cyrilzakka/clinical-trials huggingface dataset:
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer

The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.

* In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation".
* Participants will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments.
* Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy.
* We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial.
* Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
* Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT
* 18 years of age or older
* ECOG Performance Status 0
* Required laboratory data as outlined in the protocol

Exclusion Criteria:

* Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
* Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
* Tumor \> 2.0cm, nodal involvement, or metastatic involvement
* Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma
* Known mutation carrier, including BRCA1 and BRCA2
* History of cosmetic or reconstructive breast surgery
* Psychiatric illness which would prevent the patient from giving informed consent
* Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease
* Participants with a "currently active" second malignancy other than non-melanoma skin cancers
* Patients with diffuse (\> 1 quadrant or \>5cm) suspicious microcalcifications
* Women who are pregnant
Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness

Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and manipulation of upper cervical spine are the most popular treatment in this patients. The International Federation of Orthopaedic Manipulative Physical Therapists suggest different recommendations for the safety application of manual therapy techniques in the upper cervical spine, traction manipulation techniques complies with this conditions. However, there isn´t investigation about the effect of traction manipulation in patients with cervicogenic dizziness. The aim of this study is to investigate the effects of traction manipulation in dizziness intensity, range of motion of cervical spine and quality of life on patients with cervicogenic dizziness.


Eligibility Criteria:
Inclusion Criteria:

* Dizziness associated with neck stiffness and/or neck pain.
* Hypomobility of upper cervical spine.
* Sing the informed consent form.

Exclusion Criteria:

* Contraindications for Traction manipulation.
* Pending litigation or legal claim.
* Poor language and communication skills making difficult to understand the informed consent.
Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after an acute or chronic consumption in rodents. In this study, we aimed to investigate the effects of an acute consumption of proanthocyanidins before a breakfast meal in humans. Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape seed proanthocyanidins in humans should be elucidated as well as its activity on vascular function.

The intervention will consist in the administration of 2 capsules containing the grape seed proanthocyanidins extract or 2 empty capsules (placebo) just before breakfast, which will consist of 100g of white bread, 75g of salami, 50g of fatty cheese, 125g of yogurt (10% fat), 25ml of olive oil and water ad libitum. The nutritional composition of this meal is as follows: 1.200 Kcal of energy content, 15% of energy from proteins, 22% from carbohydrates and 63% from fat (35% saturated fat), and 120mg of cholesterol. Blood samples will be taken at point 0.5,1,2,3 and 6 hours after breakfast. Moreover, urine samples will be collected at time 0 and 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 20 and 40
* Signing the informed consent

Exclusion Criteria:

* Body mass index (BMI) lower than 18.5 or greater than 27 Kg/m2
* Smokers
* Regular medication
* Consumption of medication during the last week
* Following a weight-loss diet
* Vegetarians
* Abnormal glucose levels
* Diabetes
* Cardiovascular disease
* Gastrointestinal disease
* Anemia
* Nuts allergy
Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable

Colorectal cancer is prevented by colonoscopy and polypectomy. Failure to recognize the endoscopic resection scar after Endoscopic Mucosal Resection (EMR) risks unrecognized recurrent or residual adenoma (RRA), which may propagate into post-colonoscopy colorectal cancer. Expert series suggest scar recognition and interrogation is well performed with a high negative predictive value of endoscopic imaging vs histopathology. In this study the authors will investigate the performance of endoscopic imaging in detecting RRA at an endoscopic resection scar amongst general endoscopist and the impact of a learning intervention on recognition of RRA.

After consent is given, the participant will open the online survey and fill this in.

First the participant will be asked to create a pseudonym (name+year of birth) and fill in their demographical information (Grade, years in current role, colonoscopy experience, experience of colonic tissue resection, country of employment

The first 15 pictures will be shown prior to a learning intervention. For each picture the same questions will be asked:

* Is this an endoscopic resection scar?
* Based on this image does the scar demonstrate evidence of residual or recurrent adenoma (RRA)?
* What is your level of confidence?
* If the scar shows RRA, how would you treat it? (skip if you feel no RRA).
* If the scar does not show RRA do you feel there is another diagnosis? After the first 15 pictures a video-based learning tool will be shown on detection of RRA.

After the learning tool 15 different pictures will be shown, the same questions will be asked. All responses will be collected by the investigators. Statistical analysis will be performed using visual studio code (Microsoft, Redmond, USA) Images will be selected from the 'Australian Colonic LSL Endoscopic Resection Study' (ACE) database, which is an international multicentre registry of images and videos for retrospective analysis of colonic lesions. Images, videos, procedural information, and histopathological data are stored on a secure online web portal after written informed consent of every participating patient.


Eligibility Criteria:
Inclusion Criteria:

* Endoscopists of any experience level

Exclusion Criteria:

* non consenting adults
CBT for Postpartum Depression and Infant Emotion Regulation

The primary objective of this study is to determine if online group cognitive behavioral therapy (CBT) for maternal postpartum depression (PPD) added to treatment as usual (TAU) leads to greater improvements in infant emotion regulation (ER) than maternal receipt of TAU alone immediately post-treatment and 6 months later. This study will also aim to determine what mechanisms PPD treatment leads to changes in infant ER.

A prospective, single-blind, parallel randomized controlled trial (1:1 ratio) that includes an experimental (receipt of a 9-week group CBT intervention delivered online plus TAU) and control group (TAU alone) to address our objectives. Participants will have an EPDS score of 10 or more and an infant 3-12 months of age and be recruited from the community. The experimental group will receive a validated 9-week online group cognitive behavioral therapy (CBT) intervention on Zoom plus TAU. The control group will receive TAU alone. In both groups, TAU will consist of regular care from their family doctor, midwife, OB/GYN an/or any other types of care they may be accessing. The trial intervention consists of nine, 2-hour sessions occurring once per week. The first half of each session is devoted to core CBT content, including cognitive restructuring. The second half is devoted to group discussions co-led by participants on topics relevant to mothers with PPD (e.g., sleep, supports, role transitions). Groups will be delivered by two trained psychologists, social workers, nurses, and/or psychiatrists. Primary objective: Determine if online group cognitive behavioural therapy (CBT) for maternal PPD added to treatment as usual (TAU) lead to greater improvements in infant ER than maternal receipt of TAU alone immediately post-treatment and 6 months later. Secondary objective: Determine the putative mechanisms through which PPD treatment leads to changes in infant ER.

Eligibility Criteria:
Inclusion Criteria:

* women 18 years of age or older
* understand and speak English (so that they can participate in the CBT group and complete study measures)
* live in Ontario (the primary WHCC catchment area)
* have an EPDS score of 10 or more
* meets diagnostic criteria for comorbid psychiatric conditions.
* Infants must be between 4-12 months old at enrollment.

Exclusion Criteria:

* bipolar disorder
* a current psychotic disorder
* substance or alcohol use disorder
* antisocial or borderline personality disorder.
Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma.

This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma. Patients will receive hypofractionated radiotherapy with concurrent chemotherapy.

Methylprednisolone will be administered daily during radiotherapy at a dose of 2 mg/kg.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed type AB or B1-3 thymoma.
* Measurable Disease: Patients must have measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors).
* Unresectable or recurrent thymoma, with the tumor confined to the chest and neck area.
* Between the ages of 18 and 70 years, regardless of sex.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* No prior chest radiation.
* Adequate organ Functions.
* Written informed consent obtained.

Exclusion Criteria:

* Contraindications to Methylprednisolone.
* History of or Concurrent Malignancy.
* Active infection, myocardial infarction within the last 6 months or symptomatic heart disease.
* Pregnant or Lactating Women.
* Bleeding Disorders.
* Recent Participation in Other Clinical Trials.
* Drug Abuse or Severe Alcoholism.
* Uncontrolled Seizures or Mental Disorders.
* Severe Allergies or Specific Sensitivities.
Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. A possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus

Exclusion Criteria:

* hypertension
* coronary artery disease
* heart valve disease
* ventricular dysfunction
* radiotherapy or chemotherapy
* alcoholism
* limited acoustic window
Time Interval Between TVT and First Void (TIBT) Study

The primary aim of this study is to compare, in women undergoing tension-free vaginal tape (TVT) insertion under sedation and local anaesthetic infiltration, the time interval of first void following surgery between a group of patients who received intravenous fluids to those who did not.

