cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Early Intervention in an Underserved Population

The purpose of this study is to test the applicability of a caregiver-implemented autism intervention protocol to a deliberately recruited low-income, underserved population.

Families of racial/ethnic minority, lower levels of education, and those who live in non-metropolitan areas have been found to experience greater limitations in accessing services for Autism Spectrum Disorder (ASD) (Thomas, Ellis, McLaurin, Daniels, \& Morrissey, 2007). Black and Hispanic children have been found to have lower odds of having a documented ASD classification than white children (Mandell, Wiggins, Arnstein Carpenter, Daniels, Durkin et al., 2009) and of those children who do receive an ASD diagnosis, many of them are not diagnosed in early childhood. The age of first ASD diagnosis received has been found to be significantly higher for African American and Latino children compared to white children (Mandell, Listerud, Levy, \& Pinto-Martin, 2002). For these reasons, it is important that the effectiveness of intensive early intervention for children with ASD is examined across varying cultural and socioeconomic backgrounds.

This project is directed by Dr. Catherine Lord at the University of Michigan, in collaboration with Dr. Amy Wetherby at Florida State University to test the applicability of a modified caregiver-implemented autism intervention (Modified Early Social Interaction; ESI) to a deliberately recruited low-income, underserved population. UM will recruit 28 children and FSU will recruit 16 children diagnosed with ASD who are between 24 and 42 months of age over a period of 3 years, totaling 44 caregiver-child dyads. This study will utilize a multiple baseline single-subject research design. Dyads will complete 1 month of weekly 1-hour baseline observations followed by three months of the modified ESI intervention. Child and family characteristics predicting response to intervention will be identified and findings will contribute to the development of autism interventions serving families from diverse backgrounds.

Eligibility Criteria:
Inclusion Criteria:

* caregiver(s) with less than a 4-year college degree
* family income equal to or below 2x the federal poverty line
* English as the predominantly-spoken language.
* child received diagnosis of autism spectrum disorder before treatment
* child is between 24 and 42 months at the start of treatment
* child has normal hearing and adequate motor control to make simple actions (giving, reaching)
* family agrees to 2-4 weeks of weekly 1-hour observations, 3 months of 2 intervention sessions per week, and 3 months of 1 intervention session per month.
* family agrees to pre-treatment, post-treatment, and follow-up evaluation and videotaping of intervention sessions and weekly video check during the treatment.

Exclusion Criteria:

-Must meet eligibility requirements stated above.
Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

To detect atrial fibrillation after infection.

This study will prospectively recruit patients who are admitted to CUH general medical wards due to an infection or sepsis and develop new/first diagnosed transient AF. In CUH, our previous projects have shown that around 1500 patients are admitted under general medicine each month at least 1 new diagnosis of AF is made each day (30/month)26.

In particular to the cohort that develop sepsis, they may well be frail and elderly where anticoagulation is often not prescribed as a result 27 unless definitive diagnosis of recurrent AF would be made. The CAMS-AF study will closely tie in with an already existing stroke prevention service at CUH (SOS-AF) who are already screening for patient admitted with AF on general medical wards and will therefore be able to identify those with new AF during an episode of sepsis. Potential participants will be approached by the study investigators prior to discharge and if they are in sinus rhythm written consent will be obtained to place a non-invasive wearable cardiac monitor patch for 14-days, to detect any subclinical arrhythmias, particularly AF.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Admission with any infection or sepsis
* Transient AF
* Under general medicine
* Can be anticoagulated or not
* Sinus rhythm at discharge or point of Zio patch placement

Exclusion Criteria:

* Previous history of AF or paroxysmal AF
* Age less than 18 years
* Pregnancy
* Active and known malignancy
* Recent cardiac or non-cardiac surgery (3 months)
* Recent myocardial infarction (3 months)
* Individuals with skin allergies to plasters and adhesive devices
* Chest wall deformity, skin condition over sticker site
* History of thyroid disease
* Current alcohol intake above recommended limits
* Already has a cardiac monitor or pacemaker inserted
* Known contraindication for anticoagulation therapy
* Patients who lack capacity or have an estimated life expectancy \< 1 year
The Effects of Intravitreal Ozurdex Implant in DME

Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients.


