cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.


Eligibility Criteria:
Inclusion Criteria:

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history

Exclusion Criteria:

* Currently experiencing cold or flu
* History of perennial or allergic rhinitis or rhinitis medicamentosa
* Evidence of nasal polyps as documented by anterior rhinoscopy
* Evidence of significant nasal tract structural malformations including a severe deviated septum (where subjects are indicated for surgery) or a concha bullosa as documented by anterior rhinoscopy
* Visible open sores, sunburn, irritation, eczema or chronic skin condition on the face to nose
* Bacterial sinusitis infection during 2 weeks prior to entry in the baseline phase of the study
* Any other condition that in the opinion of the investigator would have an affect on nasal breathing
* Use of any product containing menthol within two hours prior to any subjective measures involved in the study
* Had an allergic contact dermatitis on the face within 30 days prior to entry
* History of chronic or active skin or other immunologic (rheumatoid, psoriasis) disease
* History of skin cancer
* Use of antibiotics or alpha adrenergic drugs (all forms) within 1 week prior to entry in the baseine phase of the study
* Use of glucocorticosteroids (all forms) within 1 month prior to entry in the baseline phase of the study
* Any current treatment which in the opinion of the investigator will affect nasal congestion
Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor

The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.

The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.

After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.

This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: newborn through age 20
* Diagnosed with Hydrocephalus
* Instrumented with an Extra-Ventricular Drainage Line

Exclusion Criteria:

* Age: older than age 20
* Not diagnosed with Hydrocephalus
* Not instrumented with an Extra-Ventricular Drainage Line
Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA

The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the Vedolizumab-2005 clinical study in the United States (US) with continued access to Vedolizumab Intravenous (IV) which is given as infusion into a vein (intravenously IV) until it becomes commercially available in the US. To be able to participate in this EAP, children and teenagers must still benefit from the treatment with Vedolizumab IV. According to the participant's treating healthcare professional (HCP): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab IV.


Eligibility Criteria:
Inclusion Criteria:

1. The participant has UC or CD and is of age less than (\<) 18 years at the time of final treatment completion of Vedolizumab-2005.
2. The participant is demonstrating continued clinical benefit from vedolizumab IV for the treatment of UC or CD that outweighs possible risks.
3. The participant, participant's legally authorized representative, or adult caregiver is informed of the nature of this expanded access program and has provided signed and dated written informed consent and/or pediatric assent.
4. The participant does not have any condition, including laboratory test result, that in the opinion of the investigator may compromise the participant's safety.
5. The participant does not have a known hypersensitivity to vedolizumab or its components.
6. According to the participant's treating healthcare professional (HCP): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab IV.
7. Female participants of childbearing potential only:

   * The participant has agreed to be abstinent or agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after completion of the last dose of vedolizumab.
   * The participant is not pregnant or breastfeeding.
   * The participant will not donate ova during the course of the program and for 18 weeks after the last dose of vedolizumab.
8. Male participants only:

   * The participant has agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after the last dose of vedolizumab.
   * The participant has agreed to not donate sperm during the course of the program and for 18 weeks after the last dose of vedolizumab.

Exclusion Criteria:

-No specific exclusion criteria.
An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies

The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.

In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion:

1. Received prior treatment with NKTR-102
2. Free of disease progression since receiving NKTR-102
3. Adequate bone marrow and organ function
4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
5. Agree to use adequate contraception

Exclusion:

1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose \< 70 mg/m2 upon entry into this study
3. Pregnancy or lactation
Effects of Simulation Practices on Breastfeeding Knowledge and Skills of Nursing Students

Objective: This study evaluated the effectiveness of breastfeeding education using different simulation techniques on nursing students' breastfeeding knowledge, counseling skills, and clinical self-efficacy.

Method: The study sample consisted of 157 nursing students. Data were collected using a sociodemographic questionnaire, the Breastfeeding Assistance Clinical Preparedness Scale, the Breastfeeding Knowledge Form, the Clinical Self-Efficacy in Performance Scale, and the Breastfeeding Counseling Skills Checklist.

Conclusion: We expect that simulation and standardized patient-based breastfeeding education will effectively improve nursing students' readiness for breastfeeding assistance, breastfeeding knowledge, breastfeeding counseling skills, and clinical self-efficacy in breastfeeding performance.


Eligibility Criteria:
Inclusion Criteria:

having taken a gynecology and obstetrics nursing course, volunteering to participate in the research, and not having received formal training on breastfeeding.

Exclusion Criteria:

voluntarily withdrawing from the research and not participating in any stages of the research.
Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain

Assessing associations between Sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population.

