cyrilzakka/clinical-trials huggingface dataset:
Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome negative transpulmonary pressure; or adjusted by use of "CStat" to achieve the best effective static compliance will have any effect on outcomes with respect to ventilator weaning in tracheotomized morbidly obese patients (BMI \>=40) with at least one failed prior weaning attempt.

Tracheotomized morbidly obese patients (BMI \>= 40) who had failed an initial attempt at ventilator weaning (defined in the investigators study as ventilator dependent) were randomly assigned to one of two methods for setting Positive End Expiratory Pressure (PEEP).

Patients randomized to the esophageal balloon arm (ESO group) had their PEEP adjusted to overcome negative transpulmonary pressure and maintain a positive transpulmonary pressure (Ptp) of 0 to 10 cm H20 - targeting as close to zero as possible.

Patients randomized to the static effective compliance arm (CStat group) had their PEEP adjusted to achieve the best static effective compliance as automatically calculated and displayed on the graphic interphase of the hamilton G5 or Galileo ventilator. For this group, the PEEP was adjusted in increments of 3 cm H20 until there was a less than 5% observed improvement in the static effective compliance. the PEEP with the best Cstat was chosen.

At the end of the intervention period, this intervention cohort (termed "PEEP intervention cohort") will be compared to a group of historical controls to compare the efficiency of a PEEP-based weaning protocol to traditional weaning methods.

The investigators hypothesized that PEEP levels titrated by use of an esophageal balloon to maintain a positive transpulmonary pressure between 0 to 10 cm H20, would lead to improved outcomes with respect to ventilator weaning in this subset of patients.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients with BMI of 40 or greater
* Ventilator dependent patients (defined as at least one prior failure at weaning)
* Tracheotomized
* No active underlying lung disease that would preclude ventilator weaning
* Stable hemodynamics
* Patient/ family able to give consent
* No naso-facial abnormalities that would interfere with placement of an esophageal balloon
* Fio2 \<= 60%
* Patient able to tolerate Pressure Support ventilation

Exclusion Criteria:

* Lack of consent
* Patient deemed not weanable from mechanical ventilation as per the clinical judgement of the pulmonary physician
* Significant lung, heart or neuromuscular disease that would interfere with or preclude ventilator weaning, including an active ongoing lung infection.
* Contraindications to placement of an esophageal pressure monitoring device - such as ulcerations, tumors, diverticulitis, uncontrolled bleeding varices, sinusitis, epistaxis or recent nasopharyngeal surgery
Effect of Adipokines in Hemodialysis Patients

This is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight or obese, diabetic and non-diabetic hemodialysis patients. This study will examine whether pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and whether these changes result in reduction of inflammation, insulin resistance and oxidative stress and increase in muscle mass.

In addition, this study will also examine the associations of adiposity with adipokines and the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes in uremic milieu.

Randomization:

100 overweight or obese patients will be randomly allocated to oral pioglitazone 15 mg/d or placebo for two weeks by blocks of five using a random number generator and monitored for adverse events including hypoglycemia. If they tolerate the 15 mg pioglitazone or matching placebo for two weeks, participants will be assigned to 30 mg of pioglitazone or matching placebo for 24 more weeks. Those who received 15 mg of pioglitazone will receive 30 mg of pioglitazone for the next 24 weeks. Those who received placebo for initial 2 weeks will receive another placebo that matches the 30 mg pioglitazone pill for 24 weeks.

Baseline:

Participants will have fasting blood drawn for adipokines: Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin-6 (IL-6), high sensitivity C-Reactive Protein (hsCRP), high molecular weight Adiponectin (HMW-A), and leptin. All patients will undergo MRI scans on the mid-week non-dialysis day. Twenty each of overweight/obese patients randomized to pioglitazone or placebo will also undergo subcutaneous fat biopsy on the mid-week non-dialysis day.

Study Period:

Participants will return to the dialysis unit at weeks 2, 4, 6, 10, 14, 18, 22, and 26. During these visits, clinical assessments will be conducted including review of blood sugars, jaundice, weight gain, and visual symptoms. Study treatment compliance will be assessed and details of adverse events experienced, particularly hospitalizations and emergency department visits will be collected. Fasting blood draws for primary and secondary outcomes will be collected on visit weeks 10 and 26.

