cyrilzakka/clinical-trials huggingface dataset:
The Effect of TENS Application for Pain

The aim of the study which was planned in a randomized controlled experimental design, it was aimed to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) application on pain level before mobilization in the postoperative period in children.

Children can often experience chronic muscle, bone, joint pain, headache and abdominal pain, and acutely experience pain due to postoperative and procedural procedures. Effective management of childhood pain is emphasized as a health priority by the World Health Organization and pain communities. The findings of various epidemiological studies emphasized that a significant proportion (49% to 64%) of children receiving treatment in a hospital setting received inadequate pain management services despite the increase in available knowledge and treatments. One of the situations in which pediatric patients encounter acute pain is the postoperative period. Mobilization is delayed in patients who cannot provide adequate pain control, and accordingly, serious complications such as impaired tissue perfusion, atelectasis and deep vein thrombosis may develop. There are studies on the use of TENS, one of the methods used in non-pharmacological pain management, in postoperative pain management in adults. Studies on pain management in children for TENS application are very limited today. There was no evidence for the effectiveness of TENS application applied before mobilization in the postoperative period in children.

Eligibility Criteria:
Inclusion Criteria:

* Be in the 7-12 age range
* Abdominal surgery indication (appendicitis or inguinal region surgery)
* Volunteering to participate in the study
* Receiving monotherapy treatment for epilepsy
* To be able to communicate in Turkish

Exclusion Criteria:

* Administering analgesic therapy other than routine administration
* Patients who have difficulties in mobilization/complications during the operation will be excluded from the study.
Paroxetine-mediated GRK2 Inhibition to Reduce Cardiac Remodeling After Acute Myocardial Infarction

This study evaluates the off-target effect of paroxetine to reverse cardiac remodeling and improve left ventricular ejection fraction in patients after acute myocardial infarction. Half of the participants will receive paroxetine, while the other half will receive placebo treatment.

Cardiac remodeling is characterized by a composite of structural, geometric, molecular, and functional changes of the myocardium, and is an important determinant of heart failure and cardiovascular outcome in survivors of acute myocardial infarction. Progression of heart failure secondary to the remodeling process results from dysregulation of the G protein-coupled receptor (GPCR). Excessive adrenergic drive in patients with heart failure results in an enhanced activation of GPCR kinases (GRKs) that is considered to have a central role in adverse cardiac remodeling after ischemic injury. The selective Serotonin reuptake inhibitor paroxetine specifically binds to the catalytic domain of GRK2 as an off-target effect, and has been shown to reverse cardiac remodeling and increase left ventricular ejection fraction in a mouse model. The effect was observed at serum levels achieved with standard dosages of paroxetine, and was robust in mice with and without concomitant heart failure treatment, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Anterior wall ST-segment elevation myocardial infarction
* Primary percutaneous coronary intervention (PCI) within 24 hours of symptom onset
* Left ventricular ejection fraction ≤ 45% within 48-96 hours after primary PCI (transthoracic echocardiography)

Exclusion Criteria:

* Female patients at reproductive age (\<50 years)
* Known intolerance to paroxetine
* Inability to provide informed consent
* Currently participating in another trial before reaching first endpoint
* Current medical therapy with MAO-blocker (during, 14 days before, and 14 days after treatment with MAO-blocker), lithium, thioridazide, or pimozide
* Concomitant tamoxifen intake
* Previous myocardial infarction
* Previous revascularization procedure (percutaneous coronary intervention or coronary artery bypass grafting).
* Contraindication to cardiac magnetic resonance imaging
* Obvious or questionable inability to appropriately cooperate (alcohol, drugs etc.)
* Relevant nephropathy or hepatopathy
Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple Sclerosis

This was a retrospective cohort study utilizing the IQVIA PharMetrics® Plus claims database from 01 August 2019 through 31 May 2022.

