cyrilzakka/clinical-trials huggingface dataset:
Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)

The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Mantle Cell Lymphoma according to REAL/WHO classification
* First or second relapse or alternatively progression during therapy. Previous use of Bendamustine is permitted, if the patient has reached at least partial remission and progression occured more than 6 months after therapy. Previous high dose chemotherapy with auto-SCT is permitted, if the patient has reached at least partial remission and progression occured more than 12 months after therapy.
* Patients must not be eligible for high dose chemotherapy with auto-SCT or allo-SCT.
* Adequate bone marrow function (hemoglobin \> 9g/dl, platelet count \>100/nL, absolute neutrophil count \>1,5 /nL)
* WHO/ECOG Performance Status 0-2
* Measurable disease (two perpendicular diameters by either physical or radiological examination)
* Life expectancy ≥ 3 weeks
* Written informed consent

Exclusion Criteria:

* Prior treatment with any m-TOR Inhibitor
* Unstable or severe uncontrolled medical condition (e.g. severe congestive heart failure, myocardial infarction within the past 6 months, severe, uncontrolled arterial hypertension, renal insufficiency requiring hemodialysis, severe pulmonary disease, severe diabetes)
* Abnormal liver function: transaminases or total bilirubin \> 2 x upper limit of normal (ULN)
* Abnormal renal function: serum creatinine \> 2 x upper limit of normal
* Previous malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
* Concurrent treatment with strong inhibitors of CYP3A4 and/or inducers of CYP3A4
* Pregnant or breastfeeding women (negative pregnancy test not older than 7 days is required for women of fertile age). Men and women of child-bearing potential must agree to use adequate contraception (i.e. failure rate \< 1% p.a. )
* Major surgery within 4 weeks before study entry; minor procedures (e.g. Implantation i.v. port catheter, Lymphnode biopsy) within 1 week before study entry
* Previous therapy with any investigational agents within 28 days before study entry
* Concomitant immunotherapy (e.g. Rituximab) or Chemotherapy other than Bendamustine. Use of systemic steroids should be documented and the Principal Investigator be informed.
* Central nervous system (CNS) lymphomatous involvement
* HIV positivity
* Current or chronic hepatitis B or hepatitis C infection
* Severe psychiatric illness or Individuals that are placed in an institution due to a magisterial or judiciary command.
* Inability to comply with study requirements
Comprehensive Long-term Follow up of Adults With Arterial Switch Operation

Background: Long-term outcomes in adults with prior arterial switch operation (ASO) have not yet been well defined. The aim of this study is to elucidate incidence and predictors of adverse cardiac outcomes in a prospectively followed cohort of adults after their ASO.

Methods: The comprehensive long-term follow up of adults with ASO is a project within the European collaboration for prospective outcome research in congenital heart disease (EPOCH). It is designed as a prospective, international multicenter cohort study. Consecutive patients (aged 16 years or more) with prior ASO will be included at 11 European tertiary care centers. Participants will be followed according to a standardized protocol following international recommendations, including standardized protocols for imaging and for exercise testing. Main outcome measures are all-cause and cardiac-related mortality, rate of cardiac re-intervention, neo-aortic dissection, myocardial infarction, stroke, infective endocarditis, sustained atrial and ventricular arrhythmias, new-onset or worsening pulmonary hypertension and new-onset heart failure. Secondary endpoints are frequency and progression of right ventricular outflow tract stenosis, neo-aortic root dilatation, neo-aortic valve regurgitation and ventricular dysfunction. The impact of demographic, anatomic (e.g. coronary artery anatomy) and functional variables on the above-mentioned outcomes, as well as quality of life and incidence of pregnancy related complications will also be assessed.

Aim: The prospective, international, multicenter EPOCH-ASO study will provide a better understanding of adverse outcomes and their predictors in adults after ASO. The results of the EPOCH-ASO study may help to optimize future care of this novel patient cohort in adult cardiology.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥16 years)
* with transposition of great arteries or a Taussig-Bing anomaly
* who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled.

Exclusion Criteria:

* Incapability of giving informed consent and previous heart transplant.
18616 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose ) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Strength Training with Eccentric Arm-cranking in Para-athletes

The new training device, the eccentric arm-crank, will be examined for its training effects in athletes with a spinal cord injury (SCI) by this project. That the training device can be used in patients with paraplegia in the future, the so-called "testing of the applicability of this concept" will be carried out during this study. Fourteen volunteer, healthy athletes with SCI are first tested for their upper body performance, followed by a training phase over 20 trainings and at the end the performance data is collected again. The training intensity and duration is continuously increased during the training phase.

At the beginning, the study design includes a familiarisation appointment with performance tests and training on the eccentric arm-crank device (KREHA). At least one week later, the first test sequence including a maximum strength test (bench press) and a test to determine the anaerobic performance (Wingate test) is conducted. The second test sequence takes place one to three days later. This includes a handgrip strength test, an aerobic endurance test (ramp test on the arm crank ergometer with ergospirometry) and a further familiarisation training on the KREHA. The training phase starts within two weeks after the pre-tests have been completed. There are two to a maximum of three trainings per week. These take 30 to 45 minutes and take place on the KREHA device under the supervision of the study staff. The training phase lasts a maximum of twelve weeks (20 training sessions). The first test sequence is repeated five to eight days after the last workout. The second test sequence takes place at the same time interval as in the pre-tests.

Eligibility Criteria:
Inclusion Criteria:

* male or female with traumatic or disease-related SCI
* age between 18 and 50 years
* experience in strength training
* Squad status or at least 4h per week training
* Biceps/triceps function
* healthy(study physician)
* adequately informed and confirmed per signature

Exclusion Criteria:

* findings during anamnesis of study physician
* pregnancy
Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease

This is a prospective observational study investigating the utility of 7 Tesla MRI to quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease and in at-risk cohorts at a premotor state of Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM sleep behavior disorder without signs/symptoms of Parkinson's disease.

Age-matched controls.

Exclusion Criteria:

* Atypical Parkinsonism
* Contraindications for MRI
Local Anesthetics After Total Knee Arthroplasty

The aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed oral and written consent to participate
* Able to speak Danish

Exclusion Criteria:

* Treatment with opioids
* Body Mass Index \> 40
Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)

The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age
2. meet Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
3. have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater

Exclusion Criteria:

1. Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.
2. Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.
3. Patients who have any history of bipolar disorder (DSM-IV) , any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.
4. Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early to Moderate Stage Multiple System Atrophy (MSA)

Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA)


Eligibility Criteria:
Inclusion Criteria:

* Patient was diagnosed with probable MSA-C (cerebellar) or MSA-P (parkinsonian) variant within 60 months of symptom onset (excluding impotence)
* Subject can ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices is allowed
* Patient cognitive state permits him to sign informed consent, according to the PI's clinical judgement, and MoCA \>= 24

Exclusion Criteria:

* Pregnant women and women before menopause
* Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the treatment or affect the treatment outcome.
* Patients with thrombocytopenia, other bleeding diathesis or taking anticoagulant therapy (not including Aspirin up to 100mg per day)
* Patients with known hypersensitivities to Plasmalyte, Gadolinium, Penicillin, and with general hypersensitivity to antibiotics
* Patients who fulfill the criteria of Parkinson's Disease
* History of electroconvulsive therapy
* History of brain surgery
Bladder Neck Surgery in Children with Neurogenic Bladder

Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding.

Surgical outcomes of bladder neck surgery in children with neurogenic bladder:

Quality of voiding: spontaneous, need for catheterization, or incontinence. Other surgical complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neurogenic bladder and younger than 18 years old , who underwent a bladder neck procedure

Exclusion Criteria:

* Patients, with neurogenic bladder and older than 18 years old ,who underwent a bladder neck procedure
Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease

This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.

The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21).

The patients included were adults suffering from Parkinson's disease (according to ICD-10). They had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. An initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Diagnosis of Parkinson's disease (ICD-10)
* L-dopa test must be positive
* Participants who gave their informed, written consent

Exclusion Criteria:

* Severe psychiatric disorder
* Major neurocognitive disorder contraindicating surgery
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a bowel preparation prior to colonoscopy in pediatric patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female between the ages of 12 to 17
* Weight more than 40kg
* Undergoing colonoscopy for routinely accepted indications
* If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
* Negative pregnancy test at screening, if applicable
* In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Exclusion Criteria:

* Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results
* Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
* Subjects with a prior history of renal, liver or cardiac insufficiency
* Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
* Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
* Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury

The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury.

This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of any severity. An initial evaluative phase using the best available technology to evaluate eye and inner ear function will be performed, and compared with typical tests that are used in the clinic. If symptoms and functional problems remain 10 days after injury, participants will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex and attention exercises as per our pilot studies) or a control group (typical rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement of goals (moderate and severe TBI) and quality of life. It is expected that this program will inform clinical practice and future research leading to a treatment program in TBI that includes multiple components.


Eligibility Criteria:
Inclusion Criteria:

* Mild TBI or moderate-severe TBI will be included

Exclusion Criteria:

-
Evaluation of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension

Establishing the euvolemic state in hemodialysis patients -the so called "dry weight"- is an important clinical conundrum in every nephrologist's daily practice. Underestimation of dry weight (with excessive ultrafiltration) results in dialysis-induced hypotension. Currently used methods to establish dry weight, including clinical assessment, bio-impedance spectroscopy and online relative blood volume (RBV) measurements, all have their limitations. RBV measurement reflects changes in blood volume during dialysis without providing any information about the initial hydration status, or the initial absolute blood volume (ABV). Recently, researchers proposed a new method to calculate ABV, by using the principle of dilution-indicator with RBV measurement. In a small cohort study they identified a total blood volume threshold of 65 millilitres per kilogram dry weight predicting for intra-dialytic hypotension associated symptoms.

The goal of current clinical trial is to re-investigate the accuracy of the above-described method and to confirm the hypothesis of a critical threshold of 65 ml blood volume per kg dry weight in haemodialysis patients. Researchers will compare adjustment of dry weight based on the ABV measurement with standard care to see if dialysis-induced hypotension will be reduced.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patients of three dialysis locations of the Haga Hospital (Zoetermeer, The Hague Leyweg and The Hague Sportlaan).
* Maintenance hemodialysis, with initiation of treatment predates inclusion in the study by at least 3 months.
* Hemodialysis scheme three times weekly for four hours
* Age above 18 years.

Exclusion Criteria:

* Clinically relevant fistula dysfunction resulting in single poold Kt/V \<1,2
* Severe volume overload with a contraindication to bolus fluid infusion during dialysis according to the treating physician.
* Severe cardiac dysfunction responsible for \>1x intradialytic hypotension associated adverse event /week according to treating physician
* Severe liver failure with or without presence of ascites
* More than three hemodialysis sessions per week
* Single needle treatment
* Central venous access
* Residual diuresis \> 500 ml/ 24h
* Inability to provide informed consent
Lymphocyte Counts in Immune Thrombocytopenic Purpura

* immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number (cooper N et al 2006)
* recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( cooper N et al 2006) ( Gern Sheimer T 2009 )

Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is associated with the production of auto antibodies directed against platelet glycoprotein complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells ( Provan \& Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et al 2006) ( Gern Sheimer T 2009)

There are many phases of the disease:

1. Newly diagnosed ITP : for all cases at diagnosis.
2. persistent ITP: for patients with ITP between 3 to 12 months.
3. chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).

   * Although lymphocytopenia is a commonly reported feature of many chronic autoimmune disorders, differential white cell counts at presentation have seldom been evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed et al 2010)

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed cases of primary ITP , adults and children.

Exclusion Criteria:

* Cases of secondary ITP