cyrilzakka/clinical-trials huggingface dataset:
Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain

Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling has shown an effective technique for the treatment of shoulder and neck disorders. The mechanisms of action of the dry needling are not well-known. This study aims to evaluate the effects of dry needling in the upper trapezius on the autonomic nervous system and nociceptive pain processing in patients with non-specific neck pain.

Hypothesis: Dry needling applied in the upper trapezius in patients with non-specific neck pain produced greater activation of the autonomic nervous system and nociceptive pain processing than sham dry needling.

A randomized, double-blind, placebo-controlled clinical trial, using Dry Needling (DN). DN is a technique to treat musculoskeletal pain and physical impairment that consists of introducing needling filaments in the muscle trigger points.

Study Aims:

Aim #1: The primary aim of the study is to compare the effect (during the technique and five minutes after intervention) of a single session of DN on autonomic nervous system as measured by skin conductance in patients with non-specific neck pain with random assignment to two treatments: DN or Sham DN

Aim #2: The secondary aim of the study is to compare the immediate effect on pain sensitivity as measured by pressure pain threshold, activation of descending inhibition pain pathways as measured by temporal summation and conditioned pain modulation in patients with non-specific neck pain with random assignment to two treatments: DN and Sham DN.

Aim #3: The secondary aim of the study is to compare the immediate effect on intensity of pain as numeric pain rating scale (NPRS), relating pain disability (Northwick Park Neck Pain Questionnaire), fear-avoidance of movement (Tampa Scale for Kinesiophobia) and Catastrophizing (Pain Catastrophizing Scale)

Aim #4: The secondary aim of the study is to correlate effects between clinical and other variables.

Eligibility Criteria:
Inclusion Criteria:

1. Pain in the neck area, including the upper trapezius muscle;
2. At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)
3. Ability to read and understand Spanish
4. Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater
5. Ability to understand, write, and speak Spanish fluently

Exclusion Criteria:

1. Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy
2. Cervical trauma
3. Systemic diseases
4. Pregnancy
5. Psychiatric problems
6. Fear of needles.
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer

Standard treatment for locally advanced cancer of the rectum is preoperative chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy with 5-FU. According to our previous study (CAO/ARO/AIO-94, published in the New England Journal of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures, yet, still 36% of all patients develop distant metastasis. Therefore, our new study (CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve the control of distant metastases. It is our hypothesis that the rate of disease free survival will improve by 5 to 8% after 3 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 18 years
* Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease
* No prior therapy except a diverting stoma
* ECOG PS less than or equal 2
* Adequate bone marrow function: Leukocytes \> 3,5 x 10\^9/L Absolute neutrophil count \> 1,5 x 10\^9/L Platelet count \> 100 x 10\^9/L Hemoglobin \> 10 g/dl
* Adequate hepatic function: Total bilirubin \< 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT \< 3 x ULN 7. Serum creatinine \< 1,5 mg/dl, creatinine-clearance \> 50 ml/min
* Written informed consent before randomization

Exclusion Criteria:

* Pregnant or breast feeding women
* Fertile patients without adequate contraception during therapy
* Past or ongoing drug abuse or alcoholic excess
* Prior chemotherapy
* Prior radiotherapy to the pelvis
* Prior (within 4 weeks) or concurrent treatment with any other investigational agent
* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:\* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; \* active uncontrolled intercurrent infections or sepsis
* Peripheral neuropathy \> 2 (NCI CTC AE grading)
* Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
* Chronic diarrhea (\> NCI CTC AE-Grad 1)
* Known allergy to substances containing platinum compounds
* Concurrent use of the antiviral agent sorivudine or chemically related analogues
* Known deficiency of dehydropyrimidindehydrogenase (DPD)
Emphysema: Physiologic Effects of Nutritional Support

To determine if enteral nutrition support (ENS) restores normal body weight and improves muscle strength, exercise performance, sensation of dyspnea, and quality of life in malnourished patients with chronic obstructive pulmonary disease.

