cyrilzakka/clinical-trials huggingface dataset:
The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study

Screening programs have been associated with a substantial reduction in colorectal cancer (CRC) mortality through endoscopic resection of preneoplastic lesions and detection of early-stage invasive cancers.

In March 2020, the World Health Organization declared as a pandemic the outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2. Since then, the SARS-CoV-2 have never stopped spreading, causing an unprecedented situation with highly restrictive considerations to be adopted by the majority of countries worldwide.

Health-care facilities have been making an enormous effort to assist patients affected by COVID-19, while adopting measures to maintain a safe environment for patients and healthcare professionals. As a result, the usual workflow in endoscopy departments changed dramatically, leading to an increase in cancelled procedures, probably increasing the future burden of Colorectal Cancer due to delays in diagnosis.


Eligibility Criteria:
* patients who underwent colonoscopy between the 1st October 2020 and the 31st December 2020 (pandemic cohort)
* patients who underwent colonoscopy between the 1st October 2019 and the 31st December 2019 (pre-pandemic cohort)
Use of Decision Support in the Management of Labour

In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: "No decision-support" - CTGs with no additional interpretation (UK standard care), compared with: "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. How the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the Guardian™ system.


Eligibility Criteria:
Inclusion Criteria:

* Require continuous electronical fetal monitoring during labour

  * they have a singleton or twin pregnancy
  * they are ≥ 35 weeks' gestation (≥ 245 days)
  * there is no known gross fetal abnormality, including any known fetal heart arrhythmia such as heart block
  * they are 16 years of age or older
  * they are able to give consent to participate in the trial as judged by the attending clinicians.

Exclusion Criteria:

* • triplets or higher order pregnancy

  * criteria for EFM not met, including elective caesarean section prior to the onset of labour
Life Balance and Bimanual Activities After Stroke

The Flemish version of the Life Balance Inventory (LBI), measuring central constructs of life balance, will be validated in a stroke population. Upon approval by the ethical committee, stroke patients will be recruited when they are at least six months post stroke (n = 30). The LBI will be administered twice with one week interval, and demographic, socio-economic variables and other measures of health related quality of life will be collected.

Next, an observational prospective longitudinal study will be set up. We will recruit stroke patients in three rehabilitation centers within one week after admission in the rehabilitation center. Patients will undergo a baseline evaluation and will be re-assessed at discharge from the rehabilitation center, at six months and at 12 months post stroke. A standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and functional outcomes as well as personal and environmental factors will be administered. This observational study will explore recovery patterns of bimanual activities after stroke from baseline evaluation to six and 12 months after stroke. Also the predictive value of motor, sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post stroke is studied, based on data collected on admission to the rehabilitation center. Finally, changes over time in life balance and its determinants will be examined at six and 12 months post stroke. The predictive value of motor, cognitive and functional outcomes on life balance at one year post stroke will be examined, based on data collected on admission to the rehabilitation center. Furthermore the influence of bimanual activities on life balance will be explored in the chronic stage after stroke.


Eligibility Criteria:
Inclusion Criteria:

* first-ever stroke, as defined by the WHO criteria
* assessed and included within the first week after admission in the rehabilitation center and within the first six weeks after stroke onset
* unilateral motor impairment in the upper limb (UL - Fügl-Meyer score ≤ 60)
* minimally 18 years old
* substantial cooperation to perform the assessments
* written informed consent

Exclusion Criteria:

* other neurological impairments with permanent damage such as multiple sclerosis or Parkinson's disease
* a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a stroke
Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer

Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.

Although there have been no confirmative data which favored preoperative chemoradiotherapy, preoperative chemoradiation have many theoretical advantage compared with postoperative one. Preoperative radiotherapy with intensive short course regimen showed significant improvement in local control even with TME, but there has been no large prospective randomized trial which proved the efficacy of preoperative chemoradiotherapy compared with the standard postoperative chemoradiotherapy. Although the final result of the German Trial may give the answer for this question, there has been no randomized controlled trial which investigated the efficacy of preoperative chemoradiotherapy using oral fluoropyrimidine which have many theoretical and clinical advantages mentioned above; the German Trial used 5-day continuous infusion of 5-FU. The investigators think that preoperative chemoradiotherapy with oral capecitabine could be new standard regimen in locally advanced rectal cancer, but this regimen must be compared with the standard postoperative chemoradiotherapy through well designed prospective randomized trial. Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed rectal adenocarcinoma
* Tumor located below 10 cm from the anal verge
* Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography (EUS) and computed tomography (CT)
* Patients must be \> 18 years and \< 76 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow reserve
* Adequate renal function
* Adequate liver function
* Signed informed consent prior to randomization

Exclusion Criteria:

* Evidence of distant metastasis
* Previous history of chemotherapy or radiotherapy
* History of malignancy during recent 5 years other than skin cancer
* Pregnant or lactating woman
* Familial history of colorectal cancer
Fresh Truck Pilot to Reduce Food Insecurity in a Medicaid ACO

This research is a randomized pilot study of an intervention to address food insecurity among intermediate risk Boston Accountable Care Organization (BACO) members receiving primary care at Boston Medical Center (BMC).

The investigators propose a parallel group, randomized pilot study among intermediate risk Medicaid ACO patients at BMC who have experienced food insecurity in the past 12 months, with a total enrollment of 120 participants (N=120). Half of the pilot study participants (n=60) will receive usual care: tailored printed paper referral guides to address health-related social needs, including resources for food insecurity (via the Health System's THRIVE Screening \& Referral Program) and referrals to Boston Medical Center's Preventative Food Pantry. The other half (n=60) will receive access to a mobile fresh produce market and a monthly stipend to purchase items available on the mobile food trucks.

This pilot study will partner with Fresh Truck, a Boston-based 501(c)(3) organization that deploys mobile fresh produce trucks throughout Boston neighborhoods. Fresh Truck recently launched a new system, called 'Fresh Connect,' which addresses affordability as a barrier to healthy eating. 'Fresh Connect' enables healthcare systems to pay for fresh produce purchased by their patients from the Fresh Truck mobile markets.

The study protocol comprises three steps:

* Risk stratification before consent process to determine if the patient, at baseline, is within the top 3-20% of cost and utilization among BACO members. (This process is part of usual care operations in the Health System for ACO members).
* Of BACO patients identified as intermediate risk, patients will be screened for proximity to Fresh Truck mobile markets (zip code is among current Fresh Truck service area), nutritional need (food insecurity identified in the last 12 months), and not documented as housing insecure.
* Half the pilot study population will receive access to a mobile fresh food market intervention, Fresh Truck, and a stipend to purchase fresh produce aboard the trucks. The other half will receive usual care.

Pilot study participation is 6 months and will include collection and measurement of data from the following sources: baseline interview; final (6-months post-enrollment) interview, electronic medical records (EMR), BMC Clinical Data Warehouse (BMC CDW), and BMC HealthNet Plan (BMCHP) claims.


Eligibility Criteria:
Inclusion Criteria:

* Be within the 3rd to 20th percentile for healthcare utilization and cost among BACO membership at the time of enrollment into the pilot study
* Zip code that is in one of Fresh Truck's current services areas
* Documented as experiencing food insecurity in the previous 12 months
* Attend a primary care or ambulatory visit at BMC's primary care suites

Exclusion Criteria:

* Documentation of housing insecurity
* Receiving services from the BACO complex care management program
Reliability and Validity of Online Cognitive Assessments

The purpose of this study is to evaluate the concurrent validity (correlation coefficient of scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a validated third party computerized assessment.

Each subject will complete two sessions, each approximately 1 hour in total duration, approximately 2 weeks apart for a total duration of participation of 2 hours over 2 weeks

Eligibility Criteria:
Inclusion Criteria:

* Electronically signed informed consent
* 18 years of age or older
* Native English-Speaker
* Consistent access to a computer with stable internet connection

Exclusion Criteria:

* Under 18 years of age
* Native language other than English
* Visual impairment that impedes computer use
* Has taken a cognitive assessment or done cognitive training in the past year
Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations

The purpose of this study is to investigate the use of telemedicine-based intervention at urban and rural skilled nursing facilities to recommend multidisciplinary dementia care to residents with dementia who are at risk for unnecessary hospitalization due behavioral or neuropsychiatric symptoms and/or complications as well as caregivers and facility staff. The multidisciplinary team is comprised of trained behavioral neurologists, social workers, advanced practice providers, primary medical team and nurse coordinators.


Eligibility Criteria:
Inclusion Criteria:

Dementia Care facility resident Problematic behavioral problems

Exclusion Criteria:

None
Effects of Nitrates and Citrulline Malate on Performance in Professional Professional Soccer

Randomized, single-center, parallel, team-stratified, stratified experimental study to evaluate the efficacy of a high sports supplement in improving high-intensity intermittent exercise performance in professional female soccer players.

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned).

The product to be consumed will be Nitrates and Citrulline Malate. Participants will consume the product for 30 days. The intake should be done two hours before each training session and the same dose will be consumed.

The women's soccer players will perform a stress test with gas analysis to measure performance, as well as a Wingate test without consumption of the products. Five days later, the players will perform the Yo-Yo IR1 test in the field and will repeat the same tests performed at the beginning of the test after product consumption.

Eligibility Criteria:
Inclusion Criteria:

* Present at the time of signing the informed consent at the age between 18 and 40 years.
* Female.
* Healthy subjects without any chronic disease.
* Volunteers capable of understanding the clinical study, willing to give their written informed. consent and comply with the procedures and requirements of the study. and requirements of the study.

Exclusion Criteria:

* Players who change teams during the experimental study.
* Smoking subjects.
* Subjects using mouthwashes during the study.
* Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study. factors that limit their ability to cooperate during the study.
* Subjects whose status makes them ineligible for the study, at the discretion of the investigator discretion of the investigator.
Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients

Vibration therapy is used for different indications in rehabilitation and sports medicine. So far, vibration therapy has not been investigated within the ICU setting. The investigators created this setting to show safety and applicability of vibration therapy in ICU patients. 30 patients will be stimulated by vibration therapy on two separate days during their ICU stay. Three collectives of equal size will be observed: One with patients on mechanical ventilation without signs of infection or suspected intracranial pressure problems, a second one with patients on mechanical ventilation in addition to signs of systemic inflammation but absence of suspected intracranial pressure problems, and a third one with patients on mechanical ventilation, signs of systemic inflammation in addition to presence of controlled intracranial pressure problems. Typical parameters of hemodynamic status, intracranial pressure and energy metabolism will be recorded for a defined period of time before, during and after vibration therapy itself. Vibration therapy will be combined with protocol based physiotherapy.

Our aim is to show the effects of vibration therapy in ICU patients and its safe applicability.

ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will perform electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg, randomized chosen. Measuring the local skeletal muscle metabolism will be done by microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration therapy combined with electrical muscle stimulation.


Eligibility Criteria:
Inclusion Criteria:

* immobilized icu patients:

  * with mechanical ventilation without signs of infection
  * with mechanical ventilation and SIRS or sepsis
  * with mechanical ventilation, with controlled elevated intracranial pressure and with or without SIRS or sepsis
* signed declaration of consent by the patient or its legal proxy

Exclusion Criteria:

* age \< 18 years old
* already known neuromuscular disease
* missing declaration of consent by the patient or its legal proxy
* implanted heart pacemaker or defibrillator
* pregnancy
* acute thrombosis
* not yet healed fracture ad the part of the body which will be trained
* implants ad the part of the body which will be trained
* a nearly done ophthalmic surgery
* acute disc prolapse
* infaust prognosis, that means death is expected into the next couple of hours, although maximum therapy is done
Impact of Sleep Extension in Adolescents

Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. This is important to know so that the investigators understand how sleep may play a role in health conditions like extra weight gain (increased food intake and less physical activity) and diabetes. To answer this question, the investigators plan to enroll teenagers who get \<7 hours of sleep on school nights and measure changes in insulin sensitivity and dietary intake after a week of typical sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour longer in bed each night).


Eligibility Criteria:
Inclusion Criteria:

1. High school students between the age of 14-19 years
2. have typically insufficient sleep, defined by ≤ 7 hours per night on school days
3. BMI 5th-84th percentile for age and sex
4. habitually sedentary (\< 3 hours of regular physical activity per week)
5. Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

Exclusion Criteria:

1. Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
2. regular use of melatonin or other sleep aids
3. a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)
4. Type 2 diabetes or prediabetes
5. IQ\<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes)
6. teens not enrolled in a traditional high school academic program (e.g., home school students)
7. schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)
8. travel across more than two time zones in the 2 weeks prior to the study.
Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel

The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.


Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome
* Prasugrel loading dose 6-24h before inclusion

Exclusion Criteria:

* Clopidogrel loading dose
* GPIIbIIIa use within 10 days before inclusion
* Known congenital thrombopathy and/or congenital coagulation defect
Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases

Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 15 years of age
* Life threatening disease documented by conventional criteria to be resistant to standard, approved therapy.
* Experimental documentation of functional significance of either Abl, Kit (CD117), or PDGF-R in the relevant target tissue (preferably on a sample taken within 6 weeks of study entry).
* ECOG Performance status of 0, 1, or 2.
* Adequate end organ function defined as: total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 x UNL (or \< 5 x ULN for patients with hepatic disease), creatinine \< 1.5 x ULN, ANC \> 1.5 x 109/L, platelets \> 100 x 109/L.
* Negative serum or urine pregnancy test for women of child bearing potential (WOCBP) within 7 days of study initiation. Post menopausal women must have experienced amenorrhea for at least 12 months. Male and female patients must use effective birth control methods throughout the study and for up to 3 months after study discontinuation.
* Life expectancy of more than 3 months.
* Written, voluntary, informed consent for retrieval, evaluation and investigational use of tissue samples.

Exclusion Criteria:

* Patients who have received any other investigational agent within 28 days of study initiation.
* Patients with another primary malignancy except if other primary malignancy is neither currently clinically significant nor requiring active intervention.
* Patients with Grade III/IV cardiac problems defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study).
* Female patients who are pregnant or breast-feeding.
* Patients who have another severe and/or life threatening medical disease.
* Patients with acute or known chronic liver disease (e.g. chronic active hepatitis, cirrhosis).
* Patients with a known diagnosis of the human immunodeficiency virus ((HIV) infection.
* Patients who have received chemotherapy within 4 weeks (6 weeks allowed for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry.
* Patients who have had major surgery within 2 weeks prior to study entry.
* Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Other protocol-defined inclusion/exclusion criteria may apply.