cyrilzakka/clinical-trials huggingface dataset:
Early Detection of Autism Spectrum Disorder in Children

Rationale: Autism Spectrum Disorder (ASD) is defined by deficits in social interaction and communication identified before the age of 3 years. Modified Checklist for Autism in Toddlers (M-CHAT) is a sensitive tool for ASD screening in children 16-23 months. A limited number of studies with a small number of patients have documented the developmental profile of children with ASD during infancy. Retrospective evaluations of videotaped behavior of children with ASD at 8 months and at 12 months identified early signs of ASD. A few studies found early signs of ASD during infancy in siblings of autistic children. Data documenting the age of onset and regression in ASD is controversial and limited. No large prospective studies documented the specific developmental profile of children with ASD starting at 6 months of age. Defining a specific autistic pattern on a developmental screening test could help identify infants at risk for ASD and improve their outcome through earlier diagnosis and treatment. More recently, genetic tests have been shown to aid in early identification of ASD which facilitates earlier intervention. Genetic testing among siblings of children with autism can aid in identification of autism or other related disorders in the siblings.

PURPOSE: The purpose of this study is to learn about the early signs of autism in siblings of children with autism spectrum disorders.

* The investigators will enroll siblings of children with ASD. Those siblings who completed the Red Flags for Communication scale (RFC) at 6 months and/or at 12 months and failed the RFC at 12 months will be given a genetic screening test.
* It is the investigators goal to define a specific autistic pattern on a developmental screening test that could help identify sibling infants at risk for ASD and improve their outcome through earlier diagnosis and treatment and to evaluate if the results of the clinical screening test will correlate with the results of the genetic screening test.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be a sibling of a child with a previous expert clinical diagnosis of Autism Spectrum Disorder.
* Subjects will be included for the genetic test if he/she meets the following criteria:

  * At 12 months of age he/she failed two or more items on the RFC with at least one failed critical item
  * They have no significant known hearing, vision or motor impairment that will impact on their ability to perform on developmental assessments

Exclusion Criteria:

* Those children who do not meet the inclusion criteria
* Those who do not speak English will be excluded from this study.
Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity

Up to date, devices capable of delivering controlled, calibrated, non-contact cold air stimuli in a MR environment are unavailable for quantitative sensory testing. This project therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold air stimulation device that produces air puffs in a broad flow and cold temperature range. By means of this device, detailed psychophysically testing and subsequent brain scanning of dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Age and between 18 - 60

Exclusion Criteria:

* Caries
* Defective restorations
* Full crowns
* Orthodontic bands
* Bleeding on probing and periodontal pockets deeper than 3 mm
* Subjects with gross periodontal disease or treatment of periodontal disease in the past 12 months.
Perception of Information and Quality of Life in Neuroendocrine Tumour on Lanreotide Autogel

The purpose of the study is to evaluate, in standard practice, the change in information received and perceived by the patient, extension of the disease and its treatment. These parameters will be evaluated by means of validated self-administered questionnaires that can be used in standard practice.


Eligibility Criteria:
Inclusion Criteria:

* Gastroenteropancreatic neuroendocrine tumor (GEPNET), histologically proven, grade

  1 or 2,
* Subject eligible for antitumor treatment initiation with lanreotide autogel\*, alone or combined with other therapies, selected freely and prior to inclusion in the study by the physician,
* Subject able to complete a self-administered evaluation questionnaire during initiation visit and liable to be seen again within 6 months of the initial visit based on the physician's usual practices
* Having consented in writing to his/her data being accessed for participation in the study.

Exclusion Criteria:

* Previously treated by lanreotide autogel
* Simultaneously participating in a clinical trial
99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis

This was a single-center, single-dose, study comprising a Proof of Concept (PoC) part and a subsequent Phase II part. The study was being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to image atherosclerotic plaque that might rupture and break off artery walls. This is caused by apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up on any artery in the body.

The sponsor decided to terminate the study earlier than planned due to strategic decisions to focus the AAA development portfolio on oncology theragnostics and not based on safety concerns. Novartis acquired Advanced Accelerator Applications SA.

