cyrilzakka/clinical-trials huggingface dataset:
Autism, Sport and Society: Conversations With Parents

In order to examine the experience of children with ASC in physical activity at home, at school, and in the local community, parents of children with ASC will be asked a number of open ended interview questions. To see if these experiences are unique to parents of children ASC, parents of non-ASC children will also be interviewed to allow for these perspectives to be compared and contrasted.

Background:

77% of boys and 80% of girls aged 5-15 in the UK fall below the national physical activity guidelines of 60 minutes of moderate to vigorous activity per day.

Research shows children with an Autism Spectrum Condition (ASC) are even less physically active than their neurotypical, age related peers and as a result are at increased risk of cardiovascular diseases, metabolic disorders, low self-esteem and depression. This physical activity gap has been shown to increase as children get older.

If a gap between the activity levels of children with ASC and the so called 'normal population' exists, there are a number of possible explanations for why this might be. Research points to either some facet of the autism spectrum causing difficulties engaging with a certain feature of a physical activity i.e. the physical environment in which activities take place which is difficult from the sensory point of view (noisy, busy, brightly lit) or lack of specific provision tailored towards children with ASC readily available in the local community. With repeated negative experiences, children and adults with ASC may come to believe these opportunities are 'not for them'.

To date, there has been limited research conducted on the attitudes of young people with ASC to sport and physical activity. The research that has been conducted has mainly focused on interviewing the young people themselves to gather their perspectives. However, little is known about their parent's perceptions of sports participation or if parents value being physically active themselves. This is of particular interest as parental modelling has been shown to be a predictor of children's PA behaviours with a positive correlation between adult and child PA levels. Furthermore, parents may offer additional insights into barriers of physical activity beyond that of their children and this information could help to advise the sports sector on how clubs and leisure centres could offer a better experience for children with ASC.

In order to examine the experience of children with ASC in physical activity at home, at school, and in the local community, parents of children with ASC will be asked a number of open ended interview questions. To see if these experiences are unique to parents of children ASC, parents of non-ASC children will also be interviewed to allow for these perspectives to be compared and contrasted.

Eligibility Criteria:
Inclusion Criteria:

* Parent of child with an Autism Spectrum Condition aged 5-15
* Parent of child aged 5-15

Exclusion Criteria:

* Parents with children with autism older than 15 or younger than 5
* Parents of children older than 15 or younger than 5
Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer

This study is being done to help researchers learn more about and successfully diagnose cancer using blood samples and tissue samples from surgeries in patients with suspicious thyroid nodules or thyroid cancer. Diagnosing cancer in this way, as opposed to biopsies, may be less invasive to the patient. Analyzing blood and tissues samples may also help researchers to differentiate non-cancerous tumors from thyroid cancer and detect high-risk mutations to guide treatment.

PRIMARY OBJECTIVE:

I. Sensitivity and specificity of molecular profile of thyroid derived extracellular vesicles (EVs) as predictor of thyroid cancer.

SECONDARY OBJECTIVES:

I. Quantity of thyroid derived EVs captured in various stages of thyroid cancer.

II. Whether quantity of EVs decreases in proportion to response to therapy in thyroid cancer patients.

III. Optimal ribonucleic acid (RNA)/deoxyribonucleic acid (DNA) panel in thyroid tumor derived EVs to diagnose thyroid cancer.

OUTLINE:

Patients undergo collection of blood samples on the day of surgery following anesthesia but prior to incision and approximately 4-6 weeks after surgery. Patients who undergo remnant ablation after total thyroidectomy with radioactive iodine have an additional blood sample collected. Patients also undergo collection of tissue samples following surgical resection of the thyroid. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and older
* Consented for thyroid surgery for thyroid cancer or indeterminate thyroid nodule

Exclusion Criteria:

* Patients with concurrent malignancy
A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults

To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.

A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.

Eligibility Criteria:
Inclusion Criteria:

Criteria for Healthy Adults:

* Informed consent has been obtained
* Subject is in general good health
* If female, then postmenopausal
* If female, then not pregnant
* If male, must be surgically sterile or both he and the partner must use birth control
* Body Mass Index is 18 to 29, inclusive

Criteria for HCV-infected Adults:

* Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
* Subject is infected with HCV genotype 1 with detectable HCV RNA of \> 50,000 IU/mL

Exclusion Criteria:

Criteria for Healthy Adults:

* If female, then pregnant or breast feeding
* Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
* Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
* Alcohol intake within 48 hours prior to study drug administration

Criteria for HCV-infected Adults:

* Need for prescription or over-the-counter medication
* Child Pugh score \> 5 or clinical evidence of cirrhosis
* No other cause for liver disease other than HCV infection
* ALT or AST \> 4 x ULN
* Creatinine \> ULN
* Clinically significant abnormal ECG
* HCV RNA levels above the level of assay quantification
* TSH values outside normal range
PROMIS and Patient Satisfaction

The primary aim for this study is to determine if patient satisfaction and experience is improved with the active discussion/inclusion of PROMIS scores during new foot and ankle clinic patient visits.


Eligibility Criteria:
Inclusion

* Patients over the age of 18
* New patient at the foot and ankle clinic

Exclusion

* Patients under the age of 18
* Patients presenting for a Follow up visit
Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension

The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older at the Screening Visit;
* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
* Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
* Qualifying IOP in the study eye;
* Best-corrected visual acuity of approximately 20/80 Snellen in each eye

Exclusion Criteria:

* Sensitivity or allergy to travoprost or timolol;
* Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
* History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
* History of cerebrovascular insufficiency;
* Any form of glaucoma other than open-angle glaucoma
* Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
* Non-qualifying prior surgeries or procedures in either eye
Microprocessor Knees in Early Rehabilitation

High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury.

The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, Unilateral transfemoral amputation, Between 4-16 weeks post amputation, Deemed ready for prosthetic fitting by a physician, No current or prior transfemoral prosthetic use, Able to read, write and communicate in English, Weight 125kg (275lbs) or less

Exclusion Criteria:

* Diagnosis of health condition (i.e. advanced cardiac disease, severe or end-stage pulmonary disease or severe dementia) that prevents safe prosthesis use or community ambulation with prosthesis, Weight greater than 125kg (275lbs)
Investigation of the Development of Infants with a History of Colic

The aim of this study was to evaluate the motor development, sleep characteristics and sensory processing skills of infants with a history of colic and to compare them with their peers without a history of colic.

Infantile colic (IC) is a condition characterized by incessant crying and restlessness in healthy, normally growing infants. Prolonged and intense crying in an otherwise healthy infant is a significant challenge for families. Infantile colic was first described by Wessel nearly 50 years ago. According to Wessel, episodes of crying and restlessness that last three hours a day, at least three days a week, for a minimum of three weeks are classified as infantile colic.

The long-term effects of IC include an increased risk of behavioral problems in children. A meta-analysis found that children with a history of excessive crying are more likely to develop general behavioral problems, internalizing problems (such as anxiety, depression, or withdrawal), and externalizing problems (such as aggression or disruptive behavior). Additionally, these difficulties are exacerbated by adverse family environments, including parental stress or poor maternal mental health. As these infants approach preschool age, they may struggle with sustaining attention, engaging in reciprocal play interactions, and tolerating change and separation.

The first two years of life are a critical period for supporting infant development, as brain growth and neural plasticity progress rapidly. When children reach 10-15 months of age and begin exploring their environment through walking and trial-and-error experiences, assessing sensory processing skills becomes particularly important. At this stage, children actively expand their motor repertoire, especially while developing skills such as crawling and walking. However, a review of existing studies reveals a lack of evaluations conducted during the toddler, preschool, and school-age periods. Furthermore, most studies focus primarily on behavioral problems and attention deficit hyperactivity disorder (ADHD). For this reason, 10-15-month-old infants were included in this study to assess early-stage development.

