cyrilzakka/clinical-trials huggingface dataset:
Blod Biomarkers for Stroke

The purpose of the project is to investigate specific markers in blood samples from patients with stroke (ischemic or hemorrhagic). This could hopefully help in the early diagnostic to separate patients with ischemic stroke from those with hemorrhagic stroke as treatment are different and patients need to come quickly to the correct treatment site.

Approximately 12,000 Danes suffer a stroke each year with major consequences for those affected, their relatives and society in general. Rapid diagnosis and treatment mean less brain damage and thus less risk of late sequelae. A marker in the blood that is specific for stroke could result in faster diagnose and thereby treatment. Until now, no such marker has been found, but measurement of the so-called metabolomics and different fragments of brain proteins like Tau has shown promising results. Currently, metabolomics has only been studied in two other projects in stroke patients, and the results were not complete and a subtype of Tau (Tau-C) has been shown to be related to brain damage after ice hockey, but this is not studied in stroke patients, so there is a need for more studies.

In this project different fragments of brain proteins and the so-called metabolomics in the blood, which are small residues from the biological processes that take place in the body, such as fat and sugar incineration, will be studied.

The project is based on blood samples from a biobank that has been established in connection with previous projects in the Stroke Unit, Neurological Clinic, Rigshospitalet, Glostrup. All subjects have given written consent to give blood for future research.

Fifty microliters of blood from each participant will be analyzed by so-called mass spectroscopy, a well-researched method and performed in a recognized laboratory using known libraries and databases of metabolites for the determination and ongoing quality control. In addition, 250 microliters of serum will be analyzed by Elisa to detect brain proteins like Tau and Brevican.

The metabolomic profile and the brain proteins is compared to the information we have about the participants, namely:

* If they had ischemic or hemorrhagic stroke or if it is a healthy control person
* The extent of brain damage; partly measured by the brain scan and partly from the patient's symptoms
* The cause of the stroke

Eligibility Criteria:
Inclusion Criteria:

* Clinical stroke

Exclusion Criteria:

* Glasgow Coma Scale (GCS) \< 15
* Non communicating patients e.g. aphasia (incompetent patients)
* Unable to cooperate to the physical examinations
* Pregnancy or nursing mothers
* If the investigators find the study participant unfit to conduct the investigations
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy

The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified prostatic cancer
* Low or intermediate risk prostatic cancer
* Lymph node negative
* Suitable for radiotherapy

Exclusion Criteria:

* Earlier treatment for prostatic cancer
* Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment
Use of Tinzaparin for Anticoagulation in Hemodialysis

The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* End stage renal disease maintained on outpatient hemodialysis for \>= 3 months
* Frequency of hemodialysis: 3 times per week
* Anticoagulation with an unfractionated heparin protocol for at least 4 weeks
* Patient or legal guardian able to provide written consent
* Baseline INR \<= 1.3
* Baseline platelet count \>= 80,000 x 10\^9/L

Exclusion Criteria:

* Therapeutic systemic anticoagulation
* Clinically apparent bleeding in the last 2 months
* High risk of bleeding
* Planned major surgery in the next 4 months
* Major surgery in the past 48 hours
* Pregnant or lactating
* Child bearing potential
* Allergy/intolerance to heparin or history of heparin induced thrombocytopenia
* Current participation in a related randomized drug trial
PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial

This is a clinical, observational, non-pharmacological, multicenter, prospective case-control no-profit study to assess the prognostic role of several circulating inflammatory biomarkers


Eligibility Criteria:
Inclusion Criteria:

1. Age \&gt; 18 years;
2. Written informed consent;
3. Squamous carcinoma of the hypopharynx, larynx and oral cavity;
4. Clinical stage I-IVa according to the VIII edition of AJCC staging system
5. Primary surgery as first line curative intent treatment, followed by ± adjuvant radiotherapy± chemotherapy based on the pathological findings following the NCCN guidelines

Exclusion Criteria:

1. Relapsing or metastatic disease
2. Locally advanced disease not amenable to curative intent treatment
3. Previous local or systemic treatment for head and neck cancer
4. Previous malignancies (exluding non-melanoma skin cancers) unless complete remission has been achieved at least 5 years before entering the study
5. Psychiatric disorder or known substance abuse
6. Concomitant immunosuppressive treatment
7. Concomitant immunostimulant treatment
8. Chronic inflammatory disease
9. Autoimmune disease
10. Major surgery in the previous year
11. History of recent onset of any condition which, in the investigator's opinion, could interfere with patient adherence for the entire duration of the protocol.
12. Positive serum pregnancy test for women of childbearing age. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
Realizing Effectiveness Across Continents With Hydroxyurea (REACH)

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for for pediatric patients with sickle cell anemia (SCA). The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs.

STUDY OBJECTIVES

1. To assess the feasibility of conducting a prospective research study using hydroxyurea therapy for SCA in sub-Saharan Africa (including adherence to monthly clinic visits and laboratory assessments, and medication compliance)
2. To monitor the safety of hydroxyurea therapy, specifically documenting hematological toxicities (cytopenias) and serious infections (bacterial and malarial)
3. To evaluate the benefits of hydroxyurea therapy, using both laboratory (e.g., fetal hemoglobin, hemoglobin, white blood cell count) and clinical parameters (e.g., pain, hospitalization, growth)
4. To explore the pharmacokinetic and genetic basis for any observed inter-patient variability in the clinical or laboratory response to hydroxyurea.
5. To evaluate the economic cost of providing hydroxyurea therapy in the REACH study sites.
6. To investigate the effects of hydroxyurea dose escalation on laboratory and clinical parameters

Eligibility Criteria:
Inclusion Criteria

1. Pediatric patients with documented sickle cell anemia (typically HbSS supported by hemoglobin electrophoresis, complete blood count, and peripheral blood smear)
2. Age range of 1.00-9.99 years, inclusive, at the time of enrollment
3. Weight at least 10.0 kg at the time of enrollment
4. Parent or guardian willing and able to provide written informed consent, with child's verbal assent as per local IRB/Ethics Board requirements
5. Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion Criteria

1. Known medical condition making participation ill-advised, (e.g., acute or chronic infectious disease, HIV, or malignancy)
2. Acute or chronic severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age \>3 z-scores below the median WHO growth standards, as defined in Appendix I)
3. Pre-existing severe hematological toxicity (temporary exclusions)

   1. Anemia: Hb \<4.0 gm/dL
   2. Anemia: Hb \<6.0 gm/dL with ARC \<100 x 109/L
   3. Reticulocytopenia: ARC \<80 x 109/L with Hb \<7.0 gm/dL
   4. Thrombocytopenia: Platelets \<80 x 109/L
   5. Neutropenia: ANC \<1.0 x 109/L
4. Blood transfusion within 60 days before enrollment (temporary exclusion)
5. Hydroxyurea use within 6 months before enrollment (temporary exclusion)
Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy

This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with a long-term treatment phase.

This study is to evaluate the safety, pharmacokinetics, and efficacy of NV1205 in pediatric patients diagnosed with childhood cerebral adrenoleukodystrophy (CCALD).

The study consists of:

* Screening period: within 30 days of first dose
* Main treatment period of 12 weeks (Part 1- from Screening to Week 12)
* Long Term Treatment (LTT) period (Part 2- Week 13 through Week 96)

In Part 1, subjects will have an initial 4-week treatment period at the assigned dose and, if no safety concerns are noted, subjects continue for another 8 weeks of extended safety assessment.

There will be several cohorts of subjects enrolled. After each Cohort has completed the 4-week initial safety assessment, the safety data will be reviewed by an independent Data Safety Monitoring Board (DSMB) and, subject to DSMB recommendation, Cohort 2 will be enrolled and receive the next dose level. After Cohort 2 has completed 4 weeks of treatment, the DSMB will review all available safety data (Cohorts 1 and 2) and, subject to DSMB recommendation, Cohort 3 will be enrolled and receive the next dose level. Additional Cohorts may be enrolled at the recommendation of the DSMB with an incremental dose increase.

In Part 2, subjects will continue to receive treatment in the LTT period of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Males ≥4 years and \<18 years of age
2. CCALD diagnosis confirmed by genetic testing
3. Loes score of \>0 and ≤15
4. Patients on VLCFA lowering agents such as Lorenzo's oil must stop the medication and have high VLCFA levels before enrollment

Exclusion Criteria:

* Significant medical conditions such as heart, thyroid, or liver disease
* HSCT recipients
Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: a Pilot Study

Chronic headaches are associated with changes in brain structure and function that may be associated with increased suffering and disability. Understanding how Osteopathic Manipulative Therapy (OMT) affects these changes would reveal new insight into how the brain processes pain and returns to normal function. Also, demonstrating these changes would provide evidence regarding how OMT causes a reduction in pain and disability, supporting the recommendation for OMT as a primary treatment option for headaches.


Eligibility Criteria:
Inclusion Criteria:

* current diagnosis of primary headache (migraine, tension-type, cluster) from a healthcare provider
* have experienced at least one headache episode a month for the previous 1 year (or longer)
* age of PH onset was less than 50 years, currently taking medication for headaches.

Exclusion Criteria:

* presence of headaches due to some other underlying medical condition (secondary headaches)
* traumatic brain injury
* fibromyalgia, epilepsy
* diagnosis of a neurodegenerative disorder
* history of brain tumor or cancer
* history of cervical radiculopathy (pinched nerve in the neck)
* currently undergoing manual therapy type treatment or have a a treatment within 2 weeks of enrollment(chiropractic, OMT, massage, PT)
* currently pregnant
* have had an injection to treat headaches within the previous 3 months from study enrollment
* contraindications to MRI.
Evaluation of Changes in Brain Connectivity After Tumor Resection

This study is being done to see the changes in structural and functional connectivity that happen in the brain of patients undergoing brain tumor surgery.

The purpose of this study is to visualize and quantify changes in the brain of patients undergoing brain tumor surgery through high-quality, high-resolution structural and functional brain imaging and brain connectivity measures. To understand the effects of the primary treatment for brain tumors, the investigators will determine changes in brain connectivity after surgery and correlate this with neurologic status. The investigators will prospectively collect brain imaging (MRI) and clinical data in brain tumor patients before and after removal of their tumor. Any adult patient with a brain tumor (primary or metastatic) for whom surgery to remove the tumor is planned is eligible. The investigators plan for recruitment of 30 subjects. This will include 27 subjects with brain tumors and 3 healthy controls. Both clinical and imaging data will be collected for tumor and healthy subjects. A two-part research scan (diffusion MRI and resting state functional MRI) will be performed within 1 week prior to surgery and again 2 weeks after surgery. The healthy controls will obtain identical research scans with the second session two weeks following the first session. Subjects will be also administered Neurocognitive and Qualitative Assessments at two time intervals, pre- and post-surgery (2 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Brain tumor subjects (27)

   * informed consent
   * age equal to or greater than 19 years (age of majority in Nebraska)
   * brain tumor that requires surgery
   * primary or metastatic brain tumor
2. Healthy subjects (3)

   * informed consent
   * age equal to or greater than 19 years (age of majority in Nebraska)
   * healthy subject with no know neurocognitive deficiencies

Exclusion Criteria:

* any contraindication to MRI (i.e. implanted devices)
* inappropriate body habitus for MRI
* no capacity to understand the study the study or consent to it
* positive pregnancy test in females
* end stage renal disease or severe renal dysfunction
* severe anxiety disorder
* metabolic encephalopathy
* significant medical co-morbidities precluding a safe surgery
* need for sedation for MRI
Neurobiological Basis of Response to Vayarin in Adults With ADHD: an fMRI Study of Brain Activation Pre and Post Treatment

The objective of this research is to use functional magnetic resonance imaging (fMRI) with a neuropsychological task to test the prefrontal mechanism of action of the medical food Vayarin.

The investigators prior research suggests that effective non-stimulant treatments for ADHD act through key prefrontal regions that subserve inhibitory and executive functions, although different medications may achieve these effects via distinct mechanisms. The objective of this research is to use functional magnetic resonance imaging (fMRI) with a face go/no-go task to test the prefrontal mechanism of action of the medical food Vayarin. Participants are not treated at the Icahn School of Medicine, but instead will be recruited from trials of Vayarin that are enrolling and treating participants at New York University and The Medical Research Network.

Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible to enroll in the Vayarin clinical study according to screening visit will be asked to participate in the fMRI study.
* Must be willing and able to perform fMRI scanning
* Must maintain compliance to their trials' protocols

Exclusion Criteria:

* pre-existing medical or psychological condition that precludes scanning (e.g., claustrophobia, morbid obesity)
* implanted medical device (e.g., pacemaker)
* metal in the body that cannot be removed (e.g., braces)
* pregnancy
* concomitant use of anti-hypertensives or any other medications affecting the blood oxygenation level-dependent (BOLD) signal
Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over

Frailty is a condition of reduced the capacity in multiple body systems and causing adverse outcomes because of decreasing the ability to cope with stressors. Female sex, the changes of the body imposed by ageing, and coping strategies for stressors are causal mechanisms in the development of frailty. This project is designed with the salutogenic model that is focused on the concepts of health, stress, and coping. The aim of this project is to assess the effect of Salutogenic Frailty Prevention Program on promoting sense of coherence and preventing the development of frailty in women aged 55 years and over


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study
* Woman aged 55 years and over
* Pre-frail (Total FRAIL scale score 1 or 2)
* Has Internet access

Exclusion Criteria:

* To be semi-dependent and dependent according to the Katz Daily Activities Activity Scale
* To have any cognitive, psychiatric and neurological disorders
* To have any surgical operation in the past 3 month
* Communication barrier (due to hearing/vision impairment)
Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are:

* Does ENDURE improve initiation of timely PORT relative to treatment as usual?
* Does ENDURE improve initiation of timely PORT in regards to racial disparities relative to treatment as usual?
* What are the mechanisms through which ENDURE improves timeliness to treatment?

In this hybrid type 1 effectiveness-implementation study, the investigators will conduct a stepped-wedge cluster randomized trial with cancer centers (n=4; 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with head and neck cancer undergoing surgery and postoperative radiation therapy (PORT). The trial will assess the effect of ENDURE vs TAU on improving initiation of timely PORT (primary objective), racial disparities in timely PORT initiation (secondary objective), and the underlying mechanisms of ENDURE (secondary objective). The investigators will concurrently conduct a mixed-methods study with quantitative measures of implementation outcomes and qualitative data about implementation determinants from semi-structured interviews with key stakeholders and site visits (exploratory objective).

Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 18 years
2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
3. American Joint Committee on Cancer (AJCC) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary.
4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings.Plan to undergo surgery at a participating site
5. Plan for curative intent surgery at one of the participating centers
6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).

Exclusion Criteria:

1. Inability to speak or read English.
2. Severe mental illness that would prevent trial participation.
3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \< 3 cm
4. Synchronous untreated malignancy expected to impact life expectancy
Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.

The central role of gut microbiota in immunity and nutritional homeostasis is now acknowledged, albeit not fully understood. Gut microbiota composition imbalances have been found in malnourished children, which were not restored by nutritional interventions as currently conducted. Therefore, the necessity to design more complete nutritional interventions that include gut health has been advised by expert committees.

Prebiotics are compound that selectively enhance the growth of beneficial gut bacteria. They have been recommended and used in infant formula and weaning cereals resulting in gut microbiota resembling that of breastfed infants in formula fed infants in developed countries. A healthy gut microbiota was shown to be associated with enhanced growth patterns and decreased morbidity in children in developed countries. Evidence of such outcome is lacking in developing countries, yet such results would be particularly valuable for children from these settings, living in rather poor sanitary conditions in an environment characterized with high infectious disease load, conditions that mostly explain the high prevalence of chronic malnutrition. This study aims to assess the effect of a 6 months' supplementation with a lipid based nutrient supplement fortified with fructo-oligosaccharides and inulin on microbiota diversity and functionality in rural Burkinabe infants, and to explore its subsequent effects on linear growth velocity and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* 6-6.5 month old infants
* Weight for height and height for age z-score above -2
* Permanent resident of the area and not intending to move for the next 6 months for more than a week
* No chronic antibiotic treatment
* Exempt of any current serious illness
* Still breastfed.

Exclusion Criteria:

* Moderate or severe malnutrition (weight for height or height for age z-score below -2)
* non-permanent residence in the study area,
* the presence of any congenital anomalies in the child or mental/physical disease of the mother that can interfere with child feeding
* a chronic antibiotic treatment i.e. more than 6 weeks treatment at the time of enrolment
* a history of allergy to a constituent of the supplement
* a serious current illness
Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.

The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status \< 2

Exclusion Criteria:

-