cyrilzakka/clinical-trials huggingface dataset:
The Effect of Tele-Health Education Provided in the Postpartum Period in the Covid 19 Pandemic

In the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.

In the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.

Eligibility Criteria:
inclusion Criteria

* literate
* Giving birth at term (between 38-42 weeks of gestation)
* Being on the 7th Postpartum Day,
* Participation in the study is voluntary,
* Absence of any psychiatric illness,
* Women who have characteristics such as not using any psychiatric medication.
* Baby with normal birth weight and APGAR score of 8 and above
* Those who have not developed postpartum complications
* Speaks and understands Turkish

Exclusion Criteria:

women who do not meet the sample selection criteria

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Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children

In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of IL-1β and its receptor antagonists in patients with severe sepsis and septic shock is discussed controversially. To date, the efficacy and safety of IL-1β and its receptor antagonists in children with severe infection is not fully evaluated.

The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded. Patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record.

Eligibility Criteria:
Inclusion Criteria:

* Children between 29 days and 18 years old.
* Severe pneumonia and/or sepsis.
* Patients were included who meet the guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children.

Exclusion Criteria:

* Notifiable infectious diseases.
* The researcher believes that he is not suitable to participate in other situations in this study.
* Participants in other clinical trials in the same period.
* Discharge within 48 hours
Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults

Investigators would like to examine, what are strategies for balance recovery in gait perturbations. Different perturbation types where used in the current study. The study involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that research including young healthy adults would help to elaborate fall prevention program for seniors.


Eligibility Criteria:
Inclusion Criteria:

* age 18-35
* female or male
* good health condition

Exclusion Criteria:

* lower limb injuries (last 6 months)
* head injuries (last 6 months)
* diseases of the vestibular system
* serious eye defects
* extreme sports athletes
Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation

To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.

Atrial fibrillation (AF) impose a substantial and growing economic burden on health care expenditures. In patients with persistent AF, there are fundamentally two ways to manage the arrhythmia: to restore and maintain sinus rhythm (rhythm control) or to allow AF to continue and ensure that the ventricular rate is controlled (rate control). As it has been stated, it goes without saying that if we could prevent atrial fibrillation (AF) or restore and maintain sinus rhythm in patients suffering from persistent AF, without any penalties due to the unwanted effects of drugs or incomplete suppression of AF and its thromboembolic complications, every physician would do so. Current strategies however, are limited to achieve such desirable goal. In the last years a growing amount of evidence and attention regarding the cardio-protective role of Omega 3 fatty acids (n-3 PUFA) became progressively clear and appealing.

Epidemiological studies and randomized controlled trials confirms the role of n-3 PUFA in reducing all cause mortality and cardiovascular events mostly in patients at high cardiovascular risk. These effects seems to be mediated mostly by an anti-arrhythmogenic effect.

Basic science confirms and extended clinical observations regarding the antiarrhythmogenic effect of these compounds. Recently both basic research and clinical science suggested a role of n-3 PUFA for the prevention and treatment of supraventricular arrhythmias, particularly AF.

The purpose of the study is to show that the addition of n-3 PUFA on the top of the best recommended therapies can improve the maintenance of normal sinus rhythm in patients with persistent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation

Exclusion Criteria:

* Contraindications or known hypersensitivity to n-3 PUFA
* Current treatment with n-3 PUFA for any reason
* Heart failure NYHA class IV
* Coronary artery bypass surgery or valve replacement within the past 3 months
* Planned cardiac procedures
* Known sick-sinus syndrome
* Diagnosis of Wolff-Parkinson-White
* Clinical significant valvular etiologies
* Presence of arrhythmia associated with an acute reversible condition
* Advanced chronic lung disease
* Contraindications for anticoagulation therapy
* Pregnancy or lactation
* Any non cardiac illness associated with a life expectancy of \< 2 years
* Treatment with any investigational agent within 3 month before randomization
* Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler

Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD) performed and a comparison of timing, sensitivity and intensity of intravenously injected bubbles will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Patients needing a TEE evaluation to rule out a cardiac source of brain emboli

Exclusion Criteria:

* Patients unable to comply with protocol requirements
* Patients unable or unwilling to sign informed consent
Screening Epidemiological Program on Compensation Evaluation of Diabetes Mellitus Type 2 (DMT2) Patients on Oral Anti-diabetic (OAD) Monotherapy and Physicians Satisfaction of Their Usage

The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients have an established diagnosis of T2D
* Experience of therapy with one OAD during the from 6 months to 5 years before the registration in the Program

Exclusion Criteria:

* Experience of therapy with two or more OADs and/or insulin therapy and/or incretin mimetics (exenatide) at any time before registration in the Program
* Absence of changes in HbAc1 level during the last year before registration in the Program
Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens

The aim of this study is to define silent breast cancer prevalence in both sexes and will be held by biopsies performed in imaging suspicious areas of the breast (ecography and mammography) in cadavers without known breast cancer.