Eligibility Criteria:
Inclusion Criteria:

* Term infatns born at term
* Infants diagnosed with colic
* Post-term infants between 10-15 months

Exclusion Criteria:

* Premature infants
* Infants with congenital malformations
* Infants diagnosed with metabolic, neurological and genetic diseases
* Children whose parents do not volunteer for the study
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment

Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins


Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to understand the study procedures, agree to participate, and give written consent.
* Patients must be able to follow the study medication regimen.
* Patients with inflammatory process in superficial veins for more than 72 hours.
* Presence of symmetric lesions to compare one side to the other.

Exclusion Criteria:

* Pregnancy or risk of pregnancy.
* Lactation.
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* Any alteration at other deep veins.
* History of atopy or allergic diseases.
* History of allergy to any component of the formulations.
* Other conditions considered by the investigator as reasonable for non-eligibility
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

The investigators conducted a randomized trial to study how well multi-day methotrexate protocol works compared to biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. It is not yet known whether multi-day methotrexate protocol is as effective as biweekly single-dose actinomycin D protocol in treating patients with gestational trophoblastic neoplasia.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:

  * Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
  * Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
  * Histologically proven choriocarcinoma
* Stage I - III disease
* WHO risk score 0-4
* No prior chemotherapy for gestational trophoblastic neoplasia
* Signed informed consent
* Performance status - GOG 0-2
* Laboratory examination： WBC≥3.5×10(9)/L, Granulocyte count≥1.5×10(9)/L, Platelet count≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Creatinine≤ normal。 Fertile patients must use effective contraception during and for one year after study entry

Exclusion Criteria:

* Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
* primary choriocarcinoma
* WHO risk score \>4
* Previous MTX treatment for suspected ectopic pregnancy
* With severe or uncontrolled internal disease, unable to receive chemotherapy;
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events

Several factors are considered as the key indicators of quality colonoscopy, including endoscopist experience, withdrawal time, and quality of bowel preparation (BP). A number of laxatives are currently used as BP, and these are mainly based on PEG agents that differ for the volume and the addition of adjuvants. Several trials have demonstrated the efficacy and safety of low volume 2L-PEG based regimens compared with high volume PEG regimens and non-PEG agents. However, for low-volume 1L-PEG plus ascorbate (1L-PEG-Asc) only the data from registration trials are available, and none of these have been performed in an "open access" colonoscopy booking system. The aim of our study was to evaluate the safety and tolerability of 1L-PEG-Asc compared to 2L-PEG plus ascorbate (2L-PEG-Asc) in an "open access" booking system.

All patients who underwent "open access" colonoscopy in our Unit from January 2019 to September 2020 were evaluated as part of a quality improvement project. Only patients taking 2L-PEG-Asc and 1L-PEG-Asc were enrolled in this study. Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. Tolerability was evaluated as the compliance to full BP intake

Eligibility Criteria:
Inclusion Criteria:

* From January 2019 to September 2020, data from all consecutive adult (aged ≥ 18 years old) patients who underwent "open access" colonoscopy performed in our Digestive Endoscopy Unit (which is based in the Hospitals of Carpi, Castelfranco Emilia, Mirandola, Pavullo and Vignola) were collected using an electronic reporting system

Exclusion Criteria:

* Pregnant of breastfeeding patients
Retrospective Study in Patients Who Have Had a Difficult Intubation.

The investigator wants to investigate if there is an increased risk of postoperative pulmonary problems in patients who have had an intubation where there was need for more than a laryngoscope.

A difficult intubation is defined as an intubation in which more than a laryngoscope was needed.

Afterwards patient data retrieved from the Clinical Work Station: age, type of operation and time, date, type of anaesthesia, de tools needed for intubation, time needed for intubation and anaesthesia.

In the Clinical Work Station of the Hospital the investigator will search for the following data in these selected patients: preoperative comorbidities, home medication, type of postoperative pulmonary problems and the treatment that was given, time of hospital stay and which department the patient stayed.

Patients with a difficult intubation will be linked to a patient with a corresponding medical history and type of operation but without a difficult intubation. The investigator will look for the same parameters of these patients in the Clinical Work Station.

By means of an odds-ratio the relative risk of a pulmonary complication after a difficult intubation in connection with an easy intubation with different variables can be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Every patient who had an intubation where another device than a laryngoscope was necessary

Exclusion Criteria:

* N/A
Probiotic Bacteria to Infants With Atopic Dermatitis

The objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated.

The aim of the study is to investigate whether two different probiotics influence the clinical and subjective symptoms in infants with Atopic Dermatitis (AD). The influence on the immunologic status and the intestinal microflora, inflammation and permeability will also be investigated.

Sixty two infants (6 to 24 months of age) suffering from AD will be randomised in 3 groups receiving either Lactobacillus acidophilus NCFM (1x10\^10 Colony forming units), Bifidobacterium lactis Bi-07(1x10\^10 Colony forming units) or placebo every day for 8 weeks.

At the beginning and at the end of the study the following analyses will be made:

1. SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms.
2. Blood samples will be drawn to examine:

   * Immunoglobulin E (IgE), total and specific for egg and milk.
   * Eosinophil Cation Protein (ECP)
   * Interleukin-10 (Il-10), Interleukin-12 (Il-12) and Interferon-gamma (IFN-gamma)
3. Fecal samples will be collected to examine:

   * Calprotectin (intestinal inflammation)
   * Bacterial Deoxyribonucleic acid (DNA) will be extracted in order to perform Polymerase chain reaction (PCR) analysis.

Eligibility Criteria:
Inclusion Criteria:

* Atopic dermatitis

Exclusion Criteria:

* Chronic diseases other than atopic dermatitis
* Chronic medication
Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.

The interventricular synchrony is one of the components of a proper cardiac function. When there is no synchrony -as in left bundle block (LBBB)- the clinic consequences should have little importance in patients with a healthy heart or a great importance in patients suffering heart failure (HF), specially in those with severe grade of HF, the benefit of cardiac resynchronization by pacing both ventricles or left ventricle (LV)should means healthy improvement in patients. All previous studies done in HF, are in patients with symptomatic HF. The importance of stop progression of latent HF in patients with asymptomatic ventricular dysfunction (VD)in permanent pacing indication patients. Pacing may accelerate HF progression by dissincronyzing ventricles. ACE inhibitors studies in asymptomatic VD gave positive results.

The PreVent-HF is an international, multicenter, prospective, randomized, single-blinded pilot trial specifically designed to evaluate as main objective the progression of VD in permanent pacing population.

Eligibility Criteria:
Inclusion Criteria:

* Meet Class I and/or Class IIa implantation criteria for permanent cardiac pacing according to the guidelines given by the American College of Cardiology (ACC)/American Heart Association(AHA).

Exclusion Criteria:

* Expected ventricle stimulation \<80% of the time
* Impossibility of dual chamber stimulation in the absence of AF
* Severe heart failure (NYHA Functional class III-IV) previous to indication for pacing device implant
* Patient needs revascularization within 3 months
* Myocardial infarction in the last 3 months
* Cardiac surgery performed in the last 3 months
* Hypertrophic cardiomyopathy
* Constrictive pericarditis
* Bad echo window
* Previous system implanted (ICD or pacemaker)
* Aortic stenosis
* Patient has a mechanical right heart valve
* Patient \<18 years
* Pregnancy
* Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation
* Life expectancy \<1year
* Patient is unwilling or unable to cooperate or give written informed consent.
* Patient is or will be inaccessible for follow-up at the study center.
* Patients who are participating or planning to participate in other clinical trials during the clinical study
Retrospective Evaluation of Liposarcoma

Retrospective Evaluation of Survival after Liposarcoma


Eligibility Criteria:
Inclusion Criteria:

* Patients with Liposarcoma treated surgically at our clinic

Exclusion Criteria:

* N/A