cyrilzakka/clinical-trials huggingface dataset:
taVNS on Pupillary Response and Perceptual Learning

This study has two parts. The study team will evaluate transcutaneous auricular vagal nerve stimulation (taVNS) and two sham settings during a passive task while measuring pupillary response. Second, the study team will assign either taVNS, sham, or no intervention during a go/no-go task and evaluate perceptual learning over three sessions which will also include measuring the pupillary response and electroencephalogram (EEG).


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals 18 to 65
* Normal audiometric testing

Exclusion Criteria:

* Co-morbidities including cardiomyopathies, arrhythmias
* Implantable devices including vagal stimulators, pacemakers
* Presence of metallic implants
* Pregnancy
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model

This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo control in the respiratory syncytial virus challenge model.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years, inclusive.
* In good health with no history of major medical conditions
* A total body weight ≥ 50 kg and a body mass index (BMI) of \> 18kg/m2.

Exclusion Criteria:

* Acute or chronic medical illness
* Positive for Human Immunodeficiency Virus, Hepatitis B or C
* Nose or nasopharynx abnormalities
* Abnormal lung function
Targeting Insomnia to Improve Outcomes in Adults with Problematic Cannabis Use

This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported chronic insomnia
* Insomnia Severity Index (ISI) score indicative of at least mild insomnia
* Cannabis Use Disorder Identification Test-Revised (CUDIT-R) indicative of at least problematic cannabis use
* A positive urine drug screen (UDS) for cannabis
* Self-reported use of cannabis to manage insomnia at least three times weekly for the past month
* Stable residence (e.g., stable sleep arrangements), consistent access to Wi-Fi, and ability to travel to Ann Arbor for sleep laboratory assessments

Exclusion Criteria:

* Individuals who do not understand English
* Individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence)
* Diagnosis or high suspicion of a sleep disorder other than insomnia
* Diagnosis of psychotic disorder, bipolar disorder, or post-traumatic stress disorder
* Terminal or progressive physical illness (e.g., cancer) or neurological degenerative disease (e.g., dementia)
* Use of medications known to have initiated their insomnia (e.g., steroids)
* Previous receipt of CBTi
* Self-reported pregnancy
* Self-reported regular work schedule of rotating or night (3rd) shift work.
Nutrition Insights Day Asia

This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered.

This study aims to obtain a contemporary overview of the nutritional status, the use of EN and/or PN and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected Asian countries.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients after elective major abdominal gastrointestinal surgery \[i.e. elective major GI resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)\] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications\*, with indications for nutritional support
2. Hospitalization on SICU or major surgical ward on the NID
3. Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
4. If patient received oral nutrition (ON) or oral nutrition supplements (ONS) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available
5. Latest surgical intervention ≤ 10 days before NID

Exclusion Criteria:

1. Patients with burn injuries
2. Patients requiring postsurgical mechanical ventilation and sedation on the NID
3. Patients receiving ON and/or ONS at any quantity on the day before the NID
4. Patients requiring emergency procedures
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy

The primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cNEP) to the upper airway as a means of preventing episodes of respiratory impairment (RI) such as hypoxemia, apnea and hypoventilation associated with the use of intravenous sedation in elective colonoscopy in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects undergoing elective colonoscopy at the Study Site who have fewer than three or more than three positive responses on the STOP BANG questionnaire

Exclusion Criteria:

* Presence of severe cardiopulmonary or neurologic disease as determined by the investigator
* History of vascular fragility associated with cutaneous pressure
* History of hypersensitivity to silicone
* Inability to properly fit cNEP collar to the subject
* The presence of excessive facial hair in the region where the cNEP collar is positioned
* Known carotid vascular disease, previous major neck surgery or radiation therapy to the cervical region
* Presence of anatomical abnormalities in the neck or pharyngeal region (such as enlarged tonsils)
* Inability to provide informed consent
Cardiovascular Health Improvement Project

The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.

The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls. The aims of the study are to collect biological specimens (blood, plasma, serum, aortic tissue) and family history; establish a biobank, establish a comprehensive database with information from consented patients, and provide researchers with high quality well annotated DNA samples with demographic and clinical information.

