cyrilzakka/clinical-trials huggingface dataset:
Mobile Sensing of Smoking Behavior

Smokers will use a smartphone app on a smartphone provided for the study that will passively sense and record information about their activities. Information collected from the smartphone app will be used to develop future smartphone apps that will predict when an individual is at risk of smoking.

Smokers will carry an Android-based smartphone, which they are to use as their own for one month. After using the smartphone for two weeks, they will abstain from smoking for 48 hours. The phone will passively sense and record information from onboard sensors and send that information to a central server. When server based algorithms detect a pattern of signals likely associated with smoking behavior, the smoker will be queried regarding their current state (smoking?, not smoking but likely to in the next 10 minutes?, etc.). Likewise, when smokers are about to smoke but were not queried, they can indicate they are about to smoke. This information will be used to update algorithms using machine learning techniques. As such, in this study investigators will gain knowledge that will increase understanding of antecedents of smoking behavior and improve the accuracy with which smoking risk can be detected.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* between the ages of 18 and 65
* smoking of at least 10 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for \> 1 year AND an afternoon expired CO concentration \>5 ppm (to confirm inhalation) or morning urinary cotinine \> 100 ng/mL
* willingness to carry and use a study smartphone as their own for one month

Exclusion Criteria:

* inability to attend all required sessions
* use of smokeless tobacco products
* current use of nicotine replacement therapy or other smoking cessation treatment
Endobronchial Intubation of Double-lumen Tube: Conventional Method vs Fiberoptic Bronchoscope Guide Method

Double lumen tube (DLT) needs to be intubated to isolate ventilations of left and right lungs for thoracic surgery. Post-operative sore throat and hoarseness are more frequent with DLT intubation than with single one. Which is may because DLT is relatively thicker, harder, sideway curved and therefore more likely to damage the vocal cord or trachea during intubation, and advanced deeper to the carina and main bronchus level. In the conventional method of intubation, DLT is rotated 90 degrees and advanced blindly to the main bronchus level after DLT is intubated through vocal cord using the direct laryngoscopy. After the blind advancement, the sufficient tube position needs to be gained and confirmed with the fiberoptic bronchoscope. In the bronchoscope guide method, after DLT is intubated through vocal cord using the direct laryngoscopy, the pathway into the targeted main bronchus is secured using the fiberoptic bronchoscope which is passed through a bronchial lumen of DLT. And then DLT can be advanced through the guide of the bronchoscope. In this study, we intend to compare post-operative sore throat, hoarseness and airway injury between the two methods. We hypothesize that the bronchoscope guide method can reduce the post-operative complications and airway injury because surrounding tissues of the airway can be less irritated by DLT intubation in the guide method than in a conventional.

For a constant guide effect, we use fiberoptic bronchoscopes with same outer diameter (4.1 mm) which can pass through a bronchial lumen of 37 and 39 Fr Lt. DLT and cannot pass through 35 Fr or smaller Lt. DLTs.

\<Lt. DLT size selection\>

* male: ≥160 cm, 39 French; \< 160 cm, 37 French
* female: ≥160 cm, 37 French; \< 160 cm, contraindication


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) class I - III
* Elective thoracic surgery
* Left-sided DLT intubation for one-lung ventilation

Exclusion Criteria:

* Female, height \< 160 cm
* Pre-existing sore throat, hoarseness or airway injury
* Duration of surgery \> 6 h
* Upper respiratory tract infection
* Cervical spine diseases
* Presence of tracheostomy
* Pharyngeal neoplasm or abscess which can induce mechanical airway obstruction
* Mallampati score 4
* Obesity (BMI ≥ 35 kg/m2)
* Obstructive sleep apnea (OSA)
* Craniofacial anomaly
* Cormack grade 3b or 4
* History or high risk of difficult intubation / difficult mask ventilation
* Patients whom the direct laryngoscopy cannot be used for, because of weak teeth or small mouth opening
* Patients who refuse to participate in the study or from whom receive informed consent cannot be received.
A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy
Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone

Postpartum depression is a serious illness that affects approximately 17% of women who have recently given birth. Untreated depression appears to have negative effects for both the mother and her baby. Postpartum depression is quite common among women with a history of depression. Sleeplessness is a common concern during pregnancy and after delivery, and it can also trigger depression in women with a history of depression. Antidepressants are the most commonly recommended drugs for prevention of postpartum depression; however, there is limited research to understand the effectiveness of the medications in preventing postpartum depression. Trazodone is a weak antidepressant, but it is commonly prescribed for sleeplessness due to physical or psychiatric disorders. We are planning a study to find out whether trazodone in a low dose is more effective than a sugar pill in preventing postpartum depression among women with histories of depression. We expect the results of our study will make it easier for healthcare providers to select the right medication for women who are at risk of developing depression after delivery and thus improve the mental health of mothers and well-being of their babies.


Eligibility Criteria:
Inclusion Criteria:

Healthy outpatients with a history of Major depressive disorder who are currently not on any psychotropic medications and who:

1. are 18- 45 years old,
2. are pregnant with gestation of 28-34 weeks,
3. have been in full remission of depression for \> 2 months (as per Diagnostic and Statistical Manual-5),
4. are able to communicate in English,
5. are capable of providing informed consent,
6. are planning to deliver at Victoria Hospital in London Ontario, and
7. live in London and the surrounding area, will be enrolled.

Exclusion Criteria:

1. current psychiatric disorder other than generalized anxiety,
2. use of psychotropic medication over the previous 2 months,
3. history of bipolar disorder or psychosis,
4. high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the Hamilton Depression Rating Scale-17 item \[HDRS\]),
5. currently receiving psychotherapy
Team-based Virtual Pediatric Cochlear Implant Clinic

The purpose of this study is to see if remote visits for pediatric cochlear implant patients are possible. The investigator will be assessing whether a multi-disciplinary team approach can be achieved remotely for patients both undergoing the cochlear implant (CI) process and for those who have already been implanted.


Eligibility Criteria:
Inclusion Criteria:

New patients undergoing CI evaluation:

1. English speaking patients (parents can speak English and/or Spanish)
2. Ages 0-12 years who are cochlear implant candidates and undergoing the evaluation process

Established CI recipients:

1. English speaking patients (parents can speak English and/or Spanish)
2. Ages 1-12 with at least 6 months of CI experience with a company that has remote programming capacity

Exclusion Criteria:

1. Patients with families who speak languages other than English or Spanish
2. Patients who do not live in Florida
3. Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass

The investigators designed this prospective observational study with the theory that alkalosis caused by decreased CO2 solubility due to temperature increase during the rewarming period of the Cardiopulmonary Bypass could be prevented by reducing the sweep gas flow during the rewarming period.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Elective CPB surgery

Exclusion Criteria:

* Patients undergoing minimally invasive surgery
* Patients undergoing robotic cardiac surgery,
* Patients undergoing deep hypothermia,
* Patients undergoing total circulatory arrest,
* Patients whose FiO2 requirement is high that cannot be applied to target gas flow
Woodsmoke Exposure and Cardiovascular Function

Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common air in many parts of the world and previous studies indicate that wood smoke induce oxidative stress in the respiratory tract. It is not determined how different types of biomass combustion affect human health. In this study the investigators plan to investigate how inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Use of regular medication except the oral contraceptive pill
* Current smokers
* Significant occupation exposure to air pollution
* Intercurrent illness
Avicena LVDP Validation Study in Healthy Volunteers

The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects \>21 years of age.
2. No known significant health problems.
3. Willing and able to participate in all study evaluations.
4. Ability to understand and sign informed consent.

Exclusion Criteria:

1. Open skin lesions at the site of Vivio application / examination.
2. Inability to obtain brachial artery blood pressure.
The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.

The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).

The purposes of the study is to assess the ability of the 6-Minute Walking Test (6MWT) as a reliable and standardized objective outcome assessment and its relation to already established subjective patient reported outcome measures in patients suffering from lumbar degenerative disc disease. We want to use an existing smartphone-application that uses global positioning system (GPS) coordinates to measure walking distance. Applying self- measurement of the 6MWT before and after a therapeutic intervention, we determine objective functional impairment (OFI) in patients. The results of this study add to the understanding of achievable objective outcomes after therapeutic interventions applied to patients with DDD and examines patients acceptance for smartphone based self-measurement.

Primary Objectives The primary objective is to determine the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD)

Secondary objectives are

1. to correlate objective functional impairment (OFI) with already established patient-rated outcome measures (PROMs) in the sense of cross-validation.
2. To correlate OFI, as determined by the 6MWT with OFI that is determined by another objective test, the TUG test
3. to then analyze the change in OFI in patients before and after surgical intervention
4. to determine whether patients prefer the objective (6MWT) or subjective (PROMs) repeated assessment of their functional condition.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for spine surgery with one of the following diagnosis (1) lumbar disc herniation (LDH), (2) lumbar spinal stenosis lumbar (LSS) or lumbar DDD with or without instability requiring lumbar fusion (transforaminal lumbar interbody fusion, posterior lumbar interbody fusion, or extreme lateral interbody fusion)
* Male and Female subjects ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Inability to walk (extreme pain or severe neurological deficits)
* Severe Chronic Obstructive Lung Disease (COPD) corresponding to ≥ Gold III
* Severe heart failure corresponding to ≥ New York Heart Association (NYHA) III
* Lung cancer and diffuse parenchymal lung disease
* Other medical reasons interfering with the patient's ability to walk and perform the 6MWT (e.g., osteoarthritis disease of the lower extremities, Parkinson's disease, heart failure, hip or knee prosthesis etc.)
* Unavailability for follow up and/or inability to complete assessment (planning to move, no smartphone, etc.).
Effects of Smoking State on Decision Making

Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-55 years
* Smokes cigarettes or e-cigarettes
* Negative urine drug screen

Exclusion Criteria:

* Unstable or serious medical or mental health condition
* History of serious head trauma
* Pregnancy
* Unsuitable for MRI
* Weight \> 350 pounds (maximum allowed for MRI)
Technology-Based Prevention for Adolescents in Primary Care

Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public health concern, and subsequently there is also a great need to prevent these behaviors and experiences. This project involves the adaptation and integration of evidence-based prevention content aimed at preventing and reducing substance use, sexual assault, and sexual risk behaviors. This project uses innovative technology within primary care visits to conduct a feasibility trial of an integrated prevention program.

Pilot feasibility trial in preparation for RCT. Adolescents aged 14-18 will be recruited for screening from community-based primary care clinics to ensure ease of dissemination and representation of community-based primary care settings. The primary goal is to develop feasibility to apply for an R01 to conduct an RCT. Power analyses indicate that 280 participants would be needed for an RCT after accounting for attrition. Given that the RCT would be conducted over a 3-year period, a recruitment rate of 8 adolescents per month would indicate feasibility for a larger RCT.

Eligibility Criteria:
Inclusion Criteria:

* Aged 14-18
* Recent visit to primary care doctor

Exclusion Criteria:

* Inability to comprehend English independently due to disability or language
Topical Antibiotic Prophylaxis for Eyelids

The investigators propose a prospective randomized control trial testing the hypothesis that routine topical antibiotic prophylaxis does not significantly reduce the rate of infection after eyelid surgery.

The use of prophylactic topical antibiotic therapy after eyelid surgery is widespread. Due to increasing antibiotic resistance, antibiotic-related complications, and healthcare costs, the investigators wish to determine whether prophylactic post-operative antibiotic ointment is truly necessary. After all, existing dermatology literature currently recommends against the routine use of antibiotic ointment after various surgical procedures (e.g. Mohs surgery). The investigators aim to perform a prospective randomized control trial at the University of California, San Francisco. The investigators aim to recruit a total of 400 oculoplastics patients undergoing eyelid surgery or surgery involving peri-orbital incisions from 2017 through 2019.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 and older who are undergoing various eyelid procedures in an office, ambulatory care center, or operating room including but not limited to:

* blepharoplasty (upper and lower lids);
* ectropion repair;
* entropion repair;
* external dacryocystorhinostomy;
* external levator resection;
* eyelid lesion removal and/or biopsy;
* eyelid reconstruction and defect repair including after Mohs surgery;
* fat pad excision (upper and lower lids);
* gold or platinum weight implantation;
* internal levator resection;
* lateral tarsal strip;
* orbital fracture repair requiring periorbital incisions;
* orbitotomy requiring periorbital incisions;
* tarsorrhaphy;
* wedge excision.
* Patients undergoing repeat procedures will also be included.

Exclusion Criteria:

* Patients aged younger than 18 years old who are undergoing the above eyelid procedures in an office, ambulatory care centers, operating rooms;
* patients undergoing chalazion removal;
* patients who have had previous wound infections at the site of the procedure;
* patients with oral or IV antibiotic use within 10 days prior to procedure;
* patients requiring IV antibiotics during the procedure;
* patients with grossly contaminated or inflamed wounds;
* patients with human or animal bites, patients with wounds resulting from trauma
* patients allergic to all study drug options.
Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure

The purpose of this study is to assess the response rate at 6 months in Myelodysplastic Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose decitabine who have previously failed therapy with 5-azacitidine.


Eligibility Criteria:
Inclusion Criteria:

1. Written signed informed consent.
2. ≥18 years of age.
3. Diagnosed MDS with 5% or more marrow blasts and IPSS risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts.
4. Patients who have failed therapy with azacitidine.
5. Performance status 0-2 (ECOG scale).
6. Adequate hepatic (bilirubin \< 1.5 X ULN or AST\< 2.5 X ULN) and renal functions (creatinine \<1.5 X ULN).

Exclusion Criteria:

1. Nursing and pregnant females.
2. Females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
3. Patients with previous malignancy or concurrent malignancy.
4. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
5. Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
6. Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
7. Patients who have received prior intensive combination chemotherapy or high-dose cytarabine (\>/= 1g/m\*2 per dose). (Prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
8. Patients who have an active viral or bacterial infection. Note: No patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
9. Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
10. Patients who have previously been treated with decitabine.
11. Patients who have known positive serology for HIV.
12. Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A

This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to \< 12 years of age and at least 25 subjects \< 6 years of age who have undergone \> 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe hemophilia A defined as \< 1% Factor VIII (FVIII) concentration (FVIII:C) documented in medical records,
* Males \< 12 years of age,
* Subjects who have received \> 50 EDs with a FVIII product,
* Prior PK data (at least incremental recovery and half-life) from previous FVIII exposure for subjects participating in the PK part
* Investigator believes that the subject is willing and able to adhere to all protocol requirements. Investigator believes that the subject's parent(s) or legally acceptable representative(s) is / are willing and able to adhere to all protocol requirements.

Exclusion Criteria:

* Any history of or current FVIII inhibitors
* Use of an Investigational Medical Product (IMP) within 30 days prior to the first rVIII-SingleChain administration,
* Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rVIII-SingleChain,
* Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein,
* Subject currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment,
* Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) values \>5 times (x) the upper limit of normal (ULN) at Screening,
* Subjects with serum creatinine values \>2 x ULN at Screening,
* Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months before Day 1,
* Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months before rVIII-SingleChain administration.