cyrilzakka/clinical-trials huggingface dataset:
Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)

The purpose of this research study is to help us learn if children with Autism Spectrum Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than children without ASD do. The investigators hope to learn if children with ASD and gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and aggression, more than children with ASD but no GI disorders do. The investigators want to learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children with ASD also have gastrointestinal disorders.

Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not identified by current diagnostic evaluation.

Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing children. The investigators anticipate that the proposed study will raise the standard of medical care for children with ASD by improving current methods of identifying GI dysfunction and determining whether there is a significant relationship between GI dysfunction and PB in this population.


Eligibility Criteria:
Inclusion Criteria:

* Children who are ATN Registry subjects between 2 and 17 years old (inclusive)
* Meet criteria for an ASD according to the diagnostic measures Autism Diagnostic Observation Schedule (ADOS) and DSM-IV Symptom Checklist, which were conducted at an established ATN center within the last 18 months

Exclusion Criteria:

* Diagnoses of Rett Syndrome, Childhood Disintegrative Disorder, or other genetic disorders (e.g. Fragile X, Down syndrome, etc.).
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 12 years of age at the time of informed consent.
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of 1 allo-SCT (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells).
* Adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: ANC ≥ 0.75 × 109/L and platelet count ≥ 20 × 109/L.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis.
* Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication.
* Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1.
* Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry.
* Active symptomatic myositis.
* Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis. Participants with CrCl of 30 to 59 mL/min on treatment with fluconazole are not eligible.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to randomization.
* Pregnant or breastfeeding.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Enjoy Your Bump : Online Cognitive Behavioural Therapy in Pregnancy

A feasibility study evaluating how acceptable women experiencing low mood or anxiety during their pregnancy find an online Cognitive Behavioural Therapy course called 'Enjoy Your Bump'. This project will also begin to explore the effectiveness of this programme as a low intensity self-help intervention for mild to moderate depressive symptoms during pregnancy.

'Enjoy Your Bump (EYB)' is an online life skills course based on Cognitive Behavioural Therapy (CBT) principles which has been designed to specifically support women in the antenatal period. A survey of women and health professionals has demonstrated that this is a resource that both groups find acceptable. The aim of this quasi-experimental feasibility study is to evaluate the user experience and efficacy of this online programme as a non-pharmacological, low intensity intervention for women experiencing mild-moderate depressive symptoms in pregnancy. This will be achieved by measuring depression and anxiety as well as measures of attachment to the developing baby, pre and post intervention. It is hoped the results from this study will help inform whether this is a resource that should be made more widely available to women in the National Health Service (NHS). It is hypothesised that the 'Enjoy Your Bump' will be an acceptable and effective intervention for women experiencing mild to moderate depressive symptoms in the antenatal period.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Mild-moderate chronic perinatal mental health identified by a score of 2 or higher on PHQ-2 and/or GAD-2.
* 16+0 to 32+6 weeks at recruitment

Exclusion Criteria:

* Severe perinatal mental health problem such as schizophrenia, bipolar disorder, substance abuse/dependence, active risk of self-harm.
* Already receiving psychological therapy.
* Insufficient English language to engage with intervention or complete questionnaires.
* Unable to give informed consent.
* Illiterate
* No internet access
* Taking part in another current research project focused on mental health.
Diagnostic Accuracy of Bedside Ultrasonography in the Management of the Shoulder Dislocations

Shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. In the standart management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. Ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.

Shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. In the standard management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. Ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.Recent literature has demonstrated the superiority of point-of-care ultrasonography (POCUS) in detecting both anterior and posterior shoulder dislocations, making it another rapidly evolving tool to improve accuracy, decrease error, and improve efficiency. The aim of the study is to evaluate the accuracy and clinical usability of ultrasonography in the management of the shoulder dislocations.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 14 years with suspected shoulder dislocation
* Accept to be participating

Exclusion Criteria:

* Patients under 15 years of age
* Diagnosed before pocus evaluation
* Open fracture dislocations of the shoulder
EFFECT of HAMMAM EXPERIENCE on GENERAL HEALTH and PERCEIVED WELL-BEING

The main objective of this study is to analyze the effect of a Hammam experience, a massage experience and a placebo in a healthy general population on their general health and perception of well-being, assessed with biophysiological, physical and psychoemotional markers, and its impact on chronic stress. Our hypothesis is that the Hammam experience will produce a more favorable acute (just after the experience) and subacute (24 hours after the experience) response on the study variables than the other interventions with at least a moderate effect size.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (50%) 25-65 years old
* No metabolic risk.
* Resident in the province of Granada.
* Socio-economic level: medium-high
* Experience in self-care
* Spanish level C2

Exclusion Criteria:

* Pregnancy
* Participation in treatments and relaxation techniques or taking medication (anxiolytics) frequently (≥ 1 per week) in the last 12 months
* Medical situations limiting participation in the study: acute musculoskeletal pathologies (fractures, wounds, etc.) or local inflammatory processes, diagnosed psychiatric disease, vascular diseases (thrombosis), contagious diseases, fever, thermoregulation problems, incontinence, craniocerebral trauma or infarction (\< 6 months), thermal allergies, hypertension, or any uncontrolled systemic disease).
Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome

The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting.

The investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week \< 37) in PCOS women diagnosed according to Rotterdam 2003 consensus criteria, with singleton pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45 years
* PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion
* Mode of conception: Any
* Single, viable fetus, diagnosed by vaginal ultrasound
* Gestational week at inclusion: week 6 + 0 to 12 + 0
* Wash out for metformin: at least 7 days
* Able to communicate fluently in the official language at the study cite or English

Exclusion Criteria:

* Any type of diabetes (except GDM in former pregnancy)
* Known liver disease or ALAT \> 100 IU/L
* Known kidney disease or creatinine \> 110 μmol/L
* Known alcohol or drug abuse
* Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidine, anticoagulation therapy
* Unsuitable for participation of other reasons
A Case Series Study of Negative Pressure Platform Wound Device

This primary case series study will demonstrate the safety and feasibility of the NP-PWD technology and treatment protocol to promote healing of surgical incision healing. In a first use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT), this project will gather data from patients with elective surgical incisions, with the intention to evaluate the NPWT capability for future use in more tenuous situations of wound closure.

A case series study of 10 subjects will be conducted by enrolling patients who are scheduled for elective surgical incisions. Patients will be screened for inclusion criteria and asked to consent to participate in the study for single application treatment with the NP-PWD for 3-6 days. Initial evaluation of the incision would occur on Day 0, including screening, pre-procedure evaluation, measurement and photography of the closed surgical incision. Follow up data is then gathered Day 3-6 with removal of the NP-PWD, surgical incision assessment and photography, and assessment for adverse effects. Day 9-14 follow up include the same assessments of progression of wound closure. Gathered clinical data of the 10 subjects will be used to evaluate the safety in using the NPWT device for effective wound healing.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18-85 years of age.
2. Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.

Exclusion Criteria:

1. Active infection as judged by the Investigator
2. Inability to give informed consent
3. Active malignant disease or subject is less than one year disease-free
4. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
5. Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with wound healing
6. On any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
7. Pregnant at enrollment
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041

A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical \[99mTc\]MDP scan

Exclusion Criteria:

* Estimated creatinine clearance (GFR) \< 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Online Flipped Learning in Nursing Student

Cancer is one of the major health problems facing Turkey and the world. One of the methods used to treat cancer is chemotherapy. During this treatment period, some side effects may develop in patients. These developing symptoms can be managed with effective nursing interventions, which in turn can increase the patient's quality of life. Managing these symptoms is among the responsibilities of the nurse. The nurses' ability to effectively manage the side effects of chemotherapy depends on gaining specific knowledge, attitudes, and skills during their vocational training and the development of problem-solving and critical thinking. The research was carried out to examine the effect of chemotherapy symptom management education based on the online flipped learning model on the achievement, critical thinking, and self-directed learning of nursing students.

Background: The online flipped learning method is an innovative learning approach that helps develop critical thinking and self-directed learning skills and increases students' interest in the course Aim: The research was carried out to examine the effect of chemotherapy symptom management education based on the online flipped learning model on the achievement, critical thinking, and self-directed learning of nursing students.

Methods: This research is a randomized controlled trial. The sample consisted of 68 students divided into experiment and control groups. The training program based on traditional learning was applied to the control group, online flipped learning was applied to the experiment group, and each group received training on chemotherapy symptom management for one hour per week for six weeks. The researchers evaluated the results by applying the Chemotherapy Symptom Management Knowledge Test (CSMKT), the Marmara Critical Thinking Dispositions Scale (MCTDS), and the Self-Directed Learning Skills Scale (SDLSS) to the control and experiment groups before, right after the training, and one month after the training.

Eligibility Criteria:
Inclusion Criteria:

* Second-year students who took the course basics of nursing, internal medicine nursing, physiology, pathology, and computer courses and were able to actively use the computer and voluntarily participated in the research were included.

Exclusion Criteria:

* Students in other classes
* Those who did not volunteer to participate in the study
Postmenopausal Women With Vaginal Microbiota

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities in postmenopausal women.

Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Owing to the decrease of estrogen level and cervical atrophy in postmenopausal women, cervical cytology is more prone to abnormal changes than in premenopausal women. Clinically, cervical lesions in elderly women are easily neglected. Therefore, cervical cancer in the elderly is usually found in advanced stage, with poor prognosis and more complications of treatment. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions in menopausal women. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

Eligibility Criteria:
Inclusion Criteria:

* Those are aged 20 to 75 years old, have had vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.

Exclusion Criteria:

* Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
Safety and Efficacy of I-020502 in Meshed Skin Autografting

This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent by the patient or his/her legal representative.
2. Male or female, aged ≥ 18 years.
3. Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
4. Patients with burn wound(s) between ≥ 5 % and ≤ 50 % TBSA.
5. Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 cm2.
6. Patients who are willing to comply with treatment applications and instructions by the protocol.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding.
2. Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
3. Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
4. Electrical and/or chemical burns.
5. Patients that are judged to have significant pulmonary compromise.
6. Transcutaneous tissue oxygenation \< 90%.
7. Clinically significant infections at wound sites.
8. Clinically significant systemic infections.
9. Suspicion or presence of active systemic or local cancer or tumor of any kind.
10. Patients with known immunodeficiency disorders, either congenital or acquired.
11. Patients with vascular or skin disorders that directly affect the designated wound site.
12. Patients with Diabetes mellitus.
13. Patients with chronic malnourishment.
14. Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery.
15. Any other acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to skin mesh grafting and study participation.
16. Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.
Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children

The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination.
* Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects who have received three documented doses of hepatitis B vaccine.

Exclusion Criteria:

* Same sex twins.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures.
* Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2.
* Acute disease and/or fever at the time of enrolment
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
* Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Administration of immunoglobulins and/or any blood products within 1 month preceding the first dose of study vaccine or planned administration during the study period.
* Child in care.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.