cyrilzakka/clinical-trials huggingface dataset:
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation

The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).


Eligibility Criteria:
Inclusion Criteria:

* Patient has a St Jude Medial device that is compatible with Merlin.net (remote monitoring)
* Patient has history of atrial fibrillation (non-continuous)
* Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation
* Patient is willing to complete a questionnaire

Exclusion Criteria:

* Patient is in atrial fibrillation all of the time
* Patient has a history of stroke or blood clot
* Patient is on warfarin or coumadin
* Patient cannot be taken off of his blood thinner medication due to another medical condition
* Patient is not capable of sending a remote device transmission to doctor once a week
Pedometers for Gestational Diabetes

Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized during pregnancy, develop diabetes within 5 years after delivery. Although intensive interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is unknown if such strategies would be effective in women with GDM. Women with recent GDM, even though no longer pregnant, face significant barriers to lifestyle modification, including caregiving responsibilities and low perception of risk. Web-based programs can reinforce physical activity through visual feedback of pedometer output, tailored messaging, education, and on-line communities. Such a program is currently available for adults with chronic disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot and feasibility study of the program. The intervention will last 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Gestational diabetes diagnosis within past three years
* Access to computer with internet, USB port and Windows XP or Vista
* Regular email user (weekly or more)
* Can walk a block on her own
* Sedentary (less than 150 minutes purposeful physical activity per week)

Exclusion Criteria:

* Pregnancy
* Unable to consent legally
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.

This is an open-label, single site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of normal BMI or high BMI. The objective of the study is to determine the effects of an estradiol patch on luteinizing hormone rise in both cohorts. The study consists of 2 periods: a screening period of up to 3 weeks and a Treatment Period of 7-10 days. During the treatment period participants will wear estradiol patches for up to 7 days and have on blood draw on day 3 of wearing the patches. Participants will also collect daily morning urine for all the days they wear the patches. Participants will use a reliable barrier method of birth control or abstain from intercourse for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-38
* Regular menstrual cycles every 25-35 days
* No use of reproductive hormones within the past 3 months
* No use of medications interacting with reproductive hormones
* Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study
* Normal thyroid stimulating hormone, prolactin and lipid profiles
* No more than 4 hours of moderate to vigorous intensity exercise per week
* No history of chronic disease impacting reproductive hormones
* No contraindications to administration of estradiol
* No history of estrogen dependent cancer
* Negative pregnancy test

Exclusion Criteria:

* Has diabetes
* Is a smoker
* History of venous thromboembolism or known thrombophilia
Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery

The primary objective of this study is to demonstrate the feasibility of using a Finite Element model of pelvic organs by evaluating the concordance of pelvic organ mobility measurements performed by this mechanical model compared to the observations on the post-operative pelvic MRI in patients undergoing a sacrospinofixation surgery


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 80
* With at least a grade II apical prolapse according to the POP-Q classification
* Treated with a sacrospinous ligament fixation (SSF) by the vaginal route

Exclusion Criteria:

* History of abdominal, pelvic, vaginal or vulvar surgery except hysterectomy
* Association of another POP or urinary incontinence surgery (subvesical plication, levator myorrhaphy, plication of anterior rectal wall, perineorrhaphy ...)
* MRI contraindication
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study
Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors

This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand this study and voluntarily sign the ICF.
* Age 18-75 years, no gender restriction.
* Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.

Exclusion Criteria:

* Medical history, CT scan, or MRI indicates the presence of CNS metastases.
* Other malignancies within 5 years.
* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
Effects of Multi-direction Stepping and Weight Shifting Exercises in Stroke Patients

Stoke is a leading cause of disability that results not only in persistent neurological deficits but also profound physical de-conditioning that propagates stroke-related secondary disability. Several kinds of research have reported that there has been asymmetrical weight bearing on the affected side while sitting and standing resulting in impaired performance especially reaching in sitting, rising from the chair, walking, and climbing stairs. Despite the stroke patient being able to walk independently with or without the walking aids, the patient still lacks the normal movement pattern especially weight transfers on the affected side while performing such activities which subsequently decreases the patient to restrain the challenges while walking, decrease confidence in functional activities. Also, further, there hasn't been enough literature on this topic. Therefore, the objective of this study is to find out the effectiveness of multidirectional stepping and weight shifting exercises to improve dynamic balance and gait speed in stroke patients.

The twenty-four subjects who fulfilled the inclusion criteria were selected for the study and were randomly assigned into two groups of 12 subjects each by simple random sampling based on inclusion criteria. First, all the subjects were assessed with a detailed neurological assessment form after the consent form was taken from the patients. The experimental group was given multidirectional stepping exercise with conventional therapy whereas are control group was given only conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stroke via CT Scan or MRI
* Maintain the independent standing posture for 30 sec
* Ability to walk 3 meters independently without an assistive device
* Mini-Mental status examination score \>21 points
* Could communicate and understand therapist's verbal command
* Voluntary agreed to participate in the study
* Age above 18 years old
* Medically stable (e.g. recent myocardial infarction, unstable angina, ventricular tachycardia)

Exclusion Criteria:

* Visual disorders and visual deficits
* History of any neurological pathology like Parkinson's or Alzheimer's disease
* Conditions affecting balance like vertigo
* Medications affecting balance
* Dementia
* Impaired conscious level or concomitant medical illness
* Lower Motor Neuron lesions
* Anti-spasmodic medication (e.g. Baclofen, Dantrolene Sodium, etc.)
* Severe orthopedic diseases in lower extremities (e.g. Osteoarthritis, fracture, sprain, strain)
Study of Nontuberculous Mycobacterial Lung Disease

The incidence of pulmonary disease caused by nontuberculous mycobacteria (NTM) has been increasing, and a substantial proportion of these patients have no preexisting lung disease and no demonstrable immunodeficiency. These patients are predominantly nonsmoking elderly women. High-resolution computed tomography scans revealed the characteristic findings of multifocal bronchiectasis combined with multiple small nodules. NTMs are ubiquitous environmental organisms. Because exposure to these organisms is universal and the occurrence of the disease is rare, normal host defense mechanisms must be effective enough to prevent the infection.

All patients with NTM lung disease do not need to receive long-term antibiotic treatment. As the American Thoracic Society guidelines point out, one of the most difficult questions may be when to start antibiotic therapy in patients with NTM lung disease. The decision to begin treatment is made by weighing the anticipated benefits and risks. The decision is relatively easy in patients with profound symptoms and destructive lesions; however, the decision is difficult in patients with mild symptoms and non-advanced lesions. Factors that must be considered include the patients' age, whether the symptoms are mild or equivocal, and the presence of comorbidities. In all cases, close observation is necessary if treatment is not performed. However, few studies have shown that patients with certain characteristics show disease progression.

The treatment of NTM pulmonary disease depends on the infecting species, but decisions concerning the institution of treatment are never easy. Treatment requires the use of multiple drugs for 18 to 24 months. Thus, treatment is expensive, often has significant side effects, and is frequently not curative. Therefore, clinicians should be confident that there is sufficient pathology to warrant prolonged, multidrug treatment regimens. In all of the situations, outcomes can be best optimized only when clinicians, radiologists, and laboratories work cooperatively.

This study will examine why some people are more susceptible to NTM lung disease and why some people of NTM lung disease are more difficult to treat. This study will examine the patient and bacterial characteristics, course of disease and treatment of NTM infections, as well as the genetics involved in these infections.

Patients with diagnosed NTM lung disease may be eligible for this study. All participants will have a medical and family history, blood tests, imaging studies that may include X-rays, computed tomography (CT) scans, and genetic and serologic studies. The aim of this study is to identify patient and bacterial characteristics that contribute to disease susceptibility, disease progression, and treatment failure. Subjects are recruited from among patients who are diagnosed to have NTM lung disease at the Samsung Medical Center in the Republic of Korea.


Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill the diagnostic criteria of NTM lung disease

Exclusion Criteria:

* Non-applicable
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)

This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).

Partial funding for this study was provided by the Office of Orphan Product Development (OOPD).

Asfotase Alfa was formerly referred to as ENB-0040

Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility Criteria:
Inclusion Criteria

* Patient completed participation in ENB-002-08 (NCT00744042)
* Written informed consent by parent or other legal guardian prior to any study procedures being performed
* Parent or other legal guardian willing to comply with study requirements

Exclusion Criteria

* History of sensitivity to any of the constituents of the study drug
* Clinically significant disease that precludes study participation
* Enrollment in any study (other than ENB-002-08) involving an investigational drug, device, or treatment for HPP (e.g., bone marrow transplantation)
Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône

The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. One of the major issues for these ever-increasing survivors is the prevention of recurrence. According to data from the 3 French registries, more than 20% of patients have at least one recurrence. Secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence.

This evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in patients included in the STROKE 69 cohort.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients treated for a stroke suspicion at the acute phase,
* with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
* Managed by the Rhône's emergency medical help service (SAMU), in one of the emergency unit or stroke unit of the Rhône area
* Having given their written consent for the extraction of their healthcare consumption data from the Health Insurance databases

Exclusion Criteria:

* Hemorrhagic stroke,
* Patient institutionalized in the year following the stroke / transient ischemic attack,
* Patient unable to take treatment alone.
Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess

The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.

The emergence of community acquired methicillin-resistant Staphylococcus aureus (MRSA) as a pervasive cause of skin and soft tissue infections has increased the number of children requiring incision and drainage (I\&D) procedures and heightened concerns about the optimal treatment strategy. Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with minor MRSA skin and soft tissue abscesses suggest that I\&D alone is sufficient therapy. However, given concerns about the pathogenicity of MRSA infections, many patients who require hospital admission and I\&D in the operating room receive postoperative antibiotics. The primary objective of this randomized controlled trial is to compare the effect of 5 days versus 1 day of postoperative antibiotics on the rate of treatment failure following I\&D of abscesses in children in the era of pervasive MRSA infection. Secondary outcomes to be measured include incidence of additional skin and soft tissue infections in other body sites and incidence of these infections in family members and household contacts. Prospective data will be collected from wound cultures, as well as from nasal, rectal and skin cultures sent at the time of initial I\&D to assess for MRSA carrier status. Finally, survey data will be used to assess epidemiologic risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Children between 1 month and 17 years of age who undergo Incision and Drainage of a skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty.

Exclusion Criteria:

* Children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge will be excluded.
* Children with surgical site infections will be excluded.
* Children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.
* Patients admitted to the Infectious Disease service may be excluded at the discretion of the ID attending.
* Patients who are found to have no discreet fluid collections at the time of attempted incision and drainage will be excluded.
* Patients allergic or intolerant to both bactrim and clindamycin will be excluded.
* Patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess (as determined by intraoperative measurements) will be excluded.
Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.

This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers.

The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups.

To determine whether there is a statistically significant interaction between factors "group" and "time" on the titer of IgG antibodies against SARS-CoV-2, a two-way repeated measures ANOVA will be used.

In both groups level of IgG antibodies against SARS-CoV-2 will be measured at the Day 1 (10 weeks from the date of first symptoms), Weeks 8 and 16 from the Day 1.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* SARS-CoV-2 infection within 10 weeks prior enrollment, confirmed by PCR or strongly suspected on computed tomography
* Providing informed consent

Exclusion Criteria:

* Refusal to provide informed consent
Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures

The primary objective of the investigators randomized controlled trial is to determine if early protected weightbearing and ankle range of motion after surgical treatment (open reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.

This is a randomized controlled trial comparing early weightbearing and mobilization VS immobilization and non-weightbearing after initial treatment of unstable ankle fractures.

The primary objective of our randomized control trial is to determine if early protected weightbearing and ankle range of motion post open reduction internal fixation (ORIF) for unstable ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.

Our secondary objective is to determine the rate of adverse events (wound healing, infection, hardware failure) with early weightbearing and ROM comparable to rates with traditional post-op ankle immobilization.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral unstable ankle fracture requiring surgical stabilization
* Treatment within two weeks of injury
* Closed or low grade open ankle fracture (grade 1 and/or 2)
* Skeletally mature

Exclusion Criteria:

* Skeletally immature
* Previous ipsilateral ankle surgery
* Bilateral ankle fractures or other major injuries that would affect recovery time
* Grade 3 open fractures
* Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient)
* Non-ambulatory pre injury
* Tibial plafond fractures including articular impaction requiring elevation
* Syndesmosis injury requiring fixation
* Posterior Malleolus fracture - more than 25% of articular surface
Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment

The purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.

The current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe TBI with documented impairment in PS. The goals of the trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. Individuals with moderate to severe TBI, with documented impairment in PS, will be randomly assigned to a treatment group or a control group. Both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday life.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Traumatic Brain Injury or Mild cognitive impairment
* Fluent in English
* processing speed impairment

Exclusion Criteria:

* prior stroke or neurological disease
* currently taking steroids and/or benzodiazepines
* history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
* significant alcohol or drug abuse history