cyrilzakka/clinical-trials huggingface dataset:
Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain

The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Adult age (18 to 75 years) and written informed consent;
* Unilateral heel pain of four weeks or longer duration;
* Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
* Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
* Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.

Exclusion Criteria:

* No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
* No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
* No clinical signs of lumbar radiculopathy at physical examination;
* No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
* No previous fractures or surgery in the affected ankle and foot;
* No rheumatologic diseases, no plantar fibromatosis
Pharmaceutical Care in VA Nursing Home

This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100 patients will be selected into this controlled study.The hypothesis are:

1. After patients receive pharmaceutical care, their drug related problems will be decreased.
2. After patients received pharmaceutical care, their self-reported medical expenditure will be decreased.

Around 200 residents in a Veteran nursing home will be selected for reviewing inclusion and exclusion criteria. A total of 100 subjected are selected into this randomized controlled trial. Each group will have 50 subjects and then divides into 4 subgroup, according to their drug items used (5-7 and over 8 items used).

The inclusion criteria:

1. Residents of the Veteran nursing home.
2. over 65 years old.
3. complete comprehensive geriatric assessment (CGA)
4. prescription drugs more than 4 times/day, excluding stat order.
5. with 2 or more chronic diseases.

Exclusion criteria:

1. residents who were in the pharmaceutical care project of Taiwan Pharmacists Association.

Eligibility Criteria:
Inclusion Criteria:

* Residents in the Veteran nursing home
* Age over 65 years old
* Complete Comprehensive Geriatric Assessment (CGA)
* Use more than 4 drug item per day (excluding stat order)
* subjects with more than 2 chronic diseases.

Exclusion Criteria:

* subjects who were in pharmaceutical care project of Taiwan Pharmacist Association.
Comparative Study Between the Analgesic Effect of Dexmedetomidine and Magnesium Sulfate As Adjuvant to Bupivacaine Using Ultrasound-Guided Transversus Abdominis Plane Block in Abdominal Hysterectomy : a Randomized Double-blinded Study

Over 80% of patients who undergo surgery suffer from acute postoperative pain, with 75% of them rating the pain severity as moderate, severe, or extreme. Studies have shown that less than 50% of patients who undergo surgery report adequate relief from postoperative pain.

Additionally, if pain is not promptly managed after surgery, it can hinder a patient's ability to walk, potentially causing adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia.

The opioid analgesics are most commonly used as parenteral agents to manage post operative pain but the problem of respiratory depression remains to be considered.

This study is designed to compare the analgesic effect between dexmedetomidine versus magnesium sulfate as adjuvant to bupivacaine using ultrasound guided Transversus Abdominis Plane block in patients undergoing abdominal hysterectomy

In addition to parenteral opioids and NSAIDS, various other methods used for post operative analgesia are infiltration of local anaesthetic agents, dermal patches, patient-controlled analgesia and epidural catheters, etc.

Numerous studies have demonstrated that when enhanced recovery procedures (ERPs) are used, hospital length of stay, time to return to normal function, postoperative ileus duration, thromboembolic complications, morbidity, and all of these factors are all reduced. In order to achieve the best pain treatment, many ERPs use a multimodal approach, decreasing the use of opioids as the primary analgesic in Favor of neuraxial and regional anaesthetic techniques.

One of the regional techniques routinely used is the transversus abdominis plane (TAP) block. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I-ll,
* Aged \>18 years,
* weight 50-85 kg,
* Patients who will undergo total abdominal hysterectomy

Exclusion Criteria:

* • ASA classification I-ll,

  * Aged \>18 years,
  * weight 50-85 kg,
  * Patients who will undergo total abdominal hysterectomy
Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy

The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged \>65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 65 years of age
* prescription for an inhaled corticosteroid

Exclusion Criteria:

* a diagnosis of chronic obstructive pulmonary disease or
* a prescription for a chronic obstructive pulmonary disease treatment
Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer

The management of colorectal cancer often requires oxaliplatin-based chemotherapy, either as part of curative treatment plans or exclusively in palliative situations. Oxaliplatin therefore plays a key role in the management of colorectal cancer. In addition to its digestive and hematological toxicity, oxaliplatin frequently induces chronic, often limiting, sensitive peripheral neuropathy.

Only early discontinuation of oxaliplatin can limit the risk of clinically limiting neurotoxicity (grade ≥ 3).

In oncology, managing the side-effects of treatment is an essential objective of supportive care, and is open to a variety of complementary medicines, including reflexology. This technique, derived from traditional Chinese medicine, involves stimulating reflex points on the arch of the foot.

This first monocentric, prospective pilot study is designed to evaluate if the intervention is feasible in routine clinical practice for patients initiating bimonthly oxaliplatin chemotherapy for colorectal cancer. It will also provide initial estimates of the parameters needed to measure efficacy and impact on patient quality of life.

Patients will receive a reflexology session with each cycle of chemotherapy, and will be assessed during all the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years treated for colorectal cancer in Digestive Oncology service Rangueil hospital
* Initiation of intravenous oxaliplatin chemotherapy at 85 mg/m² on a bimonthly schedule.
* Ability to understand and answer a self-questionnaire.
* Life expectancy egal or over 12 weeks
* Signed informed consent form

Exclusion Criteria:

* Pre-existing motor and/or sensitive neuropathy.
* Reflexology treatment within the last 6 months.
* Contraindication to reflexology: venous thrombosis, trauma, wound or metastasis of the foot.
* Patient covered by a legal protection scheme.
Pirfenidone in Adult Hospitalized Patients With COVID-19

This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Subjects Age ≥ 18 Willing and able to provide written informed consent
* SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
* Time of illness onset ≥8 days
* Have findings consistent with interstitial lung disease found on CT scan
* Willing not use other investigational agents of anti-fibrosis

Exclusion Criteria:

* Pre-existing severe liver disease
* Pre-existing severe chronic kidney disease
* Pre-existing interstitial lung disease
* Pre-existing severe COPD or other structural lung disease
* Receiving invasive mechanical ventilation
* Currently Pregnant or Breast Feeding
* Poor baseline health conditoin
* Disability to complete lung function test
* Receiving pirfenidone wthin half-year
Sildenafil and Uteroplacental Perfusion

The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.

Fetal growth retardation affects up to 8% of all pregnancies and has massive short term (increased fetal morbidity and mortality) and long-term (increased incidence of cardiovascular disorders in adulthood) health implications.

Doppler waveform analysis of these pregnancies suggests compromised uteroplacental circulation and placental hypoperfusion.

Our aim is to assess if sildenafil citrate could improve vasodilatation in FGR pregnancies.

Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental perfusion in FGR.

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil citrate, may improve uterine blood flow .

Eligibility Criteria:
Inclusion Criteria:

* FGR pregnancies in 24-37 weeks of GA

Exclusion Criteria:

* vasodilator agents usage
* history of cardiovascular morbidity specially of right heart side
* drug or alcohol abusers
* systolic BP more than 210 mm Hg or diastolic BP more than 120 mm Hg
Opiate Use and Biliary Dilation

We hope to better define the association between opiate use and biliary dilation, which was evident in our previous retrospective study. This prospective study including all endoscopic ultrasound procedures performed for further evaluation of biliary dilatation in the setting of bilirubin \<2 mg/dL will enable accurate measurement of common bile duct and pancreatic duct diameter using endoscopic ultrasound and identification of other non- obstructive factors which may modulate biliary dilation (i.e. age, cholecystectomy status, duration and type of opiate used).

We hope to better define the association between opiate use and biliary dilation, which was evident in our previous retrospective study. This prospective study including all endoscopic ultrasound procedures performed for further evaluation of biliary dilatation in the setting of bilirubin \<2 mg/dL will enable accurate measurement of common bile duct and pancreatic duct diameter using endoscopic ultrasound and identification of other non- obstructive factors which may modulate biliary dilation (i.e. age, cholecystectomy status, duration and type of opiate used).

We believe this work will be of great interest to gastroenterologists, as it provides additional data for interpretation of isolated common bile duct dilation in asymptomatic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Referral/consultation for consideration for EUS ± ERCP
2. Age 18 and older
3. Evidence of biliary dilation on abdominal imaging without obstructive pattern on liver function tests or imaging.
4. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age \<18
2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
3. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
4. Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. mass, stone, cirrhosis).
18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Female patient with histopathologically proven ER+ breast cancer.
* Diagnosed with locally advanced (primary tumor \>5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.
* Willing and able to undergo the study procedures.
* Has personally provided written informed consent.

