cyrilzakka/clinical-trials huggingface dataset:
Sí Texas Hope Family Health Center

This study evaluated whether uninsured patients living at or below 200% of the federal poverty level who received enhanced, culturally-relevant, integrated behavioral health services were more likely to improve health outcomes after 12 months compared to similar patients receiving usual care from Hope Family Health Center (HFHC), a charitable community clinic. The study employed a randomized control trial (RCT) design where intervention participants receiving integrated care at HFHC were compared to control participants receiving usual care at HFHC. Patients were placed in each group using simple random assignment. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data were subsequently collected at 6-month and 12-month follow-up points.

This study evaluated whether uninsured patients living at or below 200% of the federal poverty level who received enhanced, culturally-relevant, integrated behavioral health services were more likely to improve health outcomes after 12 months compared to similar patients receiving usual care from Hope Family Health Center (HFHC), a charitable community clinic. The study employed a randomized control trial (RCT) design where intervention participants receiving integrated care at HFHC were compared to control participants receiving usual care at HFHC. Patients were placed in each group using simple random assignment. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data were subsequently collected at 6-month and 12-month follow-up points. The primary outcomes of interest were systolic and diastolic blood pressure and depressive symptoms. Additional secondary outcomes of interest were HbA1c and BMI. These outcomes were analyzed as continuous variables using linear regression with backward model selection. Longitudinal analyses were also conducted using a likelihood-based approach to general linear mixed models. The participants (1) resided in Cameron, Hidalgo, Willacy, or Starr County, (2) were eligible to receive behavioral health services from HFHC (e.g., uninsured, living at or below 200% of the federal poverty level, residence in HFHC's service area), and (3) had a diagnosis of hypertension (blood pressure of 140/90 mm Hg or higher) and/or obesity (body mass index of 30.0 or higher) and/or poorly controlled diabetes (HbA1c over 6.8) and/or moderate depression (score of 10 or above on PHQ-9).

Eligibility Criteria:
Inclusion Criteria:

* Reside in Cameron, Hidalgo, Starr, or Willacy County
* Were eligible to receive behavioral health services from HFHC (e.g., uninsured, living at or below 200% of the federal poverty level, residence in HFHC's service area)
* Have a diagnosis of one or more chronic conditions:
* Hypertension (blood pressure of 140/90 mmHg or higher)
* Obesity (body mass index of 30.0 or higher)
* Poorly controlled diabetes (HbA1c over 6.8%)
* Moderate depression (score of 10 or above on PHQ-9)

Exclusion Criteria:

* Not actively suicidal at time of enrollment
A Study of Deflazacort (Emflaza®) in Participants With Limb-Girdle Muscular Dystrophy 2I (LGMD2I)

This study is designed to evaluate the safety and efficacy of deflazacort in participants with LGMD2I. Most participants enrolled will have a screening visit and 3 additional visits (after 1, 13, and 26 weeks of treatment).


Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of LGMD2I (confirmed mutation in the fukutin-related protein \[FKRP\] gene).
* Ability to ascend 4 stairs greater than or equal to (≥) 2.5 seconds and be able to complete the ascent and descent both at screening and baseline.
* Ability to understand the nature of the study and the consent form and to comply with study related procedures.
* Must weigh between 35 to 112.5 kilograms (kg).

Exclusion Criteria:

* Received ≥4 weeks of continuous, systemic corticosteroid therapy within 3 months of study screening visit.
* Presence of significant cardiomyopathy as defined by echocardiogram (left ventricular ejection fraction less than (\<) 30 percent \[%\]) at screening.
* Requires fulltime ventilator support.
* History of chronic systemic fungal or viral infections.
* History of recent bacterial infection (including tuberculosis) per discretion of the Investigator.
* Diagnosis of diabetes mellitus (controlled and/or uncontrolled) defined as glycated hemoglobin (HbA1c) ≥6.5% (based on historical or present diagnosis).
* History of immunosuppression or other contraindications to glucocorticosteroid therapy.
* Requires concomitant use or greater than (\>) 1 week of drugs or substances that are moderate to strong cytochrome P3A4 (CYP3A4) inhibitors (for example, clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) or moderate or strong CYP3A4 inducers (that is, rifampin, efavirenz, carbamazepine, phenytoin) at baseline.
* Participated in an interventional clinical trial within the last 3 months prior the baseline visit.
* Unable or unwilling to comply with the contraceptive requirements of the protocol.
* Female participants who are pregnant and/or breastfeeding.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, psychiatric, or allergic disease.
Treatment Strategies for Primarily Generalized Colorectal Cancer

For patients with primarily generalized colorectal cancer two treatment strategies are compared to establish which strategy gives best overall survival.

