cyrilzakka/clinical-trials huggingface dataset:
Rhythm and Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy

Cerebral palsy (CP) affects the motor function but also the cognitive function of the child. Physical activity brings motor and cognitive benefits and appears as an important aspect of the therapy that is offered to them.

The child is seating in front of a computer, seating comfortably on a chair during 1 hour. The experimental task consists in learning a sequence of taps on "Serial reaction time task" type buzzers (SRTT) in which the child must press a buzzer corresponding to one of the 4 squares that on the screen. The sequence corresponds to 10 steps in a particular order.

Cerebral palsy (CP) affects the motor function but also the cognitive function of the child. Physical activity brings motor and cognitive benefits and appears as an important aspect of the therapy that is offered to them. In particular, the learning of movements in the presence of multisensory rhythmic information seems to have beneficial effects at the cognitive and motor level. The present study aims to test the respective effects of rhythm and multisensoriality on motor learning in children with cerebral palsy.

The motor learning task is known as the "Serial Reaction Time Task" (SRTT). It consists in repeating a sequence of movements of the upper limbs using visual-spatial information alone (V). It will test the addition of synchronous auditory stimulation to visual information or rhythmic auditory stimulation(VAR), to contrast with a control condition with non-rhythmic auditory stimulation (VANR). The performance of the children will be measured by the reaction time (RT), its stability and the number of errors made throughout the motor learning.

The child is placed in front of a screen on which 4 luminous stimuli are presented on a horizontal plane. Four buzzers are placed in front of him, each buzzer corresponds to the position of a stimulus. The stimuli light up in a predetermined sequence (10 positions) and the child must press the buzzer corresponding to the position of the stimulus that comes on. Four blocks of 5 sequences are repeated to test the general learning (B1 to B4) and then a block of random stimuli is presented to test the specific learning of the sequence (B5).

Eligibility Criteria:
Inclusion Criteria:

For all children:

* Age between 6 and 14 years
* Obtaining the informed consent of the person possessing parental authority for all children

For children with Cerebral Palsy:

* Diagnosis of spastic cerebral palsy of levels GMFCS I to IV
* Ability to press buzzers with the palm of the hand, Manual Ability Classification System (MASC) I to IV
* Ability to understand instructions ("tap a buzzer along with a picture or sound") (investigator's appreciation)

For control children: no pathology diagnosed

Exclusion Criteria:

For all children:

* Children with a characteristic psychiatric pathology.
* Disorders of the understanding
* Hearing deficiency
* Uncorrected visual impairment
Niacin Skin Flush Response in Patients With Schizophrenia

Patients with schizophrenia have abnormal skin flush response to niacin, but the niacin skin test accuracy is not well studied in these patients. The study evaluated the niacin skin test accuracy in adult hospitalized schizophrenia patients and their first degree relatives, bipolar disorder patients, and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia patients and bipolar disorder patients diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders version IV criteria
* Normal healthy subjects without a psychiatric history
* First degree relatives of schizophrenic patients

Exclusion Criteria:

* Dermatological lesions, asthma or allergic disease, diabetes, chronic hypertension, vasculitis, substance use disorders (except cigarette smoking), or pregnancy
* Taking any oral medication that could affect the metabolism of prostaglandins such as nonsteroidal anti-inflammatory drugs or corticosteroids
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

This study will determine if NXY-059 will reduce functional disability from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours
* Full functional independence prior to the present stroke

Exclusion Criteria:

* Unconsciousness
* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
* Severe illness with life expectancy less than 6 months
* Known severe kidney disorder
* Current known alcohol or illicit drug abuse or dependence
* Pregnant or breast-feeding
* Treatment with acetazolamide and methotrexate is not permitted during the infusion
* Participation in a previous clinical study within 30 days
Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.


Eligibility Criteria:
INCLUSION CRITERIA:

* 16 years old or older.
* Have confident diagnosis of epilepsy.
* Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
* Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.

EXCLUSION CRITERIA:

* A history of hypersensitivity to the drug being studied.
* Currently being treated with or has been treated in the past with the drug being studied.
* Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
* If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
* Has taken an investigational drug or the medication Felbatol within the previous 30 days.
* Is abusing alcohol and/or other substances.
Intravesical Adjuvant Electromotive Mitomycin-C

In laboratory and clinical studies, intravesical electromotive drug administration increased mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive urothelial bladder cancer. The investigators' aim was to compare transurethral resection of bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will be randomly assigned to: transurethral resection alone, transurethral resection and adjuvant intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water infused over 60 minutes once a week for 6 weeks, or transurethral resection and adjuvant intravesical 40 mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA pulsed electric current for 30 minutes once a week for 6 weeks. Patients in the intravesical adjuvant electromotive and passive diffusion mitomycin groups who are disease-free 3 months after induction treatment, will be scheduled to receive monthly intravesical instillation for 10 months, with the same dose and methods of infusion as initial assigned treatment. All patients will be assessed for safety. The investigators' primary endpoints are recurrence rate and disease-free interval. Analyses will be done by intention to treat.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven primary stage pTa-pT1 urothelial bladder cancer,
* adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 × 10⁶ cells per L; platelet count ≥120 × 10⁹/L),
* normal renal function (ie, serum creatinine ≤123·76 μmol/L),
* normal liver function (ie, serum glutamic-oxaloacetic aminotransferase ≤42 U/L, serum glutamic-pyruvic aminotransferase ≤48 U/L, and total bilirubin ≤22 μmol/L),
* Eastern Cooperative Oncology Group performance status between 0 and 2.

Exclusion Criteria:

* non-urothelial carcinomas of the bladder;
* previous or concomitant grade G3 urothelial and/or carcinoma in situ of the bladder;
* urothelial carcinoma of the upper urinary tract and urethra, or both;
* previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs;
* known allergy to mitomycin;
* bladder capacity less than 200 mL;
* untreated urinary-tract
* infection; severe systemic infection (ie, sepsis);
* treatment with immunosuppressive drugs;
* urethral strictures that would prevent endoscopic procedures and catheterisation;
* previous radiotherapy to the pelvis;
* other concurrent chemo therapy, radio therapy, and treatment with biological response modifiers;
* other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer);
* pregnancy;
* any factors that would preclude study participation.
Bernese Next of Kin Survey Following Organ Donation Request

6 to 18 months after organ donation request a next of kin survey using a standardized questionnaire was conducted.


Eligibility Criteria:
Inclusion Criteria:

Next of kin involved in request for organ donation
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Early identification and Severity prediction of Acute Respiratory infectious disease has become a top priority for clinicians at department of infectious and respiratory diseases after COVID-19 broke out. This is a multicenter, prospective, and randomized study, which aims to figure out the best way of early identification and severity prediction of acute respiratory infectious diseases. Patients with suspected acute respiratory infectious diseases will be enrolled into this study and received two different diagnostic pathways.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 80 years old
2. No limits in gender
3. Patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks;
4. Patients who meet at least one of the following 4 requirements:

   1. fever;
   2. Sign of pulmonary consolidation or wet wales
   3. WBC\>10×10\^9/L or \<4×10\^9/L;
   4. patchy, infiltrating shadows or interstitial changes, with or without pleural effusion on chest radiological examination.

Exclusion Criteria:

1. Highly suspected or diagnosed pulmonary non-infectious disease (Tumor, Immune disease, etc.) without evidence for infection;
2. Pathogen has been identified without evidence for co-infection;
3. Insufficiency of respiratory and blood samples;
4. Patients who are unable to collaborate due to physical or mental disorders;
5. Patients who have been engaged to other clinical trials;
6. Any conditions make it unsafe for the subject to participate;
Left Ventricular Function and Remodelling During Permanent Pacing

1. Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure. New pacemaker types that stimulates both left and right ventricle ( biventricular pacemakers ) is introduced to the treatment of patients with heart failure, decreased left ventricular function and ECG signs with left bundle branch block.
2. Hypothesis - Ventricular pacing results in remodelling of the left ventricle and decreased left ventricular function. Biventricular pacing do not do this. Ventricular pacing results in heart failure and increased wall stress with decreased 6 minutes walk test and increased BNP in blood samples. This is not seen by biventricular pacing.
3. Materials and methods - 3 studies. All patients are examined by echocardiography 2-dimensional, M-mode, 3-dimensional and with tissue harmonic imaging. Study 1) Patients with AV-conduction disorder that needs pacemaker treatment are randomized to DDD-pacemaker or biventricular pacemaker. Study 2) Patients with sick sinus syndrome included in DANPACE are randomized to AAI- or DDD-pacemaker. Study 3 ) Acute study to examine the changes in patients AV-block before DDD-pacemaker implantation and after implantation.


Eligibility Criteria:
Inclusion Criteria:

* Sick sinus syndrome
* AV-block

Exclusion Criteria:

* Atrial fibrillation
* AMI
* Heart valve disease
The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure

The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. We would like to evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on HbA1c


Eligibility Criteria:
Inclusion Criteria:

All patients \>18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing

Exclusion Criteria:

* Pregnancy
* Having received a blood transfusion with in the preceding three months
* Known to have any hereditary or hemolytic anemia
* On a medication known to interfere with HbA1c assay (opiates, acetaminophen, vitamin C, vitamin E) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug.
* Having a blood hemoglobin \<7 mg/dl
* Bilirubin level \>20mg/dL or a triglyceride level \> 250mg/dL
* Alcohol addiction
Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved squamous cell carcinoma of the head and neck;
* stage IVc according to Union for International Cancer Control (UICC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
* 18 years or older; without other malignancy;
* proper functioning of the major organs.

Exclusion Criteria:

* allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ;
* female within gestation period or lactation;
* patients received drug of other clinical trial within 3 months
A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.

This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* cancer not amenable to curative treatment (ie advanced and/or metastatic);
* measurable or evaluable disease;
* adequate cardiac, hepatic and renal function.

Exclusion Criteria:

* patients with known CNS metastases;
* serious cardiovascular illness or other medical conditions;
* prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment;
* inability to swallow oral medications, or impaired gastrointestinal absorption.
Active Breaks in People With Type 1 Diabetes

the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.

An open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. Interstitial glucose concentrations (fGM), insulin dose and physical activity/ postural transitions (ActivPAL) will be monitored throughout. To improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.

Eligibility Criteria:
Inclusion Criteria:

* T1D diagnosis more than 3 years ago
* Sedentary (\> 10h per waking day sedentary (sitting or lying)
* Using insulin therapy with multiple daily injections or insulin pump
* Aged 18-66 (UK retirement age)
* Use of Abbot FreeStyle Libre 2 fGM (\>6 weeks to avoid potential lifestyle changes as a result of sensor use)

Exclusion Criteria:

* Engaged in structured planned exercise (e.g. running, cycling, gym, or sports)
* Pregnancy or planning to become pregnant
* \<6 months postpartum or stopped breastfeeding \<1 month before recruitment
* Existing cerebrovascular or cardiovascular disease
* Significant history of hyperglycaemia (HbA1c \>85 mmol/mol)
* History of severe hypoglycaemia requiring third party assistance within the last 3 months
Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs

The purpose of this study is to understand the effects of decreased functioning of the testes or ovaries on mental performance in males and females using illicit drugs excluding marijuana.

This research is being done to understand the effects of endocrine abnormalities, specifically hypogonadism (decreased functioning of the testes or ovaries) on cognitive (mental) performance in males and females using illicit drugs (excluding marijuana).

Eligibility Criteria:
Inclusion Criteria:

* Completed the 8th grade

Exclusion Criteria:

* Did not complete the 8th grade. Have a hormone problem for which you are taking medication e.g. testosterone or thyroid medicine, steroids, oral contraceptives, progesterone. Diagnosed with cancer. History of schizophrenia. Currently have or have been diagnosed in the past with meningitis or encephalitis.
The Effect of Thermotherapy on Recovery and Performance

This study investigates the effects of cooling on the recovery and performance characteristic in young healthy subjects. The study is divided in two projects:

Project A: investigates the effects of 20 min. post-exercise cooling on vertical jump performance and delayed onset muscle soreness and rated perceived exertion.

Project B: investigates the effects of 20 min. pre-exercise cooling on maximal voluntary contraction of the right M. quadriceps femoris and delayed onset muscle soreness and rated perceived exertion.

The aim of this study is to investigate the effects of a 20 min. external cooling application (+8°C ) versus a external thermo neutral application (+32°C) up to 72 hours post application.

The study is divided in two projects:

Project A: This study is focusing on the recovery process after a max. jump performance (3x30 counter movement jumps). Directly after the exercise subjects receive a cooling or thermo-neutral application. Recovery characteristics measured by vertical jump performance (objective) and delayed onset muscle soreness and rated perceived exertion (subjective) are measured in function of time up to 72 hours post cooling intervention.

Project B: This study is focusing on the effect of 20 min. cooling or thermo-neutral application on the M. quadriceps femoris performance (MVC). After the thermo-application, the 60% endurance MVC is measured by means of surface EMG (OT Bioelettronica 10-750 Hz) in a ergometer chair 90° degrees knee flexion (Cor 1 Bioelettronica). Muscle conduction velocity, MVC (objective), delayed onset muscle soreness and rated perceived exertion (subjective) are measured in function of time up to 72 hours post thermo-application.

Eligibility Criteria:
Inclusion Criteria:

* only healthy young subjects 18-30 years
* no musculoskeletal surgery in trunk and lower extremities
* injury history in trunk and lower extremity for more than one year
* subjects taking anticonceptive medication are allowed to participate

Exclusion Criteria:

* actual injuries or injuries for less than one year in trunk and /or lower extremities
* injury history in trunk and lower extremity for more than one year with complaints
* anxiety of cooling
* subjects on medication
* pace maker
* cardiovascular disease
* pregnancy
* skeletal problems
* appendectomy for less than two years
* Morbus Raynaud syndrome
A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty

The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. One of the most important factors to minimise the risk of complications, is to keep the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated neuromuscular abnormalities after bloodless field among many patients which may lead to a prolonged rehabilitation period since they cause a postoperative weakness in the muscles. Although in these studies an unnecessary high tourniquet pressures were used and the EMG tests were made 6 weeks and 6 months after the surgery.

With today's demand for fast rehabilitation, there is a need for better knowledge if lower tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.

Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood flow. It accounts for a patients limb and vessel characteristics and the type and fit of the tourniquet cuff. The method has developed and is now simplified, by using an automatic (plethysmographic) sensor placed on the second toe on the involved limb, and after administration of anaesthesia, and immediately before limb preparation and draping it measures the limb occlusion pressure.

When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP pressure measured. The LOP method is still rarely used it has been seen as difficult and time consuming.

The primary aim of this study is to investigate whether you can reduce the used tourniquet pressure with the new LOP measurement technique and still have a adequate bloodless field; and if this will lead to any clinical difference regarding postoperative pain. The secondary aim is to investigate the difference between the test groups concerning muscle function and wound healing and if these are remaining and of clinical importance. The third aim is to study how common neuromuscular abnormalities are after the use of bloodless field with lower cuff pressures and if there are any differences between the standard method and the LOP method.


Eligibility Criteria:
Inclusion Criteria:

* Planned for total knee arthroplasty in bloodless field
* 75 year or younger

Exclusion Criteria:

* Patients unable to read and understand Swedish
* Systolic blood pressure over 200 mmHg and a girth of the thigh over 78 cm was excluded.