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.


Eligibility Criteria:
Inclusion Criteria:

* Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)

Exclusion Criteria:

* Other primary or secondary headaches.
* Any serious systemic or neurological disease or psychiatric disorder.
* Pregnancy or breastfeeding
* Previous or current use of other or similar devices for pain control
* Heart conduction and rhythm disorders
* Cranial surgery
* Other pain conditions, accordingly with current guidelines
SFI Bars and Milled Bars Supporting Mandibular Overdentures. Three-year Randomized Clinical Trial

The aim of this study will be to evaluate the marginal bone loss and prosthetic complications of stress-free implant (SFI) and milled bars used to assist mandibular 4-implant overdentures after 3 years

Eight edentulous participants with insufficient stability of mandibular dentures will receive 4 implants in the mandibular ridge (2 implants in the canine areas and 2 implants in the first molar areas), and then after 3 months, patients will be randomly assigned into 2 groups; 1) group 1: will include 4 participants who will receive milled bar overdentures, and 2) group 2: will include 4 participants who will receive SFI bar overdentures. For both groups, marginal bone loss will be evaluated using the standardized digital periapical films at the time of insertion, 6 months, 1 year, and 3 years after insertion. Prosthetic and mucosal complications will be evaluated after 3 years.

Eligibility Criteria:
Inclusion Criteria:

* mandibular edentulous ridge

Exclusion Criteria:

* severe atrophy in mandibular ridge
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy

The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decreases infectious complications when compared to pre-operative antibiotics alone, in patients undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).

There is currently no evidence-based standard for the extended use of prophylactic antibiotics in patients receiving thoracic surgery that results in the placement of a tube thoracostomy (chest tube). The rationale for this prophylaxis is that antibiotics directed at typical skin flora may reduce the rate of infectious complications, such as surgical site infection and empyema.

Currently, clinicians' approach to post-operative antibiotic prophylaxis in patients undergoing tube thoracostomy associated with thoracic and cardio-thoracic surgery varies widely. While reducing the infectious complications of thoracic surgery is an important goal, it is also important to reduce the use of unnecessary antibiotics. As there is equipoise on the benefit of extended antibiotic prophylaxis for tube thoracostomy, our study will examine two prevailing clinical practices and attempt to determine if one leads to better patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older undergoing elective thoracic surgery at Brigham \& Women's Hospital. The majority of these patients will be undergoing lung resection for either the evaluation of a lung mass, or for the removal of a known malignancy. Some participants may be undergoing biopsy or removal of a mediastinal mass.
* Undergoing thoracic surgery procedure expected to require tube thoracostomy.
* Ability to give informed consent

Exclusion Criteria:

* Patients undergoing the following complex thoracic surgical procedures:

  * Pneumonectomy
  * Decortication
  * Chemical pleurodesis
  * Pleurectomy
  * Lung volume reduction
  * Esophagectomy
* Patients with the following conditions:

  * Prior diagnosis of empyema or lung abscess.
  * Cystic fibrosis
  * Known or suspected pneumonia pre-operatively.
  * Known hypersensitivity to beta-lactam antibiotics and vancomycin
  * Current or recent antibiotic use within one week of surgery.
  * Anticipated requirement for postoperative antibiotic in addition to 48 hours of cefazolin or vancomycin.
  * Renal insufficiency with estimated creatinine clearance \<60 ml/minute.
Dyspnea and Cardiotoxicity in Multiple Myeloma Patients Who Receive Carfilzomib

This study will explore why some multiple myeloma patients who receive carfilzomib (an anti-cancer medication) experience shortness of breath while others do not. The purpose of this research is to gather information on the effectiveness of the EndoPAT device, which is FDA-approved to assess the health of a patient's blood vessels. These assessments will help doctors leading the study determine the reasons why patients may develop shortness of breath (dyspnea) when being treated with carfilzomib and ways to better prevent this shortness of breath.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Confirmed diagnosis of multiple myeloma
* Newly-diagnosed multiple myeloma, or relapsed/refractory multiple myeloma with receipt of 1-3 previous lines of therapy and with a 2-week washout from prior therapy
* Receiving carfilzomib as either standard-of-care therapy or as part of a clinical trial

Exclusion Criteria:

* Previous receipt of anthracycline chemotherapy
* Previous receipt of carfilzomib
* Four or more previous lines of therapy
* Active pregnancy at the time of enrollment
Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy

Eighty two patients planned to undergo elective laparoscopic cholecystectomy were divided into two groups, T and G, randomly. In Group T all patients underwent laparoscopic cholecystectomy under thoracic epidural anesthesia with 12mlof 0.25% bupivacaine and 1% lignocaine plain whereas in group G all patients underwent surgery under general anesthesia. Intra-operative heart rate, mean arterial pressure (MAP) and post operative opioid consumption in first 24hrs were recorded as primary outcomes whereas presence or absence of respiratory complication and duration of hospital stay as secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

1. patients having ASA statusI-III
2. age more than 18 years,
3. both genders
4. planned to undergo laparoscopic cholecystectomy

Exclusion Criteria:

1. Patients who did not give consent,
2. Allergic to local anesthetic
3. Hemodynamically unstable,
4. Pregnant, full stomach patients
Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange

Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications. However, data about the correlation of fibrinogen blood levels and function of the coagulation system during plasma exchange therapy is scarce. In the present study we examine blood fibrinogen levels and coagulation factors as well as thrombin clotting time in patients under plasma exchange therapy.


Eligibility Criteria:
Inclusion Criteria:

* plasma exchange therapy due to humoral rejection after kidney transplantation

Exclusion Criteria:

* hereditary coagulopathy
* chronic liver disease (Child C)
* therapeutic anticoagulation
* malnutrition (BMI\<17.5)
Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression

The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old;
* DSM-IV diagnosis of Major depression disorder of psychiatrists;
* More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments;
* Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode;
* HAMD-17≥20;
* GAF≤50；
* Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria:

* Obvious medical and psychiatric comorbidities;
* Alcohol or substance abuse/dependence within 12 months;
* Antisocial personality disorder, dementia, current tic disorder;
* Subject has a history of 2 or more suicide attempts \< 12 months prior to the screening testing;
* Pregnancy and/or lactation;
* There are contraindications for DBS surgery and chronic stimulation.
Effect of Hydration Guided by Vigileo on the Prevention of CIN After PCI for Patients With AMI

In this study, Vigileo is used to guide hydration adjustment, and SCr is used to estimate renal function. The aim of the study is to investigate the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy in patients with acute myocardial infarction who undergo PCI.

This study was conducted in patients with acute myocardial infarction who undergo emergency PCI in Chinese PLA General Hospital. The patients were randomly divided into two groups: the adequate hydration group guided by Vigileo and control group. For the adequate hydration group guided by Vigileo, Vigileo equipment is used to perform hemodynamic monitoring through the femoral or radial arteries to obtain relevant hemodynamic parameters (CO, SV, SVV), and the fluid-rehydration velocity of normal saline is adjusted according to the hemodynamic parameters, and the hydration also lasts 24 hours after operation. For the control group, the routine hydration regimen is adopted, perioperative saline ≤500 ml hydration. The changes of renal function (serum creatinine, serum cystatin), symptoms and signs of cardiac insufficiency during perioperative period and cardiac objective indexes are observed. The incidence of postoperative acute pulmonary edema is recorded, and the major cardiovascular events and hemodialysis events are followed up for 6 months. By comparing the perioperative indexes of heart and kidney function between the intervention group and the control group, the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy after PCI was clarified.

Eligibility Criteria:
Inclusion Criteria:

* Clearly diagnosed STEMI or NSTEMI patients:
* Patients aged 18-80 years
* Patients are scheduled to undergo emergency percutaneous coronary interventions
* Estimated glomerular filtration rate eGFR \<120ml / min (according to MDRD formula)
* Sign the informed consent to join the group.

Exclusion Criteria:

* Patients with mechanical complications
* Patients with cardiogenic shock
* Patients with aortic dissection
* Patients who have malignant tumors or short-term progressive diseases that researchers believe improper to be included in the group
* Hemodialysis-dependent patients with end-stage renal failure
* Patients who had a history of exposure to radioactive contrast media within 1 week before or 72 hours after direct PCI
* Patients who are allergic to radioactive contrast agents
* Patients diagnosed with right ventricular myocardial infarction with hypotension (defined as systolic blood pressure ≤90 mmHg) on admission.