Exclusion Criteria:

* Age \<18
* Pregnancy
* Patients with secondary malignancies
* No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.
* Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity
* Chronic inflammatory disease such as rheumatoid arthritis.
* Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
* Inability to provide informed consent.
Mobile Integrated Healthcare and Community Paramedicine

Background:

Initially conceived of as a method to address healthcare needs of underserved rural populations, Mobile Integrated Healthcare and Community Paramedicine (MIH/CP) is a new model of inter-professional, community-based outpatient healthcare delivery that primarily utilizes the resources and training of Emergency Medical Services (EMS) to fill gaps in local healthcare infrastructure, expanding existing scope of practice in most cases while not detracting from acute transport capabilities.

Although programs have been in existence since the early 1990s, there are few objective studies of the efficacy, safety, and cost-effectiveness of MIH/CP programs, many of which are limited-scope pilot projects. The limited data already published on these measures by established programs shows substantial Medicare charge-avoidances in patients enrolled in CHF-readmission prevention and EMS frequent user programs, and a significant reduction in Emergency Department visits overall, especially in austere environments.

In summary, MIH/CP is an attempt at formalization of long-standing practices to collaborate with and supplement other healthcare system components such as primary care and home health services. Standardized, objective data collection and publication of results will be needed to support continuation and financial support of this emerging concept.

Objective/Hypothesis:

Using the existing resources of the MD-, RN- and Paramedic-staffed Lifespan Pediatric and Adult Critical Care Transport (LifePACT) service, investigators aim to study whether implementation of an MIH/CP pilot program tailored to the needs of an urban, underserved population in Providence, Rhode Island, will reduce the rate of 30-day hospital readmissions for patients after discharges for community-acquired pneumonia, acute MI, and COPD. In addition, investigators will study whether such a program is considered to be safe (in terms of not increasing the number of adverse events post-discharge for patients or compromising the efficacy of the LifePACT transport role) and considered satisfactory by patients (rated comparably to visits by other outpatient health care services such as VNA services).


Eligibility Criteria:
Inclusion Criteria:

* Current inpatient/observation status for: NSTEMI; CHF; PNA (community or HCAP); COPD; Wound infection or complication,
* English Speaking,
* Not pregnant,
* Not incarcerated,
* Able to maintain clinical sobriety for informed consent and home visitation.,
* No unstable psychiatric conditions (Patients may be under treatment for mental health conditions as long as their symptoms are controlled).,
* Accessible and reliable place of residence that is not a nursing home or "on the street" location. (Homeless patients are eligible as long as they have consistent access to a domicile that can provide shelter and privacy).,
* No anticipated VNA or home care within 24-36 hours of visit,
* Ages 18-80
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.

Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 75 years of age.
* Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.

Exclusion Criteria:

* Patient previously received or is receiving an organ transplant other than kidney.
* Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
* Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
* Uncontrolled concomitant infection or other unstable medical condition.
* Patients that received an investigational drug in the 30 days prior to transplant.
* Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
* Receiving chronic steroid therapy at the time of transplant.
* History of malignancy in last 5 years.
* Pregnant or lactating.
The Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.

The present study will be conducted on fifty participants. All participants will receive a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI). Gingival Index (GI), probing depth (PD), and clinical attachment level (CAL). All of these measurements will be recorded at six sites at baseline for all participants and 3 months after non-surgical periodontal therapy for the study group. GCF samples will be collected from the buccal aspects of teeth that had the highest signs of inflammation and attachment loss for periodontitis group at baseline and 3 months after non-surgical periodontal therapy. As for controls, the samples will be collected from buccal aspect of upper first molar at baseline. The samples will be assayed for prolactin by using an enzyme linked immunosorbent assay kits (Elisa) according to the manufacturer instruction.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe chronic periodontitis, with probing pocket depth (PPD) ≥ 4-6 mm and clinical attachment level ≥ 4-5 mm, according to the American Academy of Periodontology.7
* Highly motivated and cooperative patients

Exclusion Criteria:

* The presence of any systemic disease.
* Taking medications for the last 3 months before conducting this study.
* Pregnancy and lactation.
* Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months.
* Smoking (former or current).
Axonics SacRal NeuromodulaTIon System RegisTRY Study

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant
2. Willing and capable of providing informed consent
3. Capable of participating in all testing associated with this clinical investigation

Exclusion Criteria:

For all indications:

1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
2. Any psychiatric or personality disorder at the discretion of the study physician
3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
4. A female who is breastfeeding
5. A female with a positive urine pregnancy test

   For OAB \& UR:
6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
7. Current symptomatic urinary tract infection (UTI)

   For FI only:
8. Rectomucosal prolapse or congenital anorectal malformation