Eligibility Criteria:
Inclusion Criteria:

For all participants:

1. Males and females age 18 years or greater
2. Able and willing to comply with the study procedures
3. Negative pregnancy test for women of childbearing potential at screening and on the day of administration of 99mTc-rhAnnexin V-128.

   For participants with carotid artery disease:
4. Evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years;
5. Evidence of 50% or more carotid stenosis in the most recent US imaging within 8 weeks prior to 99mTc-rhAnnexin V-128 administration

   For control participants:
6. No significant carotid artery disease on carotid ultrasound;
7. No clinically significant abnormalities in baseline laboratory values.

Exclusion Criteria:

1. Previous carotid stending, endarterectomy or stroke;
2. Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans);
3. Pregnancy or lactation;
4. History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment;
5. Know hypersensitivity to the investigational product or any of its components;
6. Claustrophobia or inability to lie still in a supine position;
7. Participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration;
8. Unwillingness to provide consent.
Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation

Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.


Eligibility Criteria:
Inclusion Criteria:

* Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
* Busulfan should be part of the preparative protocol

Exclusion Criteria:

* Known sensitivity or allergy to Busulfan
Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer

The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed nasopharyngeal cancer
* chemotherapy or radiotherapy naive (but, including patients completed 6 months before the enrollment)
* ECOG 0-1
* at least one measurable lesion

Exclusion Criteria:

* other cancer
* pregnat
* docetaxel hypersentitivity history
* severe heart or pulmonary disease
Skilled Nursing Facility At Home Trial

Skilled Nursing Facility at Home is a multicenter randomized control trial that aims to evaluate a home-based model of providing post-acute care (PAC). We will enroll 650 hospitalized patients who require rehabilitation and/or skilled-nursing support upon discharge and randomly assign them to an intervention (home-based PAC) or control arm (facility-based PAC). Our design includes two different health systems in Massachusetts: Baystate Health and UMass Memorial Health. We will perform 1:1 randomization between the intervention and control arm using a permuted block design, with stratification by clinical site and payor group. The primary outcome of the trial will be the difference in hospital readmission and mortality rates from the time of enrollment to 30 days after enrollment. Secondary clinical, functional, and cost outcomes include length of stay in PAC, difference in health-related quality of life (HRQoL), and healthcare cost and utilization.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Admitted to an inpatient unit OR receiving home health and requiring an escalation to skilled-nursing facility care
* Require post-acute care in a skilled nursing facility based on the clinical inpatient team's assessment (or, if the participant is coming from home, based on the home health team's assessment)
* Pass the home readiness assessment
* Reside within Greater Worcester or Greater Springfield

Exclusion Criteria:

* Inability to return to a home residence where care can be provided
* Inability for patient or their proxy to provide informed consent for the study
* Requires long-term care
* Requires palliative or hospice care
* On active chemotherapy
* Post-transplant surgery
* Requires hemodialysis
* Requires radiation therapy
* Requires two-person assist or mechanical lift
* Expresses unwillingness to be randomized to SNF OR SNF at Home care
* Considered clinically inappropriate by SNF at Home clinical team
Fibrin Sealant in Renal Transplantation

Background: Post-operative wound complications arise in as many as 50% of kidney transplant recipients. Fibrin sealants have been used in many areas of surgery in attempt to reduce the accumulation of post-operative fluid collections with varying success. The use of fibrin products has been proposed as a means of reducing local wound complications in the immunocompromised renal transplant recipient but as yet has not been studied.

Methods: 145 patients were enrolled and 141 patients were randomized (74 Tisseelä fibrin sealant, 67 No Tisseelä fibrin sealant) in a prospective manner to receive fibrin sealant or not at the time of their renal transplant. Patients were analyzed per the randomization assignment. The operating team was blinded to the decision until after the iliac fossa dissection was complete. The sealant was applied via aerosol to the iliac fossa and renal allograft hilum after completion of the neoureterocystostomy in 5 ml quantity. Clinical and radiographic data were reviewed through the usual 8-week follow-up transplant ultrasound. Patients in whom the peritoneum was entered were excluded from data analysis. The incidence of lymphocele, wound infection, dehiscence, clinically significant hematoma as defined by necessitating incision and drainage, and urine leak was recorded.


Eligibility Criteria:
Inclusion Criteria:

* All renal transplant recipients

Exclusion Criteria:

* Patients declining study
Hyaluronic Acid and Vaginal Distress

The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid in menopause women with vaginal distress for treatment vaginal distress.


Eligibility Criteria:
Inclusion Criteria:

* menopause
* vaginal distress
* no other therapy

Exclusion Criteria:

* vaginal infection
* Sjogren Syndrome
Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala

Hippocampus and amygdala are parts of the brain involved in the recognition of emotions, memories, memory, language ... It is therefore very important to protect them during irradiation of the brain.

The aim of this study is to evaluate cerebral irradiation with saving hippocampus and amygdala protects these brain functions in patients with small cell lung cancer (SCLC) Radiotherapy of the brain


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients with a limited SCLC demonstrated histologically responsive or stable to radiochemotherapy or patients with a histologically proven extended SCLC responding to chemotherapy.
* WHO Performance Index 0-1 and / or Karnovsky Index\> 70
* Possibility of long-term monitoring

Exclusion Criteria:

* Concomitant chemotherapy
* Impossibility of performing an MRI or CT without injection
* Presence of cerebral metastases
* History of cerebral irradiation at any time
* Patient suffering from severe collagenosis
* Patient with cognitive disorders with MMSE score \<24
The Importance of Physiotherapy After Separation Surgery in Pygopagus Conjoined Twins

Motor function delays are observed in pygopagus conjoined twins due to limited movement experience and deficits in proprioceptive sense. This study aimed to evaluate the neuromotor development of conjoined twins who acquired independent bodies, lives, and movements as a result of separation surgery, and to examine the effect of postoperative physiotherapy intervention on gross motor function.

The study included two cases of pygopagus conjoined twins who applied for separation surgery at Acıbadem Altunizade Hospital between 2021 and 2022. The twins were 9 months and 21 days old (A1-A2) and 23 months and 11 days old (B1-B2). After separation surgery, a conventional physiotherapy program was administered regularly for 3 months, 6 days a week, with two sessions per day, each lasting 45 minutes. The Bayley-III Developmental Screening Test (DST) was used to evaluate neuromotor development, while the Alberta Infant Motor Scale (AIMS) and the Gross Motor Function Measure-88 (GMFM-88) were used to assess gross motor development. Evaluations were performed preoperatively and at the 3rd postoperative month.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of pygopagus conjoined twins
* Having normal vital signs after separation surgery

Exclusion Criteria:

* Having a diagnosis other than pygopagus conjoined twin
* Abnormal vital signs after separation surgery
Optimizing Attention and Sleep Intervention Study

The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms.

The main aims are to:

Aim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD.

Aim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.

Sleep problems may be one mechanism through which young children may be at risk for developing ADHD, although first line ADHD interventions, including parent behavioral interventions (PBIs), do not address sleep. Investigators will test a modified version of a PBI to target sleep disrupting behaviors for children 3-5 years old at elevated risk for ADHD. The intervention will be delivered by behavioral health therapists embedded in pediatric primary care to increase families' access to intervention. This pilot effectiveness trial is the first step towards developing an early intervention targeting sleep as a mechanism to reduce the prevalence, symptoms, and impairments associated with childhood ADHD.

Eligibility Criteria:
Inclusion Criteria:

Parent/Caregiver:

* (1) Legal guardian is at least 18 years of age
* (2) Reads and speaks English

Child:

* (1) 3-5 years of age
* (2) Caregiver report of 4 or more ADHD symptoms
* (3) Caregiver reports child's sleep as a "moderate" or "serious problem"
* (4) English speaking
* (5) Child receives care from participating pediatric primary care office

Exclusion Criteria:

* (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)
* (2) Severe neurodevelopmental disorder
Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

Phase IIb, randomized, double-blind, placebo-controlled study in parallel groups assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington's Disease with choreic movements.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥21 years old.
2. Patients with a diagnosis of Huntington's Disease determined by a movement disorders expert and confirmed by a number of HTT gene CAG repeats ≥36.
3. UHDRS® Total maximal chorea (TMC) score ≥10.
4. UHDRS® Total Functional Capacity (TFC) ≥7.
5. Able to walk independently or with minimal assistance.
6. Females of child-bearing potential must use a medically accepted effective method of birth control and should not be breast-feeding.
7. In the opinion of the Investigator, the patient must have adequate support to comply with the entire study requirements.
8. Able and willing to provide written informed consent.