Eligibility Criteria:
Inclusion Criteria:

* Overweight (Body Mass Index ≥ 25 kilograms per meter squared (kg/m2))
* Adult (18 years or older)
* Chronic hemodialysis patient
* Diabetic (type 2) or insulin resistant

Exclusion Criteria:

* \<18 years old
* No insulin resistance
* Active liver disease
* Class III or IV New York Heart Association heart failure
* Macular edema or hard exudates near macula on fundoscopy
* Current active malignancy (excluding squamous and basal cell skin cancers)
* Active AIDS
* Chronic lung disease requiring supplemental oxygen therapy
* Enrolled in interventional trials using drugs or devices
* Bone break of long bones, vertebrae, or hips in the past three years
Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy

This is a multi-center, randomized and controlled phase 3 clinical trial.

Subjects who have signed the written informed consent form and who were eligible for enrollment after screening will be randomly assigned to the treatment group or untreated control group. Each Participant in the treatment group will receive a unilateral subretinal injection of ZVS101e in the study eye.

Participants in the control group will receive no treatment during the first 52 weeks of enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. All of the following inclusion criteria should be met for enrollment into the trial:
2. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the informed consent form, and be able to complete all trial procedures as required by the protocol;
3. Clinical diagnosis of Bietti's crystalline dystrophy (BCD), age≥18 years ;
4. Genetic testing confirmed biallelic CYP4V2 mutations without other ophthalmic genetic diseases;
5. Best-corrected visual acuity of 5-60 ETDRS letters.

Exclusion Criteria:

1. The study eye has or has had macular lesions such as macular hole or macular neovascularization; glaucoma, diabetic retinopathy, or any other ocular disease that may preclude surgery or interfere with interpretation of the study endpoints
2. The study eye had received the following intraocular surgical treatments: retinal reattachment, vitrectomy;
3. The study eye had received any intraocular surgery, such as phacoemulsification 3 months prior to enrollment;
4. Previously treatment of either eye with gene therapy or stem cell therapy for BCD and other ocular diseases, including but not limited to viral vector gene therapy, RNA therapy;
5. Pregnant or lactating women;
Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet

The goal of this clinical trial is to compare open carpal tunnel release using local anesthesia with or without a tourniquet. The main questions it aims to answer are:

1. Do the tourniquet cause more procedural pain?
2. Does the use of tourniquet affect the outcome after the procedure? Participants will be randomized to either local anesthesia with a tourniquet or local anesthesia with adrenaline, and undrgo standard open carpal tunnel release.


Eligibility Criteria:
Inclusion Criteria:

* Primary idiopathic CTS
* Age 18 or older
* Symptoms of classic or probable carpal tunnel syndrome according to Katz hand diagram
* No previous wide awake hand surgical procedures under local anesthesia
* No planned concomitant procedures

Exclusion Criteria:

* Recurrent carpal tunnel syndrome
* Vibration induced neuropathy
* Polyneuropathy
* Cognitive impairment
* Anxiety disorder
* Swedish language insufficiency
* Active substance abuse
* Allergy to local anesthesia or adrenaline
* Patient refusal to participate
Adjusted Calculation of Heparin and Protamin Dosing and Correlation With Postoperative Bleeding and Transfusions

The study will compare a novel calculation model (HeProCalc AB) with a standard weight-based and activated clotting time adjusted calculation for the dosing of Heparin and protamine and assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.

During cardiac surgery with cardiopulmonary bypass (CPB), efficient anticoagulation is required in order to avoid microscopic clot formation or, in worst case, massive lift threatening thrombus formation. Heparin is by far the most common drug used to prevent blood from coagulating during CPB. Activated clotting time (ACT) is a point-of-care test of fibrin clotting time that has to be well prolonged to initiate safe CPB.

Following weaning from CPB, heparin is reversed by protamine. Administration of excess doses of protamine may have a deleterious effect on coagulation and contribute to postoperative bleeding with need of blood transfusions. In connection with CPB management, heparin and protamin doses are commonly calculated using body weight and ACT. However, a new Heparin-Protamin-Calculation computer program (HeProCalc) has been developed to provide patient titrated dosing of both heparin and protamin. However, any benefits regarding postoperative bleeding and transfusions has not been thoroughly investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery with the use of cardiopulmonary bypass
* Indication and planned use of heparin and protamine

Exclusion Criteria:

* Inability to leave informed consent or understanding the outline of the study
* Known coagulation disorder
Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with Qishenyiqi dripping pills; The control group was given placebo treatment. After 12 months of follow-up, the effects of Qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* 1) The history of acute myocardial infarction exceeds 3 months;
* 2) Symptoms and signs of heart failure have been stable for more than one month;
* 3) 18 years old or more;
* 4) NYHA cardiac function classified as grade II\~IV;
* 5) LVEF≤40%；
* 6) NT-proBNP≥450pg/ml；
* 7) All subjects or their guardians must sign the subject consent before entering the trial.

Exclusion Criteria:

* 1) Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
* 2) Planned to undergo cardiac surgery within 12 months;
* 3) Mechanical complications of myocardial infarction;
* 4) Pregnant or nursing, or having the intention to give birth within one year;
* 5) Patients who participated in clinical research of other drugs within 3 months before being selected;
* 6) Patients with poor sound transmission windows are examined by transthoracic ultrasound.
Effectiveness of Behavioral Activation Treatment for Schizophrenia

The purpose of this study is to implement a behavior activation remote program for negative symptoms of schizophrenia and to verify whether the behavior activation remote program for negative symptoms of schizophrenia has effects on negative symptoms, cognitive function, and social function of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received a primary diagnosis of schizophrenia
* Patients who are at least 18 years old and under 65 years old
* Patients who show a score of 3 or higher on at least two negative symptom items in the Positive and Negative Syndrome Scale (PANSS)
* The subject selection period is until December 31, 2021, from the IRB approval date.

Exclusion Criteria:

* Patients with a history of organic brain syndrome, epilepsy, or traumatic brain injury
* Patients with comorbidities such as intellectual disability, current alcohol or other substance dependence
* Patients who show a score of 5 or higher on at least two positive symptom items in the Positive and Negative Syndrome Scale (PANSS)
* Patients who have received a diagnosis of major depressive disorder according to the DSM-V criteria by a specialist in psychiatry
* Patients who have received psychological services including components of behavioral activation therapy
* Patients who are at risk of self-harm or harm to others.
Cognitive Computer Training in Patients With Depression

Cognitive impairment plays an important role in functional recovery and leads to long-term sickness absence. Therefore there is a need of a treatment specifically improving cognitive functions. In this pilot study the investigators aim to evaluate the feasibility of using cognitive computer training in patients with unipolar depression to enhance cognitive performance. Further the investigators investigate whether this intervention shortens sick leave.

This study will evaluate cognitive computer training on patients in remission from depression by measuring the compliance and effect, investigating whether patients returned earlier to work and examine patients' physical and psychological health. This is done by comparing an intervention group and a control group.

Outpatients from psychiatric department Odense in Denmark will be recruited from December 2015 to July 2017.

At enrolment the participants wil be randomized 1:1 to either the intervention group or the control group. After the participants will complete a clinical interview and answer the The Short Form (36) Health Survey (SF-36) questionnaire. The participants' cognitive function and depression severity will be measured at baseline and three months follow-up. At nine months follow-up the participants will receive an email with the SF-36 questionnaire and questions about their education and work status, which they were required to answer.

The intervention is a cognitive computer program, consisting of different computer games. The intervention will start at enrolment and finish at the three months follow-up. The participants in the intervention group will do trainings session lasting 10-20 minutes three times a week. Each participant ends up with a total of 36 training sessions.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of a moderate to severe unipolar depression according to the International Classification of Diseases -10 criteria
* receiving antidepressant medicine
* completed their treatment for depression
* not be in any risk of suicide
* study or work on reduced hours, be unemployed or on long-term sickness leave at enrolment.

Exclusion Criteria:

* neurological disease of the central nervous system
* alcohol or substance abuse
* pregnancy
* receiving disability pension
* receiving electroconvulsive therapy within the last 6 weeks.
Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke

The purpose of this study is to determine whether pomegranate supplements improve cognitive functioning following stroke.

Research suggests that antioxidants (substances that may slow or prevent cell damage) found in many fruits and vegetables may help improve brain functioning (for example, memory and attention) in healthy individuals and prevent cognitive decline in individuals who have suffered a stroke. The purpose of this research study is to examine whether dietary supplementation with an antioxidant extract can help promote healthy cognitive functioning as a component of recovery after stroke. The procedures include: Administering polyphenols via 2 POMx pills, each of which contains polyphenols derived from pomegranates equivalent to the content of approximately 8 ounces of pomegranate juice, or placebo pills (capsules containing no polyphenol ingredients), every day for one week to inpatients who are in the acute post-stroke phase. Neuropsychological testing pre- and post-treatment will determine whether cognitive functioning changes. Subjects will be randomized into either a placebo or polyphenol group.

