cyrilzakka/clinical-trials huggingface dataset:
Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective

155 Pérola Byington Hospital patients presenting early stage luminal BC were submitted to Oncotype Dx® evaluation. Changes in treatment recommendations and costs were obtained from Pérola Byington Hospital. Oncotype DX® incorporation in the Brazilian Public Health System should be considered, as it results in high clinical impact for patient and high economic impact for health system, being a tool that safely and accurately delimits the subgroup of patients who really need AC.

Background: It is known that there is significant over administration (and under administration) of adjuvant chemotherapy (AC) when standard clinical parameters (SCP) are used for patients diagnosed with early stage RE+ breast cancer (BC). Although absolute clinical benefit of AC may be modest, its toxicity and economic burden is highly significant; therefore, selecting appropriate patients for AC remains an important issue. Oncotype DX® identifies high-risk patients who are likely to benefit from AC, which otherwise might not be identified through SCP and low-risk patients who will not benefit from AC, thus avoiding toxicities and inherent risks. This study aimed to evaluate the impact of the Oncotype DX® test on treatment decisions in N0 and N1 early-stage breast cancer patients at a Public Brazilian hospital and to estimate the incremental cost-effectiveness ratio (ICER) and budget impact (BI) of incorporating Oncotype DX® under the perspective of the Brazilian Society.

Changes in treatment recommendations and costs will be obtained from Pérola Byington Hospital. Additional data will be obtained from literature. Medical costs (test, chemotherapy and adverse events), productivity loss, transportation and employment leave will be considered.

Eligibility Criteria:
Inclusion Criteria:

Women ≥ 18 years Early stage breast cancer, ER and/or PR positive with HER2 negative breast cancer.

Exclusion Criteria:

More than one operable primary breast tumor; Multifocal or multicentric tumors; 4 or more lymph node involvement; Metastatic breast cancer; Previous history of breast cancer; Invasive tumor \<2 mm ; Performance status \> 2 and / or other clinical factors that would make the patient a non-viable candidate for adjuvant chemotherapy; Previous hormonal or chemotherapy treatment; Current medical condition that would interfere with their ability to consent (psychiatric illness, for example)
Long-Term Follow-up Study for Patients From AVXS-101-CL-101

This is a long term, safety follow up study of patients in the AVXS-101-CL-101 gene replacement therapy clinical trial for SMA Type 1 delivering onasemnogene abeparvovec-xioi. Patients will roll over from the parent study into this long-term study for continuous safety monitoring for up to 15 years.

This is a long term, safety follow up study of patients in the AVXS-101-CL-101 gene replacement therapy clinical trial for SMA Type 1 delivering onasemnogene abeparvovec-xioi. Patients will roll over from the parent study into this long-term study for continuous safety monitoring for up to 15 years. The last visit of the parent study or early discontinuation from the parent study may serve as the visit at which the informed consent form process is conducted for the AVXS 101-LT-001 long term follow-up safety study. Patients will return annually for follow up study visits for five (5) years, and then will be contacted via phone annually for ten (10) years. Additionally, patient record transfers from their local physician and/or neurologist will be requested in conjunction with the annual study visits and phone contacts for review by the investigator.

If the patient is unable to return to the original investigative site, the sponsor will arrange with the patients' local established physician to serve as an additional investigator to conduct the required assessments.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Inclusion Criteria:

1. Patient who received onasemnogene abeparvovec-xioi in the AVXS-101-CL-101 gene replacement therapy clinical trial for SMA Type 1.
2. Parent/legal guardian willing and able to complete the informed consent process, comply with study procedures and visit schedule.

Exclusion Criteria:

1. Parent/legal guardian unable or unwilling to participate in the long term follow up safety study.
Ulimorelin Study of Efficacy and Safety (ULISES 008)

Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection


Eligibility Criteria:
Inclusion Criteria:

* Men or women, 18 to 80 years of age, inclusive
* Scheduled to undergo open bowel resection with colonic anastomosis
* For women who can potentially become pregnant a pregnancy test at screening and admission must be negative

Exclusion Criteria:

* Weight more than 200kg (441 pounds)
* Pregnant or breastfeeding
* Known history of drug or alcohol abuse within the previous year
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.


