cyrilzakka/clinical-trials huggingface dataset:
Removing Transfusion Dependence as a Barrier to Hospice Enrollment

Hospice care at the end of life (EOL) includes a multidisciplinary team that helps patients and families focus on symptom control and quality of life. For patients with "solid" (e.g. lung, breast) cancers it has been shown to improve quality of life for both patients and families. Unfortunately, patients with blood cancers (e.g. leukemia, lymphoma) often delay their enrollment and receive more aggressive care at the EOL. One factor in this delay is the inability for patients to receive blood transfusions while on hospice. Patients with blood cancers often require frequent blood transfusions near the EOL for symptom control. The structure of Medicare hospice benefit makes coverage for transfusions financially unfeasible for hospice agencies, and therefore patients with blood cancers will delay enrollment onto hospice in order to continue to receive blood transfusions.

The objective of this study is to evaluate whether removing this financial burden, through external funding of blood transfusions for patients while on hospice, will encourage patients with blood cancers to enroll on hospice earlier and ultimately improve their and their caregivers EOL care.

The overall objective is to demonstrate the feasibility of providing blood transfusions to patients with HM enrolled on hospice, and to evaluate both EOL care quality outcomes in these patients, and caregiver quality of life and perception of patient EOL care quality. Palliative blood transfusions will be provided to patients on this study free of cost through study funding. The hypothesis is that removing transfusion dependence as a barrier to hospice enrollment for patients with hematologic malignancies will result in improved EOL care quality outcomes. This hypothesis is derived from our previous research demonstrating that for Medicare beneficiaries with HM, transfusion dependence poses a significant barrier to timely hospice referral.

The study design is to conduct a single-center, prospective pilot study . Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be pursued for enrollment. These patients will be offered to enroll in this study in which funding will be provided to receive palliative blood transfusions while enrolled on hospice.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and older
* Advanced hematologic malignancies
* Hospice eligible as determined by their primary hematologist
* Have opted to forego further cancer-directed therapy.
* Transfusion Dependent: Requiring at least 2 units of blood products

Exclusion Criteria:

* Patients with major psychiatric illness
* Patients without the ability to speak and read English
PEEK Versus PFM Implant Supported Superstructure

The purpose of this study is to evaluate the influence of two superstructure materials Porcelain Fused to Metal (PFM) and PEEK on peri- implant soft and hard tissue reaction clinically.

Nowadays the use of dental implants for restoring missing teeth has gained a wide acceptance, due to its high success rate.

Dental implants differ from natural teeth in transmission of functional loads to the bone, where natural teeth and their periodontal ligaments provide proprioception, early detection of occlusal loads and have a shock-absorbing function. Sensitivity and mobility of natural teeth cannot be duplicated in osseointegrated implants,1 therefore most of the forces are concentrated at the crest of the ridge leading to different living reaction including bone resorption and subsequent implant loss.

Minimizing the occlusal loads on osseointegrated implants through selection of a new superstructure material that can absorb part of this excessive force could be believed to be a determining factor in the long-term success of an implant treatment program.

Many restorative materials are used nowadays for construction of final restoration of implant supported superstructures including porcelain fused to metal (PFM), all ceramic, zirconia, hybrid ceramics, and polyetheretherketone (PEEK). PFM restorations are still considered as the gold standard because of their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation. Recently, the use of new resilient superstructure material like PEEK-based restoration on implant prosthetics could modify the occlusal forces with subsequent cushioning during function.

Eligibility Criteria:
Inclusion criteria:

* Patients above 18 years old.
* Patients able to read and sign the informed consent document.
* Medically free patients or with controlled systemic disease.
* Patients with good bone quality and quantity.
* Patients willing to return for follow-up examinations and evaluation.
* Patients having single successfully osseointegrated implant in posterior region.

Exclusion criteria

* Young patients in growth stage.
* Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
* Pregnant women to avoid any complication that may occur in dental office.
* Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
* Psychiatric problems or unrealistic expectations.
* Multiple adjacent missing teeth.
* Patients with bad oral hygiene.
Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \>=18 years of age with Stage I or II hypertension defined as:
* a mean seated cuff diastolic blood pressure \>=95 and \<=119 mmHg Main

Exclusion Criteria:

* Pregnant
* breast-feeding
* unwilling to use birth control during the study
* secondary hypertension
* SBP\>=180 mmHg
* DBP\>=120 mmHg
* severe renal dysfunction
* hepatic insufficiency
* stroke within the last 6 months
* myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months
* unstable or uncontrolled diabetes
* history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.
Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair

It is recognised that women are at greater risk of death, complications and longer hospital stay following intact abdominal aortic aneurysm (AAA) repair, and the reason for this is not yet established. This disparity in outcomes for women compared to men is also recognised in other forms of cardiovascular surgery, which raises the question of whether women and men are reacting differently to the stress of operative repair.

