cyrilzakka/clinical-trials huggingface dataset:
Stress Management for High Blood Pressure

The purpose of this research study is to examine the efficacy of two stress management interventions in reducing blood pressure (BP) in patients who have prehypertension (BP between 120/80 and 139/89). It is expected that participants will be better able to control their BP through reducing stress and increasing healthy lifestyle behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Unmedicated high blood pressure (SBP of 120-139 or DBP of 80-89)
* BMI in the range of 19-40
* Interest in attempting to control blood pressure through lifestyle modification

Exclusion Criteria:

* pacemakers
* uncontrolled hypertension (SBP≥140 or DBP≥90)
* atrial fibrillation
* myocardial infarction (MI)
* percutaneous transluminal coronary angioplasty (PTCA)
* coronary artery bypass graft (CABG) within 6 months of enrollment
* congestive heart failure
* uncorrected primary valvular disease hypertrophic or restrictive cardiomyopathy
* uncorrected thyroid heart disease
* chronic kidney disease
* persistent tachyarrhythmia
* JNC risk category C (target organ damage, diabetes)
* patients who are pregnant or plan to become pregnant within 9 months
* patients who are lactating
* patients unable to comply with assessment procedures
* patients with alcohol or drug abuse within 12 months
* patients who consume more than 21 alcoholic drinks per week
* patients who are current smokers
* patients who are unable to provide informed consent or who have dementia
* patients with previous extensive meditation or yoga training
* patients with blood pressure ≥140/90
Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children

The current study will be directed to determine the effect of mechanical vestibular stimulation on fine motor skills and pinch strength in children with hemiparesis. Hemiplegic cerebral palsy causes problems with contraction, sensation, and muscular strength in the upper limbs, and its effective use of muscles for reaching, grasping, releasing, and manipulating objects is often compromised


Eligibility Criteria:
Inclusion Criteria:

* Children will be included in the study if they fulfil the following criteria:

  1. Diagnosed with hemiparetic cerebral palsy.
  2. Age ranged from 4 to 6 years.
  3. Children with spasticity grades ranged from 1 to 1+ according to Modified Ashworth Scale
  4. Both genders will be included.
  5. The child will be able to follow verbal commands and instructions.

Exclusion Criteria:

* Children will be excluded from the study if:

  1. Any congenital or developmental disorders in addition to hemiplegia cerebral palsy.
  2. Current hospitalization for urgent medical reasons.
  3. Severe mental retardation.
  4. Children having visual or auditory defects.
  5. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to the wrist and hand.
National Breast Cancer and Lymphedema Registry

The purpose of the National Breast Cancer Lymphedema Registry is to collect health information in order to study the lymphedema as a complication of breast cancer treatment. The investigators hope to learn whether early diagnosis will help to prevent lymphedema or, if it does occur, to reduce the severity.

Historically, breast cancer-associated lymphedema has been relatively ignored, with mis-diagnosis, late diagnosis, and failure to treat. The condition has a measurable, substantial impact on patient function and perceived quality of life (QOL). Recent pilot studies suggest that interventions that are designed to facilitate early diagnosis and preventive strategies have a major impact on the incidence and severity of disease burden. This registry is designed to prospectively capture the relevant data to document the impact of preemptive diagnostic and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivorship

Exclusion Criteria:

* Age \< 18 years old
Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus

New antibiotics are required to have not only the antibacterial activity against doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any cross-resistance to others.

In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were:

* Adults aged 18 years or older
* A fever of higher than 37.5°C
* The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort.
* Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.

Exclusion Criteria:

The exclusion criteria were:

* An inability to take oral medications
* Pregnancy
* Hypersensitivity to the trial drugs
* Previous drug therapy with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, fluoroquinolones or tetracyclines) within 48 h prior to admission
* Severe scrub typhus (shock requiring vasopressor therapy for more than one hour
* A stuporous or comatose level of consciousness
* Respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis) (4, 10).
* For the differential diagnosis of scrub typhus from other diseases with similar symptoms (e.g., murine typhus, leptospirosis, hemorrhagic fever with renal syndrome and systemic lupus erythematosus), patients underwent diagnostic tests. We thus excluded patients with concurrent infections who had the risk of causing different outcomes.
B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules

To compare the accuracy of the conventional Ultrasound 'TI-RADS', US elastography, DWI MRI, and its ADC value in characterization and differentiation of thyroid nodules.