Eligibility Criteria:
Inclusion Criteria:

* Positive history of perennial allergic rhinitis
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,

Exclusion Criteria:

* Previous immunotherapy with allergen extracts within the last 3 years,
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer

The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.

The prognosis for patients with locally advanced, non-Human Papillomavirus (HPV) associated head and neck squamous cell carcinoma (HNSCC) remains poor. The immunosuppressive tumor immune microenvironment in HNSCC presents a significant barrier to both conventional and immune-based therapies. Recent studies have indicated that dysbiotic oral microbiota, particularly in the context of periodontal disease, can contribute to chronic oral mucosal inflammation and the recruitment of suppressive immune cell infiltrates. Bacterial-induced chronic inflammation may play a crucial role in treatment resistance in HNSCC. Understanding the impact of microbial modulation on the tumor immune microenvironment in HNSCC could lead to the identification of novel therapeutic targets.

In this single-arm phase II clinical trial, oral cancer patients will be treated with oral metronidazole and CHX rinses prior to surgery. Investigator will assess the ability for the treatment to reduce the absolute amount of intratumoral bacteria and evaluate changes in the intratumoral bacterial community and infiltrating immune cells.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed squamous cell carcinoma of the oral cavity
* Must have planned surgery for curative intent
* Participants ≥ 18 years of age
* Participants must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Known allergy to metronidazole and/or chlorhexidine
* Severe liver or kidney disease as determined by history of laboratory tests
* Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)
* Recurrent oral cancer after prior radiation or chemoradiation
* Participants with unresectable oral cancer
* Participants unable to tolerate and/or absorb oral medication
* Participants currently or have taken other antibiotics within the prior 60 days
* Participant is pregnant
Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients

The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

The aim of this study is to appreciate the tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions between day 30 and day 120 of treatment and to evaluate:

* Quality of life evaluated with the KDQOL questionnaire
* Incidence of cardiovascular events
* Influence of the technic on cardiovascular, inflammatory and infectious risk factors
* Mortality

Eligibility Criteria:
Inclusion Criteria:

* Patient who has signed the written consent form
* Patient aged \> 65 and \< 90 years
* With creatinine clearance \< 10 mL/min
* On dialysis for a minimum of 3 months, with 3 times a week hemodialysis sessions
* Erythropoietin dosage needed to maintain hemoglobin at a constant level (range of hemoglobin: 9-13 g/dL without any variation of more than 2g/dL for less than 3 months)
* Without any problem of vascular access

Exclusion Criteria:

* Patient aged \< 65 and \> 90 years
* Presence of severe malnutrition (albumin \< 20 g/L)
* Unstable clinical condition
* Unipuncture or failed vascular access flow
* Known problems of coagulation
A Research Study Looking at Blood Sugar Control in People With Type 2 Diabetes Previously Treated With Premix Insulin and Initiating Treatment With Insulin Degludec/Liraglutide (IDegLira) in Local Clinical Practice in Croatia

The purpose of this study is to look at the blood sugar control in participants with type 2 diabetes previously treated with premix insulins and initiating treatment with IDegLira. Participants will get IDegLira as prescribed by study doctor regardless of participant's decision to participate in the study. Decision to initiate treatment with IDegLira will be made by study doctor independent from the study. The study will last for about 36 weeks. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female patients aged greater than or equal to (\>=) 18 years at the time of signing informed consent.
* Patients diagnosed with T2D and receiving treatment with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines.
* Switched to treatment with IDegLira from previous treatment of premix insulins. The decision to initiate treatment with IDegLira must be independently from the decision to enrol in the study.
* Available and documented HbA1c collected within 12 weeks prior to initiation of IDegLira.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Participation in any other T2D clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to initiation of IDegLira.
* Previous treatment with IDegLira.
* Patients diagnosed with Type 1 diabetes mellitus.
* Female who is known to be pregnant, breastfeeding or intends to become pregnant during the conduct of the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the IDegLira label in Croatia.
G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy

RATIONALE: Colony-stimulating factors, such as G-CSF, may increase the number of white blood cells found in bone marrow or peripheral blood and may prevent persistent neutropenia in patients receiving chemotherapy. It is not yet known which regimen of G-CSF may be more effective in preventing neutropenia.

PURPOSE: This randomized phase III trial is comparing two different regimens of G-CSF to see how well it works in preventing persistent neutropenia in patients with solid tumors who are receiving chemotherapy.

OBJECTIVES:

Primary

* Determine the efficacy of filgrastim (G-CSF) in preventing persistent moderate neutropenia in patients with solid tumors while maintaining chemotherapy courses.

Secondary

* Compare the tolerability of 2 regimens of G-CSF in these patients.
* Determine the number of courses of G-CSF needed in each regimen.
* Evaluate the frequency of infections.
* Determine dose intensity.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 6 days beginning 1 week after the start of chemotherapy (days 7-12). If chemotherapy begins on day 8, patients receive G-CSF SC on days 9-14.
* Arm II: Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of solid tumor
* Receiving chemotherapy in any line of treatment (adjuvant or metastatic)

  * Chemotherapy courses repeating every 21 days or beginning on day 8 allowed
  * Received at least 2 prior courses of chemotherapy
* Moderate neutropenia (grade 1-3) leading to a delay of the first course by ≥ 7 days or a delay of the second course of treatment

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No known hypersensitivity to filgrastim (G-CSF) or any of its components
* No severe immunodepression
* No malignant hematological disease
* No history of psychiatric illness
* No patients deprived of liberty or under guardianship
* No psychological, familial, social, or geographical reasons preventing follow-up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics

The goal of this study is to identify individuals at high risk of FH, and to encourage the appropriate diagnosis and treatment of individuals at high risk of FH through the use of implementation science and behavioral economics principles.

Phase 1: Applying the FIND FH tool to the health system EHR and gathering data for pilot development; Phase 2: Pilot development and implementation; Phase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2

Phase 1:

Aim 1: Adjusting and refining the application of the FIND FH tool to the UPHS EHR database Aim 2: Identifying the barriers and facilitators to making a diagnosis of FH and initiating or intensifying therapy for individuals with FH through qualitative interviews with clinicians and patients and creating a behavioral roadmap to inform the implementation approaches to test in the pilots

Phase 2:

Aim 1: Co-design implementation strategies using behavioral economics in partnership with the Family Heart Foundation Aim 2: Pilot implementation strategies with an enrollment goal of 80 patients total (40 per pilot) who have been flagged by the FIND FH tool as having probable FH to ascertain feasibility, acceptability, and appropriateness

Phase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2

Eligibility Criteria:
Inclusion Criteria:

* Must be a patient at Penn Medicine
* Must have been flagged by the FIND FH tool as having a high probability of FH
* First language is English
* Resides in PA or NJ

Exclusion Criteria:

* Already have been clinically diagnosed with FH using the proper ICD-10 code
* Currently see a lipid specialist at Penn Medicine
* Pass study clinician's Study Validity Check
Validation BITSS Brussels Infant Stool Scale

validation of stool scale in toddlers

objective : the Bristol stool form scale (BSFS) is inadequate for non-toilet trained children.

The Brussels Infant and Toddler Stool Scale (BITTS) was developed, consisting of 7 photograps of diapers containing stools of infants and toddlers. We aimed to evaluate inter-observer reliability of stool consistency assessment among parents, nurses and medical doctors using the BITTS.

Method :

In this multicenter cross-sectional study (2016-2017), Bitts photograps were rated according to the BSFS. The reliability of the BITTS was evaluated using the overall proportion of perfect agreement and the linearly weighted K statistic.

What is known :

* reliable assessment of stool consistency is important for evaluating children's defecation pattern and diagnosing gastrointestinal disorders.
* the reliability of the Bristol Stool Form Scale, developed for adults, has been debated for young children who are non-toilet trained and wear diapers

To get validation of the BITTS :

* a non-toilet trained child makes stool in diaper
* caregiver scores the aspect of the stool according to the BITTS
* caregiver takes a picture of the diaper
* after 1 monts she rescores the picture according to the BITTS

Eligibility Criteria:
Inclusion Criteria:pictures of diapers with stool of all childeren who are non-toilet trained

-

Exclusion Criteria:

* none
Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression

Mindfulness training, relaxation training, and cerebellar electrical stimulation were used to intervene in the cognitive function of healthy individuals and individuals with first episode depression

In this proposed study,the investigators will evaluate the effects of different non-pharmacological interventions (physical/psychological) on emotion-related cognitive function.This project will use a variety of intervention methods to conduct research in healthy individuals and patients with mood disorders. The main intervention methods include: (1) mindfulness training;(2) relaxation training;(3) cerebellar electrical stimulation.

The study will recruit 80 healthy subjects and 40 first-episode depression patients. The study consisted of three steps: First, subjects filled in personal data and completed the first screening, randomly assigned groups, and filled in the pre-intervention questionnaire;Second, give a one-time non-drug intervention (mindfulness training, relaxation training or cerebellar electrical stimulation);Step 3: After the intervention, the subjects filled in the post-intervention questionnaire and completed the cognitive task test.Clinical efficacy and safety assessment will be done at first time. The specific aims are to evaluate the effect of non-drug therapy on cognitive function in healthy individuals and patients with first episode depression. and the behavior was evaluated by cognitive function task.

Eligibility Criteria:
Inclusion Criteria:

-

Healthy individuals group:

1. Aged between 16 and 34;
2. Does not meet the criteria of the DIAGNOSTIC and Statistical Manual of Mental Disorders, DSM-5,Does not meet the diagnosis of depression, bipolar disorder and other mental disorders.

First episode depression group:

1. Aged between 16 and 34;
2. Clinically diagnosed as having depression according to the DIAGNOSTIC and Statistical Manual of Mental Disorders (DSM-5);
3. First attack, not taking medicine, no risk of serious suicide NSSI.

Exclusion Criteria:

1. There are serious physical diseases, such as epilepsy, brain trauma, intracranial space-occupying lesions, severe audiovisual disorders, congenital heart disease, etc.;
2. Both Hamilton Depression Scale and Beck Depression Self-Rating Scale indicate severe depression or severe mental illness;
3. Affected by mental illness, it is difficult to conduct smooth and effective verbal communication and psychological measurement operation.
Improving Disease Severity

Phototherapy, including ultraviolet B (UVB) and ultraviolet A (UVA) light, has been used to treat a number of dermatologic conditions. Psoriasis is one of the most common conditions treated with phototherapy, in which phototherapy is often indicated for extensive disease with contraindications for other systemic treatments. The mechanism of action of phototherapy for the treatment of psoriasis is not completely understood; however, it is known that UVB light induces apoptosis of pathogenic T cells and keratinocytes, which may reduce the overactive immune response and epidermal hyperproliferation. Phototherapy has shown some efficacy for other diseases, such as alopecia areata (AA) and polymorphous light eruption (PMLE). However, phototherapy is not always an accessible treatment option for patients due to cost or lack of time.

Recent advancements in nanotechnology have led to the development of medical devices (lasers and LED devices) with unique phototherapy properties that emit radiation in the infrared wavelengths, allowing patients to benefit from the effects of phototherapy treatment in a more convenient way. Preclinical studies demonstrated the positive effects of infrared radiation exposure on the skin including, increased collagen synthesis and expression of transforming growth factor-beta1 (TGF-beta1). Other studies suggested possible antimicrobial effects from infrared radiation, with decreased colonization of Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae on the skin after exposure. Compared to other fabric technology, such as Far-Infrared (FIR) fabric technology that reflects body heat, fabric made from Lumiton yarn converts external light in the UV and visible spectrum and emits light in the red and near-infrared spectrum for the body. Lumiton yarn absorbs energy from 350 nm to 600 nm (the light spectrum from UV to visible red light) and emit energy from 600 to 1000 nm (red, near-infrared spectrum). The Lumiton yarn contains red/NIR light-emitting dyes. The effectiveness of the technology is proportional to the intensity of the light, with its peak effectiveness under sunlight.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants ≥18 years of age
* Participants who live in the US,
* Participants who are diagnosed with mild-to-severe AA, PMLE, or psoriasis
* Participants have sufficient command of the English language

Exclusion Criteria:

* Participants less than the age of 18
* Participants who do not live in the US
* Participants who are not diagnosed with mild to severe AA, PMLE, or psoriasis
* Participants without a sufficient command of the English language
* Participants with concurrent medical conditions that are at risk of confounding the study outcomes
* Participants currently using concomitant phototherapy