cyrilzakka/clinical-trials huggingface dataset:
Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer

The purpose of this trial is to investigate the difference in late radiation morbidity between partial breast irradiation and whole breast irradiation given to women operated on with breast conservation surgery for early breast cancer with a low risk of local recurrence.

The study is 2-armed. In both treatment arms the radiotherapy consists of 40 Gy in 15 fractions, 2.67 Gy per fraction. The primary endpoint in the trial is late radiation morbidity evaluated as fibrosis, secondary endpoints are other types of late morbidity, rate of local recurrence and an attempt to establish a genetic risk profile for development of late radiation morbidity.

The hypothesis is that women operated with breast conservation for a breast carcinoma with low risk of local recurrence can be offered partial breast irradiation without risking more late radiation morbidity compared to whole breast irradiation.

Eligibility Criteria:
Inclusion Criteria:

* women 60 years or older
* operated for unilateral, unifocal early breast cancer pT1, pN0, M0, grade I or II, positive estrogen and/or progesterone receptor, HER2 negative

Exclusion Criteria:

* lobular carcinoma
Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

The purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy.

The overall goal of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy. This study consists of a randomized controlled trial in which the effects of NMES applied to the quadriceps femoris and triceps surae are compared to the effects of volitional isometric exercise and a non-exercising control group. This project assesses the ability of NMES to increase muscle force generating ability, the mechanisms behind changes in force generating ability, and the effects of training on spatiotemporal parameters of gait and gross motor function in children with cerebral palsy.

Subjects is the NMES group will be implanted with percutaneous electrodes in the medial and lateral heads of the gastrocnemius and the quadriceps (3 electrodes in each lower extremity, implanted bilaterally). During the intervention phase, these subjects will undergo 15 electrically-elicited contractions in each of the implanted muscle groups three times/week (at home), while positioned on an exercise board to maintain good alignment and facilitate isometric contractions. Subjects in the volitional group will perform 15 isometric contractions in each muscle group (quadriceps, triceps surae), while positioned on an exercise board. The non-exercise control group will continue with typical activities, but no intervention will be administered. Subjects are assessed at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-12 years old
* Diagnosis of spastic diplegic cerebral palsy
* GMFCS level of II or III (able to walk indoors and outdoors with or without an assistive device)
* PROM requirements (\<10 degree hip flexion contracture, \>20 degrees of hip abduction, \< 5 degrees of knee flexion contracture, \> 45 degree popliteal angle, ankle dorsiflexion to neutral with knee extension)
* Sufficient cognitive/communication skills to perform volitional muscle contractions and complete data collection procedures

Exclusion Criteria:

* Significant orthopedic impairments (hip MIGR \> 40%, significant scoliosis)
* Must be at least one year post orthopedic surgery
* Must be at least 6 months post botulinum toxin injections
* Uncontrolled seizure activity
Treatment of Major Depressive Disorder in the UK Using TMS Therapy

The major objective of this observational study is to describe clinical outcomes of patients in the UK receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.

This is a single-center, naturalistic, observational study following the use of the NeuroStar® Advanced Therapy System and assessment of clinical outcome. The goal is to collect, analyze and report information as aggregated summaries on participants receiving treatment with the NeuroStar® Advanced Therapy System.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women, age 22 - 70, out-patient
2. Participants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD. The intended treatment plan uses the labeled treatment parameters for TMS as described in the NeuroStar® System
3. Women of child bearing potential must be using a medically accepted reliable means of contraception (for oral contraceptive medication: must be in use for at least 3 months)
4. Women of childbearing potential must have a negative pregnancy test at screening using urine dipstick
5. Participants must have the capacity to consent to all tests and examinations required by the protocol and must sign a written informed consent document to participate in the study.

Exclusion Criteria:

1. History of seizures or increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure or history of significant head trauma with loss of consciousness for ≥ 5 minutes
2. Inability to locate and quantify a motor threshold as defined in the protocol
3. Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the participant's head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed. Examples include: cochlear implants; implanted electrodes/stimulators; aneurysm clips or coils; stents; bullet fragments; jewelry; and hair barrettes
4. Any psychiatric disorder which, in the judgement of the Investigator, may hinder the participant from completing the procedures required by the study protocol
5. Active or inactive implants (including device leads), including deep brain stimulators, and vagus nerve stimulators
6. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
7. Known or suspected pregnancy
Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program

This study will evaluate the effectiveness of the digital + telehealth Connect2BWell program among 336 safety net patients. Adults patients with an upcoming medical medical visit, and/or who screen positive for substance use disorder (SUD) during routine SBIRT screening during their visit, will receive an email invitation from the research team to complete an online risk assessment to assess study eligibility. The assessment will include the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Patients scoring in the moderate- or high-risk range for one or more drugs--including alcohol, excluding tobacco--and who meet all other study inclusion criteria, will alternately be assigned to the Connect2BWell Condition or a Comparison Condition. ASSIST scores will be sent to the patient's Electronic Health Record (EHR). Patients assigned to the Treatment Condition will receive three brief online intervention sessions followed by dashboard-guided telehealth sessions with a study nurse, text messages, and access to a patient portal. Patients assigned to the Comparison Condition will receive an SBIRT session delivered via telehealth by a member of their clinic care team. Outcomes, assessed at baseline, 3, 6 and 9 months, include days of use of most problematic drug during the past 30 days, the ASSIST risk score of the most problematic drug, depression, well-being, satisfaction with care, and treatment uptake, if indicated. All patient-facing materials are available in English and Spanish.


Eligibility Criteria:
Inclusion Criteria:

* Moderate/high risk use of at least 1 substance (identified using the ASSIST)
* Can receive text messages
* Can access Internet via smart phone, tablet, or computer

Exclusion Criteria:

* Pregnant
* Admitted to inpatient psychiatric hospital or substance use treatment program, past 30 days
* Has serious medical condition that could impede study participating, next 9 months
* Receiving treatment with goal of quitting or reducing use of substances
Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task

The goal of this study is to investigate the influence of transcutaneous vagus nerve stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy volunteers.

Preclinical and clinical studies indicate that noradrenaline plays a role in the working mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.

The release of noradrenaline in the brain will be measured non-invasively by the P300 component of event-related potentials in the electro-encephalogram (EEG) via an auditory oddball paradigm.

Research to elucidate the working mechanism of non-invasive neurostimulation can help to identify subpopulations who will respond well to a treatment and can provide insights that could contribute to the optimalisation of the stimulation parameters, with as possible consequence a better clinical outcome.

Some studies indicate that stimulation of the vagus nerve can optimally influence memory, possibly via the noradrenergic system. This study will investigate if the effects of invasive vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve stimulation.

The influence of transcutaneous vagus nerve stimulation on memory will be measured via a neuropsychological memory task that investigates the ability to focus attention. The correlation between the performance on the memory task and the signal analysis of the auditory oddball task could give an indication about the underlying working mechanism of transcutaneous vagus nerve stimulation on memory.

This will be the first step to investigate whether transcutaneous vagus nerve stimulation can be used as innovative intervention for cognitive decline.

First a sympathetic skin response (SSR) will be measured to investigate whether the SSR could be used as a method to measure the activity of the locus coeruleus non-invasively.

There are 3 conditions:

1. transcutaneous vagus nerve stimulation
2. sham stimulation
3. no stimulation

The conditions will be randomized.

In each condition the participant will do the oddball task and then the memory task. Between the conditions there is a wash-out period of 30 minutes. After completion of all 3 conditions and after a wash-out period of 30 minutes, the participant will do a final recognition task (part of the memory task in total).

During the oddball task EEG will be measured. An electro-cardiogram (ECG), electro-oculogram (EOG) and larynx electromyogram (EMG) will also be recorded for easy filtering of artefacts.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 30 years
* Bachelor, Master or PhD students

Exclusion Criteria:

* Neurological or psychiatric disease
Comparative Effectivenes of IASTM and MET on Post Operative Elbow Stiffness

This study is basically for the evaluation of comparative effectiveness of instrument assisted soft tissue mobilization IASTM and muscle energy technique MET on Post operative , Randomized clinical trial .

In this study 28 participants including, which is further devided into two groups,14 in each group which is named as Group A,and Group B respectively.these groups are randomly allocated and give them intervention.which is instrument assisted soft tissue mobilization IASTM given to Group A and muscle energy technique MET given to Group B,then compare the effectiveness of both groups on Post operative elbow stiffness, duration of protocol is basically for 2,3 weeks depending upon patient condition and present situation.

Eligibility Criteria:
Inclusion Criteria:

* gender both Age:30 to 50 years Who fullfil concent form

Exclusion Criteria:

* other than inclusion criteria
Thiol Disulfide Balance in Cervix Cancer

The aim of this research is to evaluate thiol-disulfide balance in cervix cancer patients

To date various oxidative stress parameters were studied in patients with cervix cancer, however dynamic thiol disulfide hemostasis has not been previously investigated.

The thiol-disulfide balance in the circulation will be measured by the automated system created by Erel \& Neselioglu (1).

References

1- Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem 2014;47:326-32. doi:10.1016/j.clinbiochem.2014.09.026.

Eligibility Criteria:
Inclusion Criteria:

• Histopathologically confirmed diagnosis of cervix cancer

Exclusion Criteria:

* pulmonary disease
* pulmonary hypertension
* cardiac dysfunction
* renal dysfunction
* liver disease
* chronic ischemia
* systemic inflammation
* concomitant malignancy
* patients who use vitamin A,C or E (antioxidant vitamins)
* patients who use smoke
* patients who use drink alcohol
* patients who use addictive for any drug
The Novel 18F-labeled MAO-B PET Tracer Study in Parkinsonism Patients

This study mainly aims to prospectively evaluate the changes of reactive astrogliosis in Parkinsonism patients of Chinese population by the novel 18F-labeled MAO-B PET tracer.

18F-SMBT-1, the novel 18F-labeled MAO-B PET tracer, was evaluated reactive astrogliosis in Alzheimer's disease successfully. In this prospective study, we assess the changes of reactive astrocytes in cerebral gray matter and white matter on Parkinson's disease by 18F-SMBT-1 PET/CT imaging among Chinese population.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 40 to 90 years old.
* Clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes.
* Can cooperate with 18F-FDG PET/CT, 18F-FP-CIT PET/CT and 3D T1-weighted structural MR scans.
* Complete clinical data, including modified Hoehn and Yahr staging scale and the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

Exclusion Criteria:

* Cannot cooperate with PET/CT or MR examination.
* Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial surgery.
Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures

Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.


Eligibility Criteria:
Inclusion Criteria:

1. All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass
2. All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass
3. All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture
4. Expected patient survival of at least 90 days
5. High likelihood of patient follow-up
6. Patient is able to give a written informed consent
7. Patient is willing and able to comply with the study procedures

Exclusion Criteria:

1. Patients with imaging suggestive of pancreatic tumor
2. Children \< 18 years of age
3. Pregnant women
4. Patients with impaired decision-making
5. Healthy volunteers
6. Primary Sclerosing Cholangitis (PSC)
7. Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation
8. Patients with any contraindication to endoscopic procedure
9. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
10. Patients unable to provide informed consent
GentleCath Air (Urinary Self-catheterization) - Pain in Female Patients With Neurological Vesico-sphincter Disorders

The purpose of this study is to evaluate the rate of occurrence of urethral pain in female patients with neurological vesico-sphincter disorders whilst performing self-catheterization using GentleCath™ Air catheters.

Intermittent catheterisation involves the insertion and removal of a hollow flexible tube called a catheter to drain urine from the bladder. Intermittent catheterisation allows the individual to empty their bladder without the need for a long term indwelling catheter and can be implemented for people who have difficulty emptying their bladder due to neurogenic disorders.

