cyrilzakka/clinical-trials huggingface dataset:
Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population

The investigators aim to assess the relationship between objectives markers (of physiological reactivity) recorded using a smartwatch and self-reported subjective outcomes measured using standardized and non-standardized questionnaires recorded in an eDiary; with stress as the model for our assessment utilizing the validated PSS-10 questionnaire.

As personal characteristics such as personality traits, resilience, and grit have been shown to modulate reactivity and mental health status, the investigators aim to explore the modulation of the study outcomes by such personality factors. Furthermore, the investigators aim to explore the association of the study outcomes with the composition and functional potential of the gut microbiome.

Finally, the investigators aim to explore the effects of a nutritional intervention on our outcome measures.

Participants will participate in a decentralized, parallel-group study with a mixed design lasting 8 days (excluding screening and enrollment). A total of 120 participants are divided into low-stress(n=40), and elevated-stress groups (n=80) based on their perceived stress score (PSS-10, cut-off score 13). A subgroup of elevated-stress participants (n=40) will be administered a nutritional intervention for 3 days. Their responses will be compared to another subgroup of elevated-stress participants (n=40) without intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 to 30 years
* Own and uses a smartphone that is capable of running the study applications
* Have access to the internet
* Adequate fluency in the English language to understand the informed consent process, study instructions and study assessments
* Sufficient vision and hearing to complete study procedures
* Willing to commit to about 20 minutes of assessments each day for a period of 8 days
* Willing to wear selected study devices 24 hours/day; 7-days per week with only occasional relief
* Willing and able to participate and to give written informed consent

Exclusion Criteria:

* Past (\< 6 months prior to the study) or current neurological or psychiatric condition
* Past (\< 3 months prior to the study) or current use of psychoactive medication
* Having received antibiotic treatment \< 4 weeks prior to the study
* Present or past history of alcohol or drug addiction and/or recreational drug use
* Maltodextrin allergy
* Members of the research team or their immediate family members. An immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
* Women participants who are currently pregnant or have been pregnant in past 6 months
Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.

Exclusion Criteria:

* Women with predominantly symptoms of urge urinary incontinence
* Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
* Detrusor overactivity on cystometrogram at urodynamic testing
* Previous surgery for incontinence
* Intrinsic sphincter deficiency (MUCP\<20 cm H2O or Q -tip \<30o)
* Voiding dysfunction with postvoid residual \>100 cc
Therapeutic Drug Monitoring of Teicoplanin in Children

In this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in Chinese children.


Eligibility Criteria:
Inclusion Criteria:

* Teicoplanin was administered intravenously;
* Teicoplanin was used for therapeutic purposes;
* Age:≤18 years;
* Clinician confirms and plans to diagnose the patient with gram-positive coccus infection;
* Patients with therapeutic concentration monitoring of teicoplanin.

Exclusion Criteria:

* Teicoplanin was administered non-intravenously;
* Teicoplanin was used for prophylactic purposes;
* Patients without therapeutic concentration monitoring of teicoplanin;
* Patients who die within 24 hours of the use of teicoplanin；
* The blood concentrations of the patient was not approved by the quality control center.
Determination of the Iodine Status in Pregnant Women in the Netherlands.

Study to determine iodine status in dutch pregnant women

Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism. During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications. Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining. Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women. Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here it is proposed to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. It is hypothesised that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-45y old
* in first 16 weeks of pregnancy
* pregnant of singleton

Exclusion Criteria:

* Thyroid-disease or any other metabolic disease
* kidney disease
* twin-pregnancy
PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

A prospective cohort study undergoing ICSI at a private fertility center in Egypt

Purpose:

To evaluate PGTai results for embryos cultured in sequential versus single step media.

Method:

Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark).

All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.

Eligibility Criteria:
Inclusion Criteria:

* Female age ≤37 years with ≥ 8 mature oocytes
* Male partner had normal semen parameters according to WHO 2010
* PGT-A was done at the blastocyst stage

Exclusion Criteria:

* sperm or oocyte donor
* severe male factors according to WHO 2010
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.


Eligibility Criteria:
Inclusion criteria:

* Male or female patients of at least 18 years of age
* Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.

Exclusion criteria:

* More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.
* Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation
* Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time
* Prior monotherapy with an EGFR inhibitor except as maintenance therapy
RecruitmEnt Assessed by eleCtRical Impedance Tomography

The RECRUIT study is a multinational, multicenter physiological observational study conducted by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography (EIT).

Despite higher positive end-expiratory pressure (PEEP) being associated with multiple physiologic benefits, randomized clinical trials comparing higher vs. lower PEEP levels failed to show improved survival of ARDS patients. Higher PEEP should fully exploit its benefits only when implemented in patients with higher potential for alveolar recruitment (i.e., the decrease of non-aerated lung tissue at higher airway pressure) or in patients with airway closure. Retrospective analysis of randomised clinical trials with PEEP suggests that when high PEEP is used in responders (oxygenation), survival may be better. Conversely, in the absence of significant recruitment, higher PEEP should be avoided and lower PEEP might be recommended.

Titration of PEEP provided by the mechanical ventilator in patients with severe lung injury should thus be based on bedside information on lung recruitability. However, no valid method exists to define the best PEEP to optimize recruitment and minimize lung overdistention. Recruitability varies and is often not assessed. Electrical impedance tomography (EIT) is a non-invasive bedside imaging technique for measuring the potential for lung recruitment in ARDS patients. By performing lung (de)recruitment maneuvers and in-depth analyses, we will define lung recruitability indices and develop methods for real-time and personalized PEEP selection. This study will prove the feasibility of minimizing risks associated with inadequate mechanical ventilation by EIT.

Eligibility Criteria:
Inclusion Criteria:

* Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio \<= 200 mmHg)
* Under continuous sedation with or without paralysis

Exclusion Criteria:

* Age \<18 years
* Bronchopleural fistula
* Pure COPD exacerbation
* Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
* Hemodynamic instability (Systolic BP \< 75 mmHg or MAP \< 60 mmHg despite vasopressors and/or heart rate \< 55 bpm)
* Attending physician deems the transient application of high airway pressures to be unsafe
Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy

Stroke remains one of the main socially significant problems in the healthcare in the third millennium. The lethality in persons with history of stroke by the end of the 1st year of disease is high. A trend to increased frequency of stroke in the young age is observed during the last decade; third of patients is working-age individuals, out of whom only 15-20% returns to labor, and others remain disabled persons requiring constant medical and social support


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form
2. Age from 18 years and older
3. Diagnosis: Acute cerebrovascular accident of ischemic type (ischemic stroke) developed within 36 hours before enrollment in the study
4. Motor neurologic deficit measurable using the NIHSS Scale (score for item 5 and/or 6 at the time of starting the therapy ≥ 1))
5. Conservative stroke treatment tactics (without reperfusion therapy thrombolysis/thrombus extraction)
6. According to the routine clinical practice, the patient is scheduled to receive the treatment as per one of the following regimens:

   * Cytoflavin® 20-40 ml/day as a course of not less than 10 days or
   * another neuroprotector - course of not less than 10 days (or without neuroprotector)

Exclusion Criteria:

1. NIHSS 1a (coma) score 3 at the time of enrollment
2. Initial severe disablement (corresponding to mRS \> 2) requiring external assistance in everyday life before development of stroke
3. History of Parkinson's disease, dementia, multiple sclerosis, and other significant diseases accompanied by neurologic deficit
4. Severe comorbidity with expected lifespan of not more than 6 months
5. Pregnancy and breastfeeding
6. Any other concomitant medical or serious psychic conditions, which make the patient ineligible for participation in the study, restrict lawfulness of obtaining the informed consent, or can influence the patient's ability to participate in the study
Energy Labelling for Alcohol Drinks in New Zealand: Consumers Perceptions and Impacts on Purchase Behaviour

A two-stage qualitative and quantitative study to provide insight into consumers' awareness of energy in alcoholic beverages, and how energy labelling effects consumer behaviour.

Rationale: In 2016/2017, one in five (19.5%) New Zealand adults (≥15 years and older) had an alcohol drinking pattern that carriers a risk of harming the drinker or another, and one in three (32.9%) young adults aged 18 to 24 years are hazardous drinkers. To reduce alcohol-related harm and help New Zealanders make positive decisions about their alcohol use, strategies are needed that not only inform them about health risks but also alter the environment they find themselves in on a daily basis. Unlike most packaged food products, alcoholic beverages are not required to present a statement of the composition of the product, such as amount of alcohol, energy or the nutrient content. It has been suggested that in the absence of this information, consumers of alcohol have no idea how much energy, alcohol or kilojoules they are consuming. Research indicates that nutrition labelling of food and non-alcoholic beverage products does impact consumer perceptions and product evaluations. A recent poll by Stuff showed that 83% of 3,300 New Zealanders indicated that they want to know what they are consuming and supported placement of ingredients and nutritional information on alcohol products.

Objectives: To provide insight into consumers' awareness of energy in alcoholic beverages, and in their views on energy labelling of alcoholic beverages. The project also aims to explore the effects of different types of energy labelling on consumers alcohol purchase behaviour.

Design: Two-staged qualitative and quantitative study.

* Qualitative stage: Focus groups.
* Quantitative stage: Four-arm randomised controlled trial. This qualitative stage aims to test the effects of three different types of alcohol energy labels on alcoholic beverages on (online) purchase behaviour, compared to a control (no label) condition, using an 'online shopping cart'.

Recruitment: Panel.

Sample size: Qualitative stage: n=36 (six focus groups with six people per group); Quantitative stage: n=600 (n=150 participants per experimental condition).

Eligibility Criteria:
Inclusion Criteria:

* are ≥18 years of age;
* having purchased and consumed at least one alcoholic beverage in the past month;
* be able to read English;
* reside in New Zealand;
* be a member of the online panel of "Research Now Survey Sampling International".

Exclusion Criteria:

* Participants not meeting the eligibility criteria will be excluded.
Emory Teaching Kitchen Collaborative

The aim of the project is to evaluate the feasibility and acceptance of a teaching kitchen program as a worksite wellness program at Emory University

The teaching kitchen model is an innovative, multidisciplinary approach for motivating and establishing healthful habits and behaviors. The self-care program combines didactic information with experiential learning in nutrition, culinary arts, exercise, yoga, and mindfulness. The aim of the project is to evaluate the feasibility and acceptance of teaching kitchen program as a worksite wellness program at Emory University. Changes in biomarkers and self-reported behaviors will be evaluated up to one year.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* body mass index greater than or equal to 30,
* willingness to appear in videotapes and photographs that will be obtained during the course of the teaching kitchen program
* preference will be given to those with a cardiometabolic risk factor, such as diabetes mellitus, hypertension, and/or hyperlipidemia.

Exclusion Criteria:

* any health condition that would limit participation, including bariatric surgery, pregnancy, cardiovascular, pulmonary, orthopedic or neurologic medical problem, or gluten or nut allergy
Evaluation of Report-Back Strategies for Long-term and Short-term Exposure Information in Rural Tribal Populations

The goal of this study is to evaluate different ways to provide feedback about environmental sampling results to participants. Specifically, we will look at exposures with long-term risk (radon) and short-term risk (indoor particulate matter, PM2.5). The hypothesis is that providing feedback in real-time will result in participants engaging in more activities to try to reduce their exposure. One of our main questions of interest is: How does the information messenger impact the effectiveness of report-back strategies in rural, tribal populations?

Participants will have radon and PM2.5 measurement equipment installed at their home and will answer questions about any actions they took to reduce exposure. Previously developed approaches to reporting back those exposures will be used to test which feedback method results in more actions to reduce exposure.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled member of the participating tribe

Exclusion Criteria:

* Participant in one of our previous studies
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years


Eligibility Criteria:
Inclusion Criteria:

* A male or female \> = 15 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* Seronegative for anti-HBs antibodies, anti-HBc antibodies \& Hepatitis B Surface antigen (HBsAg).
* If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
* Pre-haemodialysis patient\* or a patient on haemodialysis.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
* Previous vaccination against hepatitis B.
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
* Clinically abnormal ALT/AST values (\> 3 times normal values)
Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation

Caregiver's burden in rehabilitation is important for both patients physical and mental health. Therefore researching caregivers burden and treatment of any depression or associated any psychological disorders of caregiver is crucial.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke,

Exclusion Criteria:

* More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation
Serotonin-receptor Agonism in Reward Processing

There is growing animal and human evidence for role of 5HT1A receptor agonism in treating depression and reward deficits. The next step is to translate this evidence directly into humans by characterising the effects of buspirone, as a 5HT1A agonist, on cognitive models of reward and emotional processing.

There is a paucity of behavioural evidence for the effect of 5HT1A receptor agonism, using buspirone as a probe, on primary reward processing (e.g. food), effort-based decision making or reward learning. Furthermore, the effects of 5HT1A agonism on non-emotive cognition, such as working memory, has yet to be investigated at a behavioural level in humans.

This study will characterise the effects of buspirone, as a probe for 5HT1A receptor agonism, on reward processing in human cognitive models. Furthermore it will examine its role in emotional processing and working memory. This will add to the evidence base of the neurocognitive effects of 5HT1A receptor agonism in humans, which is of relevance to the development of this as a target for future treatment development.

The study will be a double blinded, placebo controlled study involving healthy volunteers. Participants will receive a single dose of buspirone and then undergo a battery of psychometric testing to examine reward processing, emotional processing and a memory. Frequent monitoring of temperature and salivary cortisol shall be taken as surrogate markers of pre- and postsynaptic 5HT1A receptor activation.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the research
* Male or female
* Body mass index in the range of 18 to 30
* Not currently taking any medications (except for contraception)

Exclusion Criteria:

* • Any current Axis 1 The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) psychiatric disorder
* Any previous episode of a severe mental illness,
* A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia
* Body Mass Index outside the range of 18 to 30 inclusive
* Any significant current medical condition likely to interfere with conduct of the study or analysis of data (epilepsy, renal disease, hepatic disease, myasthenia gravis, acute closed-angle glaucoma)
* Current use of psychoactive and / or medically significant medication as judged by a study medic, whether prescribed or bought over the counter (the contraceptive pill, the Depo-Provera injection or the progesterone implant will not result in exclusion)
* Past history of dependence to illicit substances, and any consumption of illicit substances in the three months prior to the study
* Currently pregnant or breast feeding
* Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose
* Participation in a study using the same tasks in the last year
* Any physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging. This includes any taste/olfactory disturbance e.g. secondary to Covid-19 infection