cyrilzakka/clinical-trials huggingface dataset:
A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression

This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>=18 years of age;
* breast cancer;
* CNS progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
* at least one measurable lesion;
* ECOG performance status 0-2.

Exclusion Criteria:

* prior systemic treatment of brain metastases;
* prior disease progression while on Xeloda treatment;
* previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
* clinically significant cardiovascular disease.
Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.

The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.


Eligibility Criteria:
Inclusion Criteria:

* Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)

Exclusion Criteria:

* Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye.
* Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye.
* Subjects with macular hole diameter \> 400 μm in the study eye.
* Aphakia in the study eye.
* High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length \>28 mm is an exclusion).
Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach

PTSD Coach is a mobile application (app) that aims to teach individuals self-management strategies for symptoms of Post-traumatic Stress Disorder (PTSD). Despite PTSD Coach's use of evidence-based cognitive behavioral strategies there is still a need to test the effectiveness of the app in managing PTSD symptoms. There is research evidence that self-management programs are often underutilized, but that clinician contact can increase patient involvement. The addition of clinician support may enhance the utilization and effectiveness of the PTSD Coach. In Phase 1 the investigators propose to conduct stakeholder interviews with primary care (PC) and mental health (MH) leadership staff to investigate barriers and facilitators to implementing Clinician-Supported (CS-PTSD Coach) to increase the uptake, use, and impact of PTSD Coach by PC patients. The interviews will inform the development of a CS-PTSD Coach protocol and manual that will be used in phase 2. In phase 2 the investigators propose to conduct a feasibility study where 30 (20 eligible) PC Veterans with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive Self-Managed (SM) PTSD Coach or CS-PTSD Coach. The investigators' specific aims are to 1) investigate the feasibility of recruiting and retaining participants and delivering the SM and CS conditions and 2) conduct a preliminary investigation of the efficacy of SM vs. CS. The investigators predict that CS will lead to greater treatment gains than SM. Effect sizes will be generated for the following outcomes: a) reductions in PTSD, depression, and general distress, and increases in health-related functioning, b) increases in knowledge about PTSD symptoms, PTSD management strategies, and patient coping self-efficacy, c) increases in initiation of tradition PTSD treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in primary care at the Syracuse VAMC,
2. Significant PTSD symptoms. Total PTSD Checklist Score ≥ 40.

Exclusion Criteria:

1. Gross cognitive impairment (as measured by the Blessed Orientation-Memory-Concentration; BOMC)
2. Suicide attempt or intent to commit suicide in the last two months (as measured by the Columbia- Suicide Severity Rating Scale
3. Psychotherapy or mental health counseling for PTSD in the last two months that was received outside of VA primary care
4. A new psychotropic medication or a change in dose of a psychotropic medication for PTSD in the last two months that was received outside of VA primary care
5. Intent to begin PTSD treatment in specialty care
Passive Descent in Obese Nulliparous Gravidae

Obesity rates in reproductive aged women in the United States are rising. It is now universally accepted that obesity is associated with many adverse pregnancy outcomes and post-operative complications following cesarean section. Recent studies have also shown an increased rate of cesarean section in obese women, adding to the already elevated rate of complications and adverse outcomes. Given the increased a priori risk for obese patients, it is vital that the investigators reexamine management practices routinely used for normal weight women in this specific high-risk population. Passive descent has been shown to increase the spontaneous vaginal delivery rate in non-obese women; however, high quality studies have never been performed in obese women. the investigators hypothesize that passive descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with regional anesthesia. This study will randomize women to passive descent for ninety minutes or active pushing upon entry into the second stage. Further, given that passive descent is widely accepted in the midwifery literature and clinical practice, the investigators anticipate that a high-quality study in the physician literature could increase the dialogue between practitioners and lead to development of best practices in this high-risk population.


Eligibility Criteria:
Inclusion Criteria:

* Obese - body mass index (BMI) calculated as weight (kg)/ \[height (m2)\] greater than or equal to 30 as determined at the time of admission to labor and delivery
* Regional anesthesia
* Nulliparous (defined as no deliveries after 20 weeks gestation)
* Gestational age of 37 0/7 weeks and greater
* Singleton Pregnancy

Exclusion Criteria:

* Body mass index (BMI) calculated as weight (kg)/ \[height (m2)\] less than 30 as determined at the time of admission to labor and delivery
* No regional anesthesia
* Multiparous
* Gestational age of less than 37 0/7 weeks
* Multiple gestations
* Maternal fever prior to second stage
* Severe fetal anomalies (incompatible with life)
Neurophysiology of Cough Reflex Hypersensitivity

Central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. This process is involved in some chronic pain conditions e.g. migraines and non-cardiac chest pain. Recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough.

The main questions in this study include:

1. Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?
2. Can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)?

In animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. Using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers inclusion:

* Over 18 years
* Measurable cough reflex sensitivity - required as is the primary end-point
* No current or past history of chronic cough or chronic respiratory disease

Chronic Cough Patients inclusion:

* Over 18 years
* Chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux
* Normal chest radiograph - primary respiratory cause for cough excluded
* Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point

Exclusion Criteria:

* Recent upper respiratory tract infection (\<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles
* Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion
* Current smokers or ex-smokers with \< 6 month abstinence or history \> 20 pack years - smoking can alter the sensitivity of the cough reflex
* Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity
* Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity
* Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy
The First Twenty for Volunteer Firefighters

The purpose of this study is to assess the efficacy of an internet-based firefighter health and wellness program for volunteer fire departments.

A national sample of volunteer fire departments will be recruited for a 6 month, CRCT with a cross-over treatment design to determine the efficacy of The First Twenty (TF20), a wellness program focused on nutrition and fitness for firefighters. Modifications to the existing TF20 will be made to enhance the health coaching features and include tools for program evaluation. Study outcomes (changes in weight, BMI, body fat percentage, waist circumference, dietary intakes, blood pressure, and fitness activities) will be assessed pre- and post-intervention.

This will be the first internet-based, occupationally tailored health and wellness program implemented for the volunteer fire service. TF20 will be an essential cost effective tool to address the epidemic of unhealthy body composition, nutrition and fitness among firefighters.

Eligibility Criteria:
Inclusion Criteria:

* first responder within a participating fire department
* willing to complete all assessments
* internet accessibility through a computer, tablet or smartphone and ability to use devices appropriately

Exclusion Criteria:

- not a first responder within a participating fire department
Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies

To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the OBI-1-301 study.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from participant or their legal representative.
* Participants with acquired hemophilia with autoimmune inhibitors to human factor VIII.
* Has a serious bleeding episode, as documented by the investigator.
* Be willing and able to follow all instructions and attend all study visits.
* Participants taking anti-thrombotics may be included depending on the time elapsed since taking such medications.
* Life expectancy of at least 90 days prior to the onset of the bleeding episode.

Exclusion Criteria:

* Hemodynamically unstable after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy.
* Has an established reason for bleeding that is not correctable.
* Bleeding episode assessed likely to resolve on its own if left untreated.
* Anti-OBI-1 inhibitor that exceeds 20 BU (prospectively or retrospectively).
* Subsequent bleeding episode at the site of the initial qualifying bleeding episode within 2 weeks following the final OBI-1 dose for the initial qualifying bleeding episode, or subsequent bleeding episode at a different site than the initial qualifying bleeding episode within 1 week following the final OBI-1 dose for the initial qualifying bleeding episode will not be considered "new" qualifying bleeding episodes.
* Prior history of bleeding disorder other than acquired hemophilia.
* Known major sensitivity (anaphylactoid reactions) to pig or hamster products.
* Use of hemophilia medication within 3 to 6 (depending on medication) hours prior to OBI-1 administration.
* Participation in any other clinical study within 30 days of the first OBI 1 treatment.
* Anticipated need for treatment or device during the study that may interfere with the evaluation.
* Abnormal baseline findings
* Inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures.
Differences in Music Perception Skills Between Child, Teen and Adult Cochlear Implant Recipients

Adult recipients of cochlear implants (CI) generally loose interest in listening to music. This may be due to the rather limited spectral resolution of CI. However, child CI-recipients, if offered the opportunity, like to listen to music. They participate actively in musical acitivities, such as singing, dancing or playing an instrument. Thus, there seems to be a fundamental difference in the music perception of people who receive CI as child or as adult.

This study assesses music perception skills of child, teen and adult cochlear implant recipients in settings with simple tone sequences and in a more complex, melodious context.


Eligibility Criteria:
Inclusion criteria:

* Participants are uni- or bilateral CI recipients.
* Participants are at least 3 years old.
* Participants received CI one or more years before.
* Participants are healthy.
* Participation in the study is voluntary.
* Participants and their legal custodians have read the information for participants at least one day prior to the test and given their written consent.

Exclusion criteria:

* Surgery for CI carried out less than one year before the test.
* Children less than 3 years old.
* Reduced cognitive capabilities due to old age.
* Physical or mental handicaps.
Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (\>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.


Eligibility Criteria:
Inclusion criteria:

* All non alcoholic fatty liver disease patients evidenced by abdominal ultrasound.
* Urine analysis whether normal or renal sedimentation.

Exclusion criteria:

1. Alcoholic fatty liver patients.
2. patients known to have diabetes mellitus.
3. patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune.
4. patients known to have kidney disease.
5. Hypertension.
6. Hyperuricemia.
7. Impaired urea and creatinine patients.
Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 19 and 75 years
* Signed informed consent

Exclusion Criteria:

* At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C \> 250mg/dL or TG ≥ 400mg/dL
* Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
* Has a history of multi-drug allergy
A Study Using Swedish Registries to Find Out How Many People With Type 2 Diabetes Had Cardiovascular Disease and Started Treatment With Empagliflozin Between 2015 and 2017

This study aims to describe the prevalence of type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) according to the (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME (ERO)) study definition in a Swedish population.

The aim was also to describe the prevalence of established CVD according to ERO study definition in patients with T2DM who initiates treatment with empagliflozin


Eligibility Criteria:
Inclusion criteria

Population 1: 'Prevalence of a history of cardiovascular disease (CVD) among persons with type 2 diabetes mellitus (T2DM) who were alive on 31 December 2017' :

* Diagnosed with T2DM in Sweden
* Alive on 31 December 2017
* At least one registration in the Swedish National Diabetes Register (NDR)
* Each patient provides informed consent for inclusion in the register

Population 2: 'Prevalence of a history of CVD among persons with type 2 diabetes who started empagliflozin treatment between 1 January 2015 and 31 December 2017':

* Diagnosed with T2DM in Sweden
* Alive on 31 December 2017
* Initiated on empagliflozin between 1 January 2015 and 31 December 2017
* At least one registration in the NDR
* Each patient provides informed consent for inclusion in the register

Exclusion criteria:

none
A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)

The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for coronary catheterization. Target Coronary Artery: The target vessel must have .50% reduction in lumen diameter by angiographic visual estimation throughout a segment of at least 40 mm in length (the target segment) and the vessel must be large enough to accommodate the IVUS catheter. A lesion of up to 60% is permitted distal to the target segment. Side branches of the target (imaged) vessel may be narrowed up to 70% by visual estimation, provided the target segment contains no lesion greater than 50%.

Exclusion Criteria:

Use of lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis. Subjects receiving treatment with a lipid-lowering medication within the past 4 weeks require a 4-week wash-out period following which a baseline lipid profile will be taken at visit 2.

Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study.

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Guided Bone Regeneration With Particulate Versus Block Graft

The aim of present study was to compare two bone augmentation techniques (Guided Bone Regeneration, GBR, with autogenous block graft and GBR with particulate autograft plus xenograft) in terms of efficacy, complications, operational parameters (cost of the materials used, time for patient preparation, time for surgery, fatigue of the physician caused by surgery) tolerability by the patient and patient comfort.

The aim of present study was to compare two bone augmentation techniques (Guided Bone Regeneration, GBR, with autogenous block graft and GBR with particulate autograft plus xenograft) in terms of efficacy, complications, operational parameters (cost of the materials used, time for patient preparation, time for surgery, fatigue of the physician caused by surgery) tolerability by the patient and patient comfort. 30 systemically healthy individuals with inadequate alveolar bone crest width who requested implant placement (15 Female and 15 Male) participated in this study. After an initial examination, 15 patients were assigned to GBR with block graft (GBR-BG) and 15 were assigned to GBR particulate autograft plus xenograft (GBR-AX). Bone thickness was recorded before surgery and at a post-operative 6th month. Complications as Bleeding, Hematoma, Flap dehiscence, Infection, Numbness were evaluated. Patients were requested to record pain and swelling via visual analog scale (VAS) at 3rd, 7th and 14th days after surgery. The swelling was also recorded by an experienced clinician at 3rd, 7th and 14th days after surgery. Cost, time for patient preparation, time for surgery, fatigue of the physician caused by surgery were also determined.

Eligibility Criteria:
Inclusion Criteria:

* 30 to 62 years of age
* systemically health
* no smoking
* no use of medications for previous 6 months
* no pregnancy and lactation
* no contraindications for periodontal surgery.

Exclusion Criteria:

* \<30 and \>62 years of age
* patients with systemic disease
* smoking habit ( current or past)
* any medication
* acute illness
* pregnancy or lactation
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. We hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

We plan to conduct a prospective randomized trial to assess the effect of a single immediate pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients undergoing laparoscopy for gynecologic indications. This concept has been studied in patients undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be female and planning to have a laparoscopic or robotic assisted procedure for benign gynecologic indications.
2. Patients must be treated in the department of Obstetrics and Gynecology in the division of Minimally Invasive Gynecologic Surgery.
3. The patient must be in the age range of 18-80 years, in general good health and able to comply with study procedures.

Exclusion Criteria:

1. Male patients will be excluded from this study.
2. Patients under 18 years old will be excluded from this study.
3. Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude pregnancy.
4. Patients having abdominal, vaginal or hysteroscopic procedures
5. Allergy to gabapentin
6. Chronic use of gabapentin (greater than 6 months)