cyrilzakka/clinical-trials huggingface dataset:
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.

Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
* Indication to adjuvant radiotherapy including boost radiotherapy
* Clearly identified primary tumor region preferably by radiopaque clips
* Primary wound healing after breast conserving therapy without signs of infection
* Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
* Written informed consent

Exclusion Criteria:

* Patients operated by mastectomy
* No indication for boost radiation
* Resection margins positive for disease or insufficient identification of the boost volume
* Indication for radiotherapy of the regional lymph nodes
* History of prior breast or thoracic radiotherapy
* Extended postoperative seroma at the beginning of radiotherapy
* Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
* Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Integrating Motivational Interviewing With Cognitive-behavioral Therapy

Cognitive-behavioral therapy (CBT) is efficacious for anxiety disorders and depression, but not all patients achieve remission, and dropout is considerable. Motivational interviewing (MI) may strengthen motivation to change, and influence non-response and dropout. Research shows that MI as a pretreatment to CBT produces moderate effects compared to CBT alone. Studies integrating MI with CBT (MI-CBT) throughout treatment are scarce. The present study explored the feasibility of MI-CBT in routine psychiatric care, and compared CBT alone to MI-CBT for anxiety disorders, depression, and unhealthy lifestyle behaviors. The Anxiety, Depression, Diet, Alcohol, Physical activity, and Tobacco (ADDAPT) feasibility study had a randomized controlled design, and data were analyzed using hierarchical regression.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* A principal diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) of panic disorder, social anxiety disorder, obsessive-compulsive disorder, generalized anxiety disorder, posttraumatic stress disorder, or major depressive disorder
* At least one of the following unhealthy lifestyle behaviors: unhealthy eating habits, hazardous use of alcohol, insufficient physical activity, or tobacco use, according to screening criteria suggested by the National Board of Health and Welfare

Exclusion Criteria:

* Psychotic symptoms
* DSM-IV-TR criteria for substance abuse other than alcohol
* DSM-IV-TR criteria for substance dependence including alcohol
* Moderate to severe suicide risk according to the Mini-International Neuropsychiatric Interview or a score of 2 or above on item 9 on the Patient Health Questionnaire 9
* Another simultaneous psychological treatment
Virtual Scale Function SCALE EYE: Variability and Systematic Differences

Size of colorectal polyps is important to decide on appropriate surveillance intervals and treatment modality, as well as carrying out optical diagnosis strategies. However, polyp size measurement is often prone to inter-observer variability. An easy and accurate tool to assist in polyp size measurement is required. Recently, a virtual scale function for size measurement during endoscopy (SCALE EYE), operating in real-time without the use of any additional devices, has been developed. The aim of this study is to assess whether use of the SCALE EYE for polyp size measurement can reduce inter-observer variability.

This study is designed as a single center prospective study. Polyp size measurements using SCALE EYE will be compared with several other polyp size measurement techniques: size measurements by endoscopists without a reference ('carpenters eye') , size measurements by endoscopists with an opened snare (of known size) as reference and size measurements by the pathologist during histopathological analysis.

During screening colonoscopies, detected polyps (maximum of four per colonoscopy) will be measured using all three different colonoscopy measurement techniques. This will be done by experienced endoscopists (endoscopist accredited for colonoscopies within the national colorectal cancer screening program). Since endoscopists measure polyps in multiple ways, consecutive measurements of the same polyp will be biased. For this reason, all polyp size measurements will be recorded on video. The video recordings of the different measurements of all polyps will be presented to eight expert endoscopists and four to eight trainees (depending on availability) in a randomized order. The size estimations based on these video recordings will be used for further analysis. Histopathological analysis and size measurements of the resected polyps will be performed by pathologists with expertise in gastrointestinal pathology. Variability and systematic differences in polyp size measurement between different measurements methods will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Screening colonoscopy after positive fecal immunochemical test (FIT) within the Dutch colorectal cancer screening program
* Signed informed consent

Exclusion Criteria:

* Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome
Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.

This study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.

Cervical range of motion is a frequently used assessment methods in patients with neck pain.