Eligibility Criteria:
Inclusion Criteria:

* Any patient over the age of 18 who is able/willing to give informed consent
* Patients \<18 years of age with parental consent and assent (if assent is applicable for their age)
* Diagnosis of:
* aortic pathology potentially due to a known or suspected inherited condition
* Idiopathic aortic aneurysm
* Interesting of novel vascular pathology in the aorta or main branches
* Family history of aortic or vascular disease
* Other cardiovascular disease
* Healthy controls with no apparent cardiovascular disease

Exclusion Criteria:

- Not willing or able to sign the consent
Colorectal Cancer RECHALLENGE

Primary Objective:

* To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy.

Secondary Objective:

* To evaluate other measures of tumour's responses and safety.


Eligibility Criteria:
Inclusion criteria:

* Histologically proven adenocarcinoma of colon or rectum
* Measurable metastatic disease, either inoperable, or residual after surgical procedure
* No prior chemotherapy for metastatic disease
* For colon cancer: prior adjuvant chemotherapy with oxaliplatin that ended at least 12 months prior to enrollment.
* For rectal cancer: at least 12 months since prior use of oxaliplatin in neoadjuvant or adjuvant chemotherapy
* Adequate liver and kidney function:

  * Total bilirubin inferior to 1.5 ULN
  * Serum Creatinine inferior to 150 umol/L
  * Creatinine clearance (ClCr) \> 30 mL/min
  * ALT / AST inferior to 3 ULN
* Adequate hematological function

  * Neutrophils \> or equal 1.5 x 109/L
  * Platelets \> or equal 100 x 109/L

Exclusion criteria:

* Metastatic disease presenting without prior adjuvant chemotherapy
* Metastatic disease presenting after non-oxaliplatin-containing adjuvant chemotherapy
* Peripheral sensory or motor neuropathy \> grade 1
* Eastern Cooperative Oncology Group (ECOG) Performance status \> 2
* Other active malignancy
* History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to Leucovorin or to any ingredients in the formulations or the containers
* Patients who are pregnant, or breast-feeding
* Patients with severe renal impairment (ClCr \< 30 mL/min)
* Pernicious anemia or other megaloblastic anemia with Vitamin B12 deficiency
* Patients with reproductive potential not implementing accepted and effective method of contraception (the definition of effective method of contraception will be based on the investigators' judgment)
* Participation in another clinical trial with any investigational drug within 30 days prior to study screening
* For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with know hypersensitivity to any components of the product and to Chinese hamster ovary cell product or other recombinant human or humanized antibodies
* Presence of any symptoms suggesting brain metastasis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Does Gloved Medical Personnel Scratch Less Often?

Unconscious touching of a person's own head or neck (for example by scratching) is a frequently observed and completely normal physiological movement pattern in humans, which when done by medical personnel attending a patient poses a high risk of unconscious self-contamination, even of an already disinfected hand, and of subsequent contamination of the patient. However, as compared to an ungloved hand, a gloved hand is felt to be "foreign," which could reduce the frequency of self-contact and thus the contamination rate.

Wearing protective gloves is highly recommended in medical practice. The purpose of this study is to explore how wearing, or not wearing, protective gloves affects

* the frequency of unconscious self-contact
* contamination of the gloved/ungloved hand


Eligibility Criteria:
Inclusion Criteria:

* Medical students working in a simulated OR environment
First Mobilization Protocol for Total Knee Arthroplasty Patients

This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms.

Ensuring the mobilization of patients in the postoperative period, preventing complications resulting from inactivity, maintaining homeostatic balance and accelerating recovery are among the important goals of nursing care. For this reason, it is necessary to gradually increase the patients in line with the evidence-based data and the importance of mobilization should be emphasized. In this study, it was aimed to develop the first mobilization protocol for patients undergoing total knee arthroplasty and to evaluate the effectiveness of the developed protocol on patients' state anxiety, kinesiophobia, initial mobilization related symptoms.

The research is planned to be conducted in the Orthopedics and Traumatology Clinic of a university hospital in Turkey. The protocol of the study will be completed with78 patients who meet the sampling criteria (39 interventions, 39 controls), although it was designed as a single-center, single-blind randomized controlled and prospective study. Patient Information Form, State-Trait Anxiety Inventory, Tampa Kinesiophobia Scale and Initial Mobilization-Related Symptoms Evaluation Form will be used to collect the data of the study. Study; It is a single-center and single-blind randomized controlled experimental study protocol.

The data obtained within the scope of the study will be explained after being collected and analyzed. The effectiveness of the first mobilization protocol developed for tolal knee arthroplasty patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older,
* First time knee arthroplasty surgery,
* Have not received a diagnosis that will prevent communication,
* No physical disability,
* Mobilized during the implementation process of the research,
* Bilateral arthroplasty surgery is not performed,

Exclusion Criteria:

* Revision surgery performed,
* Patients who have undergone total hip or knee arthroplasty before,
* Inability to perform or delay mobilization due to complication(s) developed in the postoperative period,
* The patient cannot be mobilized on the first postoperative day (in the first 48 hours),
* Desire to leave the research voluntarily.
Prospective Genetic Study in Patients With Ovarian Insufficiency

genetic screening and etiological analysis was conducted on patients with ovarian insufficiency and decline in ovarian reserve. All patients were enrolled in the IVF-treated and non-IVF-treated groups, followed up for long-term treatment outcomes and genomic screening.

The cause of ovarian insufficiency and decline in ovarian reserve are not clear, but most researchers think the probable causes are mainly three aspects: chromosomal abnormalities, genetic factors and autoimmune diseases，But the majority of patients with normal chromosome karyotype analysis. The screening of pathogenic genes in patients with normal karyotype is the focus of current premature ovarian insufficiency(POI) and decline in ovarian reserve(DOR) etiology, to further explain the pathogenesis of patients, improve the diagnosis of those diseases and Clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"

Exclusion Criteria:

* To rule out polycystic ovary syndrome（PCOS）, iatrogenic factors (such as surgery, radiotherapy and chemotherapy, etc.) lead to premature ovarian insufficiency in patients
UltraWee: Ultrasound Bladder Stimulation

The UltraWee study is a prospective randomized controlled trial used to compare the success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine (CCU) method and using ultrasound stimulation clean catch methods. The objectives of this study are to see if ultrasound stimulation increases success rate of micturition, decreases time to micturition, and decreases the use of more invasive techniques for urine collection.

Standard procedure for obtaining urine samples in the pediatrics emergency department consists of a clean catch urine (CCU). For those patients who are still pre-continent, this involves cleaning the genitourinary (GU) area with betadine followed with waiting with a specimen cup for the patient to produce urine.

Currently, the CCU technique has had mixed success rates of micturition, some studies showing as low as 12% success rate. Because of the mixed success rates, often times these patients are subjected to the discomfort and trauma of a urinary catheter. Catheterization also occurs in patients with clinical conditions that require urine samples under time sensitive conditions.

Less invasive ways of urine collections have been recently studied. The Quick-Wee study was a novel study that showed a promising alternative to obtaining urine samples in pre-continent children when compared to the CCU sample. This method served as a noninvasive way to obtain a urine sample, thus preventing uncomfortable and traumatic urinary catheterizations and improving parent satisfaction scores.

The investigators hope to study the effectiveness of another technique for obtaining a urine sample without urinary catheterization: ultrasound stimulation. By incorporating ultrasound evaluation of the bladder, the UltraWee study hopes to decrease the number of failed attempts at obtaining a urine sample in pre-continent children less than thirty-six months of age.

The UltraWee study will be a prospective randomized controlled trial comparing success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine method and using ultrasound stimulation clean catch methods. The objective of this study is to see if ultrasound stimulation increases success rate and decreases time to micturition.

Eligibility Criteria:
Inclusion Criteria:

* Pre-continent children
* Children between the ages of 1 month and 36 months
* Children who require a urine sample as part of their workup
* Children who are seen in the emergency department at University Hospital Downtown Campus

Exclusion Criteria:

* Children who are continent
* Children who are in foster care or who are wards of the state
The Influence of "Karate" on Bleeding in Hemophilic Patients.

Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.

none - Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.

Eligibility Criteria:
Inclusion Criteria:

* Severe Hemophilia.

Exclusion Criteria:

* No Inhibitors.
Anti-VEGF Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery

The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts.

Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery

Exclusion Criteria:

Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.

Patients with history of vitrectomy. Patients with neovascular glaucoma
An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer

This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult Chinese participants, \>/= 18 years of age
* Histologically confirmed and previously untreated metastatic colorectal cancer
* Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
* Documented participant with medical records

Exclusion Criteria:

* Recent history of serious hemorrhage or hemoptysis of \>/= 1/2 teaspoon of red blood
* Proteinuria at baseline (\>/=2 grams / 24 hours)
* Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds
* Pregnant or lactating women