cyrilzakka/clinical-trials huggingface dataset:
Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain

Researchers at the John Wayne Cancer Institute (JWCI) at Providence Saint John's Health Center (PSJHC) are trying to examine whether acupuncture reduces joint pain in patients being treated with aromatase inhibitor (AI) therapy for breast cancer and whether the reduction in pain happens by lowering inflammation.

The investigators propose to investigate the effect of acupuncture on patients experiencing joint pain from aromatase inhibitor therapy. The investigators will serially measure patient's symptoms and track current medications, joint pain, daily activities, fatigue, and quality of life. The investigators will collect peripheral blood at baseline, weeks 4 and 7, one week after the last acupuncture treatment and 4 weeks after the last acupuncture treatment. The investigators will study the samples collected at the five predetermined time-points to test for immune parameters, such as the innate and adaptive immune responses, as well as the proliferative capabilities and pro-inflammatory mediators reflected in innate and adaptive functional immune responses.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Must be on aromatase inhibitor therapy continuously for breast cancer treatment for at least the preceding two months
* Must have experienced increased or new onset joint pain daily to a degree equal to or greater than 4 on a pain scale of 0-10 after starting aromatase inhibitor therapy
* Able to read and write English
* Able to give written informed consent to participate in the study

Exclusion Criteria:

* Have a known autoimmune disease or acute infection
* Have had acupuncture treatment within 6 months of study enrollment
* Known needle phobia
* Known metal allergies
* Have an implantable device, such as pacemaker, defibrillator or other device contraindicated with electrical stimulation
* Use of nonsteroidal antiinflammatory drugs (NSAIDs) or narcotics within 7 days of study enrollment and during study period (15 weeks)
* Receipt of prior chemotherapy, immunotherapy or radiation therapy within 90 days
* On anticoagulant therapy
* Receiving physical or occupational therapy concurrently
* Taking herbs or herbal teas within 7 days of study enrollment and during study period (15 weeks)
* Have an immune-compromising medical condition or currently receiving immune-modulating therapies (including corticosteroids)
* Enrolled in any other active cancer treatment protocols
* Bone fracture or surgery of an affected extremity within 6 months
A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate


Eligibility Criteria:
Inclusion Criteria:

* The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
* The subject must have active disease at both screening and baseline

Exclusion Criteria:

* History of any documented influenza or pneumococcal infection within the last 3 months.
* Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550).
* If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.
Developing a COPD Case Finding Methodology for Primary Care

The purpose of this qualitative work is to inform the content and structure of a new screening measure for identifying undiagnosed at-risk COPD cases in primary care and support content validity of the measure. This work will build on the results of a comprehensive literature review and data mining analyses by identifying the symptomatic and health event experiences of at-risk and newly diagnosed patients, as described by the patients themselves. Specific objectives are as follows:

Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The qualitative information obtained in these focus groups will be used to develop a new questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings.

Objective 2: To review the new questionnaire with a new set of participants with a recent COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b) the content of each question is appropriate and understandable to participants, (c) the intended connotation of each questions is consistent with participants' interpretation or assigned meaning, and (d) to assure that content is not seen as redundant across items. This will be done through one-on-one cognitive interviews.

Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without or with a new diagnosis of COPD and the consistency of readings between electronic and mechanical readings in these patients. This information will be used to inform the development of peak-flow meter instructions for use as part of the screening methodology.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥40 years
* 2. Current smokers (\>10 pk yrs.) or Ex-smokers with a history of \>10 pk yrs. or Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life
* 3. Stable state PFT values from within the last 12 months available or obtainable
* 4. Willing and able to attend the focus group session or cognitive interview
* 5. Able to read and speak in English
* 6. Willing and able to provide written Informed Consent

Exclusion Criteria:

* 1. Cognitive impairment, hearing or sight difficulty, or severe psychopathology that could interfere with ability to participate in the study
* 2. Patient was hospitalized for respiratory infection within the past 30 days
Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.

The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Doctors pick which one to use based on personal preference and what is available.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 30
* Screening and surveillance colonoscopy

Exclusion Criteria:

* Colon surgery
* Therapeutic colonoscopy
* Inflammatory bowel disease
* Terminated procedure due to stool burden, stenosis, or obstructive mass.
* Colonoscopy for anemia
* History of incomplete colonoscopy due to technical difficulties
Effect of Milnacipran / Gabapentin in Fibromyalgia

Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.

Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.

The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.

The aim of the study is to evaluate the analgesic efficacy of gabapentin-MLN as combined or monotherapy on patients with FM.

Eligibility Criteria:
Inclusion Criteria:

* There are no other criteria rather than age and sex

Exclusion Criteria:

* Patient refusal.
* Pregnancy or breastfeeding.
* Active liver disease
* Renal impairment (creatinine clearance \< 60 mL/min).
* Documented autoimmune disease.
* Severe chronic obstructive pulmonary disease.
* Recent arrhythmia
* Myocardial infarction
* Stroke.
* Uncontrolled hypertension.
* Glaucoma.
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema

To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.

Aim 1:

To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on anatomical measures of internal and external LEF. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term reduction in anatomical measures of LEF.

Aim 2:

To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on patient reported biopsychosocial outcome measures impacted by LEF. Outcome measures will include: 1) symptom burden, 2) symptom burden and functional impairment, 3) quality of life (QOL), 4) work and activity, 5) perceived self-management capacity, 6) body image, and 7) diet modifications. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term improvement in patient reported biopsychosocial outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
3. Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
4. A diagnosis of either internal or external head and neck lymphedema
5. At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening
6. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation
7. Must be able to speak and understand English

Exclusion Criteria:

1. Previous APCD or Usual Care treatment for HNC LEF
2. Acute facial infection (e.g., facial or parotid gland abscess)
3. Known carotid sinus hypersensitivity syndrome
4. Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
5. Internal jugular venous thrombosis (within 3 months)
6. Patient is pregnant or trying to become pregnant
Pain in Fibrous Dysplasia

Pain remains a common and frequently debilitating symptom, particularly during adulthood of Fibrous Dysplasia/McCune-Albright Syndrome (FD/MAS). For many FD/MAS patients, the amount of pain perceived is not commensurate with the level of detectable musculoskeletal pathology. Using a combination of clinical and biological assessments, this investigation aims to understand what drives pain in FD/MAS.

In Fibrous Dysplasia/McCune-Albright Syndrome (FD/MAS), healthy bone tissue and marrow is replaced with pre-osteoblastic, fibrous tissue, yielding skeletal deformities and an increased propensity towards fracture, musculoskeletal weakness and bone pain. Despite the frequent use of pharmacological and non-pharmacological analgesic strategies, pain in FD remains common and frequently debilitating, particularly during adulthood. Moreover, for many patients there is a discordance between perceived pain levels and detectable musculoskeletal pathology. To elucidate the mechanism underlying pain in FD/MAS patients, investigators at the National Institute of Dental and Craniofacial Research (NIDCR), National Center for Complementary and Integrative Heath (NCCIH) and Boston Children's Hospital (BCH) aim to probe three inter-related domains that are projected to underlie pain experience(s) in FD/MAS patients. These include (i.) the presence of maladaptive central nervous system processes that amplify afferent pain or somatosensory signals, and also facilitate persistent pain; (ii.) aberrant interplay between neurological and musculoskeletal systems; (iii.) a mental health status shaped by the overall burden of living with FD and (iv.) the influence of childhood, FD-related complications on adulthood pain phenotypes. To investigate these four domains hypothesized to underlie FD pain as well as inform on the disconnect between pain and FD disease burden, the investigators will employ methods that complement routine clinical evaluation and diagnostic tests (i.e., 18F-NaF PET/CT or 18F-FDG PET/CT) such as neuroimaging, musculoskeletal MRI and such as neuroimaging, musculoskeletal MRI and assessment of inflammatory and pain mediator expression in blood samples.

Eligibility Criteria:
Inclusion Criteria (FD/MAS patients):

* Male and Female subjects
* 10-45 years of age
* English Speaking ability sufficient to comprehend consent (with parental assistance if minor)
* Diagnosis of Fibrous Dysplasia

Exclusion Criteria for patients:

* Younger than 10 or older than 45 years old
* Weight \> 285 lbs (weight limit of the MRI table and \< 36lbs)
* Surgery leaving implanted material
* Contraindications to MRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia, previous significant research related exposure to ionizing radiation)

Exclusion Criteria for healthy controls:

Same as for the patients, with the addition of the following:

• Use of recreational or illicit drugs History of chronic pain
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics

The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.

This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 months up to 3 years and at a flow rate satisfying clinical needs, especially in reference to changes in cardiac output observed in standard intravenous rehydration.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting to the Emergency Department (ED) with moderate dehydration (gorelick dehydration classification : presence of 3-6 moderate signs and symptoms) requiring parenteral rehydration.
* Patient has not successfully received oral or IV fluids immediately prior to enrollment
* patient's legally authorized representative has signed the informed consent and is willing for the patient to receive Hylenex augmented sub-q rehydration

Exclusion Criteria:

* patient in shock or a life-threatening situation
* immunocompromised, history of abscess or cellulitis, abscess \&/or cellulitis caused by Methicillin-resistant Staphylococcus aureus (MRSA), family history of abscess or cellulitis
* requires IV therapy for another indication
* has an indwelling catheter
* has already received rehydration therapy by IV route within the last 48 hours or substantial oral fluid in the immediate time period of enrollment
* has a condition precluding sub-q injection or infusion site evaluation in the upper middle back area or at another elected site of infusion
* has a reason for hospital admission or extended ED stay other than dehydration
* has an known hypersensitivity to hyaluronidase or another ingredient in the formulation of Hylenex
* has a know hyponatremia \< 130 milliequivalents per liter (mEq/L) or hypernatremia \>155 mEq/L
* has a know hypokalemia \<3.0 mEq/L
* has a medical condition likely to interfere with the patients ability to fully complete the study protocol or the ability to have the protocol-specified assessments
* has a medical history, screening physical exam finding or historical clinical lab result that in the opinion of the investigator would preclude the patients safe participation in the is study or which might adversely effect the interpretation of the study results
* patient participated in a study of any investigational drug or device within 230 days prior to enrollment in this study
Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients

This study aim to analyze the clinical data of patients who underwent emergency appendectomy for acute complicated appendicitis with peri-appendiceal abscess or phlegmon, identify factors influencing the post-operative length of hospital stay (LOS), and improve treatment strategies.

Appendicitis is defined as inflammation of the vermiform appendix and worldwide is the most common reason for emergency abdominal surgery. Globally, the annual incidence is 96.5 to 100 cases per 100 000 adult population. For acute uncomplicated appendicitis, antibiotic therapy has emerged as the primary treatment, often allowing patients to avoid surgery. However, the management of acute complicated appendicitis requires careful consideration of various treatment options.

Complicated appendicitis, characterized by peri-appendiceal phlegmon or abscess formation, presents additional challenges and often requires a more comprehensive treatment approach. Management strategies have evolved to incorporate both conservative and surgical treatments, tailored to the patient's condition. Typically, for early-stage appendicitis (duration of symptoms ≤72 hours) with peri-appendiceal phlegmon, surgical treatment is recommended, while late-stage appendicitis (duration of symptoms \>72 hours) or cases with peri-appendiceal abscess formation are initially managed conservatively with percutaneous drainage and antibiotics. Despite this, some patients still prefer surgical intervention for various reasons. Currently, there is a lack of studies on the outcomes of patients with acute complicated appendicitis who opt for surgery over conservative treatment, highlighting the need for further research.

In practical terms, the benefits and risks of all treatment options should be thoroughly presented and discussed. Recommendations for surgery versus a conservative treatment-first approach should be based on individual clinical and radiographic findings, as well as patient treatment expectations and preferences. This study aim to investigate the clinical significance of peri-appendiceal abscess or phlegmon in the surgical management of acute complicated appendicitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were aged ≥18 years, Patients who were clinically diagnosed with acute appendicitis, Patients who had a peri-appendiceal abscess or phlegmon on CT scan, Patients who opted to undergo immediate emergency surgery as their primary choice, Patients who refused conservative treatment first (antibiotic therapy and ultrasound/CT-guided drainage).

Exclusion Criteria:

* Patients younger than 18 years, Patients have a history of prior malignancies, Patients with diffuse peritonitis, Patients with incomplete clinical or pathological records.
Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.

The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.

The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.

Eligibility Criteria:
Inclusion Criteria:

* Mother-infant pairs in which the mother was identified as HIV-infected in the MIRIAD Study

Exclusion Criteria:

* Mother-infant pairs in which the infant is expected to be hospitalized for \>2weeks after birth
An EQA Scheme for TPMT Activity and Thiopurine Metabolites

Participation in EQA schemes, where available, is mandatory for the United Kingdom Accreditation Service (UKAS). No EQA scheme currently exists for TPMT and thiopurine metabolites, which is a potential shortcoming of these tests. A pilot of this project has been awarded funding by Clinical Pathology Accreditation (CPA).

The purpose of this work is to collect samples for an EQA scheme for whole blood TPMT (activity and genotype) and thiopurine metabolites, which will be run in collaboration with UK NEQAS (United Kingdom National External Quality Assessment Service), and facilitate a comprehensive world-wide service that enables laboratories providing these tests to fulfil quality goals and ultimately provide optimal patient care.

The thiopurine S-methyl transferase (TPMT) enzyme is involved in the breakdown of thiopurine drugs (such as azathioprine), which are commonly used to treat inflammatory bowel disease and autoimmune diseases. Different individuals in the population have different, genetically determined, levels of TPMT. An individual with absent TPMT activity has a high risk of serious side effects from thiopurine drug treatment. In routine practice, TPMT activity in the blood is measured before starting patients on thiopurine drugs to determine an effective and safe starting dose.

Thiopurine metabolites are the breakdown products of thiopurine drugs and are monitored in the blood of patients on thiopurine drugs to optimise their drug dose.

These tests are performed by laboratories across Britain and around the world. It is important for patient care that the results are of high quality and consistent across different centres. One way of assessing this is through an EQA scheme. No EQA scheme currently exists for TPMT/thiopurine metabolites, which is a potential shortcoming of the tests.

Venous blood collected from NHS staff volunteers and SWBH outpatients, who have had TPMT measured as part of their routine care, will be distributed to participating laboratories every two months. Where it is not possible to find suitable blood donors, pooled surplus blood samples from the laboratory will be used instead. The laboratories will test the samples and return results to UK NEQAS for comparison. A report will be compiled allowing them to compare themselves with other centres and make changes where necessary.

Eligibility Criteria:
Inclusion Criteria:

* Pathology staff member - able to donate 60 mL of venous blood.
* SWBH NHS Trust outpatients - have had TPMT activity measured within last 5 years. Consultant happy for them to be contacted. Able to consent and donate 60 mL of blood.

No known Hep B or C, HIV, syphilis or cytomegalovirus infection.

Exclusion Criteria:

* Donors for each distribution will be under no obligation to participate if they are no longer willing to. Only volunteers able to give informed consent themselves will be recruited (i.e. no children or adults lacking the capacity to consent themselves).