The traditional strategy is to first resect the primary colorectal tumour and then treat the metastases with chemotherapy followed if possible by surgery.

The alternative strategy is to first treat the metastases with chemotherapy followed if possible by surgery and only resect the primary colorectal tumour if there is hope for cure or if symptoms develop that necessitates treatment.

Patients are randomized between the two treatment strategies mentioned above. After initial treatment the patients are categorized as palliative or treated with curative intent. Patients are followed with quality of life evaluations every 6 months. Outpatient visits, hospital care, examinations and treatment are recorded as well as complications and side effects. Survival is recorded and for those patients treated with curative intent the tumour situation 3 years after randomization is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primarily generalized colorectal cancer diagnosed by pathology or typical appearance on x-ray or at endoscopy and where there is uncertainty regarding best treatment strategy

Exclusion Criteria:

* Patients not willing to participate or unable to sign informed consent.
* Patients with other malignancy with metastatic potential
* Patients where synchronous resection of primary tumour and metastases is planned
* Patients not fit for chemotherapy or surgery
* Patients with locally unresectable primary tumours
* Patients with symptoms from primary colorectal tumour necessitating resection
Effect of Gastric Bypass Surgery on Brain Responses

After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former preponderance in relative short time (\~ 2 years). But knowledge of the underlying biological mechanisms of decline in body weight is still inadequate.

This project intends to examine patients' background activity in the brain (i.e. "the resting state activity") and brain volume using MRI both before and one year after surgery.

We will also investigate whether hormonal changes in response to food intake after obesity surgery is associated with patients' impulsive control when exposed to pictures of food in the MRI.

Eligibility Criteria:
Inclusion Criteria:

* female
* right-handed
* scheduled for bariatric surgery in the Academic Hospital of Uppsala, Sweden

Exclusion Criteria:

* undergone more than one bariatric surgery
* suffer from mental disorders (depression, phobias, etc.) that can not be controlled with treatment.
Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics

The goal of this study is to evaluate the prognostic values of non-invasive hemodynamic parameteres in relation to 30-day mortality and/or acute deterioration in patients who are admitted acutely to the department of emergency medicine or cardiology.

Background

Identification of critically ill and high-risk patients at hospital admission is a major triage task in the emergency department. Rapid identification and treatment of such patients improves survival, reduces complications during admission, duration of hospitalization and the costs of treatment. Reduced heart rate variability (HRV), a marker of autonomic imbalance towards sympathetic dominance, has been shown in several studies to be associated with a poor prognosis in patient groups like myocardial infarction, heart failure, ischemic heart disease, and others. Besides HRV other hemodynamic variables like cardiac stroke volume, cardiac output and peripheral resistance will potentially improve diagnosis of critically ill patients by providing better prognostic value.

Aims \& objectives

To develop and validate a prognostic model (based on selected variables derived from Finapres measurements, HRV, CO, and TP) for 30-day mortality and/or acute deterioration in patients who are admitted acutely to the department of emergency medicine or cardiology, University Hospitals of Bispebjerg \& Frederiksberg

Methods \& Materials

The study is designed as an observational prospective cohort study. The aim is to enroll 1635 patients in total. During a period of 6 to 9 months all patients admitted to the acute medical/emergency department at Bispebjerg Hospital, Copenhagen, Denmark adn who fulfills inclusion criterias will be examined with a 10 minutes examination with the Finapres Nova device. Patients admitted to the departments of medicine/emergency medicine / Cardiology at Bispebjerg Hospital will also be included.

Expected outcomes and perspectives

Several scoring algorithms have been used in the emergency departments to facilitate early recognition of patients with high risk of serious outcomes. There is need to develop better clinical tools to be used in the emergency departments.

The investigators expect to outperform current triage methods by including HRV and hemodynamic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Admittance with acute illness at the department of medicine/emergency medicine / Cardiology at Bispebjerg Hospital
* Able to give informed consent

Exclusion Criteria:

* Terminal disease like advanced cancer or advanced organ failure with a life expectancy of less then three months.
* Candidate for immediate intensive care therapy
* Refuse or unable to give consent
Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy

To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head \& Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.

Middle ear complications and TD are common following RT to the Head \& Neck, where the radiation field involves the ET and ME. These are due to mucositis and swelling in the surrounding pharyngeal tissue and on the long-term fibrosis. The ET is a small channel from the middle ear to the upper part of the pharynx. It is normally closed but briefly opens while swallowing or yawning. The ME pressure then equalizes and optimize sound conduction to the inner ear. If the function of the ET is impaired it can lead to negative pressure and effusion. This causes pain, tinnitus, otitis media with effusion (OME), chronic otitis media (COM) and hearing loss. Last can be none reversible. Almost everyone experience middle ear morbidity short after RT, but on the long-term up to 20 % have chronic otitis media and TD with significant hearing impairment and the need for hearing aid. Conventional treatment with insertion of ventilation tubes in to the tympanic membrane is not recommended for radiation-induced ME problems.

Methods and materials: The investigators will by randomized controlled trials examine the effect of auto-inflation of the ET on ME morbidity with a custom-made balloon called Otovent®. Examination of the ear is conducted by otoscopy, pure tone and impedance audiometry and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients in Zealand region, Capital region and North Jutland region.
* Only patients who received or is going to receive radiotherapy or chemoradiotherapy as curative intended treatment.
* The irradiated volume involve the nasopharynx.

Exclusion Criteria:

* Patients with documented history of otitis media with effusion or chronic otitis media that is not related to the cancer diagnosis.
* Performance status \> 3.
* Surgery in the middle ear, Eustachian tube and surrounding tissue area. (Biopsies during diagnosis is accepted).
Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload

The purpose of this study is to investigate the effects of iron chelation using deferasirox in low and INT-1 risk (referring to the international prognostic scoring system, IPSS) MDS patients who show signs of iron overload due to repeated blood transfusions.

This trial is not recruiting patients in the United States.


Eligibility Criteria:
Inclusion Criteria:

* MDS patients presenting with low or intermediate-1 IPSS risk and transfusional iron overload
* Patients of either gender and age ≥ 18 years
* History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs)
* Patients can be either naïve to iron chelation or have had prior treatment with deferoxamine (DFO) or deferiprone (L1)
* Females of childbearing potential must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.

Exclusion Criteria:

* Non-transfusion related iron overload
* Treatment with deferasirox (ICL670) before study start
* Patients with a concomitant malignant disease
* Patients with out of range lab values
* History of nephrotic syndrome
* Patients with a previous history of clinically relevant ocular toxicity related to iron chelation
* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
* Patients treated with systemic investigational drugs within the past 4 weeks or topical investigational drug within the past 7 days
* Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
* Patients with active uncontrolled infectious disease
* Pregnancy or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply.
Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease

This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children \<6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded this protocol titled "Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease", protocol number NICHD-2018-DGX01. The Investigational New Drug (IND) Sponsor and Principal Investigator for this protocol is Christopher P. Hornik, MD, MPH. The Contracting Officer's Technical Representative (COTR) to represent the Government for this task order is Perdita Taylor-Zapata. The Duke IRB number for this study is Pro00102130. This study employs a central IRB, the WIRB-Copernicus Group (WCG). The c-IRB (WCG) study number is 20190888 / NICHD-2018-DGX01.

This is a prospective, multicenter Phase 1 study with a primary objective to characterize the pharmacokinetics of enteral digoxin in infants with single ventricle congenital heart disease. The secondary objective is to determine the safety profile of enteral digoxin in infants with single ventricle congenital heart disease. Digoxin is used for the treatment of heart failure in pediatric patients and acts by controlling numerous functions of the cardiovascular system. Digoxin use in single ventricle congenital heart disease may decrease interstage mortality.

The study will be conducted in approximately 48 subjects at approximately 13 investigational centers. The proposed duration of the study is approximately 196 (±) days.

Please see the protocol and synopsis for more information.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of single ventricle congenital heart disease
* Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
* Age ≤ 30 days of life at time of stage 1 palliation
* Age \< 6 months at time of enrollment
* Require treatment with enteral digoxin per their treating medical provider if their planned maintenance treatment dosing regimen is within the labeled dose range of 7.5 - 20 mcg/kg/day divided in 2 or 3 equal doses
* Informed consent from parent(s) or legal guardian(s)

Exclusion Criteria:

* Serum creatinine \> 2 mg/dL at enrollment
* Diagnosis of second degree or higher atrioventricular conduction block at enrollment
* Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
* Known hypersensitivity to digoxin or other forms of digitalis
* Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
* Received digoxin prior to enrollment
* Received or anticipated to receive a loading dose of digoxin.
* Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
tRNS Combined to Cognitive Training in Children With Dyscalculia

The present study grounds on the absence of evidence-based treatment in individuals with developmental dyscalculia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) over dorsolateral prefrontal cortex (DLPFC) or posterior parietal cortex (PPC), cerebral areas usually disrupted in individuals with DD, in addition to a usual treatment such as cognitive training.

Therefore, the investigators hypothesized that active tRNS over DLPFC or PPC combined to cognitive training will boost math and math-related skills in children and adolescents with DD, modulating theta/beta ratio around stimulated cerebral network. On the contrary, sham tRNS (placebo) over DLPFC or PPC combined to cognitive training will not have significant effect in improving math skills. Further, both active and sham tRNS combined to cognitive training will be safe and well tolerated.

The study design is randomized stratified, double blind, placebo-controlled.

A group of children and adolescents with DD will be selected and randomly assigned to three different conditions: 1. tRNS over bilateral DLPFC + cognitive training (Brainstim DLPFC); 2. tRNS over bilateral PPC (Brainstim PPC) + cognitive training; 3. sham tRNS (bilateral DLPFC/bilateral PPC; Brainstim Sham) + cognitive training.

In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS, combined to a usual treatment can improve the outcome of individual with DD.

The protocol will allow the investigators to:

1. testing the critical role of two brain regions (DLPFC or PPC) usually involved in numerical abilities and disrupted in individuals with DD;
2. examining the neural changes (using EEG recordings) due to cognitive training without tRNS (Brainstim Sham) and with tRNS (Brainstim DLPFC; Brainstim PPC);
3. predicting training outcomes based on math-related skills;
4. testing the critical role of neural markers at developmental ages using a closed-loop tRNS to improve learning and cognitive outcomes from the training;
5. investigating the safety and tolerability of tRNS.

The investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with DD (Total Quotient of BDE-2 ≤ 70)
* IQ ≥ 85

Exclusion Criteria:

* Having a comorbidity with an important medical conditions;
* Having neurological diseases;
* Having Epilepsy o family history of epilepsy;
* Receiving a treatment for DD in the previous three months before the baseline screening;
Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Patients, ages 18 years or older who have signed the informed consent
* Has qualifying bacterial pneumonia
* Female patients must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

* Known or suspected hospital-acquired pneumonia
* Evidence of significant immunological disease
* Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
* Has received an investigational drug within past 30 days
* Women who are pregnant or nursing
Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels.

To see whether our increased dosing regimen of unfractionated heparin (UF) and low molecular weight heparin (LMWH) in COVID-19 patients was effective at preventing thrombo-embolic complications. We did regular anti-Xa tests to optimise the dose of our thromboprophylaxis. Furthermore, we want to examine the time it takes to reach adequate anti-Xa levels, to determine additional risk factors and do a subgroup analysis. Lastly, we will study if there are possible complications of our thromboprophylactic therapy.

COVID-19 took the world by storm with its fast spread, high number of infected patients and its potential to range from mild illness to very severe respiratory distress. This pandemic is currently the focus of a lot of research, however there are still a lot of unknowns regarding COVID-19. Current literature shows that COVID-19 patients have an increased risk for thrombo-embolic events which is why patients at the Ghent university hospital get increased dose of thrombo-prophylactic therapy. Patients were also screened for presence of deep venous thrombosis using ultrasound.

Anti-Xa is a test in which the we determine the activity of the antithrombine-heparine complex on factor Xa. Using this test allowed us to measure the effect of our UF of LWMH and adjust the dose if needed.

At this moment It is still unclear how high the prevalence of thromboembolic events in this group of patients is and whether our thromboprophylaxic therapy prevents this. We also looked into the time it took for anti-Xa to reach adequate levels in our dosing regimen. Furthermore, current risk factors for thromboembolic complications in COVID-19 patients are still unclear. We compared the results of the COVID-19 patients to a group of critical ill patients without COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Hospitalisation required
* ICU admission

Exclusion Criteria:

* Coagulopathies prior to COVID 19 infection (known thromboembolism in the last 6 months i.e. deep venous thrombosis, pulmonary embolism, ...)
* Therapeutic anticoagulation on moment of ICU admission
* Major trauma
* Major bleeding
* Cerebro vascular accident or neuro trauma in the last month