cyrilzakka/clinical-trials huggingface dataset:
Effect of Therapeutic Diet With Physiotherapy on Gross Motor and Cognition of Autistic Children

: A clinical trial will be conducted to investigate the effect of free-gluten/ casein diet along with specific physiotherapy program on gross motor development and cognitive function in 3-12 years old children with ASD, And thus establish a streamlining of nutrition and physical activity for children with autism and ASD.

Autism is a complex neurological and developmental disability that appears within early developmental stages of life. Autism affects the normal functioning of the brain, communication development as well as social skills of the child. Autism has been regarded as a life-long condition and it cannot be cured. However, severity may decrease through special diet and physiotherapy program.

In Saudi Arabia, the prevalence revealed that confirmed cases of ASD were 42,500, and many remained undiagnosed A target group of (60) children diagnosed with autism or ASD, attending the paediatric psychiatry outpatient clinic and autism centres will be enrolled in this clinical trial study, which will be conducted in Jazan City-Saudi Arabia.

The inclusion criteria will be as follows: (1) parental consent, (2) age 3-12 years, and (3) a diagnosis of autism or ASD. Exclusion criteria were as follows: (1) autism associated with a genetic syndrome, (2) patients with comorbidities (3) known food allergy leading to avoidance of certain foods, and (4) mother or primary caretaker not available to be adherent to the prescribed diet. Three groups will be designed: (1) autistic children with regular diet and physiotherapy program. (2) Autistic children on free gluten/casein diet and (3) Autistic children on free gluten/casein diet and subjected to specific physiotherapy program. The study will be continued for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with autism spectrum disorders.
* GMFCs 4

Exclusion Criteria:

* autistic children with any musculoskeletal deformities.
* autistic children with any bulbar affection lead to problem in swallowing.
Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology

The purpose of this study was to evaluate the feasibility and compliance with a novel method for assessing mood and cognition in participants with major depressive disorder (MDD).

The novel method being tested in this study for assessing mood and cognition in participants with MDD was wearable technology. This study looked at the correlation of mood and cognition outcomes on wearable technology with traditional objective neuropsychological cognitive function tests and self-reported mood outcomes.

The study enrolled approximately 30 patients. Participants were provided with a watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.

All participants prompted to complete cognitive and mood assessments on 3 occasions across the day. Two occasions (morning and afternoon) comprised assessment of cognition, and the final assessment in the evening constituted a review of the day focusing on self-reported depressed mood.

This single-center trial was conducted in United Kingdom. The overall time to participate in this study was 6 weeks. Participants took part up to 5 study visits (1 in-person on-site visit, 3 web-based and 1 at home visit) assessing performance on traditional objective neuropsychological cognitive function tests and self-reported measures of depression symptom severity and social function.

Eligibility Criteria:
Inclusion Criteria:

1. Has MDD as the primary psychiatric diagnosis.
2. Has been treated previously with at least 1 antidepressant (monotherapy).
3. Has scores on Participant Health Questionnaire-9 items (PHQ-9) ≥5 and PHQ-9 ≤15 at Screening

Exclusion Criteria:

1. Has a significant risk of suicide according to the investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening.
2. Has a history of only responding to either combination or augmentation therapy in the current episode and has had been treated for more than a year without any period of remission.
3. Has 1 or more of the following:

   1. Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
   2. Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine).
   3. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathies

This study aims to explore the clinical characteristics and mechanism of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies

The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \& Peter Dermatomyositis/Polymyositis(DM/PM) or Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Inhibitors of janus kinase including tofacitinib 5 mg once a day or twice a day and baricitinib 2mg once a day or 4mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate inhibitors of janus kinase's clinical characteristics and mechanism. Patients would be evaluated the improvement of clinical and laboratory indexes. Changes of symptoms, immune cell subsets and cytokines were monitored. Symptoms were evaluated by Visual Analogue Scale (VAS) of patient global and physician global, manual muscle testing(MMT-8), the Health Assessment Questionnaire(HAQ), Creatine kinase, Myositis Disease Activity Assessment Tool(MDAAT).

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 years and 75 years of age.
* Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \& Peter DM/PM or American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria.
* Written informed consent should be obtained from each study subject.
* Concomitant immunosuppressive agents or glucocorticoids were allowed, but subjects should have been on these therapies at least 4 weeks and on a stable dose for ≥4 weeks(glucocorticoid doses are lower than \<0.5mg/kg/d).
* Consent to use effective contraception during the study (women of childbearing age).

Exclusion Criteria:

Any subject meeting either of the following criteria should be excluded:

* Laboratory abnormality: Hb\<8 g/dl or platelet\<60\*10\^9/L, or combined with severe hepatic, renal and cardiac insufficiency;
* Myositis in overlap with another systemic autoimmune rheumatic disorder, cancer-associated myositis, inclusion body myositis or any other non-immune mediated myopathy.
* Biologics such as rituximab are not allowed in the 3-month before enrollment.
* Patients with malignancy within 3 years of screening.
* Patients with hypersensitivity to study drug.
* Active infections(including but not limited to hepatitis, HIV).
* Uncontrolled mental or emotional disorders.
The Impact of the Head Position on the Occlusion of Implant-supported Fixed Restorations

The development of a implantology leads to an increasing use of implants in the treatment of care for the loss of one or more teeth. The question is whether the existing guidelines, originally formulated for the occlusion of natural dentition and conventional prosthetic treatment can be applied to the implant prosthodonticsDue to initial differences in the vertical mobility of teeth and dental implants, present in the same dental arch, although the model of occlusion is ideal, undesirable premature occlusal contacts on the fixed dental restorations on implants may be present.

Objective: To evaluate the effect of different head positions on dental occlusion of the natural teeth and fixed dental restorations on implants.

Methods: Volunteers with complete dentition would be included in this study as the Control Group. The Study Group would include subjects with fixed dental restorations on implants in the transcanine region. A T Scan III System will be used for occlusal analysis.


Eligibility Criteria:
Inclusion Criteria:

For the Test Group

* patients with implant-supported fixed restorations in at least one quadrant of the posterior region (pre-molar and molar) of both jaws at least for 1 year
* patients with Angle Class I in MIP
* patients who did not have orthodontic treatment

For the Control group, the inclusion criteria were:

- patients with completely dentate arches (not considering third molars) with a maximum of 4 tooth-supported restorations per dental arch).

Exclusion Criteria:

* patients with bruxism, detrimental habits, and mandibular parafunctional activities
* patients with signs of temporomandibular dysfunction, trismus, or illness of the cervical spine
* patients with a history indicating problems with alcohol or drugs or receiving any psychiatric treatment.
The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions

The optimal infusion technique (continuous rate vs. intermittent bolus) for peripheral nerve blocks has not been established. To our knowledge, this is the first study to compare the efficacy of an automated intermittent bolus technique to a continuous rate of infusion of local anesthetic in femoral nerve catheters. We hypothesized that the intermittent bolus technique would provide enhanced analgesia compared to a continuous infusion rate as assessed by intravenous patient-controlled analgesia (IV-PCA) hydromorphone consumption and visual analog scale (VAS) pain scores.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 through 3
* elective, primary, unilateral TKA

Exclusion Criteria:

* patient refusal
* pregnancy
* diabetic neuropathy or any other neurologic or neuromuscular disease
* rheumatoid arthritis
* current coagulopathy
* skin infection at needle insertion site for the femoral or sciatic blocks
* significant renal or hepatic impairment
* unsuccessful femoral or sciatic block or femoral catheter placement
* femoral catheter dislodgement after placement
* inability to understand VAS pain scales
* inability to use an IV-PCA pump
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

In this study, the study team seek to conduct a pilot clinical study to evaluate the safety and efficacy of a reformulated proton pump inhibitor (PPI) cream (Dermaprazole) in definitive head and neck cancer (HNC) patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck malignancy (including radiation therapy to primary head cancers of any histology and/or neck lymphatics, excluding brain malignancies)
* Biopsy proven diagnosis of head and neck malignancy
* Planned to receive definitive chemoradiation of at least 66Gy
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* Written Informed Consent
* History and Physical within 12 weeks of enrollment

Exclusion Criteria:

* Prior head and neck radiotherapy
* Neoadjuvant chemotherapy
* Any serious medical condition or illness that would preclude the safe administration of the trial treatment including, but not limited to, active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
* Currently taking proton pump inhibitors. Eligible if discontinues with physician approval.
* Lack of concurrent chemotherapy
* Open wound at time of simulation
* Known autoimmune, connective tissue, or skin disorder; or other theoretical radiosensitivity to include bullous pemphigoid, dermatomyositis, lupus of the skin and scleroderma
Back School Efficacy on Low Back Pain and Quality of Life of Workers. COPCORD STUDY (Stage II)

The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to Control Rheumatic Diseases). The purpose of this study is to find if Back School training has any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.

A back school will be held on at the Modava Pharmaceutical Factory, in Tehran suburbs. We estimate that this prospective study will include almost one third of the 70 workers in the factory. The study provides objective data and subjective information from patients. The clinical benefits of back school on low back pain and quality of life will be reported at the beginning and the end of intervention and after a period of 6 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* History of mechanical low back pain in the last six months

Exclusion Criteria:

* History of inflammatory spinal diseases
* Severe scoliosis
* History of spinal surgery
* History of spinal malignancy
Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients

The purpose of this study is to evaluate if motivational interviewing, performed remotely through videocalls, is effective to improve self-care in patients with heart failure

After signing the informed consent form, patients with heart failure will be assigned to the intervention or control group (1:1). The intervention group will receive a total of seven motivational interviewing sessions over 12 months. The control group will receive the standard care.

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosis of HF according to international guidelines;
2. Class II, III or IV in the New York Heart Association (NYHA) functional;
3. poor self-care, defined as at least two items of the Self-Care Heart Failure Index 7.2 (SCHFI 7.2) with a score of 0, 1 or 2;
4. age ≥ 18 years;
5. having an internet access to allow the videocalls;
6. willingness to sign the informed consent form. -

Exclusion Criteria:

1. severe cognitive dysfunction, with a score 0 - 4 on the Six-item screener;
2. acute coronary events event in the prior three months;
3. living in nursing homes a residential settings where self-care cannot be performed;
4. if the patient's informal caregiver is not willing to participate in the study.
Validation of the MoistureMeterD in Local Edema by Histamine

In lymphedema there is increase in water content of the tissue. We studied a device (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the apparatus is commercially available, no validation study had been performed in vivo with local edema.

We designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema

The multiprobe Delfin MoistureMeterD is a unique and compact water-specific instrument for the measurement of water content of biological tissues. It measures the dielectric constant values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. The dielectric constant value is directly proportional to the amount of water in the tissue.

As lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. This method is well known in type I allergy testing.

The aim of the study is:

1. research the inter- and intra observer variability
2. measure the reproducibility of edema formation in a standardized edema formation

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older;
* Coming for intra-cutaneous allergy scratch test;
* Gender: male and female.

Exclusion Criteria:

* Patients who have a pacemaker or other inbuilt stimulator;
* Lymphoedema;
* Patients who have an infection;
* Patients with skin problems in research area.
* No use of anti-histamines medication
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts

To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.

Multidrug- or extensively resistant tuberculosis tuberculosis is a major public health threat worldwide and the global burden of drug-resistant tuberculosis is increasing. Drug-resistant tuberculosis is associated with long period and high costs for treatment, high rates of default, treatment failure and death.

Drug-resistant tuberculosis should be diagnosed rapidly so as to reduce potential transmission. In the United States, at least one-fifths cases of multidrug-resistant tuberculosis can be linked to transmission. Close contacts to drug-resistant tuberculosis are at high risk for being transmitted and developing drug-resistant tuberculosis. There are two options suggested for close contacts to drug-resistant tuberculosis: preventive therapy and close observation. But both strategies are lack of sufficient evidence.

Ultralow chest CT scan may be an alternative for early identification and risk stratification of developing active tuberculosis in close contacts to drug-resistant tuberculosis with minimal radiation exposure similar to that of chest x-ray.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who had household contact with or who had worked in the same rooms as patients with smear-positive, culture-proven multidrug-or extensively drug-resistant pulmonary tuberculosis for longer than 8 hours per day
* Older than 20 years

Exclusion Criteria:

* Pregnant women
* Individuals with abnormality on chest x-ray suspected of active tuberculosis
Inter-Observer Reliability and Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected PE in the ED

The purpose of this study will be to evaluate the measurement of tricuspid annular plane systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the pulmonary arteries (CTPA)

This will be a prospective observational cohort study aimed at determining the utility and reproducibility of TAPSE, in patients who present to the emergency department with suspected pulmonary embolism (PE). The gold standard diagnostic test for PE is computed tomography of the pulmonary arteries (CTPA). Any patient for whom a CTPA is ordered because of suspected PE is eligible for study inclusion

Eligibility Criteria:
Inclusion Criteria:

* Concern for PE by attending physician and CTPA ordered

Exclusion Criteria:

* If patient is under the age of 18, a prisoner, or a ward of the state
* CTPA ordered but not performed
Efficacy Testing of Collagen Elixir

To assess Isagenix-Collagen Elixir on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Constant drug use
* Participated cosmetic product human study in the past 3 months.
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).


Eligibility Criteria:
Inclusion Criteria:

Patient has ECOG performance status of 0-1

One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment

RLY-5836 single agent arm key inclusion criteria

* Disease that is refractory to standard therapy, intolerant to standard therapy, or participant has declined standard therapy.
* A histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor

Combination arms key inclusion criteria

* Males, postmenopausal females, or pre-/perimenopausal females previously treated with gonadotropin-releasing GnRH agonist at least 4 weeks prior to start of study drug with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy.
* Had previous treatment for advanced or metastatic breast cancer with antiestrogen therapy including, but not limited to, selective estrogen receptor degraders (e.g., fulvestrant), selective estrogen receptor modulators (e.g., tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane)
* Part 1: Prior PI3Kα inhibitor treatment is allowed if taken for \< 14 days and not discontinued due to disease progression, hypersensitivity, or ≥ Grade 3 TEAEs.

Exclusion Criteria:

* Part 2: Prior treatment with PI3Kα inhibitors.
* Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.