The database is comprised of fully adjudicated (i.e., paid by the health plan) medical and pharmacy claims and is representative of the commercially insured United States population. Adults treated with ofatumumab (OMB), oral disease-modifying therapies (DMTs) (dimethyl fumarate, diroximel fumarate, monomethyl fumarate, fingolimod, siponimod, ozanimod, ponesimod, teriflunomide, cladribine) or platform self-injectable DMTs (glatiramer acetate, interferon beta-1a, peginterferon beta-1a, interferon beta-1b) between 01 August 2020, through 30 November 2021, were identified. The date of the first incident DMT (OMB, oral DMT, or injectable DMT) during the identification window served as the index date. The baseline period was the 12 months before the index date, and the follow-up period was at least 6 months after the index date. Patients treated with OMB were selected first to maximize sample size, and these patients were allowed to have an oral or injectable DMT in the baseline period. Patients without OMB use during the identification period were categorized into the oral DMT or platform self-injectable DMT cohort based on the first-observed incident DMT during the identification period. For the purpose of this study, platform self-injectable DMTs were referred to as 'self-injectable DMTs.'


Eligibility Criteria:
Inclusion criteria:

* Patients with 1 claim or more for ofatumumab, a newly initiated oral DMT (dimethyl fumarate, fingolimod, teriflunomide, cladribine, siponimod, ozanimod, diroximel fumarate, monomethyl fumarate, ponesimod) or a newly initiated self-injectable DMT (daclizumab, glatiramer acetate, interferon beta-1a, peginterferon beta-1a, interferon beta-1b) occurring during the index window.
* Patients with 12 months or more of pre-index continuous enrollment \[CE\] with medical and pharmacy benefits.
* Patients with 6 months or more of post-index CE with medical and pharmacy benefits.
* Patients with 2 or more non-ancillary outpatient medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\] code: G35) in any position or 1 or more inpatient claims with a diagnosis of MS in the first position during pre-index period.
* No data quality issues (defined as missing age or sex).
* Having two DMTs on the same day was very rare in MS patients per clinician's inputs, but if it happened, those patients were excluded from analysis.
Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated with the metabolic syndrome. As the disease stems from excess calorie intake and lack of physical activity, the correction of unhealthy lifestyles is the background of any prevention and treatment strategy

The majority of NAFLD patients are characterized by high body mass index, insulin resistance and they show a remarkably higher energy intake in comparison to individuals without hepatic steatosis. Several authors have proposed dietary weight loss strategies to ameliorate or reverse fatty liver because of the potential role of weight loss on the supposed risk factors of liver injury, mainly insulin resistance, free fatty acid levels, and pro-inflammatory and profibrotic adipokines. There are no definite data regarding how much and how rapidly weight loss should be to have the more favorable effects, but in obese children, the larger the weight loss, the larger the decrease of liver enzyme levels and the lower the prevalence of NAFLD. The American Gastroenterological Association recommends a weight loss target of 10% of baseline. A loss of at least 10% of body weight in obese patients is associated with a normalization of previously abnormal liver function tests as well as decreased hepatomegaly, but even a moderate weight loss (approximately 6% of baseline weight) can improve insulin resistance and intrahepatic liver content.

Eligibility Criteria:
Inclusion Criteria:

* Subject enrolled in the cohort Nutriep assembled in 2005-2007
* Moderate or severe NAFLD

Exclusion Criteria:

* Middle NAFLD
* Not enrolled in the Nutriep cohort
* Pregnancy
Wearable Evaluation of Ambulatory Readings for Blood Pressure

The purpose of this project is to compare the performance and validity of novel wearable technologies that measure blood pressure (BP) and physical activity with a Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device.

The investigators will recruit community-dwelling participants to wear novel cuffless BP monitoring devices for comparison with a Spacelabs ABPM device throughout a 24-hour period. The identification of accurate cuffless BP technologies would greatly improve access to ABPM and allow for BP measurements at times when the use of cuff-based devices are not feasible. Knowledge from this project will inform subsequent research protocols among adults and under-represented groups.