Thyroid nodules are one of the most common endocrine carcinomata (1) Most thyroid tumors have a good prognosis if early diagnosis and timely treated (2) An Ultrasound (US) exam is a safe, non-invasive imaging technique for detecting thyroid nodules (3) However, still there are no dependable criteria to discriminate malignant from benign lesions. (4) In 2009, Horvath et al proposed the Thyroid Imaging Report and Data System (TI-RADS). The new version of TI-RADS was launched by ACR in 2017. (5) Color Doppler ultrasound is also used to differentiate benign from malignant thyroid nodules. The presence of intra-nodular vascularity (Type 1b) was considered close to be malignant (6) US elastography is a novel tool to increase the diagnostic value of Ultrasound and as an adjuvant tool (7) Shear wave elastography evaluates elasticity through the propagation speed of shear waves, with the wave speed being faster in hard tissue (8) Conventional T1-and T2-weighted MR imaging can-not differentiate benign from malignant nodules (9) Diffusion-weighted imaging (DWI) is a non-invasive tool used to distinguish benign from malignant nodules (10). Malignant thyroid nodules usually have a lower ADC value attributed to cellular density and tissue perfusion. (11) Combining subjective MRI features with a quantitative measurement could improve the diagnostic yield of DW-MRI (12) The cytological examination by fine-needle aspiration (FNA) has become a reliable tool to diagnose thyroid cancers (2) Suspicious cytological findings reach up to 30% of all aspirated nodules, suggesting the need for less invasive methods (13)

Eligibility Criteria:
Inclusion Criteria:

* Patients should have a normal bleeding profile.
* Presence of solitary or multiple nodules in the thyroid gland.
* In the case of patients having multiple nodules, the nodule having suspicious ultrasound features (having TI-RADS score 4 or 5) was selected for further analysis.
* The nodules were either solid or mixed (containing both solid and cystic parts) with a predominant solid component

Exclusion Criteria:

* Contraindicated biopsy (as thrombocytopenia or bleeding disorder).
* Patient with cystic and mainly cystic nodules (TI-RADS 1 nodules).
* Nodules with complete shell-calcification which may cause color mapping artifacts.
* MRI contraindications such as Claustrophobia, MR-incompatible pacemakers, and MR-incompatible prosthetic heart valves.
* Patients with recurrent thyroid masses.
* History of operative procedure, chemo, or radiotherapy on the thyroid gland.
* Declined consent.
Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent

The purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.

In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.

The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.

There are two types of biliary stent:

1. plastic stent made from polyethylene or polytetrafluoroethylene
2. metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.

The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.

In the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.

Eligibility Criteria:
Inclusion Criteria:

* All patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis
* Patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness

Exclusion Criteria:

* Patient with ASA 4 or 5
* Patient who inability to comply with follow up
* Patient refused to join the research
Tranexamic Acid in Pregnancies With Vaginal Bleeding

Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.

Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis, and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.

Eligibility Criteria:
Inclusion Criteria:

* pregnant woman having vaginal bleeding
* Second and third trimester of unknown etiology
* No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding
* Primigraivid, multiparous and grand multiparous woman
* Accept to participate in the trial

Exclusion Criteria:

* Hypersensitivity to tranexamic acid
* Women with acquired defective color vision
* History of venous thromboembolism
* Refused to participate
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.


Eligibility Criteria:
Inclusion Criteria:

Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.

Exclusion Criteria:

Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.
An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care

Americans only receive 50% of indicated preventive services. We hypothesize that an interactive preventive health record (IPHR) will increase the delivery of recommended screening tests, immunizations, and counseling. The IPHR will function as a highly sophisticated personal health record for prevention, linking patients directly to their health information in the electronic record of their primary care physician. The functions of the IPHR will extend beyond those of personal health records by providing tailored recommendations, links to educational resources and decision aids, and patient and clinician reminders. Year one will focus on updating and refining an existing IPHR prototype. The second and third year, through a randomized controlled trial, will examine the effectiveness of the IPHR. Outcomes will include (1) whether the IPHR increases the delivery of recommended preventive services, (2) whether participants use the IPHR, and (3) whether the IPHR increases shared decision-making and improves clinician-patient communication. The study will take place in seven primary care practices in the Virginia Ambulatory Care Outcomes Network (ACORN) that utilize a common electronic medical record (EMR). A randomly selected sample of 5,500 of the practices' 228,000 patients, stratified by age and gender, will be assigned in a one-to-one ratio to receive a request from their clinician to use the IPHR (intervention group) or receive "usual" preventive care (control group). A Preventive Services Survey, which uses standardized questions to evaluate the delivery of preventive care, will be mailed to 4,500 patients and the CAHPS Clinician \& Group Survey will be mailed to 1,000 patients. Surveys will be mailed pre-intervention, 6 month post-intervention, and 18 months post-intervention. Delivery of preventive care will be measured by the Preventive Services Survey and EMR data, while shared decision-making and clinician-patient communication will be measured by the CAHPS survey. The change from baseline to 6 and 18 months post-intervention for the control and intervention groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients seen in the study practices within the previous year

Exclusion Criteria:

* Age \<18 years
* Age \>75 years
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

The purposes of this study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

The safety associated with switching from a medication you may be taking for depression to taking duloxetine.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.


Eligibility Criteria:
Inclusion Criteria:

* You must be at least 18 years old.
* You must have been diagnosed with major depressive disorder.
* You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding.
* You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
* You have had a primary diagnosis of an anxiety disorder within the past 6 months.
* You have a history of alcohol or drug dependence or abuse within the past 6 months.
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Rectal Neoplasms.

By enrolling patients with unresectable Rectal Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Rectal Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Rectal Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Systematic Description of the Post EMR Defect

To date there are no available data on the utility of the endoscopic mucosal resection (EMR) defect in stratifying the risk of immediate or delayed adverse outcomes, particularly clinically significant post EMR bleeding (CSPEB).

The investigators aimed to analyse the data to determine if any of these EMR defect features allow us to estimate the risk of CSPEB. This will help endoscopists to identify defects with a high risk of adverse outcomes and may translate into improved patient outcomes.

CSPEB is the most frequent serious complication after wide-field EMR of laterally spreading lesions ≥ 20mm (LSLs). There is no proven therapy for CSPEB and it remains a significant drawback of EMR. Visible vessels within the post EMR defect (PED) present themselves as logical targets for prophylactic treatment to prevent CSPEB. However, the clinical significance of these vessels is largely unknown. In the majority of studies risk factors identified for CSPEB include right colon location, lesion size and aspirin use. The investigators aimed to systematically describe and evaluate the clinical significance of the various endoscopic features of the post EMR defect PED including visible vessels.

A prospective study of LSLs ≥ 20mm referred for EMR at a single tertiary referral center will be performed.

Data collection includes patient, procedural and lesion characteristics. In all cases a systematic description of the PED is undertaken. The data of particular interest to this study includes: use of blood thinners, PED features including size, number and herniation of visible vessels, submucosal haemorrhage, fibrosis, fat and exposed muscle and the rate of CSPEB.These features were analysed for significant association with CSPEB. CSPEB was defined as any bleeding occurring after the completion of the procedure necessitating emergency department presentation, hospitalization or reintervention. CSPEB was compared to features of the PED to detect significant associations, using chi2 or Fisher's exact tests. Significant univariate variables will be taken forward for binomial logistic regression modelling.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred for EMR of a LSL 20mm or larger
* Signed the informed consent

Exclusion Criteria:

* Clips used during the EMR procedure to close the defect, totally or partially
* Inadequate images to adequately assess the defect
* Use of blood thinners which have not been ceased according to the current guidelines for EMR
Clinical Guidelines in Premedication Visit

The purpose of the study is to determine the frequency with which individual guideline recommendations on preoperative evaluation of patients scheduled for non-cardiac surgery are implemented as well as identifying the guidelines that are most frequently violated.

This study is a monocentric retrospective analysis. Data are extracted from the electronic premedication protocol (premedication patient data management system, PDMS). A total of 2000 adult patients are randomly selected who were seen in the premedication outpatient clinic of Klinikum rechts der Isar between June 2018 and June 2020. The information from the premedication questionnaire will be transferred to a new premedication module. The new premedication software then outputs the appropriate guideline recommendations that would have been applicable in the particular case. Using a logic stored in this system, the current guideline recommendations of the European Society of Anaesthesiology (ESA) (De Hert, Staender et al. 2018) and the recommendations of the German Society for Anesthesiology and Intensive Care Medicine (DGAI) (Geldner 2017) that apply to the respective case are pointed out on the basis of the patient data entered, for example the recommendation to discontinue or change medication or the order of additional examinations such as pulmonary function testing or echocardiography.

By comparison with the old premedication sheet, it is determined which guideline recommendations were followed and which were not. The respective guideline recommendations and their compliance or non-compliance are transferred to a table for further evaluation. A random sample of 2000 patients will be studied.

Guideline adherence to each recommendation is determined, as well as the possible organizational reasons for not following them.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen in the outpatient clinic between June 2018 and June 2020

Exclusion Criteria:

* age\<18
Nutritional Support for Rehabilitation In Parkinsonism

This randomized, trial will tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o parkinsonism


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease o parkinsonism
* admission for physical rehabilitation
* Informed consent

Exclusion Criteria:

* Any malignant disease during the last five years
* Known kidney failure (previous glomerular filtration rate \<30 ml/min);
* Known liver failure (Child B or C)
* Psychiatric disease
* Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
* Indications related to the study product:

More than 10 μg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.

* Known allergy to milk, milk products or other components of the proposed interventions
* Indication to or ongoing artificial nutrition support
* Inclusion in other nutrition intervention trials
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Refusal