Eligibility Criteria:
Inclusion Criteria:

* Suffered an ischemic stroke and admitted to LLUMC Rehabilitation Institute for inpatient care
* Fluent in English
* Between the age of 18 and 89 years old

Exclusion Criteria:

* Less than 6 years of education
* Global aphasia
* Pregnant
* History of allergy to pomegranates
* History of traumatic brain injury
* Neurodegenerative disease or neurologic condition with known cognitive impact (e.g., Alzheimer's disease)
* Active renal disease
* Active liver disease
* Intracerebral hemorrhage in past 6 months
* Neurosurgery in past month
* Taking warfarin (Coumadin)
Prognostication in Acute Pulmonary Embolism

To evaluate the effect of a prognosis-guided vs standard medical therapy in the: 1) duration of hospital stay; 2) cost-effectiveness; 3) satisfaction and quality of life; 4) in-hospital and 30-day all-cause mortality; and 5) 30-day readmissions in normotensive patients with acute symptomatic pulmonary embolism (PE).

Design: Prospective, randomized, controlled, single blind trial. Normotensive patients with acute symptomatic PE will be randomly assigned to follow a prognosis-guided treatment, or to receive usual care.

Setting: Respiratory, Medicine and Emergency Departments in 15 Spanish hospitals.

Analyses: Data for the primary and secondary end points will be analyzed according to the intention-to -treat principle. The intention-to-treat analysis will include all randomly assigned patients. For the efficacy end points, investigators will use the Mann-Whitney U test. We will also use competing risk regression models according to Fine and Gray. For the safety end points, comparisons will be made with the use of the chi-square test. Separate analyses will be done in key prespecified subgroups of patients, according to age and hospital size.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed PE by objective testing
* Signed and dated informed consent of the subject available before the start of any specific trial procedures

Exclusion Criteria:

* Pregnancy
* Haemodynamic instability
* Contraindication to anticoagulant therapy
* Life expectancy less than 3 months
* Participation in other clinical trials during the present clinical trial
* Use of a fibrinolytic agent, surgical thrombectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE
* Inability to the follow-up visits
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
* Adequate renal, hepatic and bone marrow function.
* Performance status 0 or 1.

Exclusion Criteria:

* Prior treatment with any systemic chemotherapy for metastatic disease.
* Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
* Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
* Inability to take oral medication.
NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up

This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment.

Participating centres are located in Denmark, Norway and Sweden.


Eligibility Criteria:
Inclusion Criteria:

* The patient should have been diagnosed with Pulmonary Arterial Hypertension
* The patient has received or will receive treatment with the implanted pump LenusPro

Exclusion Criteria:

* The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice
Study of Food Aversion in Patients With Anorexia Nervosa

This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment strategies.

Anorexia nervosa is a brain-based disorder that often leads to serious health consequences including death. The EPHX2 gene has been identified as a susceptibility gene for anorexia nervosa. This study utilizes a multi-omics biomarker system approach to investigate how genetic factors interact with dietary factors to influence food aversion, psychopathology, and clinical outcome in patients with anorexia nervosa.

Eligibility Criteria:
Inclusion Criteria:

* Ill AN subjects will meet current Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis of AN, body mass index (BMI) between 11 kg/m² and 17.5 kg/m², or BMI \> 17.5 kg/m² with active eating disorder symptoms.
* Recovered AN must meet the following criteria at time of study entry: 1) Current or past DSM V diagnosis of AN; 2) BMI between 18.5 kg/m2 and 30 kg/m2; 3) Having maintained a BMI of \>18.5 for at least one year.
* Control must be healthy adolescent or woman negative on our screen for AN, other Axis I psychiatric illnesses, and having maintained a BMI of between 18.5-30 kg/m² since the age of 18.

Exclusion Criteria:

* Exclusion criteria for AN and control subjects include: Organic brain syndrome, schizophrenia and schizoaffective disorder, untreated thyroid disease, renal disease, hepatic disease, and the regular use of fish-oil containing supplements within the last three months of the study. All pregnant and lactating individuals will be excluded.