Up to 250 participants (at least 100) will be involved in this study each wearing up to 7 devices (6 BP devices and 1 activity monitor). The assignment of devices will be randomized by day and by the arm or wrist on which they are worn. During the first visit, participants will provide their consent and be randomly fitted with 3 BP devices; either the Spacelabs ABPM device or the ABPMpro device, the Aktiia wristband BP monitor, and one of two other cuff-based wrist BP monitors, along with an activity monitor to track body positions. These devices will be worn continuously for at least 24-hours, including overnight, before being returned. On the following day, for Visit 2, participants will be fitted with a different set of 3 BP devices; the ABPMpro device or Spacelabs ABPM device, the Aktiia wristband BP device (on the opposite wrist from the previous day), and the final cuff-based wristband BP device. Additionally, participants will wear an ambulatory BP device as a patch on the chest. These devices will also be worn for at least 24 hours. This study will enable characterization of the feasibility, practicality, and effectiveness of the measurements and the devices\&#39; accuracy and precision.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 100 years
* All neighborhoods in Boston area
* Be able to walk with two limbs and have two arms
* Willing and able to complete required measurement procedures
* Able to provide informed consent

Exclusion Criteria:

* Failure to receive informed consent
* Arm circumference of more than 50cm
Prospective RCT Comparing Perioperative Pain

This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.


Eligibility Criteria:
Inclusion Criteria:

* All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

* Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
* Revision arthroplasty or arthroplasty for fracture
* Unable/unwilling to consent for enrollment
* Unable to complete postoperative pain survey
* Known adverse drug reaction or allergy to the medications used
* Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
* Patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone)
* Patients under the age of 18 years
* Patients with history of hepatic disease
* Pregnant or breastfeeding women.
Outcomes of Vitrectomy Combined With Subtenon Triamcinolone Injection for the Idiopathic Epiretinal Membrane

This study compares the anatomical and visual outcomes of patients with idiopathic epiretinal membrane(ERM) treated by vitrectomy and membrane peeling with or without subtenon triamcinolone acetonide injection


Eligibility Criteria:
Inclusion Criteria:

* 1.The participant must have idiopathic epiretinal membrane 2.The participant must be willing and able to comply with the protocol.

Exclusion Criteria:

* 1. The participant has idiopathic epiretinal membrane with other ocular vascular diseases such as Diabetes retinopathy, BRVO, etc.

  2. The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.

  3. The participant has had intraocular surgery (including lens replacement surgery).

  4. The participant has a history of (within the last six months), or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).
CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results

The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation.

The comparison between the two techniques will be performed in terms of clinical-functional results, perioperative bleeding and healthcare costs (surgical time, hospital stay).

The research protocol involves the participation of 160 total patients divided into two groups, of 80 patients each, by type of surgical technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant
* Males and females aged ≥ 45
* Willingness to participate in the study
* Acquisition of informed consent to participate

Exclusion Criteria:

* Patients who are not capable of understanding and willing, and therefore unable to express consent to participation in the study
* Patient refusal to participate in the study and to sign the informed consent
* Nickel allergy (suspected or diagnosed)
* Pregnant women or women of childbearing age who cannot exclude pregnancy
HCT Versus CT in Elderly AML

A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60years and ≤ 75 years
* primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
* First complete remission following one or two cycles of induction chemotherapy
* Chemotherapy was administered according to current participating cooperative group protocols
* Karnofsky score ≥ 70
* Written informed consent

Exclusion Criteria:

* AML FAB M3
* HIV positivity
* Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if

  * The second study exclusively concerns induction therapy
  * Consolidation cycle one and two are given according to the accredited study group policy
  * No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
  * Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted
Effects of Natural Sounds on Attention Restoration Outdoors

This study aims to examine whether listening to natural sounds in a noisy outdoor environment compared to no natural sounds influences behavioural, cognitive, affective, and physiological markers.

The investigators hypothesize that listening to natural sounds has restorative effects on attention by supporting greater use of involuntary attention. This generates the prediction that exposure to natural sounds in the context of a noisy outdoor environment will have greater restorative effects on attention (i.e., physiological, affective, cognitive, and behavioural) as compared to the control group (exposed to environmental noise only). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, noise sensitivity, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for. Environmental factors (i.e., outdoor humidity, temperature, and noise) will also be accounted for.

Eligibility Criteria:
Inclusion Criteria:

* Singapore-based
* Non-clinical
* 18-35years

Exclusion Criteria:

* Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing
* Individuals with a history of ear, developmental, neurological, or psychiatric disorder
A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Previous history of adverse reaction to pentamidine.
* History of asthma.
* Pulmonary Kaposi's sarcoma.

Patients with the following are excluded:

* Previous history of adverse reaction to pentamidine.
* History of asthma.
* Pulmonary Kaposi's sarcoma.
* Inability to understand the consent procedure.

All patients hospitalized at Cedars-Sinai Medical Center with AIDS and possible Pneumocystis carinii pneumonia (PCP) will be eligible.

* Patients with HIV antibody or AIDS and a clinical presentation suggesting PCP are eligible.
Study on the Mechanism of Ganoderma Lucidum Spore Powder in the Treatment of Depression

To clarify the clinical effect of Ganoderma lucidum spore powder intervention on postoperative depressive symptoms of papillary thyroid carcinoma ; to elucidate the antidepressant mechanism of Ganoderma lucidum spore powder.

After being informed of the study and potential risks, all patients who gave written informed consent were enrolled. A total of 300 eligible patients were randomly assigned in a double-blind manner and divided into experimental group and control group at a ratio of 2 : 1. The subjects were given oral test drugs ( Ganoderma lucidum spore powder or placebo ) 4g per day for 90 days from the first day after enrollment.

Eligibility Criteria:
Inclusion Criteria

* patients with depressive symptoms after surgery for papillary thyroid carcinoma in the outpatient department of Zhejiang Cancer Hospital
* Han nationality
* No previous depression and other mental diseases
* 18-80 years old
* Women
* BMI 19 \~ 24

Exclusion Criteria

* suffering from other diseases of the intestinal system
* Gastrointestinal surgery was performed before intervention
* Including patients with other malignant tumors, who need chemotherapy, radiotherapy, biological therapy or traditional Chinese medicine treatment received antibiotics or microecological modulators within 3 months before the intervention
* Acute intestinal obstruction
* Patients with severe depressive symptoms who must receive antidepressant treatment organic diseases such as heart and brain diseases, brain trauma history of mental illness, use of psychoactive drugs such as drugs
* Severe liver and kidney dysfunction
* Pregnancy, lactation
Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.


Eligibility Criteria:
Inclusion Criteria:

* Study IIA: Patients with cervical cancer, FIGO IB1, tumor size 2-4 cm
* Study IIB: Patients with high risk endometrial cancer, presumed FIGO I, type 1 histology grade 3 Endometrioid adenocarcinoma or type 2 histology (serous-, clearcel-, carcinosarcoma or undifferentiated adenocarcinoma.

Exclusion Criteria:

* Prior PL
* Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
* Women included in other studies affecting outcome-measures of the present study
Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis

This is a prospective, randomized clinical trial looking to determine the role of prophylactic treatment with topical corticosteroids in preventing recurrences in patients with a history of infectious epithelial keratitis, stromal keratitis,endotheliitis, or iridocyclitis. Patients will be enrolled to one of two treatment arms: Control arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg daily or Study arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Subject capable of giving informed consent and if not, an acceptable surrogate capable of giving informed consent on behalf of the subject.
* Diagnosed with a history of herpetic eye disease
* Three or more episodes of HSV keratitis based on medical record documentation of episodes with infectious epithelial keratitis, immune stromal keratitis with or without epithelial ulceration, endothelitis, or iridocyclitis.
* Prior history of HSV keratitis based on medical record documentation of episode of infectious epithelial keratitis, immune stromal keratitis with or without epithelial ulceration, endothelitis, or iridocyclitis and corneal scarring in the central 4mm zone.

Exclusion Criteria:

* Persons who are pregnant or nursing or intend to become pregnant or nurse in the next one year.
* Allergy to acyclovir, fluoromethalone, loteprednol, prednisolone acetate, prednisolone sodium phosphate, or any components of the formulations.
* Persons who are incarcerated.
* Unable to give informed consent or have an acceptable surrogate capable of giving informed consent on behalf of the subject.
* Persons with systemic medical problems who do not agree to have continued medical follow-up.
* History of topical corticosteroids to the eyelids or ocular surface of the involved eye within the prior 30 days prior to enrollment.
* Patients with 3 or more episodes of uveitis in the past 12 months.
* History of keratoplasy or keratorefractive surgery of the involved eye.
* History of open or closed angle glaucoma or ocular hypertension on gtts.
* History of systemic steroid use within the prior 30 days.
* Unable to comply with the study protocol or in the opinion of the investigator would not be a candidate for participation.
* Persons who are unable to instill gtts despite training/caregiver.