cyrilzakka/clinical-trials huggingface dataset:
A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children

To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads. Not all doctors order these though, especially when there is no history of injury or when children don't look too sick. Unfortunately, this means that some children's bleeding doesn't get diagnosed as early as it could. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.


Eligibility Criteria:
Inclusion Criteria:

* All children under 3 years of age who undergo a CT of the head or MRI of the head.

Exclusion Criteria:

* Lack of parental consent
* Neurosurgical intervention between CT/MRI and NIRS scanning.
* Scalp hematoma
Respiratory Complaints Checklist Trial

This is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.

This is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.

Study setting: emergency department related acute evaluation outpatient clinic

Inclusion criteria: 18 years of age or older; patients presenting to the ED reporting cough or dyspnea;

Exclusion criteria: acute respiratory failure; SpO2 \< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )

Primary outcome: need of reassessment in the ED or hospitalization within 1 month of index evaluation (intervention).

Secondary outcomes: number of complete blood counts ordered in the index evaluation; number of other diagnostic tests ordered in the index evaluation;

Randomization: block 1:1; stratified by gender and age (\>50 years old).

Masking will be appllied to: patients; outcome assessors; data analysts;

Eligibility Criteria:
18 years of age or older; patients presenting to the ED reporting cough or dyspnea; legally capable.

Exclusion criteria: acute respiratory failure; SpO2 \< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )
RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention

RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.

It is hypothesized that routine use of the pelvic lead shield and radiation protection cap during these procedures will reduce the amount of radiation in which the interventional cardiologists get exposed.

Patients referred for coronary angiography or PCI will be randomized to undergo their procedure with or without the pelvic lead shield and the operator will wear a radiation protection cap.

Clinical efficacy will be assessed based on the total radiation dose that the interventional cardiologist got exposed to as well as a secondary outcome measuring the total radiation exposure dose per minute.

Eligibility Criteria:
Inclusion Criteria:

* Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI)

Exclusion Criteria:

* Age ≤ 18 years
* Previous inclusion in RADIATION PROTECT trial
VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease

Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's disease. The aim of this study is to capture the early real life UK experience of vedolizumab including the outcomes of treatment, describing the patient population treated, drug persistence, IBD control PROM, durable remission, tolerance and safety.


Eligibility Criteria:
Inclusion Criteria:

* Participants being given vedolizumab as part of routine care, and vedo naïve prior to study
* Age 18 or over
* Written informed consent obtained from patient for participation in the UK IBD Registry

Exclusion Criteria:

* Patient unwilling to take part in the UK IBD Registry
* Unable to obtain written informed consent
* Patient is, in the opinion of the investigator, not suitable to participate in the study
* Patients with contraindications to the use of vedolizumab
Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination

This study was conducted to compare post-extraction augmented sockets using Atorvastatin loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and spontaneously healed socket (Control) both clinically and by histomorphometric analysis of formed bone quality.

Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as part of the natural physiological healing process. There are many techniques in the literature used for socket preservation as bone grafts, barrier membranes, immediate implant and socket shield. Many other techniques also are used such as bone and tissue healing promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the widely used group of cholesterol lowering drugs which also increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area of growth factors, there is no high-quality evidence to either support or refuse their use.

This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its biocompatibility, ease of use, stimulation of production of growth factors and its effect on the already differentiated osteoblasts, when combined with statin with its effect on progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts, prevent bone resorption and stimulate bone formation at the extraction socket.

Eligibility Criteria:
Inclusion Criteria:

* 1. Both genders, aged from 20 to 50 years
* 2. Patients free from any systemic diseases
* 3. Hopeless teeth indicated for extraction (badly decayed tooth, tooth contraindicated for crown preparation such as tooth with subgingival caries, broken roots, periodontally affected teeth, remaining roots) in the premolar and first molar area.
* 4. Socket type I: The facial soft tissue and buccal plate of bone are at normal levels in relation to cement-enamel junction of the pre-extracted tooth and remain intact postextraction as determined by clinical examination and periapical radiographs
* 5. Patient agreed to sign a written consent after explanation of study nature.

Exclusion Criteria:

* 1. Smokers.
* 2. Pregnant and breast feeding females.
* 3. Previous radiation, chemotherapy, or immunosuppressive treatments.
* 4. Known hypersensitivity to statin drugs.
* 5. Teeth with periapical infections, type II or III sockets or with dehiscence or fenestrations
* 6. Vulnerable groups such as (Prisoners and handicapped or mentally disabled)
Non-invasive Brain Stimulation in Adults Who Stutter

Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.


Eligibility Criteria:
Inclusion Criteria:

* history of persistent developmental stuttering
* stuttering severity ranging from mild to very severe, specifically Stuttering Severity Instrument (SSI) total score of 20 (mild) or higher and stuttering rates of 3% or higher
* scores within 1 standard deviation of the norm on the standardized tests for the study

Exclusion Criteria:

* received any treatment for stuttering within the past year
* other neurological conditions such as Tourette's syndrome or post-traumatic stress disorder
* taking any medications/drugs that affect brain function
* history of past or current mental illness for example, schizophrenia that may affect brain development and function
* history of serious medical or neurological illness such as epilepsy and Parkinson's disease
* history of closed head injury (e.g., concussion)
* history of reading disorders
* hearing loss
* taking any medication, prescription or non-prescription with any psychotropic effects at the time of the study
* metal or electronic implants such as cochlear implants, and pacemakers
The Neighborhood & Health Study

The objective of The Neighborhood \& Health Study is to use a quasi-experimental mixed-methods approach to assess the impact of living in an agrihood-an agriculturally integrated community. This study follows a longitudinal cohort of residents of a newly developed neighborhood (the Indigo Neighborhood) and a geographically and socio-demographically matched neighborhood (the Elyson Neighborhood), both located in Fort Bend County, Texas, providing a unique opportunity for a natural experiment.

Poor nutrition and inadequate physical activity are prevalent in many communities across the United States. Agriculturally integrated communities called "agrihoods" are a potential responsive agriculture solution that may support healthy living. The aims of the study are to 1) Assess short-term changes in healthy eating, physical activity, cardiometabolic health indicators, and social connectedness as compared to a comparison neighborhood that is not an agriculturally integrated neighborhood; 2) Document time use with features of the Indigo Agrihood and assess consumer preferences for built and nature design features to provide resident-driven data for future developments; 3) Assess the economic benefits of the Indigo Agrihood.

Eligibility Criteria:
Inclusion Criteria:

Indigo Neighborhood Participants:

* 18 years or older
* Lived in the Indigo Neighborhood for less than 3 months or intend to move. to the Indigo Neighborhood by July 31, 2025.

Elyson Neighborhood Participants:

* 18 years or older
* Live in the Elyson Neighborhood (the comparison neighborhood group).

Exclusion Criteria:

Indigo Neighborhood Participants:

• Pregnant women.

Elyson Neighborhood Participants:

• Pregnant women.
A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance

This study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal of the study is to further our understanding of anxiety in men who have been diagnosed with prostate cancer and are undergoing Active Surveillance. Men who have elected Active Surveillance for their management of prostate cancer are eligible to participate in this study. After signing informed consent, all participants will complete two brief questionnaires (The Memorial Anxiety Scale for Prostate Cancer \[MAX-PC\] and the General Anxiety and Depression Scale 7 \[GAD-7\] to measure their anxiety levels. If the participant scores above a certain number, they will be asked to participate in the study. Patients will be randomly assigned to either a control group, who will receive no treatment, but continue to follow up with their urologist to manage their prostate cancer as usual, or the treatment group. The treatment group will receive 12 one-hour group therapy sessions that will take place once a week for 12 weeks with a licensed psychologist free of charge. They will be instructed to follow up with their urologist as previously determined for their prostate cancer management. Patients in both groups will be monitored for anxiety completing three questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If patients require further therapy beyond the group treatment sessions, the investigators may refer them to a psychologist or psychiatrist for further treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age of 40
* Primary diagnosis of Prostate Cancer
* Initial MAX-PC score of ≥16.
* Sign a consent form allowing related information to be included in this research.

Exclusion Criteria:

* Prostate cancer is not their primary diagnosis.
* Have pre-existing diagnosed psychiatric conditions, are currently taking psychotropic medications (e.g., antidepressants, anxiolytics, mood stabilizers.)
* Have been diagnosed with cancer other than prostate cancer (and non-melanoma skin cancer)
* Evidence of active substance abuse.
* Participants in the treatment group who are absent from more than 3 therapy sessions will be excluded.
Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile

The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from Valparaiso and another from Santiago.

Rotavirus is the leading cause of gastroenteritis in children. Our group has developed a surveillance system for acute rotavirus diarrhea in two large hospitals in Chile since 2006. Patients visiting the ER for acute non-bloody diarrhea will be enrolled after an informed consent is signed by parents. A fresh stool sample will be collected to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization. Stool samples will be tested for rotavirus by ELISA IDEIA - Rotavirus - OXOID. Rotavirus positive samples will be genotyped as described previously (Iturriza-Gomara et al. J. Clinical Virol 2004). Overall medical visits and hospitalizations, proportion of visits and hospitalizations caused by acute diarrhea, estimated numbers of rotavirus visits and hospitalizations will be calculated for each site. Proportion of rotavirus VP7 and VP4 genotypes will be calculated for three month periods per center. Differences in proportion will be compared by chi square and Fischer's exact test when appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Children with acute diarrhea
* Children younger than 5 years

Exclusion Criteria:

* Illiterate parents
* Chronic gastrointestinal disease
Oral Anticoagulation in Haemodialysis Patients

Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.

The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years)
* Patient on hemodialysis treatment for at least 1 month
* Patient with a history of, or presenting a new episode of atrial fibrillation (either permanent or paroxysmal).
* Patient with a CHADS2VASC score ≥2
* Patient with high risk of bleeding as defined by (1) HASBLED score ≥3 OR (2) HASBLED ≥ CHADS2VASC score, OR (3) recent history of severe bleeding (type 3a, 3b, 3c), particularly cerebral or gastrointestinal, OR (4) prior recurrent (\>2) history of falls.
* Patient capable of understanding information about the study and of giving his/her consent
* Patient informed of the preliminary medical exam results
* Patient with healthcare insurance
* Written consent signed

Exclusion Criteria:

* Formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome)
* Life expectancy \< 6 months (e.g., terminal cancer)
* Live donor transplantation scheduled within 6 months
* Pregnancy (β-HCG blood-based assay)or nursing (lactating) women
* Women of child bearing potential, unless they are using an effective method of birth control
* Patient under legal guardianship
* Patients under law protection
* Known hypersensibility to coumadin or indoine derivatives or to any excipients (CI to oral AVK)
* Severe liver failure (CI to oral AVK)
Robotic and Conventional Hand Therapy After Stroke

Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use.

Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such as the InMotion2, have been shown to be useful in restoring some motor function in the upper limb. However, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. They have not specifically addressed hand function.

Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. Initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the Amadeo device as compared with conventional rehabilitation methods. The purpose of this study was to compare results of training with the Amadeo device or training with conventional therapies.

A total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. Subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. One group underwent training with the Amadeo device and the other group underwent training with conventional therapy. All training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the training program.


Eligibility Criteria:
Inclusion Criteria:

* history of stroke (\>3 months from time of ictus)
* paresis or plegia of the upper extremity.

Exclusion Criteria:

* severe spasticity (defined on the Ashworth Scale with a score of 4-5)
* severe pain despite conventional pain therapy of the paretic upper extremity
* swelling, infection, fracture or ulcers of the paretic extremity
* arthritis of the hand joints
* pregnant
* botulinum toxin- therapy to the upper extremity within 3 months prior to study entry
* severe contractions
A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.

The purpose of this phase III study is to verify the clinical benefit of tisagenlecleucel for the treatment of r/r FL by comparing the tisagenlecleucel treatment strategy to standard of care therapy in patients with r/r FL after two or more lines of systemic therapy, with progression-free survival (PFS) as the primary endpoint.

The primary objective is to demonstrate superiority of the tisagenlecleucel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by blinded independent review committee (BIRC) based on the Lugano response criteria.

Participants randomized to Arm A (tisagenlecleucel treatment) will receive a single infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells.

Participants randomized to Arm B (Standard of Care) will receive R2 or R-CHOP based on investigator choice and this has to be determined prior to randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the date of signing the informed consent form.
2. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
3. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
4. Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
5. ECOG performance status of 0, 1 or 2 at screening.
6. Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
7. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
8. Must be eligible for treatment with the selected standard of care regimen.

Exclusion Criteria:

1. Follicular lymphoma grade 3B or evidence of histologic transformation.
2. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
3. Active CNS involvement by malignancy.
4. Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
5. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
6. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
7. Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.

Other protocol defined inclusion/exclusion criteria may apply