cyrilzakka/clinical-trials huggingface dataset:
Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People

This longitudinal study aims to countervail age-related cognitive and cerebral decline in healthy retired people through intensive piano / keyboard music practice in Switzerland and Germany.

Recent data suggest that music making might prevent cognitive decline in the elderly. However, experimental evidence remains sparse and no information on the neurophysiological basis has been provided, although cognitive decline is a major impediment to healthy aging. This study combines for the first time protocolled music practice in elderly with cutting-edge neuroimaging. The investigators propose a multi-site Hannover-Geneva longitudinal randomized intervention study in altogether 100 retired healthy elderly (64-76) years, 70 Geneva, 100 Hannover), offering either piano instruction or instruction on musical culture for one year. Participants will be tested at 3 time points on cognitive, perceptual and motor abilities as well as via wide-ranging functional and structural neuroimaging data (Magnetic Resonance Imaging, MRI). The research team expects positive transfer effects from intensive piano training not only on subjective well-being, but also on executive functions, working memory, hearing in noise and relationships of these behavioral features with morphological and functional brain plasticity. This study may therefore for the first time be demonstrate, that music making can provoke important societal impacts by diminishing cognitive and perceptual-motor decline underpinned by functional and structural brain plasticity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy right-handed volunteers, between 64 and 76 years of age, native French speakers. No regular musical practice over the lifespan. Only retired individuals may participate.

Exclusion Criteria:

* Impaired/not-corrected auditory or visual accuracy, neurological diseases in the present or the past, cardiovascular diseases, excessive hypertension, obesity, diabetes mellitus, beginning dementia, mild cognitive impairment, clinical depression.
Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8% while 90% patients eventually relapsed with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the conventional transplantation approach may not be able to overcome the refractory disease. A new strategy to combined a low dose regimen following intensive chemotherapy for tumor reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this study, we focus on a new treatment strategy for particular refractory AML patients.

This is a single arm phase II trial to test the efficacy and feasibility of new sequential intensive chemo and transplantation approach for refractory leukemia. Patients with refractory acute myeloid or lymphoblastic leukemia are enrolled in this trial. Patients will received intensive chemotherapy including Fludarabine, cytarabine and idarubicin as (FLAG-IDA). Seven days after the chemotherapy, sequential transplantation conditioning regimen as fludarabine and busulfan will be given.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with refractory or relapse acute myeloid leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse
* age 16-60 years
* with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA matched related (6/6) or unrelated donors (at least 8/10)

Exclusion Criteria:

* age less than 18 years or over 61 years
* liver function/renal function damage (over 2 X upper normal range)
* with mental disease
Effectiveness of Bifidobacteria in Children Affected by Seasonal Allergic Rhinitis

This study is aimed at assessing the efficacy of supplementation with a mixture of three bifidobacteria , on the allergic rhinitis..The rhinitis symptoms were assessed by validated score ( TSS ) , for children aged between 4 and 17 years with allergic rhinitis parietaria , mild , moderate or severe , than children not supplemented .

Secondary Objectives

* The effectiveness of treatment by VAS :
* Evaluation of the rescue medication consumption
* Evaluation of quality of life ( using structured questionnaire )
* Evaluation of the frequency and school performance ( using structured questionnaire )
* Assessment of sleep quality and attention (through structured questionnaire )
* Satisfaction rating and satisfaction of parents
* Evaluation of asthma exacerbations in children susceptible

This is a randomized , double-blind , placebo - controlled , phase 3 , 2 arms , in which patients were selected to receive placebo or a mixture powder composed of three bifidobacteria : Bifidobacterium Longum BB536 ( 3 billion units ) + Bifidobacterium infantis M - 63 ( 1 billion units ) Bifidobacterium breve M + -16 V ( 1 billion units ) . The subjects included in our study are represented by children aged between 4 and 17 years , with seasonal allergic rhinitis moderate and presenting positive skin prick test against parietaria.The participation of each subject in the study was based on evaluation of its clinical history. The recruited patients were divided into two groups according to the drug used.The group A received placebo , while the group B mixture bifidobacteria. The treatment was performed for a period of two months. At the beginning and at the end of therapy several surveys have been carried out , so as to be able to compare results and to draw some preliminary conclusions about the effectiveness of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes , aged from 4 to 17 years
* History seasonal allergic rhinitis mild , moderate or severe , according to the guidelines defined AIR 2013 , documented by recurrent episodes in the previous year and confirmed by skin prick test positive
* Written informed consent of one parent or a legal representative

Exclusion Criteria:

* Lack of written informed consent by at least one parent or a legal representative
* Concurrent disorders such as infection of the upper or lower respiratory tract , nasal surgery in the past year , respiratory tract abnormalities , immune diseases
* Use of antihistamines , nasal or systemic corticosteroids , leukotriene modifiers , or cromolyn sodium , on an ongoing basis used in the last six weeks.
A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line

Peripherally Inserted Central Catheters (PICCs) are commonly used in patients with cancer to administer chemotherapy and supportive care medication. However, PICCs and other medical devices that come into contact with blood increase the risk of blood clots (thrombosis) inside the blood vessels. Conventional blood thinners (anticoagulants) may reduce the risk of thrombosis but they also increase the risk of bleeding. CSL312, a monoclonal antibody that inhibits the activated blood clotting factor 12 (FXIIa) will be assessed for its potential to prevent thrombus formation in subjects with cancer at risk of PICC-associated thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older at the time of providing written informed consent
* Diagnosis of malignancy that requires placement of a PICC within the next 3 weeks for administration of chemotherapy (PICC anticipated to be required for at least 1 month)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 \[Oken et al, 1982\], and investigator's expectation that performance status will remain 0, 1, or 2 for the duration of the study

Exclusion Criteria:

* Active bleeding or with a current clinically significant coagulopathy (eg, international normalized ratio \[INR\] \> 1.5) or clinically significant risk for bleeding (eg, recent intracranial hemorrhage or bleeding peptic ulcer within the last 4 weeks)
* History of venous thrombosis, myocardial infarction or cerebrovascular event within 3 months, or a prothrombotic disorder (eg, antithrombin III, protein C or S deficiency)
* Life expectancy less than study duration (110 days)
* Platelet count of \< 20 × 109/L on the day of dose 1 (Day 1) or within 7 days before first dosing
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
* Treatment with antiplatelet or anticoagulant medication, including thrombosis prophylaxis, within 10 days prior to insertion of the PICC
* Chemotherapy regimen that would be expected to drop the platelet count to \< 20 × 109/L
* Chemotherapy regimen with heparin mixed into IV bags (eg, dalteparin 2500 IU/day)
* Difficult IV access that would prevent infusion of the IP
* In situ central venous catheter (CVC) or PICC in the 3 months before the Screening Visit. The study PICC must be inserted in the contralateral side, which must be PICC / CVC naïve
* Undergoing dialysis or have another inserted intravascular foreign surface device
* Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≥ 4 × upper limit of normal
Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions

Randomized control trial studying the effect of medical assistant health coaching for patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care community clinics, Mission Neighborhood Health Center and Southeast Health Center


Eligibility Criteria:
Inclusion Criteria:

Active patients at Mission Neighborhood Health Center, SF, USA or Southeast Health Center, SF, USA age 18-75 years Uncontrolled diabetes II, hypertension or hyperlipidemia Spanish or English speaking

Exclusion Criteria:

Cognitive dysfunction, mental health or physical condition that prevents participation in health coaching.
Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers

Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting studies examining their vascular effects in young adults. We evaluated microvascular reactivity (MR) before and after ED in young healthy male volunteers.

Methods: Systemic MR was evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis before, 90 and 180 minutes after the consumption of one can of ED or the same volume of water (control), followed by postocclusive reactive hyperemia (PORH).

Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. These products are marketed as boosters of mental and physical performance and are increasingly used in Western societies. Case reports of adverse effects related to ED consumption have been described in healthy young individuals, including coronary artery vasospasm, and myocardial infarction. These data suggest that endothelial dysfunction (EDysf) plays a role in ED cardiovascular effects and have prompted studies with conflicting results. The present study evaluated the microvascular reactivity (MR) after ingestion of one can of ED compared to a control, in young healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers with no relevant findings in the medical history

Exclusion Criteria:

* being a competitive athlete;
* being on regular medication;
* using illicit drugs;
* being allergic to coffee, taurine or any of the components of the selected energy drink; - -
* having a body mass index ≥ 30 kg/m2.
Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.

This is a randomized, placebo-controlled, cross-over study design of the effects of gabapentin on chronic irritability in neurologically impaired children. The study will involve a 22 day medication titration, followed by a 7 day stable dosing period and a 6 day medication taper period. After an additional 3 day washout period, the subject will cross-over to the remaining arm of the study. Subjects will be evaluated for symptoms of chronic pain. Since the subjects are generally non-communicative, the subjects will be evaluated by two questionnaires and the Non-Communicating Children's Pain Checklist-Revised, to be completed by their parent or primary caregiver.

The primary aim is to determine if gabapentin provides symptom relief for chronic irritability in neurologically impaired children.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* 1 month to 16 years of age at enrollment
* neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability from a variety of etiologies
* chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period
* Subject must have an acceptable surrogate capable of giving consent on the subject's behalf

Exclusion Criteria:

* Children with resolved symptoms after treatment of identified sources of pain
* Identified potential source of irritability without adequate trial of appropriate management
* Ketogenic diet
* Renal insufficiency or failure
* Current treatment with gabapentin or pregabalin for another existing condition.
Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search

The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

The secondaries objectives of the study are:

* Sensitivity and specificity in detecting multifocality of breast tumor
* Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors
* Predetermination of potential targets for ultrasound

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years.
* Patients with a breast tumor, regardless of the stage and size
* Compulsory affiliation to a social security system.
* Obtaining informed consent in writing, signed and dated.

Exclusion Criteria:

* Patients with cognitive or psychiatric disorders.
* Patient deprived of liberty by a court or administrative.
* Patients with indications against the achievement of MRI, mammography and tomosynthesis
* Pregnant Women
Muscle Vibration and Joint Position Sense

The present study aimed to investigate and compare the acute effect of local vibration (63 Hz vs 42 Hz frequencies) on the biceps brachii muscles on the elbow joint position sense (JPS) in healthy young men. Forty-five healthy young men aged 19 to 30 years were enrolled in the study. The participants were randomly assigned to receive either 63 Hz (n=15) or 42 Hz (n=15) or sham vibration (control group) (n=15). Participants in the experimental group received five bouts of 1-minute of each vibration exposure localized to the biceps brachii muscle, with a 1-minute rest between the bouts. Active elbow joint position error (in degrees) was selected as an outcome measure to assess elbow JPS. To measure active elbow joint position error, the subject was made to sit on the chair with eyes closed and shoulders in 0 degree of abduction and elbows fully extended. The examiner passively moved the elbow to 90 degrees of flexion (target position) and maintained it for 10 seconds. The subject was requested to memorize the target position. The subject was asked to actively flex the elbow to the target position from the initial starting position (elbow fully extended) and hold it for 5 seconds. Three trials were conducted, with a 30-second rest given between each trial. The target and reproduced angles in each trial were measured using a standard plastic goniometer. The difference between the target and reproduced angles in each trial was calculated to determine active elbow joint position error. Measurements were taken at baseline and immediately after the vibration protocol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young men

Exclusion Criteria:

* history of recent upper extremity surgery
* history of sensory deficits in the upper extremity
* recent upper extremity injury
* undergoing any resistance training
N-methylglycine (Sarcosine) Treatment for Depression

Major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. N-methyl-D-aspartate (NMDA), one subtype of glutamate receptors, plays an important role in learning and memory. N-methyl-D-aspartic acid (NMDA) enhancing agents, such as sarcosine (N-methylglycine), have been used as adjunctive therapy of schizophrenia. Sarcosine improved not only psychotic but also depressive symptoms in patients with schizophrenia. To confirm its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine in efficacy for major depressive patients.

Major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. Novel therapies via manipulating other neurotransmission (e.g. glutamate receptor) are being developed.

NMDA enhancing agents, such as sarcosine have been demonstrated to improve negative symptoms and depressive symptoms of schizophrenic patients. The purpose of this study is to compare citalopram and sarcosine in aspects of efficacy, safety in major depressive patients.

In the study, 40 major depressive patients are recruited into the 6-week trial and randomly assigned into the two groups (20-60 mg/d citalopram, or 500 - 1500 mg/d sarcosine) with a double-blind manner. Hamilton Depression Rating Scale(17-item), CGI(Clinical Global Impression), GAF(Global Assessment of Function)and side effects are evaluated every two weeks during the trial. The efficacies of two groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-55 years
* Fulfilled the DSM-IV criteria of major depressive disorder
* Had a 17-item Hamilton Rating Scale for Depression (HAMD-17)\>or= 18
* No DSM-IV diagnosis of substance abuse or dependence (including alcohol) within the past 6 months
* Had been drug free for \> 3 months
* Physically healthy and had all laboratory parameters within normal limits.
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Had history of epilepsy, head trauma or other major neurological or medical diseases
* Had psychotic depression, bipolar I/II disorder, schizophrenia or any other psychotic disorder
* Moderate-severe suicidal risks
* Severe cognitive impairment
* Female subjects who were pregnant, or at risk of pregnancy or lactation
* Initiating or stopping formal psychotherapy within six weeks prior to enrollment
* Had a history of poor response to SSRIs or previously received electroconvulsive therapy
* Had a history of severe adverse reaction to SSRIs.
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)

The purpose of this study is to create a resource that will advance research that is focused on discovery of novel therapies, risk stratification, and aggressive interventions for those at highest risk for non-alcoholic fatty liver disease (NAFLD). To achieve this, we will generate a biobank of liver tissue collected during standard of care liver biopsies. Paired blood/urine samples, FibroScan and relevant data will also be collected.


Eligibility Criteria:
Inclusion Criteria

* Females and Males ≥ 18 years of age.
* Understands the procedures and agrees to participate by giving written informed consent.

Biopsy Group Only:

• Scheduled for standard of care liver biopsy for any reason.

Non-Biopsy Group Only:

• BMI ≥ 25, with or without type 2 diabetes, without any level of NAFLD based on: (1) Recent medical history (within 6 months of screening visit). (2) Data collected from participation in a prior research study where they consented to be re-contacted for future studies.

Exclusion Criteria

* Women who are pregnant when referred for a liver biopsy will be excluded.
* Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.

Otherwise, all eligible patients who consent will be included in AVAIL. If participants in the non-biopsy group are found to have NAFLD based on the FibroScan done for this study, then they will be informed of this and advised to follow up with their physician. Their data will still be part of the registry and analyzed with the biopsy group that is found to have NAFLD.
To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301.
2. Able to understand and voluntarily sign informed consent.

Exclusion Criteria:

1. Medication compliance was \< 80% in double-blind studies.
2. In double-blind study, EOT visit (V10) eGFR\< 60 mL/min//1.73m2
3. Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study.
4. Hepatitis B Surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV Ab) positive during screening \[further hepatitis B virus deoxyribonucleic acid (HBV DNA) titer detection or hepatitis C virus ribonucleic acid (HCV RNA) detection (beyond the detection limit of assay need to be excluded)\], human immunodeficiency virus antibody (HIV) Ab) positive, serum antibody to treponema pallidum (TP Ab) positive (further test for treponema pallidum titer, if positive, excluded).
5. Women who are pregnant, planning to become pregnant during the study, or breastfeeding; Participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the ICF or planning to use progester-containing contraceptives during this period.
6. The researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.
Noninvasive Optical Measurement of Critical Care Neonates

The purpose of this study is to determine whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This study device is called laser speckle imaging.

The researchers can use the laser speckle imaging device to image superficial cerebral blood flow in the infant's head. The researchers can quantify blood flow and measured vessel diameter, versus actual diameter assessed with conventional digital camera imaging.

Eligibility Criteria:
Inclusion Criteria:

* New born or infant

Exclusion Criteria:

* non- new born or infant