cyrilzakka/clinical-trials huggingface dataset:
Asia Pacific and Russia Diagnostic Study for EGFR Testing

Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.

A diagnostic study to determine the prevalence of EGFR mutations in Asian and Russian patients with advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma histologies

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC
* Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naive (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
* Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable) and Provision of a routine blood (plasma) sample in China, Russia, Taiwan and Korea
* Patients aged 18 years and older

Exclusion Criteria:

* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
* Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
* Pregnancy or breast-feeding
Hearing Health Equity Through Accessible Research and Solutions for Korean Americans

The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.


Eligibility Criteria:
PARTICIPANT CRITERIA Participant inclusion criteria

* Self-identified as first-generation KA in the target region
* Age 60 years or older
* Has a communication partner who lives in the same household or has at least weekly interactions
* Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) \>25 decibel (dB) hearing loss (HL) in better ear
* Hearing handicap as measured by HHIE-S score \>=8 Participant exclusion criteria
* Current use of hearing aid
* Medical contraindications to use amplification device (e.g., draining ear)
* Plan to move from the area within 6 months
* Active treatment for a terminal illness or in hospice

COMMUNICATION PARTNER CRITERIA Communication Partner inclusion criteria

* Age 18 years or older
* Able to read and speak Korean
* Lives with the older adult or has at least weekly interactions Communication Partner exclusion criteria
* Plan to move from the area within 6 months
* Active treatment for a terminal illness or in hospice
Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic

The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes, type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of prognostic factors leading to development of DME.

Epidemiological study, prospective, non-interventional

1. Patient with history of diabetes ≥ 10 years or with suspected visual impairment will be enrolled and screened in NIED during hospitalization
2. Anamnesis and history of diabetes, other co-morbidities, treatment will be recorded
3. Patient undergo in NIED detailed diabetology examination and basic ophthalmology examination (best non-corrected visual acuity in ETDRS score and Amsler grid test)
4. Patient undergo in NIED examination of the back of the eye using fundus camera to take images of retina to assess long-term changes of macula, optic disc, retina vessels and surrounding tissues
5. The assessment of the ophthalmology examination will be carried out in one of two specialized reading centers - II. Eye Clinic SZU FNsP F.D.R., Banská Bystrica or OFTAL Specialized Hospital for Ophthalmology, Zvolen by Retina specialist

The process of screening will be continuous, whilst each patient will sign an informed consent.

Patients records will be stored electronically and data transmission between NIED and Reading Center will be protected using validated and secured software.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years treated in National Institute of Endocrinology and Diabetology
* Patients diagnosed with Diabetes mellitus type I and type 2 respectively
* Presence of Diabetes ≥10 years or patients with suspected visual impairment (duration of diabetes \<10 years)
* Signed patient´s information and informed content

Exclusion Criteria:

* Non-compliant patients
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.

This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of drug-resistant epilepsy
* Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
* Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
* A caregiver must consent to participate together with the subject for purposes of observation and data collection
* The caregiver must be present when the investigational product is administered
* Screening body weight between 26 to 111 kg, inclusive

Exclusion Criteria:

* Female subject who is pregnant, breastfeeding, or planning to become pregnant
* Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
* Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
* Positive screening test for ethanol or other drugs of abuse
* Unable to receive medications intranasally
Environmental Enteropathy Among Infants and Children With Growth Faltering

The study was conducted on 200 patients with growth faltering on 2 phases. In the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 SD for age and sex on the WHO scores were defined as non responders and entered the second phase. In the second phase Upper Gastrointestinal endoscopy was done and then patients received nutritional rehabilitation with peptide based formula and probiotics then were reassessed after 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose weight below -2 SD for age and sex on the WHO scores.

Exclusion Criteria:

* Secondary cases of malnutrition or undernutrition.
* Patients with symptoms of GIT problems as chronic vomiting, chronic or bloody diarrhea, chronic abdominal distension, hematemesis or bleeding per rectum.
* Patients who can't commit to a follow up visit every two weeks.
EFFECT OF NEUROMUSCULAR ELECTRICAL STIMULATION ON DYSPHAGIA IN CHILDREN WITH DOWN SYNDROME

Although some western studies have been conducted to determine the nature of eating problems and oral motor training in children with Down syndrome, these studies are limited. Most of the studies were done in Down syndrome infants. Since feeding is a skill that develops by 2 years of age and refines till 6 years of age (Delaney \& Arvedson 2008), it is essential to study the children in this age group as well. Moreover, there is a dearth of studies investigating the impact of oral motor exercises on feeding problems of the child, which may, in turn, hinder the progress of the child during the intervention. Blissett J., (2018) reported that the behaviours of both caretaker, therapist and infant during feeding contribute significantly to the overall success of the feeding interaction as well as feeding performance. Parents/caregivers play an important role in feeding the child, as they have the first-hand exposure and experience in feeding their child, awareness of the child's feeding behaviours, likes and dislikes of food and communication behaviour during hunger. Consequently, they are the best people to describe their child's feeding problems. Hence, this study involves the administration of a scale on the parent/caregiver to elicit information about the physical, functional and emotional aspects of drooling. Such studies in the Egyptian context are limited. The paucity of literature makes it clear that there are deeper underlying complex issues about oral motor exercises in children with Down syndrome that needs to be investigated. The in-depth assessment and treatment of oral motor skills will provide valuable input to the physical therapists during the treatment of feeding problems in children with Down syndrome. This would help the therapist and clinician in planning and prioritizing the goals during therapy. The information will also help in counselling the caregivers, deciding the success or failure of feeding therapy and thereby help in predicting the prognosis of the child.


Eligibility Criteria:
Inclusion Criteria:

* 1- Their age ranged from 3 to 6 years. 2- Both genders were included. 3- The participating children having the ability to understand and follow simple instructions (IQ level not less than 50).

  4- They did not have any visual or auditory problems. 5- They did not be treated with special medications affecting mental functions. 6- They had score from 4 to 7 according to functional oral intake scale.

Exclusion Criteria:

* 1- Children with history of epilepsy. 2- Children with dental deformities. 3- Children with chest infections or unstable cardiac status. 4- Children with infective skin conditions. 5- Children with gum disorders.
Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate

In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 \< 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 \< 2.6) at 30 weeks with this predifined treatment strategy.


Eligibility Criteria:
Inclusion Criteria:

* patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months disease activity : DAS28 \> 5.1

Exclusion Criteria:

* allergy to ADA present active infection including TB history of demyelinating disease, HBV infection and malignancy
Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence

The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had received an SNM treatment in the last 10 years

Exclusion Criteria:

* pudendal nerve stimulation
* refusal to allow use of clinical data for retrospective data analysis
Salivary Cystatin S Levels in a Group of Egyptian Children

Aim of the study

1. Measuring the levels of salivary cystatin S protein and salivary buffering capacity to determine their relation to early childhood caries.
2. Predection of early childhood caries by using salivary cystatin S levels with demographic, clinical and nutrition habits characteristics of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Medically free children aged 36 to 71 months with one or more decayed (noncavitated or cavitated lesions), missing, or filled teeth due to caries in any primary tooth(cases).
* Medically free children aged 36 to 71 months with no decayed, missing, or filled teeth due to caries in any primary tooth(controls).

Exclusion Criteria:

* Children receiving antibiotic therapy within three month and fluoride prophylaxis within one year.
* Parents who will refuse to participate or refuse to sign the informed consent.
* Children who will not agree or cooperate with participation.
The Effects of Short-foot Exercises in Foot Posture

Therefore, the aim of this study is to examine the effects of the short foot exercises compared to placebo exercises in the foot posture index after a daily period of 4 weeks.

The intrinsic foot muscles collaborate in maintain the media longitudinal arch and in the postural control of the body.1 The plantar intrinsic foot muscles play a crucial role providing the foot stability and flexibility. 2 There are few studies about the relationship between hyperpronation and the training of the intrinsic muscles.

A specific training program as a "short foot exercise" (SFE) may improve pathological conditions involving the foot and the lower extremity including plantar fasciitis, tendinopathies and foot hiperpronation.3 Several balance training techniques have been applied for improving postural stability, and the SFE have been widely accepted by physiotherapists to improve the longitudinal arch foot and the body segments.4 In this study, the foot posture will be evaluated with the foot posture index (FPI) and the navicular drop test (NDT). The foot posture index is a validated and useful method like a complementary tool for evaluating foot disorders. 5. The foot posture quantify the foot posture as normal, pronated or supinated. The foot posture index indicates a pronated foot position in a support relaxed position when IPP is equal to or superior to a +6 value. 5 The Navicular Drop Test quantifies, in millimeters, the descent of the navicular tuberosity. It was developed to evaluate the pronation of the foot and, consequently, the drop of the medial longitudinal arch, a excessively pronated foot (NDT≥10mm).6.

Therefore, the aim of this study is to examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks.

There is a lack of evidence of the effect of training intrinsic muscles in foot posture.

The hypothesis of the researches is that the SFE may contribute to improving the pronated foot posture. This treatment may allow normalizing the foot posture and the kinematic interaction of the lower extremity joints during walking.

Eligibility Criteria:
Inclusion Criteria:

Males and females between 18 and 65 years old.

-

Exclusion Criteria:

* The exclusion criteria: serious illness, current participation in another research study, pregnancy, previous foot surgery, current treatment of foot pathology.
The CASCADE Project

People with cancer, treated for cancer, or have been recently treated for cancer are at a higher risk of becoming rapidly unwell. This is referred to as an oncological emergency and can be life-threatening.

The investigators want to see if a new, standardised assessment of acute oncology knowledge and skills of all health care staff (The Acute Oncology Passport) following education and training, has an effect on the diagnosis and treatment of two relatively-common oncological emergencies: sepsis and MSCC? Sepsis is blood poisoning, which causes serious injuries if it is not diagnosed and treated as an emergency and may result in death if not treated quickly enough. MSCC is metastatic spinal cord compression, where the cancer presses on the spinal cord and can cause permanent paralysis. The investigators have chosen these two conditions, not only because of how serious and relatively common they are for people living with cancer, but also because all NHS Trusts in the UK routinely collect and report standardised data about patients who are admitted with suspected sepsis or MSCC.

The investigators plan to compare data that is routinely collected about the diagnosis and treatment of patients with suspected sepsis and MSCC before and after education, training and assessment of staff about acute oncology. The investigators will conduct 'secondary analysis' on the data, as it was originally collected for another purpose. The routinely data collected at five hospital Trusts across the UK from 1st April 2023 to 30th June 2023 and 1st October to 31st December 2023 will be included in this study.

This research is part of a larger UK-wide project, funded until March 2024 by NHS England Workforce, Training and Education Directorate. If acute oncology education, training and assessment of staff is shown to make a difference to patient diagnosis and treatment, the Acute Oncology Passports will be rolled-out nationally.


Eligibility Criteria:
Inclusion Criteria:

* All patient KPI's of interest that occur in the study time frame will be collected.

Exclusion Criteria:

* KPI data collected from people under the age of 18 KPI data other than items stated in this application, i.e. data that is not reporting neutropenic sepsis nor MSCC outcomes
Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

This project will expand current knowledge of reproductive biology in women with bipolar disorder as well as assessing the impact of lamotrigine use for the treatment of bipolar disorder on reproductive function. Specifically, this study examines mood over the menstrual cycle and ovulation for three consecutive menstrual cycles in women treated for bipolar I, II, or NOS (not otherwise specified) with lamotrigine. In addition, testosterone and lipid concentrations will be measured before the participant starts receiving lamotrigine, as well as six months after receiving lamotrigine.


Eligibility Criteria:
Inclusion Criteria::

* Female
* Ages 18 through 45
* Diagnosis of bipolar disorder (I, II, or NOS)
* Willing to sign the Human Subject Protection Consent Form prior to enrollment into the study
* Willing to use lamotrigine
* Never used lamotrigine prior to study entry Exclusion Criteria:- Unwilling or unable to comply with study requirements, e.g. complete forms, or attend scheduled evaluations
* Significant alcohol and/or substance abuse or dependence within the prior 6 months
* Used lamotrigine prior to study entry, or currently using lamotrigine at study entry
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.

Uncontrolled study

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Participants with Paget's disease randomized to the zoledronic acid arm from the CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months
* Confirmed relapse of Paget's disease of bone (i.e., serum alkaline phosphatase (SAP) above upper limit of normal (ULN), bone scan, worsening clinical symptoms)

Exclusion Criteria:

* A participant previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months
* Bisphosphonate Hypersensitivity
* Participants with suspected/proven metastases at re-treatment
* Calculated creatinine clearance \<35 milliliter/minute (mL/min) at screening
* Serum calcium level \<2.07 millimole/liter (mmol/L) at screening
* Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism

Other protocol-defined inclusion/exclusion criteria may apply.
Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:

The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (MSC) recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.

Overall Study Design: This is a prospective, longitudinal cohort study of patients undergoing primary ACL reconstruction following ACL rupture. Surgical treatment and treatment timelines do not deviate from the national and international standards of care. Enrolled patients for study participation will undergo assessments involving blood, urine, and synovial fluid collection, clinical evaluation involving questionnaires and joint laxity testing, and MRI analysis.

Patient Selection and Enrollment: The participating physicians at each site will identify potential subjects from their clinics' patients according to the inclusion/exclusion criteria listed below. Based on surgical volumes at both sites, patients generally undergo ACL reconstruction 8-12 weeks after initial screening. In the preoperative timeframe, all patients will undergo standard physical therapy to address pain, swelling, and motion deficits, as is standard of care at both institutions. Arthroscopic ACL reconstruction will be performed by Dr. Bedi at the University of Michigan, by Professor Ao at Peking University, and by 5 additional surgeons at Peking University. All surgeons will utilize a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.

Eligibility Criteria:
Inclusion Criteria:

* Isolated, traumatic primary anterior cruciate ligament rupture requiring surgical reconstruction
* Surgical reconstruction performed using a single-bundle technique utilizing an autograft
* No history of ipsilateral traumatic knee injury or fracture
* No evidence of Posterior Cruciate Ligament injury or more than grade 1 injury to the Medial or Lateral Collateral Ligament

Exclusion Criteria:

* Body Mass Index \< 18.5 or \>35 - Injury occurred longer than 4 weeks before enrollment
* Intra-articular steroid injection within 3 months of injury
* Chondral defects greater than 3 cm2 or Outerbridge grade II or higher lesions
* Pregnant women as they are not eligible for surgery