cyrilzakka/clinical-trials huggingface dataset:
Study of AggreGuide A-100 (ADP) Assay

Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.

Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a history of cardiovascular disease OR
* Subject has 2 or more cardiac risk factors:

  * Smoking
  * Hypertension
  * Hyperlipidemia
  * Family History of Heart Disease
  * Post-menopausal female
  * Diabetes
  * Obesity (BMI \> 30)
  * Sedentary lifestyle

Exclusion Criteria:

Taken nonsteroidal anti-inflammatory drugs (NSAIDs) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the Investigator that would pose safety concerns, or possess contraindications for any of the study medications.
Improving Quality of Life of Children With Cancer Through Psychosocial Screening

In Canada, approximately 1450 children are diagnosed with cancer annually. Diagnosis of childhood cancer and its aggressive treatment can have devastating psychosocial effects on the whole family (e.g. unpleasant feelings or emotions that impact your daily activities). It is not known whether health care providers who treat these children use and value psychosocial tools or how beneficial the use of these tools is for these families. This research team will test the benefits of using psychosocial screening on the quality of life of treated children, parents and siblings.

In Canada approximately 1450 children are diagnosed with cancer annually. Childhood cancer diagnosis and treatment can have devastating psychosocial effects on the family. Tools to screen for psychosocial risks (PSR) in pediatric oncology are rare. Our preliminary work adapted the Psychosocial Assessment Tool (PAT) for the Canadian population, PATrevised (PATrev), and developed the Psychosocial Care Checklist (PCCL). The PATrev is completed by parents of children with cancer, and yields a summary of the psychosocial needs of the patient, parents, and siblings. The PCCL assesses HCPs knowledge of family's psychosocial needs and services. Importantly, psychosocial screening is associated with reduced parental anxiety and improved child's quality of life (QOL). Demonstration of the tool's ability to maximize patient and family psychosocial outcomes is needed. Participants will be parents of children newly diagnosed with cancer, (patients and siblings (\> 8 years), if available). Design: RCT with concealed allocation to experimental group (EG) and control group (CG), with repeated measures (after diagnosis= T1, 6 months later=T2). The EG treating team will receive a summary of PATrev risk information based on parent report. No risk information will be provided in the CG. Parents in both groups will complete the PATrev, family environment questionnaire, self--report and proxy reported QoL, distress and mood measures for the patient and one sibling. Patients and siblings will self-report on QOL, distress and mood. Patient charts will be reviewed (T2) to determine treatment intensity and documented psychosocial services for each family.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children newly diagnosed with cancer, within 2 to 4 weeks post-diagnosis.
* Siblings of children newly diagnosed with cancer, within 2-4 weeks post-diagnosis, between the ages of 8 years and 16 years, able to complete outcome measures, without a physical chronic condition.
* Children with cancer, newly diagnosed, within 2 to 4 weeks post-diagnosis, between the ages of 8 and 16 years, able to complete outcome measures.

Exclusion Criteria:

* Parents of children not diagnosed with cancer.
* Sibling of children not diagnosed with cancer
* Children not diagnosed with cancer.
Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR

Low testosterone may be responsible for "soft" erections in men. The purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the "hardness" of a man's erection.


Eligibility Criteria:
Inclusion Criteria:

* Testosterone \<350 ng/dL,
* 21-59 years of age,
* BMI \<30

Exclusion Criteria:

* Those with carcinoma of the breast or known or suspected carcinoma of the prostate or with known hypersensitivity to any of the ingredients in AndroGel.
* Men will be excluded if they have unstable angina, hypertension, diabetes, heart failure, or coronary artery disease.
* Men will agree to discontinue use of current testosterone replacement, as well as Viagra or any other PDE5 inhibitors for 30 days.
Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy

The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy.

The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.

* description of the anaesthetic procedure (duration, volume of anaesthetic local, efficiency)
* realization of the surgery (pain, injection of anaesthetic local...)
* post operative evaluation (pain, satisfaction...)

Eligibility Criteria:
Inclusion Criteria:

* adult
* carotid endarterectomy performed under regional anaesthesia

Exclusion Criteria:

* age \< 18 years
* contralateral phrenic palsy
Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease

120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD combination will be given once every other week for 12 treatments. The hypothesis is that intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the intervention with a combination of ABVD.

The primary objective is to compare the efficacy of R-mabHD with a combination therapy of Adriamycin, Bleomycin,Vinblastine and Dacarbazine (ABVD) in bringing about remission of Hodgkin's lymphoma and reduction in tumor size.

Primary Study Endpoint: Primary efficacy criterion is percentage of patients achieving a functional score of 1.

Efficacy evaluation is based on assessment of functional score. At the end of six months, a functional assessment of the tumor will be undertaken to record the score as follows:

Score 1: \>/= 50% reduction in size of tumor Score 2: \< 50% reduction in size of tumor.

Secondary Study Endpoint: Additional secondary endpoint is the average time to achieve 50% reduction in size of tumor.

