cyrilzakka/clinical-trials huggingface dataset:
Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes

The goal of this single-group prospective study is to examine the impact of the Healthy Eating and Active Lifestyle (HEAL) Breast Cancer program on participants' perceived stress, biometrics, basic labs, lifestyle behaviors, self-efficacy, mental health, and quality of life.

Participants will participate in an 8-week program of 90-minute virtual sessions each week to decrease risk of cancer recurrence. Program participants can choose to participate in the research study which will include data collection (surveys, biometrics, basic labs). The data collection will occur at four timepoints - baseline prior to program start, post-program, 3 month follow-up, and 6 month follow-up.

The study will include 45 subjects recruited from AdventHealth Medical Group in the HEAL Breast Cancer Program that consent to participate in the research study. The research study will include data collection along with the program participation. Patients who decline participation in the research study are able to participate in the HEAL Breast Cancer Program. The program sessions will be conducted virtually via Zoom by Dr. Amber Orman, a breast cancer physician board certified in radiation oncology and lifestyle medicine. There are eight program sessions, one per week, each lasting 90-minutes. The survey package includes nine questionnaires and is expected to take 60 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 18 years old
2. Diagnosis of breast cancer
3. Enrolled in the HEAL: Breast Cancer Program
4. Able to speak, read, and understand English fluently
5. Willing and able to provide informed consent
6. Willing and able to comply with all study procedures and requirements for the duration of the study

Exclusion Criteria:

1. Not willing or able to provide informed consent
2. Not willing or able to comply with all study procedures and requirements for the duration of the study
Self-defining Memories in Patients With a TBI

The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.

A total of 40 participants (20 non-consecutive adults with a moderate or severe TBI and 20 volunteers with any history of neurological or psychiatric disease) will be recruited into the study. The duration of the protocol is 70 minutes. As regards the assessment, three questionnaires will be administered in order to evaluate self-defining memories, apathetic manifestations and anxio-depressive symptoms. In addition, four cognitive measures will be used to assess verbal episodic memory, working memory, cognitive flexibility and verbal fluency.

Eligibility Criteria:
Inclusion Criteria:

* patients with a moderate or severe TBI occurred at least 6 months ago (initial Glasgow Coma Scale score ≤ 12 or post-traumatic amnesia duration \> 1 week)
* patients ≥ 18 years old and who have signed a letter of information

Exclusion Criteria:

* history of neurological and/or psychiatric disease
* persistent motor, sensitive and instrumental disorders that could disturb the efficient evaluation of the participant
* patients who refused to participate in the study
* non affiliation to a social security scheme
* patients under guardianship or trusteeship
* pregnant woman
Protein Requirements in Children With Phenylketonuria (PKU)

Phenylketonuria (PKU) is an inherited inborn error of an amino acid phenylalanine (PHE) metabolism affecting 1:15,000 births. It is caused by a decreased activity of an enzyme in the liver called phenylalanine hydroxylase (PAH) which is important to convert PHE into tyrosine, another amino acid. Consequently, PHE accumulates in the blood leading to mental and developmental delays. Nutritional management is the primary choice of treatment that includes providing sufficient protein in the diet and at the same time restricting PHE. However the amount of protein to be given is unknown. A new technique called Indicator Amino Acid Oxidation (IAAO) will be used to determine the protein requirements in children with PKU (5-18y). The study will help treat and manage these children with sufficient protein to ensure proper growth and development. Current dietary recommendations range from 35-65 g/day and is based on factorial calculations.

The investigators hypothesize that the protein requirement in children with PKU will be higher than the current mathematically calculated recommended intake of 35-65 g/day for the 5-18y children.


Eligibility Criteria:
Inclusion Criteria:

* Children (5-18y) who are diagnosed with Phenylketonuria (PKU), and clinically stable with no acute illness

Exclusion Criteria:

* Children less than 5y of age and who are diagnosed with PKU, as it may be difficult to take breath samples and perform indirect calorimetry in very young children.
* Children diagnosed with PKU, but are currently ill, with a fever, cold, vomiting or diarrhea.
3D Ultrasound in Women With Vacuum or Forceps Deliveries

The purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women within 1-5 years after first delivery who did not have an internal delivery will be included. The total number of subjects is forty. This will include ten primiparous subjects who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Females age \>18 and \<45.
* Primiparous females with singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery.
* Birth weight \>2500g and \<4500g.
* Delivery should have occurred more than one year ago, but less than five years ago.

Pregestational BMI \<35kg40kg/m2.

Exclusion Criteria:

* Presence of interim delivery.
* Presence of both vacuum and forceps use during delivery.
* Presence of pregestational or A2 gestational diabetes mellitus.
* Presence of neuromuscular disorder (i.e., spinal cord disease, Multiple Sclerosis, Myasthenia Gravis) or connective tissue disorder (i.e., Lupus and Sjogren's disease).
Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of developing kidney damage after heart surgery. There is evidence that patients with high levels of a substance called ouabain have an increased risk of developing kidney damage. This study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain levels will reduce the risk of developing kidney damage after heart surgery.

This is a randomized double-blinded study investigating the role of DigiFab in patients with elevated risk of acute kidney injury undergoing CABG surgery. University of Maryland Medical Center (UMMC) and University of Maryland St Joseph Medical Center (UMSJMC) patients who are undergoing CABG, meet the inclusion criteria and provide consent will be enrolled in this study and randomized to either DigiFab arm or the placebo (vehicle) arm. The study involves a follow up period of 72 hours post CABG surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing coronary artery bypass surgery
* glomerular filtration rate \> 15 History of Diabetes Mellitus or GFR \< 60

Exclusion Criteria:

* Allergy to Digifab Contrast dye within 3 days Creatinine \> 25% above baseline
The Retention Rate Between Brand A and Brand B Punctal Plugs

The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).

Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.

Eligibility Criteria:
Inclusion Criteria:

* moderate dry eye, severe dry eye

Exclusion Criteria:

* silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
Balloon Dilation of the Eustachian Tube in Children

Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures.

Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.

Introduction:

Otitis media with effusion (OME, "glue ear") is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Fluid in the middle ear causes conducting hearing loss. OME has a large impact on health care costs and recurrent or persistent OME can effect the proper development of children. Frequently OME resolves itself, therefore guidelines strongly recommend watchful waiting for 3 months after which treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Furthermore there are various short and longterm side-effects of tympanostomy tubes.In Balloon Eustachian Tuboplasty (BET) a ballon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx. BET has recently been applied in children for therapy-resistant recurrent OME and inflammatory ear diseases with promising results. Risk and complications rates are very low.

Methods:

Goal of this study will be the evaluation of Balloon Eustachian Tuboplasty (BET) in children as a primary treatment of OME. Children between the ages of 4 and 10 years with OME and tympanometry type B on both ears, will prospectively be recruited and assigned for adenoidectomy and myringotomy. Parents then will be asked for participation in this trial and fully informed about purpose, technique and possible side effects. If consent is given, adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. If necessary (very thick fluid) tympanostomy tubes are placed. One Eustachian tube of each patient is randomly assigned for BET.

Eligibility Criteria:
Inclusion Criteria:

* OME on both sides measured by flat tympanometry

Exclusion Criteria:

* Patients with cleft lip and/or palate and other severe craniofacial abnormalities
Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab (Avastin). At present there are no data on the correlation between occurrence of arterial hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will investigate whether glioma patients developing hypertension under bevacizumab treatment have a better outcome in terms of progression free survival, response rate and overall survival than equally treated patients remaining normotensive. Moreover, we will describe the dynamics of change in blood pressure after administration of bevacizumab in those patients developing hypertension.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria: Patients aged 18 or older with histological diagnosis of anaplastic astrocytoma (WHO grade III) or glioma (WHO grade IV) Assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons by an oncologist Patients should be on a stable or decreasing dose of steroids Willingness and ability to comply with the protocol Patient should present with a KPS of \>=70 Signed informed consent

Exclusion criteria: Previous anti-angiogenic drugs other than bevacizumab Allergy or hypersensitivity against bevacizumab Contraindications to bevacizumab according to the Summary of Product of Characteristics Unwillingness to comply with regular assessments of response and performance of study-related procedures Any condition considered relevant for proper performance of the study or risk to the patients, at the discretion of the investigator
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial

This clinical trial tests how well a telehealth exercise intervention works to improve cardiovascular health in lymphoma survivors. Telehealth exercise is a service to help perform physical exercises at home with a care provider online. With the use of telehealth exercise lymphoma survivors may be able to participate in exercise programs safely to improve heart health and reduce the risk of cardiovascular disease.

PRIMARY OBJECTIVE:

I. Determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention.

SECONDARY OBJECTIVE:

I. Explore the effects of an 8-week telehealth exercise intervention on cardiovascular health, assessed by cardiopulmonary exercise test, pulmonary function test, body compositions, and blood biomarkers.

OUTLINE: Participants are randomized into 1 of 2 groups.

GROUP I (TELEHEALTH EXERCISE): Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.

GROUP II (DELAYED CONTROL): Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.

After completion of study treatment, participants are followed up after 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Hodgkin or non-Hodgkin lymphoma.
* \>= 18 years old.
* Are between 2-5 years after completing anti-cancer therapy and with no evidence of disease.
* Intermediate (4-5) to high ( \>= 6) risk of cardiovascular risk factors based on six key variables: Age 30 to 50 years (y) \[2\]) and \>= 50y \[3\]; anthracycline dose \>250mg/m \^ 2 \[1\]; hypertension \[2\]; diabetes \[2\]; smoking \[1\]; and chest radiation \[1\]).
* Able to understand and sign the informed consent document.
* Physically able and willing to complete all study procedures.

Exclusion Criteria:

* Have overt cardiovascular disease within 6 months (e.g. myocardial infarction, stroke, angina).
* Have contraindications to exercise.
* Participate in structured exercise (\>60 minutes/week).
* Female patients who are pregnant or planning to become pregnant.
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma

This is an observational, prospective cohort study that will recruit a diverse sample of 84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma (HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment tools with participants 65 years and older and collects adverse events and exploratory markers of aging for all participants.

The results from this study will allow us to identify unique disease characteristics of older participants and to study treatment patterns that may be barriers to treatment and risk factors for increased morbidity. Characteristics of Comprehensive Geriatric Assessment will be obtained prior to standard interventional treatment for participants that are 65 years or older. Observations will be made of treatment toxicities and cellular senescence with treatment outcomes. Findings from this study will result in the development of R01 intervention studies that develop and validate a treatment algorithm based on these associations to provide older adults with a personalized treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or radiographically (CT or MRI) confirmed newly diagnosed hepatocellular carcinoma.
* Age 18 years and older.
* Patients with advanced, unresectable HCC as determined by the treating physician.

Exclusion Criteria:

* Patients with resectable HCC who are still candidates for locoregional therapy
* Patients receiving prior systemic or locoregional therapy
Eculizumab (Soliris) in Covid-19 Infected Patients

Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.

Recorded Endpoints:

* Mortality
* Time in the ICU
* Time on a ventilator

Administrative:

An Emergency FDA IND must be submitted (FDA form 3926) for each patient.

Subsequent to approval the primary investigator will obtain an authorization letter from Alexion Pharmaceuticals.

Implementation:

Prior to dosing the patient must receive ceftriaxone IV and this must be continued during the entire duration of therapy (vaccination will be mentioned shortly and is the only exception to prophylactic antibiotic coverage). If there is a clinical reason why the patient cannot receive Ceftriaxone (allergy, supply, etc) then an alternative prophylactic antibiotic covering Neisseria meningitis must be given for the duration of therapy. The SeroB and Quadrivalent meningococcal vaccines can be given if the duration of antibiotic therapy becomes unsafe or unfeasible. In that case, antibiotic therapy should be withdrawn no sooner than 2 weeks after vaccination with both meningococcal vaccines (see ACIP guidelines in complement deficient patients). It is preferred that vaccination is avoided while the patient is acutely ill and that prophylactic antibiotics are used as meningococcal vaccination can upregulate the immune system possibly worsening the patient's condition.

Standard dosing protocol - Eculizumab 900mg IV every 7 days. Eculizumab is given IV over 30 minutes without the need of a pump (although one can be used if available).

Supplemental doses of eculizumab can be given if clinically warranted at the discretion of the investigator and clinical team.

The team should perform Murray scores daily for the first 72 hours THEN every other day unless a change is deemed necessary by the attending physician. (table 2)

Complement blood levels should be drawn every 72 hours. They may be drawn sooner if there is clinical inquiry which would affect clinical decision making and/or after a dose of Eculizumab is given.

The duration of therapy is at the discretion of the clinical team and investigator.

Follow up at day 7, 14, and 28 after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Confirmed Covid-19 infection
* ARDS
* ICU patient

Exclusion Criteria:

* Active Neisseria infection.
* Concomitant enrollment in another experimental/off-label immunosuppressive therapy trial.
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis

Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays in order to detect bacteria, fungi and viruses. Ten control patients with normal sinuses will have the same samples taken. The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques.

Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays: 16S rRNA PhyloChip (to detect bacteria), MycoChip (to detect fungi) and ViroChip (to detect viruses). Ten control patients with normal sinuses, as assessed by CT scan and a sinusitis-specific survey, will have the same samples taken. The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques. Comparing diseased and control flora will provide insight into the relative contribution of each pathogen to CRS and may guide the development of future therapies.

Eligibility Criteria:
Inclusion Criteria (CRS patients):

* History of CRS as defined as symptoms (nasal discharge, nasal obstruction, facial pain and/or hyposmia) for \>12 weeks despite therapy.
* Impaired CRS-specific quality of life (SNOT-20 score \>1.5).
* Evidence of sinus disease on a CT scan (Lund MacKay score greater than or equal to 10).
* Patients with positive skin or RAST testing to an inhalant allergen and/or aspirin hypersensitivity will be included. Evidence of atopy is not required but will be recorded, along with serum IgE levels, when available.

Inclusion Criteria (Control patients):

* No history of CRS
* SNOT-20 score \<1.0
* No evidence of sinus disease on preoperative imaging

Exclusion Criteria:

* Control patients with any evidence of CRS, by history, survey, or imaging criteria would be excluded.