cyrilzakka/clinical-trials huggingface dataset:
Racial Distribution of Heterotaxy Syndrome

Heterotaxy syndrome is a heterogeneous disease that is the result of a failure of normal right-left lateralization of the abdominal and thoracic organs during development. The major clinical manifestations include intestinal malrotation, functional asplenia and complex cyanotic heart disease.

Hypothesis: There exists a yet, un-recognized, racial distribution in heterotaxy syndrome.

The exact etiology of heterotaxy is unknown, but presumed to be multifactorial. While candidate genes have been suggested, no common gene has proven responsible for this constellation of lesions. Various modes of inheritance have been described. Though there are reports of familial occurrences, no reports of racial/ethnic predominance exist. We, therefore, propose to examine the racial/ethnic distribution of heterotaxy syndrome with congenital heart disease in patients treated at this institution. In addition, the investigators will determine if race/ethnicity is a factor in clinical outcomes.

Aim 1: To determine any pattern of racial/ethnic predominance within a cohort of patients with heterotaxy syndrome with congenital heart disease.

Aim 2: To correlate race/ethnicity with disparities in morbidity and mortality in patients with heterotaxy syndrome with congenital heart disease.

This study will be a retrospective, chart review of approximately 90 - 100 medical charts, conducted on the Egleston campus of Children's Healthcare of Atlanta. Charts reviewed will cover a period between January 1, 1990 and December 31, 2005.

Data to be collected includes: DOB, diagnosis, surgical procedure, surgical outcome, survival, length of hospitalization, repeat surgical intervention, incidence of hospitalization, length of inotropic support, ventilator time, infection rate, insurance provider, list of antibiotics and zip code of residence at initial admission. In addition to the above information, data to be extracted from the medical chart of a decedent will include age at death, cause of death, laboratory data at time of death and autopsy results.

Eligibility Criteria:
Inclusion Criteria:

* All medical charts diagnosed clinically and at autopsy with heterotaxy syndrome, left atrial isomerism, right atrial isomerism or situs inversus totalis with congenital heart disease over a 16 consecutive year period at Children's Healthcare of Atlanta at Egleston.

Exclusion Criteria:

* Those who do not meet Inclusion Criteria
Examining Digital Health Care Delivery Models Through Medicaid Collaborative

The purpose of this study is to examine the intervention effectiveness and dissemination of digital health care delivery models for improving selected health outcomes in the Medicaid population.

The investigators will conduct a mixed method study that includes a controlled interrupted times series (CITS) design to study hypertension (HTN) and diabetes, a cohort to study pregnancy, and longitudinal patient and provider interviews to study experiences. This approach is appropriate when randomization is not desirable or feasible and is frequently utilized for evaluation of public health interventions (Lopez Bernal et al., 2018; Hategeka et al., 2020).

Eligibility Criteria:
Inclusion Criteria:

* Patient of one of four medically qualified health care centers and/or OSF HealthCare as defined by insurance type
* Insured by Medicaid or dually eligible for Medicare or Medicaid
* Has one or more of the three following conditions:

Hypertension, Diabetes Mellitus, or Pregnancy

* Able to read and understand English or read translated materials in language provided (e.g. Spanish)
* Minors who are pregnant and less 18 years of age who are enrolled in the MIC Program

Exclusion Criteria:

* Not enrolled in the MIC Program
* No one will be excluded on basis of sex or race
Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project

In a 3 years longitudinal, observational, multicentre study, about 500 women will be recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after delivery. The primary aim of the present study is to systematically explore and characterize risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of potential markers during the perinatal period (Life-ON study). Secondary aims are to explore the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3).

The characterization of specific predictive and risk factors for PND may substantially contribute to improve preventive medical and social strategies for the affected women. The study results are expected to promote a better understanding of the relationship between sleep disorders and the development of PND and to confirm, in a large sample of women, the safety and efficacy of BLT both in prevention and treatment of PND.


Eligibility Criteria:
Inclusion Criteria:

* Medically healthy
* Normal ocular function
* Gestational age between 10 to 15 weeks at time of screening
* Written informed consent

Exclusion Criteria:

* Diagnosis of bipolar I or II disorder (DSM-5)
* Recent history (less than 6 months) or current major depression or an Edinburgh Postnatal Depression Scale (EPDS) score \> 12 at time of inclusion
* Any psychotic episode, substance abuse, recent history of suicide attempt (less than 12 months)
* Use of antidepressants or other pharmacologic treatments for depression in the last 6 months
* Fetal malformations and intrauterine fetal death
Programmed Intermittent Epidural Bolus Compared With Continuous Infusion in Multiparous Women

The goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in multiparous women compared to continuous epidural infusion.

multiparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.

There are several pharmacological and non-pharmacological techniques for pain relief during labor. Epidural analgesia is considered the most effective modality for intrapartum pain relief.

Maintenance of epidural analgesia is achieved by different techniques; continuous epidural infusion (CEI), intermittent epidural analgesia (IEA), patient control epidural analgesia (PCEA) and combination between the techniques.

Another technique, the Programmed Intermittent Bolus Epidural Analgesia (PIBEA). The advantage of this technique is that boluses are given all the time at planned intervals, so laboring women do not depend on the medical staff to receive the bolus when there is a breakthrough pain.

This method has been reported to be associated with less motor block, lower incidence of instrumental vaginal deliveries, and less consumption of anesthetic agents when compared to CEI. There are no conclusive data regarding the use of PIBEA in combination with PCEA compared to CEI and PCEA on the effect of pain relief during labor and birth outcomes. The hypothesis of the current trial is that PIBEA and PCEA will decrease the incidence of breakthrough pain, and probably shorten the second stage of labor, lead to fewer instrumental deliveries and higher women's satisfaction compared to CEI and PCEA.

Eligibility Criteria:
Inclusion Criteria:

1. multiparous women
2. Term pregnancy
3. Singleton
4. Vertex presentation
5. Latent phase (cervical dilatation less than 6 cm)
6. Epidural analgesia request
7. Visual Analogue Scale score greater than 40

Exclusion Criteria:

1. Estimated fetal weight greater than 4.0 kg
2. Intra uterine fetal death
3. Drug sensitivity

5. Anomalous fetus 6. Contraindication for epidural analgesia
Vestibulo-Ocular Reflex for Balance and Stimming in Autism Spectrum Disorder

Autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, Communication and present with Rapid repetitive behaviors. Autism spectrum disorder also presents with inability of body to process sensory information which can causes symptoms such as balance deficits, sensitivity to certain sounds or an exaggerated reaction to a normal stimulus. Autism spectrum disorder can affect the quality of life of an individual to a severe extent. This disorder due to sensory processing deficits also shows difficulty in motor planning, coordination and execution of tasks which can make performing activities of daily living highly difficult to perform. It is called a developmental disorder because it affects the growth. Milestones are often delayed in individuals with autism. Due to these deficits individual with autism if not provided with therapies at the right age can stay dependent on caretaker for their whole life. Rapid repetitive behaviors also known as self-stimulatory behaviors are a way to compensate with anxiety, difficulty in processing sensory information and are often used to stimulate themselves to feel calm. Though not a diagnostic symptom autism often still presents with vestibular dysfunction which affects the balance. Several individuals with autism have showed abnormal vestibular ocular reflexes; abnormally long latency of saccades. Rehabilitation protocol of Autism often includes symptomatic treatment and several therapy protocols such as physical therapy, occupational therapy, applied behavior analysis therapy and play therapy.

Stimming behaviors and balance deficits play a huge role in life of an individual with autism. There is indeed a huge gap and lack of literature on how or if exercise protocols from physical therapy can influence balance and reduce stimming behaviors. Although, Previous studies have recommended that Balance and stimming are directly related and that vestibular dysfunction plays a huge role in frequency of stereotyped stimming behaviors. The aim of the study is to investigate the effects of Vestibulo Ocular reflex exercises on balance and frequency of stimming. This study will also influence how a physical therapist can improve quality of life of an individual with autism by reducing their stimming behavior. Earlier studies also mentioned that Vestibular ocular reflex is affected in kids with autism. Hence this study can play an important role in determining the direct connection between these behaviors, Vestibular ocular reflex and balance.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-18 years
* Both male and female
* Diagnosed Autism Spectrum disorder.
* Visual and/or Vestibular stimming diagnosed by physician.

Exclusion Criteria:

* Patients diagnosed with other neurological diseases
* Tumors or neoplasms
* Visual and auditory impairments
* Inability to respond to verbal command through verbal or non-verbal communication cues.
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis

The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

he role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* UC known and diagnosed by established clinical-endoscopic and histological criteria or newly-diagnosed UC, based on clinical and endoscopic findings, and about to start treatment with corticosteroids.
* current hospitalization with severe Ulcerative Colitis exacerbation as defined by a Lichtiger score of \>10
* age \>18
* if taking thiopurines, the dose must be stable for 2 months prior to admission

Exclusion Criteria:

* pregnant women
* allergy/unable to take study medications
* active infection
* severe renal/liver/cardiorespiratory condition
* toxic megacolon or signs of imminent colectomy
* treatment with an anti-tumor necrosis factor in 3 months prior to admission
* prior treatment with cyclosporin or tacrolimus
* alcohol dependancy
* unwilling/ unable to give an informed consent
* participation in clinical trials in the last 2 months prior to admission
The Effect of Facial Effleurage on Acute Rhinosinusitis

Rhinosinusitis accounts for 12% of the total antibiotic prescriptions filled in the United States annually; however, the majority of rhinosinusitis cases have been proposed to have a viral etiology, or are capable of spontaneously resolving. This overuse of antibiotics is contributing to the development of antibiotic-resistant human pathogenic bacteria, and increasing patient mortality to previously easily cured diseases. This is also causing an unnecessary financial burden especially for uninsured, rural families. Facial Effleurage (FE) is an osteopathic manipulative therapy that allows physicians an alternative therapy to prescribing antibiotics; however, the only scientific literature on the technique is weak in design and execution. This will be a randomized, placebo-controlled clinical trial to test the ability of FE to reduce symptom severity over time, reduce the cellular infiltrate into the nasal cavity, and to more quickly resolve the symptoms of rhinosinusitis compared to antibiotic treatment. This methodical approach to the efficacy of FE has the potential to impact the treatment recommendations of physicians immediately, and to convince more physicians to prescribe less antibiotics and rely more heavily on FE.


Eligibility Criteria:
Inclusion Criteria:

* Presents with no acute disease OR
* Presents with anterior/posterior mucopurulent drainage and nasal obstruction/facial pain/pressure/fullness
* Independently and without coercion read, understood, and signed the informed consent form
* Is between 18-69 years old.

Exclusion Criteria:

* History of: cancer, HIV, HIV exposure, osteoporosis, acute hepatitis, cystic fibrosis, type-1 diabetes, taking insulin for diabetes, deep vein thrombosis, pulmonary embolism
* History of recent trauma to the liver or spleen or surgery within the past 6 months
* Currently pregnant or nursing
* Have a comorbidity that requires antibiotics or antiviral therapy
* Have a fever greater than 102.5F
* Used topical antimicrobials in the past 30 days
* Taken oral antimicrobials in the past 15 days
* Participated in a clinical trial in the past 6 months
* Have current face or neck bone fractures
* Have abscesses, incisions, or nasal polyps visible on physical examination
* Need to be hospitalized for any reason
Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
* Duration of diabetes at least 12 months
* Body Mass Index (BMI) below 33 kg/m\^2
* HbA1c maximum 10 % based on analysis from the central laboratory

Exclusion Criteria:

* Current treatment with insulin above 1.2 U/kg/day
* Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
* Blood donation of more than 500 mL within the last three months
Physical Activity and Participation

The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.

Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among Veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.

Eligibility Criteria:
Inclusion Criteria:

* Veterans
* Aged 60 years or older
* Has Type 2 diabetes mellitus
* Able to operate accelerometer
* Competent to consent to the study
* No dementia diagnosis
* Ambulatory with or without assistive device
* English-speaking
* Community living (i.e., not a nursing home resident)
* Not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week)

Exclusion Criteria:

* Medically unstable
* Hospitalized within the last 6 months
* 2 or more days of complete bed rest in the last month
* hemiplegia or limb amputation
* Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study
* work involved in shift schedule
* current enrollment of a physical activity program
* replacement of hip or knee within the last 6 months.
* Parkinson's disease
* frequent falls
Woebot for Substance Use Disorders

Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.


Eligibility Criteria:
Inclusion Criteria:

* All genders
* 18-65 years
* Must have access to a smartphone and able to download the W-SUDs app
* Committed to engage with app and complete assessments
* Be willing to provide email address (to distribute incentives)
* Be literate in English (as W-SUDs conversational and video materials will be in English)
* Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs for problematic use

Exclusion Criteria:

* Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
* Suicide attempt or within the past year
* Drug or alcohol overdose within the past year
Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer

The purpose of this study is to monitor:

* Tumor biological alterations following two weeks of neo-adjuvant statin therapy.
* Effects of statins on tumor proliferation.
* Functional studies on the mevalonate pathway.

Blood samples and three core biopsies are taken after diagnosis. Treatment with atorvastatin at a daily dosis of 80 mg is initiated 14 days before planned surgery. Translational research will be performed from the core biopsy and blood samples taken before surgery and from the specimen from surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women with primary breast cancer who are candidates for radical surgery.
* Breast tumours clinically ≥ 15 mm, Nx, M0.
* Breast tumours identified on mammography and verified on fine needle aspiration.
* Age \> 18 years.
* Performance status of ECOG ≤ 1.
* Laboratory requirements at the day of diagnosis (t1-):Prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
* Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
* Negative pregnancy test for pre menopausal women before inclusion in the trial

Exclusion Criteria:

* Ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
* Prior breast cancer treatment.
* Current HRT.
* Known liver disease.
* History of hemorrhagic stroke.
* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
* History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
PTSD Mobile App for Cancer Survivors

The purpose of this study is to use a stepped-care approach in treating symptoms of posttraumatic stress disorder (PTSD). The information learned by doing this study may help us to develop some target treatments for PTSD symptoms in survivors of stem cell transplant.

Participants in this study will be randomized to a mobile app or usual care. An assessment will be made after 4 weeks and a determination made of adding more intensive treatment. Participants will be asked to complete a questionnaire 4 times over a period of 6 months, at the time your participation is complete.


Eligibility Criteria:
Inclusion Criteria:

* Completion of autologous or allogeneic HCT 1-5 years previously
* Partial or complete remission (NED), may be receiving chemoprevention
* Absence of severe psychological impairment (eg hospitalization for suicidality)
* Approved for contact by oncologist
* Able and willing to participate in a one-hour baseline interview
* No prior CBT for PTSD
* Owns a smart device with internet and email access
* Able to read and write English
* Significant PTSD symptoms as indicated by at least one of the following two criteria: probable cancer-related PTSD on the PCL5 by using the symptom cluster criteria; subthreshold or partial PTSD symptoms as determined by endorsement of reexperiencing cluster and less than or equal to 1 other symptom cluster

Exclusion Criteria:

* If the participant does not fulfill the inclusion criteria