BACKGROUND:

Chronic obstructive pulmonary disease is a major health problem and a leading cause for hospital admission in the United States. A severe form of chronic obstructive pulmonary disease that is accompanied by weight loss is commonly referred to as pulmonary cachexia. Studies in the 1960s demonstrated associations in chronic obstructive pulmonary disease patients between weight loss, low FEV1, and early mortality. This observation was strengthened by a retrospective analysis of the Intermittent Positive Pressure Breathing Trial data that suggested malnutrition was an independent predictor of outcome in men with chronic obstructive pulmonary disease. The underlying basis relating malnutrition to adverse outcome in chronic obstructive pulmonary disease was unknown, although there was a large body of information indicating that pulmonary cachexia was associated with respiratory muscle atrophy, myofibrillar substrate depletion, and impaired skeletal and respiratory muscle function. The primary question was whether the nutrition-related functional deficits observed in underweight patients could be reversed.

The first three years of the study supported a pilot project of oral nutrition therapy in malnourished chronic obstructive pulmonary disease patients.

DESIGN NARRATIVE:

All subjects underwent intubation during the initial testing interval and subsequently underwent dietary counseling and oral nutritional supplement during a two-month stabilization phase. Subjects who demonstrated adequate weight gain defined as achievement of more than 90 percent of ideal body weight or who were unable to tolerate intubation were eliminated from further investigation. Eligible subjects were randomized to either ENS or to dietary counseling only. Subjects randomized to ENS received enteral supplementation with Osmolite delivered by continuous infusion pump. Feedings were continuous or nocturnal for sixteen weeks in order to deliver a caloric intake of 1.7 times the resting energy value. Following the intervention phase, all subjects were maintained on dietary counseling on a monthly basis with oral nutritional supplements. Outcome variables were measured before and after the stabilization phase, at eight and sixteen weeks during the intervention phase, and at eight and sixteen weeks during the post-intervention phase. The primary outcome variable was muscle strength and its effect on exercise performance, dyspnea, and quality of life. Secondary outcome variables included morbidity and mortality. The grant was extended through November 1995 for data analysis.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Men and women with uncomplicated stable chronic obstructive pulmonary disease.
End-of-Life Management Protocol Offered Within Emergency Room: a Multicentre Study (EMPOWER)

End-of-life (EOL) care has garnered increasing recognition and acceptance in the field of emergency medicine. Some emergency departments (EDs) in Singapore have instituted or plan to institute EOL care as part of the workflow. However, the EOL protocols are not standardised across all these EDs. The adherence to and quality of EOL care have not been formally measured in all institutions. Hence, gaps to improve the quality of care have yet to be determined.

The aims are to systematically measure the current quality of EOL care in three Singapore hospital EDs and identify the quality gaps; formulate interventions to address these gaps and implement the improved EOL care; and measure the improvement post-implementation. The investigators hypothesise that the current quality of EOL care in three EDs is suboptimal and the interventions planned will improve the quality of care provided.

The study team plans to conduct an interrupted time series study to detect whether the interventions have an effect significantly greater than any underlying trend over time. The quality of care indicators to be measured are timely identification of patients who require EOL care, adequacy of symptom control based on compliance to prescriptions, opportunities to discuss and develop an individualised care plan, perceived quality of care by healthcare providers and next-of-kin, and cost effectiveness. Planned interventions include refining the protocol with collaboration of content experts in palliative care, education and training of healthcare providers, and addressing specific gaps identified to improve cost effectiveness. The results of this study will form the standardisation and foundation for establishing the national benchmark for quality of EOL care in Singapore EDs.


Eligibility Criteria:
Inclusion Criteria:

* Actively dying patient or high likelihood of mortality within 48 hours
* Family accepts that the goals of care are provision of comfort, symptom relief and respect of dignity
* Patient is not a candidate for cardiopulmonary resuscitation, endotracheal intubation or transfer to the intensive care unit
* Family members want to stay by patient's bedside
* Any of the life-limiting conditions such as chronic frailty with poor functional state and limited reversibility (Karnofski Performance Scale \<40%), chronic severe illness with poor prognosis, or other deteriorating conditions and at risk of dying with complications that are not reversible, as subject to the treating clinician's judgment

Exclusion Criteria:

* Vulnerable population e.g. prisoners, pregnant women
* Patients, relatives or staff who refused to participate
* Patients who have been recruited, or had declined participation, in the previous ED attendance(s)
Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.

Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. The investigators conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model, hypothesizing that behavioral counseling through this lens would enhance cessation. The investigators compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* report being HIV-infected
* be a resident of the Washington, D.C. area
* current, daily smokers of tobacco
* have a confirmed smoking status of 6 parts per million (ppm) or more by using an exhaled carbon monoxide breath monitor
* agree to participate
* be willing to set a quit date within 7 days of baseline assessment.

Exclusion Criteria:

* are currently using smokeless tobacco or electronic cigarettes at least every day
* are currently using nicotine replacement therapy or other smoking cessation treatment
* report being HIV-uninfected
* report having heart disease or high blood pressure not controlled by medication
* are currently in an alcohol treatment program
* are pregnant (exclusion items 4-6 are contraindications of nicotine replacement therapy, which will be provided)
* do not have a primary care provider or HIV care provider to refer to in the event of an adverse reaction to nicotine replacement therapy.
Epidural Clonidine Versus Corticosteroid for Low Back Pain

Low back pain is a common condition, affecting majority of the adults in the United States at some point in their lives. Fortunately, most resolve, even without treatment. However, some suffer from continued or recurrent pain.

For those suffering from continued or recurrent low back pain, numerous treatment options exist. One such option is an epidural injection, particularly when other non-surgical treatment options have failed. An epidural injection is the placement of a needle into the space around the spinal cord with the aid of a live X-Ray machine, followed by an injection of various medications. Typically, the medication that is injected is a steroid, commonly with the combination of local anesthetic medication. Epidural steroid injections, with or without local anesthetic is part of the established standard of care in the United States for those with continued or recurrent low back pain. The steroid is believed to reduce inflammation and edema of the injured or irritated nerves. However, despite the routine use of epidural steroids, the steroid itself is not without risks or side effects. Though rare, the steroids have been associated with complications including osteoporosis, steroid induced myopathy, cataracts and many others. In order to minimize the side effects associated with epidural steroids, limiting the dose and frequency have been outlined.

Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and Drug Administration approved the medication for epidural use for cancer pain but studies have shown effectiveness in non-cancer pain was well and is routinely used for various conditions. There is growing evidence on the use of epidural clonidine for treatment of pain, including low back pain.

This research will study and compare the effectiveness, if any, of clonidine compared to steroid in an epidural injection for low back pain.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has clinical diagnosis of low back due to intervertebral disc disease, spinal stenosis or herniated disc
2. Subject has average pain score (VAS) at least 5
3. Subject has persistent pain despite conservative care
4. Subjects has experienced pain for at least 1 month
5. 18 years of age or older when written informed consent is obtained
6. Signed Institutional Review Board (IRB) approved informed consent form

Exclusion Criteria:

1. Allergy to clonidine, dexamethasone, ropivicaine or lidocaine
2. Coagulopathy
3. Active Infection
4. Serious neurologic deficit
5. Subject is pregnant or planning on becoming pregnant during the course of the study
6. Subject is member of a vulnerable population
7. Investigator suspects substance abuse that might confound the study results
8. Subject has unresolved major issues of secondary gain (as determined by the investigator)
9. Subject exhibits major psychiatric morbidity, untreated or refractory to treatment as determined by the investigator
10. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Antibiotic-associated Coagulopathy

Over the past few decades, a good number of studies with regard to coagulopathy and increased bleeding tendency which is defined as macro- or microscopic hemorrhage, declination of hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially caused by the use of antibiotics through a variety of suggested mechanisms, including myelosuppression, immune-mediated destruction of thrombocytes and coagulation factors, and suppression of vitamin K epoxide reductase or vitamin K-dependent γ-glutamate carboxylase which may lead to inhibition of biosynthesis of coagulation factor II, VII, IX, and X, have been reported or published. Nevertheless, many of them are case-series studies or case reports with low level of evidence, and there have been no large-scale retrospective cohort studies regarding antibiotic-associated coagulopathy being published. Moreover, in addition to exposure to antibiotics, there are several risk factors, including severity of illness, hepatic or renal function, nutrition status, comorbidities such as cancer and hematologic disease, surgery or other invasive procedure, concomitant use of anticoagulants, NSAIDs, and salicylates, and age, which may exert influence on the function of the coagulation system as well. Therefore, the study aims to clarify the association between the use of antibiotics and the increase of bleeding tendency or the development of bleeding event and to identify possible risk factors of the increase of bleeding tendency or the development of bleeding event in patients receiving antibiotic treatment through the application of nested case-control design and the usage of both the National Health Insurance Research Database (NHIRD) and medical records in National Taiwan University Hospital during the time period from January, 1995 to December, 2013.


Eligibility Criteria:
Inclusion Criteria:

* patients aged older than 20 years old
* using antibiotics for more than 48 hours in the emergency department

Exclusion Criteria:

* shift of antibiotic prescription in the ER
* patients with hemorrhage -related diagnoses
* non-temporally consecutive referral from the ER to the ward
Effects of Home-based Surface Electrical Stimulation for Patients with Cervical Myofascial Pain Syndrome

The aim of this study is to compare the developed home-based surface electrical stimulation program to the controls in computer office workers with MPS.

Cervical myofascial pain syndrome (MPS) is a common problem among workers who have large amount of computer use. Additionally, owing to the high workload and long hours of staying in thier cubicle, the office employees are often unable to have extra time to receive rehabilitation and treatment regularly. A home-based surface electrical stimulation (SES) program is developed to help intervention be time-saving and more accessible for office-based staff busy at work.

In this single-blind randomized controlled trial, participants will be assigned to one of the following three groups and undergo 3 weeks (20 minutes/ time, three times/ week) of intervention:

1. SES combined with telemedical support
2. SES
3. No intervention

The outcome assessments will be performed before and after the intervention (0-wk and 4-wk) and 4 weeks after the endpoint of intervention (8-wk). The outcome assessor was blind to the intervention and group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Time of using computer \> 4hrs/day
* Neck pain \> 2 months
* Diagnosis of cervical myofascial pain syndrome
* VAS pain ≥ 3 (0\~10)

Exclusion Criteria:

* Had a history of neck surgery
* Pregnancy
* Systematic disease (e.g. autoimmune disorders, arthritis, infection, etc.)
* Malignancy
* Neurological signs such as radiating pain, motor weakness in the upper extremities.
* Skin defect or scars at the planned placement of SES
* Pacemaker user
* History of seizure attack
* History of diabetes
* Fear of receiving SES
IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

The primary aim of the study is to determine if provision of a patient information film about Oncotype DX improves patients' knowledge and understanding about Gene Expression Profiling (GEP) test and risk of recurrence results in early breast cancer (EBC) patients, identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.

Advances made in our understanding of the molecular biology of breast cancer have improved diagnostic testing and therapeutic options available to patients. Importantly results from genomic testing provide more accurate tailoring of treatments potentially enhancing the benefit to harm ratio by only offering adjuvant chemotherapy to those patients at highest risk of recurrence, and sparing those at lower risk the unwanted side effects of cytotoxic treatment. Conversations about risks and optimal treatments can be complex.

To aid understanding about GEP tests many clinical teams provide patients with information leaflets about GEP testing. Unfortunately these are often written by either academic or commercial sponsors and designed to meet certain ethical and regulatory guidelines rather than effectively educate the end-user.

There is some evidence that user-friendly patient information films might enhance patient knowledge and understanding and are more accessible to certain individuals, especially those with low literacy.

IMPARTER project has developed eight-minute film explaining why Oncotype DX GEP tests is used in EBC, what it is, and how the results help determine whether or not chemotherapy is recommended as a useful treatment option.

This study wish to examine the utility of the information film in the clinic setting with EBC patients identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.

Eligibility Criteria:
Inclusion Criteria:

* First presentation of early stage breast cancer with all known disease surgically removed
* Estrogen Receptor (ER) positive and Human Epidermal growth factor Receptor 2 (HER-2) negative
* No clear decision on whether chemotherapy should be given as adjunct based on current prognostic criteria
* Consented to GEP testing
* Able to give full informed consent to IMPARTER study
* Good comprehension of the Italian language
* Access to internet connection and devices (e.g. smart phone, tablet, laptop or desktop computer)

Exclusion Criteria:

* Other breast cancer diagnosis (e.g. Ductal carcinoma in situ, Metastatic)
* Unable to give fully informed consent
* Under 18 years of age
* Unable to understand and speak Italian
* No access to internet connection or devices