cyrilzakka/clinical-trials huggingface dataset:
A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers

This project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. The project includes a program development phase, Phase I (pilot test of full study procedures using developed treatment protocol), and Phase II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child behavioral inhibition and parenting, using parent and teacher reports and observational data. Families are assessed at three time points: baseline, post-treatment (or at approximately 8 weeks for the control group), and 2 month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire; child has a biological parent with at least 50% physical custody who consents to participate

Exclusion Criteria:

* Child has a diagnosis of pervasive developmental disorder or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.

See brief summary.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age ≥ 18).
2. Diagnosis of CRS.
3. Worsening sinonasal symptoms.
4. Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
5. English speaking.
6. Open sinuses (open middle meatus bilaterally; determined on endoscopy).
7. Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.

Exclusion Criteria:

1. Patients \< 18 years of age.
2. Treatment with systemic or topical antibiotics within the last 1 month.
3. Pregnant women.
4. Non-English speaking persons.
5. Systemically ill at initial visit necessitating treatment prior to culture data.
6. Allergies to chosen susceptible antibiotics.
7. Sinonasal culture with less than 1+ growth.
8. Multiple organisms grown on culture that are not sensitive to a single antibiotic.
9. Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
10. Patients with immunodeficiencies.
Identifying Novel Aging Targets for Treatment of Delirium

The long-term goal of this research program is to improve understanding of the mechanistic link between Alzheimer's disease (AD) neuropathology, acute delirium, and cognitive impairment following acute respiratory failure. In this pilot study, the study team will establish a prospective cohort of older patients with acute respiratory failure and obtain data on delirium duration, AD imaging and CSF biomarkers, and cognitive outcomes following critical illness.

The study team will recruit patients with no known history of dementia for enrollment into the cohort during their hospital stay for acute respiratory failure. The cohort will undergo testing including cognitive testing, MRI imaging, lumbar puncture for cerebrospinal fluid (CSF) analysis at 3 months following hospital discharge. The study will examine the association of delirium duration during the hospital stay and cognitive impairment at 3 month follow-up with CSF levels of amyloid- β42, tau, and phospho-tau. Measures of delirium will also be related with structural/functional MRI dependent measures. The goal is to design a larger prospective cohort study to evaluate the relationship between AD imaging and CSF biomarkers with delirium and post-ICU cognitive impairment. The results of this pilot study with provide important information with regard to future study design including: (1) ratio of eligible to recruited patients (2) retention rate; (3) safety and feasibility of protocol; and (4) preliminary effect size estimates.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 55 years
* Anticipated ICU stay of at least 48 hours
* Delirium during ICU stay defined as CAM-ICU positive on at least two occasions at least 12 hours apart within 72 hours.

Exclusion Criteria:

* Diagnosis of dementia in electronic medical record at time of ICU admission
* Blindness, deafness, or inability to understand English as this prevents ICU delirium assessment
* Cognitive impairment prior to hospitalization (inability to follow instructions/comply with study/sign consent)
* Score of \> 3.30 on Informant Questionnaire of Cognitive -Decline in the Elderly (IQCODE)\[34\]. Questionnaire will be given to family member or legally authorized representative.
* Pregnancy/lactating/breastfeeding
* Legally incapacitated: Prisoner/Ward of State
* History of prior large vessel cerebrovascular accident (CVA)
* History of neurologic disorder prior to ICU admission including multiple sclerosis, Parkinson disease, epilepsy, amyotrophic lateral sclerosis (ALS), Guillain-Barre Syndrome (GBS)
* Psychiatric illness including schizophrenia, bipolar disorder, depression with psychotic features
* Not expected to survive 24 hours
* Judgment of investigator that subject participation could jeopardize subject health/safety or integrity of study
* Active malignancy requiring treatment in the prior 6 months
* Inability to return for study procedures
* Inability to obtain consent
Drowning Incidents in Danish Harbours

A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning.

Based on the GPS coordinates and advanced text-searching, it is possible to identify drowning incidents in Danish harbours and extract data from the Danish Prehospital Drowning Data.

This study is a nationwide registry-based study with data from the Danish Prehospital Drowning Data from 2016 to 2023. In this study, we will use 30-day mortality to differentiate between fatal and non-fatal drowning.

The primary objective is to estimate the yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016 to 2023 and calculate the fatal to non-fatal ratio. The secondary objective is to assess risk factors associated with 30-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* All the patients registered in the Danish Prehospital Drowning Data from 2016-2023 will be assessed for inclusion AND
* Incidents registered at GPS coordinates corresponding to a Danish harbour OR
* Incidents identified using advanced text-search algorithm searching for "harbour"-related words

Exclusion Criteria:

* Patients without a 30-day follow-up (e.g., due to missing or invalid civil registration numbers) and patients with a valid DNAR code will be excluded from the mortality analysis.
Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male subjects with the diagnosis of severe haemophilia A (FVIII\<1%) from age 18 years
* Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
* Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count \>200/microL)

Exclusion Criteria:

* Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
* History of FVIII inhibitors
* Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
* Known or suspected allergy to trial product (FVIII) or related products
* Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
* Body mass index (BMI) above 30 kg/m\^2
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee

A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) Pain of the Knee

This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The study will consist of up to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment Phase, and a 1-week safety Follow-up Phase.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology criteria.
* Has an X-ray of the target knee, taken no more than 1 year before Baseline, showing evidence of OA.
* Has pain of OA in the designated/target study knee.

Exclusion Criteria:

* Body mass index (BMI) \> 40.
* Any subject who did not follow the restriction of prohibited therapies during Washout period.
* Arthritis of the target knee that is not caused by OA but caused by diseases such as rheumatoid arthritis, gout, psoriasis, syphilitic arthropathy, ochronosis, metabolic or other primary bone disease, or acute traumatic injury.
RELIEF - Resistance Training for Life

Sarcopenia is an age-related gradual loss of muscle mass and strength and is associated with physical disability and mortality risk. Currently, the most promising remedy for preventing and treating sarcopenia is physical activity, particularly progressive resistance training. Yet, the amount of resistance exercise needed to achieve optimal benefits remains largely unknown. This lack of knowledge is underpinned by the notion that aging reduces the ability to adapt to (and benefit from) resistance training, and is further complicated by a relative large degrees of between-subject heterogeneity. The primary aim of the study is to compare the effects of 10 weeks of resistance training with low- and moderate volume (one vs. three sets per exercise) on muscle mass accretion in lower and upper body extremities in young (\<30 years of age) and elderly individuals (\>70 years of age). Specifically, the study addresses the hypothesis that elderly individuals will benefit more from higher exercise volume (moderate vs. low) compared to their young counterparts. In addition, the study aims to compare the efficacy of the two volume conditions for altering other characteristics such as muscle strength and biology, including assessment of associations between individual changes in muscle mass, strength and biology (e.g. the relationship between muscle mass accretion and muscle content of rRNA/rDNA), and also to investigate the general health effects of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 30 or \> 70

Exclusion Criteria:

* Resistance training, \> 1 session per week
* Endurance training, \> 3 sessions per week
* Unstable cardiovascular disease
* Illness or serious injury contradicting resistance training
* Serious mental illness
* Allergy to local anaesthesia
Early DHA Supplementation in Very Low Birth Weight Infants

This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.


Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infants weighing less than 1500 grams
* Consent signed within 72 hours of life

Exclusion Criteria:

* Infants with know metabolic disorder
* Infants with known congenital GI anomaly
* Infants who are deemed to be inappropriate for enrollment per attending neonatologist
Standardizing the Management of Patients with Coronary Microvascular Dysfunction

The SAMCRO is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes (PROBE). The diagnosis of angina in non obstructive coronary artery disease (ANOCA) will be confirmed with coronary artery angiography and with the invasive assessment of coronary microvascular dysfunction (CMD) and coronary vasomotion. At least 120 ANOCA patients with invasively confirmed CMD will be randomized to i) multi-domain lifestyle intervention (experimental arm) vs. ii) standard of care (control arm). All patients will undergo follow-up visits at 6, 12, 24, 36, 48 and 60 months. The study endpoints will be the improvement of angina status and quality of life as assessed by validated questionnaires at one year. All participants in the multi-domain lifestyle group will receive five different kinds of intervention: i) dietary counselling, ii) strict management of cardiovascular (CV) and metabolic risk factors, iii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iv) exercise training and v) psychological intervention. Patients randomized to the control group will be managed according to current guidelines. The angina status will be assessed by the Seattle Angina Questionnaire (SAQ). Quality of life will be assessed using the EuroQoL (EQ5D-5L). Anxiety and depression will be assessed using the Beck Depression Inventory (BDI).

The aim of the SAMCRO trial is to determine whether a multidomain lifestyle intervention improves angina status and quality of life in ANOCA patients as compared to current standard of care.

Patients will be randomized to:

EXPERIMENTAL ARM: MULTI-DOMAIN LIFESTILE INTERVENTION

Patients will receive five different kinds of intervention:

i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling CONTROL ARM: STANDARD OF CARE Patients randomized to the control group will be managed according to current guidelines

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to hospital for chronic coronary syndrome (CCS) with indication for coronary artery angiography
* absence of obstructive coronary artery disease at invasive coronary artery angiography
* Coronary microvascular dysfunction as identified by invasive coronary physiology

Exclusion Criteria:

* Planned coronary revascularization
* Co-morbidity reducing life expectancy to less than 1 year
* Any factor precluding 1-year follow-up
* Prior Coronary Artery Bypass Graft (CABG) surgery
* Presence of a chronic total occlusion (CTO)
Spaced Retrieval as Treatment for Aphasia

Spaced Repetition training has been found to be more effective than massed repetition for individuals with aphasia. This study seeks to examine the relative efficiency of three kinds of spacing for picture-naming training: traditional random presentation, non-adaptive spaced repetition, and adaptive spaced repetition.

Participants undergo a screening evaluation including the Quick Aphasia Battery (administered via teleconferencing software), and a preliminary picture naming test of approximately 300 pictures, used to select individual items for treatment. Participants then undertake online picture naming training for 30 minutes a day, over two weeks. Pictures are repeated according to three different schedules to be compared: random presentation, non-adaptive spaced repetition, and adaptive spaced repetition. We compare the number of pictures successfully learned and the verbal reaction time for the pictures assigned to the three conditions.

Eligibility Criteria:
Inclusion Criteria:

* presence of a post-stroke word finding deficit (i.e. aphasia), or primary progressive aphasia.
* ability to evaluate the correctness of one's own responses when subsequently provided the with the correct answer

Exclusion Criteria:

* diagnosis of a neurological disorder other than post-stroke or primary progressive aphasia
* inability to evaluate the correctness of ones responses when subsequently provided with the correct answer
Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation.

When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
2. Age \>18 years
3. Planned AF cryoablation procedure

Exclusion Criteria:

1. LA diameter \>55mm
2. Severe LVH (LV wall ≥ 15mm)
3. LA thrombus
4. Decompensated heart failure
5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
6. History of previous pulmonary vein isolation
7. Inability to place esophageal temperature probe or TEE probe
8. Previously documented phrenic nerve injury
9. Known esophageal pathology (complete GI history worksheet)
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma

This is an open, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability and preliminary effectiveness of B7-H3-targeting Chimeric Antigen Receptor-T (CAR-T) cell therapy on patients with recurrent glioblastomas. The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18-75 years (including 18 and 75 years old)；
2. Patients with relapsed glioblastoma, as confirmed by positron emission tomography (PET) or histologic pathology；
3. A \>= 30% staining extent of B7-H3 in his/her primary/recurrent tumor tissue by the immunochemical method;
4. Karnofsky scale score\>=50
5. Availability in collecting peripheral blood mononuclear cells (PBMCs) ；
6. Adequate laboratory values and adequate organ function;
7. Patients with childbearing/fathering potential must agree to use highly effective contraception；

Exclusion Criteria:

1. Pregnant or breastfeeding females；
2. Contraindication to bevacizumab；
3. Within 5 days before the CAR-T cell infusion, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid)；
4. Comorbid with Other uncontrolled malignancy；
5. Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection;
6. Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
7. Autoimmune diseases;
8. Receiving long-term immunosuppressive treatment after organ transplantation;
9. Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;
10. Not recovered from the toxicities or side effects by previous treatment;
11. Subjects who have participated the other interventional trial within one month before the enrollment, or have received other CAR-T cell therapies or gene-modified cell therapy before enrollment.
12. Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures, the medical conditions including, but not limited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonary embolism, coagulation disorders, active systemic infection, uncontrolled infection et. al; or patients who are unwilling or unable to comply with the research procedures; these
13. Subjects with other conditions that would interfere trial participation at the investigator's discretion.