cyrilzakka/clinical-trials huggingface dataset:
Young Consumers' Attitudes and Behaviour Towards Sustainable and Healthy Eating

The purpose is to investigate young consumers' attitudes and behaviour towards sustainable and healthy eating by applying a multidisciplinary approach, taking into account economical, marketing, public health and environmental related issues. In order to achieve this goal, consumers' reactions on interactive tailored informational messages about sustainable from social, environmental and economical point of view, as well as healthy eating behaviour in a group of Polish young adults will be investigated. Main research questions that will be addressed: What is consumer's current behaviour and perception of sustainable healthy eating? What are factors determining consumers' reactions to messages about sustainable healthy eating? What are consumers' reactions on interactive tailored communication about sustainable and healthy eating behaviour? About 200 Polish consumers will take part in this randomized controlled trial. A stratified design will be used to recruit 18-30 years old adults using smart phones. The sample will be represented for gender and region. Participants will be randomly assigned to either a study or a control group. They will complete a baseline and follow-up survey. An application for smart phones will be developed by a professional IT company in order to deliver personalised messages to the participants. Intervention will take one month. Messages developed following the theory-linked definitions of behaviour change techniques will be sent to the participants every 2-3 days. The six principles of sustainable and healthy behaviour introduced in the campaign "Livewell 2020" will be used as a base to communicate to consumers.


Eligibility Criteria:
Inclusion Criteria:

* user of a smart phone
* Internet user

Exclusion Criteria:

* user of an older version of a mobile phone
Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells

The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.

Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.

Eligibility Criteria:
Inclusion Criteria:

* Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision
* Consent to participate in the study

Exclusion Criteria:

* No consent to participate
* No surgery
Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

This study is an observational study to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Tamoxifen is an antiestrogen drug with concentration dependent properties, with z-endoxifen known as active metabolite. Until know therapeutic range for z-endoxifen to improve treatment response was not known. Variation response on tamoxifen can be cause of genetic polymorphism CYP2D6 that can be different between interindividul and ethnic.

The aim of this study is to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients on tamoxifen treatment for at least 4 months

Exclusion Criteria:

* Abnormalities in liver markers (AST \>2.5 x ULN)
PAS Balance Training for Parkinson Disease (PD)

Gait initiation (GI) difficulty is a common problem in individuals with Parkinson's disease (PD), often linked to impaired anticipatory postural adjustments (APA). Currently, there are no targeted rehabilitation programs designed specifically for GI-related APA in PD patients. Research has shown that while motor learning deficits are common in PD, explicit learning is better preserved than implicit learning. Therefore, a GI-related APA training system using an explicit learning model could be particularly effective for this population.

During motor learning, long-term potentiation (LTP) increases the excitability of the primary motor cortex. Paired associative stimulation (PAS) has been demonstrated to induce LTP-like changes in the motor cortex, making it a potential priming method to enhance motor learning. However, the priming effect of PAS targeted at leg muscles and the motor cortex on motor learning related to GI-APA has not been previously studied.

The objectives of this study are:

1. To investigate the effects of explicit and implicit training on GI-related APA.
2. To evaluate the priming effect of PAS on GI-related APA training and the associated plasticity changes in the motor cortex.


Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

* Musculoskeletal injuries on legs
* Osteoporosis.
* Any peripheral or central nervous system injury or disease patients.
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults

To perform a variety of assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).


Eligibility Criteria:
Inclusion Criteria:

* who are between 18 to 64 years of age. Subject must be at least 18 years of age and no older than 64 years of age at the time informed consent is obtained;
* eligible female subjects, who are of childbearing potential, who have a negative urine pregnancy test results prior to study vaccination. Females who are surgically sterile or post-menopausal do not require pregnancy testing.
* who are determined by medical history, physical examination and clinical judgement to be eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible.
* who have provided written informed consent after the nature of the study has been explained;
* who, will be available for two month duration of the trial (from enrollment to study completion);
* who can be reached by study staff for the post-vaccination contact \[telephone, clinic or home visit\]

Exclusion Criteria:

* who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents;
* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
* have an immunosuppressed or an immunocompromised individual living in the same household;
* with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
* who were administered any live virus vaccine within one month prior to enrollment;
* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
* who, received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
* who receive any influenza vaccine in the 6 months prior to enrollment, or a non-study influenza vaccine since enrollment;
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment.
Bioavailability and Food Effect Study of Two Formulations of PF-06650833

Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of nonchild bearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Subjects with any of the following characteristics/conditions will not be included in the study:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Any condition possibly affecting drug absorption (eg, gastrectomy).

* A positive urine drug test.
* History of regular alcohol consumption within 6 months before screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
* Screening supine BP greater than equal to 140 mm Hg (systolic) or more than equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential;
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
* History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON-TB Gold test.

History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).

-Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality
Human Blood Specimen Collection to Evaluate Immune Cell Function

Natural killer (NK) cells are leukocytes of the innate immune system and play a central role in the control of cancer metastases. NK cells and other innate immune cells often do not function well in patients with cancer and are also profoundly suppressed after cancer surgery. Dr. Auer's Lab and others have shown that NK cells are critically important in the clearance of tumor metastases and that their impairment can be recovered with immune therapy augmenting the innate immune system. Several studies suggest that cancer patients have depressed NK cell cytotoxicity as compared to healthy controls but that following resection of the cancer, NK cell cytotoxicity returns to normal levels. In this observational study, the investigators will measure NK cell cytotoxicity by the gold standard method (51Cr, a chromium51 release assay) and by a new interferon-ɣ (IFN-ɣ) based assay (NK-Vue™) in healthy humans and colorectal cancer (CRC) surgery patients seen a The Ottawa Hospital. The results of this study will determine if the NK-Vue™ is able to discriminate between healthy human volunteers and newly diagnosed cancer patients and is sufficiently sensitive to detect transient NK cell suppression immediately following surgery.

Rationale:

The purpose of this program is to obtain consent for and to outline the process for collection of fresh blood sample from healthy humans and colorectal cancer patients before and after surgical resection.

Procurement of fresh human blood is required for the following:

* To compare NK cell function, measured by two different assays, in healthy humans and newly diagnosed colorectal cancer patients at the Ottawa Hospital.
* To compare NK cell function, measure by two different assays in colorectal surgery patients preoperatively and at various time points postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have had a recent diagnosis of cancer (any stage) and will be undergoing surgery (cancer group)
* Subjects who are being seen by their physician for other reasons, or healthy volunteers (control group)
* Subjects who provide informed consent to participate in the trial
* Subjects \>40 years of age

Exclusion Criteria:
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Stage IV or recurrent non-small cell lung cancer (NSCLC)
* Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
* Measurable disease (at least one lesion \>= 10 mm in longest diameter)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Patients with T790M single mutation only
* Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
* Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
* Symptomatic or uncontrolled central nervous system (CNS) metastases
* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
* Any significant ophthalmologic abnormality
* Pre-existing parenchymal lung disease such as pulmonary fibrosis
* Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)
Second Ejaculate and IUI

The WHO operation specification requires men to maintain a 2-7-day ejaculation abstinence period before semen examination, but it does not mention the possibility of obtaining a second sample immediately after the first sample for evaluation, and the significance of the evaluation of the second sample for fertility. There is a certain fluctuation level in sperm concentration detection. Patients with normal previous detection may have lower sperm concentration on the day of IUI, resulting in the trouble of canceling IUI. It is not clear whether patients with previous oligospermia can obtain more sperm with better vitality and improve the success rate of IUI by taking sperm again. Some retrospective studies found that when the semen abstinence period of oligozoospermia men was as short as 40 minutes, the changes of sperm motility and sperm concentration were significantly improved, but there was no difference in the conclusions of other studies. A small number of assisted reproduction studies found that IUI with samples obtained during abstinence period of less than 2 days could obtain better pregnancy rate. However, the quality and sample size of these retrospective studies are limited, the repeatability is not good enough, and the conclusions are still controversial. We designed a randomized controlled study. Semen examination was performed after sperm extraction. If the sperm concentration after treatment was less than 10m, the subjects were included in the study. They were randomly divided into two groups. Group 1 received IUI for pregnancy assistance directly, and group 2 received IUI for pregnancy assistance 1 hour after the first sperm extraction. The two semen were mixed and treated. 205 subjects were included in the two groups. We tried to explore whether secondary sperm extraction in patients with low IUI concentration can improve the success rate of IUI pregnancy.


