cyrilzakka/clinical-trials huggingface dataset:
Optical Coherence Tomography Angiography in Neurological Disease

Optical Coherence Tomography Angiography (OCTA) is a non-invasive tool that images the neurovascular structures of the eye by using near-infrared light. Previous literature has demonstrated the potential of OCTA as a screening tool in stroke, but its utility in other neurological illness such as intracranial hemorrhage is unclear. Hence, this pilot study will gather preliminary data to support future grant applications to investigate this area more fully by recruiting patients with neurological illness and healthy controls and comparing their OCTA imaging parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patient admitted to the neuroscience intensive care unit with a diagnosis of: subarachnoid hemorrhage, intracerebral hemorrhage, intracranial aneurysm (ruptured or unruptured), intracranial vascular malformation, ischemic stroke, seizure disorder, intracranial infection, intracranial tumor(s), inflammatory demyelinating disease, traumatic brain injury and/or neuromuscular respiratory failure OR subjects from the community without major neurologic, cardiovascular, pulmonary or metabolic disease

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* GCS motor score less than 6 (i.e. must be able to follow commands)
* Temporary or permanent physical limitation that renders the patient unable to sit up and look inside OCTA device
Frailty and Functional Ability in Alzheimers

The primary aim of this study is to investigate the association between frailty as defined by the Fried Frailty Phenotype and risk of functional decline in patients with Alzheimer's dementia. The hypothesis is that frailty is associated with greater functional decline in community-dwelling older people with Alzheimer's dementia compared to those without frailty.

Secondary aims include investigation of long-term risk of institutionalization (through administrative follow-up) and trajectories of assessment components in future assessment.

The study is designed as a prospective cohort study. Participants in the study will undergo an assessment battery at baseline, 1 years of follow-up, and administrative follow-up for 5 years.

Participants will be recruited from patients of the Unit of Dementia at Aalborg University Hospital within 3 months of dementia diagnosis. The time frame of 3 months after diagnosis was chosen to ensure that cognitive assessment in the Unit of Dementia was reflective of patient's cognitive level and thereby ability to consent at inclusion. Patients will be eligible for inclusion if they are 65 years or older, have a diagnosis of mild or moderate Alzheimer's or mixed (Alzheimer's and vascular) dementia, live at home, and are able to walk 5 meters independently of other people (walking aids will be allowed). The severity of dementia will be defined according to score on the Mini Mental State Examination (MMSE) as it has done in other studies. According to this definition a MMSE score between 20-30 indicates mild Alzheimer's dementia and a MMSE score from 15-19 indicates moderate dementia. People with moderately severe and severe Alzheimer's dementia defined as MMSE score below 15 will not be eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimers Dementia
* MMSE \> 14
* Age \>= 65
* Not living in institution
* Able to walk 5m without assistence (walking aids accepted)

Exclusion Criteria:

* No available caregiver/proxy
* Unable to give informed consent as judged by caregiver/proxy or researcher
* Time from diagnosis \> 3 months
Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension

In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D supplementation in patients with type 2 diabetes and hypertension


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* hypovitaminosis D
* hypertension

Exclusion Criteria:

* pregnant or lactating
* patients using vitamin D supplementation
* using drugs that interfere on vitamin D metabolism (corticosteroids, anticonvulsants)
* illicit drug use
* diseases such as chronic renal failure (serum creatinine greater than 2.0 mg/dl)
* liver cirrhosis
* alcoholism
* dementia
* malignant disease that compromises the 5-year survival,
* digestive tract (malabsorption) diseases
* BMI\> 40 kg / m2
Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.

OBJECTIVES:

Primary

* Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer.

Secondary

* Determine the long-term cosmetic result and quality of life of patients treated with this regimen.
* Determine the long-term local control in patients treated with this regimen.

OUTLINE: Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks.

Quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years.

Patients are followed at 6 weeks and then every six months for 5 years.

PROJECTED ACCRUAL: A total of 37-74 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed carcinoma of the breast

  * Invasive or in-situ disease
  * Stage Tis, T1, or T2 (AJCC stage 0, I, or II) disease
* Treated with breast-conserving surgery within the past 8 weeks
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 18 and over

Sex

* Not specified

Menopausal status

* Not specified

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3

Hepatic

* Not specified

Renal

* Not specified

Other

* No other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
* No active systemic lupus
* No history of scleroderma
* No other medical or psychiatric condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No more than 6 weeks since prior adjuvant systemic chemotherapy
* No concurrent chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the breast

Surgery

* See Disease Characteristics
Graded Exposure in Patients With Painful Diabetic Neuropathy

Objective: To investigate the effects of a cognitive behavioural intervention targeting specific fears in patients with painful diabetic neuropathy, on physical activity and quality of life.

Intervention: Graded Exposure in vivo (GEXP) is a second-generation cognitive-behavioural intervention, and is characterized by systematic and repeated exposure to feared movements, activities and/or sensations in order to decrease fear and subsequently increase physical activity.

Main study parameters/endpoints: The purpose of this project is to develop and test a cognitive behavioural intervention targeting specific fears in patients with PDN, in order to increase physical activity and improve QOL.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type II diabetes mellitus,
* aged \> 18 years who suffer from peripheral polyneuropathy.

Exclusion Criteria:

* Patients with lower limb morbidities other than PDN such as peripheral arterial disease
* severe osteoarthritis, any other neurological disease than PDN or any other disease that may cause pain in the feet and/or damage to the peripheral nervous system (e.g. ulcers).
Study of Symptoms Caused by Cancer and Cancer Therapy in Patients With Invasive Breast, Lung, Prostate, or Colorectal Cancer

RATIONALE: Questionnaires that assess symptoms caused by cancer and cancer therapy may help improve the ability to plan treatment for patients with invasive cancer to help them live longer and more comfortably.

PURPOSE: This clinical trial is studying symptoms caused by cancer and cancer therapy in patients with invasive breast, lung, prostate, or colorectal cancer.

OBJECTIVES:

Primary

* Determine the prevalence, severity, and interference due to physical and psychological symptoms experienced (over a 4 to 5 week period) by patients with invasive primary breast, lung, prostate, or colorectal cancer who are being followed on an outpatient basis at ECOG institutions.

Secondary

* Determine if the number of symptom-related interventions are related to the providers' perception of symptom severity.
* Determine whether physical symptoms are more commonly prioritized and treated compared to psychological symptoms.
* Determine the percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief.
* Determine the focus and scope of interventions chosen by oncologists to improve the symptom control of patients seen in outpatient clinics.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease type, prevalence according to gender, race/ethnicity, age, and type of treatment.

Patients complete the M.D. Anderson Symptom Assessment Inventory and other questionnaires, rating the symptoms most frequently found in this patient group and how much these symptoms interfere with mood and activity-related domains, on day 1 and again between days 28-35.

At the same time points, a healthcare provider (treating physician, nurse, or physician assistant) completes the Revised Edmonton Staging System for Cancer Pain questionnaire, assessing the patient's cancer pain on the basis of mechanism of pain, incidental pain, psychological distress and addictive behavior, and cognitive function, for clinical prognosis on pain control.

PROJECTED ACCRUAL: A total of 2,310 patients and their physicians will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Being seen in an outpatient setting at an ECOG-affiliated academic institution, a CGOP site, or a CCOP site

  * In pretreatment, active treatment, or follow-up for their cancer
* Clinically diagnosed invasive cancer involving at least 1 of the following primary sites:

  * Breast
  * Lung
  * Prostate
  * Colorectal
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Male or female
* Menopausal status not specified
* Willing to complete a written survey between day 28 and day 35 after completion of the baseline assessment
* Able to read, write, and understand English
* No significantly impaired cognitive status which, in the opinion of the investigator, would hinder ability to provide responses

PRIOR CONCURRENT THERAPY:

* Not specified
Physiological and Psycho-social Variables of People With a Spinal Cord Injury Participating in Competitive Rugby in Wheelchairs

People with Spinal cord injury with tetraplegia suffer from respiratory problem due to weakness of the muscles and because the autonomic system dysfunction.

Exercise is one way of preserving and improving physical fitness and directly and indirectly reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects with spinal cord injury with tetraplegia have limited options for exercise: table tennis, gym, pool and more. Because of the nature of the injury which includes the sympathetic failure, they can not easily get the desired pulse to improve physical fitness.

Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could not participate in wheelchair basketball. The game combines short, quick races with different aerobic capabilities. Previous studies have shown that participants in wheelchair rugby Improve anaerobic power, oxygen consumption, physical fitness and daily functioning. Wheelchair rugby improves self-confidence and as a result it affects other areas of life. Another study examined sense of self-efficacy, saw improvement in this index for rugby players in a wheelchair at high levels.

In the present study the investigators aim to examine whether regular participation in wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym, swimming).


Eligibility Criteria:
Inclusion Criteria:

* subjects with tetraplegia who play wheelchair rugby

Exclusion Criteria:

* suffering from a medical condition that prevents from performing the tests required by the study protocol.
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements

To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.

Wounds will be assessed for inclusion into the study, digital images of the wound will be taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover dressing with be used to keep in place. The wound will be assessed and a dressing change will take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.

Eligibility Criteria:
Inclusion Criteria:

* venous leg ulcer

Exclusion Criteria:

* pregnant females
Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects

The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976 (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose administration in overweight and/or obese, but otherwise healthy, male adults.


Eligibility Criteria:
Inclusion Criteria:

* Overweight and/or obese, but otherwise healthy males
* Weight ≥ 50.0 kg
* Body Mass Index (BMI): 25.0 - 32.0 kg/m\^2, inclusive

Exclusion Criteria:

* Intolerance to or malabsorption of fructose
* A history of clinically significant gastrointestinal disease and/or surgery, which would result in the subject's inability to absorb or metabolize the study drug (e.g., gastrectomy, gastric bypass, cholecystectomy).
* In the opinion of the Investigator, a history of clinically significant hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, metabolic , endocrine disorder (e.g., diabetes, thyroid disease), or cardiovascular disease.
Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer

The purpose of this research study is to collect information on a new treatment of prostate tissue participants with intermediate risk prostate cancer using a medical device called the Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the prostate where cancer has been identified. The medical device delivers thermal energy in the form of water vapor to the prostate tissue through the urethra. Previous research has shown successful prostate tissue ablation. Additional research may help show successful ablation of the prostate tissue where cancer is located.


Eligibility Criteria:
Inclusion Criteria:

* 45-80 years old
* Biopsy confirmed unilateral, adenocarcinoma of the prostate
* Minimum of 12 biopsy cores obtained ≥4 weeks and ≤12 months before treatment. Targeted fusion biopsy is preferred if there is a MRI PI-RADs ≥3 lesion. It is preferred a standard 12 sector biopsy is mapped. MRI required if biopsy was completed \>6 months prior to treatment date to confirm no MRI progression of disease that would be considered exclusionary.
* ≤4 of 6 standard sector biopsy cores positive for prostate cancer (unilateral); positive core(s) from a targeted lesion count as one positive core.
* Gleason score of 7 (3+4) / International Society of Urological Pathologists (ISUP) Gleason Grade Group (GGG) 2
* Clinical Stage less than or equal to T2b N0 M0
* PSA (Prostate Specific Antigen) less than or equal to 15ng/mL
* Prostate size 20-80cc

Exclusion Criteria:

* Malignant tumors identified by extraprostatic extension, sphincter involvement/lesion abutment seminal vesicle invasion or lymph node invasion or metastasis
* Narrow Peripheral Zone
* MRI identified PI-RADs ≥4 lesion contralateral to the side that has biopsy confirmed adenocarcinoma
* Prior definitive treatment of prostate cancer
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of Chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections.

The prospective placebo controlled cross-over study aims at the evaluation of the efficacy of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.


Eligibility Criteria:
Inclusion Criteria (most important):

* Subject has a confirmed diagnosis of cystic fibrosis.
* Subject has chronic or recurrent rhinosinusitic disorders.
* Subject is 5 years or older.

Exclusion Criteria (most important):

* Subject has a critical condition (FEV1\<30% and SaO2\<93%).
* Subject had an ENT surgery within 6 months prior to study.
Develop a Risk Prediction Model for Phthalate-ester-induced Diseases

This exploratory study collected basic demographic and laboratory data from the Taiwan Biobank using artificial intelligence algorithms and applied data mining to identify the correlations between phthalate esters \[di(2-ethylhexyl) phthalate, DEHP\], lifestyle, and disease.

This study was designed as exploratory research. The Institutional Review Board and the Taiwan Biobank approved the study before it was conducted (Approval Number: TWBR11007-06). The data set included information from participants between 30 and 70 years old who were tested for PAEs between 2016 and 2022 (1337 cases). The data set includes (1) questionnaire responses, such as basic personal information, individual health behaviors, and female health issues; (2) physical examination results, such as body mass index (BMI), body fat percentage, waist circumference, hip circumference, waist-to-hip ratio, blood pressure, heart rate, pulmonary function, and bone mineral density; (3) blood and urine analyses results from blood tests, serology tests, hepatobiliary function tests, renal function tests, and urinalysis; and (4) data on PAE content of urine

Eligibility Criteria:
inclusion:

1. The target subjects of this study are individuals aged 30 to 70 years old
2. who were tested for PAEs from January 1, 2016 to December 31, 2020.

exclusion:

1who have not been tested for plasticizers
Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin

The study is aimed at Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.

Proposal Steps:

1. 100 Patients recruited from Alexandria Main University Hospital (AMUH), Oncology Unit are randomly assigned in to two groups:

   * Control group (n=50) the patient will receive AC regimen (Doxorubucin \& cyclophosphamide) for 4 cycles every 21 day (i.e. 3 months.)
   * Vitamin D group (n=50) who will receive 4 Cycles AC regimen in addition to vitamin D (Bon One 0.5 microgram®) once daily.
2. Echocardiography (Echo) will be done at base line and at the end of the treatment.
3. Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.

Research Objectives: Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.

Proposal Steps:

1. Assessing breast cancer patients taking part in the study receiving adjuvant chemotherapy AC (Anthracycline (Doxorubucin)-cyclophosphamide) for breast cancer for 4 cycles every 21 day (i.e. 3 months.)
2. 100 Patients are randomly assigned in to two groups:

   * Control group (n=50) the patient will receive AC regimen (Doxorubucin \& Cyclophosphamide) for 4 cycles every 21 day (i.e. 3 months.)
   * Vitamin D group (n=50) who will receive 4 Cycles AC regimen in addition to vitamin D once daily.
3. All participants are recruited from AMUH Hospital Oncology Unit. All participants will be given their consent. The study will be approved by research ethics committee of Damanhour University.
4. Tumor staging is done according to American joint committee on cancer (TNM staging of breast cancer eighth edition (Amin et al., 2017).
5. All patients will be submitted to:

   * Full patient history and clinical examination.
   * Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests.
6. Echocardiography (Echo) at base line and at the end of the treatment.
7. Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.

Methodology:

Venous blood samples will be analyzed using ELISA Vitamin D, IL-6 kits and immuno-histo-chemistry Troponoin-T and LDH and kits.

Eligibility Criteria:
Inclusion Criteria:

* Patients has a good performance status (ECOG 0-2) according to eastern cooperative oncology group (ECOG) score.
* Adequate complete blood picture patients.
* Females from (30-65) years of old.
* Normal renal and liver functions.

Exclusion criteria:

* Cardiac diseased or reduced cardiac output with left ventricular ejection fraction less than 50%.
* Hepatic impaired patients.
* Pregnancy or breast feeding or child bearing state.
* Patient with history of allergy to vitamin D.
* Concomitant use of other vitamins.
* Renal impaired patients.
* History of breast cancer.
PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.


Eligibility Criteria:
Inclusion Criteria:

Subject has undergone primary THA for any of the following:

* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or having pending incarceration