Although it seems to be used frequently, clinicians still prefer hands-on assessment. Furthermore it is interesting, if cervical range of motion,self-assessed by the patient is a valid and reliable tool.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain \> 90 days
* Able to speak, read and write German

Exclusion Criteria:

* Red Flags e.g. Fracture of the cervical spine
Impact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs

The prevalence of superficial chronic venous insufficiency (CVI) of the lower limbs is estimated at 18 million French people. The number of patients operated for varicose veins is around 300,000 per year. Post-operative complications such as venous ulcer, venous thrombosis and varicose vein rupture require a lot of medical care. Varicose veins are responsible for a decrease in quality of life and represents 1 to 2% of total health expenditure.

Currently, operating techniques tend towards minimally invasive procedures in order to minimize the surgical trauma, improve patient comfort and reduce the time of postoperative work stoppages.

This study aims to compare two surgical techniques for the treatment of superficial chronic venous insufficiency of the lower limbs : phlebectomy, the gold-standard technique, and endovenous steam treatment. Several studies have already been carried out on endovenous steam treatment for saphenous veins but none has been published concerning the tributary veins.The main objective of INVOLVE is to assess the quality of life of patients 1 month after surgery. Clinical improvement and economic impact will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
* Signature of the informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
* Affiliation to a French social security scheme or beneficiary of such a scheme
* Patient with a reflux of the tributary veins, associated or not with a reflux of the large saphenous veins
* Patient with a reflux of the tributary veins already treated for a reflux at the saphenous level
* Clinical stage between C2 and C5 (from the CEAP classification). Diameter of the vein between 3 and 13 mm
* Patient treated with one or two lower limbs
* Patient able to understand and complete a quality of life questionnaire

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
* Subject without health insurance
* Pregnant woman
* Subject in the period of exclusion from another study or provided for by the "national file of volunteers"
* Patient with an absolute or relative contraindication to the treatment of his varicose veins by an endovenous technique
* Venous insufficiency at the expense of the small saphenous vein
* Patient with a history of venous thrombosis
* Patient with hemostasis disorders
* Patient with an associated severe pathology (cancer, heart failure, renal failure)
* Patient treated with sclerotherapy
Characteristics of Hospitalized Patients With Community-acquired Pneumonia

At present, the epidemiological characteristics and the distribution of pathogens of community-acquired pneumonia in Shandong Province are not clear. In order to understand the characteristics of community-acquired pneumonia, the distribution of pathogens and the risk factors of complications in Shandong Province, it is necessary to carry out investigation and study, which will provide the basis and support for the future prospective cohort study of pulmonary infection.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 14 years.
* In the community.
* Chest X-ray showed patchy, patchy infiltrative shadows or interstitial changes with or without pleural effusion (in or out of hospital) .
* Pneumonia-related clinical manifestations: 1) recent cough, expectoration or respiratory disease symptoms aggravated, and the emergence of purulent sputum, with or without chest pain. 2) fever: armpit temperature ≥37.3℃ or hypothermia: armpit temperature \<36℃. 3) signs of pulmonary consolidation and/or Wet Rales. 4) white blood cell \> 10 × 10\^9/L or \< 4 × 10\^9/L with or without left shift of nucleus. Comply with 1,2,3 above plus any one of 4 above.

Exclusion Criteria:

* The patients were initially diagnosed with pulmonary neoplasms, tuberculosis, non-infectious interstitial disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil granulocyte infiltration and pulmonary vasculitis.
* Human Immunodeficiency Virus.
* The patient was readmitted within 72 hours of discharge and was classified as a single hospitalization.
Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit

The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package. This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4) Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling. These components have strong theoretical and empirical support, but their relative, additive, and interactive effects are unknown.


Eligibility Criteria:
Inclusion Criteria:

* age \>=18 years; smoking \>4 cigarettes/day for the previous 6 months; able to read, write, and speak English; have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts; and if currently using NRT, agreeing to use only study medication for the duration of the study. We will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses); not currently attempting to quit smoking; not intending to quit smoking (defined as no plans to quit in the next month); and planning to remain in the intervention catchment area for at least 12 months.

Exclusion Criteria:

* currently taking bupropion or varenicline; medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days; diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years; and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.
A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders

The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders


Eligibility Criteria:
Inclusion Criteria:

* Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
* Willingness to discontinue all antipsychotic medications during the study period

Exclusion Criteria:

* Patients who are clinically stable on treatments that are well tolerated
* Substance-induced psychotic disorders
Individualized Automatic Target Coaching Message for Glycemic Management and Depressive Symptom

This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are determined to use continuous glucose monitoring based on their physician's medical judgment.
* Patients with type 1 diabetes, age 20-69 years old
* Currently receiving treatment with multiple insulin injection therapy
* Patients who have access to KakaoTalk via smartphone and are able to communicate with it
* Voluntarily agreed to participate in this clinical study.

