cyrilzakka/clinical-trials huggingface dataset:
Smoking, Sex Hormones, and Pregnancy

The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence

The sample population will consist of oral contraceptive users, both "low" and "high" dose levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants will complete data collection procedures including providing saliva (cortisol to measure stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab session after a 14-hour abstinence. These sessions will contain a nicotine challenge via smoking a cigarette or nasal spray with timed-series physiological, subjective, and behavioral responses.

Eligibility Criteria:
Inclusion Criteria:

* currently taking oral contraceptives
* English fluency
* Ability to provide informed consent

Exclusion Criteria:

* use of progestin only contraceptive
* pregnancy
Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
* No previous treatment with insulin and/or SU agents
* HbA1c between 7.5% and 10.0%
* Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic function
* Impaired renal function
* Cardiac diseases
* Uncontrolled hypertension
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Current treatment with systemic corticosteroids
Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC

The purpose of this study is to establish the genetic profile of families in British Columbia with HME.

The purpose of this study is to establish the genetic make-up of families and patients with HME. This will occur as the patient presents to a regular clinic visit. Dr. Alvarez will be introduced to interested patients and their parent(s) and a brief discussion about the project will occur. If the patient and their direct family are interested they will be entered into the study. This will involve interviewing the patients and their direct family. This interview will take about 1 hour. We are interested in identifying all affected family members as far up the family tree as possible. We ask that the idea of the study be introduced to extended family members by the participating family members and then have them call Dr. Alvarez to set up an appointment. Each available member will be interviewed and a physical exam done to determine the location of osteochondromas. In addition, Xrays will be done to determine the location of all osteochondromas. All Xrays will be reviewed. No new ones will be taken unless it is part of the patient's routine care.

To complete the genetic work up DNA analysis will be done on all available family members. This will entail obtaining a blood sample from each family member willing to partake in the study. These blood samples will be used only for the purpose of identifying abnormalities in the genes related to osteochondromas. The blood samples will be taken at British Columbia's Children's Hospital and processed there. DNA samples will be kept confidential.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HME
A New Track Ablation Device for Liver Biopsy: A Feasibility Study

The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.

Background:

* Percutaneous biopsy for hepatic masses has a potential risk of bleeding and peritoneal tumor seeding.
* A new device for biopsy track ablation has been invented to reduce the risk of bleeding and peritoneal tumor seeding.

Method:

* Routine percutaneous biopsy for hepatic masses is performed.
* Immediate after obtaining tissue, biopsy needle track is ablated with a new biopsy tract ablator.
* Immediate (with ultrasound) and 24 hours (with CT scan) after procedure, occurrence of complications is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients with a hepatic mass on CT scan or MRI
* patients who are referred for percutaneous biopsy of a hepatic mass
* patients with normal range of platelet count and coagulation test

Exclusion Criteria:

* pregnant women
* patients with ascites
* Uncooperative patients
The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.

This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time.

In this study, elderly DLBCL patients will be treated with ZR2 regimen for the first-line treatment. Investigators will compare the complete response rate, survival and incidence of adverse reactions between the RCHOP/RCDOP chemotherapy and the ZR2 regimen. In addition, immune function tests will be performed before treatment and every 2 courses after treatment, including peripheral blood lymphocyte-monocyte ratio, cytokines, immunoglobulins, T and B cells and their quantitative analysis. Patients with ZR2 regimen will undergo gene second-generation sequencing before treatment to compare the gene mutation differences between complete response (CR) and ≤ partial response (PR) in the efficacy of ZR2 regimen, in order to find biomarkers with better efficacy in ZR2 treatment. Moreover, investigators intend to conduct pharmacokinetics/pharmacodynamics (PK/PD) correlation analysis of ZR2 regimen and pharmacoeconomic evaluation of the two regimens.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed DLBCL
* Without treatment
* ≥ 65 years old
* Measurable lesions on CT or PET-CT before treatment
* Life expectancy of at least 3 months
* Voluntary participation with the consent of the patient
* Heart, kidney, liver and other organ function evaluation were basically normal before treatment

Exclusion Criteria:

* Patients who previously received chemotherapy
* Uncontrolled cardiovascular diseases, cerebrovascular diseases, thrombotic diseases, autoimmune diseases and serious infectious diseases
* Laboratory indicators before enrollment (unless caused by lymphoma):

  * Neutrophils \< 1.5 × 10\^9/L
  * Platelets \< 80 × 10\^9/L
  * Alanine aminotransferase or aspartate aminotransferase \> 2 × ULN
  * Alkaline phosphatase or bilirubin \> 1.5 × ULN
  * Creatinine \> 1.5 × ULN
* Patients who cannot comply with the agreement due to mental diseases or other unknown reasons such as pregnancy and lactation
* HIV infection
* If HBsAg is positive, HBVDNA should be tested, and patients with positive DNA cannot be enrolled; if HBsAg is negative and HBcAb is positive (regardless of HBsAb status), HBVDNA should be tested, and patients with positive DNA cannot be enrolled
* Other uncontrolled medical conditions that may interfere with the study
Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging treatment with the advantage of being able to target subcortical transcranial targets, which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation. This study will investigate the effect of this stimulation on the left subgenual cingulate cortex, a highly connected node in the depression network that is correlated with clinical symptomatology.

The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). Participants will receive either LIFUP or sham stimulation with crossover of sham participants into the treatment group halfway through the treatment course. The initial visit will involve consent and an MRI scan, followed by several more either active or sham treatments outside of the MRI environment delivered over the course of two days over one week. Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments.

Eligibility Criteria:
Inclusion criteria:

* Male or female
* Age 18-70
* Normal or corrected-to normal vision and hearing
* Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS \>20)
* The duration of the illness must exceed one year
* Must be medically stable as determined by investigator
* Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
* History of rTMS is permitted, but not required

Exclusionary criteria:

* Diagnosis of primary DSM-5 depressive disorder other than MDD
* Anxiety disorders such as GAD are permitted as long as MDD is primary
* Diagnosis of schizophrenia or bipolar disorder
* Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD)
* Contraindication to enter the MRI environment.
* Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
* Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
* Inability to adhere to treatment schedule.
* Initiation of new antidepressant treatment at the time of study randomization.
REThinkGame4training: Training Emotion Regulation Abilities Using an Online Therapeutic Game

To test the efficacy of the REThink therapeutic game in training emotion regulation abilities of children and adolescents.

The primary aim of this study is to evaluate the effectiveness of the REThink therapeutic game in training emotion regulation abilities in children aged 8 to 12 years. The participants will be recruitedfrom various schools and counties, ensuring a diverse sample. Those in the experimental group will engage with the REThink game over a four-week period. To assess the impact of the intervention, standardized pre-test and post-test measures will be administered, allowing for a comparison of mental health outcomes before and after the use of the therapeutic game. The study seeks to determine whether this digital tool can serve as an effective training for improving emotion regulation abilities in this age group.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents aged 8 to 12 years
* non-clinical levels of mental health symptoms on any SDQ subscale or total score
* parental consent provided

Exclusion Criteria:

* intellectual disability or physical limitations precluding the use of the online game
* does not have parental informed consent
* clinical or subclinical level on the SDQ measure, total score, or any subscale
Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:

* Unknown adverse drug reactions (especially important adverse drug reactions)
* Incidence and conditions of occurrence of adverse reactions in the clinical setting
* Factors that may affect the safety and effectiveness of Humira


Eligibility Criteria:
Inclusion Criteria:

* All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Exclusion Criteria:

* Contraindications according to the Package Insert
* Patients who have serious infections
* Patients who have tuberculosis
* Patients with a history of hypersensitivity to any ingredient of Humira
* Patients who have demyelinating disease or with a history of demyelinating disease
* Patients who have congestive cardiac failure
Network-Level Mechanisms for Preclinical Alzheimer's Disease Development

The purpose of this project is to test the hypothesis that AGB101 low dose levetiracetam extended release formulation can reduce abnormal hyperfunctional activity in the hippocampus in normal, healthy adults. The investigators will compare the functional connectivity results after taking AGB101 or placebo.

In this study the investigators want to find out whether the use of a perturbation, such as AGB101 low dose of levetiracetam extended release formulation, in healthy adults can reduce abnormal hippocampal network activity. The investigators also want to study whether this low dose of LEV can improve memory function.

Generic levetiracetam is a type of drug called an anti-epileptic or anti-seizure medication. It is FDA approved worldwide for adults and children as young as one month with seizures. It is a generic drug used in long-term epilepsy treatment. It is relatively safe and has an acceptable side-effect profile.

AGB101 has been developed as a novel extended release formulation of low dose levetiracetam (below clinically marketed doses for epilepsy) for slowing the progression of amnestic mild cognitive impairment.

It is known that age and the APOE 4 gene are important risk factors for late-onset Alzheimer's disease. Further studies have shown that cognitively normal, older adults have more hyperfunctional brain network activity, increased alpha beta accumulation, decreased memory function, and decreased brain volume, which is consistent with Alzheimer's disease patterns.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* At least eight (8) years of education
* Geriatric Depression Scale (GDS) (62) score \< 6
* Hachinski Ischemic Score ≤ 4
* Normal general cognitive function as well as 1) normal memory function, documented by MOCA score of 23 or greater, and a RBANS Delayed Memory Index score of 85 or greater.

Exclusion Criteria:

* Neurological disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or a history of significant head trauma or known structural brain abnormalities
* Major psychiatric disease or chronic unstable medical conditions
* History of drug abuse
* History of alcohol abuse (4 or greater drinks per day on average)
* Unable to complete MRI scans (no Pacemaker/Defibrillator)
* Known clinically significant abnormalities in B12 or thyroid function tests
* End Stage Renal Disease (ESRD)
* Hemodialysis (HD)
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy

This is a descriptive prospective study of safety and efficacy of the reflective PT ring device. Neonates with an elevated total serum bilirubin (TSB) meeting PT criteria per their clinician during hospital admission will be eligible for enrollment after informed parental consent.