Eligibility Criteria:
Inclusion Criteria:

- Man

1. Male infertility (primary or secondary infertility)
2. Age 22 \~ 80 years old;
3. Body mass index \< 30 kg / m2;
4. Normal levels of FSH, LH, t and PRL;
5. Semen concentration and vitality were normal or slightly abnormal (TSC ≥ 10 million / ml, PR ≥ 20%, vitality ≥ 30%), which was consistent with the indication of IUI assisted pregnancy;
6. On the day of IUI, the male side took the semen and the TSC was less than 10m / ml

Women's standard

1. Age 20 \~ 40 years old
2. Body mass index \< 30 kg / m2;

3）FSH\<10U/L、AMH\>1.1ng/ml

4) Bilateral fallopian tubes are unobstructed

Exclusion Criteria:

* Man

It has performed vasectomy, orchitis, unilateral orchiectomy, ejaculation difficulty, retrograde ejaculation, diabetes, cardiovascular disease, drug treatment of psychological or genetic diseases.

Woman

1. Previous history of intrauterine adhesion;
2. Hydrosalpinx;
3. B-ultrasound suggests that endometriosis cyst may be;
Post Stroke Ambulation Recovery Using Robotic Exoskeletons

The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.

This study will systematically compare various commercially available REs and aid in identifying the appropriate devices for gait training prescription in individuals post-stroke based on their deficits. The objective of this study is to evaluate and compare the four groups (3 REs and standard of care treatment) using biomechanical, functional and community participation \&amp; quality of life metrics. The robotic exoskeletons being used in this study are the AtalanteX (Wandercraft), Ekso NR (Ekso Bionics), and Restore (Lifeward).

Eligibility Criteria:
Inclusion Criteria:

* Stroke survivors 3 - 8 months from a recent stroke.
* Age: 50 - 80 years
* Unilateral hemiparesis
* Medical clearance by the Medical Director
* Be able to physically fit into the exoskeleton device: Height between 60\&#34; and 76\&#34; and weight below 220 lbs
* Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation (e.g. can follow directions).
* Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback.
* Have a joint range of motion within normal functional limits for ambulation.
* Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE.
* No history of injury or pathology to the unaffected limb.
* Have an appropriate walking speed as determined by the study staff.

Exclusion Criteria:

* Any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
* Skin issues that would prevent wearing the device.
* Pre-existing condition that caused exercise intolerance (documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure).
* Hospitalization for heart attack, heart surgery, or acute heart failure within 3 months of enrollment in the study.
* Uncontrolled seizure disorder, spasticity, or joint contracture that would interfere with walking.
* Neuromuscular, neurological, or orthopedic pathologies that interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs.
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy

This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.

The purpose of this phase II study is to assess the safety and efficacy of up to two intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.

Eligibility Criteria:
Inclusion Criteria:

1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria
2. Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age
3. The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
4. All infants must have signs of encephalopathy within 6 hours of age

Exclusion Criteria:

1. Major congenital or chromosomal abnormalities
2. Severe growth restriction (birth weight \<1800 g)
3. Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
4. Moribund neonates for whom no further treatment is planned
5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
6. Infants suspected of overwhelming sepsis
7. ECMO initiated or likely in the first 48 hours of life
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis

The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS by physician
* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months,
* ≥10 on Insomnia Severity Index
* English speaking
* Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia

Exclusion Criteria:

* Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>4 on STOP BANG indicating high risk of sleep apnea
* Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index
* Nervous system disorder other than MS
* Relapse and/or corticosteroid use in past 8 weeks