Urinary incontinence is a global condition and its prevalence increases with age. It impairs quality of life of patients and has a significant burden on the health care system. Stress urinary incontinence (SUI) is defined as involuntary leakage of urine when there is an increase in pressure on the bladder, i.e. during exercise, coughing or sneezing. It is the commonest form of urinary incontinence and affects around 50% of women with symptoms of incontinence.

The development of mid urethral tapes (e.g. the tension free vaginal tape \[TVT\]) in 1998 has greatly changed clinical practice. The introduction of TVTs has reduced the average length of hospital stay for patients undergoing surgical treatment of SUI by over 50%. As a result, the hospital bed occupancy for the treatment of SUI has decreased by a similar amount. Studies have shown it to have similar effectiveness to the main alternative surgical treatments in SUI.

In Gloucestershire Royal Hospital, we perform the procedure as a daycase with local anaesthetic infiltration under sedation. Routine cystoscopy is performed as a part of the procedure to exclude bladder trauma. The bladder is emptied at the end of procedure. Patients are then allowed to drink as normal and post void residuals are checked before discharge to rule out any problems emptying the bladder. It has been observed that the major limiting factor in early discharge of patients is the time to first void following surgery. As the patients are starved for surgery, they are often dehydrated and therefore require enough oral fluids to rehydrate and fill their bladder in order to void. If we can somehow reduce this waiting period, we can discharge patients sooner improving their experience with the surgery. We would like to examine whether filling up the bladder intra-operatively with intravenous fluid will reduce this time limiting step.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* TVT performed under general or spinal anaesthetic
* Women under the age of 18 years
* Women unable to give informed consent
* TVT performed in addition to another procedure
* Women not suitable for a fluid challenge due to co-morbidities.
Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy

The aim of this study is to answer the questions below;

1. Is there a difference between patients with lumbar radiculopathy suffering from radicular pain and healthy subjects in terms of static and dynamic postural stability?
2. Is there a relationship between postural stability and the neuropathic characteristics of radicular pain?

Patients presenting to our outpatient clinic with radicular pain and MRI findings associated with radiculopathy will be tested for static and dynamic postural stability. Patient demographics, pain intensity, neuropathic pain scores, and level of disability will also be recorded. The demographic data and postural stability scores will also be collected for the control subjects. Differences between the patient and control groups in terms of postural stability parameters will be sought. In addition, the relationship between the variables representing balance in the patient group and the neuropathic pain score and disability will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Having radicular pain due to lumbar disc herniation.
* Root compression on the dominant side on imaging.
* Root compression at no more than two levels.
* Radicular pain with at least 3 points on a numerical rating scale.

Exclusion Criteria:

* No radicular pain despite root compression on imaging.
* Midline disc herniation or root compression on the nondominant side.
* Radicular pain on the non-dominant side.
* Treatment with neuropathic pain medication or psychotropic medication.
* Loss of muscle strength on clinical examination.
* Evidence of lower extremity atrophy, joint contractures, shortening of limbs, or similar disabilities.
* Presence of vision loss, vestibular or neurological disorders that may cause balance disorders.
A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.

A randomized study is planned for 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and abstinence in unemployed injection drug users. Participants will be recruited through street outreach, at agencies that serve the target populations, and informal word-of-mouth referrals. Participants will be invited to attend the workplace and to enroll in the methadone treatment. To engage participants in the workplace, they will be allowed to work independent of whether they enroll in methadone treatment and independent of their drug use. The workplace participants (N=162) will be randomly assigned to three groups. The "Usual Care Control" participants will be allowed to work independent of their methadone use or urinalysis results. The "Methadone Contingency" participants will be required to take methadone to attend work, and will receive a brief pay decrease for failing to take their medication. The "Methadone \& Abstinence Contingency" participants will be required to take their medication in order to attend work, as well as receive a brief pay decrease for any positive urine samples for both cocaine and methadone.

Eligibility Criteria:
Individuals were eligible if they were:

* at least 18 years old,
* reported injection drug use in the past 30 days,
* met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence,
* reported using heroin at least 21 out of the past 30 days,
* provided an opiate-positive urine sample,
* showed visible signs of injection drug use (i.e., track marks),
* reported not receiving substance abuse treatment in the past 30 days,
* lived in Baltimore,
* and were unemployed.

Participants were excluded if they

* had current severe psychiatric disorders or chronic medical conditions that would interfere with their ability to participate in the workplace,
* reported current suicidal or homicidal ideation,
* had physical limitations that would prevent them from using a keyboard,
* had medical insurance coverage (as this would disqualify them from receiving interim methadone treatment),
* were pregnant or breastfeeding,
* or were currently considered a prisoner.

Eligible participants were invited to participate in a 4-week induction. Participants who attended the workplace for at least five minutes on two out of five workdays in the last week of induction were randomly assigned to one of three conditions and were invited to attend the workplace for an additional 26 weeks
Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 0 to 30 years old at time of transplant
* Bone Marrow Transplant (BMT) recipient at Children's Hospital Colorado (CHCO) between 1/1/2007 and 7/31/2016

Exclusion Criteria:

* Preexisting diabetes mellitus or known hyperglycemia
* Inadequate blood glucose data for analysis
Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications

Peripheral intravenous catheters (PIVCs) can be used frequently in pediatric hematology oncology patients. There are different types of PIVCs as open and closed. There are studies on adults using the closed IV catheter system, which is a type of PICK. However, no study was found in the literature in which the closed IV catheter system was used in the pediatric population.

The primary purpose of this research is; to evaluate the effect of two different catheter systems (closed IV catheter system: BD Nexiva™/ peripheral open IV catheter: BD Insyte™ Autoguard™) on catheter stay in pediatric hematology and oncology patients aged 1-12 years.

The secondary aim of the research is; to evaluate the effect of two different catheter systems on the success of catheter placement and the development of complications in the first attempt in pediatric hematology and oncology patients.

Eligibility Criteria:
Inclusion Criteria:

* Age range of pediatric patients is between 1-12
* Obtaining an informed consent form from the child patient and parent
* Child patient receiving intravenous therapy

Exclusion Criteria:

* port or central venous catheter in the pediatric patient
Effects of Core Stabilization Exercises With and Without Dry Cupping in Patients With Sacroiliac Joint Dysfunction

The aim of this study is to compare the effects of core stabilization exercises with and without dry cupping on pain and disability in patients with sacroiliac joint dysfunction.

Low back pain (LBP) is recognized by its most common symptom - pain - and is known as the primary cause of disability one of the most frequent pain-producing factors in patients with LBP is sacroiliac joint dysfunctions (SJD). The sacroiliac joint dysfunction syndrome (SIJDS) is a contentious topic that is a common cause of low back pain (LBP) and patients often seek physical therapy helps to deal with their symptoms. Dry cupping on the SIJ is a physical therapy technique that has been supported by research in numerous areas, including pain reduction and SIJ mobility promotion.

But, in previous studies, there is very less literature regarding determining effects of the dry cupping on sacroiliac joint dysfunction. Therefore there is a dire need to explore the effect of dry cupping on sacroiliac joint dysfunction. This study aims the management of pain disability and functional impairment in persons with sacroiliac joint dysfunction particularly core stabilization exercises along with dry cupping therapy.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain for more than 3 months
* Pain on performing pain provocative tests for sacroiliac dysfunction
* Oswestry disability index above 20% but below 80%

Exclusion Criteria:

* Participants suffering from specific low back pain like PIVD with instability or any radicular symptoms, lumbar spondylosis, lumbarcanal stenosis, spondylolisthesis, sensory deficits, malignancies and tuberculosis.
* Any traumatic conditions around the pelvis and lower limbs, any infectious, tumors conditions around the pelvis.
* Pregnancy, any lower limb abnormalities, any recently underwent abdominal and low back surgery.