cyrilzakka/clinical-trials huggingface dataset:
A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain

The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in patients with pain associated with osteoarthritis of the knee.

The study will be randomized, double blind, placebo and active control, a 3-way, 3-period crossover design, where each of the estimated 50 enrolled patients will receive alternately (i) NEO6860 (500 mg bid), (ii) placebo and (iii) Naproxen (500 mg bid). To ensure blinding, double dummy techniques will be used, so that at each period, patient will receive an oral liquid suspension (NEO6860 or its placebo) and one capsule (naproxen or its placebo).

Following a screening period, a maximum of 28 days before dosing, subjects will be randomized to one of the scheduled sequences. At each dosing period, subjects will be requested to participate in 2 clinic visits:

* One residential visit, the morning of investigational product dosing. Subjects will stay in the Clinical Research Unit approximately 13 hours
* One end of period visit, 24 h after first dosing A total of 2 washout periods of 1 to 3 weeks will separate the dosing periods. Once the 3 dosing periods will be completed, the subjects will come back to the clinic for a follow up visit (7 to 10 days post last dose).

Note: for a subpopulation, at one site, an assessment of heat pain threshold and tolerance will be conducted requiring a residential period of approximately 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive;
* Patients diagnosed with osteoarthritis of the knee, according to American College of Rheumatology (ACR) guidelines, by meeting at least 3 of the following: age \> 50, morning stiffness \< 30 minutes, crepitus on active motion, bone tenderness, bone enlargement, no palpable warmth of synovium;
* Grade I, II or III using Kellgren-Lawrence classification on an X-Ray of the knee
* WOMAC pain subscale ≥ 8
* R square of the Focused Analgesia Selection Task (FAST) outcome value greater than 0.70

Exclusion Criteria:

* Patients with, or with a history of, any clinically significant disorders (including fibromyalgia and other painful disorders) which may interfere with the primary objectives of the study
* Patients treated in the previous 3 months with topical capsaicin or intra-articular corticosteroids;
* Patients with a contra-indication for the use of Naproxen or acetaminophen;
The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans

Cataract is globally the most common cause of blindness and in Denmark the operation with - 50.000 treatments per year - is the most common eye operation. The cause of cataract is growth and denaturation of the lens proteins. This leads to an increased absorption of blue light and increased light scatter. This may affect newly discovered cells in the retina that are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is not synchronized with the external day and night a phase-shift occurs. Most people know of this discomfort as jet-lag, but the consequences may be much more severe such as heighten risk of cancer and cardiovascular disease.

The goal of this project is to study how the circadian regulating cells of the retina is affected by cataract and by the operation. Cataract patients are studied before and after the operation with questionnaires, hormone and activity measurements and with a specialized pupil measurement that measures the indirect response of the circadian regulating cells to blue light.

Results from this study aim to shed light on the regulatory mechanisms of the eye on the circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular lens is evaluated. This may have impact on clinical practise especially with regard to choice of intraocular lens and widened indications for cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age related/senile bilateral cataract
* Eligible for phaco-emulsification on both eyes

Exclusion Criteria:

* Known eye disease other than cataract.
* Known systemic disease, which may affect the retina (untreated hypertension, DM etc.)
* Known systemic disease, which may affect the lens.
* Known psychiatric disease.
* Known sleep or circadian rhythm disorder, not caused by lowered blue light transmission by the lens.
* Per- and post operative complications
* Use of drugs that may affect the sleep.

For a subpopulation also:

* Poor cooperation.
* Severe refraction abnormalities.
* Previous eye surgery
* Nystagmus
* Congenital or acquired abnormalities of: eye lids and eye area, cornea or iris.
* Use of medicine that may affect the pupillary response.
* Use of drugs that may affect the pupillary response.
Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children

Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as well as future behavior related to dental problems in children. A common cause of such anxiety and fear is the procedural intervention that uses needles and syringes since a visual impact due to the needle acts as a deterrent to the child's cooperation during dental procedures. We therefore improvised the syringe such that it will camouflage the needle. We hypothesized that the use of this needle will alleviate the child's anxiety and therefore will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group randomized trial to test the efficacy of the camouflage syringe as compared to the conventional syringe in children.

The present study was conducted with an aim to evaluate the efficacy of a needle-covering camouflage syringe as compared to the conventional syringe in reducing dental anxiety and fear in children. The study was carried out in 100 children who consecutively reported to the study center and were allocated to the camouflage syringe arm or conventional syringe arm using block randomization to ensure equal distribution across trial arms. The study assessed the degree of dental anxiety and fear using Venham's clinical rating scale in conjunction with rating scale for movement, crying and overall behavior and Venham's Picture Test. The study also assessed parental emotional stress status when the child underwent the injection procedure and the reaction of the child after going home by Parental Emotional Stress Questionnaire and Recall Questionnaire, respectively. The study used appropriate statistical methods to determine the efficacy of the camouflage syringe in reducing the anxiety and fear.

Eligibility Criteria:
Inclusion Criteria:

* Children reporting to study center with dental problems
* Dental procedure requiring local anesthesia
* Informed consent from the parents

Exclusion Criteria:

* Mentally challenged children
* Medical problems negating use of local anesthesia and/or surgical intervention
Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. Eligible teams with written consent are randomized to the intervention or control arm by random number generator. Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. Teams in the control arm will continue with usual clinical care.

The aim of the EPIC trial is to assess if a multicomponent computer-based system incorporated into the workflow can reduce days of therapy (DOT) per admission after cardiovascular surgeries in the intervention surgical teams compared with controlled surgical teams, over a one-year period. This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. Eligible teams with written consent are randomized to the intervention or control arm by random number generator. Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. Teams in the control arm will continue with usual clinical care. The intervention includes re-evaluation alerts and decision support for the duration of antimicrobial treatment, re-evaluation alerts and decision support for the choice of antimicrobial, and quality control audit and feedback. Nine teams per arm with an average size of 1125 admissions will be recruited. Primary outcome will be the overall systemic antibiotic use measured in DOT of systemic antibiotic use per admission. Secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption and user compliance/satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age;
2. Receiving at least one open-chest cardiovascular surgery during the same admission.

Exclusion Criteria:

1. Intravenous or oral antimicrobial use within two weeks before surgery;
2. Emergent/urgent surgery;
3. Admitted for isolated stenting or heart transplantation or implantation of ventricular assist device or implantation of extracorporeal membrane oxygenation;
4. Admitted for subacute bacterial endocarditis;
5. Length of ICU stay over 48 hours.
Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules

The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed to evaluated the added value in BI-RADS 4A nodules

Eligibility Criteria:
Inclusion Criteria:

patients with nodules which were sonographically classified as BI-RADS 4 A breast lesion

Exclusion Criteria:

(i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel

Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.

Small bowel capsule endoscopy is considered the diagnostic gold standard in the diagnosis of diseases of the small bowel. Most indications for capsule endoscopy are overt small bowel bleedings - defined as gastrointestinal bleeding after negative gastroscopy and colonoscopy - or occult iron deficiency anemia. Timing of small bowel capsule endoscopy seems to be decisive for the diagnosis of small bowel bleeding: corresponding to the actual guidelines the detection of small bowel bleeding can be up to \> 70% if the intervention is performed within 2 days. Treatment of small bowel bleedings can be performed with small bowel enteroscopy such as balloon or motorized spiral enteroscopy. Against this background this study investigates the rate of small bowel bleeding diagnosed in capsule endoscopy. The aim of the study is to report tumorous, vascular and inflammatory findings as well as complications and cecal accessibility. One focus of the study is the time between small bowel bleeding and small bowel capsule endoscopy and small bowel enteroscopy, respectively. Endoscopic therapies and further bleeding episodes are recorded. In order to determine the improved clinical outcome after the introduction of the shortened timing for recommendation published in 2022, a retrospective cohort should be included in addition to a prospective cohort.

Eligibility Criteria:
Inclusion Criteria:

* suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy
* informed consent

Exclusion Criteria:

* contraindications for small bowel capsule endoscopy (e.g. stenosis)
tACS Improves Memory in Elders With Subjective Memory Complaints

Subjective memory complaints (SMC), the main cognitive component of which is event memory, is a predictor of Alzheimer's disease in elderly people. The purpose of this study was to investigate the effect of transcranial alternating current stimulation (tACS) with theta frequency (6 Hz) on the medial prefrontal cortex in the improvement of episodic memory in individuals with SMC in a double blind, randomized, and sham-controlled parallel study. Sixteen participants with SMC received either active or sham theta tACS on the medial prefrontal cortex (mPFC). EEG was recorded and Rey Auditory Verbal Learning Test (RAVLT) was administered. The aim of the current study was to see if theta tACS over the mPFC can improve event memory in individuals with SMC and thus can be considered a potential therapeutic intervention for this population or not.


Eligibility Criteria:
Inclusion Criteria:

* Being 50 or older,
* Mini Mental State Examination (MMSE) grade from 27 to 30
* Total score of 58 or more on the Everyday Memory Questionnaire (EMQ)
* no indications of depression and anxiety measured by Geriatric Depression Scale (GDS) and State-Trait Anxiety Inventory (STAI)
* No sign of dementia based on Diagnostic and statistical manual of mental disorder, 5th edition (DSM-V) criteria

Exclusion Criteria:

* History of a major psychological or neurological condition
* History of head trauma leading to unconsciousness,
* Presence of metal in the head
* History of seizures
* Serious cardiovascular disease
* Use of medications with an impact on cognitive functions
* Recent use of alcohol or substance abuse
The Practice of Providing Palliative Care in the Situation of the COVID-19 Pandemic

The practice of providing palliative care in the situation of the COVID-19 pandemic in the perspective of physicians and nurses - survey study (PEOpLe-C19 study)

Pandemic of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus 2) causing the disease COVID-19 (Coronavirus Disease 2019) overwhelmed healthcare and brought new challenges and stressful situations. In a short time, intensive care units (ICU) capacities were filled in many countries and regions. Due to the need for an excessive number of patients requiring intensive care, physicians and nurses who do not routinely provide care to critically ill patients or do not have the appropriate training (non-ICU clinician) were involved in the care of COVID-19 patients. In this context, ICU directly dedicated to caring for patients with COVID-19 ARDS (Acute Respiratory Distress Syndrome) was also opened. Non-ICU clinicians were more or less involved together with the standard ICU staff in palliative care, including End-of-Life decision (EOLD) making, even in a situation of limited, scarce resources (equipment or personnel). New workplace and scope of work, which did not correspond to the standard activity or education, most likely led to an increased stress load. EOLD can also be one of the factors leading to increased stress levels. The project aims to describe the practice of palliative care for patients with COVID-19 in a situation of pandemic COVID-19 and to identify factors leading to possible moral distress related to EOLD.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare providers (physicians/nurses)
* Involvement in care for patients with COVID-19 admitted at intensive care unit

Exclusion Criteria:

* Non-ICU staff
* not involved in care for patients with COVID-19
Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs

To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Cryptosporidiosis infection.
* Life expectancy of at least 1 week.
* Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
* Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.

Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity or significant intolerance to macrolide antibiotics.
* Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.

Required:

* Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.
Nevada Initiative to Reduce Long-Term Foster Care

The evaluation of the Nevada Initiative to Reduce Long-Term Foster Care (LTFC) includes three populations. It will examine how the interventions SAFE- FC and FSE impact or relate to permanency outcomes for children most at risk for long term foster care and currently in care.

The project targets three populations of children. For populations 1 and 2, the study will evaluate an intervention known as SAFE-FC. The intervention aims to prevent long term foster care by providing tailored services and intensive engagement with all new families with children identified as unsafe (Population 1) and for cases that are currently in care and at risk of LTFC where reunification is the case goal (Population 2). Family Search and Engagement (FSE) is the intervention for Population 3; it involves intense search practices to identify possible permanency resources. For Populations 1 and 2 the study is a randomized, intent-to-treat design to measure safety and permanency outcomes. For Population 3 the evaluation will be a descriptive study to analyze relationships between the intervention approach and outcomes. Both studies aim to examine how the interventions (SAFE- FC and FSE) impact or relate to permanency outcomes for children most at risk for long term foster care.

Eligibility Criteria:
Inclusion Criteria:

* Children assessed to be unsafe via the Nevada Initial Assessment
* children in foster care with specific risk characteristics.

Exclusion Criteria:

-
Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus

The goal of this observational study is to learn if percutaneous transverse osteotomies for hallux valgus deformity are safe and effective. The main questions it aims to answer are:

1. What is the change in clinical patient reported outcome measures after minimally invasive bunion surgery
2. What severity of bunion deformity can be corrected with minimally invasive surgery
3. What factors may lead to recurrence of bunion deformity
4. What is the rate of complications following bunion deformity surgery

Researchers will retrospectively review a research registry containing prospectively collected clinical and radiographic deformity data collected as part of routine care.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of hallux valgus that has failed conservative treatment

Exclusion Criteria:

* Degenerative changes of first MTPJ
* Previous hallux valgus deformity correction surgery
Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico

Given the magnitude of the epidemic in Puerto Rico, congenital Zika virus infection may have devastating complications to a significant population of children, also affecting families and society at large. This proposal takes a critical first step to ensuring that children with exposure to congenital Zika virus infection receive the follow-up care they need for optimal clinical outcomes. We anticipate that lessons learned from this study may also positively impact models for adherence to early intervention services in Puerto Rico.

Overview:

Participants will be the primary caregivers (age ≥18 years) of children with possible congenital Zika virus infection. Participants will be recruited from the pediatric services of the University of Puerto Rico Medical Sciences Campus (UPR-MSC), as well as other clinics and community-based organizations in Puerto Rico. In the intervention, a community health worker (CHW) will deliver personalized sessions framed around a multi-media health communication tool. The CHW will deliver the intervention over a 6-month period.

Study procedures:

Participants will be the primary caregivers (age ≥18 years) of children with possible congenital Zika virus infection. Participants will be recruited via provider referral, peer referral, and flyers. Once an individual expresses interest in the study, a study staff member will screen that individual to assess eligibility. Individuals who are eligible will be invited to enroll through an informed consent process and complete a baseline interview. After completion of the baseline interview, study staff will randomize participants into an enhanced control condition (ECC) or intervention condition that receives an individually-tailored community health worker intervention. At trial exit, all participants, including the ECC group, will complete an in-depth assessment to measure their barriers to follow-up Zika-related pediatric services and provide feedback about their experience in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older and able to communicate in Spanish
* Being the primary caregiver of a child with possible congenital Zika virus infection

Exclusion Criteria:

* Those who are too sick/unable to understand the implications of their participation, those who are unwilling to participate.
Prognostic Prediction of NPC Based on MR Diffusion-weighted Imaging

The purpose of this study is to explore whether the imaging model based on RESOLVE-DWI sequence can exploiting the heterogeneity of nasopharyngeal carcinoma and indicate the prognosis, so as to provide intervention information for clinical decision-making. All patients were randomly divided into the training group and the validation group. Radiomics features extracted from T2-weighted, DWI, apparent diffusion coefficient (ADC), and contrast- enhanced T1-weighted were used to build a radiomics model. Patients'clinical variables were also obtained to build a clinical model. Model of training cohort was established using cross-validation for nasopharyngeal carcinoma prognosis by machine learning, including Logistics Regression, SVM, KNN, Decision Tree, Random Forest, XGBoost, and then, the model will be verified in the validation cohort. Area under the curve (AUC) of the Machine learning model was used as the main evaluation metric.


Eligibility Criteria:
Inclusion Criteria:

1. patients with nasopharyngeal carcinoma diagnosed by pathology;
2. complete clinical data and MR imaging data;
3. without radiotherapy, chemotherapy or operation before MR examination.

Exclusion Criteria:

1. incomplete follow-up data;
2. poor image quality and can not be used for analysis;
3. patients with other tumors in the past or at the same time.