cyrilzakka/clinical-trials huggingface dataset:
A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)


Eligibility Criteria:
Inclusion Criteria:

* Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study
* Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
* A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

  1. Not a woman of childbearing potential (WOCBP) OR
  2. A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)

Exclusion Criteria:

* Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
* Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
* Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
* Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
* Study participant plans to participate in another study of a medicinal product or device under investigation during this study
Gastrointestinal Motility in Patients With Neuroendocrine Tumors

We will study the total gastrointestinal transit time (GITT), gastric emptying and small intestine motility in NET patients before and after treated with somatostatin analogues and compare these to healthy subjects. For this we will use radio-opaque markers and the newly developed Motility Tracking System (MTS).

Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying and small bowel transit time and an increase in phase III MMC activity compared to healthy subjects. Treatment with somatostatin analogues increase transit times and decrease phase III MMC activity and improves the clinical symptoms.


Eligibility Criteria:
Inclusion Criteria:

* NET confirmed by histology
* Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.
* Newly referred patients without previous somatostatin analogue treatment or
* NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.

Exclusion Criteria:

* Subjects unable to understand the information
* Severe diabetes with late complications or known metabolic disorder
* Inflammatory bowel disease
* Known clinically significant stenosis of the bowel
* Bile acid malabsorption due to intestinal surgery
* Small bowl bacterial overgrowth
Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention

Half or nearly half of college students with prescriptions divert their stimulant medication, and a similarly high percentage misuse their medication or use someone else's prescription. Diversion may lead students to go without needed medication to mitigate their symptoms, increasing their risk for unintentional injuries and substance use. Further, diversion perpetuates the non-medical use of prescription stimulants (NMUPS), which has become increasingly common among college students. Diversion also perpetuates medical misuse of stimulants among students with prescriptions, which is associated with poorer attention-deficit/hyperactivity disorder (AD/HD) symptom management and may increase the risk for addictive disorders. There are no evidence-based interventions targeting diversion of stimulants in college students. Being approached for one's medication is a key risk factor for diversion, as is medication non-adherence and believing NMUPS and diversion are more prevalent than they are. Accordingly, in this multi-site study, the investigators will conduct a randomized, controlled trial of 300 college-attending adults with current stimulant prescriptions to examine the preliminary efficacy and feasibility of a single-session, computer-based simulation intervention (with two booster sessions) to prevent prescription stimulant diversion and medication misuse and compare it to a placebo condition. The intervention, which is grounded in social learning theory and the theory of planned behavior uniquely engages students in interactive discussions with virtual humans to (a) learn about the actual prevalence of NMUPS and diversion and their related risks, (b) practice using refusal strategies when approached for their medication in high-risk situations, and (c) understand how to effectively communicate with prescribers and avoid medication misuse. The primary aims are to determine if the intervention reduces diversion, intentions to divert, and medication misuse, and to assess user satisfaction with the intervention. The secondary aims are to examine change in potential mechanisms of action targeted in the intervention, such as self-efficacy to resist diversion, knowledge about diversion and NMUPS, use of behavioral strategies to resist requests for one's medication, and prescriber communication. If effective, the intervention could be readily and widely disseminated to college counseling centers, psychiatrists, pediatricians, and other prescribers.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate or graduate student at Trinity College (CT); University of Wyoming; Texas State University.
* Will be enrolled at Trinity College (CT); University of Wyoming; Texas State University 6-months from their baseline study session.
* Have a recent (within the past 3 months) prescription for a stimulant medication
* Between the ages of 17 and 25.

Exclusion Criteria:

* None.
Amplitude-integrated EEG in Improvement of Seizure Detection and Prognostication in Children With TBI

The goal of this study is to determine whether the addition of aEEG to cEEG in clinical practice does in fact help PICU physicians detect subclinical seizures in this population.

Children with moderate to severe TBI are at risk of significant long-term neurological sequelae. Careful post-injury management is crucial in optimizing their recovery. Seizures are a frequent complication. They are associated with worse outcome and require prompt intervention. However, they are often subclinical and are only detectable by gold-standard conventional electroencephalography (cEEG); a costly, complex monitoring device that is not readily available 24/7 in many pediatric intensive care units (PICUs) and can only be interpreted by neurologists. On average, PICUs obtain only 1-2 cEEG reports per day from neurologists and this can lead to significant delays in seizure identification and treatment. Amplitude-integrated EEG (aEEG) is a compressed form of real-time cEEG monitoring that can be added to cEEG monitoring. It is more easy to interpret and can be taught to PICU providers with limited training. It is a promising complementary tool that could help PICU physicians identify subclinical seizures and treat seizures more promptly. This could significantly improve the global outcome of this vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe TBI defined by a post-resuscitation Glasgow Coma Scale (GCS) of 3-8 (severe) or 9-12 (moderate), this includes those with accidental TBI, abusive head trauma, and cases of polytrauma
* decision by the primary medical team to initiate cEEG monitoring

Exclusion Criteria:

* patients for whom it is impossible to record cEEG for any reason will be excluded from the study
* premature neonates
* brain death or suspected brain death at PICU entry
* unavailable equipment for cEGG and/or aEEG
* consent to participate denied by parents and/or patient
Systane Hydration in Subjects Undergoing Cataract Surgery

The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.

Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.

Eligibility Criteria:
Key Inclusion Criteria:

* Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation;
* Able to provide informed consent;
* Willing and able to attend all study visits and comply with treatment;
* Have dry eyes per dry eye questionnaire.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study;
* History of intraocular or corneal surgery in the study eye;
* Use of artificial tears, steroids, or other medications as specified in the protocol;
* Clinically significant corneal scarring;
* Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol.
* Other protocol-specified exclusion criteria may apply.
The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.


Eligibility Criteria:
Inclusion criteria:

1. healthy male subjects
2. age of 18 to 55 years
3. body mass index of 18.5 to 29.9 kg/m2
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Berlin Deep Brain Stimulation Depression Study

In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* patient is diagnosed with a severe major depressive episode
* patient is in a chronic current MDE and/or has had a history of recurrent MDEs
* patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode.
* patient has a score \> 20 on the HAMD24
* patient is stable on current psychotropic medication for at least 6 weeks
* patient is \>25 and \<80 years
* Global Assessment of Function (GAF) score of \< 45

Exclusion Criteria:

* Atypical Depression (according to DSM IV)
* Other relevant psychiatric axis I or axis II diseases
* Relevant neurological diseases
* Relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (ASA Score \> 3)
* Patient is currently enrolled in another investigational study not associated with the current study
* Patient has a history of, or evidence of, significant brain malformation or significant head injury
* Patient is likely to require a whole body MRI after implantation
Emotion Regulation in Preschoolers With Autism and Their Parents

In the proposed study, the investigators would like to investigate the emotion regulation (ER) strategies children with Autism Spectrum Disorders (ASD) demonstrate, and the influence parents have on their children's ER. More specifically, the investigators would like to examine what are the ER mechanisms that parents use, what mechanisms of self regulation children with autism internalize, and how parents support and improve the ER capabilities of their child with ASD. These will be studied in a behavioral level, using micro-analysis of parent-child interaction, and in a physiological level, using indexes of stress control and affiliation. In addition, in order for parental ER support to be effective, it is important to consider more innate neuro-developmental difficulties children with ASD demonstrate that strongly affect their ability to regulate themselves. These include sensory regulation difficulties, temperament, attention disorders and poor executive functioning.

Hypotheses:

1. ER strategies used by children with ASD will be more poorly developed and less effective, compared to those of children in the control groups.
2. Difficult temperament and sensory regulation difficulties will hamper ER in children with ASD.
3. ER strategies of parents of children with ASD will be more poorly developed and less effective than those of parents in the control groups.
4. Good parental self-ER and parental attunement to the child will be predictive of improved ER in children with ASD, and in parent-child synchrony, both in the behavioral and in the physiological levels.


Eligibility Criteria:
Inclusion Criteria:

* For the study group:Children diagnosed with ASD
* For the comparison group:Children with typical development

Exclusion Criteria:

* For the study group:Non verbal children.
* For the comparison group: Any major developmental disability.
Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy

Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2\<60 mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal value.

Laparoscopic radical prostatectomy (LRP) is a wide used, well tolerated procedure. However, the general anesthesia, the need for pneumoperitoneum and Trendelenburg position may have detrimental effects on both pulmonary volumes and mechanics, and they may increase the risk of postoperative respiratory failure (PORF). Continuous positive airway pressure (CPAP) improves oxygenation and reduces the rate of re-intubation in the presence of PORF.

The aim of our study is to investigate postoperative respiratory function and the likely benefits of the use of CPAP, compared with Venturi mask in terms of prevention of post-operative hypoxaemia and worsening of lung spirometry.

CPAP is delivered with "CASTAR" Helmet by StarMed.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective laparoscopic prostatectomy
* American Society of Anesthesiologists status I-II

Exclusion Criteria:

* Cardiac functional status New York Heart Association (NYHA) \>II
* Chronic Obstructive Pulmonary Disease (COPD) Gold Class \>2
A Study of Structure and Function of Radial Artery After Transradial Coronary Intervention

Several approaches have been proposed to reduce the risk of RAO, including anticoagulation, immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal end rather than distal part of the artery,which was ignored by a majority of interventional cardiologists. Different insights into occlusion location may lead to different options of sheath materials, models, catheters and puncture access. Thus, the investigators designed this present study to explore the reason of radial artery endothelial dysfuction and damage and occlusion location by ﬂow-mediated dilation (FMD) to determine the suitable method to reduce occlusion risk during TRI.


Eligibility Criteria:
Inclusion Criteria:

* admitted for transradial catheterization.

Exclusion Criteria:

* femoral access, arterial circulatory disease, pathological Allen tests, decompensated heart failure, chronic renal failure
Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients

This study examines whether wearing a shoulder sling can improve balance and mobility in people who are recovering from a stroke. Participants will perform simple movement and balance tests twice-once with the sling and once without. The goal is to find out if using the sling helps patients feel more stable and safe during walking and everyday activities.

This is a cross-over study designed to evaluate the impact of shoulder sling use on balance and functional mobility in patients recovering from stroke in the subacute phase. Participants will be asked to complete three validated functional tests: the Timed Up and Go (TUG) test, the Functional Reach Test (FRT), and the Modified Four Square Step Test (mFSST). Each test will be performed twice, once with the shoulder sling and once without, in randomized order. The study aims to determine whether the sling provides measurable benefits in stability and performance during movement tasks. Data will be collected in rehabilitation centers under the supervision of clinical researchers.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke in the subacute phase (up to 6 months post-onset)
* Hemiplegia affecting one upper limb
* Brunnstrom stage \< 4 for the affected upper limb
* Functional Ambulation Category (FAC) score \> 3
* Age between 40 and 80 years
* Ability to follow simple instructions
* Medically stable to participate in balance and mobility testing
* Signed informed consent

Exclusion Criteria:

* Severe cognitive impairment (e.g. MMSE \< 23)
* Visual or vestibular disorders affecting balance
* Significant orthopedic or musculoskeletal conditions of the lower limbs
* Uncontrolled cardiovascular or pulmonary disease
* Use of assistive devices that prevent sling application
* Severe aphasia interfering with understanding or communication
* Skin lesions or injuries at the shoulder region preventing sling use
Diagnostic Efficacy of CNN in Differentiation of Visual Field

Glaucoma is currently the leading cause of irreversible blindness in the world. The multi-center study is designed to evaluate the efficacy of the convolutional neural network based algorithm in differentiation of glaucomatous from non-glaucomatous visual field, and to assess its utility in the real world.

Glaucoma is the world's leading cause of irreversible blind, characterized by progressive retinal nerve fiber layer thinning and visual field defects. Visual field test is one of the gold standards for diagnosis and evaluation of progression of glaucoma. However, there is no universally accepted standard for the interpretation of visual field results, which is subjective and requires a large amount of experience. At present, artificial intelligence has achieved the accuracy comparable to human physicians in the interpretation of medical imaging of many different diseases. Previously, we have trained a deep convolutional neural network to read the visual field reports, which has even higher diagnostic efficacy than ophthalmologists. The current multi-center study is designed to evaluate the efficacy of the convolutional neural network based algorithm in differentiation of glaucomatous from non-glaucomatous visual field, compare its performance with ophthalmologists and to assess its utility in the real world.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18;
2. Informed consent obtained;
3. Diagnosed with specific ocular diseases;
4. Able to perform visual field test

Exclusion Criteria:

Incomplete clinical data to support diagnosis
The Molecular Mechanism of RAS Wild-type mCRC Resistance to Anti-EGFR-antibody

Establishing the genetic map of primary and secondary resistance of Chinese wild RAS colorectal cancer received anti-EGFR treatment through tissues and peripheral blood NGS testing. Combination genetic data with clinical characteristics, prognosis and treatment data to explore the molecular mechanism of resistance of anti-EGFR-antibody.

Cetuximab is a chimeric (mouse/human) monoclonal antibody, an epidermal growth factor receptor (EGFR) inhibitor. Many large clinical trials demonstrated that for RAS wild-type metastatic colorectal cancer (mCRC), especially left-sided RAS wild-type mCRC, cetuximab can prolong OS. But some of patients have primary resistance to cetuximab and for all patients received cetuximab will develop secondary resistance. Cell-free or circulating tumour DNA (ctDNA) including primary site and metastatic site genetic information, which can avoid tumor heterogeneity. The results of paired test detection of tissue and ctDNA showed there is 93% consistency in RAS testing. Therefore, dynamic monitoring ctDNA during anti-EGFR targeted treatment of RAS wild-type mCRC patients can implement prognosis of efficacy and response evaluation in real-time. Besides, it can monitor the variation features of resistance gene and find resistance gene in real-time. According the situation of gene change to find potential drug resistance mechanism and formulate individualization treatment plan.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years, ≤75 years, all gender;
2. Histologically proven metastatic adenocarcinoma of colorectal cancer, no previous history of cancer;
3. The clinical data of patient is intact;
4. The data of patients after surgery is intact, and the prognosis follow-up data of patient is available.

Exclusion Criteria:

1. Previous history of cancer；
2. Intact clinical data or diagnosis results of histopathology is unavailable;
3. Time of progression disease after treatment and follow-up data are unavailable;
4. Patient received blood transfusion within 3 months;
5. Other situation that researchers think it will impact the results of trails or violate ethics.