cyrilzakka/clinical-trials huggingface dataset:
A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders

The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated the effect of Ticagrelor on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented stable Coronary Artery Disease (CAD) (stable angina, previous MI history, previous history of revascularization)
* Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception

Exclusion Criteria:

* History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or coronary artery bypass graft (CABG))
* Any acute or chronic unstable condition in the past 30 days
* Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma
* History of intolerance or allergy to aspirin or clopidogrel
At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study

Radish Health and ProofPilot in coordination with Sanesco are running this study to help establish whether the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma Authorized for distribution under emergency use authorization - though not yet FDA reviewed) can be conducted effectively at home to detect COVID-19 antibodies among individuals who have tested positive, or suspect they have previous contracted from COVID-19 and recovered. The study also aims to examine how the results of those tests change social-distancing behaviors and general anxiety over 8 weeks post-test.


Eligibility Criteria:
Inclusion Criteria:

* Reside and Currently in New York City
* Does not have a blood clotting disease
* Is not abnormally queasy about taking a blood sample
* Not on any blood thinning medications
* Able to consent
* Willingness to take a blood sample
* Confirmed of highly likely past infection with COVID-19 over 14 days ago and fully recovered
Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients

To investigate the associated risk factors of rectovaginal fistula

To investigate the associated risk factors of rectovaginal fistula in cervical caner patients after radiotherapy

Eligibility Criteria:
Inclusion Criteria:

Rectovaginal fistula Cervical cancer

Exclusion Criteria:

Nil
Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

This study will try to determine if the measure of the platelet reactivity of the patients receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary angioplasty allows to predict the hemorrhagic risk.

The use of thienopyridines in patients undergoing percutaneous coronary intervention (PCI) has dramatically decreased the rate of early stent thrombosis. Further the CURE trial demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular events in acute coronary syndrome patients (ACS) . However clopidogrel has several limitations including a long delay of action which is a potential limitation in acute settings of coronary artery disease. Another major limitation of the drug is the wide inter individual variability in clopidogrel responsiveness related to various factors.

In addition recent studies suggested that platelet reactivity inhibition does also determine the bleeding risk.

The ticagrelor is a new blocker of the receiver P2Y12 which distinguishes itself from the clopidogrel by a superior biological efficiency. This biological property was translated in the study PLATO, having compared it with the clopidogrel in the ACS, by a reduction of the risk thrombotique. The ticagrelor is thus recommended in first intention in this indication. There seems be a variability of answer to the ticagrelor. Besides the ticagrelor infers a level of intense platelet inhibition which could explain on hemorrhagic risk which is associated with it.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines.

Exclusion criteria:

* New York Heart Association functional class III or IV
* Cardiac arrest
* Contra-indications to antiplatelet therapy
* Platelet count \<100 G/l
* History of bleeding diathesis
* Concurrent severe illness with expected survival of \< 1 year month
* Pregnant of childbearing woman
* Inability to provide an informed consent
* Contra indication to ticagrelor.
Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.

Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders among older adults. Anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. Because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. There is, however, limited evidence of the effectiveness of psychotropic medications. Given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts.

The treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (CBT) or usual care. Follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Generalized Anxiety Disorder

Exclusion Criteria:

* Active suicidal intent
* Current psychosis
* Current bipolar disorder
* Substance abuse within past month
* Cognitive impairment
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. The general hypothesis is that the signal properties are stable from night to night during baseline studies, and are different between controls and patients with primary insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention. Then the new kind of study is repeated in the patients. The controls only are examined in baseline studies.

Patients are carefully screened to have DSM primary insomnia, and do not have another disorder than may cause a sleep disturbance. After a 2-week baseline period, the subjects undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder. Then they undergo the NSLP procedure. In that procedure, there pre-bedtime EEG recordings and questionnaire responses taken. Then at a planned time, the subjects go to bed and try to sleep while there EEG signals are recorded. After the first and second sleep cycles, they are awakened for one minute, then asked to return to sleep. In the morning additional recordings and questionnaire responses are obtained. Two nights later they repeat a baseline NSLP procedure. The controls then end their participation. The Patients then receive an open treatment with eszopiclone and behavioral treatments so that their insomnia may improve. After 2 weeks intervention, the patients complete one NLSP night. The goal of the study is to see if there can be data to support the idea that the sleep onset process might harbor a sign of primary insomnia that could be used for the development of a better medical model of primary insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Primary Insomnia (N = 12) Age \& Gender matched Healthy controls (N = 12)

Exclusion Criteria:

* Unstable Medical illness No other Sleep disorder BMI \> 35, AHI \> 10, PLM Index \> 10, Ferritin \< 50. Unable to communicate in English
Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy

In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA \[43 probable (1.7%) and 13 proven (0.5%)\]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).

The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.

In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP.

Evaluate the protective role of mold active PAP in patients older than 60 years underwent to chemotherapy of consolidation with intermediate or high doses of cytarabine

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent according to ICH/EU/GCP and national/local laws
* Patients aged older than 60 years underwent to consolidation course with intermediate/high doses of cytarabine

Exclusion Criteria:

• Diagnosis of IA during induction course and previous antifungal treatment
Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Male/female with refractory diarrhea for at least 1 month, after normal extended work-up to exclude causes of diarrhea, not or not enough responding to standard anti-diuretics as evaluated by the investigator
* Patient mentally fit for completing a diary

Exclusion Criteria:

* Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea
* Had a weight of stool \< 600g in a 72hrs stool collection
* Has received a treatment with laxatives within the last week before study entry
* Suffers from IBS with alternating bowel habits and predominant constipation, suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn's disease and macroscopic colitis)
Optical Sensor for Photodynamic Detection of Oral Pathology

Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and optical approaches. All different areas of the mouth will be imaged, including healthy, diseased, dysplastic and malignant, as well as oral biofilm, and the imaging data compared against conventional diagnostic approaches such clinical and histopathological and molecular evaluations to (1) gain a better understanding of processes involved in oral pathology and (2) develop a combined patient specific, non-invasive method for the detection, diagnosis and screening of oral pathology and biofilm. Thus our goal is to identify and evaluate microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.

We are recruiting patients with a wide range of oral conditions including plaque, dry mouth, toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune conditions and others as well as healthy control subjects. We will use a range of non-invasive imaging modalities to obtain information on the ways in which the oral health status affects optical properties, and determine means of detecting and quantifying these factors.. Imaging modalities to be utilized include:

1. Coherence and Doppler Tomography
2. Laser Speckle Imaging
3. Various forms of Spectroscopy
4. Fluorescence

Purpose of the research is to identify optical predictors and biomarkers of health and disease.

Hypothesis: microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.

Researchers of the Beckman Laser Institute (BLI) have developed many non-invasive imaging modalities for assessment of oral tissue. This protocol will allow data acquisition with these multiple modalities to allow validation of data. Imaging modalities to be utilized include:

1. Coherence and Doppler Tomography (OCT)
2. Laser Speckle Imaging (LSI)
3. Photon Migration Spectroscopy (PMS)
4. Autofluorescence Imaging

In addition, saliva samples from the patients will be analyzed and the resulting data regarding the dysregulation in the activities of genes, proteins and other molecules will be correlated with findings from different imaging systems with respect to the stage of oral carcinogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 18 years and older
* Have oral lesion or not have oral lesion
* Have condition of dry mouth
* Have condition of Gum disease
* Non-smoker

Exclusion Criteria:

* Age less than 18 years old
* Advanced gum disease, diseases of oral tissue
* Untreated cavities
* Pregnant or breastfeeding
* Immune compromised individuals
Integrating Palliative Care Into Self-Management of Breast Cancer

The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 21
* Stage I-IV breast cancer
* Live in the State of Connecticut
* Speak English
* Receiving any kind of treatment for breast cancer
* Prognosis of at least 6 months
Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain

25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.


Eligibility Criteria:
Main Study

Inclusion Criteria:

1. Male
2. Age between \>18 and \<65 years
3. Unilateral post surgical groin pain for \>6 months
4. Pain localized to the region defined by the anterior superior iliac spine (ASIS), the pubic tubercle, and the groin-gluteal-greater trochanter triangles (3G) point,
5. Pain has no surgical indication
6. Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline
7. Pain characterized by neuropathy and/or allodynia
8. Average daily baseline pain intensity baseline VAS greater than or equal to 50 mm on a 100mm VAS scale
9. Patient willing and able to give informed consent and to participate in observational study

Exclusion Criteria:

1. Inability to speak/read Dutch
2. Bilateral and/or recurrent hernia.
3. Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
4. Current illicit drug use and/or alcohol dependence
5. Active infection, or conditions or indwelling devices that pose an increased risk of infection
6. Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
7. Participation in another clinical study during the study period.
8. Any other disorder, condition, or circumstance that, in the opinion of the principal investigator, represents a risk to successful completion of all study activities.

Additional Criteria for nested feasibility study

Additional Inclusion Criteria

1. Participation in the observational study
2. Sign off for sub-study on patient informed consent

Additional Exclusion Criteria

1. For sub-study participation only: pain conditions \[aside from the post surgical groin pain to be treated\], extensive scar tissue, skin conditions, or sensorimotor abnormalities in the areas for QST assessments: the painful groin, the contralateral groin, the ipsilateral arm, and the contralateral hand
Study of Telbivudine in Chronic Hepatitis B

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (\<=300 copies/ml or 60IU/ml, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg positive/negative patients at physician's general practice.

Primary objective: To evaluate the antiviral efficacy of telbivudine by maintained suppression of HBV DNA(\<=300 copies/ml or 60 IU/ml,undetectable by current PCR-based assays) in HBeAg positive patients from Week 24 to Week 48.

Methodology: This will be an open-label, prospective, observational, single-center and single arm post marketing surveillance study.

Number of patients: It is estimated to enroll 240 intent-to-treat patients in Taiwan.

Population: Male or female patients, at least 18 years of age diagnosed with chronic hepatitis B with liver disease and telbivudine is prescribed by physicians based on clinical justification. And patients are able to communicate well, provide written informed consent, and willing to participate in the entire study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age.
2. Documented chronic hepatitis B defined by all of the following:

   * Clinical history compatible with chronic hepatitis B.
   * Detectable serum hepatitis B surface antigen \>= 6 months at screening visit, with either HBeAg positive or negative.
3. Willing and able to comply with the observational drug regimen and all other study requirements.
4. Willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

1. Females who are pregnant,intending to become pregnant or breast feeding.
2. Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
3. Patients with hypersensitivity to telbivudine or to any of the excipients.
4. One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, steatohepatitis, autoimmune hepatitis, hemochromatosis, alpha-1 anti-trypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). Gilbert's syndrome and Dubin-Johnson syndrome will not exclude patients from participation in this trial.
5. Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
6. Unable to receive safety and tolerability assessments.
Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy

Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea and undernutrition in developing countries. These include intestinal inflammation, mucosal damage, and alterations in intestinal barrier function that lead to malabsorption, growth failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea. Recent studies from Northeast Brazil demonstrate the benefits of a novel alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the recovery of damaged intestinal barrier function in cell culture, animal models, patients with AIDS, and underweight children.

Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves short-term gut integrity and weight velocity 4 months after therapy in a group of undernourished children from Northeast Brazil. Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves intestinal barrier function, intestinal inflammation, and nutritional status in children at risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts these benefits?


Eligibility Criteria:
Inclusion Criteria:

1. Children who are undernourished or at risk of undernutrition, with anthropometric z-scores less than or equal to -1 for one of these parameters: height-for-age, weight-for-age, or weight-for-height.
2. Children ages 2 months to 5 years old.

Exclusion Criteria:

1. Children who are exclusively breastfed.
2. Have participated in another intervention study in the past two years.
3. Fever greater than 38.8 ° C.
4. Use of antibiotics.
5. Systemic disease or other serious medical condition (including, but not limited to meningitis, pneumonia, tuberculosis, and chickenpox).
6. Children who are unable to ingest, retain or absorb nutritional supplements.
7. Children whose families plan to move from the study area within the next 6 months.