This study aims to examine whether there are differences baseline stress markers and in the stress response to AAA repair between men and women. It will also examine whether markers of stress are associated with poor clinical outcomes and slower recovery (indicated by longer hospital stay).

The study will take the form of an observational cohort study. It will not alter any of the treatment that men and women receive, but will monitor their stress levels using physiological markers (through ECG (electrocardiogram) monitoring using a non-invasive holter, biochemical markers using blood samples (which will be taken at the same time as routine testing, so as not to require further invasive procedures), and psychological testing, using short forms that the patient will be able to fill out independently at different stages of their recovery. Clinical data will be used to look for relevant factors (clinical history or medications) which may alter the stress markers we are observing, and to compare outcomes with markers of stress.

Patients will be asked for their consent to share their data with the research team in order to participate in the study. It will be made clear that there will be no change in their clinical or operative management if they participate in the study and they will be able to withdraw consent for further participation at any time.


Eligibility Criteria:
Inclusion Criteria:

* Men and women undergoing primary elective intact AAA repair, open or endovascular (EVAR) at participating centres.
* Capacity to consent.

Exclusion Criteria:

* Participants undergoing a secondary or emergency aortic procedure, or procedure for alternative aortic pathology.
* Relevant confounding pathology such as hypothalamic-pituitary axis pathology (e.g. Addison's disease).
* Lack of capacity to consent.
* Participants with pacemaker dependency, or a significant arrhythmia, will be excluded from analysis of heart rate variability, but will be included in the study for analysis of psychological and biochemical markers of stress.
* Participants on steroid treatment will also be excluded from analysis of biochemical markers but may be included for analysis of physiological markers and/or heart rate variability.
* Participants must be over the age of 50 (In order to facilitate capture of degenerative aortic aneurysmal pathology rather than an alternative aortic pathology e.g. traumatic, connective tissue disorder).
Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710

The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline NLR is correlated with overall survival after curative treatment for BC and 2) that baseline NLR is correlated with the survival benefit of NAC. The study will look at the data from participants of the SWOG 8710 study.


Eligibility Criteria:
Inclusion Criteria:

1. SWOG 8710 original trial inclusion criteria included:

   * Node-negative, muscle-invasive transitional cell carcinoma of the bladder, T2-T4aN0M0 per the AJCC 4th edition staging manual.
   * SWOG performance status of 0 or 1
   * Adequate organ function by lab criteria (WBC \> 4,000 cells/mm3, platelets \>150,000 cells/mm3, creatinine \<1.5 md/dL (men) or \<1.3 md/dL (women), baseline liver tests \< 2 times normal limits)
2. Inclusion criteria for this secondary analysis are:

   * Eligible for original SWOG 8710 trial
   * Had complete blood count with differential prior to first treatment (radical cystectomy or NAC).

Exclusion Criteria:

1. SWOG 8710 original trial exclusion criteria included:

   * No age restrictions
   * Previous or concomitant malignancy other than bladder cancer or basal cell skin cancer
   * Prior pelvic radiation
   * Metastatic or incurable disease
   * Laboratory values exceeding those detailed in 3.1.c
2. Exclusion criteria for this secondary analysis are:

   * Ineligibility for the original SWOG 8710 study
   * Lack of complete blood count with differential prior to first treatment (cystectomy or NAC).
Corneal Endothelium Evaluation After Phacoemulsification in Diabetec and Non-diabetic Patients With Pseudoexfoliation

Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.

Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Senile cataract with age between 50 to 70 years
* Clear cornea with no zonuler dehiscence
* Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)

Exclusion Criteria:

* Uncontrolled DM in diabetic groups
* Presence of autoimmune diseases
* Patients with glaucoma
* Corneal guttata
* Zonular dehiscence
* Rupture posterior capsule during cataract surgery
The Neurocircuitry of Relief During Avoidance Learning in Patients With Obsessive-compulsive Disorder

To investigate the neuro-mechanisms underpinning persistent avoidance in OCD patients

Many compulsions displayed by obsessive-compulsive disorder (OCD) patients serve to protect against perceived threat and can, therefore, be conceptualized as 'avoidance responses'. Exposure treatment with response prevention (ET+RP) is aimed at exposing patients to their obsessive thoughts and perceived threats while preventing engagement in compulsive avoidant responses. This induces extinction of threat perception and fearful arousal and hence reduces the motivation to avoid. While successful in many patients, however, as much as 40% dropout during treatment or display persistent avoidance after ET+RP. There is a clear need for treatment improvement for these often highly disabled patients.

Improving ET+RP outcomes requires a deeper understanding of the mechanisms that drive excessive and persistent avoidance in OCD patients. Psychological theories ascribe an important role to the relief that follows avoidance when the anticipated threat is successfully averted. This positive feeling arguably functions as a reward to reinforce the foregoing avoidance actions. Indeed, fMRI studies have found that the neurocircuitry of relief overlaps with that of reward, including the ventral tegmental area, ventral striatum and orbitofrontal cortex. Here, the authors will test the hypothesis that excessive-persistent avoidance is linked to exaggerated activation of the relief circuitry in OCD patients. For that purpose, we will acquire functional brain images of OCD patients in an MRI scanner and compare to healthy participants, while they participate in a computer task that is designed to model avoidance learning and relief.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers 18-60 years old;
* Participants are motivated and give written informed consent;
* Adequate demand of Dutch language;
* Subjects have never participated in a fear conditioning task;
* Diagnosis of OCD (for OCD group only);
* Contraindications for the MRI exam.

Exclusion Criteria:

* Current neurological (e.g. Epilepsia), respiratory, cardiovascular, metabolic, gastrointestinal, endocrine (especially diabetes), renal or urinary diseases, psychiatric disorder or other relevant medical histories (except for OCD in the OCD group);
* Being pregnant or lactating;
* Alcohol intake greater than 14 alcoholic units per week (one alcoholic unit = 10 gr ethanol);
* History of cannabis use or any other drug of abuse during the 3 months prior to the study;
* The medical doctor has asked to the participant to stay away from stressful situations;
* Electronic implants (e.g., pacemaker);
* Pain or other condition of the hand or the wrist.
Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery.

The aim of the study is to examine nasal airflow parameters after septoplasty and turbinoplasty .

Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery.

The aim of the study is to examine nasal airflow parameters at pre-defined intervals in patients after septoplasty and turbinoplasty .

Eligibility Criteria:
Inclusion Criteria:

* patients with nasal obstruction (nasal septal deviation, hypertrophy of nasal mucosa)
* 18 to 70 Years
* patient capable of general anesthesia
* signing of the informed consent

Exclusion Criteria:

- patient incapable of general anesthesia
Electroencephalogram (EEG) in General Anaesthesia - More Than Only a Bispectral Index (BIS)

Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia.

Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia. In addition to the bispectral (BIS) index displayed as an index, the raw frontal EEG can be displayed as a curve on these monitors. After a short training, anaesthetists might be more accurate and faster in assessing depth of anaesthesia by recognizing the pattern of the EEG curve than by using the BIS index. This may further enhance the positive effects that could be demonstrated for the use of BIS monitors.

Therefore, the aim of the investigator's study is to investigate the clinical relevance of interpreting the raw frontal EEG in addition to only using the BIS index for titrating intravenous anaesthetics.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing in-hospital laparoscopic abdominal surgery with general anaesthesia using Propofol based on the Schnider model (target controlled infusion)42, 43
* Minimal duration of surgery of 60 minutes
* Written informed consent

Exclusion Criteria:

* Same-day surgery
* Language barrier
* Patients under 18 years of age
* Pregnancy (using a beta-human chorionic gonadotropin (HCG) measurement in a blood sample of women in childbearing age)
* Allergy to Propofol
* Administration of hypnotics other than Propofol, such as ketamine or midazolam preoperatively or intraoperatively
* Known brain pathology, such as seizure disorders, dementia, cerebrovascular disease or brain death
A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology

A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Participants with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Locally advanced or metastatic (stage IIIB or IV) squamous NSCLC
* No prior systemic chemotherapy, targeted therapy for metastatic NSCLC
* Evidence of at least one radiologically measurable lesion as per RECIST version 1.1
* Adequate hematological, liver and renal function
* Participants must agree to either remain completely abstinent or to use effective contraceptive methods from screening until 6 months after the last dose of study treatment
* Histologically confirmed squamous NSCLC participants eligible for enrollment must provide archival tumor biopsy tissue or if unavailable must be willing to undergo a fresh pretreatment primary tumor or metastatic biopsy
* Participants with Gilbert's Syndrome will be eligible for the study

Exclusion Criteria:

* Concurrent therapy with any other investigational drug
* History or clinical evidence of central nervous system (CNS) primary tumors or metastases
* Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
* Any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
* Major surgery or significant traumatic injury less than (\<) 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
* Pregnant or breast-feeding women
* History of other malignancies that could affect compliance with protocol or interpretation of results. Participants with malignancies diagnosed more than 5 years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible
Changes in Body Composition and Nutritional Status in Patients Undergoing Liver Transplantation

Liver transplant is the goal treatment for every patient with end-stage chronic liver disease.

Quality of life improves after transplant because the main complications of end-stage liver disease disappear, but due to immunosuppression other alterations appear such as metabolic alterations, weight gain, among others.

Body composition and nutritional status can be affected do to post-transplant pharmacologic therapy.

Body composition and nutritional status can be affected due to post-transplant pharmacologic therapy.

This is a prospective cohort study, patients from liver transplant waiting list will be assessed, pre and post-transplant measures of body composition and nutritional status will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis (any etiology)
* Enrolled in waiting list for tliver transplant

Exclusion Criteria:

* Hepatocellular carcinoma
* Chronic renal failure
* Congestive cardiac failure
* Extremity amputation
* Pregnancy