cyrilzakka/clinical-trials huggingface dataset:
Development and Validation of a Deep Learning Algorithm to Evaluate Endoscopic Disease Activity of Ulcerative Colitis.

The purpose of this study is to develop an artificial intelligence(AI) assisted scoring system, which can evaluate the disease severity and mucosal healing stage in patients with ulcerative colitis. Then testify whether this new scoring system can help physicians to enhance the accuracy of disease severity assessments in a multi-center clinical practice.

Ulcerative colitis is a non-specific chronic inflammation of gut characterized by referral bloody stool, diarrhea and abdominal pain. Endoscopic features of the disease severity and mucosal healing stage are strongly associated with treatment response and prognosis in the future. Currently, the Mayo endoscopic sub-score (Mayo ES) and Ulcerative colitis endoscopic index of severity (UCEIS) are commonly recommended to guide therapeutic adjustments. However, the accuracy of these scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. Recently, deep learning algorithm based on convolutional neural network (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. Up to now, no randomized controlled trials have been conducted to evaluate the performance of deep learning algorithm for assessing disease activity in ulcerative colitis. This study aims to train a deep learnig algorithm to assess severity and mucosal healing stage of ulcerative colitis using the Mayo ES and UCEIS scale, then testify whether the engagement of AI can improve the evaluation accuracy of physicians in a multi-center clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ulcerative colitis undergoing colonoscopy

Exclusion Criteria:

* Known or suspected bowel obstruction, stricture or perforation
* Compromised swallowing reflex or mental status
* Severe congestive heart failure (New York Heart Association class III or IV)
* Uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
* Pregnancy or lactation
* Hemodynamically unstable
* Colonic surgery history
* Bad bowel preparation (segmental BBPS\<2)
* Unable to give informed consent
Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study

Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.

This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?

Euglycemia after Antenatal Late Preterm Steroids, the E-ALPS Study:

There is a fundamental gap in understanding the adverse metabolic effects of antenatal late preterm steroids (ALPS). In 2016, an important randomized clinical trial of 2827 late preterm pregnancies showed that antenatal betamethasone (BMZ) significantly reduced neonatal respiratory complications compared with placebo. However, those neonates exposed to BMZ were also more likely to have hypoglycemia at birth. This unexpected adverse outcome raised concern among both obstetricians and neonatologists and remains an important knowledge gap to be filled. The rationale for the proposed research is that steroid-induced maternal hyperglycemia leads to transient fetal hyperinsulinemia, which causes hypoglycemia in neonates that are delivered during this time-period. Thus, the fetal metabolic consequences and subsequent neonatal hypoglycemia observed after exposure to BMZ in utero can be prevented by achieving maternal euglycemia prior to delivery.

This protocol describes a randomized clinical trial to evaluate whether screening for and treatment of steroid-induced hyperglycemia in non-diabetic women treated with BMZ in the late preterm period can decrease the rate of fetal hyperinsulinemia, thus reducing neonatal hypoglycemia and improving short-term neonatal outcomes.

This study was formerly approved as Institutional Review Board #16-3200.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation with no known major fetal anomalies
* Gestational age at randomization between 34 weeks 0 days and 36 weeks 5 days
* Receiving antenatal betamethasone due to high probability of delivery in late preterm period

Exclusion Criteria:

* Pre-gestational or gestational diabetes mellitus
* Maternal contraindication to insulin
* Planned outpatient treatment with antenatal betamethasone
* Participation in clinical trial that could affect primary outcome or participation in this trial in a previous pregnancy
Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression

Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.


Eligibility Criteria:
Inclusion Criteria:

* Main Study participant must be aged 12 years or older AND at high risk of progression of COVID-19 or \> 55 years old
* Sub-Study participants must be aged 18 years or older at time of consent AND at high risk of progression of COVID-19 or ≥ 55 years old
* Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 7 days from onset of symptoms

Exclusion Criteria:

* Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
* Symptoms consistent with severe COVID-19
* Participants who, in the judgement of the investigator are likely to die in the next 7 days
* Known hypersensitivity to any constituent present in the investigational product
Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection. COVID-19.

In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.

Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.

Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.

Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

Procedures added by the research:

Phone calls for collection of reported symptoms. Nasopharyngeal swabs for determination of the presence of SARS-CoV-2 detected by PCR.

Blood sampling for determination of the presence of SARS-CoV-2 IgM or IgG. Saliva or blood sampling for whole exome sequencing of the subject.

Eligibility Criteria:
Inclusion Criteria:

1. High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
2. Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
3. Obtaining informed consent.

Exclusion Criteria:

* Subject deprived of freedom
* Subject under a legal protective measure
The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery

Many people spanning from air traffic controllers to simple production line workers share regular compulsive breaks to revert fatigue whilst they work. This is uncommon for medical operators - a macho image is still as prevalent in real life as it is in countless TV series.

We report on the first clinical trial on regular intraoperative breaks. For one time we turned our scientific curiosity to ourselves. This included the intraoperative collection of body fluids and required transparency which was not easy to obtain. It was rewarded with striking results: Regular intraoperative breaks lowered significantly the operators stress hormone levels, improved error-performance testing results and musculoskeletal fatigue scores. Subjectively the breaks enhanced the practitioners satisfaction.

Surprisingly the operator's breaks were not at the cost of the patient: because the did not prolong the overall operation time at all and - in our setting- they significantly increased of cardiac output and urine production.

Abstract

Background: Work breaks at close intervals are common in fields with high workload but not yet for medical operators. We evaluated the effects of intraoperative breaks (five minutes every half hour) on the surgeon and on the patient.

Methods: Operations were randomized to either a scheme with intraoperative breaks and release of the pneumoperitoneum (intermittent pneumoperitoneum = IPP) or a conventional conduct (CPP). Stress hormones and α-amylase were determined in the surgeon's saliva pre-, intra- and postoperatively. Mental performance and error scores, musculoskeletal strain and continuous ECG were secondary endpoints. The children's physiology was monitored.

Findings:

Regular intraoperative breaks did not prolong the operation. The surgeon's cortisol levels during the operation were reduced. There were fewer intraoperative events in the IPP vs. the CPP group. The pre- to postoperative increase in the error rates of the bp-concentration test was reduced in the IPP group. The relevant locomotive strain-scores were reduced by IPP.

There was no negative impact on the patient. Interpretation: Our data support the idea that work breaks during complex laparoscopic surgery can reduce psychological stress and preserve performance with at least similar patient outcome compared to the traditional work scheme.

Eligibility Criteria:
Inclusion Criteria:

* complex laparoscopic operations in children (duration \> 100 minutes)

Exclusion Criteria:

* age under 4 weeks
* operations which had to be performed in an open surgery mode
Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

The investigators will design and implement a randomized clinical trial to test, on a community-wide level, the effectiveness of managed care based tracking/reminder/recall on improving vaccination coverage among adolescents.

The investigators propose a randomized controlled trial to evaluate the effectiveness of reminder/recall for adolescents: 10,599 adolescents within the managed care organization (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone messages or 3) standard of care of their practice (no messages from the intervention).

Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive services

Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders

Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which have low baseline immunization rates.

Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone reminders.


Eligibility Criteria:
Inclusion Criteria:

* Member of the Monroe Plan for Medical Care (managed care organization)
* Patient of a participating practice
* Ages 10.75 to \<18 years of age

Exclusion Criteria:

* Member of the Monroe Plan for Medical care for less than 6 months
* ICD-9 diagnosis of 999.4 for anaphylactic reaction to a vaccine or its components.
* Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause
* Guillain-Barre- ICD-9 code is 357.0
The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea

The overall aim of this study is to estimate the effect of orofacial myofunctional therapy (OMT) plus auto-monitoring compared to auto-monitoring alone. Moreover, the investigators aim to identify anatomical and behavioural predictors of OMT adherence

The overall aim will be addressed by reqruiting 100 participants to orofacial myofunctional therapy. 50 will be randomized to immediate treatment after the baseline consultation while 50 will get access to the treatment module after 3 monts of waiting. Outcomes will be assessed by a researcher blinded for the randomization result.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to Ahus or the Fertilitas clinic

  * A diagnosis of obstructive sleep apnea according to the current International Classsification of Sleep Disorders (ICSD) version 3 criteria {Berry, 2020, The AASM Manual for the Scoring of Sleep and Associated Events: Rules', Terminology and Technical Specifications', Version 2.6.;, 2014, International classification of sleep disorders', 3rd ed.}, with a respiratory event index (REI) \<30.
  * Not previously or currently treated with PAP or MAD
  * Signed informed, written consent.
  * Owning a mobile phone with software compatible for the study application Age ≥18 year.
  * Body mass index \<30
  * Ability to breathe through the nose
  * Ability to read and willingness to follow the protocol as described in the written consent form
  * Teeth 5-to 5 should be present or fixed by prosthesis or implants.
  * No botulinium toxin in facial muscles last three months

Exclusion Criteria:

* Failure to fill in at least 70% of days in the electronic sleep diary provided in the mobile app for two weeks.

  * Medical or psychiatric conditions which may interfere with the study protocol in the opinion of the investigator. Examples are acute psychosis, drug abuse and dementia. This will be noted in the study inclusion-exclusion document for each approached candidate for the study. The information will then be discussed in an exlusion committee consisting of dr. Skirbekk, Jagomägi, Dammen and Hrubos-Strøm.
  * Tongue-tie as described below. Participants with mouth opening of \<50% with the tip of the tongue at the incisive papilla compared to total mouth opening will be excluded.
Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism

We plan to analyze the data to meet the primary objective of the study:

To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children.

In addition, we plan to analyze the data to meet 2 secondary objectives of the study:

1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy.
2. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.

We plan to analyze the data to meet the primary objective of the study:

To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children.

In addition, we plan to analyze the data to meet 2 secondary objectives of the study:

1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy.
2. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.

Eligibility Criteria:
* Data Analysis Only
A Brief Intervention

This randomized controlled trial (RCT) study is a small scale test of the feasibility and preliminary efficacy of a brief motivational interview-style intervention. The intervention took place in the pediatric emergency departments by a trained interventionist and will followed an intervention algorithm developed by a team of dating abuse and brief intervention experts. The research design is as follows: the investigators will randomize youth ages 12-19 years old to one of two groups: one group who receives the intervention (N=\~18), and the other which does not (N=\~18). The investigators compared changes in outcomes from baseline to 1-month follow-up for those in both groups. The investigators looked at outcomes including dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization).

Statement of study hypothesis: Youth who receive the intervention will show improvements in dating abuse-related knowledge, attitudes and behavior that are maintained for 1 month, while those in the comparison group will show no similar change.


Eligibility Criteria:
Inclusion Criteria:

* 15-19 years old
* English-speaking
* Have used at least one form of physical or sexual aggression against a dating or sexual partner in the past three months

Exclusion Criteria:

* Patient's reason for ED visit is an acute mental health problem (e.g., suicidal ideation or attempt, severe anxiety attack)
* Patient is a prisoner
* Patient is determined to be potentially lethal
* Patient attends batterer intervention classes
Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke

Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving upper limb function after stroke. All these robotic devices have been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the impact on physiological responses is still lacking.

This trial is to examine (1) the immediate effects of treatment intensity in RT on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the physiological markers of inflammation, oxidative stress, and erythrocyte deformability. These overall findings will help better understanding of the efficacy of RT on functional outcomes, brain and movement reorganization, and physiological markers.

Subacute stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 3 groups: RT with higher-intensity group, RT with lower-intensity group, and conventional intervention group. Assessments on sensorimotor impairments (Fugl Mayer Assessment, Motor Status Scale, Modified Ashworth Scale, Myoton, Muscle Metabolism, Box and Block Test, and Revised Nottingham Sensory assessment) and functional performance (Functional Independence Measure, Motor Activity Log, ABILHAND Questionnaire, Adelaide Activities Profile, EQ-5D-5L, and accelerometer) take about 40 minutes to complete. Evaluation of brain reorganization using functional magnetic resonance image and movement patterns by kinematic analysis take about 1 hour for each examination. Blood samples of the patients (12 ml.) will be collected to examine the physiological markers (ie, inflammation-related markers, oxidative stress markers, and erythrocyte deformability) before and after intervention. Total 24 ml blood will be collected in this study. Except for the blood taking, all the examinations are non-invasive.

Eligibility Criteria:
Inclusion Criteria:

* first episode of unilateral stroke
* time since stroke less than 3 months, i.e., acute or subacute stage
* initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment
* no serious cognitive impairment (i.e., Mini Mental State Exam score \> 23)

Exclusion Criteria:

* pregnant or breastfeeding women
* aphasia that might interfere with understanding instructions
* major health problems or poor physical conditions that might limit participation
* currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity.
Geriatric Syndrome in Nursing Home Residents

Disability in daily living activities (ADL) is a typical issue among nursing care residents. The goal of this study was to look at the geriatric syndromes that cause incapacity in nursing home residents.

More often than not, people who live in nursing homes can't move out. One of the main reasons they leave their own home is to lose their freedom. Nursing homes also have a lot of people with geriatric diseases like cognitive impairment, balance problems, urinary incontinence, and disability. But it's not known what role geriatric syndromes play in ADL impairment. To come up with good ways to treat geriatric syndromes, which are the main causes of ADL disability in nursing home patients, we need to know more about them. So, the point of this study was to look into geriatric syndromes that are linked to disability and find out what causes disability in nursing home patients.

Eligibility Criteria:
Inclusion Criteria:

* age over 65
* staying in a nursing home for at least 12 months
* consent to participate in the study were the inclusion criteria.

Exclusion Criteria:

* people who were mentally unable to answer questions,
* people who were hospitalized
* people who had severe hearing or vision problems that made it hard to communicate
* people who took benzodiazepines or psychotropic drugs that made it hard to walk or balance
* people who had fractures or endoprostheses in any part of their bodies.
Treatment of Overweight Children and Adolescents

The intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific.

The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.


Eligibility Criteria:
Inclusion Criteria:

* overweight children

Exclusion Criteria:

* primary disease