120 subjects with Hodgkin's Disease will be divided randomly into two groups. 60 subjects (Group I)will receive R-mabHD by intravenous infusion in a dose of 375mg/m2 once a week for eight weeks in a row. The other half (Group II) will receive a combination of intravenous Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments. Enrollment period will be three years and subjects from both genders will be accepted. Subjects should be between the ages of 18 and 65. No healthy volunteers will be accepted. Females who are nursing babies or are pregnant will be excluded from the study. Subjects will be evaluated every month for the first six months and then at one year and then at eighteen months after the baseline visit one.

Eligibility Criteria:
Inclusion Criteria:

1. Must sign an informed consent form
2. Must have histologically proven diagnosis of Hodgkin's lymphoma
3. Both genders and age between 18 and 65
4. Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet\>50,000/mm3)
5. Must have bidimensionally measureable disease
6. LVEF \>50% by echocardiogram
7. Serum creatinine upto one fold
8. Serum bilirubin upto one fold
9. Hepatitis B surface antigen negative
10. Hodgkin's Disease patients who relapse after radiation therapy alone or surgical treatment alone or both,or previously untreated patients with stage II bulky, III and IV.

Exclusion Criteria:

1. HIV positive
2. Pregnant women and women of child bearing age who are not practising adequate contraception
3. Severe pulmonary disease including COPD and asthma
4. Evidence of other malignancy except superficial nonmelanoma skin carcinoma or carcinoma in situ of the cervix
5. Nursing mothers
6. Uncontrolled active infection
7. concurrent prednisone or other systemic steroid therapy
8. Less than 4 weeks since prior radiotherapy
9. Less than 30 days since prior investigational therapy.
Functional Organization of the Superior Temporal Gyrus for Speech Perception

The basic mechanisms underlying comprehension of spoken language are still largely unknown. Over the past decade, the study team has gained new insights to how the human brain extracts the most fundamental linguistic elements (consonants and vowels) from a complex and highly variable acoustic signal. However, the next set of questions await pertaining to the sequencing of those auditory elements and how they are integrated with other features, such as, the amplitude envelope of speech. Further investigation of the cortical representation of speech sounds can likely shed light on these fundamental questions. Previous research has implicated the superior temporal cortex in the processing of speech sounds, but little is known about how these sounds are linked together into the perceptual experience of words and continuous speech. The overall goal is to determine how the brain extracts linguistic elements from a complex acoustic speech signal towards better understanding and remediating human language disorders.

Intracranial high-density electrodes make it possible to record neural activity directly from the brain surface with unparalleled spatial and temporal resolution to unravel both local and population encoding of speech sounds. This study proposes to assess speech perception in patients who are undergoing surgery for seizure localization or awake intraoperative brain mapping. Electrode placement is based on the clinical needs of each patient. The research study team will examine the mechanisms of phonetic encoding to reveal both the organization of auditory speech feature selectivity and the distributed population-level processing that give rise to the emergent properties of spoken language perception. The aims of this study seeks to determine the cortical encoding of phonological sequencing (Aim 1), representation of amplitude landmark coding in speech (Aim 2), and the shared and distinct mechanisms for speech and music melody encoding (Aim 3). Together, these aims will advance our understanding of speech encoding in the human brain beyond consonants and vowels, addressing questions pertaining to sequencing, amplitude coding, and auditory specialization. These results should heavily impact current theories of speech processing and, therefore, will have significant implications for understanding and remediating human language disorders.

Eligibility Criteria:
Inclusion Criteria:

* Participants with epilepsy or brain tumors at UCSF undergoing surgical electrode implantation for seizure localization or awake intraoperative brain mapping for resection of brain tumors or epilepsy and
* Participants with electrodes implanted in at least two regions of interest who are willing and able to cooperate with study tasks.

Exclusion Criteria:

* Participants who lack capacity or decline to provide informed consent,
* Participants who have significant cerebral lesions or
* Participants with cognitive deficits that preclude reliable completion of study tasks.
Von Willebrand Factor and Protein C Ratio in Graft Function After Liver Transplant

In liver cirrhosis (LC),the activity of von Willebrand factor (vWF)-cleaving enzyme ADAMTS13 is reduced in LC patients and consequent progression of liver injury. Remarkably, it has been reported that a severe vWF/ADAMTS13 imbalance develops during liver transplantation (LT) and persists even after LT. Such changes are thought to contribute to postoperative thrombotic complications, which may lead to early adverse events of thrombotic microangiopathy after living-donor LT (LDLT). We investigated whether vWFPCR could predict EAD or graft failure following LT and compared it with FVIIIPCR, procoagulant, such as vWF and FVIII and anticoagulant, such as PC.


Eligibility Criteria:
Inclusion Criteria:

patients who underwent LT

Exclusion Criteria:

deceased-donor liver transplant, and insufficient data, ABO-incompatible LT
Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety

The purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems.

