cyrilzakka/clinical-trials huggingface dataset:
Dual-tasking Effect on Gait in Children With Developmental Coordination Disorder

The aim of the study is to collect data in children with developmental coordination disorder (DCD) aged between 7 and 17 years for analyses of the gait pattern while walking at the Gait Real-time Analysis Interactive Lab (GRAIL) at the university hospital of Ghent.

Children with DCD will be asked to take a motor test (M-ABC-2) as well as walk on the treadmill during a single session of approximately 3 hours.

The following data will be collected on the GRAIL while subjects walk at different gait speeds: 3D kinematics, kinetics, and EMG.

Additionally, 3D kinematics, kinetics, and EMG data will be collected when performing either a cognitive (Stroop Color and Word Test) or motor (requiring arm swing) dual-task while walking at comfortable walking speed..

The aim of the study is to collect data in children with developmental coordination disorder (DCD) aged between 7 and 17 years for analyses of the gait pattern while walking at the Gait Real-time Analysis Interactive Lab (GRAIL). This is a treadmill linked to a virtual environment used to analyse and train gait at the Children's Rehabilitation Centre of Ghent University Hospital. The data from children with DCD will be compared with typically developing children. In this study, only children with DCD will be included and the data resulting from this study will be compared to the data from the previous study in typically developing children (ID: B670201942108).

Children with DCD will be asked to take a motor test (M-ABC-2) as well as walk on the treadmill during a single session of approximately 3 hours. While walking at comfortable walking speed, two short games will be played i.e. dual-tasking. This involves both a cognitive (Stroop Colour-Word Test) and a motor (requires the use of the arms) dual task projected in the virtual environment of the GRAIL. The cognitive and motor task will be performed both while standing still (single tasking: ST) and while walking (dual tasking: DT). Simultaneously, kinetics, kinematics, and EMG data will be collected for 3D gait analysis. Using muscle synergy analysis (based on EMG data), the degree of gait automatization will be analysed. The data from children with DCD will be compared with typically developing children to determine whether a reduced gait automatization can be observed in children with DCD.

Parents will be asked to complete a screening list (CVO/DCD-Q) for motor problems in daily life. This aims as a support to the motor test (M-ABC-2), together providing additional insight into children's motor functioning (in daily life).

Eligibility Criteria:
Inclusion Criteria:

* They have an official DCD diagnosis;
* Are aged between 7 and 17 years old;
* Can walk at least 15 minutes consecutively;
* Have good or corrected vision.

Exclusion Criteria:

* They suffer from a neurological disorder;
* Take medications that affect gait and balance;
* Have undergone surgical procedures on the lower limbs in the past;
* Experience pain in their lower limbs or back at the time of testing.
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

To evaluate the safety of the long-term use of pregabalin.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
* Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion Criteria:

* Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
* Patients exhibiting treatment non-compliance in the preceding study (A0081120)
Stress, Anxiety, and Mood Group Therapy

The purpose of this study is to identify cognitive mechanisms that might facilitate treatment response for individuals experiencing depression and/or anxiety. The Stress, Anxiety, and Mood group helps individuals experiencing symptoms of stress, anxiety, and mood by providing concrete coping skills to regulate emotions, to let go of negative thoughts, and build courage to talk to others about tough topics. Groups meet for 8 weeks, with sessions lasting 90 minutes each. In addition to group therapy, you will be asked to complete some computerized and paper and pencil-based tasks.

If you are interested in learning more, please contact us at 650-417-2000 ext. 3642 or paloalto.study@gmail.com. All inquiries will be kept strictly confidential.

PRIMARY OBJECTIVES:

I. Identify specific patterns of executive function impairment that distinguish affective and cognitive symptoms in anxious and/or depressed patients.

II. Identify specific components of executive function that predict Unified Protocol treatment response. This will set up subsequent cognitive intervention studies targeting those components.

The phone screen includes a confidentiality statement explaining how their information will be kept confidential, demographic questions, and questions regarding the participants' medical and psychiatric history, and current psychological state. Responses to these questions will be used to determine if the individual meets inclusion criteria to engage in the study. If the participant meets study eligibility criteria, he/she will be invited to an informational session not exceeding two and a half hours at Dr. Warren's lab, which involves an explanation the project, informed consent, some questionnaires, and a diagnostic clinical interview. Also during the first visit, participants will be informed of the upcoming visits and the types of activities they will be asked to engage in for the purposes of this study. During a second visit, subjects will undergo cognitive testing designed to measure set shifting, working memory updating, cognitive inhibition, processing speed, general intelligence, and attentional control. These tests will be administered at Dr. Warren's lab and will not exceed two and a half hours. The remainder of the study visits will involve an 8-week, cognitive-behavioral group therapy titled "Unified Protocol," to take place at the Gronowski Clinic. Treatment groups will be facilitated by Dr. Warren and co-facilitated by trained graduate students selected by Dr. Warren.

Eligibility Criteria:
Inclusion Criteria:

* Normal color vision
* Ability to travel to Palo Alto University
* Experiencing symptoms of stress, anxiety, and/or depression
Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).


Eligibility Criteria:
Inclusion Criteria:

* A male or female \> 6 months of age at the time of the first vaccination.
* Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

* Clinical signs of acute febrile illness at the time of entry into the study.
* Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.
A Study of LY2886721 in Healthy Participants

The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and non-childbearing potential women
* Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m\^2)
* Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

* Taking over-the-counter or prescription medication with the exception of vitamins or minerals
* Smoke more than 10 cigarettes per day
* Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
IV Cocaine Abuse: A Laboratory Model - 2

The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.


Eligibility Criteria:
Please contact site for information.
IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
* No prior surgery or chemotherapy/biological therapy/radiation therapy
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Life expectancy of more than 12 weeks

Exclusion Criteria:

* Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
* Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.

Paravalvular leak (PVL) is a condition that could be treated surgically or by the transcatheter deployment of the occluder devices (plugs).

No PVL-specific occluder device is available on the market. VALE consortium plans to design and validate a new PVL dedicated devices (sizing balloon and occluder) in the context of computer 3D modeling, bench testing, preclinical evaluation and clinical research.

Transcatheter closure of PVL has emerged as a new treatment strategy that can be offered to patients with isolated PVL or to those with a very high risk of repeat surgery. The transcatheter approach involves deployment of occlude devices or coils and adopting either a percutaneous or a transapical approach. Limitation of such approach is the fact that no PVL-dedicated device is available on the market, and either vascular-specific plugs or other types of occluders used commonly for closure of ventricular septal defects or patent ductus arteriosus can be used. Several technical issues can make the procedure challenging.

The primary problem is the localization and track of the canal which can be very difficult to engage and cross with the guidewire. Also the maneuverability of the guide catheter in often enlarged left atrium and the passage of the occluder device through narrow and serpiginous canal between calcified annulus and sewing ring is challenging.

Clearly the limitations of current devices and increasing number of patients with significant PVL warrant the attempts to design and validate new PVL-dedicated devices in the context of computer modeling, bench testing, preclinical evaluation and clinical translation. These devices, as sizing balloon, could significantly simplify and shorten the procedure, decrease the risk of complications and incomplete defect closure as well as optimize cost-effectiveness of the procedure by decreasing number of the occluders.

Eligibility Criteria:
Inclusion Criteria:

* The presence of clinically and haemodynamically significant leakage around the surgically implanted cardiac prosthesis in the mitral or aortic position.
* Heart surgery (heart team) disability after another cardiac surgery.
* Technical feasibility of paravalvular leakage closure according to experienced operator.

Exclusion Criteria:

* Active endocarditis on artificial valve
* Instability of artificial valve
* The amount of cavity that prevents effective closure with an occluder
* A history of acute coronary syndrome in less than 3 months before enrollment
* Confirmed echocardiography of transplatin or transesophageal echocardiography
* Hypersensitivity to contrast media
* Any condition associated with the expected life expectancy of less than 6 months
* Haemorrhagic diathesis
* Significant renal impairment (eGFR \<30 mL/min/1.73m2)/chronic kidney disease at \>G3 stage
* Pregnancy or lactation
* Under 18 years of age
* Patient unable or unwilling to give an informed consent to participate in the study
Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects

The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* Japanese men or women at least 20 years of age
* Histological or cytological confirmation of a solid, malignant tumour excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist
* WHO performance status 0-2 with no deterioration over the previous 2 weeks

Exclusion Criteria:

* Previous therapy with medication against IGF (ie, monoclonal antibodies with IGF-1R or IGF-targeting tyrosine kinase inhibitors)
* Inadequate bone marrow reserve or organ function
* Poorly controlled diabetes mellitus as defined by the investigator's assessment and/or glycosylated hemoglobin (HbA1c) reading \> 6.5% within 28 days prior to the first dose of MEDI-573
* History of allergy or reaction to any component of the MEDI-573 formulation or drugs with a similar chemical structure or class to MEDI-573
Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of colorectal cancer
* No prior chemotherapy and scheduled to receive FOLFOX chemotherapy (oxaliplatin,leucovorin and 5-fluorouracil)
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
* Laboratory index: Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10\^9/L, Platelet Count ≥ 75×10\^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance\>60ml/min
* Be able to read, understand and complete the questionnaire and diary
* Be able to understand the study procedures and sign informed consent.

Exclusion Criteria:

* Treatment with any other study medicine within 4 weeks before enrollment.
* Nausea or vomiting ≤ 24 hours prior to registration
* Ongoing emesis due to obstruction of digestive tract
* Concurrent use of olanzapine, phenothiazine or amifostine
* Female with pregnancy or lactation
* Severe cognitive compromise
* Known history of CNS disease (e.g. brain metastases, seizure disorder)
* Concurrent abdominal radiotherapy
* Chronic alcoholism
* Known hypersensitivity to aprepitant, tropisetron, or dexamethasone.
* Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months.
* History of uncontrolled diabetes mellitus
* Serious or uncontroled infection
* Known active HIV, viral hepatitis or tuberculosis infections
Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening
* Have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
* Lifetime history of meeting DSM-5 criteria for:
* Schizophrenia spectrum or other psychotic disorder
* Bipolar or related disorder
* Major neurocognitive disorder
* Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
* Dissociative disorder
* Posttraumatic stress disorder
* MDD with psychotic features
* Significant suicide risk, as judged by the Investigator.
Dorsal Nerve Block and Caudal Block in Hypospedius Repair in Children

Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial

• Group A receive caudal block placing the patient into the left lateral decubitus position. Povidone iodine was used to sterilize the skin. The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal membrane by using the loss of resistance method, the caudal epidural space was entered. Negative aspiration was used to make sure there was no blood or cerebrospinal fluid present and 0.25% bupivacaine was administered at a dose of 0.2 ml/kg. Once the procedure was completed, the patient was placed into the supine Position.

Group B US guided Dorsal penil block. General anesthesia induction was followed by skin sterilization using 70% alcohol in 2% chlorhexidine. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis.

Eligibility Criteria:
Inclusion Criteria:

* aged 2-12 years
* ASA physical status I or II

Exclusion Criteria:

* asthmatic patients
* emergency surgery
* intellectual disability
* neurological diseases with agitation-like symptoms
* renal or hepatic disease,
* cardiac or respiratory disease
* allergy to the study drugs
* parent refusal
* psychiatric diseases
EMS-I: Validation of the Italian Version of the Elderly Mobility Scale

This study is an observational study that aims to validate the Elderly Mobility Scale (EMS) in Italian (EMS-I) by comparison with the Barthel Index scale, already validated in Italian. Furthermore this study wants to evaluate the inter-rater reliability comparing the scores assigned to the same sample of patients by two independent evaluators. The study population includes 50 elderly in-patients eligible for physiotherapy.

This study is an observational study that aims to validate the Elderly Mobility Scale (EMS) in Italian (EMS-I) by comparison with the Barthel Index scale, already validated in Italian.

The Elderly Mobility Scale (EMS) is considered a suitable tool to assess basic motor function in hospitalized geriatric patients. It has shown good psychometric characteristics.

The study process requires a standardized translation protocol, including forward and backward translation. The protocol provides enrollment of 50 geriatric in-patients eligible for physiotherapy admitted to IRCCS-INRCA Hospital. Two physiotherapists independently evaluate the same enrolled patient with Italian EMS (EMS-I) and Barthel Index.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the IRCCS-INRCA Hospital
* Request for physiotherapy evaluation
* Sign of the informed consent

Exclusion Criteria:

* Lack of Medical approval for sitting and standing position.
Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging

The aim of the study is to prospectively evaluate the value of pelvic MRI including diffusion- and perfusion-weighted sequences in the selected group of patients that have an undetermined ovarian mass at ultrasound.


Eligibility Criteria:
Inclusion Criteria:

\*Any woman with an adnexal mass undetermined by gynecological ultrasound

Exclusion Criteria:

* Any lesion with definite diagnosis by gynecological ultrasound
* Denial or withdrawal of oral informed consent.
* Contra-indication for MRI
Novel Photosensitizer in The Treatment of Chronic Periodontitis

The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.

LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD ≥5mm in each quadrant

Exclusion Criteria:

* Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers