cyrilzakka/clinical-trials huggingface dataset:
VR-based Physical Activity and Reminiscence Therapy

The goal of this clinical trial is to learn if active Physical activity + virtual reality cognitive therapy (aPAVRCT) works to slow the progression of AD cognitive decline in older adults. It will also learn about the physical effects and mental effects of the aPAVRCT. The main questions it aims to answer are:

Does aPAVRCT slow the progression of AD cognitive decline? (e.g., HK-MoCA, ADAS-Cog) Does aPAVRCT improve physical function? (e.g., ADL) Does aPAVRCT improve mental health? (e.g., GDS-15, PANAS) Does aPAVRCT improve life satisfaction? Does aPAVRCT improve other cognitive or physical capacities? What issues and benefits do participants and stakeholders (e.g., families, caregivers, managers) have when taking aPAVRCT? (e.g., NPI-Q) Researchers will compare the intervention group (aPAVRCT) to a control group (rehabilitation bike) to see if aPAVRCT works to slow the progression of AD in cognitive decline.

Participants will:

Take aPAVRCT (interventional group) or usual physical acitvity (control group) at least twice a week, 15 minutes for each session, for 12-16 weeks Physiotherapies (assistants) and care professionals will do the intervention, research group will operate, observe, and assist the experiment.

All the experiment processes will be recorded. Visit the sites everyday for checkups and tests Keep a diary of their symptoms, the number of times, and any essential information

Sites: around 3-5 nursing homes, under one institution. Inclusion criteria: older adults in the setting who have the ability to pedal a rehabilitation bike.

The aim of study is to investigate the effect of active Physical activity + virtual reality cognitive therapy (aPAVRCT) on cognitive function in older adults with Alzheimer's Dementia and related dementias. The investigator hypothesizes the "Physical activity + virtual environment brain stimulations' would slow the process of AD cognitive decline. The life satisfaction score in the intervention group would be higher than that of the control group.

The investigator will conduct measurements on three aspects: The Chinese version of the MoCA, physical functions, and emotional changes. Data will be collected at baseline, 4-week, 8-week, 12-week after interventions for the two groups, and a follow-up measurement. In addition, the investigator will use some qualitative methods, such as focus group, interview, observation, during and after the first 3-month intervention to identify some issues during the intervention and to probe caregivers. The investigator will use both the Ttest between the two groups (to compare cognitive decline progressions, and life satisfaction) and mixed methods to illustrate life satisfaction, especially among caregivers.

Eligibility Criteria:
Inclusion Criteria:

* older adults in the setting who have the ability to pedal the rehabilitation bike

Exclusion Criteria:

* Individuals self-reporting or identified by stakeholders as unwilling or unsuitable to participate.
Chronic Low Back Pain and Neck Pain Prospective Study

This prospective observation multifaceted study aims:

1. To perform a large prospective study and identify multiple "omics" biomarkers in chronic low back pain
2. To validate identified biomarkers for progression of acute to chronic low back pain
3. To validate identified biomarkers and test their heritability/validity in additional cohorts
4. To identify pathways and relevant individual variations for generation, propagation and subsidence of pain
5. To identify new imaging biomarkers related to chronic low back pain
6. To develop a registry of neck and low back pain subjects to help monitor the health-care management and utility to improve protocols and patient outcomes.

This novel study aims to identify genetic variants associated with chronic low back pain as well as "omics and imaging biomarkers". To achieve this, we will link and relate clinical data (clinical and neurological signs leading to anatomical diagnosis plus a careful evaluation of inflammatory response of patient) to a multiple "omics" analysis in order to investigate promising biomarkers that could answer unmet needs: identification of predisposition to develop chronic low back pain, diagnosis and an objective measure of pain intensity in order to correlate to its pathophysiology, and validate predictors of response to specific (drug) treatments.

Eligibility Criteria:
Inclusion Criteria:

* Neck and/or low back pain
* New cases\*
* Males and females
* 18 years or older
* Willing to participate in the study short- and long-term

Exclusion Criteria:

* Previous spine surgery
* Cognitively impaired
* Drug addiction
* Incarceration (prisoner)
* History of infections, tumors, chronic inflammation (e.g. rheumatoid arthritis, ankylosing spondylitis)
* Congenital/syndromal
* Pregnant females
* Diagnosed psychological impairment
* Inability to read or write
Reduce Stress Associated With Needle Aspiration, in Voluntary and Replacement Blood Donors

Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.

This study has not been completed.

The purpose of the study is to investigate the effectiveness of Virtual Reality (as a form of distraction) to reduce the stress associated with extraction needle puncture in the volunteer blood donors and reposition of Fixed Collection of the Valparaiso Blood Center, Of the Valparaíso San Antonio Health Service.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and / or visualize the numerical scale of pain
* Spanish spoken
* Greater than 50 Kilograms of weight
* Blood hemoglobin: Greater than 12.5 g% in women and greater than 13.5 g% in men
* Have been accepted as a blood donor.

Exclusion Criteria:

* Unable to understand and / or visualize the numerical scale of pain
* Does not speak Spanish
* Less than 50 Kilograms
* Blood hemoglobin: Less than 12.5 g% in women and less than 13.5 g% in men.
* Have been rejected as a blood donor.
Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome

This is a phase III, multi-centre, randomised, placebo-controlled, patient and investigator-blind study in paediatric patients with early stages of Alport syndrome to assess the safety and efficacy of the ACEi ramipril in slowing disease progression.

Alport syndrome stages that describe the extent of renal damage and loss of function are defined as:

* 0 Microhaematuria without microalbuminuria (usually at birth)
* I Microalbuminuria (30-300 mg albumin/gCrea)
* II Proteinuria \>300 mg albumin/gCrea
* III \> 25% decline of normal renal function (creatinine clearance)
* IV End stage renal failure (ESRF)

Eligible patients with Alport stages 0 and I will be randomly assigned at a 2:1 ratio to receive once daily ramipril or placebo. In addition, Alport stage II patients may be treated open Label. Eligible patients who, or whose parents/legal guardian refuse randomisation after eligibility is confirmed, and patients who have been treated with ramipril prior to the study, may be treated open-label with ramipril as per protocol. The total number of patients will not exceed 120, with the number of randomised patients not exceeding 60, and the number of patients treated open label from Day 1 of the study aimed to be approximately 60.

Randomised patients whose disease progresses to the next disease level during the 3 year treatment period will be unblinded, and open label ramipril treatment will be initiated and continued, respectively, depending on prior treatment randomisation.


Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of Alport syndrome: Kidney biopsy (patient or affected relative/s), and/or mutation analysis (hemizygous X-chromosomal or homozygous autosomal-recessive) and assessment of criteria for clinical diagnosis (haematuria, positive family history regarding kidney diseases, ocular changes, labyrinthine hearing loss)
* Alport syndrome levels 0, I or II at screening (microhaematuria without microalbuminuria or microalbuminuria \[30-300 mg albumin/gCrea\]) or proteinuria \>300 mg albumin/gCrea with GFR\>80ml/min). Patients with Alport stage II are not subject to randomization but are treated opel label.
* Aged between ≥24 months and \<18 years at screening
* Assent from patient and informed consent from parents/legal guardian

Exclusion Criteria:

* Uncertain diagnosis or variants of Alport syndrome such as a heterozygous carrier
* Alport syndrome levels III, or IV (albuminuria \>300 mg/g Crea, creatinine clearance \<60 mL/min, or end stage renal failure \[ESRF\])
* Known allergies or intolerances to ramipril or related compounds
* Known contraindication for ACEi-therapy
* Additional chronic renal, pulmonary or cardiac diseases
* Pregnancy and lactation
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.

OBJECTIVES:

* Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
* Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs all other brain tumors).

Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection.

Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the MTD.

Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of supratentorial or infratentorial brain tumor

  * Localized, non-disseminated
  * Primary tumor or solitary metastasis
  * Recurrent or progressive
  * Unresectable
  * Negative CSF
* Must have failed standard therapy including radiotherapy
* Measurable disease as evidenced by CT scan or MRI

  * Single or multiple masses accessible to light administration

PATIENT CHARACTERISTICS:

Age:

* 3 to 70

Performance status:

* Not specified

Life expectancy:

* At least 2 months

Hematopoietic:

* Absolute neutrophil count at least 1,000/mm3
* May transfuse platelets

Hepatic:

* PT and PTT normal

Renal:

* Not specified

Other:

* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 6 weeks since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* No prior brachytherapy

Surgery:

* See Disease Characteristics

Other:

* No other concurrent antitumor therapy
Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea

This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with rosacea.


Eligibility Criteria:
Inclusion Criteria:

-Documented clinical diagnosis of rosacea.

Exclusion Criteria:

* History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled cardiovascular disease, or any other current uncontrolled systemic disease
* Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or chronic recurring facial acne
* Current treatment with monoamine oxidase (MAO) inhibitors
* Current treatment with niacin ≥ 500 mg/day
* Greater than 3 inflammatory lesions on the face
* History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit.
Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

This is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic cardiomyopaty and HF II-IV NYHA class
* MI more than 6 months before the study
* LVEF less than 35%
* Absence effect of coronary revascularization during 6 months
* Optimal pharmacological therapy no less than 8 weeks
* Heart transplantation is contraindicated
* Patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
* Patients giving informed consent

Exclusion Criteria:

* Acute coronary syndrome
* Coronary revascularization less than 6 months
* Patients requiring surgical correction of post-MI aneurism
* LV wall thickness less than 5 mm in site of possible injection
* Patients with CRT implanted within 3 month before cells injection
* Clinically significant associated diseases
* Active oncology desiase
* Pregnancy
Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with early-stage breast cancer between the ages of 18 and 70.
2. Breast cancer was confirmed by histology or biopsy.
3. Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (\<5cm) can be accepted.
4. After neoadjuvant therapy, large monofocal carcinoma (\>5 cm) confined to the breast shrunk to \<5 cm.
5. No chest wall, cutaneous or NAC invasion (including Paget's disease).
6. Mild to moderate breast sagging, and the patient has the willingness to undergo autologous reconstruction of the latissimus dorsi.
7. There is no need to obtain additional back skins.
8. Willing to participate and able to complete follow-up and evaluation during the study.

Exclusion Criteria:

1. Patients with advanced breast cancer (stage III and above) or metastatic breast cancer or inflammatory breast cancer.
2. The risk of recurrence is expected to be high.
3. History of thoracic and dorsal vascular injury.
4. Patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia.
5. Patients with active infection or severe immune system disease.
6. Patients with severe allergic reactions to materials related to latissimus dorsi muscle flap transplantation.
7. Patients with other major surgeries or reconstructive surgeries planned for the near future.
8. Patients with cognitive dysfunction or psychiatric disorders who cannot understand and cooperate with the requirements of the study.
9. Patients who refuse to participate in the study or are unable to complete follow-up and evaluation during the study.
Long-Term, Open Label Atomoxetine Study

To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).

Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study
* Must meet the study criteria for ADHD
* Must be willing to have blood drawn and to complete other test required for this study

Exclusion Criteria:

* allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
* taking certain medicines that could interact with atomoxetine
* plan to move too far away from a doctor participating in this study in the next 5 years
* current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study
A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

* overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
* transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
* active malignancy;
Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment


Eligibility Criteria:
Inclusion criteria:

* Documented bone metastases from breast cancer, prostate cancer or multiple myeloma
* Prior treatment with zoledronic acid for 1-2 yrs
* Life expectancy of at least 6 months

Exclusion criteria:

* Prior treatment with bisphosphonates other than zoledronic acid
* Abnormal kidney function
* Current or previous dental problems or planned dental surgery
* Pregnant or likely to become pregnant during the study

Other protocol-defined inclusion/exclusion criteria may apply
Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical

The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the "concentration-time profile".


Eligibility Criteria:
Inclusion Criteria:

* Male and female non-obese subjects (18kg/M2\<BMI\<28kg/M2)
* Age 20-45 years)
* Sign an informed consent form approved by UMN-IRB
* Willing to avoid oat consumption and rigorous physical activity the day prior to and through test, and consume a low-flavonoid diet for 1 week prior to the study

Exclusion Criteria:

* Presence of GI conditions that interfere with absorption;
* Clinically significant endocrine, cardiovascular, pulmonary, renal, hepatic, pancreatic, biliary or neurologic disorders;
* Major trauma or surgery within 3 months of visit;
* Cancer in the prior 2 years;
* Allergic to oat products;
* Women who are pregnant or lactating;
* Smoking;
* Drinking alcohol \>5 drinks/week;
* Using nutraceuticals;
* Blood pressure medication;
* NSAID (\>800 mg ibuprofen/week);
* Vitamin supplementation;
* Anticoagulants or hypoglycemic drugs;
* Oat products consumption the day before the test;
* Rigorous physical activity the day before the test;
* Consumption of a high-flavonoid diet in the week prior to the test.
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL

This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).

The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in elderly patients with primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Exclusion Criteria:

* Involved sites other than the brain, meninges, CSF, or the eyes.
* Age less than 18 years or greater than 75 years.
* Inadequate bone marrow capacity (defined as neutrophils\<1.5 ×10\^9/L, platelets \<100 ×10\^9/L, and hemoglobin level\< 8 g/dL).
* Known cause of immunosuppression (ie, HIV type I infection).
* Any previous malignancy.
* Creatinine clearance below 60 mL/min.
* Heart insufficiency (NYHA IIIB or IV).
* Uncontrolled infection.
* Noncompensated active pulmonary or liver disease.
* Previously treated for PCNSL, except by corticosteroids.