Neonatal jaundice (NNJ) continues to be a significant global problem affecting over 80% of neonates while severe neonatal jaundice affects at least 481,000 neonates annually. Jaundice and jaundice related complications like Kernicterus Spectrum Disorder (KDS) are gaining recognition among the world's health policy leaders as an important area for further research and development. The long-term sequelae of KSD include choreoathetoid cerebral palsy, sensorineural hearing loss, and upward gaze palsy. KSD is irreversible resulting in a lifetime of physical, emotional, social and economic challenges. Access to cost-effective methods of improving pediatric jaundice care along with improved circumferential (full body) illumination technologies is an affirmed objective of the AAP (American Academy of Pediatrics). The investigators hypothesize that unused therapy light (irradiance) surrounding the neonate using an existing single-lamp bank phototherapy (PT) device is sufficient in quantity and if redirected onto the patients untreated or poorly illuminated skin surfaces, it will accelerate metabolism and excretion of bilirubin. This PT ring device redirects unused phototherapy light sideways onto the neonate body using an open-faced ring approach. The technology will illuminate previously unexposed and poorly exposed skin regions where treatable bilirubin exists. The device is superior to current PT devices in that it converts existing waste light into treatment efficacy while integrating into existing overhead lamp systems offsetting the purchase of secondary devices that are often unaffordable and create hospital complexity, cost and inefficiency issues. A further benefit of the device will be reduced ambient blue-light spillover in patient care areas, an ongoing concern for medical staff.

Eligibility Criteria:
Inclusion Criteria:

* Males or female neonates greater than or equal to 35 weeks gestational age
* Elevated total serum bilirubin levels meeting PT criteria in the first 7 days of life

Exclusion Criteria:

* Neonates, who are mechanically ventilated
* Neonates requiring continuous positive airway pressure
* Neonates with a history of apnea, bradycardia
* Patients with known cyanotic heart disease
* Patients experiencing temperature instability or desaturation episodes in 24hr prior to enrollment will be excluded.
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Engineering Immune Organoids to Study Pediatric Cancer

To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)


Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis ≤ 25 years except for patients with malignant gliomas and renal tumors for whom no upper age limit is applied
* Medical suspicion or diagnosis of one of the following diseases, regardless of stage:
* Brain tumors
* Renal tumors
* Neuroblastoma
* Sarcomas
* Adult patient or parents or guardians should understand, sign and date the appropriate written informed consent from prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
* Affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

* Any histology not mentioned in the inclusion criteria
* Adult patient or parents/guardians incapable/incapable of giving its/their consent
* Patients deprived of their liberty by a judicial or administrative decision
An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer

This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age \>/=18 years
* Proven metastatic colorectal carcinoma
* Patients have measurable disease
* Patients are eligible to receive first-line Avastin
* Patients have signed data release form

Exclusion Criteria:

* Contra-indication to receive Avastin according to the local labeling
* Participation in a clinical study within 30 days prior to enrolment
* Patients have any other primary cancer
* Concomitant treatment with other biologics
* History of other malignant disease in the past 5 years except basal cell carcinoma
Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children

The purpose of this study is to examine the effects of fluid dairy products on blood glucose and insulin, satiety and energy intake in normal weight and overweight/obese children in the age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F. yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and tropical punch consumed before and with a pizza meal 60 min later on food intake, blood glucose, and appetite hormone response.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Born at term

Exclusion Criteria:

* Diabetes
* Medications
* Lactose-intolerance or allergies to milk
* Breakfast skippers and those on an energy restricted diet
Sleep Restriction Treatment for Insomnia

With a prevalence of about 10% chronic insomnia is a common problem. The standard treatment for insomnia is cognitive behavioral therapy. According to many, the core element within this treatment is sleep restriction. This element has been examined separately in a couple of studies and also appears to be effective in isolation. In the current study the aim is to get more information about the effectiveness of this core element of the treatment. For this reason, a randomized study is conducted to compare sleep restriction with a diary control condition.

The second aim in this study is to determine mechanisms behind treatments. Network intervention analysis will be used to determine which specific symptoms are associated with therapy success. This is the reason that throughout the study weekly and daily measures will be conducted.

The expectations are that:

* Participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome)
* Participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)


Eligibility Criteria:
Inclusion Criteria:

* Insomnia Severity Index Score ≥ 10
* 18 years or older
* Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months
* Daytime problems related to sleep complaints
* Sleep efficiency \< 85%
* Dutch speaking

Exclusion Criteria:

* (1) No acces to internet
* (2) Pregnant or breastfeeding
* (3) working in night shifts
* (4) currently in psychological treatment (started \< 6 months) or on wait-list for treatment
* (5) cognitive behavioral treatment for insomnia in last 12 months
* (6) concrete suicidal ideation
* (7) schizophrenic or psychotic disorder
* (8) high level of depressive complaints (BDI-II \> 28)
* (9) Instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed
Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients

Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT and last weeks of RT .


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* HIV positive cancer patients
* Photon beam RT, conventional fraction \>= 4000 cgy in 4 weeks

Exclusion Criteria:

* CD4 count \< 200 cell/ml and not received anti retro viral