cyrilzakka/clinical-trials huggingface dataset:
Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Phase 1: Single blind/ Phase 2: Double blind

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female children or adolescents, 6 to 17 years of age, inclusive, at the time of the baseline visit
* Meets current diagnostic criteria of the Diagnostic and Statistical Manual-of Mental Disorders IV-Text Revised for autistic disorder and displays behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Diagnosis of autistic disorder will be confirmed by the Autism Diagnostic Interview-Revised.
* Participant or designated guardian or caregiver is able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
* Demonstrates behaviors such as tantrums, aggression, or self-injury or a combination of these problems
* An Aberrant Behavior Checklist Irritability subscale score ≥18 AND a Clinical Global Impressions Severity score ≥4 at the Screening and Baseline Visits.
* Mental age of at least 24 months

Key Exclusion Criteria:

* Treatment resistant to neuroleptic medication, based on lack of therapeutic response to 2 different neuroleptics after treatment for at least 3 weeks each.
* Previous treatment with aripiprazole for at least 3 weeks duration at an adequate daily dose, without demonstrating a clinically meaningful response.
* Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
* Diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder, or Fragile X Syndrome
* History of neuroleptic malignant syndrome
* At significant risk for suicide based on history or routine psychiatric status examination
* A seizure within the past year
* History of severe head trauma or stroke
* History or current evidence of any unstable medical conditions that would expose the patient to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
* Weight lower than 15 kg
* Known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils
* History of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia
* Any other medically significant abnormal laboratory test or vital sign result or electrocardiogram finding
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
* RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
* All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment

Key Exclusion Criteria:

* A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
* Previous history of clinically significant disease.
* Plans to undergo elective major procedures/surgeries at any time during the study.
* Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
* RRMS subjects with any history of inadequate response to any approved interferon β preparation
* History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
* History or evidence of drug or alcohol abuse within 2 years prior to randomization

Note: Other protocol defined inclusion/exclusion criteria may apply.
Validating TEE Measurements of Right Ventricular Function

Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and diagnosis in the perioperative setting for critically ill patients and patients undergoing cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography (TTE) data and have not validated by transesophageal means. The aim of this study is to validate TEE assessment of right ventricular function by comparing them to simultaneously measured TTE measurements.

Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the investigators will attempt to define a range of normal values of RV free wall strain as compared to the other measures of RV function.

Traditionally, all echocardiographic measurements have been studied utilizing TTE. Therefore the normal values and ranges for pathology findings have been defined by transthoracic means alone. TEE offers different images planes when compared to TTE, which may make the measurements obtained differ from those obtained by TTE. In the operating room environment the vast majority of echocardiography is completed by transesophageal means for many reasons; largely access to the patient and the continuous use of TEE as a hemodynamic monitor. However, given the fact that most echocardiographic measurements have only been validated by TTE, there remains a question as to the validity or precision of TEE-derived measurements.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective cardiac surgery requiring TEE

Exclusion Criteria:

* Patient who do not wish to consent
* Patients with contraindications to TEE
* Urgent or emergent cardiac surgery
* Patients with preexisting open chest
* Patients with intrathoracic hardware (VAD, thoracostomy tube, etc)
* Non-English speaking subjects
* Cognitively impaired adults
* Pregnancy
Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis.

Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.

Design: a prospective, single-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, and Shoulder Pain And Disability Index.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of frozen shoulder by physical examination and ultrasonography

Exclusion Criteria:

1. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region)
2. neurologic deficits affecting shoulder function in normal daily activities
3. shoulder pain caused by cervical radiculopathy
4. a history of drug allergy to xylocaine or corticosteroid
5. pregnancy or lactation;
6. received injection into the affected shoulder during the preceding 3 months
7. history of surgeries on the affected shoulders
8. Secondary frozen shoulder
Evaluation of Profile Changes and Torque Control in Dental Bimaxillary Proclination Cases Using Lingual Lever Arm Mechanics vs Conventional Lingual Orthodontic Mechanics A Randomized Controlled Trial

This study evaluates the profile changes and torque control using lingual lever arm vs conventional lingual mechanics. Half of the patients will receive lever arms and the other half will receive conventional lingual orthodontics.

Conventional lingual orthodontic biomechanics leads to torque loss during en masse retraction of the anterior segment in the bimaxillary proclination cases treated by first premolar extraction. Torque loss affects the final outcome of the treatment negatively.

Adding a lever arm to the lingual wire will transmit the point of force application at or apical to the center of rotation which will reduce or eliminate toqrue loss during anterior segment retraction.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patients with age range 18-30 yrs old.
* Class I bimaxillary dentoalveolar proclination.
* Full permanent dentition.
* Good oral hygiene.
* Maximum anchorage is required.
* Healthy bone around the first molars is needed.

Exclusion Criteria:

.Systemic disease.

* Severe crowding.
* Extracted or missing upper permanent tooth/teeth (except for third molars).
* Signs, symptoms or previous history of temporomandibular disorders (TMD).
* Previous orthodontic treatment.
Heterodyned Whole-Body Vibration in Treatment of Opioid Withdrawal-Induced Anxiety

In this randomized, double-blind, controlled, parallel group study (conducted over 12-months), enrollment is expected of up to 60 subjects (30 men and 30 women) ages 18+ who are currently going through withdrawal of OUD and being treated at local substance abuse clinics. The study visits will include screening, baseline, Weeks 1, 2, 3, and 4, with both safety and efficacy assessments.

Approximate time commitment is 30 minutes / day, for 5 days / week, in testing effects of specialized 'massage' chair for a period of 4 weeks (up to total 20 treatment periods). Only about 20 minutes time is in the test chair, and the rest is setup time and completing questionnaires.

* Upon arrival to the clinic for treatment, some short questions are asked.
* Participant is seated in a HWBV chair device.
* A clip is attached to one finger to track heart rate and skin response to the treatment.
* After relaxing for about 5 minutes, the HWBV chair actuated for 10 minutes.
* The finger attachment is disconnected.
* Post-treatment, some more survey questions conclude the session.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 (female and male)
* Confirmed diagnosis of opioid use disorder and deemed appropriate to participate in this study as referred by the medial director of a local outpatient treatment clinic for OUD
* Concurrent craving for drug
* In otherwise good physical health
* Access to a phone (communication device) and willingness to communicate with study staff
* Ability to understand and provide informed consent in English

Exclusion Criteria:

* Inability to provide verifiable contact information or unwillingness to assist with follow-up
* Unwilling to allow potential access to medical, drug treatment records or criminal history or criminal activity records that in the opinion of the site investigator would interfere with the conduct of the study
* History of violence or violent, erratic behavior that would indicate a risk to other participants, study staff or to the participant her/himself
* Psychoses, major depression, bipolar disorder, or other mental disorder that in the opinion of the site investigator, would interfere with the participant's ability to participate in the study
* A score of \> 2 on the Beck Depression Inventory-II (BDI-II) \[Suicidality\]
* A score of \< 6 on the Clinical Opiate Withdrawal Scale, which indicates mild opiate withdrawal symptoms
* Prior history of severe brain injury or seizures
* Prone to fainting
* Suffering from a recent injury from which they are still recovering or needing medications for recovery
* Not have used opiates within the last 24 hours or longer than the past 60 days
Efficacy of Warming Device During Surgery

This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system.

Subjects undergoing major plastic surgery lasting approximately 5 hours will be randomized to either the Hot Dog resistive heating system or the Bair Hugger forced air heating system. Core temperature will be measured using a distal esophagus and mean skin temperature. Warming will continue until the subjects' core temperature reaches 37°C. Subsequent temperature will be adjusted as clinically necessary. Data will be recorded at 15 minute intervals. Core temperature will be first measured after intubation when the esophageal temperature probe is inserted. The primary outcome will be the rate of core rewarming over the range of 35°C to 37°C.

Eligibility Criteria:
Inclusion Criteria:

* Plastic surgery lasting approximately 5 hours
* Subjects over the age of 18 years
* Patient signed Informed Consent

Exclusion Criteria:

* Plastic surgery lasting less than 5 hours
* Individuals under the age of 18 years
The Prevalence of Micronutrient Deficiency in Early School-age Children

This study aim to assess the prevalence of deficiency in micronutrients in early school-age children and its correlation with picky eating behavior, physical activity, nutritional status, and health status.

A structured questionnaire is used to conduct a cross-sectional descriptive study of 250 early school-age children aged 4-7 years (\<7 years old) in Taiwan. Data collection would include: demographics, food preferences, eating behavior, body weight and height, body mass index (BMI), physical activity, records of medical illness, peripheral cell blood count, serum values of ferritin and micronutrients (iron, zinc, copper). Data from children define as picky or non-picky eaters base on parental' questionnaire responses, are analyzed and compared using standard statistical tests. The correlations among eating behavior, dietary habits, development, physical activity, nutritional status, and health status, and micronutrient deficiency are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 4-7 years old (\<7 years old) school-age children, legal representatives willing to sign the consent form and fill in the questionnaire

Exclusion Criteria:

* At the time of the enrollment, there is an acute infection (respiratory, gastrointestinal or urinary tract), and there are organic diseases (heart, lung, brain, hepatobiliary, kidney, endocrine metabolic disease or heredity).
Effect of Quercetin in Treatment of Periodontitis

Periodontitis is an immune-inflammatory disease affecting the supporting structures of the teeth. It is a disease of multifactorial etiology, with microbial, genetic, environmental and host factors involved, with the release of oxygen-free radicals by the inflammatory cells. Quercetin, have shown potential antimicrobial activity, lowering of inflammatory markers, cholesterol reduction and inhibiting bone loss. However, this data has largely been obtained from in vitro and animal studies, but data from human studies are limited.

Quercetin has been found to decrease the extracellular matrix degradation, promote wound healing when tested in gingival fibroblasts, and showed excellent antibacterial properties. It also possesses antioxidant effect which can be explored to restrict the inflammation in periodontitis. Despite the beneficial effects of Quercetin, its poor aqueous solubility and poor bioavailability result in limited absorption, so scientists have worked on improving the bioavailability of Quercetin using various approaches, such as nanosuspension , self-nano emulsifying systems , microemulsion , solid lipid nanoparticles and cyclodextrin complexes. The combination of oils and emulsifiers enhances the absorption of Quercetin. Hence, nanoemulsion could be a suitable drug delivery vehicle for the loading of Quercetin. Nanoemulsions are more beneficial than microemulsions, as they have high kinetic stability and a smaller droplet size. Therefore, the present study will investigate the efficacy of nanoemulgel of quercetin as adjunct to conventional therapy in treatment of periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  * Patients with periodontitis stage ( Ⅰ \& Ⅱ ). Stage I have CAL 1 to 2mm with no tooth loss and probing depth ≤4 mm. Stage II have CAL 3 to 4mm with no tooth loss and probing depth ≤5 mm..
  * Patients who have teeth with both mesial and distal neighboring teeth .
  * Patient with more than 20 natural teeth .
  * Patient free from any systemic disease that may effect the periodontal status according to the criteria of Cornell Medical Index and its modification.

Exclusion Criteria:

* Long-term therapy with medications within a month prior to enrollment that could affect periodontal status or healing.
* Pregnant woman and lactating mothers .
* Patients with a history of traumatic occlusion.
* Teeth with both endo-perio lesion .
* Patients with previous periodontal treatment including scaling and root planing and periodontal surgery in the last 3 and 6 months, respectively .
A Cohort Study on the Clinical Characteristics and Prognosis of HIV/AIDS Patients Infected With SARS-CoV-2

On February 11th, 2020, the International Classification of Viruses named the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as novel coronavirus (COVID-19, Covid-19 for short). At present, COVID-19 has become a global pandemic. However, the persistent replication of HIV in PLWH and the cellular immunodeficiency and persistent inflammation caused by it may have different effects on the susceptibility, severity and course of Covid-19. Several large cohort studies have found evidence of increased risk of hospitalization and death in patients with HIV and Covid-19 co-infection. Meanwhile, a meta-analysis of 22 studies shows that HIV infection is still an important risk factor for acquiring Covid-19 infection, and it is associated with a higher risk of death in COVID-19. In order to further clarify the clinical features and prognosis of HIV co-infection with Covid-19 and explore its immune mechanism, so we will carry out the study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old; Patients diagnosed with HIV in accordance with the Chinese AIDS Diagnosis and Treatment Guidelines.

Exclusion Criteria:

* Hypertension, diabetes and other metabolic related diseases; Severe circulatory and respiratory diseases; Patients with immune-related diseases and immunosuppressants; Pregnant and lactating women.
A Novel Ballet-inspired Low-impact At-home Workout Programme for Adults with Stroke

To explore the feasibility of a novel ballet-inspired low-impact at-home workout programme for community-dwelling stroke survivors in Hong Kong.

A mixed methods exploratory study incorporating a randomised controlled trial (RCT) and qualitative evaluation will be conducted. A total of 40 stroke participants will be recruited from two acute public hospitals. Participants will be randomly assigned to receive the interention and usual care, or usual care only. Data will be collected in multiple forms: recruitment/retention rates, adherence to the intervention, journals, field notes, verbal feedback, audio records, semi-structured interviews, and questionnaires on outcomes (balance, confidence in balance, gait, walking endurance). This study is the first of its kind in Hong Kong. Findings will address the cross-cultural applicability of dance interventions and lay the groundwork for examination in a larger-RCT about its effects on survivors' balance, gait and memory.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 years or above
2. clinically diagnosed with a first-ever ischaemic/ haemorrhagic stroke
3. living in home settings
4. mild-moderate lower limb paresis with a modified Functional Ambulation Classification (MFAC) of III (Dependent walker) or above
5. a Montreal Cognitive Assessment (MoCA) score\>20
6. able to follow three-step directions
7. able to communicate in Cantonese and read Traditional Chinese
8. their hearing and/or visual disturbances corrected by hearing aids and/or glasses
9. consent to participate in the study

Exclusion Criteria:

1. diagnosed with transcient ischaemic attack, subdural or epidural haemorrhage
2. experienced cerebrovascular events due to tumours or head trauma
3. have pre-existing neurological, cardiovascular or orthopaedic conditions that contradict participation in dancing such as shoulder dislocation, myocardial infarction, seizures or acutes illness
4. mental condition such as depression, schizophrenia or personality disorder
5. incomprehensible speech
6. severe hearing and/or visual disturbance
Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study

With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock.

Prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients with sepsis or septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a new diagnosed sepsis or septic shock: emergency department, operating theatre, intensive care unit and planed blood culture diagnostics.
* informed written consent

Exclusion Criteria:

* Pediatric patients (\< 18 Years)
* DNR-order