cyrilzakka/clinical-trials huggingface dataset:
Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System

The purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.

Primary Objective:

- To assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma.

Secondary Objective:

- To evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.

Eligibility Criteria:
Inclusion Criteria:

* Radio-iodine therapy for thyroid cancer
* Radioiodine therapy ≥100mCi
* Patient wears soft contacts on both eyes

Exclusion Criteria:

* Use of eye drops, other than artificial tears
* History of periocular trauma with tear duct involvement/lacrimal gland trauma
* History of lacrimal drainage disease: canaliculitis, dacryocystitis
* Prior radiotherapy
* Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
* Medical conditions that predispose to NLD stenosis

  * Sarcoid
  * Granulomatosis with polyangiitis
  * Chronic lymphocytic leukemia
Cardiorespiratory Fitness Using Electrically Assisted Bicycles

This study aimed to examine cycling time and distance when inactive subjects were provided with electrically assisted bicycles, and secondly, to examine changes in cardiorespiratory fitness.

Method: Inactive employees in a selection of public and private corporations in three Norwegian cities were invited to participate. Inclusion criteria were: a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines. There were 25 participants in the study and we provided them all with electrically assisted bicycles fitted with GPS bike computers to record usage. The participants were followed for three to eight months, 226 days on average. Measures of maximal oxygen uptake were performed before and after the intervention. Demographic characteristics and prior transportation habits were reported in a questionnaire at baseline.

Eligibility Criteria:
Inclusion Criteria:

-a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines

Exclusion Criteria:

-
Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.

Develop time-to-event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as last known well dates.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes.
* Subject must have been ≥ 18 years of age at the time of the CCTA

Exclusion Criteria:

* Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
* CCTA taken less than 3 months after deployment of new scanner
* Subject with insufficient CCTA image quality
Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)

Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3 supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.

Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3 supplementations on non-invasive vascular measures including pulse wave velocity (PWV), flow-mediated dilation (FMD), carotid arterial compliance (CAC), carotid Intima-Media Thickness (cIMT), and 24-hours Ambulatory Blood Pressure (ABP) monitoring as well as casual BP.


Eligibility Criteria:
Inclusion Criteria:

1. African-Americans (blacks)
2. Age 13-45
3. Overweight/obese (BMI ≥ 85th percentile for their age and gender for age 13-17 and BMI ≥ 25 kg/m2 for age 18-45)
4. Relatively healthy (no medical history of any heart, lung, endocrine or malignant disorder)
5. Non pregnant
6. Not on any medication or vitamin supplements that can influence the study outcomes
7. Serum 25 hydroxy Vitamin D (25\[OH\] D) levels ≤ 20 ng/ml (50 nmol/L) at the time of screening

Exclusion Criteria:

1. Not meeting any one or more of the above criteria
2. Females who become pregnant/test positive on urine pregnancy test during the screening or any of the testing visits
3. Anyone who is taking any multivitamin supplements that contains vitamin D
Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.

This study included women referred to two academic centres for the diagnosis and treatment of endometriosis (cases) and women referred to our Institutions because of routine gynaecologic consultations (controls). In this age-matched case-control study, the aimdy was to assess quality of sleep, the average daytime sleepiness and insomnia in patients with endometriosis by using three different self-reported questionnaires.


Eligibility Criteria:
Inclusion Criteria:

Reproductive age Surgical and histological diagnosis of rectovaginal endometriosis

Exclusion Criteria:

Suspicion of endometriosis (based on evaluation of symptoms, gynaecological examination and transvaginal ultrasonography) History of infertility Previous diagnosis of endometriosis Gynaecological, intestinal and urological diseases causing abdominal pain (e.g. pelvic congestion syndrome, bladder pain syndrome) Severe underlying comorbidities (cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological, or psychiatric) Pregnancy at any gestational age Suspicion or diagnosis of oncological pathology Use of gonadotropin releasing hormone analogues (GnRH-a) Restless legs syndrome Shift work Use of antiallergic drugs Narcotics Refusal or inability to sign the informed consent form or complete the study questionnaires
ImPACT Normative Extension

The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 60-80
2. Primary English speaking or fluent in English.
3. Currently does not reside in a skilled nursing facility.
4. Currently not suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
5. No known physical, neurological, behavioral or psychological impairment that would affect their ability to perform the test.
6. Hearing or vision impairments that have not been corrected within normal limits.
7. A score of 24 or greater on the MMSE (Mini-Mental State Examination).

Exclusion Criteria:

1. English is not their primary language nor are they proficient in the English language.
2. Currently resides in a skilled nursing facility.
3. Currently suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
4. Known physical, neurological, behavioral, or psychological impairment that would affect their ability to take or complete the test.
5. Hearing or vision impairments that would affect their ability to perform the test.
6. Score of 23 or below on the MMSE(Mini-Mental State Examination).
Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury

The training consists of 6 weeks of functional electrical stimulation leg cycling exercise (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the stimulation intensity based on the participant's tolerance level.


Eligibility Criteria:
Inclusion Criteria:

* Participants were diagnosed with incomplete spinal cord injury (SCI) at least one year prior to participation.
* Age between 18-75 years old.
* Both male and female.
* Have at least 90º bilateral knee flexion.
* Moderate neurological induce weakness in quadriceps muscle of 1 leg that is responsive to electrical stimulation (moderate weakness was defined as 3/5 or 4/5 on manual muscle testing).
* Able to perform cycling activity.
* Normal upper limb function.
* Able to follow command.

Exclusion Criteria:

* Had a recent history of trauma to the lower limb.
* Severely infected skin pressure sore on weight-bearing skin areas.
* Illness caused by acute urinary tract infection.
* Uncontrolled spasticity or pain.
* History of cardiovascular/cardiorespiratory problem.
* Orthostatic hypotension.
* Unhealed decubiti at electrode placement area.
* Recurrent autonomic dysreflexia.
* Active heterotopic ossification.
* Other peripheral or central neurologic injury.
Improving Safety by Basic Computerizing Outpatient Prescribing

The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.


Eligibility Criteria:
Inclusion Criteria:

* provider practicing at sites implementing order entry with basic clinical decision support using either the longitudinal medical record (LMR) or Medical Gopher

Exclusion Criteria:

* provider or practice unwilling to participate
Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience

The study will compare patient's experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue.

Bowel cleansing with high dose laxative is the standard bowel preparation prior to whole colon investigations but such regimens are associated with considerable patient discomfort and inconvenience, potentially affecting compliance rates \[1-3\].

Unlike existing whole colon investigations (conventional colonoscopy and barium enema), reduced laxative regimens can be successfully used with VC, with the aim of improving patient experience, whilst maintaining diagnostic accuracy. These regimens utilize faecal tagging; a method of labeling residual faeces and fluid with radiodense liquids, such as iodine or barium based fluids, which are taken orally by the patient. Once faecal residue and fluid is labeled in this way, it can easily be discriminated from true pathology (which remains 'untagged').

We are proposing to compare different bowel preparation regimens, and ascertain patient experience of the different regimes, while monitoring diagnostic accuracy of the 2 different regiments.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptoms attributable to colorectal cancer

Exclusion Criteria:

* patients with known colorectal cancer referred for staging VC
* patients who take laxatives regularly or with previous inadequate colonic examination due to excessive faecal residue
* patients deemed too frail to undergo full bowel preparation
Enhancing Balance and Mobility in Incomplete Spinal Cord Injury

The goal of this clinical trial is to compare the effects of balance therapy with an overground gait trainer in incomplete spinal cord injury (SCI). The main questions it aims to answer are:

* Is balance therapy with an overground gait trainer effective in improving functional ambulation in SCI?
* Is balance therapy with an overground gait trainer effective in enhancing Activities of Daily Living in SCI?

Participants treated with either:

• Overground gait trainer along with conventional exercise therapy

Background: Spinal Cord Injury (SCI) and similar pathologies not only negatively affect a person's ability to walk but also have adverse effects on their participation in social, vocational, and recreational activities. The correction of walking impairments resulting from SCI is one of the most important goals of rehabilitation, as it is essential for a person's social and vocational integration. When considering balance function, the use of challenging balance and walking exercises at an adequate level is necessary to trigger motor learning. Ensuring the patient's safety is the primary priority when using advanced balance and walking exercises based on the patient's current condition. In this study, Andago V2.0 (Hocoma AG, Volketswil, Switzerland) has been preferred for ensuring safety by adapting to patient movements. The main objective of the study was to assess the impact of Andago on balance in patients with motor incomplete SCI. The secondary aim was to evaluate its influence on quality of life and independence. Methods: The study included five participants who were over 18 years of age and had experienced a spinal injury within the past year. These participants were classified as AIS D (American Spinal Injury Association Impairment Scale). Patients underwent eight-week treatment, with walking and balance exercises on Andago performed three days a week. In addition, conventional in-bed exercises, including stretching, strengthening, and mobility exercises, were administered for 40 minutes, two days a week. Modified Borg Scale (MBS), Ten-Meter Walking Test (10MWT), Timed Up and Go Test (TUG), Walking Index in Spinal Cord Injury II (WISCI II), Berg Balance Scale (BBS), Visual Analogue Scale (VAS) for fear of falling, Spinal Cord Independence Measure (SCIM III), World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) were used for evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injured below T4
* Time from injury \< 1 year
* D level on AIS (American Spinal Injury Association Impairment Scale)
* Patients with spinal stabilization

Exclusion Criteria:

* Osteoporosis
* An implanted electronic device
* other neurological diseases
* Cardio-pulmonary diseases
* Orthopedic diseases
Human Bone Graft in Epiphysiodesis

This observational study is to document the application of human bone graft in the surgical treatment (epiphysiodesis) of leg length discrepancy or primordial gigantism and its subsequent healing process.


Eligibility Criteria:
Inclusion Criteria:

* Planned epiphysiodesis to stop the growing of a bone indicated by leg length discrepancies or primordial gigantism
* Age 10-18 years
* Written consent to participate in the study after previous written and oral education (additional consent for the participation of minors in the study after prior written and oral education by at least one parent)

Exclusion Criteria:

* Insufficient knowledge of the german language
* Foreseeable compliance issues
* Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
* Patients with non-treated pre-existing conditions, which could be the cause of leg length differences
* Active osteomyelitis
* Ulcerations in the area of the skin of the surgical area
* Immunosuppressive drugs that can not be discontinued
Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease

The aim of this study is to adjust and test an existing internet-based tool for collecting patient-reported outcome measures and to use the internet-based tool in an multidisciplinary follow-up of patients treated for malignant hematological diseases. The patient-reported outcome measurements will be used in describing the patients' health-related quality of life (HRQoL) and to investigate whether the HRQol will increase due to participation in multidisciplinary follow-up.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with malignant hematological disease; Morbus Hodgkin and B- and T-cell disease
* patients followed before or after 1. line treatment
* patients in stable phase \> 6 months after 1. line treatment
* the patients participation in the study must be assessed and decided by the doctor responsible for the patient's course of treatment

Exclusion Criteria:

* Health conditions which demands close medical monitoring
* conditions which compromise the ability to understand the study and submit informed consent (ex.: dementia and severe mental illness / disability)
* lack of capability to fill out electronic questionnaires
* poor self-care and/or compliance
Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)

Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in veterans, and that trauma-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although trauma-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for veterans.


Eligibility Criteria:
Inclusion Criteria:

Participants will be:

1. patients at the VA in the Trauma Recovery Program;
2. English-speaking;
3. reporting at least one Posttraumatic Nightmare in the past week (due to any type of trauma);
4. have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
5. consenting to be randomized into treatment.

In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision and treatment integrity ratings. Participants receiving other forms of group or individual psychotherapy and/or psychotropic medication are eligible for the nightmare treatment condition of the study, provided that those interventions do not specifically target nightmares or PTSD. Thus, the study interventions will be in addition to standard care, except as indicated above.

Exclusion Criteria:

Patients

1. with current active suicidal/homicidal ideation and intent;
2. with current substance dependence;
3. a diagnosis of bipolar or psychosis; 4) prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).

Patients in the nightmare treatment condition of the study will also be excluded if they are actively participating in another psychosocial treatment directly addressing their PTSD symptoms. Patients will not be excluded if they are taking psychotropic medication (except for Prazosin) and may continue to take their medication as prescribed throughout the study.
Chest and Abdominal Wall Strapping in Infant With Bronchiolitis

Bronchiolitis is the most common cause of admission to the Paediatric Intensive Care Unit (PICU) for respiratory distress.

The care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). The lower part of an infant's chest is larger than that of an older child, which can flatten the diaphragm, especially in obstructive disease with air trapping. Strapping the lower part (at the junction of the chest and abdomen) may provide a better condition for diaphragmatic contraction. Based on respiratory mechanics in infants and physiological studies in adults, investigators hypothesise that chest wall strapping may improve the ventilation and the diaphragmatic contraction.

Infant \< 6 month with severe bronchiolitis admitted to the PICU will be recorded in 4 conditions with or without chest wall strapping and with a Continuous Positive Airway Pressure (CPAP) at 7 cmH2O or without CPAP. Physiological parameters (including work of breathing, respiratory parameters, distribution of ventilation) will be recorded and analysed.


Eligibility Criteria:
Inclusion Criteria:

* Infant \< 6 months
* Admitted to the PICU for less than 48 hours
* With a diagnosis of bronchiolitis
* With a respiratory distress sign (mWCAS ≥ 3) and non-invasive ventilatory support
* With a naso or oro gastric tube for feeding
* With written informed consent from parents or legal guardians

Exclusion Criteria:

* Infants with severe bronchopulmonary disease, severe laryngomalacia, neuromuscular disease, bone disease, cyanotic heart disease
* Contraindication to the use of a gastric tube
* recent abdominal or thoracic surgery
* investigator able to perform physiological recording not available
* Patient who is not affiliated (or does not benefit from) to a national social security system
PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance

The goal of this study is to develop and validate a haptic assistive method in order to support walking in patients with Parkinson's disease, delivered to the patient's hips through a wearable robotic pelvis orthosis.

None of the existing robotic devices used for gait rehabilitation in Parkinson's disease is wearable. Thanks to the wearable robotic pelvis orthosis we will use, the rehabilitation sessions can take place in an ecological environment.

The other advantage of the proposed assistance protocol is its adaptability: patients will feel their hips pattern to be "smoothed" by the robot, but they will keep the freedom of continuously steering their main movement variables (like stride frequency, duration, and length). A key measured metric will precisely rely on this variability between stride durations. Indeed, the degree of stride-to-stride variability was shown to reflect the patient's physiological state, and to be correlated with the stage of the disease.

Experimental trials will be conducted to assess both the assistive (i.e. the therapy effect during the therapy itself) and rehabilitative (i.e. effect after the therapy) natures of our protocol. The second main objective of this project will be the analysis of the effects of our protocol regarding the stride-to-stride variability of patients with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease diagnosis positive according to UK Brain Bank criteria
* Hoehn and Yahr score of 1 to 3
* Mini-mental state (MMSE) higher than 24
* Optimal drug treatment for at least 4 weeks at the time of inclusion
* No contraindication to physical exercising (ACSM criteria)

Exclusion Criteria:

* Not being able to understand French well enough
* Not being in the targeted age range