cyrilzakka/clinical-trials huggingface dataset:
Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.

During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with invasive or non-invasive breast cancer;
2. The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;
3. Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).
4. No distant metastasis;
5. Life expectancy ≥6 months;
6. Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.);
7. Patients are willing to cooperate to follow up;
8. Patients should sign the informed consent;
9. Women of childbearing age need effective contraception.

Exclusion Criteria:

1. Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
2. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
3. Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
4. Concurrent active connective tissue disease;
5. Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma);
6. Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
7. Pregnant or breast-feeding.
VA Integrated Medication Manager

The purpose of this study is to advance the science of healthcare informatics and to improve medication management through the development of a new approach to the electronic medical record called the Integrated Medication Manager (IMM).

In an attempt to address problems patient non-compliance with quality goals barriers to access and integration of health information that impede achievement of treatment goals, the VA is developing a new approach to the electronic medical record. The VA is moving away from the paper-chart metaphor and towards an integrated representation of the patient's status and care process across time. One of the first steps in the development phase has been to explicitly relate patient conditions, therapies, and goals in the domain of pharmacotherapy. This is called Integrated Medication Management and draws on Hollnagel's Contextual Control Model. Providers will be able to plan care and create orders directly in the context of these explicit relationships. This application will be implemented nationwide through a web interface embedded within the existing Computerized Patient Record System (CPRS), the graphical user interface to VA Information Systems (VistA).

Aim 1: Identify cognitive components of providers' therapeutic decision making in the field.

Aim 2. Refine and evaluate the Integrated Medication Manager using simulation studies.

* Aim 2.a. Refine interfaces and logic of the Integrated Medication Manager.
* Aim 2.b. Compare the performance of the Integrated Medication Manager and usual CPRS.

All hypotheses (below) test the use of IMM versus usual electronic medical record (EMR).

* Speed of decision-making will be faster.
* Accuracy of data interpretation (clinical assessment) will be higher.
* Appropriateness of therapeutic plans will be higher.
* Efficiency of gathering information will be higher.
* Common ground measures will be higher.
* Appropriateness of therapeutic plans will be higher when relevant data is outside the usual time horizon.
* Appropriateness of therapeutic plans will be higher when complex associations among patient therapies and goals exist.
* Appropriateness of therapeutic plans will be no lower when relevant data is not captured by the displays of the IMM.
* Appropriateness of therapeutic plans will be higher when highly salient data is not germane to the most important problem.
* Appropriateness of therapeutic plans will be higher when cognitive load is high due to interruptions.

Eligibility Criteria:
Inclusion Criteria:

* Practiced in primary care for at least two years
* Third year residents with two years of residency in internal medicine or family practice
* Do not have to be currently practicing

Exclusion Criteria:

* None
Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners

Running form and technique have a direct influence on a runner's economy, and therefore small changes in specific running mechanics could be useful to improving running performance. The thumb plays an important role in the functionality of the foot. During standing, the big toe is more loaded than the head of the five metatarsals and the heel.

The study design will be a Randomized Controlled Trial. This study will be conducted in Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of eight to ten months after the approval of the synopsis. The sample size will be 30 subjects. Non-probability convenient sampling technique will be used to recruit the individuals for the study. Then randomization will be done by lottery method to divide the individuals into 2 treatment groups. The experimental group is given big toe strengthening program for 3 weeks along with running training on the other hand control group will do only their running training and after that measure their pre-post values on spss.

In this study, it will be aimed to examine the relationship of big toe strength with parameters that affect anaerobic athletic performance in runners such as vertical jump, horizontally jumping, strength, agility and speed.

The objective of my study is to explore the effects of big toe strengthening on agility, jump and speed among runners.

Eligibility Criteria:
Inclusion Criteria:

* Age; 16-28yrs
* Male runners
* Doing Running practice for 3 days in a week(40-60minutes per day)

Exclusion Criteria:

* Participants a will be excluded if they have any neurological signs.
* Any lower limb trauma and history of fracture past six month
* Systematic illness ; diabetic ,hypertension(6)
Experiential Avoidance as the Mechanism of Mindfulness Intervention in Reducing Emotional Distress: Daily Dairy Research

This study hopes to:

1. explore whether three weeks of MIED could promote experiential avoidance.
2. explore experiential avoidance could be a mediation of outcomes of MIED.

