cyrilzakka/clinical-trials huggingface dataset:
Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

Retrospective case-control study to assess the diagnostic accuracy in autism spectrum disorder (ASD) of a new smartphone-based platform designed to conduct neurometric evaluations by measuring facial and behavioural reflexes.

This is a retrospective multi-centre case-control study to measure sensorimotor anomalies linked to autism spectrum disorder (ASD) to assess the diagnostic accuracy of smartphone-based neurobehavioral evaluations. The primary objective of the study is to evaluate diagnostic accuracy of the smartphone-based assessments compared to a formal clinical diagnosis using machine learning algorithms.

Neurobehavioral testing will be performed using BlinkLab, a smartphone-based platform. The tests include general measurement of spontaneous and stimulus-evoked postural, head, facial, and vocal responses along with specific neurometric tests, including the acoustically evoked eyelid startle reflex (ASR), and tests that involve the modulation of the ASR, including prepulse inhibition (PPI) and habituation (HAB). Children required to participate in two consecutive 15-minute tests. During the experiment, the children will watch an audio-normalized movie while the trials containing the auditory stimuli will be delivered via headphones. For each trial, computer vision algorithms will be used to track and record the position of the participant's facial landmarks over time. The study will compare responses in children with ASD who received a formal DSM-5 based diagnosis prior to study inclusion and neurotypical children that had no formal psychiatric diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals between the ages of 3 - 12 years old at the time of consent.
* Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
* Normal or corrected-to-normal vision with visual acuity sufficient to watch short videos.
* Hearing adequate to hear the auditory stimuli delivered via headphones.

Exclusion Criteria:

* Participants under 3 or over 12 years old.
* Severe hearing or visual impairment.
* Participants using medication that affects the nervous system (classified as ATC N0 medication, https://www.whocc.no).
Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium

This study aims to assess health and quality of life outcomes in patients treated with benralizumab, within a Belgian Real-World setting. To prove the clinical value of benralizumab in a Real-World setting, the study will document the effect of benralizumab within a time frame of 112 weeks after initiation of treatment.

The aim and objective of this single arm, prospective observational study is to provide supporting RWE on the symptom relief of asthma patients qualified for benralizumab therapy in Belgium. The PRO measures consist of the Asthma Control Questionnaire (ACQ 6) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S), healthcare resource utilization (HCRU) and treatment satisfaction (TSQM-9). In addition change in daily OCS use and rate of exacerbations after initiation of benralizumab in real-world setting will be assessed

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years or older with physician's confirmed diagnosis of severe, uncontrolled asthma
* Asthma requiring high dose inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment
* A decreased lung function (FEV1 \<80%), demonstrated by spirometry in the 12 months before initiation of treatment
* Patients need to fulfil one of the criteria:

  * at least 2 hospitalizations or ER treatments for severe asthma during last 12 months, or
  * at least 2 asthma exacerbations during last 12 months (worsening of asthma with need of systemic corticotherapy for at least 3 days for non cortico-dependent patients, and/or an ER visit and or a hospitalization),
  * or cortico-dependent (at least 6 months treatment with OCS at a daily dose of 4 mg or more of methylprednisolone or 5 mg or more of prednisolone for adults)
* Peripheral blood eosinophil count ≥300cells/μl at initiation of benralizumab treatment and in the year before.
* Obtained reimbursement for treatment with benralizumab
* Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation in the study.
* Patients must be able and willing to read and comprehend written instructions and comprehend and complete the questionnaires required by the protocol.
* Benralizumab naïve and have not previously received benralizumab prior to the start of this study.

Exclusion Criteria:

* Patients currently enrolled in an interventional clinical study in parallel (i.e. have not completed) including those with biologic treatment, will be excluded from the study except for patients who are in parallel documented in the Belgian Severe Asthma Registry (BSAR).
* Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment. Acceptable wash-out periods for other asthma biologics:
* ≥30 days from last dose of previous biologic
* Patients with other documented lung disease other than asthma and not within reimbursed label.
The Association of Telephone Head Tilt With Cervical, Thoracic, and Lumbar Spine Mobility and Disorders in Young Adults

To determine the relationship between telephone head tilt and cervical, thoracic, and lumbar spine mobility and disturbances in young adults.

Today, the fact that smartphones are easily portable and can be used for many purposes such as playing games, surfing the Internet, accessing information, shopping, and listening to music has made them widespread at an unexpected rate. This situation has brought the issue of device addiction to the agenda. Smartphone addiction can lead to many physical ailments such as visual impairment, numbness, and tingling in the hands, neck, back, hip, and knee pain. In the studies conducted, smartphone addiction was determined in university students and this situation was found to be associated with musculoskeletal pain. Considering the smartphone usage rates, durations, and smartphone usage postures of young adults, it can be predicted that spinal mobility may be adversely affected and may cause spine-related disorders. This study aims to determine the relationship between telephone head tilt and cervical, thoracic, and lumbar spine mobility, and disorders in young adults. In addition, it is aimed to examine the relationship between these parameters with quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Using smartphone,
* Not having any diagnosed chronic disease,
* No past or present mental illness,
* Individuals who can speak, read and write Turkish.

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder,
* Individuals who cannot speak, read or write Turkish.
Acute Labetalol Use in Preeclampsia

The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's body-mass index, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.

The investigators seek to asses the effect of obesity (BMI\>30) on severe hypertension control in patients with preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30
* Age ≥ 18 years
* Gestational age ≥ 24 weeks
* Singleton gestation
* One sustained severe range blood pressure at Albany Medical Center

Exclusion Criteria:

* Known allergic reaction to labetlol
* Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
* Obstructive airway disease
* Bradycardia \< 70 beats/min
* Heart block \> 1st degree or history of heart failure
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial

This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age or older
2. Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.
3. Subject must be receiving regular hemodialysis for at least 12 weeks
4. BMI ≥18 kg/m2 and ≤35 kg/m2
5. iPTH≥ 300pg/ mL

Exclusion Criteria:

1. Subject has received a a history of malignant tumor within 5 years prior to screening
2. Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
3. Postdialysis systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg
4. Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients
5. Subject has a history of drug use or excessive alcohol use within 6 months prior to screening
6. Female subjects who were pregnant or lactating
7. Other reasons for not participating as deemed by the investigator
Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion

Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.

The investigators research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old

Exclusion Criteria:

* Age \<18
* Non-English speaking
* Illiterate
* History of pregnancy with delivery \>20 weeks
* History of prior IUD insertion or attempt
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)

This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma diagnosed within 3 months prior to study enrollment.
* T1, N0, M0 or T2, N0, M0. (AJCC Lung 7th Edition)
* At least 18 years old at the time of consent.
* Adequate bone marrow function.
* Medically inoperable. Medically operable candidates are allowed if they refuse surgical resection.
* If the patient has a large pleural effusion, it must be biopsy negative.

Exclusion Criteria:

* Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3).
* Synchronous primary.
* T2 tumors \> 5 cm; T3, T4 primary tumor.
* Previous radiotherapy for lung cancer.
* Concomitant local, regional, and/or systemic therapy during radiotherapy.
* Active systemic, pulmonary, and/or pericardial infection.
ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) Trial

This study is a prospective multicenter observational study for external validation and model advancement of a deep learning based 12-lead electrocardiogram analysis algorithm targeting adult patients presenting to the emergency department with chest pain and acute myocardial infarction equivalent symptoms.

About 9,000 adult patients will be enrolled at 20 emergency medical centers in Korea. Artificial intelligence algorithms are manufactured by Medical AI Co., Ltd. It is an advanced version based on the model developed and published in 2020. It had the diagnostic performance of area under the receiver operating curve 0.901 and 0.951 for acute myocardial infarction and ST-segment elevation myocardial infarction, respectively. The primary endpoint is a diagnosis of acute myocardial infarction on the day of the emergency center visit, and the secondary endpoint is a 30-day major adverse cardiac event. From March 2022, patient registration will begin at centers that have been approved by the Institutional Review Board.

This is the first prospective multicenter emergency department validation study for a 12-lead electrocardiogram artificial intelligence algorithm to diagnose acute myocardial infarction. This study will give insight into the direction of future development by verifying whether the deep learning algorithm works well for patients visiting the real-world adult emergency medical center.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age with suspected chest pain and acute myocardial infarction
* The onset or worsening of the symptom occurs within 24 hours

Exclusion Criteria:

* Out-of-hospital cardiac arrest (OHCA): patients with sustained (\>20 minutes) return-of-spontaneous-circulation are not excluded
* Patients in whom acute myocardial infarction can be clearly excluded, such as pneumothorax and traumatic chest pain
The Healthcare Professionals and the Leishmaniasis

The aim of this work was to investigate the healthcare professionals' knowledge about leishmaniasis in Divinópolis, an endemic county of Minas Gerais state, Brazil.


Eligibility Criteria:
Inclusion Criteria:

* work in the healthcare centers, in the case of primary care professionals;
* have a university degree for nurses, physicians, dentists and veterinarians;
* be working effectively at the time of the interview;
* accept the terms of the research through written informed consent.

Exclusion Criteria:

-
Continuous Intrapartum Support to Reduce Primary Cesarean

The objective of the study was to evaluate the intervention of intrapartum continuous support by a professional nurse with a university degree to reduce the nulliparous, term, singleton, vertex (NTSV) cesarean birth rate, in women pregnant less than 40 years in the HGZ No. 4 of the Guanajuato delegation of the Mexican Institute of Social Security, Mexico

Continuous intrapartum support is a strategy used to decrease the cesarean section rate, where multiple factors influence its effectiveness (start and duration of support, professional training of support staff, and others.). The objective of the study was to decrease the rate of deliveries by cesarean, through continuous intrapartum support during the active phase until birth, by a professional nurse with a university degree, the support was based on three basic aspects: 1) emotional support, 2) physical support and comfort measures and 3) information and counseling, for which a quasi-experimental study was conducted, with a study population of 115 women in labour (nulliparous, full-term, single product, vertex position) and under 40 years, a group control was formed (n = 55) who received routine maternal care and a study group (n = 60) who received continuous intrapartum support.

