cyrilzakka/clinical-trials huggingface dataset:
A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack

Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan to be used by patients to treat acute migraine treatment. Study participation will last one month and include 2 doctor visits and 2-4 phone calls.

This study will evaluate how patients will interact with the needle-free Intraject system during actual self-administration to the abdomen or thigh for treatment of migraine headache while outside the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine with an average of ≥2 to ≤6 attacks/month
* Female subjects of child-bearing potential must agree to use acceptable birth control
* Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection
* Fluent in the spoken and written English language
* Provide written informed consent to participate in the study and be willing to comply with the study procedures
* Access to a telephone for call center interactions

Exclusion Criteria:

* A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease
* Other significant underlying cardiovascular diseases including uncontrolled hypertension
* Hemiplegic or basilar migraine
* A history or diagnosis of severe hepatic or renal impairment
* A history of epilepsy or seizure or other serious neurologic condition
* A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs
* A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
* Tattoos in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation
* Birthmark or other significant skin discoloration in the thigh or abdominal area large enough to restrict injection site selection and/or evaluation
* Pregnancy or breast-feeding
* Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing
The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips

The study aimed to investigate the effects of breast milk sniffing and breast milk tasting and sniffing on sucking success and early feeding cues in term newborns who were started to breastfeed for the first time.

In the literature, there are many studies examining the odor effect or odor and taste effect during gavage feeding of premature and low birth weight infants hospitalized in the Neonatal Intensive Care Unit (NICU). However, no study was found to examine the effect of smell and taste application on breastfeeding success and early feeding cues during initiation of breastfeeding for the first time in healthy term newborns. It is clear that sick newborns need much more support and intervention in the transition to oral feeding. However, the low rates of breastfeeding in our country indicate that the use of effective and facilitating methods to initiate and maintain breastfeeding is also necessary for term and healthy infants. Therefore, this study may guide healthcare professionals on the effectiveness of odor and taste stimulation for early breastfeeding and provide ideas for designing new research and projects.

Eligibility Criteria:
Inclusion Criteria:

* For the mother
* Having a term and healthy baby,
* No communication and language problems,
* No maternal illness preventing breastfeeding (active chemotherapy, HIV positive, neurological or psychological problems, etc.),
* Willingness to breastfeed, For the baby;
* Not having a disease condition that prevents breastfeeding (cleft palate, cleft lip, galactotemia, choanal atresia, etc.),
* Being at normal birth weight (2500gr-4000gr),
* Apgar score of 7 and above.

Exclusion Criteria:

* Under 18 and over 40 years of age,
* Development of postpartum complications (in mother or baby),
* Multiple pregnancy.
Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus

This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 65 years of age
* Males and females of non-childbearing potential
* Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
* Fasting plasma glucose ≤240 mg/dL
* Body mass index \<42 kg/sq m
* HbA1c of 7-11%
* C-peptide of ≥1.0 ng/mL
* Ability to provide written informed consent

Exclusion Criteria:

* History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
* Current use of any blood glucose-lowering agent other than metformin
* Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
* History of HIV, Hepatitis B, or Hepatitis C
* Surgery within 6 months of screening
* Donation or loss of \>400 mL of blood or blood product within 8 weeks prior to start of study
* Use of proteins or antibodies within 12 weeks prior to screening. (Flu shots are allowed.)
* Exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study
* History of drug or alcohol abuse within 12 months prior to screening.
Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings

The proposed project is to develop a Pediatric-Mental Health Digital Toolkit (P-MHDT) Toolkit to support innovative child mental health preventive interventions in FBO settings. This project focuses on developing a P-MHDT and carrying out a pilot feasibility evaluation in real world settings. A group of Mental Health Professionals (MHPs)/ Community Healthcare Workers (CHWs) will be trained and the P-MHDT Toolkit intervention will be tested in 6 Faith Based Organizations (FBOs) in Uganda.

The specific aims of this proposed study include:

Aim 1. To develop a P-MHDT (by employing qualitative focus-group interviews and user-centered design to enhance usability).

Aim 2. To train mental health professionals and community health workers (CHWs) for the P-MHDT approach of child mental health promotion in Uganda (including monitoring impacts of training on CHWs' program implementation competency).

Aim 3 (11-24 month). To estimate impacts of the P-MHDT on FBOs and families (i.e., caregivers' mental health literacy, practices, and children's mental health) when implemented in the real world FBO settings.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years of age. Participating parents must be caregivers of age 1-7 years old children.
* Children are not the subjects of this study, and will not participate in research activities.

Exclusion Criteria:

* Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
* Minors (age \<18) will also be excluded.
Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy

The goal of this single center retrospective cohort study with observational longitudinal follow up is to compare food - allergic children (egg, milk and peanut allergy) with children in control group (children without any food allergy).

The main question\[s\] it aims to answer are:

* If children with food allergy groups will have lower food intake od micronutrients?
* If growth in children with food allergy is worse as in control group?
* If they are more malnourished and in the food allergies group is more stunting than in the control group?
* If children with milk allergy have lower intake of calcium in their diet and lower mineral bone density?

Participants will be asked to do 3 day food diary and to have blood analysed (hemograme, complete blood count, serum iron status, serum protein).

If there is a comparison group: Researchers will compare milk, egg and peanut allergy group to the control group (peers without food allergy) to see if the food allergy affects growth, macronutrient, micronutrient intake.

Study design A single center retrospective cohort study with observational longitudinal follow up will be performed. The study will include three intervention groups (milk, egg and peanut allergy) and a control group (children with no food allergy). Patients will be 2 to 12 years old. The patients will be recruited at our University Medical Center Ljubljana, Pediatric hospital Ljubljana, outpatient care of our Department for Allergology, Rheumatology and Clinical Immunology. This study will be conducted according to the guidelines in Declaration of Helsinki and approved by Ethics Committee of Slovenia. Written informed consent will be obtained from all the subject's caregivers. The investigators will follow patients from confirmation of food allergy on and will collect data about their weight (kg) and height (cm) from our information system or patients' doctor (or caregiver). The investigators will collect data prospectively for 3 months from outpatient registry of our clinic. At the day of appointment patients will bring 3-day nutrition diary which was later analyzed by dietitian. The parents will attend an appointment by the dietitian where they will be informed about food diary analysis result and given the advice to enhance nutrition if necessary.

Eligibility Criteria:
Inclusion Criteria:

* IgE-mediated food allergy (skin prick test and/or speciﬁc IgE combined with an allergy focused history)

Exclusion Criteria:

* other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),
* vegetarian or vegan nutrition.
Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

This study aims to evaluate whether pre-treatment MRI can be used to predict treatment response for anti-angiogenic treatment in glioblastomas.

Although overall the effects on prolonging survival in bevacizumab-treated patients is modest at best, it is still unclear whether there is not a more substantial positive effect in a subset of patients, potentially identifiable by imaging markers. Allowing for prediction of good or bad responder from anti-angiogenic therapy prior to treatment completion is important to select patients most likely to benefit from anti-angiogenic treatment.

This is a prospective observational study and no active comparator will be used. Study participants include adult patients with recurrent glioblastoma.

We hypothesized that quantifying changes in multi-modal advanced MR imaging techniques would allow early treatment response and long-term prediction in glioblastomas.

Eligibility Criteria:
Inclusion Criteria:

1. Patients had histologically confirmed glioblastoma with progression diagnosed on the basis of clinical data and MRI after standard treatment of operation, concurrent chemoradiotherapy, and adjuvant temozolomide;
2. Patients were more than 3 months from chemoradiotherapy to avoid the confounding factor of radiation necrosis (pseudoprogression);
3. Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria:

1. Patients were not subject to therapies other than anti-angiogenic treatment, including re-operation, re-irradiation, or immunotherapies, because of the patient's clinical status and indication
2. Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
The Effect of Family Counseling Program on Anxiety and Conscious Awareness Levels

This study investigates the effect of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on the anxiety and mindfulness levels of university students experiencing future anxiety. The research highlights the significance of university education in career development, noting the associated biopsychosocial challenges faced by students. These challenges often manifest as future anxiety-a condition characterized by fear, uncertainty, and stress about future prospects, which can impact students' academic performance, social relationships, and overall mental health. Literature reveals that interventions like CBT, mindfulness practices, and family counseling are effective in managing anxiety and enhancing emotional resilience. The program integrates these approaches to provide dual-layer support, addressing individual thought patterns and family dynamics, thus potentially reducing anxiety and increasing mindfulness among students. This study aims to provide a comprehensive understanding of the program's effectiveness in a controlled setting, contributing to both national and international literature on mental health interventions.

This research was conducted as a pre-test, post-test randomized controlled study to determine the effects of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on anxiety and mindfulness levels in university students experiencing future anxiety. The study collected data from 20 students, divided equally between 10 participants in the intervention group and 10 in the control group. Data were gathered using a Personal Characteristics Form, the Future Anxiety Scale for University Students, and the Turkish version of the Mindfulness Awareness Scale for Adolescents and Adults.

The intervention group participated in an online CBT-based Family Counseling Program, which was conducted weekly for 8 weeks, each session lasting between 50-60 minutes. For the first 6 weeks, the sessions included only the students, while the last two weeks also involved family members' participation. No intervention was applied to the control group. Both groups were assessed with the aforementioned scales before the intervention and after its conclusion. This study aims to provide insights into the effectiveness of integrating family dynamics into therapeutic practices for reducing anxiety and enhancing mindfulness among students.

Eligibility Criteria:
Inclusion Criteria:

* The level of future anxiety is above 40 points
* No problems with speech, perception or hearing

  * The person or persons who will be included in the study from family members will be able to participate in the online session at the time required for counseling
  * The student will regularly participate in the interview sessions to be held
Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9

The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.

In this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the AcrySof® IQ Toric High Cylinder Power IOL or the AcrySof® IQ Aspheric NATURAL monofocal IOL.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bilateral cataracts and in the targeted astigmatism range.
* Planned cataract removal by phacoemulsification.
* Pupil size greater than or equal to 6 mm after dilation.
* Able to undergo second eye surgery within 30 days of first eye surgery.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Irregular corneal astigmatism.
* Any inflammation or swelling of the cornea.
* Any corneal abnormality other than regular corneal astigmatism.
* Previous corneal refractive surgery.
* Amblyopia.
* Diabetic retinopathy.
* Uncontrolled glaucoma.
* Currently participating in another investigational drug or device study that may confound the results of this investigation.
* Other protocol-defined exclusion criteria may apply.
Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.

The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer.

Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.

Moreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally.

This study is a prospective and non-randomized with one group of 10 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol).

Before the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci.

Objectives of the study: to asses safety of IRE in patients with localized PCa, to asses short-term oncologic efficacy of IRE in patients with localized PCa, to asses functional outcomes after IRE.

All patients will be followed up for 1 year (each 3 months).

Eligibility Criteria:
Inclusion Criteria:

* Verified with MR-fusion biopsy localized Pca
* PSA \< 15 ng/ml
* Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2
* Life expectancy \> 10 years
* No post-void residual urine or infravesical obstruction

Exclusion Criteria:

* patients with artificial cardiac pacemaker
* patients without rectum
* patients not eligible for general anesthesia
* PIRADS\<3
* patients after primary Pca treatment
* hormonal therapy six months before the study
* radiotherapy of pelvic organs
* urinary infection
* extracapsular Pca
* patients with metastatic lesions
Serum and Tissue Metabolite-based Prediction of Sentinel Lymph Node Metastasis in Breast Cancer

Breast cancer is a malignant tumor with the highest morbidity and mortality among women worldwide. Accurate staging of axillary lymph nodes is critical for metastatic assessment and decisions regarding treatment modalities in breast cancer patient. Among patients who underwent sentinel lymph node biopsy, about 70 % of the patients had negative pathological results and in other words, these 70 % of the patients received unnecessary surgery. At present, imaging and pathological diagnosis is the main measure of lymph node metastasis in breast cancer. However, limitations remained. Artificial intelligence, including deep learning and machine learning algorithms, has emerged as a possible technique, which can make a more accuracy prediction through machine-based collection, learning and processing of previous information, especially in radiology and pathology-based diagnosis. With the intensification of the concept of precision medicine and the development of non-invasive technology, the investigators intend to use the artificial intelligence technology to develop a serum and tissue-based predictive model for sentinel lymph node metastasis diagnosis combined with imaging and pathological information, providing specific, efficient and non-invasive biological indicators for the monitoring and early intervention of lymph node metastasis in patient with breast cancer. Therefore, the investigators retrospectively include serum samples from early breast cancer patients undergoing sentinel lymph node biopsy, including a discovery cohort and a modeling cohort. Metabolites were detected and screened in the discovery cohort and then as the target metabolites for targeted detection in the modeling cohort. Combined with preoperative imaging and pathological information, a prediction model of breast cancer sentinel lymph node metastasis based on serum metabolites would be established. Subsequently, multi-center breast cancer patients will prospectively be included to verify the accuracy and stability of the model.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of breast cancer
* No preoperative therapy including chemotherapy or endocrine therapy
* No distant metastasis
* Underwent mastectomy or breast-conserving surgery with sentinel lymph node biopsy
* Agreed to provide preoperative peripheral blood samples
* Had access to imaging, pathological and follow-up data for preoperative and postoperative evaluation of the disease

Exclusion Criteria:

* Neoadjuvant therapy
* Presence of distant metastasis at time of diagnosis
* Primary malignancies other than breast cancer
* Bilateral breast cancer or previous contralateral breast cancer
* Undergo modified radical surgery for breast cancer without sentinel lymph node biopsy
* Incomplete pathological data and follow-up data
* Pregnancy and other conditions determined by the investigator to be ineligible for inclusion in the study
Study of FTY720 in Patients With Uveitis

This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis


Eligibility Criteria:
Inclusion Criteria:

* Acute noninfectious posterior, intermediate, or pan uveitis
* Vitreous haze score of 1+ or more in the study eye at screening and baseline visits

Exclusion Criteria:

* Vaso-occlusive vasculitis involving the retinal macula
* Behçet's uveitis
* Patients requiring corticosteroid or another systemic immunosuppressive medication for any other disease (e.g., asthma or some other autoimmune disease) that would contraindicate tapering (topical steroids permitted)
* Other protocol defined inclusions and/or exclusions may apply.
The Cardiovascular Changes Associated With Septal Local Anaesthesia

The purpose of this study is to determine the effects on the heart of injecting local anaesthetic into the nose prior to surgery on the pituitary gland?

People sometimes require surgery on their pituitary gland. This is a gland at the base of your brain which secretes hormones. At the Royal Hallamshire Hospital the investigators are currently conducting a study into the effects of local anaesthetic (a medicine which causes numbness) injection on patients undergoing this particular type of operation.

After patients are anaesthetised (asleep) but before surgery starts the surgeon injecst a local anaesthetic solution into the nose. This is routine practice and is done to provide pain relief afterwards and also to decrease the amount of bleeding during the operation to ensure that the surgeon has a good view.

The investigators have known for a long time that local anaesthetic affects the heart rate and blood pressure, however the investigators would like to describe exactly how, in much more detail.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient undergoing trans-sphenoidal pituitary surgery.

Exclusion Criteria:

* Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.