Medication errors cause substantial morbidity and mortality in the United States. However, relatively little is known about medication errors in the outpatient setting. The broad goal of this proposal is to improve outpatient safety. Specifically, this research plan promotes the understanding of the causes of outpatient prescription errors. The specific aims of this project are:

1. To develop and evaluate a novel reporting system in physicians' offices for detecting prescription errors
2. To develop and evaluate a novel improvement system in community pharmacies to increase prescription error reporting by pharmacists
3. To analyze reports of outpatient prescription errors and understand their root causes

To achieve these specific aims, statewide research will be conducted utilizing qualitative and quantitative methods including root cause analysis, failure mode and effects analysis, and surveys. This research plan will promote patient safety by furthering the understanding of the causes of outpatient prescription errors in all outpatient populations, including rural, women, children, elderly, low income, and the chronically ill.

Eligibility Criteria:
Inclusion Criteria:

* Employed in a physician's office or community pharmacy

Exclusion Criteria:

* Not employed in a physician's office or community pharmacy
Mayo Clinic Foregut Surgery Report Card Questionnaire

The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing foregut surgery in order to standardize and validate outcome measures.

Foregut surgery includes conditions of the esophagus, stomach and proximal small intestine. More specifically foregut surgery includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias. Patients undergoing foregut surgery report having varying degrees of symptoms of reflux, regurgitation, dysphagia, and pain following surgery. Providers also note varying degrees of outcomes. Some of these issues can be assessed using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, and other testing. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's outcomes but there is currently no assessment tool that brings all of the test findings and information reported by the patient as symptoms or answers to the questionnaires in a format that that is usable for the clinician and understandable for the patient who has specifically undergone foregut surgery. The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing surgery in the foregut in order to standardize and validate outcome measures. Data will be used to establish the validation of the Mayo Clinic Foregut Surgery Report Card Questionnaire. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of foregut procedure.

Eligibility Criteria:
* ≥ 18 years old
* Scheduled to undergo Foregut surgery at Mayo Clinic Rochester which includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias.
Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness

The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.

Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major muscular troubles such as spasticity. This spasticity may induce pain, loss in range of motion and permanent joint deformities. The aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50 with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter).

Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).

Eligibility Criteria:
Inclusion Criteria (DOC):

* Altered state of consciousness according to international criteria since more than three months
* Stable condition
* Ashworth score \> 1 for at least one upper limb joint

Exclusion Criteria:

* Bone fracture/lesion at the upper limbs
* Serious neurological disorder (MMSE \> 24) prior to the accident
* Botox injection on the upper limbs in the 6 months preceding the inclusion

Inclusion Criteria (stroke):

* Central nervous system injury responsible for the spasticity
* Ashworth score \> 1 for at least one upper limb joint

Exclusion Criteria:

* Bone fracture/lesion at the upper limbs
* Serious neurological disorder (MMSE \> 24)
* Botox injection on the upper limbs in the 6 months preceding the inclusion
Long-term Follow-up of Living Liver Donors: A Single-center Experience

Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.

Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.

We used the 36-item short-form health survey (short form-36 health survey, version 1 \[SF-36\]). The scores for the 4 following subscales were higher in nondonors than in donors: physical functioning (P = 0.009), role limitations due to physical health (P = 0.002), energy/fatigue (P \< 0.001), and bodily pain (P \< 0.001). The scores on the 8 subscales of the SF-36 were higher in donors with living recipients than in donors whose recipients died (P \< 0.001). Our results suggest that living donor right hepatectomy is safe and results in a postdonation HRQoL similar to that of nondonors in those donors whose recipients are healthy, while donors whose recipients die have a lower HRQoL that is significantly negatively correlated with the time since recipient death and improves over time.

Eligibility Criteria:
Inclusion Criteria:

* age 18-50 years
* no comorbidities.
* BMI less than 30 kg/m2.
* compatible ABO group.

Exclusion Criteria:

* Older than 50 years.
* Associated comorbidities.
* Obesity.
* Noncompatible ABO group.
Postoperative Pain Management of Caesarean Section

Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.

This is a prospective, observational, cohort study. Patients undergoing elective caesarean section will be invited to the study. The written informed consent will be obtained prior to participation. After getting the written informed consent, data will be collected from medical records, questionnaires, patient diaries, visit records and telephone visit records. Through telephone visits, postpartum depression scale and postpartum chronic pain will be evaluated six weeks and three months after delivery. Demographic data, consumption of analgesics, analgesic methods, intensity of postoperative pain, complications, recovery time, score of depression scale will all be summarized. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20 to 40.
2. Planing to undergo caesarean section with spinal anesthesia.
3. Scheduled to undergo cesarean section between 37 and 40 weeks of gestation.
4. American Society of Anesthesiology Physical Class 1-2.
5. Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.

Exclusion Criteria:

1. Not willing to provide informed consent.
2. Unable to receive opioids or NSAIDs due to contraindication.
3. Long-term use of opioids or drug abuse.
4. Suffering from chronic pain disease.
5. Having medical history of mental illnesses.
6. Diagnosed with Pre-eclampsia or eclampsia.
7. Diagnosed with gestational diabetes.
8. Unsuitable for participation judged by investigator.