Therefore, the investigators aims are:

* The primary aim of the study is to assess associations between Sensory Profiles (Adolescent/Adult Sensory Profiles) and Nociplastic pain Symptoms, in the acute and chronic low back pain population.
* The secondary aim is to assess the prognostic value of sensory profiles in the transition to central sensitisation and pain, in the acute and chronic low back pain population at twelve weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients with non-specific LBP
* with or without radiating pain
* aged 18-65 years
* able to read and understand the Dutch language

Exclusion Criteria:

* previous lumbar spinal surgery
* radiculopathy or any specific cause of low back pain such as lumbar spinal stenosis, current malignancy, spondyloarthropathy, osteoporosis, spondylolisthesis, major trauma, infection, or systemic disease.
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain

In this study, it was planned to investigate the effectiveness of instrument-assisted soft tissue mobilisation (IASTM) in patients with chronic neck pain. Forty eight individuals with chronic neck pain between the ages of 18-70 were included in the study. Individuals were randomly divided into two groups as Combined Therapy (CT) (n = 24) and Exercise Therapy (ET) (n = 24) groups. All exercises were applied to the participants for 4 weeks, 3 times a week, by an experienced physiotherapist for 5 years under supervision. ET which included stretching and strengthening exercises involving the neck, shoulder and around the scapula muscles applied according to the tolerance of the individuals and targeted to be most beneficial in daily life activities.

CT in addition to the ET applied 3 times a week for 4 weeks, the participants received a total of 8 sessions of IASTM on the days they came to the treatment twice a week, before the ET. As soon as the participants came to the session, IASTM was applied first. Following the IASTM application, ET was applied in the same protocol and under the same therapist supervise with the ET group.

Before and after treatment, deep neck flexor muscle endurance (DNFME), pain severity with Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI), functional status with Neck Disability Index (NDI), quality of life with Nottingham Health Profile (NHP) treatment and treatment satisfaction was evaluated.


Eligibility Criteria:
Inclusion Criteria, Exclusion Criteria:

Individuals aged 18-70 years with neck pain due to a nonspecific disorder for at least 3 months were included.

Individuals with history of cancer (within the last five years), pregnancy, serious skin disorders, previous neck surgery, disc prolapse, spondylolisthesis, vertebral fractures, spinal stenosis, arthritis, osteoporosis, recent neck trauma (within the last 48 hours), severe night pain, symptoms of infection, psychological disorder, and those who received therapy for neck pain in the last 6 months were not included.
Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.


Eligibility Criteria:
Inclusion criteria:

* Diagnosed with benign prostatic hyperplasia
* Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
* PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml.

Exclusion criteria:

* Prostate cancer.
* Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
* Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
* History of chronic UTIs (urinary tract infections)
* Presence of acute bacterial prostatitis at screening
Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).


Eligibility Criteria:
Inclusion Criteria:

* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
* Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
* Body mass index (BMI) 18-26 kg/m\^2 (both inclusive)
* Weight 60-90 kg
* Non-smoker

Exclusion Criteria:

* Any condition requiring the regular use of any medication
* Known or suspected allergy to the trial product or related products
* Family history of type 1 diabetes mellitus
Resistance Training and Appetite Regulation

This study plans to learn more about how resistance training impacts appetite and the brain's response to food. The study will be evaluating how the brain responds to food images as well as how behaviors and hormones change with a 12 week resistance training intervention.

Aim 1: To determine if RT impacts neuronal function associated with food intake behavior in a manner favoring reduced EI in overweight/obese adults.

Hypothesis: Compared to pre, post-RT fMRI measures will demonstrate ↓ neuronal responses to food cues in the insula, prefrontal cortex, and hypothalamus, brain regions implicated in reward, impulsivity, motivation, and regulation of ingestive behaviors. These changes will be associated with ad libitum EI.

Aim 2: To determine if RT impacts appetite-related peptides, ratings, and food intake behaviors in a manner favoring reduced EI in overweight/obese adults.

Hypothesis: Compared to pre, post-RT measures will show changes in appetite-related peptides, ratings (↓ hunger ↑ satiety), and behaviors (↓food-related cravings \& impulsivity, ↑ self-efficacy) consistent with EI reduction. Changes in appetite regulation indices will be associated with changes in relevant brain networks (Aim 1). These changes will also be associated with ↓ ad libitum EI.

Exploratory Aim: To determine if RT impacts neuronal function and appetite-related peptides and behaviors in a manner favoring ↓ EI in Non-Compensators (top tertile of fat mass loss) as compared to Compensators (bottom tertile of fat mass loss).

Hypothesis: Compared to Compensators, Non-Compensators will show ↓ neuronal responses to food cues and default network, and changes in appetite-related peptides, ratings, and behaviors consistent with ↓ EI.

Eligibility Criteria:
Inclusion Criteria:

* all ethnic groups
* both sexes
* age: 18-55
* BMI: 27-40 kg/m2
* weight stable (±5% in last 6 months)
* sedentary (\<2 hours of planned physical activity/week by self-report, no RT in previous 12-months)

Exclusion Criteria:

* history of CVD
* DM
* uncontrolled Hypertension
* untreated thyroid disease
* renal disease
* hepatic disease
* other condition affecting weight/metabolism
* unable to exercise
* smoker
* medications affecting weight
* EI or EE in past 6 months
* weight loss/gain \>5% in past 6 months
* post-menopausal women (defined as age appropriate women with 6 months or more of amenorrhea)
* currently pregnant, lactating, \< 6 months post-partum
* woman who have undergone oophorectomy
* bariatric surgery
* major psychiatric disorder
* alcohol or substance abuse
* depression by history and/or score \>21 on CES-D
* history of eating disorders and/or score \>20 on EATS-26
Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica

Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age.
2. Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician.
3. Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (\< 30 mg of oral morphine-equivalents per day).
4. Ability to understand the purpose and instructions of the study and to sign an informed consent.

   -

   Exclusion Criteria:

1.Diabetic Neuropathy 2.Pain in upper limbs 3.Receiving anti- depressants and/or anticonvulsants 4.Pregnant women 5.Inability to comply with study protocol. 6.Allergy to Opioids 7.A diagnosis of Raynaud's Syndrome 8.History of substance abuse

-
Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.

Lung surgery, open aortic surgery, TEVAR, and EVAR are major operations that carry a higher incidence of perioperative mortality and complications compare to other surgery. The study of the incidence of mortality and complications will help the hospital to benchmark with the others. Also the study of the risk factors of mortality and major complications will help to improve the patients' outcomes.


Eligibility Criteria:
Inclusion Criteria:

Patients underwent

* thoracic surgery
* open thoracic aortic surgery
* TEVAR
* EVAR

Exclusion Criteria:

* Emergency lung surgery
* Conversion from TEVAR to open thoracic surgery
* Conversion from EVAR to open aortic surgery
Advanced Endo-therapeutic Procedure : Registry-based Observational Study

Advanced therapeutic endoscopy procedures are of increasing importance to provide minimal invasive treatment for GI diseases. The Centre Hospitalier de l'Université de Montréal as tertiary university center is dedicated to increase the availability of therapeutic endoscopy procedures for our population in Montreal and Quebec. Advanced endotherapeutic endoscopy can replace surgery for treatment of benign and malign GI diseases and the aim of this registry-based study is to improve quality related to advanced endotherapeutic endoscopy, as it will provide quantitative means to assess advanced endotherapeutic practice and may identify practices of low quality (possible intervention) or high quality (desired).

Advanced therapeutic endoscopy procedures included for this registry-based study are endoscopic mucosal resection (EMR), Endoscopic mucosal dissection (ESD), Assessment of Polypectomy quality for colorectal adenomas/polyps, Radio frequency Ablation (RFA) and Argon Plasma Ablation (APC), and Per Oral endoscopic Myotomy (POEM). All patients who present for an advanced endotherapeutic endoscopy (ESD, EMR, deep resection, POEM or Zenker treatment) may be included into the registry. Data will be collected prospectively. Data will be recorded on case report forms (CRF), which will then be transferred to an electronic data base (= registry), located on a protected drive.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Presenting for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment)
* Signed informed consent form

Exclusion Criteria:

* Patients that are not capable understanding the trial and patients without consent.
* Patients with coagulopathy
* Patient with poor general health defined as an American Society of Anesthesiologists class greater than three
* Pregnancy
Short-term Intervention and Health Trajectories After Mass Trauma

This study has two aims. The first is to understand more of what may be typical health trajectories after mass trauma for children and adults and what predicts these trajectories. The second is to understand what may be effective early interventions to prevent long-term health and psychosocial problems for youth (6-19). Participants are recruited from an outreach program implemented after a landslide killed 11 persons and destroyed 33 houses in Gjerdrum in Norway. One third of the inhabitants were evacuated. All evacuated are contacted and screened for trauma related difficulties. Those who have significant post-trauma reactions are offered trauma focused interventions.

Two short step-wise interventions are developed for this study as an early intervention after mass trauma based on components from TF-CBT to test the relative importance of dosage and the sequencing of components.

Eligibility Criteria:
Inclusion Criteria:

* Exposed to the landslide
* Between 6-19 years old
* A score of 15 or more on the CATS
* A score between 11 - 14 on the CATS and have additional problems that have started or worsened after the landslide.

Exclusion Criteria:

* Suicidal
* Psychotic
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly

The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
* A man or woman 65 years of age or older at the time of vaccination.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

Exclusion Criteria:

* Any confirmed or suspected influenza illness within the last 6 months.
* Previous vaccination against influenza with any seasonal vaccine since December 2008.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature \>= 37.5°C on oral setting.
  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Any medical conditions in which intramuscular injections are contraindicated.