cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility

The purpose of this study is to improve spasticity diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral.

The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral. This will be done by assessing the relatedness of comorbid conditions in patients with spasticity. Emphasis will be placed on urinary incontinence, as previous work has suggested a link between the two conditions. An additional aim of this study is to assess health-related quality of life measures in this population. A medical record review will be performed for all consenting participants residing in Tennessee State Veterans' Homes, which is a long-term care facility in Murfreesboro, TN. Participants will also be asked to complete a brief questionnaire assessing their perceived health-related quality of life, physical wellbeing, and mental wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any race, aged 18 and above
* Resident of the selected long-term care facility
* The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.

Exclusion Criteria:

* Subjects for whom participation in the study may cause medical harm
Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment

This study is to investigate the effectiveness of computerized cognitive training, and corresponding neural substrates through multimodal neuroimaging assessment, in the elderly with normal cognition, subjective cognitive impairment, and mild cognitive impairment.

Computerized cognitive training has the advantage of easy accessibility for community-dwelling elderly. It can be much cheaper than traditional neuropsychological training methods, which require trained neuropsychologists. Furthermore, it may be more fun and easier to be optimized to an individual patients' cognitive status than other traditional methods.

Clinical efficacy of these kinds of cognitive training applications has been validated through several studies. A recent systematic review reported that the domains of working memory, executive function, and processing speed benefited the most by classic computerized cognitive training tasks, and that these benefits were comparable with traditional cognitive training methods. Apart from neuropsychological data, neuroimaging studies focusing on the effectiveness of computerized cognitive training are scant.

There have been no previous studies investigating the possible neural substrates of computerized cognitive training using multimodal neuroimaging modalities simultaneously. Thus, we aimed to investigate the effectiveness of computerized cognitive training and corresponding neural substrates in subjects with mild cognitive impairment, subjective memory impairment, and normal controls through a multimodal approach.

Eligibility Criteria:
Inclusion Criteria:

* Ages \>50 to ≤70
* Years of education ≥ 6 years
* No physical barrier preventing the dominant hand from using the computer mouse

Exclusion Criteria:

* Subjects who had any structural lesions or psychiatric disorders that explained the memory deficits
* Subjects had to be able to undergo pre- and post-training evaluations such as electroencephalography (EEG), FDG-PET, and magnetic resonance imaging (MRI)
* Subjects who had scalp lesions, severe back pain, or claustrophobia that precluded pre- and post-training evaluations.
Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old

This subject is mainly to study difference of Congenital cataract preoperative related parameters in children with or without Microcornea within Less than one year old. A total of 186 eyes of 117 people were collected with relevant ocular biological parameters, including age, horizontal diameter of the cornea, Eye axis, intraocular pressure, steep axis of corneal curvature, flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth. At present, because the definition of patients with small cornea is not clear enough, the study subjects are divided into 4 groups according to the horizontal corneal diameter of 9.0mm, 9.5mm, and 10.0mm, namely ≤9.0mm group, 9\~9.5mm group, 9.5\~10.0mm group and The \>10.0mm group compares the differences between each other, and tries to provide a reference for the diagnosis of children with small cornea at a young age.


Eligibility Criteria:
Inclusion Criteria:

* Congenital cataract children with or without Microcornea within Less than one year old
* Complete collection of eye biological parameters before the first-stage Congenital cataract surgery
* The nutritional status and development of the included subjects have no obvious defects

Exclusion Criteria:

* congenital persistent pupilary membrane
* lens sublaxation or lens dislocotion
* Marfan syndrome
* Down's Syndrome
* Peters abnormality
* Fevr
* history of obvious eye trauma
* obvious macula
* long-term (local or systemic) use of glucocorticoids.
INEC Study: Immuno-modulating Enteral Nutrition in Cancer

The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet \[Impact (R), Novartis\] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

Malnutrition is frequent in head and neck (H\&N) and esophageal cancers and alters immune status, anti-infectious and anti-tumoral defenses and the response to the treatment (surgery, chemotherapy, radiotherapy). Treatment of these 2 types of cancer is often chemoradiotherapy which frequently induces mucositis. Mucositis enhances nutritional risk and could impose a modification or an interruption of the treatment. The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet \[Impact(R), Novartis\] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

Eligibility Criteria:
Inclusion Criteria:

* H\&N and esophageal cancer patients, not treated by surgery and needing chemoradiotherapy
* Performance status: Objective Mucositis Score (OMS) of 0, 1, 2 or Karnofsky \> 50%
* Acceptance of a gastrostomy, jejunostomy or a nasogastric tube to conduct enteral nutrition
* Informed consent form signed

Exclusion Criteria:

* H\&N cancer treated by exclusive radiotherapy
* H\&N and esophageal cancer which can be treated by exclusive surgery
* Tonsil cancer
* Existence of metastases
* Concomitant cancer
* Repeat of cancer at site
* Insulin dependant diabetes
* Thyroid diseases
* Subjects with major surgery or severe infectious status in the 3 preceding months
* Biological assessment incompatible with the esophagus chemotherapy treatment (polynuclear cells \< 1500/ml; blood platelets \< 100000/ml; serum creatinine \> 130 µmol/ml; ASAT, ALAT, ALP and bilirubin \> twice the norm)
* Patients taking food or supplements enriched with omega 3 (arginine and nucleotides), during the period of the study and in the preceding month
* Breast feeding women or in period of fertility without effective means of contraception
* Patients who refuse to participate or are unable to receive information or are unable to sign written informed consent.
Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2\* in beta-thalassemia patients with deferasirox treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female β-thalassemia outpatients on chronic transfusion therapy (defined as \> 8 transfusions per year)
* Lifetime minimum of 100 previous packed red blood cell transfusions
* Patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug
* Age ≥ 10 years
* Sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy.

Exclusion Criteria:

* Ejection Fraction \< 56 % measured using steady-state free precession imaging by MRI
* Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia
* Abnormal laboratory values as defined by the protocol
* Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
* History of HIV positive test result (ELISA or Western blot)
* Uncontrolled systemic hypertension
* Second or third degree A-V block
* Life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year
* History of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy
* History of clinically relevant ocular toxicity related to iron chelation
* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
* Pregnancy or breast feeding (documented negative pregnancy test required for study entry)
* Patients enrolled in an ongoing clinical trial of deferasirox (ICL670) cannot be withdrawn in order to participate in this study
* Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
* History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
* Other inclusion/exclusion criteria may apply
Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%.

Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases. Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head of AR), but it also provides other crucial information such as bowel wall viability (thickness or thinning) and free abdominal fluid. These additional findings are helpful in expediting diagnosis and management of NEC.

Methods and analysis The hypothesis being tested is that preforming an AUR in patients with clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and expedite treatment in infants born at \<32 weeks.

Discussion The use of AUS together with AR as an add-on test may increase the accuracy of diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest is extremely important. To our best knowledge, our study will be the first to focus only on VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the use of AUS as an add-on test, enabling us to recruit a significantly higher number of patients compared to published studies.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal distension
* Visible bowels loops
* Feeding intolerance (defined as emesis ≥ 2 consecutive feeds, or gastric residuals of \>50% per feed in ≥ 2 consecutive feeds, bilious residuals, bilious emesis)
* Temperature instability (defined as ≥ 2 consecutive measurements)
* Frank bloody stools
* Cardiovascular instability (hypotension; defined as MAP \< 30mmHg, tachycardia \>160/' or bradycardia \< 80/')
* Recurrent apnea
* Increase of abdominal girth \> 2cm (allowing inter-observer variability of 1 cm) within 12 h
* Abdominal wall erythemia

And/or at least 2 of the below laboratory findings5:

* Thrombocytopenia \< 50 x103/uL
* Leukopenia \<6 x106/uL
* CRP \> 10 mg/L
* PCT \> 1 ng/ml
* Coagulopathy

Exclusion Criteria:

* • \< 22 weeks of gestational age or \> 32 weeks (estimated by ultrasound)

  * Congenital abnormalities
  * No parental consent
Treatment of Depression in the Elderly

The study is designed to establish the efficacy and tolerability of escitalopram in the treatment of depressive episodes of mild to moderate severity in the elderly.

The study is designed as a mainly naturalistic study including all patients of 65 years of age or above that judged by the clinician would benefit from treatment by an antidepressant medication. The study is designed as a double-blind, randomised placebo controlled study with two groups of active treatment (escitalopram in two doses, 5 or 10 mg daily) in a twelve week period.


Eligibility Criteria:
Inclusion Criteria:

* In- or out-patients of 65 years of age or above fulfilling the International Classification of Diseases-Tenth Edition (ICD-10) diagnosis of depressive single episode (F32.00-32.11. 32.8 or 32.9), depressive recurrent episode (F33.00-33.11, 33.8 or 33.9) or organic depressive episode (F06.32).
* The depressive state should be mild to moderate and reach a score on HAM-D6 of ≥ 7 and ≤ 11
* Patients with dementia can be included provided they have a mini mental state exam (MMSE) score of ≥ 17

Exclusion Criteria:

* Patients with a current depressive episode of a severity reaching a score of ≥ 12 on the HAM-D6-item depression factor. This is to exclude patients with severe or psychotic depression
* Patients with suicidal thoughts or behaviour
* Patients with conditions where treatment with escitalopram is contraindicated: e.g. hypersensitivity to escitalopram or other contents of escitalopram tablets, concomitant treatment with non-selective, irreversible mono-amine-oxidase inhibitors, such as Marplan
* Patients who in the current depressive episode have had a failed trial of treatment with escitalopram
* Co-morbid dementia with a severity corresponding to a score on the MMSE of less than 17 as these patients will often be without the ability to give informed consent
* Patients with sensory defects rendering psychometric assessment impossible, e.g. deafness, blindness, severe aphasia
* Patients who cannot speak Danish well enough to make psychometric assessment possible and meaningful
* Patients with congenital or early acquired intellectual deficits
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)

The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer.

Based on preclinical experiments conducted in our laboratories, we hypothesize that the aggressive behavior of HER2-overexpressing breast cancers is due in part to increased angiogenesis resulting from HER2-induced increases in vascular endothelial growth factor (VEGF) expression. In vivo experiments suggest that combined blockade of the HER2 receptor and VEGF results in superior anti-tumor efficacy compared with either treatment alone.

The current clinical trial, for which the phase I portion has been completed, will examine the efficacy and safety of trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in the treatment of HER2-overexpressing metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or relapsed locally advanced breast cancer
* HER2-positive by FISH
* No prior chemotherapy for metastatic disease
* ECOG performance status 0-2
* Normal left ventricular ejection fraction
* Bidimensionally measurable disease
* Oxygen saturation \> 90% on room air

Exclusion Criteria:

* Other invasive malignancy within 5 years
* More than 3 different metastatic sites
* \>50% liver involvement by metastasis
* Newly diagnosed untreated Stage IIIB breast cancer
* Prior chemotherapy for metastatic disease
* Clinically significant cardiovascular disease
* History or evidence of CNS disease
* Major surgery within 28 days prior to day 0
* Current or recent use of parenteral anticoagulants
* WBC \< 3,000/uL
* Platelet count \< 75,000/uL
* Hemoglobin \< 9.0 g/dL
* Total Bilirubin \> 2.0 mg/dL
* AST or ALT \> 5 time upper limit of normal for subjects with documented liver metastases; \> 2.5 times upper limit of normal for subjects without evidence of liver metastases
* Proteinuria (\> 1g protein/24 hours at baseline)
* Prior therapy with Herceptin or rhuMAb VEGF (bevacizumab)
Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

212 patients with colorectal cancer will be investigated before surgery and 100 of them after surgery. 597 individuals from a previous population based study will serve as controls to the prevalence of sleep apnea in the general population.

Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and questionnaires.

Controls: Men and women from two population-based cohort studies

Inclusion: 212 patients with colorectal cancer will be investigated before surgery and 100 of them will also be investigated in the same manner after surgery. Due to drop-outs we calculate a need of inviting at least 250 patients.

Controls: 597 individuals from a previous population based study will serve as controls to the prevalence of sleep apnea in the general population.

Exclusion: Dementia, CPAP treated sleep apnea investigations: Patients are investigated with lung function, blood-gas samples, questionnaires, overnight polysomnographic sleep apnea recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.

Controls: Men and women from two population-based cohort studies the "Sleep and health in women" and the "Men in Uppsala: A Study of Sleep, Apnea and Cardiometabolic Health" and older men and women from a local senior organization.

Outcomes: Prevalence of sleep apnea and hypoxia, sleep quality, and lung function, blood gas, STOP-BANG, Epworth sleepiness scale, Mallampati score, symptoms of sleep apnea, surgical complications, mortality, cancer severity.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery of colorectal cancer

Exclusion Criteria:

* Dementia, CPAP treatment for obstructive sleep apnea
Bosentan Therapy in Children With Functional Single Ventricle

Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to investigate if Bosentan therapy can modify the outcome of children with functional single ventricle.

Increased pulmonary vascular resistance (PVR) is a serous issues in children with functional single ventricle during the staged operative period. The purpose of this study is to investigate if Bosentan therapy can improve the survival and life quality after staged Fontan procedure in the children with high risk of increased PVR.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained from patient's legally acceptable representative.
* Pediatric patients waiting for staged Fontan procedure with high risk of increased PVR after bidirectional cavopulmonary connection (BCPC)

  * Transpulmonary pressure gradiant (TPG) \> 10mmHg when the obstruction of anastomosis and lung problem were excluded.
  * With the diagnosis of high risk of increased PVR, such as associated with TAPVC, after pulmonary artery banding, after systemic to pulmonary shunt more than 6 months, and et al.
  * Diagnosed as increased PVR with catheterization.

Exclusion Criteria:

* PAH associated with conditions other than those mentioned above, e.g., iPAH, PAH secondary to portal hypertension, HIV patient with opportunistic infection
* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
* AST and/or ALT \> 3 times the upper limit of normal ranges.
* Hemoglobin concentration \< 75% the lower limit of normal ranges
* Treatment or planned treatment with another investigational drug within 3 months of screening
* Treatment with calcineurin-inhibitors (e.g., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of enrollment of this study
* Known hypersensitivity to bosentan or any of the excipients
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck

The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC).

Additionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.

The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC).

Additionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.

The aim of this study is to determine the survival, functional and quality of life outcomes of patients undergoing all salvage surgery for recurrent, residual and new primary head and neck SCC, and to establish the genetic architecture and clonal evolution H\&N SCC after previous treatment for radiotherapy cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Aged over 18
2. Previous H\&N SCC treated with radiotherapy with or without chemotherapy
3. Local or regionally recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx
4. Ability to give informed consent for biological sample collection (molecular analysis study only)

Exclusion Criteria:

1. Nasopharyngeal and cutaneous SCC of the H\&N
2. Thyroid, salivary gland, and non-squamous cell H\&N cancers
3. Presence of distant metastasis (M1) or surgically inoperable T4b tumours