cyrilzakka/clinical-trials huggingface dataset:
Motor Intervention for Children With Developmental Coordination Disorder

This study focuses on the effects of physical activity in schools on the cognitive function and physical fitness of children with and without developmental coordination disorder (DCD). Methods: 58 children with DCD participated in an 8-week exercise program. Children's standing broad jump (SBJ), 50m dash, 50m\*8 shuttle run, mental rotation and executive functions were assessed before and after training. A mixed-design analysis of variance (ANOVA) was conducted separately for each performance variable.

Potential children were identified from elementary schools in three districts of Shanghai. The study protocol was approved by the Ethics Committee of Shanghai Uni-versity of Medicine and Health Sciences. In order to select the research sample, recruitment letters were sent to the parents of all children; these letters detailed the purpose, significance and research process of the study, and a consent form was attached. If parents were willing to participate in the study, they were asked to sign the consent form and scan the QR code to fill in the questionnaire, including DCDQ, the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-VI and other personal information. All questionnaire contents were only accessible to research team members, and the researcher's name and telephone number were provided in case parents had questions. A total of 2,761 children and their parents volunteered to participate in this study. Children were screed using the Developmental Coordination Disorder Questionnaire (DCDQ) . Teachers selected those children with probable DCD but without any intellectual or cognitive impairment. These children were then tested using the Movement Assessment Battery for Children, 2nd edition. Finally, 116 pDCD children were randomly divided into a training group (TG, mean age 10.67 ± 1.25 years, 50 boys and 8 girls) and a control group (CG, mean age 10.27 ± 1.04 years, 48 boys and 10 girls) and gender matched typically developing (TD, mean age 10.35 ± 1.87 years; 48 boys and 12 girls) controls were included in the study. TG and TD will receive an additional 8 weeks of physical training intervention, while CG will not participate in the physical training intervention.

Eligibility Criteria:
Inclusion Criteria:

* DCDQ scores as follows: (8-9 years: \< 56 points; 10-12 years: \< 58 points)
* one subitem of the MABC-2 rank below 15%
* age 9 to 11 years old (elementary school age)

Exclusion Criteria:

* Children with other mental illness who are unable to exercise
* IQ \>90
* ADHD
Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.

This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cervical cancer
* Squamous, Adenosquamous, Adeno carcinoma cell type
* International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
* Gynecologic Oncology Group (GOG) performance status 0 - 2

Exclusion Criteria:

* Previous history of chemotherapy or radiation
* History of other cancer
* Hypersensitivity to platinum agents
* Pregnancy
* Serious medical disease
Pain in Endometriosis And the Relation to Lifestyle

The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet and cognitive behavioral therapy (CBT) on pain symptoms, health related quality of life and the effect on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome in women with endometriosis.

Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy or CBT alone.

Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines or CBT or a combination of both interventions for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet.


Eligibility Criteria:
Inclusion Criteria:

* Age from 17 years
* Premenopausal status
* Body Mass Index (BMI) 18-30 kg/m2
* Ability to understand the explanation about the diet intervention (DI) and CBT
* Willing to follow the DI
* Willing to continue their use of food supplements
* Willing to undergo CBT
* Willing to collect menstrual effluent, and therefore willing to have two stop weeks from hormonal contraception (if applicable) during the study period.

Exclusion Criteria:

* Recurrent miscarriages (\> 2)
* Eating disorder
* Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease
* Self-reported celiac disease
* Vegan diet
* Smoking
* Use of immunosuppressive or psychotropic medication
* Score on FFQ \> 120
* Diagnosed with severe mental disorder currently requiring treatment by psychiatrist
* NRS average score below 4 during the last month
* Participation in another intervention study
* Unable to speak Dutch or to understand the intervention
* Need for surgery during the participation in the study
* Serious pain (NRS \> 4) from other origin than endometriosis
* Pregnant
* Scalp hair shorter than 4 cm
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).

No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.

The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.

All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.

Note: This protocol posting deals with the objectives \& outcome measures for the booster phase of the study. The objectives \& outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)

Eligibility Criteria:
Inclusion Criteria:

* Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study

Exclusion Criteria:

Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

* History of measles, mumps, rubella or varicella.
* Previous vaccination against measles, mumps, rubella or varicella.
* Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
* Patients receiving immunosuppressive therapy.
* Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Individuals with primary and acquired immunodeficiency states.
* Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* Individuals with active tuberculosis.
* Acute disease at time of booster vaccination
Intron A for the Treatment of Hypertrophic Scar

This study assesses the intervention with antifibrotic agents, specifically interferon (IFN) to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic scar are randomly assigned to either an intervention IFN group or a placebo control group by subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter, standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability, itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six month treatment period.

Burn patients being followed and treated in the Outpatient Burn Clinic with large areas of HTS are approached to participate in the study. Patients who agree to participate and who have signed an informed consent are entered into the trial.

Pre-treatment evaluation and monthly examinations include:

* standardized photographs of scar
* scar volume
* Vancouver Burn Scar Assessment (VBSA)
* blood work (TGF-beta, histamine)
* urine collection (histamine)
* 6mm punch biopsy of HTS and adjacent normal skin (every two months)

Patients are randomized to received with placebo or Intron A 1x106 IU a day for 7 days, then 3x106 IU 3 SC, three times a week for 23 weeks.

Eligibility Criteria:
Inclusion Criteria:

* burns \> 5% tbsa
* informed consent
* no prior exposure to interferon or other cytokines

Exclusion Criteria:

* history of cardiac or CNS disorder or disease
* autoimmune disease
* immunodeficiency
* abnormal renal or hepatic function
* pregnancy
* serious intercurrent illness
* active infection
* malnutrition
* active drug or alcohol abuse
Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine

The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.

The main objective of this study is to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per week in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years)
* HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years.
* Standard plasma viral load below the limit of detection for at least 2 years.
* CD4 count above 350/mm3 at the time of the consideration for the study.
* Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug.
* Patients should be given written informed consent
* In the opinion of the investigator, be able to follow the design of the protocol visits

Exclusion Criteria:

* Patients who have experienced virologic failure prior to any antiretroviral regimen
* Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine
* Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study
* Any contraindication to study drug
* Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient
* Uncontrolled preexisting psychiatric illness
* Any current sign of alcoholism or other drug use.
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B

To evaluate the effect of ARC1779, a therapeutic oligonucleotide ("aptamer") in patients with Type2B von Willebrand Disease.

ARC1779 will be investigated in an open-label, uncontrolled study in up to 3 vWD-2B patients. Patients with vWD-2B will be screened for eligibility based primarily upon a single major criterion, i.e., presence of any degree of chronic thrombocytopenia. Eligible patients will be treated by intravenous infusion of ARC1779 for 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients;
* ≥ 16 to ≤ 75 years of age;
* Diagnosis of VWD-2B according to national expert guidelines for the USA \[1\] and Europe \[2\] based on medical history and findings from a matrix of laboratory assays which may include: platelet count, concentration of VWF antigen (VWF:Ag), VWF ristocetin cofactor activity (VWF:RCo), Factor VIII (FVIII) activity, ristocetin-induced platelet aggregation (RIPA), platelet function analyzer (PFA-100®) closure time, bleeding time (BT), VWF multimer test, VWF: platelet-binding (VWF:PB) activity, etc.)
* Thrombocytopenia (defined as a platelet count \< 100 per nL on at least 2 occasions within the month preceding enrollment;
* Female patients of reproductive age must be enrolled within 1 to 7 days of the cessation of preceding menses;
* Female patients must be non-pregnant and willing to use effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment;
* Male patients must agree to use a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment;
* All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.

Exclusion Criteria:

* Patients with a possible co-existing or alternative hematologic diagnosis which can account for the laboratory findings of thrombocytopenia, etc.;
* Any significant medical co-morbidity which would pose an increased risk of bleeding (e.g., recent trauma or surgery, a history of gastrointestinal ulcers, etc.) or thrombosis (e.g., history of recurrent deep vein thrombosis (DVT).
The Significance of Sentinel Node Analysis in Colon Cancer

This study is for the patient with colon cancer, who is going to have colon cancer surgery. The purpose of this research study is to examine a specific lymph node, called the sentinel node. Lymph nodes are located throughout your body and cancer may spread by means of those lymph nodes. The sentinel node is the one located closest to your tumor. This study will find out if examining the sentinel node can help to predict disease progression. Since the value of this exam is unknown, taking part in this study will not change your clinical care.


Eligibility Criteria:
Inclusion Criteria:

* All patients must consent to participate in study
* Patients will be tracked for five years
* A blood test (CEA) will be collected every six months
* A CT scan will be performed annually
* A colonoscopy will be performed at 1 and 5 years post-surgery
Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship

The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economic and mental-health challenges, especially for vulnerable populations such as pregnant and post-partum females. In this study, we aimed to evaluate the relations between the fear of COVID-19 and postnatal depression symptoms.

This is a multicenter prospective cohort study of childbearing women during COVID-19. Participants completed a comprehensive online questionnaire including demographic, socioeconomic, obstetric, and postnatal mental-health questionnaires. Data were verified with each center's perinatal database and information regarding physiological stress during pregnancy/birth was also collected. Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale and postnatal depression was evaluated using the EPDS. Pre-existing maternal disability was defined as prior physiological or psychological chronic health condition.

Eligibility Criteria:
Inclusion Criteria:

* women who delivered during the Covid-19 pandemic at the site, since 01-March-2020

Exclusion Criteria:

* women age 18 and below
* Gestational age under 34 weeks
* Intra Uterine Fetal Demise
* Ante-partum Fetal Demise
* Maternal post partum death
Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).


Eligibility Criteria:
Inclusion Criteria:

* Participation in the GHLIQUID-1517 trial
* Patients with SGA (small for gestational age) short stature that are still growing

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Diabetes Mellitus
* Patients with malignant tumor(s)
* Pregnant or likely to get pregnant
Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients

Biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab in psoriasis patients.

Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of ixekizumab (i.e. one loading dose of 2 subcutaneous injections (160 mg) at week 0, followed by one subcutaneous injection (80 mg) every 2 weeks for 12 weeks, and then one subcutaneous injections (80 mg) every 4 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards ixekizumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
2. Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

1. Participants who have currently a predominant nonplaque form of psoriasis
2. Participants who are pregnant, nursing or planning a pregnancy
3. Participants who are unable or unwilling to undergo multiple venapunctures
4. Participants who are treated according to a different dosing schedule than standard dosing of ixekizumab
Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples

The VALHUDES study is a Diagnostic Test Accuracy study that aims to document the clinical accuracy of hrHPV testing on urine samples, collected under standardised and optimised conditions, and on two types of vaginal self-samples and compare results with those from matching samples taken by a clinician.

The samples are collected from patients referred to colposcopy because of prior cervical abnormalities. The patient takes at home two urine samples with the Colli-Pee device (a device that allows to collect first-void urine), the day before the visit to the colposcopy centre. At the colposcopy centre, two vaginal self-samples are taken by the patient herself: one with a cotton swab and a second with a plastic brush. Finally, the gynecologist takes a cervical Pap smear with a Cervex-Brush Combi.

A real-time PCR test will be used to detect DNA of high-risk HPV types. It is possible that in the future also other tests will be validated on these samples. The colposcopy and histological findings will be used as the gold standard. The main purpose of the study is to assess the relative diagnostic tests accuracy of hrHPV testing on self- and urine samples compared to hrHPV testing on cervical samples taken by a clinician. Furthermore, the participating women will receive also a questionnaire which can give insights into the attitudes and preferences of the women with regard to the self-sampling devices.

Eligibility Criteria:
Inclusion Criteria:

* Women with previous abnormal cervical cancer screening test results
* Women between the ages of 25 and 64

Exclusion Criteria:

* Hysterectomised women
* Women with known pregnancy
* Non-consenting women
* Women that are not able to understand and to sign the informed consent
Nellix Registry Study: EVAS-Global

Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 18 years old
2. Subject has signed informed consent for data release
3. Subjects with with AAA and eligible for endovascular repair

Exclusion Criteria:

1. Currently participating in another study where primary endpoint has not been reached yet
2. Known allergy to any of the device components
3. Pregnant (females of childbearing potential only)
Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage

Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).

It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).


Eligibility Criteria:
Inclusion Criteria:

* patients at least 18 years old,
* willing and able to provide written informed consent,
* with documented atherosclerosis critical limb ischemia (pain rest and/or ulcer and gangrene manifestations)
* with hemodynamic measures (ankle pressure less than 50mmHg and/or TBI less than 30mmHg and/or TcPO2 less than 30 mmHg),
* followed or send to CHU Amiens Picardie, and eligible to chirurgical revascularization.

Exclusion Criteria:

* with non atherosclerosis arteriopathy,
* ineligible to the gold standard treatment such as the chirurgical revascularization,
* with life expectancy less than 3 months.