Experiential avoidance refers to individuals resisting experiences or trying to eliminate certain experiences (such as emotions, thoughts, physical feelings, memory and behavioral tendencies, etc.), and trying to adopt corresponding strategies to change these experiences and the situations in which the experiences are generated (Hayes, Wilson, Gifford, Follette, \& Strosahl, 1996). Experiential avoidance has been proved to be a maintenance factor for many psychological disorders (Boelen \& Reijntjes, 2008), and trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences (Gross,1998; Gross,2002; Sloan, 2004; Wegner, 1994). According to some reviews, experiential avoidance is one of the beneficial effects of mindfulness (Brown, Bravo, Roos, \& Pearson, 2015; Shapiro et al., 2006). However, no study has examined experiential avoidance as mediator in mindfulness intervention whether in the between-subject or in within-subject level . Therefore, this study uses daily diary research explore the role of experiential avoidance as the effective mechanism of mindfulness intervention.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

Exclusion Criteria:

* Subjects who could not access the Internet;
* Subjects with insufficient Chinese ability;
* Subjects who have participated in mindfulness based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week;
* Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
* Subjects at risk of suicide.
Testing a Novel Dairy Protein to Counteract Immunosenescence

Aging populations experience a decline in adaptive immune system function also known as immunosenesence. Nutritional approaches to stimulate and strengthen the immune system are needed for this growing segment of the population. A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response. Our objective was to examine the immune stimulating effects of dairy protein subjected to ultraviolet radiation (UV-C) radiation treatment process instead of pasteurization. Participants were 21 healthy individuals over 60 years of age who consumed 6 g of the dairy protein or a comparison, soy isoflavone protein, twice a day for eight weeks. DTaP vaccine administered at week 4. Non-parametric t-tests revealed a significant increase in Tetanus antibodies in the dairy group compared to the soy group at week 8. These findings suggest additional benefits of UV-C treated unheated dairy protein as a solution to counteract immunosenescence, but warrant further study in elderly and other populations that might benefit from immune system stimulation.


Eligibility Criteria:
Inclusion criteria included participants be more than 60 years of age. Volunteers underwent a physical examination and health assessment by a physician to ensure the absence of exclusion criteria which were regular consumption of greater than one unit of milk and/or milk products (milk, yogurt, fresh cheese, etc.) a day at the time of enrollment, known milk allergy, food faddism, other non-traditional diet, prolonged consumption of dairy supplements (greater than one daily during the previous four weeks), use of tobacco products in the previous 10 years, underlying neoplasia or immunological disease, including hypergammaglobunemia, renal disease or failure, use of steroids or immunosuppressive drugs in the previous eight weeks, reduced physical activity (New York Heart Association classes III-IV). Having received a DTaP vaccine within the last five years was an exclusion criteria for the study, but patient records were incomplete for many volunteers on this aspect. Therefore, volunteers with an initial Tetanus antibody level above 3 IU/mL were excluded from the study results as the volunteer was assumed to have had the DTaP vaccine within the last 5 years.
Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms

The main purpose of this project is to further explore the metabolic effects and the mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. The project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both pre-diabetic as well as diabetic subjects with obesity will be included. This part of the project focuses on patients with manifest T2D and they will be assigned to surgical and non-surgical intervention, respectively, in a strictly controlled and randomized manner.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-60 years
* Type 2 Diabetes Mellitus with duration of no more than 10 years, treated with 0-3 oral anti-diabetic drugs or Glucagon-like peptide-1 (GLP-1) analog.

Exclusion Criteria:

* Pregnant or planning to be pregnant during the study.
* Known or suspected history of significant drug abuse.
* History of alcohol abuse or excessive intake of alcohol as judged by investigator.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator
* Sleep apnea
* Any previous serious cardiovascular event, stroke , acute myocardial infarction.
* Diabetes complications : proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an Estimated Glomerular Filtration Rate (eGFR) \<60, foot ulcers, symptomatic neuropathy
* Medications within 3 months : Insulin, Thiazolidinediones
* Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety
* Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.
Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin

To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Dyslipidemia with hypertesion
* msSBP \< 180 mmHg
* msDBP \< 110 mmHg
* LDL-C ≤ 250 mg/dL
* Triglycerides \< 400 mg/dL

Exclusion Criteria:

* At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
* CK normal range ≥ 2 times
* Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
* AST or ALT ≥ 2 times
* Uncontrolled diabetes mellitus (HbA1c≥9%)
* CLcr \< 30 mL/min/1.73m\^2
* K \> 5.5 mEq/L
* Other exclusion applied
Vaasa Childhood Obesity Primary Prevention Study

This study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. The recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are at risk to get gestational diabetes.

Exclusion Criteria:

* Foreigner with language problems
* Major psychosocial problems
* Diabetes mellitus type I or II
* Physical disability,
* Major medical problems in pregnancy
Spanish Academy of Dermatology and Venereology (AEDV) Melanoma Registry

The goal of this patient registry is to describe risk factors for bad prognosis of melanoma in Spain. The main questions it aims to answer are:

* To describe socioeconomical individual risk factors associated with melanoma prognosis, such as gender, residence area or socioeconomic level.
* To describe potentially modifiable characteristics of health care associated with prognosis, such as waiting times, type of centre that makes the diagnosis or use of teledermatology Participants data will be gathered for analysis, without any change in the way that they are being treated.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.

Exclusion Criteria:

* In-situ melanomas
* non-cutaneous melanomas,
* metastatic melanoma with unknown primary site.
Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)

This study will evaluate if there is a difference in survival between elective treatment of draining lymph nodes vs. clinical nodal observation in patients undergoing Mohs surgery for high risk skin squamous cell carcinoma of the head and neck who have a normal lymph node exam. Each treatment arm is accepted as a current standard of care, and the objective is to compare outcomes between the two arms.

This is a prospective, randomized, non-blinded, controlled trial of high risk head and neck cutaneous squamous cell carcinomas which will compare specific outcomes between two treatment arms. Subjects are eligible patients who are sent to Zitelli \& Brodland PC for Mohs micrographic surgery of tumors that meet our high risk criteria. These patients with clinically-negative lymph node exams will either enter into the arm of nodal observation or the arm of elective management of the neck, which is currently the standard protocol per the UPMC ENT department. The patients in the observation arm will have evaluation and treatment of their lymph nodes if an abnormality is detected clinically. The primary endpoint is disease-specific survival. Secondary endpoints will include overall and disease-free survival, complications, and quality of life measures for each arm.

Eligibility Criteria:
Inclusion Criteria: Major criterion and at least one minor criteria

* Major criterion: \> 6 mm depth of invasion
* Minor criteria (one or more):
* Greater than 2cm diameter
* Recurrent (prior Mohs, wide local excision, electrodesiccation and curettage, topical imiquimod or 5 fluorouracil, cryotherapy or photodynamic therapy)
* High risk location: any portion of cutaneous lip, ear, temple, scalp
* Immunosuppressed host (organ transplant recipient or chronic lymphocytic leukemia)
* Perineural invasion (yes/no; nerve involved must be greater than 0.1mm)
* Direct involvement of subcutaneous tissue (Clark's V), muscle, cartilage,or bone

Exclusion Criteria:

* Satellite metastases
* Clinically abnormal lymph node exam
* Location other than head or neck
* Exclusively mucosal squamous cell carcinoma
* Previous head and neck radiation
* In situ disease, keratoacanthoma subtypes, metatypical or collision tumors
* Inability of subject to give written informed consent
* Pregnancy
Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus

Although diabetes has been controlled since insulin became available, it is still considered incurable and poses serious threats to human health. Reports have suggested that the hyperglycemic condition of patients with diabetes mellitus may be greatly alleviated or even reversed if it could be controlled at an early stage of diabetes. Thus, early detection and diagnosis of diabetes and prediabetes are become increasingly important in the treatment and prevention of diabetes. Diabetes mellitus is currently diagnosed by recurrent or persistent hyperglycemia. In an effort to identify novel biomarkers for diabetes, research has shown that neither plasma glucose nor glycated hemoglobin (HbA1c) levels are unable to be used in the early detection of diabetes. In this work, the investigators have found 8 biomarker candidates by developing a standard-free, label-free MS-based proteomics method based on standard protein (human serum albumin, the highest abundance protein in human plasma) model in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical plasma samples to see if there is significant quantitative difference between normal people and diabetes patients.

The procedure of clinical study was:

1. to get plasma samples from hospital;
2. digestion of plasma protein-mixture by trypsin;
3. run mass spectrometry and monitor the amount of target HSA-peptides.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus cases;
* Impaired Glucose Tolerance cases;
* Normal Glucose Tolerance cases

Exclusion Criteria:

* Type 1 Diabetes Mellitus cases;
* Gestational Diabetes Mellitus cases;
* Hepatitis patients
The ClearCoast™ Magnetic Resonance Outcome PMS Study

Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent BCS will serve as the historical control group, accounting for a 1:1 ratio. All study patients and the patients in the historical control group will be required to meet the study eligibility criteria.

BCS will be performed with the routine standard of care (SOC), including intra-operative methods used to improve margin assessment. In addition to SOC process, the main specimen from patients found eligible will be scanned in the ClearCoast™ system. The surgeon will utilize the information from the ClearCoast images in his margin assessments evaluation which includes the diffusion at the surface of a particular aspect (suggesting irregular tissue at the specimen's surface), and decide whether to excise additional tissue. The decision-making process including MR images interpretation and the surgical decisions will be evaluated and documented. Following procedure, routine histopathology examination will be performed accompanied by the ClearCoast optical and parametric maps.

This study is a controlled design, in which subjects previously having undergone BCS by the same surgeons, will serve as the historical control group, comparing the following endpoints:

* Complete surgical re-excision rate
* Total excised breast tissue volume

The study Control group is composed of historical data from patients previously undergone BCS, under the same site SOC surgical practice, practicing surgeons, and study eligible criteria. This allows reducing inter-group variability and bias.

A device operator trained by ClearCut Medical will operate the device throughout the study.


Eligibility Criteria:
Inclusion Criteria:

1. Women histologically diagnosed with invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure
2. Age ≥18
3. Patient is willing and capable to provide written Informed Consent Form (ICF)

   Exclusion Criteria:
4. Prior surgical procedure in the same breast within 12 months prior to the surgery date
5. Recurrent breast cancer surgery
6. Neoadjuvant chemotherapy and/or neoadjuvant hormone therapy
7. Previous radiation therapy in the operated breast
8. Pregnancy
9. Lactation
10. Patient has subglandular breast implants in the operated breast
11. moribund patient and/or patient with comorbidities, per principal investigator discretion
12. Participating in any other investigational study for either drug or device which might influence collection of valid data under this study.

    Intraoperative:
13. Specimen undergoing pathological specimen assessment (e.g. by frozen section, imprint cytology or gross assessment by sectioning), resulting in deformation of specimen shape/tissue properties (e.g. Formalin conservation)
14. Specimen dimension is larger than the Tissue container volume (200cc)
15. Inability to define aspect color/orientation and/or margin border
Validity and Reliability of 6 Minute Stepper Test in Kidney Transplant Recipients

The aim of our study was to investigate the validity and reliability of the 6 minute stepper test in kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney transplantation
* At least 6 months after the kidney transplant
* Not having regular exercise habits
* Voluntary participation in the study

Exclusion Criteria:

* Having a musculoskeletal problem that may interfere with the tests
* Having neurological impairment
* Having chronic lung disease
* Having had any cardiovascular event in the last 6 months