cyrilzakka/clinical-trials huggingface dataset:
Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients no more than 16 years of age.
* Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant.
* The graft must be functional within 48 hours post transplantation.

Exclusion Criteria:

* Cold ischemia time greater than 40 hours.
* Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs.
* Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.
The Sinonasal Outcome Test - 22, Validated for Danish Patients

Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both incidence and prevalence. It calls into attention consensus about diagnosing, assessing symptoms and treatment of patients with CRS. Therefore a validated Danish measure of health-related quality of life in sinonasal disease is needed.

Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22.

Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the initial test and 0.92 in the retest. Pearson was 0.70 (p\<0.001) revealing good correlation between the initial scores and the retests scores. Kappa was calculated for each item with a mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant difference in the subscales.

Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and nasal polyposis.


Eligibility Criteria:
Inclusion Criteria: Persons diagnosed with Chronic Rhinosinusitis -

Exclusion Criteria: Change of treatment or acute change of symptoms due to common cold/influenza in the time between completing the test and the retest. If SNOT-score was very low. Persons who left before offered test or declined testing.

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Cognitive Training in Patients With MCI Using fMRI

The current project aims to investigate the efficacy of the visual imaging training (VIT) and alphabet search training in comparison to an active control intervention, namely psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

We will include 30 subjects with amnestic mild cognitive impairment (MCI) single domain or multiple domain clinical diagnostic, over 60 years old, recruited through the Cognitive and Behavioral Neurology Group ambulatory of University of Sao Paulo General Hospital. We will also include 30 healthy subjects, over 60 years old, recruited in the community. All the participants will be evaluated by neurologists specialized in cognitive neurology and subjected to a neuropsychological assessment. The 30 participants with MCI and 30 healthy subjects will be divided in 6 groups: the G1 MCI group (N=10) will receive 4 sessions of visual imaging training; the G2 control group (N=10) will receive 4 sessions of visual imaging training; the G3 MCI group (N=10) will receive psychoeducation intervention; the G4 control group (N=20) will receive psychoeducation intervention; the G5 MCI group (N=10) will receive cognitive training with alphabet search training and the G6 control group will receive cognitive training with alphabet search training. This will be a longitudinal, randomized, double blind study. MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

Eligibility Criteria:
Inclusion Criteria:

* Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment identified by a doctor and neuropsychological tests; Able to give informed consent.

Exclusion Criteria:

* History of neurological disorder; History of serious systemic disease; History of severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study
Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease

The research is aimed at exploring the application of novel tracking technique for the study of spatial activity among dementia patients and its implication on their families. The study sample will be composed of three groups of volunteers, each including100 participants aged over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The second group will include patients that suffer from mild dementia. The third group will include age matched healthy participants. The tracking equipment will be a GPS apparatus of 450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data will be transferred via the cellular network to operator center at the Hebrew university at Jerusalem, and will be documented in assigned data files. This monitoring procedure will be held every year and along a period of five years. The impact of the patient behavior on the care giver will be studied by means of five interviews along the tracking period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with MCI, Alzheimer's disease, or mixed type dementia; OR
* Healthy control subjects who meet the following criteria:

  * Mini Mental State (MMSE) of at least 21
  * Age 60 years or older
  * Patients with history of stroke which is not followed by cognitive decline may be included
  * Fluent language skills

Exclusion Criteria:

* Other dementias (e.g. vascular, frontotemporal, metabolic etc);
* Other major psychiatric disorders (e.g. major depression, schizophrenia);
* Substance abuse;
* MMSE 20 or less;
* Severe motor disturbances;
* Sensory deficits potentially affecting mobility; OR
* Severe physical disorders (e.g. cancer, major operation)
HOPE Pilot for Veterans With Complex Diabetes

The purpose of this study is to determine if behavioral health coaching for rural veterans with diabetes and depression will improve self-management behaviors and lead to improvement in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.

The co-occurence of diabetes and depression is highly prevalent and has dramatic consequences for quality of life and health. Due to the complex interrelation between diabetes and depression, patients often experience both psychological and physiological difficulties. These comorbid problems demand focused interventions that blend physical and emotional health treatments with self-management strategies.Rural-dwelling veterans with diabetes and depression are typically treated in community-based outpatient clinics (CBOCs). Patients with diabetes in rural areas tend to have more problems controlling their blood sugar, blood pressure and cholesterol compared to urban patients; thereby increasing their risk of diabetic complications. Similarly, rural patients with depression have similar barriers to care that increase their risk of poorer health outcomes as well. Using behavioral health coaches (BHCs)to deliver telephone-mediated therapies may enhance the reach of treatments for co-occurring diabetes and depression. The implementation of such treatments requires the development and testing of therapeutic manuals and BHC training protocols to ensure standardization and effectiveness. The BHC intervention has been labeled Health Outcomes through Patient Empowerment (HOPE) and will be offered to eligible patients receiving care through MEDVAMC and its CBOCs. Preliminary data obtained through this pilot grant is to support a larger VA grant.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes and Primary Care Physician intent to treat
* Clinically significant symptoms of depression per self-report
* HA1C average of 7.5 or greater in past 12 months AND no HA1C \< 7.0 in past 12 months.

Exclusion Criteria:

* Factors that render a telephone-based behavioral activation intervention inappropriate
* Significant cognitive impairment
* Meet criteria of bipolar, psychotic or substance abuse disorder
* Serious medical issues; e.g., terminal cancer
* Reports severe depression or suicidal ideation
Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors

The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent and commit to recommended EAP assessments.
* ≥18 years of age.
* Able to swallow tablets.
* Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
* Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable GIST that resulted in disease progression.
* Meet clinically acceptable local laboratory results.

Exclusion Criteria:

* Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial.
* Prior or known intolerance to sunitinib.
* Patients who have previously participated in a bezuclastinib clinical trial.
* Patients with persistent \> Grade 2 toxicities from prior therapy.
* Known PDGFR driving mutations or known SDH deficiency.
* Pregnant or currently breastfeeding.

Other protocol-defined criteria apply.
Cobalamin Absorption From Fortified Food

To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

Cobalamin (vitamin B12) deficiency is highly prevalent in the US and worldwide. Deficiency is most common in the elderly, with an average prevalence ≈25% over age 60 y. About 40% of older persons with low serum cobalamin have food cobalamin malabsorption (F-CM), in which gastric atrophy/achlorhydria and/or dysfunction is implicated. Because of the prevalence of deficiency in those over age 60 y, it is generally recommended that the elderly consume a higher proportion of their cobalamin from fortified foods than what is recommended for younger people. However there is considerable debate about whether crystalline cobalamin is absorbed as well by the elderly with F-CM as it is by younger people, especially if it is added as a fortificant to food. The data to be collected in this study will provide information useful to on-going deliberations concerning the future fortification of wheat flour with vitamin B12 in the United States.

Eligibility Criteria:
Inclusion Criteria:

* good overall health
* normal absorptive capacity (controls) or with a serum B12 \<300 pg/mL and a pepsinogen I level \>100 μg/L (ACs).
* All subjects must be available to complete the protocol

Exclusion Criteria:

* Any chronic health disorder
* Anemia of any kind
* Renal insufficiency
* excessive alcohol consumption
* Prior GI surgery
* Use of OTC or prescription drugs that interfere with B-12 absorption or metabolism
* Use of vitamin supplements
* Pregnancy or lactation
A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.


Eligibility Criteria:
Inclusion Criteria:

The patients with bronchial asthma and who satisfy the following criteria

1. Patients aged \>= 20 years or older
2. Patients with mild to moderate severity
3. Patients must be able to understand the patient information form

Exclusion Criteria:

1. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the screening test
2. Patients using corticosteroid medication( p.o./ i.h.) at a dose in excess of the equivalent 10 mg/day of prednisolone
3. Patients with glaucoma
4. Patients who have prostatic hypertrophy
5. Patients with hypersensitivity to anticholinergic drugs
6. Patients who began treatment with hyposensitization or immunoregulator therapy within 3 month before the screening test
7. Patients complicated with chronic bronchitis, emphysema or bronchiectasis, making the assessment of drug efficacy against bronchial asthma difficult
8. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
9. Women who are pregnant or who may become pregnant, or nursing women
10. Patients who are judged by the investigator as inappropriate as the subjects of the study
Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane

The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic epiretinal membrane (ERM).

Pars plana vitrectomy with membrane peeling has been used for years to successfully to treat ERM (epiretinal membrane). However, despite successful surgery, approximately 10-30% of patients may not experience any improvement in visual acuity (ref. 1-7). Macular causes of unsatisfactory visual outcome following vitrectomy include persistent macular edema and reoccurrence of epiretinal membrane (ref. 1-7). Concomitant administration of intravitreal corticosteroids (triamcinolone acetonide) after pars plana vitrectomy and membrane peeling for epiretinal membrane has been reported to speed up and improve the anatomic and functional outcome (ref 8). Given that intravitreal triamcinolone has been reported to last approximately 113 days ina post-vitrectomy eye (ref. 9); the investigators postulate that a longer-acting corticosteroid such as Ozurdex could not only have the benefits of improved anatomic and functional outcomes, but also a longer sustained effect.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic epiretinal membrane
* Preoperative visual acuity of snellen equivalent 20/32 or worse

Exclusion Criteria:

* History or presence of any of the following:
* uveitis
* macular hole
* previous vitreoretinal surgery
* any other retinal pathology that could affect anatomic or functional results
* Age Related Macular Degeneration
* Diabetic Retinopathy
* Diabetic Macular Edema
* Retinal Vein Occlusion
* Pre-existing Macular Disease
Pomegranate Juice and Metabolic Syndrome

The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome.

The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome in shabestar.

Eligibility Criteria:
Inclusion Criteria:

* presence of ≥3 of the following diagnostic of MetS:

  * serum TGs of at least 150 mg/dL,
  * waist circumference of more than 102 cm (40 in) in men and more than 88 cm (35 in) in women,
  * high-density lipoprotein (HDL) level less than 40 mg/dL in men and less than 50 mg/dL in women,
  * blood pressure 135/85 mm Hg or higher, or
  * fasting glucose 100 mg/dL or Higher

Exclusion Criteria:

* liver cirrhosis,
* chronic pancreatitis,
* gastrointestinal or connective diseases,
* kidney stones, or
* renal failure,
* alcohol Consumption,
* having an allergy to pomegranate juice,
* a change in diet,
* the large increase in LDL so that required drug treatment.
* use of statins of fibrates, corticosteroids, nitrates, acetyl-salicylic acid or other anti-platelet drugs, oral hypoglycemic drugs, nonsteroidal anti-inflammatory drugs, or drugs interfering with coagulation;
* pregnancy or lactation in the past 6 mo, supplementation with vitamins or antioxidants
Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy

COPPER is an international, multicenter, parallel-arm, phase III randomized controlled trial comparing two local treatment strategies (SABR or metastasectomy) for patients with an indication for local treatment for limited (max. three) colorectal pulmonary metastases

The study is formally endorsed by the Dutch Society of Lung Surgery (NVvL), the Dutch Society of Cardiothoracic Surgery (NVT), the Dutch Society of Radiation Oncology (NVRO). The main objective of the proposed randomized trial is to compare efficacy of SABR to the efficacy of metastasectomy with regards to the primary endpoint (local recurrence free survival at 5 years) in patients with limited colorectal pulmonary metastases. This will determine the most effective local treatment modality. The investigators hypothesize that patients with limited colorectal pulmonary metastases will have non-inferior overall survival after pulmonary metastasectomy compared to SABR, however metastasectomy will result in superior local recurrence free survival at five years when compared to SABR. In addition, the investigators hypothesize that SABR is associated with lower morbidity, comparable quality of life and comparable health care costs compared to metastasectomy. Recurrent metastases are preferably treated by the index treatment to which the patient was randomized, local recurrent metastases are preferably treated by means of cross-over between both arms. Comparing metastasectomy to SABR for patients with colorectal pulmonary metastases will present the international community the evidence needed to better select patients for local radical treatment, while diminishing uncertainty for patients and care givers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG)-Performance status 0 - 2
* Willing to provide informed consent
* Patients with 1 to 3 lung metastases from colorectal cancer eligible for both a minimally invasive surgical resection and SABR, as assessed by the multidisciplinary tumor board (MDT)
* Radically treated primary colorectal cancer
* Patient is able and willing to complete the quality-of-life questionnaires
* Previous liver metastases are radically treated with curative intent
* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.

Exclusion Criteria:

* Previous or present metastases outside liver or lungs
* Concurrent malignant cancer, or history of other malignant cancers within the past 5 years (excluding prespecified low-risk cancers)
* Hilar or mediastinal lymph node metastases
* Poor cardiopulmonary function test
* Inability to treat all colorectal metastases
* Surgical resection by means of a bilobectomy or pneumonectomy
Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions

The German Quality Network Sepsis is an association trying to improve quality of care for patients with sepsis, severe sepsis and septic shock or being in risc thereof.

The icosmos trial investigates the impact on the use of routine data, a risk adjustment algorithm and feedback to all hospitals as well as a structured implementation for regular screening for deteriorating patients, and education on in-hospital mortality.

All German hospitals provide a set of routine data to federal adminsitration for reimbursement. This dataset includes all ICD-10-Codes (German adaption) as well as all procedure codes.

This dataset is pseudonomized and risk adjusted for every individual case and afterwards feedbacked to each participating hospital including all accumulated data from all other hospitals as well as the German Average for sepsis mortalities provided by the German Federal Institute of Statistcs for benchmarkings.

Based on this data, the icosmos trial will provide support to all participating hospitals for two major strategies to be implemented

1. An algorithm for structured analysis of

   1. low-risk-fatalities as potentially preventable deaths for underlying problems in diagnosis, treatment, etc
   2. high-risk-survivors as "best practice"
   3. coding errors for improvement of coding quality
2. a structured sreening program of every patient on every ward in every shift for deterioration and support algorithms including consiliary support and outreach teams as well as structured education

The icosmos trial will investigate the effects as well on quality of coding and sepsis incidence as well as on sepsis-related sepsis in-hospital mortality for participating hospitals in comparison to the German Average.

Eligibility Criteria:
Inclusion Criteria for hospitals:

* hospitals willing to participate

Inclusion Criteria for patients / patients' data

* age over 16
* coding of sepsis, severe sepsis, septic shock

Exclusion Criteria for hospitals:

* no intensive care unit on site
Grid Laser for Diffuse Diabetic Maculopathy

Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive procedure.Laser power if kept to aminimum can get the desired results without severe destruction to the retina . In this study, the investigators are going to document the effect of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with macular edema.
* both sexes
* conset to participate.

Exclusion Criteria:

* focal edema.
* patients requiring only the focal laser.
* patients with proferative diabetic retinopathy.
* Patients with ischaemic maculopathy on fundus fluorescein angiography.
Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance

This is a randomized, double-blind, placebo-controlled study enrolling 36 (16 Elite and 20 Sub-Elite trained endurance runners (18 placebo and 18 Mitopure intervention) who are 18-40 years of age. Mitopure or Placebo supplement, will be given as a daily oral dose for 4-weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-40 years
* Participants will be running \>100 km/week
* Elite participants will be required to have a 3,000 m running personal best time below 9:00 (mm:ss), and/or a VO2max result greater than 65 ml·kg-1·min-1
* The sub-elite cohort will have a 3,000 m running personal best faster than 10:00 min and/or a VO2max \>60 ml·kg-1·min-1
* Agree to participate in one of two \~4 week training camps been held between March-October 2021.
* Signed informed consent

Exclusion Criteria:

* Subjects with diagnosed medical conditions involving thyroid function or other chronic disturbances of metabolic rate
* Subjects who are unable to complete the training or testing protocols