Eligibility Criteria:
Inclusion Criteria:

The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

* Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
* Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
* Diabetic patients with cystoids macular edema
* Minimum central thickness on OCT not less than 300 microns
* BCVA 20/30\~20/320

Exclusion Criteria:

* Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
* Patients with history of ocular hypertension or glaucoma
* Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
* Patients with macular ischemia on FFA
* Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
* Patients whose posterior lens capsule is not intact.
* patients with known hypersensitivity to any components of this product.
* patients with vitreous hemorrhage
* patients who have systemic treatment effect on study results
* patients who enrolled other clinical study
Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection

This is a prospective clinical study recruiting 510 men at risk of PCa to undergo urine, blood, AI-assisted ultrasound and AI-assisted MRI investigations to stratify risk of clinically significant PCa (csPCa). (sample size calculation in section 5)

All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of csPCa in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy. This will be followed by machine learning techniques to find the best combination in predicting csPCa.

Eligibility Criteria:
Inclusion Criteria:

* Men ≥18 years of age
* Clinical suspicion of prostate cancer
* Serum Prostate-specific antigen (PSA) 4-20 ng/mL
* Digital rectal examination ≤ cT2 (organ confined cancer)
* Able to provide written informed consent

Exclusion Criteria:

* Prior prostate biopsy
* Past or current history of prostate cancer
* Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia)
* Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail TRUS probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped
The Effect of Physical Effort in the Decision Making Process of Preadolescents With ADHD

In the current study we will examine a specific aspect of these processes that has yet to be studied. We will test the effect that a physically effortful assignment has on the choices that a preadolescent makes using a forced choice paradigm in which the participant will be asked to choose between and carry out either a high cost-high reward option (HR) or a low cost-low reward (LR) option. The HR option will demand a significant amount of physical effort and will be paired up with a large reward as opposed to the LR option which will be less demanding physically and paired up with a small reward. The assignment will be carried out using a hand held dynamometer which measures the power produced by the participants' upper extremity.

We propose that a child with attention deficit hyperactivity disorder (ADHD) will choose a task that involves less effort despite the small reward tied to it compared to a control child who will choose the more demanding task and the larger reward.

In the current study we will examine a specific aspect of these processes that has yet to be studied. We will test the effect that a physically effortful assignment has on the choices that a preadolescent makes using a forced choice paradigm in which the participant will be asked to choose between and carry out either a high cost-high reward option (HR) or a low cost-low reward (LR) option. The HR option will demand a significant amount of physical effort and will be paired up with a large reward as opposed to the LR option which will be less demanding physically and paired up with a small reward. The assignment will be carried out using a hand held dynamometer which measures the power produced by the participants' upper extremity.

We propose that a child with ADHD will choose a task that involves less effort despite the small reward tied to it compared to a control child who will choose the more demanding task and the larger reward.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of ADHD

Exclusion Criteria:

* any other neurological or psychiatric diagnosis
The Effect of Manipulation on Dysfunction of the Talo-crural Joint

The purpose of this trial was to explore the effects of chiropractic manipulation in patients with talo-crural joint dysfunction.

Ankle sprains is one of the most common problems in clinical practice, mostly due to loss of mobility. Factors affecting the mobility of the joints may be due to muscle tension, ligamentous or anatomical anomalies.

Research over the last years have reported a scarce of trials investigating chiropractic treatment of the ankle joint. Previous studies have focused on investigating ROM and proprioception. This study aimed to determine whether a single high-velocity, low-amplitude (HVLA) thrust manipulation to the talo-crural joint altered ankle function in subjects with dysfunction of the talo-crural joint.

Eligibility Criteria:
Inclusion Criteria:

* First league handball player
* Talo-crural joint dysfunction
* Age \>16 yrs

Exclusion Criteria:

* Patients with a history of recent trauma or previous operations with remaining fixation material in the foot or ankle
Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)

Several recent studies have shown an increase in the signal intensity of the unenhanced T1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to an accumulation of gadolinium based contrast agent. These studies were mainly conducted in patients with primary or secondary brain tumor. Multiple sclerosis is a particular model since it involves patients with a break of the blood-brain barrier, a long life expectancy, and who received many injections of contrast enhancing agents. In this context, it appears fundamental to know whether contrast agents accumulate in the brain for this disease. The French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without injection. The purpose of this study is to evaluate the accumulation of two commonly used gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple sclerosis, who received at least 5 injection of exclusively one of these contrast material.


Eligibility Criteria:
* Inclusion Criteria:
* Clinical diagnosis of Multiple sclerosis
* At least 5 MR imaging with the same Gadolinium based contrast agent (either Dotarem or Multihance)
* Have performed an unenhanced T1-weighted image before Gadolinium based contrast agent injection according to the OFSEP protocol
* Exclusion Criteria:
* Never experienced other contrast agent then the one specified by the group to which they belong (either Dotarem, or Multihance)
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study

This clinical trial studies how well an electronic (e)-health intervention (day-by-day) woks in managing fears or worries about cancer growing, spreading, or getting worse (progression) in patients with stage III or IV gynecologic cancer. Fear and worries about cancer progression or recurrence (coming back) are common concerns. This may contribute to concerns related to illness, worries, and uncertainty about the future. Day by Day is adapted from a program called "Conquer Fear" which was shown to benefit patients with early-stage cancer. Day-by-day intervention may help refocus patient thoughts and help patients learn skills to manage anxiety and fears.

PRIMARY OBJECTIVES:

I. Will adapt the intervention into a hybrid format including two group and three web based self-study sessions. (Phase 1) II. To determine the feasibility and acceptability of a new hybrid e-health intervention to manage fear of progression (FOP) in patients with stage III or IV gynecologic (GYN) cancer. (Phase 2)

SECONDARY OBJECTIVE:

I. To explore the preliminary efficacy of day-by-day (DBD) on reducing FOP (primary outcome) and improving secondary outcomes of distress, anxiety, depression, metacognitions, and mindfulness. (Exploratory)

OUTLINE:

PHASE I (DEVELOPMENT): Patients complete surveys and participate in focus groups.

PHASE II (DBD): Patients receive DBD intervention consisting of group and web-based self-study sessions and check-in calls on study. Patients also watch videos and receive handouts to reinforce the group sessions.

Eligibility Criteria:
Inclusion Criteria:

* Women with stage III or IV GYN cancer (ovarian, endometrial, cervical, vulvar/vaginal);at least 3 months from initial diagnosis
* Age: \>= 18 years
* Score \>= 34 on the Fear of Progression Short-Form, indicating dysfunctional levels
* Ability to read and understand English
* Patients in remission or with progressive disease are eligible

Exclusion Criteria:

* Enrolled in hospice
* Severe depression as assessed by Patient Health Questionnaire (PHQ-9)
* Non-English speaking
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)

The purpose of this study is to define the dose for a Phase II study and to investigate safety and tolerability of intravenous administration of recombinant soluble human Angiotensin Converting Enzyme 2 in healthy volunteers.

APN01-1-01 is a placebo controlled double blinded Phase I study composed of a single dose, dose escalation part followed by a multiple dosage part. The first four cohorts (four individuals each) will receive 100, 200, 400 and 800 µg/kg APN01 i.v. or placebo. Cohorts 5 and 6 (three individuals each) will receive three and six i.v. APN01 administrations daily, respectively. Planned dosage of the multiple dose part will be 400 µg/kg.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥18 years
* Use of acceptable form of birth control
* Willing to comply with study protocol
* No significant background illness
* Signed informed consent form

Exclusion Criteria:

* Significant hematological, renal, hepatic, metabolic, psychiatric or pulmonary diseases.
* Heart disease or elevated blood pressure.
* Any other significant disease that could interfere with the subject's ability to complete the protocol
* History of alcohol or drug abuse
* Abnormal urinalysis
* Pregnant or lactating female subjects
* Use of anticoagulants or antihypertensive drugs, particularly drugs interfering with the renin-angiotensin-aldosterone system, Obesity or anorexia (BMI \<18 or \>30)
* History of malignancy, except basal cell carcinoma of the skin, Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or positive serology testing in the study screening procedures (except indicating immunization)
* Participation in a clinical trial within the last 30 days
* Any of the following laboratory abnormalities:

  * WBC 15% outside of normal limits
  * Hemoglobin 15% outside of normal limits
  * Platelets 15% outside of normal limits
  * Aspartate transferase (AST) or alanine transferase (ALT) above 15% outside of normal limits
  * Alkaline phosphatase above 15% outside of normal limits
  * Urea above 15% outside of normal limits
  * Creatinine above 15% outside of normal limits.
Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia

OBJECTIVES:

I. Determine the effect of supplementation with donor T-cell depleted, CD34+ peripheral blood stem cells on durable engraftment and incidence of graft-versus-host disease in patients with aplastic anemia undergoing allogeneic bone marrow transplantation.

PROTOCOL OUTLINE: Bone marrow and peripheral blood stem cells (PBSC) are harvested from a HLA identical or 1 antigen mismatched related donor. PBSC are selected for CD34+ cells and T cells are depleted.

Patients receive cyclophosphamide IV over 2 hours on days -6 to -3 and anti-thymocyte globulin IV with methylprednisolone IV over 10-12 hours on days -5 to -3. T-cell depleted PBSC and bone marrow are infused on day 0. Patients receive cyclosporine IV over 12-24 hours on days -1 to 120 followed by a taper and methylprednisolone IV on days 7-64 for graft-versus-host disease prophylaxis.

Patients are followed every 30 days for 1 year, every 60 days for 2 years, and then as needed for a minimum of 3 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of life-threatening or transfusion-dependent marrow or immune-mediated failure involving one or more hematopoietic cell lines evidenced by one or more of the following: Granulocyte count less than 500/mm3 Platelet count less than 20,000/mm3 Absolute reticulocyte count less than 60,000/mm3
* Immune-mediated anemia and/or thrombocytopenia must have failed corticosteroids and cyclosporine
* Paroxysmal nocturnal hemoglobinuria with progressive marrow failure allowed
* Either congenital or acquired severe granulocytopenia with a history of life threatening infections No diagnosis of Fanconi's anemia
* HLA identical or 1 antigen mismatched related donor meeting the following criteria: No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgery, such as head and neck cancer or stage I breast cancer, considered on an individual basis) Negative pregnancy test

--Patient Characteristics--

* Hepatic: Hepatitis B surface antigen negative Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal (in the absence of Gilbert's disease)
* Renal: Creatinine no greater than 2.0 mg/dL
* Cardiovascular: No history of coronary artery disease LVEF at least 40% by MUGA
* Pulmonary: FEV1 at least 50% predicted FVC at least 50% predicted DLCO at least 50% predicted
* Other: No uncontrolled diabetes mellitus No other illness that would preclude aggressive chemotherapy No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgery, such as head and neck cancer or stage I breast cancer, considered on an individual basis) No psychiatric illness or mental deficiency that would preclude study Not pregnant or nursing Fertile patients must use effective contraception HIV negative
Better Asthma Outcomes: Lowering Tobacco Smoke Exposure

To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma

BACKGROUND:

Secondhand tobacco smoke (SHS) exposure increases asthma morbidity in children. Efforts to reduce exposure have had mixed results. This study is a randomized controlled trial of an exposure reduction intervention, with objective feedback to parents on the child's exposure based on urine cotinine measurement, and counseling tailored to the child's specific exposure sources/locations and parental readiness to take specific actions to reduce exposure from each source/location. This trial involves 350 SHS-exposed children with persistent asthma, 3-12 years of age, receiving care from the Kaiser Health Care Program in Northern California. Primary outcomes over the 18 months of follow-up will be asthma acute care utilization and urine cotinine/creatine ratio. Changes in controller medication adherence will be evaluated using a pharmacy-based dispensing index.

DESIGN NARRATIVE:

Primary objective: To evaluate the efficacy of a behaviorally-based, cotinine-feedback-and-monitoring program designed to reduce SHS exposure in an 18-month randomized controlled trial (RCT) with 350 children with persistent asthma, 3-12 years of age, in comparison with usual medical care.

Secondary objectives: 1) to investigate the behavioral mechanisms that mediate between the intervention and associated improvements in asthma outcomes, and 2) to determine the influence of initial caregiver stage of change with regard to smoking practices on response to the intervention.

Hypotheses:

1. Disease outcomes: A behaviorally-based, individually-tailored intervention that emphasizes SHS exposure reduction, provides sequential feedback to the parent on the child's urine cotinine level, and is tailored to the parent's stage of change with regard to smoking practices will be associated with decreased asthma crisis care utilization and improvements in secondary disease outcomes over an 18-month follow-up period when compared with usual medical care.
2. ETS exposure: The SHS reduction intervention will be associated with lower SHS exposure at follow-up (assessed by urine cotinine/creatinine ratio), compared with usual medical care.
3. Mechanism: Decreases in urine cotinine/creatinine ratio will be instrumental in intervention-associated improvements in asthma crisis care utilization.

Eligibility Criteria:
* Age 3-12 years
* Kaiser member for \>= 1 year
* \>= 1 asthma care visit in prior year
* Persistent asthma likely based on prior year:

Physician diagnosis code of persistent asthma OR \>= 4 beta agonist (BA) dispensing events OR \>= 4 Anti-inflammatory (AI) dispensing events

* Secondhand smoke exposure by parent report.
* Parent agrees to participate in a clinical trial of a smoke exposure reduction interventio