Exclusion Criteria:

* Subjects using oral hypoglycemic agents
* Steroid and immunosuppressant users
* Subjects receiving anticancer medications
* Breastfeeding or pregnant patients
* Patients who do not voluntarily consent to the study
* Anyone deemed unsuitable by the investigator to participate in the study
Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression

A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram

In this study we aimed at investigating to what degree rTMS applied over the left dorsolateral cortex relieves depressive symptoms when the treament is combined with antidepressive medication. The study will also be able to supply knowledge on how long any possible effect of the rTMS treatment lasts.

In the first 12 weeks of the trial participants are randomised to either rTMS combined with escitalopram or sham rTMS combined with escitalopram. rTMS is given daily for the first 3 weeks.

The next phase is a relapse prevention study where the responders from the initial phase are randomised to either active or placebo escitalopram for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Major depression Hamilton score above 18
* Age 18 to 75

Exclusion Criteria:

* Pregnancy og breastfeeding
* Mental retardation and organic brain disease
* Alcohol and substance abuse
* Metal implants in brain, pacemakers and other electronic implants
Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy

The purpose of this study is to determine whether or not the Angioshield device can be safely applied to support saphenous vein grafts used in standard coronary bypass surgery.

\\This is a first in human study which is intended to determine if a larger pivotal study is justified.

Eligibility Criteria:
Inclusion Criteria:

Subject will be eligible for inclusion in the investigation if he/she:

* is between the ages of 18 and 80 years of age, inclusive
* requires Coronary Atery Bypass Graft (CABG) surgery with minimum of one SVG used to bypass a stenosis in the Right Coronary, the Circumflex, a Diagonal, or an Obtuse Marginal artery, due to atherosclerotic coronary artery disease
* is able to give their informed written consent
* is willing and able to complete all follow-up visits and procedures

Exclusion Criteria:

Subject will be excluded from participation in the investigation if he/she:

* is currently enrolled in another clinical investigation
* is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
* is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
* shows a presence of hypercoagulable state or history of idiopathic venous or arterial thrombosis
* has had an acute MI within the last 21 days
* has had a previous CABG
* requires emergency surgery
* has a left ejection fraction (LEF) less than 20%
* has a target vessel stenosis of less than 70%
* has a transmural infarct of the target artery territory
* currently requiring dialysis
* is having concomitant-surgery of any kind
* has varicose veins
* has had previous saphenectomy
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers


Eligibility Criteria:
Inclusion Criteria:

* Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13

Exclusion Criteria:

* Previous ascertained or suspected disease caused by N. meningitidis;
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
* Any serious chronic or progressive disease
* Known or suspected impairment/ alteration of the immune system,
* Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
An Outpatient Study Investigating Non-prescription Treatments for COVID-19

This is a platform study to investigate the effectiveness of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently tested positive for COVID-19.

This study will screen for the activity of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently diagnosed with COVID-19. This will be a randomized, blinded placebo-controlled study with respect to the active treatment (chlorine dioxide) vs placebo, and randomized open-label with respect to a non-prescription medication (famotidine) and supplements including zinc, EGCG and lactoferrin. Treatment will last for 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 20-70
4. Confirmed diagnosis of COVID-19 by positive COVID-19 test. Symptoms of a mild degree such that hospitalization is not required. Within 7 days of symptom onset.
5. Ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen

Exclusion Criteria:

1. COVID-19 symptoms of a severe enough nature that requires hospitalization
2. Pregnancy or lactation
3. Diagnosis of diabetes mellitus
4. currently taking paroxetine or digoxin
5. Individuals with diabetes mellitus
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.

Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).

Eligibility Criteria:
Inclusion Criteria:

* Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.

Exclusion Criteria:

* Cerebral death, Locked-In Syndrome, blindness, deafness
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid

The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.

Not Provided

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TTO
* Age 18-60
* Willing and able to provide consent

Exclusion Criteria:

* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Older than 60 years of age
* Any patient considered a vulnerable subject
* Have bleeding or clotting disorder
* Preoperative anticoagulation therapy
* Abnormal coagulation profile
* Renal disorder or insufficiency
* Sickle cell disease