cyrilzakka/clinical-trials huggingface dataset:
Lymphoedema Among Persons With Head- and Neck Cancer

Lymphedema in the head and neck area is common after treatment for head and neck cancer.

The aim of the research project is:

• to assess the prevalence of lymphedema in patients with head and neck cancer (HNC) by measuring the amount of tissue water in the head and neck area before and after different kinds of cancer treatment, and to evaluate the quality of life before and after cancer treatment.

Measurement of tissue water is performed with a device (MoistureMeterD) see appendix 1. In addition, the neck circumference will be assessed with a measuring tape, according to Purcell (9), see appendix 2. The measurement will be completed by Agneta Hagren, or one of her colleagues, with specific education.

The assessments will be performed before treatment begins as part of the clinical routine (baseline), and at 3 months, and 9 months after treatment completion.

Each participant will respond to quality-of-life QLQ-c30 and QLQ H\&N35 questionnaires, appendix 3 and 4, at the same time points as the measurements of tissue water. Ratings of physical activity according to Frändin and Grimby will also be performed (23). The questionnaires will be sent home to the patients before the time for follow-up. A modified LyQLI questionnaire will be given to all patients with lymphedema and filled out at 9 months after treatment completion, appendix 5.

Post-treatment measurements +/- four weeks of the dedicated time point will be considered appropriate.

Discontinuing participation in the trial will be on:

1. Patient request
2. Locoregional tumor progression or failure during the study period. For example, residual neck tumor requiring neck dissection after (C)RT for OPC
3. Locoregional deep infection i.e., suspected abscess at the scheduled time points for measurements.

Any interventional therapy for lymphedema during the follow-up is not cause for exclusion but will be registered.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy or cytology confirmed HNC (all malignant types are accepted) from the oropharynx (OPC), oral cavity (OC) or neck metastases from unknown primary cancer of the head and neck (CUP).
* Tumour stage T1-4, N0-3.
* Planned for treatment with curative intent as recommended at the multidisciplinary tumour board.
* Age \>18 years. Able to give informed consent

Exclusion Criteria:

* Previous treatment of HNC or radiation to the head and neck area.
* Planned surgery that includes free tissue transfer or pedicled flaps in the neck (local facial pedicled flaps are accepted).
* Planned neck dissection involving less than three regions of the neck.
* Planned proton therapy.
* Pre-treatment surgery or Botox injections in the tissue in the head and neck area.
* Pregnancy
Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

The goal of this clinical trial is to evaluate the digital stabilizing splint in management of masticatory muscle disorder. The main question it aims to answer are:

• is the digital stabilizing splint effective in treatment of masticatory muscle disorder signs and symptoms after 3 months follow up ? Participants will be asked to ware the splint and progressively increasing the duration of splint wear, starting from 8 hours per day for 3 months .

The current research was conducted for evaluation of the digital stabilizing splint in the management of masticatory muscle disorder. Subjects and Methods: Eight patients over the age of 18 with masticatory muscle disorders received treatment using a stabilizing splint that was digitally created. The Each patient's response to therapy modifications was assessed and compared before and after splint insertion for each patient subjective symptoms were assessed using a patient questionnaire that was repeated before treatment (baseline), one month, and 3 months post-insertion. Moreover, The masseter and temporalis muscles' electrical activity was measured using electromyography at baseline and after three months.post-splint insertion. Clinical signs such as mouth-opening lateral movements and protrusive movements were measured before and 3 months after the splint was inserted.

Eligibility Criteria:
inclusion criteria

1-Anterior disc displacement without reduction or osteoarthritis cases 2-Pain and/or tenderness of masticatory muscles exclusion criteria

1. Absence of previous occlusal splint therapy.
2. Absence of apparent dental or periodontal diseases.
3. Patients having full or partial dentures that would compromise the support of an occlusal splint were excluded.
4. Patient taking analgesics, muscle relaxants, or Anti-inflammatory medications will not be included because they may affect the outcome.
5. Patients with multiple teeth loss that affects occlusal splint support were excluded.
Capstan Medical TMVR Study: FIH

This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of consent.
* Moderate-severe (3+) or severe (4+) mitral regurgitation
* NYHA II or greater symptoms despite optimal medical treatment.
* The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).
* Ability and willingness to provide written informed consent prior to any study related procedure(s).

Exclusion Criteria:

* LVEF less than 20%
* Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System
* Severe aortic valve stenosis or regurgitation
* Severe mitral stenosis
* Severe right ventricular dysfunction or severe tricuspid valve disease
* Evidence of intracardiac thrombus, vegetation, or mass
* Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve
* Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure
* Myocardial infarction within 30 days prior to procedure
* Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure
* Active endocarditis, other ongoing infection requiring antibiotic therapy
* Stroke or transient ischemic attack (TIA) within 30 days of procedure
* Active peptic ulcer or active gastrointestinal bleeding
* Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg
* End-stage renal failure on dialysis
* Life expectancy less than 1 year
* Subject is on the waiting list for a heart transplant or has had a prior heart transplant
* Pregnant (Participants of childbearing age are required to have a negative pregnancy test).
* Known allergy to antiplatelet therapy, heparin, or to device materials
* Inability to tolerate anticoagulation or antiplatelet therapies
* Absence of appropriate venous access
* Unable to have transesophageal echocardiography
* Unwillingness to complete the required follow-up visits
Trypan Blue Versus Brillant Blue for Epiretinal Membranes

Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic eperetinal membranes
* Phakic or pseudophakic eyes
* Age over 60 years

Exclusion Criteria:

* Secondary epiretinal membranes
* Severe ocular pathologies
TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study

This project will evaluate the effectiveness and mechanisms of mindfulness-based relapse prevention (MBRP) delivered via video conferencing, as compared to referral to online mutual support groups, in supporting long-term whole-person recovery and improvements in neurobiologically-informed domains of addiction among individuals with alcohol use disorder who are interested in reducing or stopping drinking. The project will also examine the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible and freely available continuing care option that supports long-term recovery from alcohol use disorder in all communities nationwide, including medically underserved and health professional shortage areas.

The goal of this study is to examine the effectiveness of mindfulness-based relapse prevention (MBRP) groups delivered via Zoom in promoting whole-person recovery from alcohol use disorder, and to examine how MBRP affects mechanisms of behavior change based on neurobiologically-informed addiction cycle domains. The investigators will use a hybrid effectiveness-implementation design to prospectively test the effectiveness of MBRP, as well as identify barriers and facilitators of MBRP group participation to inform future implementation of MBRP continuing care. Individuals (n=430) who have recently engaged in a change attempt to stop or reduce their drinking (via treatment or self-change) will be randomized to either MBRP groups via Zoom or referral to online mutual support. Participants will complete measures of psychosocial functioning, alcohol and other drug use, addiction cycle domains, and previously established predictors of recovery every 6 months for 3 years. Using a mixed methods design in the MBRP group, the investigators will examine facilitators and barriers to participation and engagement in MBRP, and assess the reach, effectiveness, adoption, implementation, and maintenance of MBRP via Zoom as continuing care in communities nationwide.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Received AUD treatment or made a self-change attempt to reduce or stop drinking in the past 3 months or is interested in reducing or stopping drinking
* Meet criteria for a current AUD
* Engaged in heavy drinking (more than 14 standard drinks per week or more than 4 drinks on a single day for men and more than 7 drinks per week or more than 3 drinks on a single day for women) in the past 6-months
* Able to understand all study procedures and able to consent in English or Spanish.
* Be willing to use a personal smart phone or tablet that is connected to the internet, or being willing to use a study-provided tablet
* Have access to a valid U.S. mailing address for receiving dried blood spot card or blood collection device.

Exclusion Criteria:

* Current symptoms of psychosis or mania.
* Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

Levetiracetam (LEV) is one of second-generation antiepileptic drugs that has been used to treat partial and generalized epilepsy. LEV is eliminated from the systemic circulation by renal excretion. Therefore, patients with renal impairment may experience a reduced drug excretion and increased adverse drug reactions. Moreover, patients with end-stage renal disease who need dialysis may experience low serum LEV concentration because of drug loss via dialysis. LEV loss via dialysis can cause low serum level of LEV that insufficient for seizure control. The present study was aimed to evaluate pharmacokinetics of LEV in patients undergoing 4 hour-intermittent hemodialysis (IHD). The results of the study may benefit to determine the appropriate LEV initial dose and supplemental dose for patients undergoing IHD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who were at least 18 years old.
2. Patients who were diagnosed with seizure.
3. Patients who were undergoing intermittent hemodialysis and were treated with intravenous Levetiracetam not less than 2 days

Exclusion Criteria:

1. Patients who were pregnant or lactating
2. Patients who were treated with intravenous Levetiracetam more than once a day
3. Patients who were undergoing sustained low efficiency dialysis (SLED)
4. Patients who have intermittent dialysis duration less than 3 hours
Energy Protector Aids for Improving the Lower Back Pain, Sports and Autonomic Nerve

The purpose of this study is to explore the impact of Protective gear irradiated by infrared rays intervention on back pain, motor protection and autonomic nerves.

Before and after the experimental control study design, each case, using the Chinese version of the simple pain scale and autonomic nerve measurement and exercise protection knowledge as a research tool, before and after the test (3 months after using the protective gear), collected Lower back pain level: changes in pain intensity and pain effects, and changes in autonomic and motor protection knowledge before and after testing. The research data uses SPSS for Windows 25.0 software package English version for data processing and analysis. The main statistics are Independent t test, Pair samples t test, Chi-square test and Odds ratio etc. It is expected that in the future, patients will be able to provide a safe and effective pain care and improve the quality of life, thereby reducing the recurrence rate of back pain and reducing the social cost of medical treatment

Eligibility Criteria:
inclusion criteria were: (1) individuals aged 20 to 80 with self-determined lower back pain who scored 3 points or higher on a brief pain scale; and (2) individuals accustomed to using far infrared devices for lower back pain.

excluded criteria were: Unconscious individuals were excluded.
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus

This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
* HbA1c greater than or equal to 7% and less than or equal to 10.5%
* Total body weight \>50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m\^2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
* Any malignancy not considered cured
* Personal or family history of MTC or MEN2, or participants with suspected MTC
* Acute pancreatitis or history of chronic pancreatitis
* Acute gallbladder disease
* Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
* Clinically relevant ECG abnormalities
* Positive urine drug test
* Clinical relevant laboratory tests abnormalities
Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia

The purpose of this study is to investigate the benefits of giving filled prescription of a medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to reduce the need to present to Health Care centres for treatment.

In Canada, asthma affects more the 12% of children. Exacerbation are a common feature of asthma. In children, upper respiratory tract infection (URTI's) are responsible for over 80% of asthma exacerbation.

Experts in asthma care acknowledge this critical problem and have developed guidelines to reduce asthma exacerbation.

The criteria for participation in this study to have 2 or more presentations to a Health Service centre in the past 12 months for URTI induced asthma. These patients will be followed and interviewed monthly over a 12 month period to investigate whether the use of Oral cortico-steroids upon early onset of URTI induced asthma prevents the need for presentation to hospital

Eligibility Criteria:
Inclusion Criteria:

* 2 or more presentations to Emergency department in a 12 month period

Exclusion Criteria:

* less then 2 presentations to Emergency department in a 12 month period
Bright Light on Fatigue in Women Being Treated for Breast Cancer

This proposed study will examine feasibility and implement therapeutic bright light that is tailored to the individual's circadian typology to estimate its therapeutic effects on sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* Newly diagnosed with stage I-III breast cancer
* Scheduled to receive 21-day cycles of intravenous chemotherapy
* Experiencing disrupted sleep (determined by Pittsburgh Sleep Quality Index)
* Morning or evening types (determined by Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
* Sighted
* Mentally competent to consent
* Able to under English

Exclusion Criteria:

* Concurrent malignancy
* Undergoing other cancer treatments
* Engage in shift work or travel across more than 3 time zones within 2 weeks prior to study
* Known history of seasonal affective disorder or substance abuse
* Current diagnosis of major Axis I psychiatric disorders, neurological impairments, or muscular dystrophies
* Regularly use steroid or other immunosuppressive medications
* Take prescribed sedative hypnotics or sleep medications because these conditions may affect fatigue and/or sleep/wake patterns.
* Have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g. migraine), or take photosensitizing medications (e.g. some porphyrin drugs, antipsychotics, antiarrhythmic agents)
The Effect of Self and Peer Assesment Education Given to Nursing Students: Stoma Care Skill Example

Self- and peer-assessment is one of the important methods among student-centered assessment methods. The ability of the student to evaluate himself and his peers provides many contributions to him in his education and professional life.Nursing education aims to gain many psychomotor skills.Aim is to examine the effects of self and peer assessment training on the success of stoma care skills.

There are different results regarding the effects of self-assessment and peer assessment on psychomotor skill achievement. It is thought that the reason for this difference in results may be student-related reasons or may be related to the effectiveness of the education.

The aim is to measure the stoma care skill success of the students who are given self and peer assessment training through the rating scale.

Eligibility Criteria:
Inclusion Criteria:

* Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing 1st year AGNO score not to be below 1.8
* To be registered in the HMSR 2016 Surgical Diseases Nursing course in the spring semester of the 2019-2020 academic year
* Not having received peer and self-assessment training before
* Having no previous stoma care training
* Not working as a part-time or full-time nurse

Exclusion Criteria:

* To have training in stoma care
* Having received self- and peer-assessment training
* Working as a part-time or full-time nurse
* Having an AGNO score below 1.8
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin (Caduet® Combination Tablets) in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.

All the subjects whom an investigator prescribes the first Amlodipine /Atorvastatin (Caduet®) Combination Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians

Exclusion Criteria:

Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.
Exercise and Endocannabinoids for Brain and Mental Health

This study will explore how exercise affects brain chemicals called endocannabinoids, which may improve thinking skills and reduce feelings of stress, anxiety, and low mood in children and teens aged 9 to 17. Participants will take part in a single 30-minute activity session, where they will be randomly assigned to one of three groups:

1. Moderate-intensity exercise (walking or running on a treadmill at 50-70% of their maximum heart rate).
2. Light stretching (gentle movements at less than 40% of their maximum heart rate).
3. Seated meditation (relaxing without movement at less than 30% of their maximum heart rate).

The investigators will measure endocannabinoid levels, thinking skills, and mood before and after the activity to see how these activities affect the brain and emotions.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and available for the duration of the study
* 9-17 years of age
* Adolescent and parent/guardian are English-speaking, as study assessments are in English
* Right-handed

Exclusion Criteria:

* Head injury
* Sensory (e.g., hearing) impairment
* Physical (e.g., motor, balance) impairment
* Physical disabilities
* Neurological disorders
* Any condition that would contraindicate blood draws
Assessment of the Educational Experiences for Patients Newly Diagnosed With Nephrotic Syndrome

The purpose of this study is to learn about patient, caregiver and healthcare worker perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to participate in this study.

The survey included questions addressing the following areas: 1.) Information that is important to know when learning to manage Nephrotic Syndrome. 2.) Preferred resources for the education of patients and caregivers with newly-diagnosed Nephrotic Syndrome. 3.) The time frame required to acquire confidence in the management of Nephrotic Syndrome. 4.) Disease-specific information such as diagnosis, length of disease duration, medications used, need for kidney biopsy, dialysis and/or transplant. 5.) Demographic data such as race/ethnicity and educational background.

The survey data is stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected. Upon conclusion of the study period, the data will be sent to the NEPTUNE consortium lead at the University of Michigan.

Eligibility Criteria:
Inclusion Criteria:

Patient and Patient Caregiver:

* 18 years or older
* English literate
* History of Nephrotic Syndrome \> 3 months or caregiver of a child diagnosed with Nephrotic Syndrome \> 3 months prior to enrollment
* Informed Consent

Healthcare Worker Inclusion Criteria:

* Age \> 18 years
* English literate
* Provides medical care for children or adults with Nephrotic Syndrome
* Informed Consent

Exclusion Criteria:

* Inability to provide informed consent and complete survey
* Other criteria as specified by Consortium and based on the data we collect in the Contact Registry