Cadavers of both sexes are going to be submitted to bilateral mastectomy. The specimens are going to be examined by palpation, ecography and mammography and all areas with (Breast Imaging Reporting and Data System) BI-RADS classification \>= 3 are going to be biopsied.

Biopsy specimens are going to be processed by the pathology department and cancers are going to be identified and classified by their molecular type.

The investigators intend to know which is the disease reservoir in various ages.

Eligibility Criteria:
Inclusion Criteria:

* Female and male cadavers above 40 years

Exclusion Criteria:

* Known breast cancer
* Breast tissue accidental damage
Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease

Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias. A drug called amantadine can reduce these movements. To date, there are no objective measures of these movements. The purpose of this study is to measure the reduction of the movements by amantadine and/or topiramate using an objective measure.

Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Currently, one of the very few treatments for these unwanted and involuntary movements is Amantadine. New options to treat dyskinesia would be clinically very valuable. In a previous study, we developed an objective measuring device to quantify dyskinesia.

All PD participants will receive all three of the drug treatment intervention (placebo, Amantadine 300 mg, Amantadine 300 mg plus Topiramate 150 mg). After 2 weeks of one drug treatment, the participants will complete an overnight visit at the OCTRI Inpatient unit. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100. The subjects will be split into 'high' and 'low' dose groups. Those who take \<50 mg/hour of oral levodopa or levodopa equivalents will be considered 'low' dose subjects and will receive 1 mg/kg/hr of IV Levodopa during the study visits (1, 2, and 3). Those who administer \> 50 mg/hr of oral levodopa to themselves normally will be considered 'high' dose subjects and will received 1.5 mg/kg/hr levodopa. Both groups will receive the infusion for two hours from 0900 - 1100. The study drug will be taken orally at 0800.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease
* At least 21 years of age
* Must be taking Oral levodopa
* Must have dyskinesias by history or previous clinical observation

Exclusion Criteria:

* Significant cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA) score of \< 25
* Subjects with unstable medical or psychiatric conditions (including hallucinations)
* Use of dopamine receptor blocking medications (e.g., neuroleptics, certain antiemetics, tetrabenazine)
* History of unstable medical conditions (ie active cardiovascular disease, recent unwellness or surgery etc.)
* Use of anticoagulants
* Current substance abuse
* Previous adverse event on amantadine
Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study

The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with treatment naive nasopharyngeal carcinoma who had finished radiotherapy for 6 months or more
* The previous magnetic resonance imaging examination had showed complete remission in the primary site
* Images are acquired using a 3T magnetic resonance imaging device, including unenhanced T1-weighted and T2-weighted sequences and contrast-enhanced T1-weighted sequences

Exclusion Criteria:

* Patients are enrolled in this study for a specific magnetic resonance imaging scan and not for subsequent follow-up magnetic resonance imaging scans.
HBOT and Exercise Recovery

The purpose of this pilot study is to investigate the effect of hyperbaric oxygen treatment on recovery from exercise in high performance athletes. Outcome measures will be both physical outcome measures from a force plate, as well as physiologic measures of recovery (including blood lactate and muscle oxygenation) and perceived rates of exertion and recovery.

Initial visit to discuss the study and obtain consent. At this visit, baseline subject demographics (height, weight, body composition) and a medical history will be taken to confirm that there are no medical contraindications to either exercise or HBOT. This visit will likely take 30-45 minutes.

There will be 15 subsequent visits. Each of these visits will be conducted concurrent with their standard off-season workouts. An additional 15 minutes per workout session may be required for the collection of study-related, non-standard of care, outcome measures.

During the second week of the study, the experimental group will have four daily 90 minute sessions of HBOT. Travel time from the site of their workouts (West Haven CT) to the HBOT facility (Bridgeport Hospital) is approximately 20 minutes.

Immediately following exercise, each experimental subject will be fitted with the surface muscle oxygenation monitor on their vastus lateralis. This monitor (Moxy, Fortiori Design LLC) utilizes near-infrared spectroscopy. The monitor will be applied to the distal third of the vastus lateralis muscle (12cm above the knee joint) as identified and marked by the PI (an orthopaedic surgeon). This will provide continuous muscle oxygenation report following exercise, including during and immediately after the HBOT treatment.

Both the experimental and control groups will have blood lactate measurements taken within 15 minutes before the start of their daily exercise, as well as within 5 minutes of the completion of exercise, utilizing The Edge blood lactate monitoring system (Apexbio, Taiwan). Once per week the performance of The Edge monitor will be validated utilizing The Edge Lactate Control Solution.

The Edge monitor measures blood lactate from a drop of blood from a finger tip applied to a sterile lancet. The result is reported in approximately 45 seconds.

Eligibility Criteria:
Inclusion Criteria:

* Yale University varsity student-athletes
* Cleared for unrestricted participation in varsity athletics training at the time of data collection
* No implantable electronic medical device (ie. Deep brain stimulator or insulin pump) or with other contraindication to HBOT
* Those who consent to participation
GalaFlex Mesh in Facelift

In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
* Be at least 21 years of age.
* Be willing and able to comply with the requirements of the protocol.
* Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
* Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.

Exclusion Criteria:

* Subject is unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
* Subject has known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies.
* Subject has any serious skin disease, e.g., Eczema and psoriasis of the face, severe rosacea, scleroderma, local infections and severe acne.
* Subjects has diabetes, coagulation disorders, connective tissue disorders, lipodystrophy, or other serious systemic disease.
* Active herpes labialis
* Subject is infected with HIV and/or received or may receive immunosuppressive therapy over the course of the study (such as rheumatoid arthritis).
* Received any experimental drug or device within the previous three months.
* Known alcohol or drug abuser.
* Female subject who is pregnant or lactating or intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
* Possesses any psychological condition, or is under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s),would constitute an unwarranted risk.
* Presents with severe jowling or severe cervical skin redundancy.
* Subject is currently a smoker or is a prior smoker who quit in the last 12 months.
* Active abscess or infection
* Currently involved with claims for, or is accepting, workers compensation
* Currently engaged in medical malpractice litigation.
P60 Program Project Grant-Outreach for Smoke-Free Homes

Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. This study focuses on learning how to make your home smoke-free.

This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.

Those randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.

Eligibility Criteria:
Inclusion Criteria (adult):

* Age 18 years or older
* Female
* Smoked ≥ 1 cigarettes per day for at least the past 6 months
* Smoked on 20 days or more in the last month
* Smoking status confirmed via cotinine verification strips
* Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver
* Will agree to provide a urine sample at study enrollment
* Will also agree to the child providing a urine sample at study enrollment and at follow-up visits (for children who are not toilet trained, a diaper sample will be collected in lieu of the urine sample)
* Has a home address
* Has a functioning home phone or cell phone
* Provides written informed consent

Inclusion criteria (child):

* \< or = 10 years of age
* Non-smoker -no cigarette use within prior 30 days to enrollment; however experimentation with smoking (a puff) will not exclude the child
* Lives in the primary home with the adult study participant at least 5 days a week

Exclusion criteria (adult):

* Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation
* Planning to move outside of Minnesota within the next 3 months
* Have complete home smoking restrictions currently in place verified by the nicotine dosimeter
* Currently pregnant
Minimum Effective Volume of 0.375% Bupivacaine in Interscalene Brachial Plexus Block

The use of ultrasound in regional anesthesia enables reduction in the local anesthetic volume. The present study aimed to determine the minimum effective volume of 0.375% bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery. Following approval by the Research Ethics Committee, patients with a physical condition of I or II according to the American Society of Anesthesiologists, between 21 and 65 years old and subjected to elective surgery of the shoulder and interscalene brachial plexus block will be recruited. The volume of the anesthetic will be determined using a step-up/step-down method and based on the outcome of the preceding block. Positive or negative block results in a 1mL reduction or increase in volume, respectively. The success of the block is defined as the presence of motor block in two muscle groups and the absence of thermal and pain sensations in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis, pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will undergo statistical analysis in order to determine minimum effective volume of 0.375% bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function, evaluate diaphragm paralysis and its influence in pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 65 years
* Candidates for an elective surgical intervention on the shoulder with indication for anesthesia via brachial plexus block
* Physical condition of I or II according to the American Society of Anesthesiologists
* Body mass index up to 35 kg.m-2

Exclusion Criteria:

* Chronic obstructive pulmonary disease
* Cognitive impairment or active psychiatric condition
* Infection at the site of the puncture for the block
* Coagulopathy
* Bupivacaine allergy
Left-colon WEC May Reduce Insertion Time Compared With Whole-colon WEC.

In most of situation, left colon (especially SD junction) is considered the most difficult part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and patients may feel pain or uncomfortable. It is suggested more than half of the whole time for scope insertion should be used in left colon. Many methods, such as water immersion, abdominal palpation, have been used to facilitate insertion in left colon.

Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing medication used, pain experienced during colonoscopy, increasing the success rate of cecum intubation and adenoma detection rate in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents lengthening and distension of the colon during colonoscopy. This will facilitate the colonoscopy in average or difficult colonoscopy. However, it is not known whether the benefits of water exchange method of colonoscopy was mainly due to its effect on the left colon.

We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect regarding the maximal pain score and mean pain score in unsedated patients compared with whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion time compared with WWE. Here we performed a prospective, randomized controlled study to investigate the efficacies of whole-colon water exchange, left-colon water exchange and air methods of colonoscopy on pain score and insertion time in unsedated outpatients.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with unsedated colonoscopy

Exclusion Criteria:

* history of colon resection
* severe colonic stricture or obstructing tumor
* hemodynamic instability
* current pregnancy
* inability to provide informed consent