Exclusion Criteria:

1. Onset of HD symptoms prior to age of 21 years (juvenile forms of HD).
2. HD patients presenting rigid akinesia.
3. Use of other VMAT2 inhibitors such as tetrabenazine, deutetrabenazine, or valbenazine; and use of other antichoreic treatment such as any neuroleptic, or amantadine, memantine, riluzole.
4. Patients who experienced severe depression or suicide attempt in the last 5 years.
5. Severe untreated or under-treated psychiatric illness such as active suicidal ideation or behavior or depression.
6. Patients with a history of, or current, hypotension, bradycardia, or orthostatic hypotension.
7. Patients with hypertension already treated with more than 2 antihypertensive drugs.
8. Other active clinically significant illness, which could interfere with the study conduct, counter-indicate the study treatment, place the patient at risk during the trial, or compromise their study participation.
9. Any significant serious abnormality in the electrocardiogram (ECG), or a known history of long QTc syndrome.
10. Patients with severe hepatic impairment, or with severe renal impairment, or with any other significant abnormality in the physical examination or clinical laboratory results that, in the Investigator's opinion, would not be compatible with study participation or represent a risk for the patient while in the study.
11. Females who are pregnant or lactating, or who intend to become pregnant during the study period.
12. Patients with allergy under desensitization, with known psoriasis, or a known allergy/hypersensitivity to any ingredients of the trial medication or placebo.
13. History of alcohol or substance abuse in the previous 12 months.
14. Patients participating in any other study, and the use of any investigational therapy.
Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations

The aim was to evaluate the clinical performance of HEMA-containing and HEMA-free all-in-one self-etch adhesives with and without a surface sealing process with a nanohybrid composite in occlusal caries restorations. The hypothesis is that the HEMA-containing and HEMA-free all-in-one self-etch adhesive and the surface sealing process would significantly effect clinical performance of occlusal restorations.


Eligibility Criteria:
Inclusion Criteria:

* patients who received four direct Class I composite restorations, those with good oral hygiene with no active periodontal or pulpal diseases, whose permanent first or second molar required restorations for occlusal carious lesions with neighboring teeth and were in occlusion with antagonist teeth, and were willing to return for follow-up examinations as outlined by the investigators.

Exclusion Criteria:

* patients with uncontrolled parafunction, those presenting with poor oral hygiene and disinterested in or refused oral hygiene instructions, molars and premolars with carious lesions on a surface other than the occlusal surface and in continuity with the occlusal cavity, pulp exposure during caries removal procedure or cavities with the risk of pulp exposure, having spontaneous pain or sensitivity to percussion, and patients with periodontal or gingival disease.
Effectiveness of a Therapeutic Exercise Protocol Vs a Mobilisation with Movement Protocol in Improving Ankle Dorsiflexion in Amateur Football Players

Objective: To evaluate and compare the immediate and short-term effectiveness of a therapeutic exercise protocol and a mobilisation with movement protocol, compared with a control group, in improving ankle dorsiflexion in amateur footballers.

Material and methods: A single-blind randomised controlled pilot study was developed. Participants were amateur football players randomized into 3 groups (therapeutic exercise, mobilization with movement and control). The intervention was carried out with 2 weekly sessions for 4 weeks. Assessment tools included the Ankle Lunge Test and the Single Leg Squat.


Eligibility Criteria:
Inclusion Criteria:

* Football players over 18 years old who train a minimum of 3 days a week.
* Football players with ankle DF less than 9 cm or a difference greater than 1.5 cm between both feet, measured with the Ankle Lunge Test (ALT) using the LegMOtion© device.

Exclusion Criteria:

* Players who, during the ALT, achieve less than 9 cm or a difference greater than 1.5 cm between both feet but reporting limitation due to tension in the gastrocnemius muscle.
* Those with serious traumatic or rheumatological conditions that may interfere with the study.
* Players who have participated in specific programs to improve ankle DF in the last 3 months.
* Players with a history of ankle-foot surgery within the last 6 months.
* Non-registered players training in those clubs.
* Players unable to arrive 20 minutes prior to the beginning of the training session.