One of the complaints of female patients performing intermittent self-catheterization for neurological bladder is the occurrence of urethral pain on insertion or removal of the catheter, in particular in patients retaining sensitivity at this level.

The GentleCath™ Air catheter was designed to improve its tolerance and in particular to reduce the risk of pain. However, no studies have addressed this in real life. Therefore, the purpose of this study is to investigate the rate of occurrence of urethral pain when using GentleCath™ Air catheters as a bladder emptying method.

In this multicentre observational study each subject will participate for 90 days. Women under the care of the participating investigator and receiving their first prescription of GentleCath Air catheter for urinary dysfunction due to neurological disorders will be approached for potential participation in the study.

The primary outcome will be the pain assessment score measured on a VAS (Visual Analog Scale) during insertion and removal of the GentleCath™ Air catheter in naive female patients with confirmed neurological pathway on D1, D3, D7, D14, D21, D28, D35, D45 and D90.

The secondary outcomes will be to assess the patients' satisfaction of self-catheterization (based on InCaSaQ score) at D45 and D90, to describe patient compliance on D45 and D90, to measure the post-voiding residue on inclusion on D45 and D90, to assess compliance with the self-catheterization throughout study duration, to describe the tolerance of the GentleCath™ Air catheter throughout study duration and to measure the overall satisfaction on Gentle Cath Air on D90.

Eligibility Criteria:
Inclusion Criteria:

* Naive women of any self-catheterization,
* aged 18 years old or over,
* having been diagnosed with vesico-sphincteric disorders of neurological origin (spinal cord injury, multiple sclerosis, parkinsonian syndromes, ponytail syndrome),
* requiring self-catheterization and having a prescription for a GentleCath™ Air catheter.

Exclusion Criteria:

* Current participation in another clinical research,
* Patients not able to complete questionnaires.
NovoX®Cup as Primary Dressing After Breast Reduction

Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of life.However, as in every surgery, there can be complications. Wound disorders, such as open wounds and skin loss account for the most commonly encountered postoperative complications. NovoX® Cup is a new single-use wound dressing that is shaped cupular in order to tightly adapt to the breast anatomy. It is internally coated with oxygen-enriched oil releasing reactive oxygen species and is free from active pharmaceutical ingredients. It is intended, among other indications, for the use in surgical wounds after oncological breast surgery, breast reconstruction and cosmetic breast surgery. In two studies, a total of 140 patients (surgical wounds after breast augmentation-mastopexy, mammary lesions) were treated successfully with NovoX® Cup and no product-related adverse events were reported.The claimed advantages sound promising but an advantage compared to established wound dressings such as sterile strips or tapes has still to be investigated.

The aim of the following study is to compare the outcomes (postoperative complications, scar quality and patients' satisfaction) of breast reduction and application of the wound dressing NovoX® Cup in comparison to already established wound closure systems 2 weeks and 3 months after surgery.

A prospective intra-individually controlled cohort study.

One breast will be chosen (left or right) to be treated with the NovoX®-Cup.

The other breast will serve as the "standard of care" control.

Randomization within this clinical investigation will be done intra-individually in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Female patients 18 years and older
* Patient able to give informed consent
* Patients undergoing bilateral breast reduction

Exclusion Criteria:

* Absent informed consent
* Patients from protected groups and those who are not personally able to give consent.
* Patients younger than 18 years
* Pregnancy (pregnancy test before enrollment) and breastfeeding women
* Former radiation of the breast(s)
* Former surgery at the operation site
* Skin abnormalities in the operation area (e.g. burn scars)
* Participation in other clinical trials during this study
* Active malignant disease
* Breast cancer history
* Radiation or chemotherapy during the study period or up to 6 months before possible enrollment
* Immune disease
New Mammographic Techniques Versus MRI in Assessment of Breast Lesions

Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions

Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.

Eligibility Criteria:
Inclusion criteria

1. Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
2. Clinical indication for MRI breast imaging.
3. No histologically proven cancer before enrollment. Exclusion criteria

1. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination