cyrilzakka/clinical-trials huggingface dataset:
Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation

Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.

A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.

tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in chronic stroke patients with motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during performance of bimanual activities and/or motor learning. A few minutes/hours/days/weeks after completing one trial's arm, the patients will enter the other trial's arm (double-blind cross-over design).

Baseline and follow-up outcomes about bimanual and unimanual motor tasks will be collected.

For a subset of subjects, motor learning and data acquisition will be performed with a neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) .

Eligibility Criteria:
Inclusion Criteria:

• stroke with at least slight deficit

Exclusion Criteria:

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* inability to understand / complete behavioral tasks
* chronic intake of alcohol or recreational drugs
* major health condition
* presence of pacemaker (for the fMRI part only)
* pregnancy
A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups

The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.


Eligibility Criteria:
Inclusion Criteria:

AML project

* inclusion in studies of the DSIL or OSHO group for AML
* AML M3/M3v can be included only when in complete remission
* age 16 - 80 years
* written informed consent

Autologous project

* AMl and ALL patients in first or second remission
* low grade or high grade non hodgkin lymphoma or morbus hodgkin or multiple myeloma
* conditioning regime: TBI 8-12 Gy/Cy 120 or BEAM or BU/CY or Melphalan 140-200mg/m2 or a similarly intensive chemotherapy regime
* age 16 - 65 years

Exclusion Criteria:

AML project

* known refractoriness to platelet transfusion
* known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
* known plasmatic coagulation disorder
* patient unable to give informed consent

Autologous project

* known refractoriness to platelet transfusion
* known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
* known plasmatic coagulation disorder
* patient unable to give informed consent
* patients with pulmonal or cerebral lesions due to infection or neoplasm
* patients with al-amyloidosis
A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19

New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in participants with proven SARS-CoV-2 infection

The study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. Participants will be actively followed for 28 days.

Participants will be randomized into one of two treatment plans

* Triple combination:

  * Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
  * Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
  * Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
* No active Medication:

  * Placebo administered according to the above schedule

Viral load (qPCR via nasal swab) will be assessed at baseline (day 0) as well as at days 3, 6, and 10 to monitor response to antiviral treatment. Immune status will be determined by antibody testing of blood collected at baseline and day 28. Symptom questionnaires will be completed daily for 10 days and day 28.

Eligibility Criteria:
Inclusion Criteria:

* Documented SARS-CoV-2 infection by qPCR assay performed within the past 7 days

Exclusion Criteria:

* COVID-19 symptoms requiring hospitalization
* PO2 \< 92%
* Short of breath at time of enrollment
* Retinal eye disease
* Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
* Known chronic kidney disease, stage - 5 or receiving dialysis
* Current use of:

  * Class 3 AAD (amiodarone, dronaderone, dofetilide, sotalol)
  * Class 1A AAD (procainamide, quinidine, disopyramide)
  * Flecainide
  * SSRI: citalopram (Celexa), Escitalopram (Lexapro)
  * chlorpromazine
  * Cilostazol (Pletal)
  * Donepezil (Aricept)
  * Droperidol
  * Fluoconazole
  * Methadone
  * Ondansetron (Zofran)
  * Thioridazine
  * Macrolides (clarithromycin, erythromycin)
  * Fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin)
  * Tamoxifen
* Pregnancy or women who are breast feeding
* Inability to tolerate oral medications
* Allergy or prior adverse reaction to either hydroxychloroquine sulfate, ribavirin, or nitazoxanide
* Allergy to adhesives
* QTc interval \> 450 mSEC for men and women
* History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval
* Non-English-speaking
Impact of Microbiome-changing Interventions on Food Decision-making

The investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. To this end, 90 overweight/obese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. Before and after the intervention/control period, participants will undergo task-based functional and structural MRI and cognitive testing. The gut microbiota will be assessed using 16S rDNA next-generation sequencing (V3/V4 region) in stool samples. Diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. SCFA). Using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. Related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 25 kg/m2 or WHR \>= 0.9/0.85 (m/d, f)
* no MRI contra-indication
* written informed consent

Exclusion Criteria:

* athletes
* occurrence of a clinically relevant psychiatric disease in the last 12 months, e.g. depression, substance abuse, eating disorders, schizophrenia
* any chronic inflammatory or malignant disease
* type 1 diabetes
* previous bariatric/gastric surgery
* pregnancy or breastfeeding woman
Adenosine Cardioplegia; Improved Cardioprotection?

60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.


Eligibility Criteria:
Inclusion Criteria:

* Elective patients
* Ejection fraction \> 40%
* Age 40-75
* No release og TnT or CKMB within last week before CABG
* Pure CABG

Exclusion Criteria:

* Age \>75 or \< 40
* EF \< 40%
* Emergency operations
* Unstable angina
* Release of TnT or CKMB within the week before operation
A Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons

The primary purpose of this study is to compare, in retired persons living in the Balearic Islands, the effectiveness on low back pain related disability of three educational programs. All consist of a group talk and the handout of a booklet, each one different in its content.


Eligibility Criteria:
Inclusion Criteria:

* To attend regular talks for retirees, and accept to attend one health talk, whether or not subject has nonspecific low back pain; to accept participation in the study.

Exclusion Criteria:

* Inability to fill out questionnaires (due to blindness, functional illiteracy, or dementia);
* Having a diagnosis of rheumatologic inflammatory disease, fibromyalgia, or cancer in last 5 years.
Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.

Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are ambiguous.

Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammatory response in humans. The assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. Moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to assess endothelial function. The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as well
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians

The aim of this BZKF project is to record the current care structure for breast cancer patients in order to use this as a basis for developing possible future models for improvement. The active involvement of representatives of regional and national patient organizations in the creation of a patient-based and patient-oriented survey ensures that the needs of patients are the focus. In addition to and in contrast to other projects, relevant questions are explicitly addressed not only to patients but also to physicians in order to identify and specify the interfaces between patient wishes/suggestions and to develop clinical consequences for care.

The first objective is to survey the "current situation" by recording the current care structure for breast cancer. The focus is on the survey of both groups on patient-physician communication, time management and coping strategies.

By planning the future harmonization of national data structures, the basis is created for the long-term goal of an improved "target", a concept developed jointly by physicians and patients for an improved communication and care structure that focuses on the patient.


Eligibility Criteria:
Inclusion Criteria (patients):

* Breast cancer or DCIS
* women and men aged 18 years and older

Exclusion Criteria (patients):

* women and men \< 18 years
* no histologically confirmed breast cancer or DCIS diagnosis

Inclusion Criteria (physicians):

- Treatment of breast cancer patients
Standardized Physical Activities Measured by Accelerometers

STANDARDIZED PHYSICAL ACTIVITIES MEASURED BY ACCELEROMETERS Background and aims: Physical activity may be assessed by several different methods. However, the use of accelerometers is the most direct method available for real-time measurements. The piezoelectric element of accelerometers records an electric voltage during movement which is then transcribed to Activity Counts (AC). Few studies have used Actical accelerometers to assess standardized physical activities and most of these were not applicable to patients in a hospital setting. No previous studies have applied Actical accelerometers to the wrists or ankles during standardized activities. The aim of this study is to record AC during different standardized activities frequently done by patients hospitalized for acute ischemic stroke.

Methods: Patients discharged since February 2012 after a transient ischemic attack have been invited to participate in the study scheduled for June-September 2012 (nexpected=25). All participants wear 5 accelerometers (Actical), one at each wrist and ankle and one over the hip. Standardized physical activities include:

* treadmill walking (5 minutes, 1 and 4km/h)
* staircase walking (1 floor, normal pace)
* cycling with fixed load (5 minutes)
* standing up from sitting position and sitting down again (x5)
* standing up from supine position
* turning from left to right and back while lying in bed
* raising outstretched arm 90° (x5, standing position)
* eating (5 minutes, sitting position)
* drinking a glass of water
* sleeping (6 hours)


Eligibility Criteria:
Inclusion Criteria:

* Previous Transient Ischemic Attack
* age \> 18 years

Exclusion Criteria:

* pregnancy and lactation
* time limit of more than 2 days of standardized activities exceeded
* no informed consent
* disability when tested with Scandinavian Stroke Scale (score \<58), National Institutes of Health Stroke Scale (score \>0), modified Rankin Scale (score \>0) and Barthels Index 100 (score \<100)
The Safety and Efficacy of FFR Protocol in NTUH System

FFR-guided PCI has been performed in National Taiwan University Hospital(NTUH) for many years. Nevertheless, the method of FFR measurement in NTUH is different from that in literature. In this study, the investigator would like to evaluate the effectiveness and safety of NTUH experience in FFR prospectively. First, the investigator will record any intracoronary (IC) injected adenosine-related complications, such as bradyarrhythmia or chest discomfort. Second, the investigator will follow up on the clinical outcome of the participants for 2 years, record if any target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death. Finally, left ventricular diastolic pressure, serum pro-brain natriuretic peptide (pro-BNP), and high sensitivity C- reactive protein (hsCRP) will be checked and determined their relationships with the maximum dosage of IC adenosine.

FFR has been introduced for the determination of physiological ischemia in the myocardium for many years. Nowadays, FFR-guided PCI is highly recommended for the assessment of physiologic ischemia in intermediate coronary lesions. FFR-guided PCI has been performed in National Taiwan University Hospital(NTUH) for many years. Nevertheless, the method of FFR measurement in NTUH is different from that in literature. In this study, the investigator would like to evaluate the effectiveness and safety of NTUH experience in FFR prospectively. First, the investigator will record any intracoronary (IC) injected adenosine-related complications, such as bradyarrhythmia or chest discomfort. Second, the investigator will follow up on the clinical outcome of the participants for 2 years, record if any target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death. Finally, left ventricular diastolic pressure, serum pro-brain natriuretic peptide (pro-BNP), and high sensitivity C- reactive protein (hsCRP) will be checked and determined their relationships with the maximum dosage of IC adenosine.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for FFR examination

Exclusion Criteria:

* Hypersensitivity to adenosine
* Severe valvular aortic stenosis
* Resting heart rate less than 50 beats per minute
Proteomics and Genomics Combined With CT to Predict CVD

This study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 50 and 75 years old
* Subjects at intermediate to high risk for ASCVD
* Asymptomatic patients without cardiac chest pain
* Evidence of atherosclerosis on baseline CCTA

Exclusion Criteria:

* Renal insufficiency, defined as eGFR \< 30 ml/min
* History of cardiovascular events (myocardial infarction, peripheral artery disease and ischemic stroke)
* Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid monotherapy
* Change in lipid lowering therapy in the last 6 months
* Use of more than two antihypertensive agents
* No coronary atherosclerosis at baseline imaging
* Active malignancy requiring treatment
* Atrial fibrillation
* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Intervention on Socio-emotional Development and Well-being Through ICTs in Early Adulthood

emoWELL is a serious game, that is, a video game designed to inform and train in skills and competencies in a more dynamic way. emoWELL focuses on understanding and developing healthy emotional regulation strategies to improve well-being.

Computer-based videogame. The program has a graphic adventure format, where the player controls an avatar who embarks on a train journey. Throughout this journey, the train will make five different stops where the player will learn about emotional regulation through activities or puzzles, readings and different interventions with the game's characters. At the first stop, the player will receive psychoeducation about emotional regulation and the most frequent adaptive and maladaptive regulation strategies. In the next three areas, exercises will be carried out to apply these strategies on variables such as self-esteem, self-care, stress, time management and social support. Finally, in the last area, the player will review the different contents learned. In addition to the train and the five stops or areas described, the game includes the area of the avatar's house and a final scenario that will vary depending on the player's answers throughout the adventure, in order to highlight the most important learning and conclude the game. Therefore, emoWELL consists of 8 areas in total.

The intervention is carried out autonomously. In addition to the computer game, emoWELL is linked to a mobile application so that the user can practice, integrate and reinforce the knowledge learned in the remote game, being both platforms indispensable in the intervention.

Eligibility Criteria:
Inclusion Criteria:

* To have signed the informed consent (or their legal tutors).
* Being between 16 and 29 years old.

Exclusion Criteria:

* Inability to understand the activities or the language used.
A Study of Prexasertib (LY2606368) in Japanese Participants With Advanced Cancers

The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
* Participant must have diagnosis of cancer that is advanced or metastatic
* Participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy
* If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug
* If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding

Exclusion Criteria:

* Participant must not have symptomatic central nervous system malignancy or metastasis
* Participant must not have current hematologic malignancy
* Participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
* Participant must not have a serious cardiac condition