cyrilzakka/clinical-trials huggingface dataset:
External Trigeminal Nerve Stimulation for Epilepsy

This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS). TNS involves external electrical stimulation of sensory nerve located above the eyes and over the forehead. The purpose of this study is to determine if TNS is safe and effective using a rigorous randomized active-control clinical trial design in 50 people with epilepsy.

Poorly controlled epilepsy is a disabling condition, affecting over one million Americans. Neurostimulation is a promising alternative for patients who have failed medical therapy, and who are not resective surgical candidates.

Trigeminal Nerve Stimulation (TNS) is a novel form of neurostimulation, and has a strong antiepileptic effect in an animal model of seizures. Preliminary data in humans indicates TNS is well tolerated and may be effective in people with intractable epilepsy.

TNS is an alternative mode of neurostimulation, because the Trigeminal Nerve can be stimulated in minimally-invasive fashion.

This is a randomized double blind study of Trigeminal Nerve Stimulation, which compares high stimulation to an active control. Subjects with poorly controlled partial onset seizures who meet all inclusion and exclusion criteria, enter a 6-week baseline period, and then are randomized in double-blind fashion to high or low intensity stimulation for 18 weeks. 50 subjects are to be enrolled at two sites.

Study outcomes are the following:

1. Percent change in seizure frequency during the treatment period compared with the baseline (pre-treatment) period.
2. Time to the 4th seizure

The primary comparisons will be between and within groups.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 70;
* No serious or progressive medical illness;
* A history of intractable partial seizures;
* At least two complex partial or tonic clonic generalized seizures per month in the last two consecutive months;
* MRI or EEG consistent with localization-related or partial epilepsy;
* Exposure to at least two antiepileptic drugs at adequate doses;
* Concurrent use of at least one antiepileptic drug at adequate doses;
* No change in antiepileptic dose for at least 30 days before study enrollment

Exclusion Criteria:

* History of non-epileptic seizures;
* Inability to maintain accurate seizure calendars (self or caregiver);
* Frequent use of benzodiazepines for clusters defined as greater than four times a month;
* History of facial pain or trigeminal neuralgia;
* Concurrent vagus nerve stimulation;
* Pregnancy
Low Salt Diet in Idiopathic Hypercalciuria

Randomized clinical trial comparing water therapy plus low-salt diet to water therapy alone in patients affected by idiopathic calcium nephrolithiasis.

Treatment duration: three months Primary end-point: correction of hypercalciuria Main inclusion criteria: calcium stone formers with idiopathic hypercalciuria, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (\>300 mg/day in males and \>200 mg/day in females); 18-65 years.

Main exclusion criteria: primary hyperparathyroidism, primary hyperoxaluria, enteric hyperoxaluria, bowel resection, inflammatory bowel disease, renal tubular acidosis, sarcoidosis, sponge kidney, hyperthyroidism, use of hypercalciuric drugs such as Vitamin D, acetazolamide, anti-epileptic drugs


Eligibility Criteria:
Main inclusion criteria:

* idiopathic calcium stone formers, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (\>300 mg/day in males and 20 mg/day in females);
* 18-65 years.

Main exclusion criteria:

* primary hyperparathyroidism,
* primary hyperoxaluria,
* enteric hyperoxaluria,
* bowel resection,
* inflammatory bowel disease,
* renal tubular acidosis,
* sarcoidosis, sponge kidney,
* hyperthyroidism,
* use of hypercalciuric drugs such as Vitamin D,
* acetazolamide,
* anti-epileptic drugs
Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer

This trial will pilot a psychosocial intervention called Conquer Fear Support (CFS) in patients with stage III-IV lung or gynecologic cancer who are experiencing fear of cancer progression. The intervention is adapted from a novel program called "Conquer Fear" which was developed by researchers in Australia. CFS may help in reducing worries, fears, and uncertainty in patients with advanced lung or gynecological cancer.

PRIMARY OBJECTIVES:

I. Assess the feasibility and acceptability of the CFS intervention in patients with advanced lung and gynecologic (GYN) cancer (stages III or IV) who have clinically significant levels of fear of cancer progression (FOP) or cancer-related distress.

SECONDARY OBJECTIVES:

I. Assess preliminary effects of the intervention on FOP, cancer-specific distress, anxiety, depression, overall symptom distress, metacognitions, and mindfulness.

OUTLINE:

Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1 in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients also complete home practice assignments comprising attention training technique and mindfulness practice sessions after each session.

After completion of study intervention, patients are followed up at week 12.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gynecologic (GYN) and lung cancer will be recruited
* Stage III or IV disease
* At least 3 months from initial diagnosis
* Receiving disease-focused treatment or active surveillance mode
* A score of ≥ 34 on the Fear of Progression Questionnaire-Short Form (SF) or ≥ 24 on the Impact of Event Scale-Revised
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Current severe depression or psychosis; significant cognitive impairment
* Patients enrolled in hospice care or who opt to receive no further disease-focused treatment
* Patients who are currently receiving ongoing psychiatric treatment
* Non-English speaking
Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes

The MIRON-PLATELET study is a retrospective, observational multi-center analysis assessing the impact of different antiplatelet therapies on hemorrhagic myocardial infarction (HMI) incidence and outcomes in STEMI patients. Key endpoints include hemorrhagic transformation, MACE, bleeding complications, and 30-day mortality. Findings will offer insights into the safety and clinical implications of antiplatelet therapy in high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18-79 years at the time of STEMI diagnosis
2. Diagnosed with ST-segment elevation myocardial infarction (STEMI) based on standard clinical criteria
3. Received antiplatelet therapy as part of STEMI management
4. Underwent primary percutaneous coronary intervention (PCI)
5. Evidence of hemorrhagic MI confirmed by Cardiac Magnetic Resonance Imaging OR Post-PCI biomarker diagnostics
6. Availability of comprehensive medical records documenting STEMI presentation, treatment details, and clinical outcomes
7. Minimum of 30-day follow-up data, with extended follow-up available for up to 10 years

Exclusion Criteria:

1. Diagnosis of non-STEMI (NSTEMI), unstable angina, or other non-ischemic cardiomyopathies
2. History of prior hemorrhagic stroke or active intracranial bleeding before the index STEMI event
3. Known bleeding disorders (e.g., hemophilia, thrombocytopenia \<50,000/µL)
4. Use of chronic antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel) before STEMI diagnosis
5. Use of long-term anticoagulation therapy (warfarin, DOACs such as apixaban, rivaroxaban, dabigatran) before STEMI diagnosis
6. Incomplete or missing medical records preventing outcome assessment
7. History of malignancy with life expectancy \<1 year at the time of STEMI diagnosis
8. Patients lost to follow-up before 30 days post-STEMI
3D Structural Imaging of Human Breast Tissues

This project aims to develop an advanced ex vivo medical microscopic imaging technology. By developing breast tissue staining techniques, acquiring microscopic images, and performing structural reconstruction, we seek to observe the 3D structure of breast tissue. This includes examining cell distribution, mammary ducts, and blood vessel distribution, to explore the different biological characteristics between normal breast tissue and various types of cancerous tissues.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and above.
* Patients clinically diagnosed with breast cancer.

Exclusion Criteria:

* Patients unable to provide consent (e.g., inability to speak, inability to communicate in Chinese, etc.).
* Patients for whom a definitive pathological diagnosis cannot be established.
* Patients suitable only for biopsy and not for surgical excision.
* Excised tissue showing severe radiation-induced changes under pathological examination.
* Tumor specimens smaller than 1 cm.
* Patients with ductal carcinoma in situ (DCIS).
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets

To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Evaluation of New Feedback Canceller for Carina™ Implant

The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.


Eligibility Criteria:
Inclusion Criteria:

* successfully implanted with a commercial available CE-labelled implant device, resulting in measurable open set speech understanding
* native speaker in the language used to assess their clinical performance, i.e. French

Exclusion Criteria:

* unwillingness or inability to comply with all of the investigational requirements
* additional handicaps that would prevent or restrict participation in the audiological evaluations
Nasal High Flow (NHF) in COPD - Effects on Ventilation in Wakefulness

Controlled randomized crossover trial in patients with chronic obstructive respiratory disease (COPD), who are treated with Nasal High Flow (NHF) therapy during wakefulness with a small amount of CO2 added to the inhaled air to keep the patients' PaCO2 stable despite the washout effect. Aim of the study is to examine respiratory rate, tidal volume and work of breathing under NHF without the CO2 washout effect.

In this controlled randomized crossover trial, 10 stable patients with chronic obstructive respiratory disease (COPD) are treated with Nasal High Flow (NHF) therapy during wakefulness. NHF treatment will inevitably result in increased upper airway washout and thus in a slight reduction of PaCO2 of approximately 2 mmHg. For compensation, a small amount of CO2 is added to the inhaled air during this experimental situation, which keeps the patients' PaCO2 stable. This will allow to examine the effects of NHF therapy on respiratory rate, tidal volume and work of breathing, that are not attributable to the CO2 washout effect.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized COPD patients GOLD (3 and 4) in stable phase after an acute exacerbation.
* Written informed consent is required for participation.

Exclusion Criteria:

* Acute respiratory failure with clinical instability or respiratory acidosis defined by pH\<7.35
* Severe acute physical illness that does not allow the subject to participate in a clinical trial
* Unable to give consent
* Language, cognitive, or other impairments that may prevent independent completion of questionnaires
Migraine and Recurrent Abdominal Pain in Children

This study will evaluate a new model for assessing and treating migraine and recurrent abdominal pain in children. The model combines behavioral techniques such as relaxation training with biologic components such as thermal biofeedback.

Recurrent pain syndromes (RPS) are relatively common in pediatric populations. Two of the most common types of RPS are recurrent abdominal pain (RAP) and migraine. Similar patterns of pain are described in children with RAP and migraine, and similar factors (particularly stress) may initiate both types of RPS.

This study will assess a new biobehavioral model for evaluating and treating children with RPS. This model relates precipitating, intervening, and functional status factors in chronic and recurring pain in children. The model proposes that stress is a precipitant of pain. This study will evaluate the model in children who receive therapy for RPS that is based on stress management strategies. The therapy includes relaxation training, cognitive coping skills training, thermal biofeedback, and parent education. It will be compared to a control treatment program of hand-cooling biofeedback and supportive therapy.

Consenting participants will be randomized to receive either biobehavioral therapy or control therapy. Participants will have 6 study visits over the course of 2 months. The first study visit is an evaluation visit; the remaining five study visits are treatment visits. Participants will be followed for 24 months and will be asked to complete mail-in forms at Months 3, 6, 12, and 24.

Participants will be recruited through local pediatricians, pediatric neurologists, and pediatric gastroenterologists. Brochures about the study will be sent to these physicians to pass on to their patients informing them about the study. Children in the control group will be recruited through Children's Hospital outpatient clinics.

Eligibility Criteria:
Inclusion Criteria

* Migraine or functional abdominal pain of at least 3 months duration, occurring at least weekly or 5 days per month
* Child assent
* Parental consent

Exclusion Criteria

* Medical illnesses that cause similar pain symptoms (e.g., inflammatory bowel disease, brain cancer)
* Psychiatric diagnosis that would interfere with participation in the study (any Axis I diagnosis of moderate severity)
Xbox Kinect Promote Physical Fitness and Lean Mass in Severely Burned Children

The outcome measures included quadriceps muscle strength as measured using an isokinetic dynamometer, LBM is measured by DEXA and cardiopulmonary fitness was assessed by measuring VO2 peak during a standardized treadmill exercise test using the modified Bruce protocol. All outcome measures were evaluated immediately after discharge as baseline and after 12 weeks of intervention.

Forty healed pediatric burn patients (24 boys and 16 girls), aged 10 - 15 years, were enrolled from the outpatient clinic in the faculty of physical therapy, Cairo university, Egypt. The inclusion criteria were: total body surface area (TBSA) of 40-60%, being ambulatory without an assistant. The exclusion criteria included metabolic disorders, neuropathy, visual or vestibular disorders, amputation, participation in another study, any adverse medication reactions, history of epilepsy, loss of balance, and lower or upper limb deformity. All patients received similar standard medical care and treatment from the time of admission until the time of discharge.

Total burn surface area was assessed by the "modified Lund and Browder charts" method during excisional surgery immediately following hospital admittance. Informed written consent was obtained from each patient's guardian prior to enrollment.

All procedures were approved by the ethical committee of the faculty of physical therapy, Cairo university, Giza, Egypt. After consent was obtained, patients were randomly assigned to standard of care group (SOC) or Xbox training group (Xbox).

The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program (N=20). In contrast, the SOC group participated in the routine physiotherapy program (N=20).

A normal activity of daily living (ADL), diet and patient's lifestyle were maintained for all participants as much as possible.

Eligibility Criteria:
Inclusion Criteria:

* total body surface area (TBSA) of 40-60%.
* being ambulatory without an assistant.

Exclusion Criteria:

* metabolic disorders.neuropathy.
* visual or vestibular disorders.
* amputation.
* participation in another study.
* history of epilepsy.
* loss of balance.
* lower or upper limb deformity.
Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy

Febrile neutropenic patients are at high risk for developing sepsis and other infections which often necessitates acute admission to the Intensive Care Unit (ICU) and are associated with high mortality. Neutropenic fever is a medical emergency and early detection of fever allows for prompt infectious work up. In this study, the investigators will collect pilot data from outpatients utilizing a remote outpatient continuous temperature monitoring device to compare the incidence of ICU admission and severe sepsis to historical data for prior patients who did not receive at home monitoring device.


Eligibility Criteria:
Inclusion Criteria:

Patients who have acute myeloid leukemia (AML) and are candidates for consolidation chemotherapy with high dose cytarabine (HiDAC) after successful remission induction chemotherapy

* Both male and female
* Age 18 years and older

Exclusion Criteria:

Patients who have already developed febrile neutropenia during their hospitalization for their consolidative cycle of chemotherapy will not be eligible for monitoring for that cycle; however, these patients will be able to participate in subsequent cycle if they do not develop febrile neutropenia during their subsequent HiDAC hospitalization.

• If a patient is admitted to the hospital between cycles of chemotherapy for reasons other than febrile neutropenia or its sequelae, they will be taken off study for that cycle and data not collected while they are admitted
Evaluating and Improving the Sustainability of State-level Tobacco Control Programs in the United States

The purpose of this study is to empirically develop, test, and disseminate sustainability training to improve the institutionalization of evidence-based state tobacco control (TC) programs, and thus, tobacco-related health outcomes.

This study defines program sustainability as the ability to maintain programming and its benefits over time.

The project builds upon the empirically-developed Program Sustainability Action Planning Model and Training Curricula. The training will incorporate experiential learning methods and includes: action planning workshops, development of action plans with measurable objectives to foster institutional changes, and technical assistance. The goal is to demonstrate change in sustainability outcomes in states who receive the Program Sustainability Action Planning Training compared to states that do not. After conclusion of the study, the sustainability training curriculum will be disseminated to all participating state TC programs. Additionally, the curriculum will be adapted for the use by any public health program in need of building sustainability capacity.

Eligibility Criteria:
Inclusion Criteria:

* All participants will be non-institutionalized adults ages 18 and older.

Exclusion Criteria:

* Participants must be involved in their state's tobacco control program and must be selected by their state's Program Manager to participate.
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children

Local anesthesia is an anxiety-provoking procedure. Pain control is important for effective behavior guidance, specially among pediatric patients.

This study aims to evaluate the effectiveness of Buzzy® as a topical anesthetic in pain perception through two ways: once using vibration mode without the cold pack and the other using the cold pack without vibration and comparing it to topical anesthetic gel during different anesthetic techniques Methods: A randomized controlled clinical trial involving 72 healthy cooperative patients aged 5-9 years. They will be allocated to receive local anesthesia either using the vibration mode of Buzzy Bee (test group) or the cold pack of Buzzy Bee (test group) or conventional topical anesthetic gel (control group). Pain response will be assessed using Visual Analog Scale (VAS) and SEM scale.


Eligibility Criteria:
Inclusion Criteria:

1. Patients indicated for simple restorative procedures.
2. Children with physical status ASA I, II.
3. Children with no learning disabilities
4. Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
5. Patients whom parents will give consent to participate

Exclusion Criteria:

1. Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
2. Patients with acute oral or facial infection (swelling and/or cellulites)
3. Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
4. Children with special health care needs.
Evaluation of the Effects of a Novel Dietary Microalgae Based Ingredient on Muscle Recovery and Endurance Capacity

The purpose of this investigation is to examine the effects of consuming a new dietary microalgae based supplement vs. placebo on neuromuscular function, energy utilization, soreness, perceptual wellness, swelling, and markers of muscle damage and inflammation in healthy young men before and after an acute exercise-induced muscle damage protocol (downhill running), and influence on endurance capacity after prolonged consumption.


Eligibility Criteria:
Inclusion Criteria:

* Male participants
* Healthy as assessed by Medical and activity history questionnaire (MHQ)
* Recreationally active according to American College of Sports Medicine guidelines
* Able to provide written and dated informed consent to participate in the study

Exclusion Criteria:

* Untrained
* Any response of "yes" on the PAR-Q+
* Physical limitations preventing running, countermovement jump, and strength (peak isometric torque and peak isokinetic torque) assessments
Radiomics Multifactorial Biomarker for Pulmonary Nodules

The investigators aim to investigate the utility of radiomics to differentiate malignant nodules from benign nodules and invasive adenocarcinoma from non-invasive adenocarcinoma.

With the development of computed tomography (CT) equipment and the increasing use of lung cancer screening programs with low-dose CT, a growing number of early-stage lung cancers were detected so that a large number of patients have undergone surgery.

Although a number of radiological studies have been used morphological signs so-called semantic features to make a differential diagnosis, it is still hard to apply by clinician because pulmonary nodules especially ground-glass nodules and small size nodules have atypical radiology signs and have strong subjectivity from different observers. Recently, CT-based radiomics, extracting the quantitative high-throughput features from medical images and facilitating clinical decision-making system, showed a good performance to predict diagnosis and prognosis of diverse cancer.

Therefore, the proposed project aims to develop and validate radiomics models based on CT images to identify malignant nodules and then to discriminate the different types of lung adenocarcinoma in patients with pulmonary nodules.

Eligibility Criteria:
Inclusion Criteria:

* intraoperative frozen section diagnosis and final pathology diagnosis are available
* preoperative standard non-enhanced CT is available
* Pathologically confirmed

Exclusion Criteria:

* with a previous history of radiation therapy, chemotherapy or biopsy
* the time interval between the CT examination and surgery was more than two weeks