cyrilzakka/clinical-trials huggingface dataset:
Effect of Simple Simulator-based Training on Initial Performance of Novices Iultrasound-guided Adductor Canal Block

This prospective descriptive study is effect of simple simulator-based training on initial performance of novices in ultrasound-guided adductor canal block. The main question is Can we improve performance on simple simultor-based training ultrasound-guide adductor canal block?. We evaluate in First-year residents in Anesthesiology, Faculty of medicine, PSU.


Eligibility Criteria:
Inclusion Criteria:

* First-year anesthesiology residents in faculty of medicine, PSU

Exclusion Criteria:

* Residents with previous experience in ultrasound-guide adductor canal block
Near Infrared Spectroscopy (NIRS)

This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.


Eligibility Criteria:
Inclusion Criteria:

* Is male or female
* Is of any race or ethnicity
* Is greater than or equal to eighteen (18) years of age
* Weighs greater than or equal to 40 kilogram
* Is not known to be pregnant
* Understands English
* Is undergoing aortic arch surgery with planned deep hypothermia circulatory arrest, either with or without select antegrade cerebral perfusion
* Is able and willing to provide informed consent

Exclusion Criteria:

* Is less than eighteen (18) years of age
* Weighs less than 40 kilogram
* Is known to be pregnant
* Does not understand English
* Has known sensitivity to adhesives
* Is unable or unwilling to provide informed consent
Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy

Investigators compared the patients' subjective postoperative symptoms and complications between the double lumen endotracheal intubated patients under general anesthesia and non-intubated patients under sedation and local anesthesia including

1. postoperative Visual scale of pain
2. postoperative sore throat/voice change
3. postoperative nausea/vomiting
4. intraoperative Arterial blood gas analysis
5. cost for anesthesia
6. morbidity

Thoracoscopic bullectomy for primary spontaneous pneumothorax is relatively simple and short procedure compared to other thoracic surgery. However, in the anesthetic preparation, complicated technique and procedures are needed including a double lumen endotracheal intubation, auscultation, and flexible bronchoscopic confirmation of the tube location, even during lateral decubitus position. The double lumen endotracheal tube has a bigger outer diameter. And postoperative sore throat and voice change can develop after the intubation procedure.

Recently, single lumen intubation using carbon dioxide gas instillation under general anesthesia during thoracoscopic surgery is reported. However, if safety and efficacy are warranted, thoracoscopic surgery using nonintubated and self-ventilated anesthesia will be a best solution for above mentioned postoperative discomforts.

Investigators designed the comparative study of nonintubated local anesthesia under sedation and intubated general anesthesia in thoracoscopic bullectomy through the single port. Investigators will investigate postoperative pain, sore throat, voice change, nausea, vomiting, and intraoperative arterial blood gas analysis.

This study will be performed at Korea University Ansan Hospital. A total of 40 patients will be enrolled (20 patients in each arm).

Eligibility Criteria:
Inclusion Criteria:

1. primary spontaneous pneumothorax
2. Age between 13 and 30
3. ASA score 1,2
4. written informed consent

Exclusion Criteria:

1. A history of previous bullectomy or ipsilateral thoracic operation
2. Pregnant or lactation female
3. A cognition or mental dysfunction
4. Consumption of oral sedatives
5. A present sore throat or hoarseness
6. ASA score greater than 3
Niclosamide for Mild to Moderate COVID-19

This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).

Niclosamide, which has potent antiviral activity against single-stranded RNA viruses including coronaviruses, was proposed as an antiviral during the Severe Acute Respiratory Syndrome (SARS) outbreak in 2002 and has activity including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) where it was found to inhibit SARS coronavirus, SARS-CoV, in in vitro studies and similarly structured RNA viruses (both in vitro and in vivo). The investigators hypothesize that the antiviral activity of Niclosamide may be extended to COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 test by PCR
* No requirement of oxygen supplementation
* Ability to take oral medication

Exclusion Criteria:

* Known allergic reactions to any components of Niclosamide medication
* Participation in another trial or use of any experimental treatment for COVID-19, including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir
* Hospitalization or requirement of hospitalization at the time of enrollment
Body PSOriasis: Long-term Relapse CONTROL

This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will map actual strategies and focus on patients' and dermatologists' experience with the different topicals used, including unspecified products with and without active drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patients planned to receive topical treatment of any kind to prevent relapse of symptoms
* Written informed consent

Exclusion Criteria:

* Contraindications to selected treatment
* Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled.

The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

This is a single center prospective randomized controlled study at Brigham \& Women's Hospital (BWH), a teaching hospital of Harvard Medical School. Patients with clinical and MRI findings of shoulder tendinopathy, moderate to severe shoulder pain (VAS \> 40), and pain refractory to at least 6 months of physician directed conservative therapy will be eligible for enrollment.At screening patient will undergo a shoulder MRI to evaluate for tendinopathy, and patients with complete full thickness tendon tears will be excluded.

Patients will be randomized to either the TAE +PT or PT group. Patients in the TAE + PT group will undergo angiography to evaluate branch shoulder arteries for hyperemia. If hyperemia is present, then embolization will be performed. This treatment will be followed by 3 months of structured PT. Patients in the PT group will undergo 3-months of structured physical therapy with isolated eccentric exercises.

Eligibility Criteria:
Inclusion Criteria:

1. Male, female, transgender female, transgender male, non-binary
2. Moderate to severe shoulder pain (VAS \> 40)
3. Pain refractory to at least 6 months of physician-directed conservative therapy (analgesics or injections or PT), including a minimum of 6 weeks of PT
4. Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy

Exclusion Criteria:

1. History of peripheral arterial disease or peripheral artery disease symptoms including claudication, diminished or absent upper/lower extremity pulses, or known upper extremity arterial atherosclerosis or occlusion that would limit selective angiography
2. Known history of anaphylaxis to iodinated contrast agents or gadolinium based contrast
3. Acute kidney injury
4. Allergy to poppy seeds or lipiodol
5. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 obtained within 30 days of procedure.
6. Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.8 within 30 days of procedure
7. Active systemic or local upper extremity infection
8. Patient pregnant, intending to become pregnant during the study.
9. Prior shoulder replacement surgery
10. Prior rotator cuff repair surgery
11. Previous history of complete full-thickness tear of the rotator cuff
12. Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker).
A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).


Eligibility Criteria:
Inclusion Criteria:

Cisplatin Combination Expansion:

Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the metastatic setting.

* Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell lunch cancer that are candidates for treatment with a docetaxel-based combination.
* Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian cancer or non small cell lunch cancer that are candidates for a cisplatin-based combination.
* Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+ esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch cancer that are candidates for treatment with a dacomitinib-based combination.
* Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
* Eastern Cooperative Oncology Group \[ECOG\] performance must be 0 or 1.
* Adequate bone marrow, renal and liver function.

Exclusion Criteria:

* Prior therapy for Cisplatin Combination Expansion:

  * Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic setting;
  * Prior radiation to \>25% bone marrow as estimated by the Investigator.
* Patients with known symptomatic brain metastases.
* Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the lead-in dose.
* Major surgery within 4 weeks of the baseline disease assessments.
* \>2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.
* Active bacterial, fungal or viral infection.
* Uncontrolled or significant cardiovascular disease.
Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis

The clinical diagnosis of sleep apnea is difficult among ESRD patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the evaluation of patients with possible sleep apnea is the same among ESRD patients as in the general population.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and able to give written informed consent to the study
* On chronic hemodialysis for ≥ 90 days at time of enrollment
* Ability to read
* Consent to have video recording taken during study visit

Exclusion Criteria:

* Subjects with cognitive impairment to consent
* Sickle cell anemia
* Prescription of nasal oxygen
* Simultaneous participation in another clinical trial that may affect breathing frequency/patterns, blood oxygenation, sleep/wake cycle or other parameters related to the outcomes of interest to this study
* Use of a breathing device, e.g. CPAP
* Central venous catheter used as vascular access for hemodialysis
* Artificial fingernails (may disturb the measurement of the WatchPAT)
* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
* Permanent pacemaker
* Sustained non-sinus cardiac arrhythmias.
Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing

The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.

To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).

Eligibility Criteria:
Inclusion Criteria:

* At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown
* Patients of legal age (≥18 years old)

Exclusion Criteria:

* Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c \> 7% or \>53 mmol/mol)
* Pregnant or lactating patients
* Severe smoking (\>20 cigarettes/day)
* Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck)
* Patients who missed study control visits
* Patients who have received systemic antibiotic therapy in the last 2 months
* Patients with allergies to any of the components used in the study, namely to erythritol
* Implants that have previously undergone surgical treatment for peri-implantitis
* Implants with bone loss greater than 2/3 of their length and/or mobility
Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics

A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.

The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product.

During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily.

Infant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. In addition, sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be collected. Mothers will be asked to complete electronic questionnaires daily during the course of the study.

Eligibility Criteria:
Infants to be enrolled at birth.

Inclusion Criteria for Infants (study subjects)

* Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks
* Birthweight more than 2500 g
* No exposure to oral or intravenous antibiotics
* No complications that need medical interventions (e.g. respiratory distress symptoms or infections)
* Both legal guardians provided voluntary written informed consent on behalf of the infant

Pregnant women:

* Women age above 18 years at informed consent
* Singleton pregnancy
* Uncomplicated pregnancy
* No use of medication
* Aim to give birth vaginally and breastfeed
* No use of probiotics during the last month before estimated birth and until six weeks postpartum
* Provided voluntary written informed consent

Exclusion criteria for Infants (study subjects)

• Admission to the neonatal intensive care unit (NICU)
An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia

This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic lymphocytic leukemia treated with rituximab (MabThera)
* rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles
* informed consent to data collection

Exclusion Criteria:

* participation in an interventional clinical study
Breakfast Cereals Consumed in Dairy and Non-dairy Medium: the Effects on Blood Glucose, Satiety and Food Intake

The effects of dairy-free products consumed with a breakfast meal on food intake and glycaemic regulation remain unexplored. It is known that dairy products are an excellent source of protein, low glycaemic sugar lactose, calcium, and vitamin D. In our recent study the consumption of a dairy snack with high protein content resulted in reduced blood glucose response compared to non-dairy snack with the similar amount of available carbohydrate. The investigators hypothesize that the ad libitum intake of breakfast cereals served with a high-protein fermented dairy product will result in reduced and sustained blood glucose response compared to non-dairy control. The objective of this study is to investigate how dairy and non-dairy cultured products used as carriers for breakfast granola cereals and consumed ad libitum affect short-term food intake, satiety, and glycaemia within two hours.


Eligibility Criteria:
Inclusion Criteria:

* Healthy females

Exclusion Criteria:

* Overweight or obese
* Breakfast skippers
* Have any chronic metabolic diseases
* Smokers
* Taking medications
Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Participating families will meet with a nurse 6 times or receive 6 educational handouts. Participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.

The present study is assessing the feasibility and preliminary effectiveness of a brief behavioral intervention to enhance children's sleep and prevent development of obesity. Fifty short sleeping (\< 9 hours/night) children 6-11 years old who are primarily AA/Black and from lower socioeconomic backgrounds will be enrolled into a 6-month study. Children will be randomly assigned to 1 of 2 conditions: 1) optimize sleep primary care (OSPC; behavioral intervention to enhance sleep duration delivered by a nurse in primary care) or 2) enhanced usual care (EUC; usual care plus sleep education). All children will receive standard pediatric care. Families randomized to OSPC will receive a four-session intervention (two zoom-delivered sessions and two brief phone follow-ups) over the first two months with two additional phone follow-ups during maintenance (months 2-6). Families randomized to EUC will receive sleep education that is delivered at the same points of contact as OSPC sessions. At baseline, end of treatment (2 months), and 6 months, the following will be measured from a Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) perspective: reach (e.g., enrollment), adoption (e.g., pediatric provider engagement), implementation (e.g., session attendance, treatment fidelity), maintenance (e.g., retention), and preliminary effectiveness (e.g., changes in sleep duration (actigraphy), eating behaviors (24-hour dietary recalls), physical activity (accelerometry), and anthropometrics (measured height and weight).

Eligibility Criteria:
Inclusion Criteria:

* Patient at Temple Pediatrics
* Child age 6-11 years
* Child time in bed of less than 9 hours per night on most days per week
* Body Mass Index (BMI) for age and biological sex great than the 10th percentile but less than the 95th percentile
* Understanding of and ability to complete the protocol
* Parent age at least 18 years and primary caregiver
* Willingness to be randomized to either condition

Exclusion Criteria:

* Diagnosed sleep disorder
* Medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status
* Current or planned treatment for weight control
Mapping of Electrical Properties in the Brain

This study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis.

PRIMARY OBJECTIVES:

I. Optimize pulse sequence acquisitions for diffusion imaging on clinical MRI vendor systems.

II. Develop image-based MRI models (including diffusion-based MRI) that accurately depict the multi-regional electrical properties in the brain (e.g., resistivity, current) to inform of neural integrity and function (including white matter tract integrity) in diseased and non-diseased states.

III. Compare/correlate image-based MRI models (e.g., diffusion) with existing structural, physiologic, and functional MRI methods (e.g., tensor imaging, fMRI, DSC-MRI, etc).

IV. Further train image-based models/measurements with loco-regional benchmarks including (but not exclusive to) electrophysiologic monitoring, functional and structural tissue assays (from available biopsies), and correlative clinical features (e.g., histology, outcomes, treatment, etc).

OUTLINE: This is an observational study.

Participants complete a survey and undergo MRI on study.

Eligibility Criteria:
Inclusion Criteria:

* Aim 1: normal healthy volunteers
* Aim 2, 3, 4: participants included in IRB 16-002424, including those that have undergone surgical biopsy/resection for suspected or known glioma

Exclusion Criteria:

* Healthy volunteer unable to have an MRI