cyrilzakka/clinical-trials huggingface dataset:
Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.

Preliminary experience in the neo-adjuvant setting of Locally Advanced Breast Cancer (LABC) has recently demonstrated that hormone receptors negative patients have approximately 50% chance to achieve a pathological response after concurrent chemo-radiation. In a multi-institutional collaboration of 105 patients it was found that triple negative (TN) tumor carriers achieved pathological response in 54% of the cases and that the response reflected on 5-year disease free survival and overall survival. Our group has speculated that these effects on the risk of distant recurrence could depend on the recovery of antitumor immunity among the patients achieving pathological response, after tumor cell death induced by concurrent chemo-radiation.

The investigators are proposing a novel study that translates these findings to the adjuvant setting of TN tumors. TN breast cancer is a more aggressive form of the disease often coinciding with basal-like tumors. BRCA mutated-cancer is more frequently TN.

The current protocol converges the experience NYU has developed in accelerated prone breast radiotherapy with encouraging finding from the use of concurrent chemoradiation in LABC.

The investigators will study the feasibility of combining weekly carboplatin with concurrent 3-weeks prone breast radiotherapy in the adjuvant setting of 35 women with TN tumors, after segmental mastectomy and nodal assessment. Primary endpoint of the study is acute toxicity of the combined regimen, with a target of \< 25% of grade II-III dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18
* Pre- or post-menopausal women with Stage I and II breast cancer, triple negative tumors
* Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
* Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (Tumors \< 5 mm in size do not require nodal assessment) or after mastectomy
* No previous chemotherapy
* Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast
* Active connective tissue disorders, such as lupus or scleroderma
* Pregnant or lactating women
Cohort Study on the Outcome and Influencing Factors of Perinatal Depression

1. Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;
2. Factors affecting the outcome of the disease;
3. Recurrence of PND in pregnancy again;
4. The influence of different intervention methods on the course of the disease.

Research objectives

1. Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester;
2. Factors affecting the outcome of the disease;
3. Recurrence of PND in pregnancy again;
4. The influence of different intervention methods on the course of the disease. Research process: 1. The pregnant women who were filed at Xinhua Hospital and Tongji Hospital and were receiving perinatal care from July 2019 to December 2019 were evaluated in the third trimester of pregnancy using the General Situation Questionnaire, SSRS, PHQ-9, and GAD-7. Those with PHQ-9 score ≥ 5 or GAD ≥ 5 were classified as having symptoms of depression and anxiety, and those who were screened positive were included in the study cohort; 42 days postpartum, 3 months postpartum, 6 months postpartum, 12 months postpartum, 18 months postpartum , 24 months postpartum, use PHQ-9, GAD-7 scale, 6 quality of life questionnaires, and SSRS to evaluate the cohort. If the PHQ-9 score is greater than or equal to 5 or the GAD is greater than or equal to 5, the psychiatrist will perform a clinical examination based on DSM-IV to make a clinical diagnosis; the outcome of the cohort and the incidence and influencing factors; 2 . During the follow-up process, the cohort developed high-risk pregnant women with depression, anxiety symptoms and other perinatal depressive disorders during the follow-up process. Based on the WeChat platform, integrated general hospitals, psychological counseling centers, social families and other service resources were carried out throughout the prenatal and first delivery period. Intervention methods such as community intervention for perinatal depression that focus on the comprehensive "physiology, psychology, and society" of the whole process after the first childbirth. Pregnant women diagnosed with PND will be evaluated by a psychiatrist to determine the treatment plan, and follow-up will continue.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome

The aim of this study will be to evaluate the effects of the use of manual therapy and diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain intensity and pain threshold the pressure.


Eligibility Criteria:
Inclusion Criteria:

* history of anterior lateral and unilateral shoulder pain
* with more than 3 months duration
* intensity of at least 4 points on the Numerical Rating Pain Scale
* positivity in at least 2 of 3 orthopedic tests for impingement syndrome: Neer, Hawkins or Jobe
* Associated with these characteristics volunteers should submit myofascial trigger points unilateral and active, centrally located in the trapezius muscle descending fibers associated with painful shoulder

Exclusion Criteria:

* diagnosis of bilateral impingement syndrome shoulder
* fibromyalgia
* muscle injury
* history of trauma on the shoulder
* ruptured tendons
* ligamentous laxity
* symptoms of numbness and / or tingling in the upper limbs
* corticosteroid injection use shoulder
* making use of anti-inflammatory
* they performed surgery or physical therapy treatment in the last 6 months in the affected shoulder.
Incremental Cost-Utility Study on Prehabilitation Among Older Patients With Colorectal Cancer Undergoing Surgery

A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.

