cyrilzakka/clinical-trials huggingface dataset:
Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

Women undergoing late preterm birth are at high risk of delivering a newborn with neonatal hypoglycemia. The investigators plan to monitor interstitial glucose levels prior to delivery in these women in order to develop a better understanding of the relationship between maternal hyperglycemia and neonatal hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy admitted to labor and delivery between 34w0d and 36w5d
* English speaking women
* High probability of delivery in late preterm period defined by any of the following:

  1. Membrane rupture by 2 criteria (pooling, positive nitrazine, or ferning) OR leaking amniotic fluid from the cervix
  2. Preterm labor with intact membrane, defined as at least 6 uterine contractions in 60 minutes and at least: cervical dilation greater than or equal to 3cm dilated OR 80% effaced OR planned delivery by induction of labor or cesarean in no less than 24 hrs and no more than 7 days, for any indication as deemed necessary by the provider
* Received at least one dose of corticosteroid within twelve hours of enrollment

Exclusion Criteria:

* Any prior antenatal corticosteroid course in current pregnancy
* Systemic corticosteroid administration during current pregnancy
* Fetal demise or known major fetal anomaly, including cardiac anomaly or hydrops
* Maternal contraindication to betamethasone: hypersensitivity reaction to any component of the medication, idiopathic thrombocytopenic, purpura, systemic fungal infection, or current use of amphotericin B
* Diabetes, pregestational or gestational
* Preexisting plan for intrapartum monitoring of maternal glucose levels for any reason
* Delivery expected within 12 hours of randomization, because of insufficient time for corticosteroids to confer benefit, including:

  1. Ruptured membranes with cervical dilation ≥ 3cm or with more than 6 contractions per hour unless Pitocin is deferred for at least 12 hours
  2. Chorioamnionitis
  3. Cervical dilation ≥ 8cm
  4. Evidence of non-reassuring fetal status requiring immediate delivery
* To ensure that there is an adequate proportion of women presenting at 34 to 35 weeks gestation, enrollment will be restricted so that no more than 50% of the women in the trial present at 36 weeks.
Cross Sectional Study to Evaluate Effects of Kinesiotaping on Muscle Activity During Climbing Stairs and Sport Activity

This study aims to evaluate the effects of IQ-Tape, Kinesiotaping and no Taping on muscle activity during daily activity and sport activity.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* able to perform daily activities and sport performance

Exclusion Criteria:

* lower body and pelvic injuries
* fractures of the spine oder lower limb
* cardiac or neurological diseases
Night Ambulatory Monitoring Of Blood Pressure

To determine accuracy of nightly non occlusive blood pressure measurements by the non-occlusive CSEM Pulse Watch compared to a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor, Spacelabs Healthcare, Washington, USA) internationally validated for the 24h ABPM in Patients.

Elevated Blood Pressure (BP) is a chronic medical condition with a prevalence of about 45% in the middle-aged population.

The particular interest of this project is given to the diagnosis and treatment of so-called nocturnal hypertension. Unfortunately, current monitoring practice relies on the use of occlusive pneumatic cuffs inflated around the arm to assess BP. Based on oscillometric technique, occlusive cuffs perform intermittent BP measurements every 20 minutes, thus providing only a limited view of the BP regulation landscape. In addition, oscillometric measurement performs a full occlusion of the measured arm inducing awakening reactions, and leading to non-representative overestimated BP values. The non-occlusive measurement of BP is thus an unsolved problem of modern medicine.

The aim of the NAMBP (Night Ambulatory Monitoring of Blood Pressure) project is to develop, implement and test in clinical trials a first-ever non-occlusive BP sensor to be used during sleep.

A novel technology for the non-occlusive measurement of BP from photoplethysmographic (optical) signals, known as Pulse Wave Analysis (PWA), has been investigated for the past decade by the Centre Suisse d'Electronique et de Microtechnique (CSEM, Neuchâtel, Switzerland). The herein proposed system - the CSEM Pulse Watch - consists in a single sensor (watch-like device) attached at the wrist that measures photoplethysmographic waveforms induced by the pulsatility of the skin arteries of the wrist. These waveforms are then post-processed via PWA: The system will detect features in the measured waveforms that correlate, through the phenomenon of wave reflections, to the underlying BP of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18y
* Good understanding of written and oral German
* Signed informed consent
* Scheduled for 24h blood pressure exam

Exclusion Criteria:

* Patients with unhealthy mental state
* Patients with an active implantable medical device (AIMD)
* Arteriopathy of the upper limbs with/without stenosis
* Severe congestive heart failure (LV-EF ≤25%)
* Sever aortic-valve stenosis mean gradient \>40mmHg, valve area \<1cm2)
* Congenital heart disease including aortic isthmus stenosis
* Untreated heart rhythm disorders, heart rate at rest \> 120/bpm
* Severe untreated arterial hypertension (BPsyst \> 180mmHg, BPdiast \> 100mmHg)
* Atrial fibrillation
* Instable angina pectoris
* Malcompliance concerning medication intake
* Active alcohol or drug abuse
* Pregnancy or lactation (women of childbearing age will be asked to performed urinary pregnancy test before the screening phase)
PACCT: Partnering Around Cancer Clinical Trials

This research has the overall goal of increasing rates at which African American and White men with prostate cancer make an informed decision to participate in a cancer clinical trial.

This research utilizes two distinct research designs to evaluate two separate behavioral interventions.

The first is a between-subject randomized controlled trial to evaluate a patient-focused intervention. The intervention consists of a booklet designed to encourage patients to view themselves as part of the patient-physician team and to participate actively in clinical interactions by asking questions and stating concerns.

The second is a within-subject interrupted time series design to evaluate a physician-focused intervention. The intervention is an educational module and email reminders designed to encourage physicians to discuss trials with all eligible patients using patient-centered communication.In the patient-focused intervention, patients are randomized to an intervention or usual care group, and comparison of outcomes is made between groups.

Eligibility Criteria:
Physician participants

Inclusion criteria:

* Treat patients with prostate cancer
* Able to recruit patients to clinical trials

Exclusion criteria:

* Do not treat patients with prostate cancer
* Not able to recruit patients to clinical trials

Patient Participants

Inclusion criteria:

* Black, African American or White; Non-hispanic confirmed diagnosis of prostate Cancer
* Seeing a participating physician for less than a year and expect to see this physician at least once in the coming year
* Able to read and write English well enough to understand and sign consent forms and respond to questionnaires

Exclusion criteria:

* Not black, African American or White; non Hispanic
* No confirmed diagnosis of prostate cancer
* Not seeing a participating physician or seeing a participating physician for \> than one year
* Not able to read and write English well enough to understand and sign consent forms and respond to questionnaires
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.


Eligibility Criteria:
Inclusion Criteria:

* meconium aspiration syndrome diagnosed based on clinical and radiological findings,
* respiratory failure requiring mechanical ventilation

Exclusion Criteria:

* congenital malformations or congenital genetic syndromes,
* persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide treatment
Effect of Ca2+ Ionophore on Embryonic Development and Clinical Outcome in Cases With Previous Fertilization Arrest

We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+ ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear stage i.e: cleavage failure to find out if there is any improvement in embryonic developmental stages.

Many studies reported that Ca2+ ionophore has a positive effect on embryo development in cases with complete or partial fertilization failure. However, only one preliminary report suggested a beneficial effect of Ca2+ ionophore activation in four cases with fertilization arrest.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previous history of complete fertilization arrest.
* ovarian stimulation with the GnRH agonist and recombinant FSH in a long protocol.

Exclusion Criteria:

* Female age \>40 years
Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia

To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients.

Fifty patients with chronic insomnia disorder diagnosed by the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017) were recruited from the first affiliated Hospital of Anhui Medical University. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the subjective measures consisting of sleep questionnaires, polysomnography (PSG) and tDCS treatment conducted by trained researchers at the Neurology Department of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode electrode was placed on the DMPFC (Fz) surrounded by four cathodes with a 1cm diameter (FPz, F3, Cz, and F4). Each participant received 30 min of tDCS stimulation once daily for 10 consecutive days. The stimulation direct current magnitude was set at 2 mA in the active group. In the sham intervention phase, the sensation was simulated by applying a 30s rising current until 2 mA was reached, with a 30s immediate decline at the beginning and end of each phase.

At the beginning and after a 10-day intervention, subjective measures consisting of sleep questionnaires, including the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI), were assessed. The Flinders Fatigue Scale (FFS) and the Epworth Sleepiness Scale (ESS) were used to assess daytime sleepiness. Additionally, the HAMA and HAMD were used synchronously for emotional assessment. Afterwards, they were unblinded by the study coordinator.

Eligibility Criteria:
Inclusion Criteria:

1. age between 15 and 65 years,
2. diagnosed with chronic insomnia based on the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017),
3. no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.

Exclusion Criteria:

1. diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REM behaviour disorder, and restless legs syndrome,
2. history of head trauma or presence of serious organic diseases,
3. presence of comorbid anxiety or depression, as assessed by a Hamilton Anxiety Scale \[HAMA\] score of 17 or Hamilton Depression Scale \[HAMD\] score of 14.
Legal-Education Plus Trauma-informed Therapy to Improve Community Acceptance and Reintegration of Repentant Terrorists in Nigeria

Terrorism is an issue of global concern, and reintegrating repentant terrorists, including their families, has often proved challenging considering the damages done by the terrorist group. Despite Boko Haram atrocities in Nigeria, the focus seems directed toward the repentant terrorists with limited attention to the communities, the trauma they suffered, and their involvement in the design of reintegration programmes. There is also limited community awareness of legal support channels to foster positive reintegration (Ike et al., 2021). The implication is that it risks undermining the social context that informs successful reintegration, improves acceptance, and reduces reoffending. However, there appears to be limited research on this important policy problem in Nigeria. Our study proposes to fill this gap by contributing to the research initiative through a novel cross-disciplinary intervention drawing on law and psychology entitled Legal Education plus Trauma-informed Therapy (LETiT) to improve community acceptance and reintegration of repentant terrorists in Nigeria.


Eligibility Criteria:
Inclusion Criteria:

* ages 18 - 85 years
* able to give consent
* able to understand and speak English
* score a minimum of 5 on Trauma Screening Questionnaire
* residents of designated communities of intervention (Adamawa, Maiduguri, and Plateau states)
* available for the study and follow up at 3- and 6-months post-intervention

Exclusion Criteria:

* less than 18 or above 85 years
* unable to give consent
* clinically diagnosed with severe PTSD/suicidal ideations or undergoing treatment
* temporary or non-residents who are unlikely to be available for follow up
Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA

Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled. After a first stroke, there is a significant risk of recurrence (around 5-10% over the first year). While there are benefits from addressing general risk factors such as exercise, weight and smoking, selecting the best treatments for preventing a further stroke depends on understanding the underlying mechanism. Most strokes results from a blood clot causing a blockage in a blood vessel in the brain ("ischaemic" strokes, about 85% of cases). The clot may originate in the heart, the major blood vessels supplying the head, or result from disease of the small blood vessels in the brain itself (around 25% of cases each), and in around 25% of people a cause cannot be determined (sometimes because more than one exists). Different treatments are given depending on cause (for example, anticoagulant medication for clots from the heart, surgery for some arising from large arteries in the neck).

Current investigations involve multiple tests spread across different hospital departments, and commonly take several weeks to be completed. This may contribute to a high rate of strokes of uncertain cause, and may delay the start of the best treatment.

This trial will investigate the value of a single comprehensive scan to look at the heart and major blood vessels (using CT scanning) in a pilot study, comparing the classification of causes of stroke and the time to starting treatments with routine care, in a randomised study of patients with recent stroke or transient ischaemic attack (TIA, a short-lived stroke episode).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ischaemic stroke or TIA
* Male or non-pregnant female≥18 years of age.
* Informed consent.

Exclusion Criteria:

* Known impaired renal function precluding contrast Computed Tomography (CT).
* Contraindications to MRI scans
* Known severe hypersensitivity to iodine based contrast media for CT or gadolinium based contrast agents for MRI.
* Severe concurrent medical condition that would prevent participation in study procedures (e.g. severe pulmonary oedema or severe septicemia) or with life expectancy ≤ 1 months.
The Effect of ADT on PSMA Expression in Metastatic Prostate Cancer

Thirty-five men with newly diagnosed, metastatic prostate cancer are scanned with 18F-PSMA 1007 PET/CT at baseline, 3 weeks after the initiation of GnRH-antagonist, at one year and at the time of castration resistant prostate cancer (CRPC). The aim of the study is to classify metastatic lesions into those with PSMA-flare and those without and determine their potential to progress during the follow-up until CRPC.

In metastatic prostate cancer androgen deprivation therapy (ADT) has been traditionally used as a first line approach. Based on histological studies, animal models and PSMA-PET imaging, it is known that administration of ADT increases prostate specific membrane antigen (PSMA) expression.

Preliminary results of our previous prospective clinical trial (clinicaltrials.gov identifier: NCT03313726) with nine men demonstrated a heterogenous flare in PSMA expression 2-3 weeks after ADT, more evidently in bone metastases. Our hypothesis is that metastatic lesions having PSMA-flare respond differently to ADT and have different outcome than those without PSMA-flare. Therefore, the objective of the study is to demonstrate the PSMA-flare seen in bone lesions 3 weeks after ADT and then determine the potential predictive value of the phenomenon in the progression to castration resistant prostate cancer (CRPC).

Thirty-five men with newly diagnosed, metastatic PC will undergo 18F-PSMA 1007 PET/CT before and 3 weeks after the initiation of sub-cutaneous injection of GnRH-antagonist (Degarelix, Firmagon®). A subgroup of 20 patients will receive an additional FDG PET/CT scan before ADT to investigate whether lesions with PSMA flare show a different metabolic behaviour on FDG PET. During the follow-up, 18F-PSMA 1007 PET/CT will be also performed once a year. Finally all patients will repeat 18F-PSMA 1007 PET/CT at the time of CRPC. In addition to imaging, PSA is measured, and blood drawn for androgen levels and biomarkers in three months interval.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 to 85 years old
* Language spoken: Finnish
* Diagnosis: Histologically confirmed adenocarcinoma of prostate
* Adequate histological sampling consisting of at least 3 biopsy samples from each lobe
* No previous surgical, radiation or endocrine treatment for prostate carcinoma
* Clinical stage:T1c-T4NanyM1
* Serum creatinine ≤ 1,5 x ULN
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Previous PC treatment
* Uncontrolled serious infection
* Prior usage of 5-ARI medication in past 12 months
Virtual Reality for Coping With Involuntary Early Pregnancy Loss

This study aims to provide psychological support to women that experienced an Early Pregnancy Loss (when the loss occurs until the 20 weeks of gestation) using an innovative Virtual Reality prototype and compare the presence and evolution of psychological distress symptoms pre and post-intervention.

The main goals of this study are:

1. Evaluate the impact of the proposed VR paradigm in women who suffered a gestational loss in the first 20 weeks of gestation, compared to a control group that follows the usual standard care;
2. Evaluate the usability, user experience, and acceptance of the proposed approach.

Participants in the VR group will have an intervention program lasting four weeks, with 3 weekly sessions of 45-60 minutes, using the developed prototype.

Early pregnancy loss occurs in about 20% of all pregnancies and can lead to chronic grief and psychological distress symptomatology. Although the high prevalence, it is still a very undervalued event, and proper follow-up and psychological guidance are often absent.

The present research study aims to evaluate the feasibility of a psychological VR-based approach in a controlled pilot study with 20 women who suffered an early gestational loss in the last 6 months. Using the developed prototype, the experimental VR group will have an intervention program lasting four weeks, with 3 weekly sessions of 45-60 minutes.

The investigators aimed to verify if the use of the proposed VR paradigm will significantly reduce symptoms of grief, depression, anxiety and post-traumatic stress, and that this reduction will be significantly greater compared to the control group.

The study proposed is very innovative in terms of the target population and the use of VR, specifically designed to address gestational loss. In addition, it opens a new avenue of research on a topic that is still silenced and considered taboo in society. Thus, this interdisciplinary research has an expected scientific, technological, and social impact, namely: 1) contributes to a better understanding of the process of psychological recovery after an early gestational loss; 2) contributes to the advancement of technologies aimed at psychological support; 3) has the potential to accelerate the resolution of grief by bringing emotional and psychological support to women who do not have access to other means of support; and 4) contributes to reducing the economic burden on health care by providing tools to improve the well-being of patients.

Eligibility Criteria:
Inclusion Criteria:

- Women that have experienced an involuntary pregnancy loss in the first 20 weeks in the last 6 months;

Exclusion Criteria:

* current pregnancy
* having a diagnosis of mental disorder,
* undergoing any psychological intervention,
* vision impairments that could interfere with the execution of the VR tasks.
Wear-Time Trial for Self-Fitting Hearing Aid

This document describes a clinical validation study for a double-blind repeated-measures comparative study of the Great Nordic (GN) self-fitting method to a validated audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover wear-time field trial will be conducted. The focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the GN Self-fitting Hearing Aid, and the safety and effectiveness of the device.


Eligibility Criteria:
Inclusion Criteria:

* Mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 - 8000 Hz less than 60 decibels Hearing Level (dB HL) and from 2000 - 8000 Hz, at least one threshold greater than 20 dB HL)
* Mix of male and female subjects (aiming for a representative balance)
* Mix of prior hearing-aid use (aiming for 70-80% persons with no prior hearing aid use)
* 18-75 years old (aiming for primarily 50-70 years old, with avg. age \~65 years)
* Apple iPhone (iOS 14 compatible or greater, as required for the SELF-FIT app)
* Able to read and comprehend English
* Patient willing to provide informed consent

Exclusion Criteria:

* Hearing outside of limits noted above
* Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)
Workplace HIIT: Feasibility and Preventive Effects of HIIT in the Real-World

The aim of this study is to investigate the effects of an extremely time-efficient high-intensity interval training program, performed over a period of six months in a real-world (workplace) setting, on cardiorespiratory fitness, cardiometabolic risk profile, and self-reported outcomes including perceived stress and subjective work ability in previously sedentary employees.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary Lifestyle over at least 1 year prior to the study

Exclusion Criteria:

* Pregnancy, Lactation
* Psychological disorders, epilepsy, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* coronary heart disease, heart failure
* malignant disease
* severe rheumatic or neurological disease
* severe/unstable hypertension (resting RR: \>180/\>110 mmHg)
* severely restricted lung function (FEV1 \<60%)
* unstable Diabetes mellitus
* severe orthopedic disease/restriction
* acute / chronic infectious diseases
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction