cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcome in Patients With Syringomyelia（COPSM）

The aim of this study is to determine the clinical spectrum and natural progression of Syringomyelia (SM) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.

Syringomyelia is a chronic central spinal cord injury, which is characterized by dilation of the central canal of the spinal cord. At present, the treatment of syringomyelia is mainly through surgical decompression to restore the disturbance of cerebrospinal fluid circulation. Due to the heterogeneity of the etiology of syringomyelia, almost all published studies on the clinical outcome and prognostic factors of syringomyelia are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of syringomyelia and determine the main prognostic factors through clinical scales, biomarkers and electrophysiology.

At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.

Optionally, additional examinations may be performed including imaging, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* patients who was diagnosed as syringomyelia including: Chiari malformation， Basilar Impression， subarachnoid obstruction， patient not received surgical or interventional treatment before， patient willing and able to participate in the registry，
* Hydrocephalus or other neurodegenerative disease and normal subjects.

Exclusion Criteria:

* patient received surgical treatment or interventional treatment before
* patient is pregnant
* patient unable to complete follow-up
* patient with other spinal lesions
* other nervous system diseases
Bolus of Saline in Stroke

This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke within 96 hours of enrollment. The study intervention will be a one hour monitoring session. There will be a 15 minute baseline measurement period, followed by intravenous administration of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All study measurements will cease after 1 hour. Subjects will be followed during their hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse events and to collect clinical information.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery territory on either side of the brain
* Study intervention can be initiated within 96 hours of symptom onset
* Willingness and ability to sign informed consent by patient or legally acceptable surrogate decision-maker

Exclusion Criteria:

* Infarct limited to the brainstem and/or cerebellum with no involvement of the cerebral hemispheres
* Bi-hemispheric infarction or acute infarct in the contra-lateral hemisphere within the past 30 days
* Symptoms of active congestive heart failure (dyspnea, orthopnea, increased oxygen requirement)
* Exacerbation of congestive heart failure, requiring hospitalization, within the past 30 days or severe systolic dysfunction with a known ejection fraction \<20%
* End stage renal disease requiring hemodialysis or a creatinine clearance \<20 ml/min/1.73 m2
* Hemicraniectomy or other skull defect that would interfere with monitoring
* Pregnant women are excluded. Women of child-bearing age must have a negative pregnancy test prior to enrollment
* Participation in another clinical trial
* Any other illness or condition that the investigator feels would pose a hazard to the subject from participation in the study
Safety Study of rhASM Enzyme Replacement Therapy in Adults With Acid Sphingomyelinase Deficiency (Niemann-Pick Disease)

The purpose of this study is to determine the safe range of single doses of rhASM administered to adults with ASM deficiency.

ASM deficiency (ASMD), also known as Niemann-Pick A and B disease, is a rare genetic disorder in which reduced activity of the lysosomal enzyme, ASM, leads to the accumulation of sphingomyelin primarily in macrophages throughout the body. This deficiency results in characteristic features such as hepatosplenomegaly, thrombocytopenia, interstitial lung disease, growth retardation, coronary artery disease, fatigue, and in severe cases, neurodegeneration with death in early childhood. There is no specific treatment for this disease. This Phase 1 safety study will seek to enroll a minimum of 12 and a maximum of 30 eligible adults patients with ASMD with each patient participating for approximately 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed, informed consent by the patient or legal guardian prior to performing any study-related procedures;
* Have ≤ 0.2 nmol/hr/mg protein ASM activity in peripheral leukocytes, as measured by the reference laboratory;
* Have a diffusing capacity (DLco) \> 30% of the predicted normal value;
* Have a spleen volume ≥ 2x normal
* Female patients of childbearing potential must have a serum pregnancy test negative for β-hCG and agree to use a reliable birth control method for the duration of the study.

Exclusion Criteria:

* Is pregnant or lactating;
* Has received an investigational drug within 30 days prior to study enrollment;
* Has a medical condition, including serious intercurrent illness, active hepatitis B or C or human immunodeficiency virus (HIV) infection, cirrhosis, \> stage 3 liver fibrosis, INR \>1.5, platelet count \< 60.0x10\^3/µL, significant cardiac disease (e.g. pulmonary artery pressure \> 40 mm Hg, moderate or severe valvular dysfunction, or \< 40% left ventricular ejection fraction by echocardiography (ECHO)), or any other extenuating circumstances that may significantly interfere with study compliance including all prescribed evaluations and follow-up activities;
* Has had a major organ transplant (e.g. bone marrow or liver);
* Has had a total splenectomy;
* Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>250 IU/L or a total bilirubin \>3.6 mg/dL;
* Is unwilling or unable to avoid the use of alcohol, medications that may decrease rhASM activity, medications or herbal supplements that may cause or prolong bleeding, and the use of medications or herbal supplements with potential hepatoxicity within 14 days prior to and 28 days afte the rhASM infusion.
Pilot Study of Maintenance Therapy With Intravenous AMANTADINE

This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with PARKINSON'S Disease who are not well balanced with medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson disease
* Age\<80
* Patients with no motor improvement under optimal treatment with anti parkinson medications
* Patients with moderate to severe dyskinesias
* Patients with PD with side effects who can not tolerate anti parkinson medications

Exclusion Criteria:

* Age\>80
* Patients with Parkinson syndromes, vascular parkinsonism or drug-induced parkinsonism
* Patients with PD who developed adverse reactions to oral amantadine
* Contraindication of amantadine treatment
Adapting an Advocacy Services Intervention for Latinx Families of Transition-aged Youth With Autism Spectrum Disorder

When youth with autism spectrum disorder (ASD) transition from school to adult services, they fall off a "service cliff." To increase access to services, the investigators developed the ASSIST program, which teaches parents how to advocate for adult services on behalf of youth with ASD. In a pilot randomized controlled trial (RCT: R34 MH104428), treatment group (versus control) participants demonstrated significantly improved knowledge of adult services, advocacy, and empowerment. Sons/daughters of treatment group participants had increased access to services. For advocacy services interventions like ASSIST to be equitable, they need to reach families who are at greatest risk for service disparities. Latinx youth with ASD are one such underserved population. Relative to White youth, Latinx youth with ASD receive significantly fewer post-secondary education, health, and employment services and face worse post-school outcomes. In addition to the barriers which hinder service access for all families, Latinx families face unique barriers to service access (e.g., language, cultural differences, citizenship, discrimination) making them a marginalized population. In this project, the investigators are adapting the ASSIST curriculum and related measures for Latinx parents of transition-aged youth with ASD. Specifically, the investigators will leverage ASSIST data and data from Latinx, non-ASSIST parents to inform adaptations to the ASSIST curriculum. The investigators will also conduct pre-testing and a cross-cultural adaptation process to revise the ASSIST measures for Latinx families. The investigators will test the adapted ASSIST curriculum with a randomized controlled trial to determine its feasibility, acceptability and efficacy on intervention targets (knowledge, advocacy, and empowerment) and outcome of interest (service access). This project is aligned with NIMH priorities by examining services from adolescence to adulthood (PA-21-199) and by adapting a program to improve mental health services for underserved populations NIMH 2020 Strategic plan). It is also responsive to the Interagency Autism Coordinating Committee core value of "equity" in reducing disparities with respect to cultural backgrounds. Further, if successful, it will be the first intervention to directly address service disparities for Latinx families of youth with ASD who are transitioning to adulthood.


Eligibility Criteria:
Inclusion Criteria: To be included in the study, the participant must be:

* over the age of 18,
* identify as Latinx,
* have a child with autism who is over the age of 12,
* speak Spanish, and
* reside in Illinois.

Exclusion Criteria:

* Must understand Spanish
A Study for Adults With Plaque Psoriasis

In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis.


Eligibility Criteria:
Inclusion criteria:

* Are ambulatory and greater than or equal to 18 years of age. Females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate(\<1% per year) during the study.
* Chronic psoriasis vulgaris for at least 6 months prior to randomization.
* Moderate and severe (plaque) psoriasis involving at least 10% body surface area (BSA) or at least 8% BSA in subjects with severe palmar-plantar involvement at randomization.
* Psoriasis Area and Severity Index (PASI) total score of at least 12 at screening.

Exclusion criteria:

* Have had a clinically significant flare of psoriasis during the 12 weeks prior to randomization or a biologic agent/monoclonal antibody within the longer of 5 half lives or 12 weeks prior to dosing, had systemic treatment for psoriasis or phototherapy within 4 weeks prior to dosing, or had topical psoriasis treatment within 2 weeks prior to dosing.
* Have had a vaccination within 4 to 12 weeks (depending on type) prior to or intend to have one within 4 weeks after the dosing period.
* Are immunocompromised or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus \[HIV\]); or have had a recent serious systemic infection (such as mononucleosis or herpes zoster).
* Have a history of or current lymphoproliferative disease or malignant disease (except for resolved cervical dysplasia; or no more than 3 successfully treated basal- or squamous- cell carcinomas of the skin), or severe drug allergies/hypersensitivity.
* Have a history of serious cardiac disease within 12 weeks before randomization; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
* Have laboratory test values outside the reference range for the population or investigative site that are considered clinically significant and/or have any of the following specific abnormalities:

  * Aspartate transaminase (AST) or alanine transaminase (ALT) \>2 x the upper limit of normal (ULN; upper reference range of the central laboratory for the study)
  * Hemoglobin \<100 g/L (10 g/dL)
  * White blood cell (WBC) \<3.0 G/L (3,000/mm3)
  * Neutrophils \<1.5 G/L (1,500/mm3)
  * Platelets \<75 G/L (75,000/mm3)
  * Serum creatinine \>133 µmol/L (1.5 mg/dL)
  * Random glucose \>11.1mmol/L (200 mg/dL).
* Have significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids
Partnering for Student Wellness

This study will evaluate whether the evidence-based Wellness framework paired with an evidence-based Partnership compared to Wellness alone will improve middle school students\&#39; social, emotional/behavioral, and academic functioning.

The mental health needs of children and youth are well-documented as an under-addressed and significant public health need in the United States. A number of barriers prevent children, youth, and families from accessing behavioral health services in standard clinic settings, including lack of sufficient transportation, cost, and stigma related to receiving services. School behavioral health (SBH) programs-in which community mental health providers join school teams to better address the social, emotional/behavioral, and academic needs of students-are growing in the United States because of their ability to reach youth who need, but may not otherwise receive, services. However, these efforts are limited by a lack of patient and stakeholder engagement. This has commonly resulted in SBH programs not being implemented, implemented inconsistently, or underutilized. The study will compare an evidence-based Patient-Centered Enhancements (i.e., Partnership) intervention added to an evidence-based framework termed Wellness in a three-year intervention for students in middle schools. Investigators predict the addition of the Partnership intervention will improve school climate and enhance SBH services, resulting in significantly improved social, emotional/behavioral, and academic outcomes in students. The study has three aims:

1. Investigators will evaluate the extent to which Partnership increases the number of students and families receiving school behavioral health services and expressing satisfaction with services received.
2. Investigators will evaluate the impact of Partnership on students' social, emotional/behavioral, and academic outcomes throughout the course of the intervention period (sixth through eighth grade).

Eligibility Criteria:
Inclusion Criteria:

* Middle school student
* Receives school-based behavioral health services
* Parent of a middle school student
* Parent of a student receiving school-based behavioral health services
* Enrolled in a participating school

Exclusion Criteria:

* Not a middle school student
* Not receiving school-based behavioral health services
* Not a parent of a middle school student
* Does not have a child receiving school-based behavioral health services
* Not enrolled in a participating school
Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting

PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable diseases.

SPECIFIC AIMS

1. Determine the feasibility of implementing a successful vaccination program for adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel \& office staff on their:

   * Attitudes towards vaccination of women against preventable diseases
   * Perceived barriers to implementing a program to vaccinate women in their offices
   * Ideas on how to overcome barriers to successful program implementation
   * Current vaccination practices and office-specific administrative processes
2. Design \& implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, \& pertussis
3. Determine the effectiveness of the vaccination program based on

   * Pre- and post-program vaccination rates
   * Program satisfaction amongst Ob/Gyn providers and office staff
   * Willingness to continue and possibly extend the program to additional vaccines
4. Quantify the level of support and resources needed to develop and implement the vaccination program


Eligibility Criteria:
Inclusion Criteria:

* 4-5 community Ob/Gyn practices
BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden

Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.

(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)

Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.

(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication...)
2. Fully recognize and understand patient information
3. Signed informed consent

Exclusion Criteria:

1. If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire
2. Age \< 18 years
3. Pregnant women
4. Known allergy to gold, silver and palladium
5. Participation in other clinical studies which may interfere with this study as judged by the Investigator
Nigelle 5 in Prevention of Influanza

This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)

This study will focus on the evaluation of the natural product Nigella Sativa in the fractalized form. "Lactose Nigelle 5" from the Tunisian company Fractal Tun, in terms of possible contribution to the prevention of influenza-like illnesses, in particular COVID-19

It will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)

The monitoring and evaluation will last for 3 weeks with taking the product Nig5, followed by a week without taking the product. That is 4 weeks in all.

More than 30 physicians volunteered to participate in this study without remuneration and without consultation fees for the candidates.

This study will be supervised by Professor Riadh Boukef, head of emergency services at Sahloul University Hospital, who will collect all the data afterwards in order to submit them to the statistical tools in force.

Professor Boukef will be responsible for preparing the abstract and publishing it on his behalf in the scientific journals of his choice, naming the doctors who participated as well as the product in question and the company that markets it in Tunisia.

27 free practice doctors participate in patient recruitment: AMICHE Sondèss BAHA Mohamed BEN AMARA Mohamed Khalil BEN ARBIA Karima BEN AYAD Afef BEN AYED KTARI Fouzia BENTALEB Mourad BESBES Mohamed CHTOUROU Iteb DHOUIB Manel DJAIT Mohamed DJEMAL Najla ELFIDHA Mongi FOURATI Imen FRIH Sabria FRIKHA Fahmi GHARBI Nadia KAMMOUN Naziha KETATA Mourad MHIRI Ikram NJAH Jamil OUARGHI Sameh REGAIEG Mourad SAKKA Samar TRABELSI Hinda ZOUARI Imen ZOUARI Nassira

Eligibility Criteria:
Inclusion Criteria:

* patients with an age\> 40 years

Exclusion Criteria:

* Being positive for COVID or having contracted it previously
* Positive for COVID between D1 and D5 of the study, meaning that there was infection before inclusion.
* Immunocompromised (HIV, other ...)
* Under chemotherapy
* On immunosuppressants
* Pregnant women
Merck IISP Stewardship Grant for Antibiotic Best Practices

The purpose of this study is to pilot the use of best practices alerts to enhance an antimicrobial stewardship program using the electronic medical record, EPIC.

The purpose of this study is to pilot the use of best practices to enhance an antimicrobial stewardship program using the electronic medical record, EPIC. Screening information technology tools via SETNET/Safety SUrveyor(Premier) and the electronic anti-infective order form would allow for sufficient medical record review to create best practices alerts for the purpose of appropriate de-escalation of anti-invectives.

Eligibility Criteria:
Inclusion Criteria:

* Physicians with prescribing privileges at the UWHC

Exclusion Criteria:

* None