This study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an American Society of Anesthesiologists (ASA) score of III. We also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years or American Society of Anesthesiologists (ASA) score of III
* Scheduled for colorectal cancer surgery

Exclusion Criteria:

* Metastatic disease known preoperatively
* ASA IV score or higher
* Paralytic or immobilized patients (not capable to perform exercise)
* Prior use of neoadjuvant therapy for the same indication
* Not able or willing to provide written informed consent
Impact of MINST With and Without Splinting in Periodontitis Patients With Mobile Anterior Teeth

The goal of this clinical trial is to evaluate impact of Minimally Invasive Non-Surgical Therapy (MINST) with and without splinting on clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) in periodontitis patients with mobile anterior teeth. The main questions it aims to answer are:

* Does splinting provide additional benefit to MINST alone for improving the clinical periodontal parameters ?
* Does splinting provide additional benefit to MINST alone for improving OHRQoL ?

The increased mobility of a periodontally affected tooth can be caused by a shift of centre of rotation of the tooth apically due to clinical attachment loss (CAL) and alveolar bone loss (ABL) and/or due to secondary occlusal trauma.

Tooth splinting continues to be a topic of controversy. It remains one of the most poorly understood and controversial areas of dental therapy.

Minimally invasive non-surgical periodontal therapy (MINST) has been introduced for minimizing tissue trauma and enhancing clinical outcomes by the adjunctive use of magnification devices .

This study aims to compare clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) following Minimally Invasive Non-Surgical Therapy (MINST), both with and without splinting, in patients with Stage III and Stage IV periodontitis who have mobile anterior teeth.

Patients will be screened and enrolled based on specific eligibility criteria. Baseline measurements of outcome parameters will be taken, followed by supragingival scaling, and patients will be recalled after one week.

During the subsequent visit, patients will be randomized into either the test group or the control group. The test group will receive MINST along with splinting of the mobile anterior teeth, while the control group will receive MINST alone.

Patients will be recalled after 8 weeks and 6 months to assess changes in the outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria at the patient level: systemically healthy patient with presence of stage III or IV periodontitis, age ≥ 18 years.
* Tooth-related inclusion criteria: presence of at least one anterior tooth with mobility in combination with a clinical attachment loss (CAL) ≥ 5 mm and a relative alveolar bone loss (ABL) of ≥ 50% at the affected tooth.
* Dentition with at least 3 antagonistic contact zones opposing posterior teeth, that is Eichner Class A1, A2, A3, B1

Exclusion Criteria:

* Patients with anterior cross bite
* Bruxism or signs of parafunction
* Implant in Anterior teeth
* Any active periodontal therapy in last 1 year
* Mobility of teeth due to acute trauma
* Pulpal or periapical pathology in anterior teeth
* Patient requiring any emergency dental procedure
* Patient on antibiotic therapy in last 1 month
* If patient want to undergo surgical treatment for management of periodontitis.
Genetic Study of Sitosterolemia

OBJECTIVES:

I. Identify the genetic defect and fine map the gene that causes sitosterolemia.

PROTOCOL OUTLINE: Patients, family members, and normal volunteers provide blood samples for genetic studies and may fill out a general health and medication history.

Linkage analysis and microsatellite screening is performed on genomic DNA, especially chromosome 2p21, between microsatellite markers D2S1788 and D2S1352.

Positive results may be reported to the patient and may influence future treatment.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of sitosterolemia Presence of tendon and tuberous xanthomas Premature atherosclerotic disease No family history of premature coronary artery disease Normal or elevated plasma cholesterol levels

OR

* Family member of patient with sitosterolemia

OR

* Normal volunteer
Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients

The primary aim is to study change of critical frailty scale (CFS) and health related quality of life (EQ-5D-5L) in a long-term follow-up of ICU survivors. We aim to identify important ICU related predictors for change in CFS and EQ-5D-5L in long term follow up (1 yr).

Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level, severity score and mortality.

This is a multi-centre norwegian observational, prospective multicenter Norway coordinated from University hospital North Norway, Tromso.

The study is approved by The Regional Committee for Medical Research Ethics Northern Norway.

The following scores will be assessed by asking the patient and relative during ICU stay: CFS, EQ5DL before current critical illness.

The following demographic and clinical data will be retrieved from the medical records: Comorbidity before critical illness, reasons for ICU admission, daily severity score (SOFA- score), length of mechanical ventilation, dialysis, tracheostomy, Habitat before and after ICU treatment, ICU and hospital length of stay, complications retrieved during intensive care treatment, mortality, limitation of treatment.

The patients will be followed up with telephone interview after hospital discharge for evaluation of: Comorbidity, CFS, EQ5DData for all sites are collected and managed using RedCap electronic data capture tools.

Three research nurses will do the follow up with telephone interviews on all sites and record the data in RedCap.

We aim to enroll 300 patients before 31. Des 2024.

Eligibility Criteria:
Inclusion Criteria:

* \>= 65 years
* ≥ 24 hours mechanical ventilation
* Written informed consent from patient or next of kin

Exclusion Criteria:

* Readmission of patient included in the study
* Not possible to obtain a valid CFS or and EQ-5D-5L at admission or follow-up of CFS because of social context or language.
Stevia Extract and Glucose Homeostasis

This study aims to assess the effect of stevia extract on postprandial glucose and insulin levels in overweight and obese adults when compared to sugar and water.

The study is a three-arm crossover trial involving participants attending the Lab on 3 different occasions (separated by 3-5 day washout period), where they will be administered water, sugar solution (65g), water and stevia extract (5g) solution. The solution will be followed by a consumption of a fixed meal (after 30 minutes). Breakfast will be standardised. Capillary blood glucose will be collected every 30 min until 2 hours post meal. Venous blood samples will be collected before the intake of the solution and at 2 hours after meal intake.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* BMI 27-40 Kg/m2
* Males and females

Exclusion Criteria:

* Athletes
* Pregnant or breastfeeding women
* Patients with chronic disease (diabetes, CVD etc...).
Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy

Due to COVID 19 (Corona virus disease)pandemic, majority of surgeries, including surgery for cancer patients got delayed across the globe. Surgeries were limited to emergency set up only. At our institute we tried to perform colorectal cancer surgeries through out the pandemic, albeit in less numbers, as we thought cancer in itself is an emergency setting. we are planning to analyse the prospectively managed database of this particular group of patients over a period of last six 6 months and look out at 30 day post operative morbidity and mortality. Besides we will try to analyse the implications of our decision to carry on with cancer surgeries in terms of number of health care workers who got infected while being involved in primary care of these patients.

INTRODUCTION Health systems all across the globe have been under tremendous stress due to COVID 19 pandemic. Based on information suggesting that India was faring better compared to the west \[1\] and that oncology patients were likely to get deferred care with significant implications \[2\], the department of general surgery (colorectal division) took a conscious decision to continue offering elective cancer surgeries albeit in less numbers.in this study we will try to collect 30 day post operative outcome data of elective colorectal cancer resections at our department and discuss the implications of our decision.

Such reports are still sparsely reported from Covid hotspots around the world.

Methods:

We will analyze the prospective database of the department of colorectal surgery at Sheri Kashmir Institute of Medical Sciences, Srinagar, a tertiary referral centre and a high volume centre for colorectal cancer surgeries ( with more than 300 colorectal cancer surgeries performed every year) in North India wef 23rd March to 22nd September 2020 (6 months).and report outcomes of all elective colorectal cancer surgeries. Each patient will be followed up for 30 days, thereby last follow up will end on 22nd October 2020.

All colorectal cancer patients subjected to elective and emergency surgeries during COVID 19 pandemic will be included. Patients who were positive for SARS CoV2 (Severe acute respiratory syndrome coronavirus 2) infection and underwent surgery for colorectal cancer will be excluded.

The data will be statistically analysed using Statistical Product and Statistical Solutions(SPSS) sotware v 23. All categorical variables will be shown in the form of frequency and percentage. Continuous variables will further be analysed by independent t test and using multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer patients subjected to surgery during COVID 19 pandemic

Exclusion Criteria:

* SARS CoV 2 infected patients
Testing the SNOWDROP Intervention: Using a Clinical Decision Support System and Patient Portal for Falls Prevention Among Older Patients in Primary Care

Falls are a leading cause of injuries among older patients. Medication use is a major risk factor for falls. Because we lack tools to assess individualized risks, general practitioners (GPs) struggle with fall-related medication management for older patients. Furthermore, these older patients are often not properly equipped to engage in the joint management of their medication. A Clinical Decision Support System (CDSS) for GPs and a patient portal for older patients may stimulate shared decision making between GPs and older patients when discussing the medication-related fall risk. The CDSS provides the GP with advice on how to alter medication in such a way that the fall risk decreases, and the patient portal helps the older patient to prepare for a consultation and to engage in the joint management of their medication.


Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years or older
* High fall risk
* Takes at least 1 Fall Risk Increasing Drug (FRID)
Testimonials and Navigation in Rheumatology

The overall goal of this study is to determine whether a novel, multi-modal, patient-directed behavioral intervention initiated in rheumatology clinics is an effective approach to improve uptake of updated COVID-19 vaccine.

Black and Latinx persons are at higher risk for certain autoimmune and inflammatory rheumatic diseases (AIRD) and have experienced worse COVID-19 outcomes compared to their white counterparts. Given the risks of severe COVID-19 outcomes such as hospitalization and death in people with AIRD, COVID-19 vaccine is recommended in this population. Historically, overall vaccine uptake among people with AIRDs has been low, and this vaccine reluctance has extended to COVID-19 vaccination. While additional COVID-19 vaccine doses have offered considerable added protection against severe outcomes, only 20% of all vaccinated persons in Alabama (AL) and 45% in Massachusetts have obtained an additional dose of COVID-19 vaccine as of October 2022. Racial and ethnic minority groups have faced disparities in obtaining subsequent COVID-19 vaccines, particularly in under-resourced communities, including those in Alabama and Massachusetts. Together, these obstacles exacerbate existing health inequities among people of color and perpetuate worse COVID-19 outcomes.

We will conduct a randomized controlled study to test an intervention that seeks to address gaps in COVID-19 vaccine information and access inequities common in Black and Latinx populations.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18+ years) with known AIRD
* Black race and/or Latinx ethnicity
* Individuals who have not obtained the updated COVID-19 vaccine series (self-report)

Exclusion Criteria:

-Lack of access to phone
Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* one or more oral antihyperglycemic medications
* once-daily insulin glargine
* HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
* Non-smoker

Exclusion Criteria:

* taking a TZD dose greater than what is indicated
* more than two episodes of severe hypoglycemia during the 6 months prior
* Have had a lower respiratory infection in the 3 months prior
* systemic glucocorticoid therapy
* clinical signs or symptoms of liver disease, acute or chronic hepatitis
* history of renal transplantation
* Have an active or untreated malignancy
* Require more than 150 U/day of insulin glargine
Effect of Caffeine on Myocardial Oxygenation

The purpose of this study is to investigate the impact of caffeine on myocardial oxygenation and other cardiovascular magnetic resonance parameters in healthy controls.

Caffeine is presumed to create a confounder with diagnostic imaging. The vasodilatory capacity is considered a key measure for the detection of significant coronary disease with stenosed epicardial arterial conduit vessels and overall microvascular function, including endothelial dysfunction. Twenty nine healthy controls will undergo a baseline cardiovascular magnetic resonance (CMR) exam. Afterwards, participants will consume coffee in the presence of study personnel. This will consist of 3 espresso shots, which will be consumed within 15 minutes. Approximately 2h after coffee consumption the CMR exam will be repeated. The goal will be to investigate the impact of caffeine on myocardial features. In particular the effect on the myocardial oxygenation response to vasodilating and vasoconstricting stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent, documented by signature
* Aged 18 to 45

Exclusion Criteria:

* MRI Contraindications following current institutional guidelines at the time of the CMR exam
* Knowledge or suspicion of pregnancy (verified with a pregnancy test).
* Consumption of caffeine 12h prior to the baseline CMR exam (outside of the study protocol).
* Known cardiovascular disease, diabetes, severe respiratory disease, obstructive sleep apnea syndrome, chemotherapy and radiation treatment, cerebrovascular and occlusive peripheral vascular disease.