Eligibility Criteria:
Inclusion Criteria:

* Women pregnant
* Nulliparous
* Term pregnancy
* Singleton pregnancy
* Vertex position

Exclusion Criteria:

* Patients with maternal, fetal, or mixed cesarean indications were excluded.
Amphotericin B Suspension in Refractory Chronic Sinusitis

The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of refractory, postsurgical chronic sinusitis
* Has a documented history of chronic sinusitis symptoms for more than 12 weeks
* A CT scan showing a certain level of mucosal thickening in at least 1 maxillary sinus
* An endoscopy documenting the presence of inflammation and absence of stage 4 polyps
* Ability to comply with the study requirements including the ability to administer a nasal lavage twice daily for 4 months
* Females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study.
* Ability to read or speak English

Exclusion Criteria:

* Has a hypersensitivity to Amphotericin B or the compounds of any study medications
* Is an immunosuppressed patient or is receiving disease modifying agents
* Has an acute upper or lower respiratory illness
* Has an acute exacerbation of chronic sinusitis within 1 month prior to randomization
* Has used systemic antibiotic therapy for reasons other than acute sinusitis within 3 weeks prior to randomization
* Has used any antibiotic therapy for acute complication of chronic sinusitis within 1 month prior to randomization
* Has orbital or central nervous system complications
* Has acute asthma at study initiation
* Began using nasal corticosteroids or had a dosage change within 3 months prior to randomization
* Has taken a dose of oral or intravenous steroids to treat any condition other than asthma within 1 month prior to randomization
* Has used any systemic antifungal therapy within 3 months prior to randomization
* Has used intranasal antifungal therapy for chronic sinusitis within 3 months prior to randomization
* Currently has a clinically significant deviated nasal septum that has not been remedied by surgery
* Has an anatomical abnormality which would significantly obstruct the nasal passages
* Has cystic fibrosis
* Is pregnant
* Has stage 4 polyposis
* Has any significant medical condition that in a doctor's opinion could affect the patient's participation in the trial
* Has used any investigational product within 1 month of study initiation
* Has a history of cancer other than treated squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to study initiation
Leptin Signaling in Lean and Obese Humans

Obesity does not respond to high circulating levels of the hormone leptin. This study is aiming at finding out why this happens and open new avenues for treatment of obesity.

Ex vivo and in vitro identification and study of leptin signaling pathways in commercially available cell lines serum/ plasma samples and discarded tissues from humans.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* ages 18 to 65
* BMI ranges between 20 and 45 kg/m2

Exclusion Criteria:

* subjects requiring special diets
* history of illness other than obesity of diabetes
* taking medications known to influence glucose metabolism
* subjects with history of anaphylactic reaction or hypersensitivity to e. coli derived proteins or anesthetic agents
* women who are breastfeeding, pregnant or wanting to become pregnant
* subjects with bleeding dyscrasia or poor wound healing
Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.

This is a pilot study to examine the feasibility of integrating a mindfulness-based stress reduction (MBSR) intervention in addition to an existing group-based, peer supported clinical care model (JUMP) among patients with pre-diabetes or diabetes using a mixed-method design.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English speaking
* Having a diagnosis of diabetes or prediabetes
* Participation in a previous group-based clinical care model-JUMP (as in "JUMPing into Diabetes Control")

Exclusion Criteria:

* Under 18 years old
* Non-English Speaking
* not having a diagnosis of diabetes or prediabetes
* No participation in JUMP model
Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation

In this comparative study, the investigators aim to compare prospective pediatric patients who receive total lymphoid irradiation (TLI) using tomotherapy with age- and disease-matched controls who receive conventional total body irradiation (TBI) as part of conditioning for haploidentical hematopoietic stem cell transplantation (HSCT) for both malignant and non-malignant diseases. The investigators shall evaluate graft failure-free, graft-versus-host disease (GVHD)-free survival, overall survival, frequency of rejection, GVHD, relapse of malignancy, adverse effects and post-transplant immunoreconstitution.

Radiotherapy at a dose of 6Gy divided into 3 equal fractions (2Gy per fraction) to all lymphoid organs (TLI) over 2 days using tomotherapy will be given to participants as part of the conditioning treatment before haploidentical hematopoietic stem cell transplantation (HSCT). Retrospective patients who are age- and disease-matched with the recruited patients and had received radiotherapy to the whole body (TBI) with or without lung shielding at a total dose of 2-12 Gy delivered as 1-6 equal fractions by conventional opposed fields radiotherapy as part of conditioning will be compared for the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged 0-18 years who requires allogeneic HSCT, has no human leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.
* Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy
* Karnofsky or Lansky performance status score ≥50

Exclusion Criteria:

* Pregnant or lactating woman
* HIV infection
* Patients for whom alternative treatment is deemed more appropriate by treating physician
* Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure