cyrilzakka/clinical-trials huggingface dataset:
AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma

The aim is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in a fully-powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver


Eligibility Criteria:
Inclusion criteria are:

1. Adolescent is 12-15 years old
2. Caregiver is between 18-70 years-old
3. Adolescent lives in the residence of caregiver
4. Adolescent and caregiver can speak and read English
5. (a) Adolescent has been diagnosed as having asthma, OR (b) Doctor has stated the adolescent has asthma, OR (c) Adolescent has had breathing problems in the past 12 months
6. Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks
7. (a) During the past 14 days (that is, during the past fourteen 24-hour periods that include daytime and nighttime), the adolescent has experienced one or more of the following: (i) Asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on more than 4 separate days; (ii) Woken up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on 1 or more separate nights; (iii) Had to slow down or stop play or usual activities or missed school because of asthma, wheezing, or tightness in the chest, or cough on more than 4 separate days; (iv) Used any asthma rescue medicine (sometimes called a quick relief medicine) on more than 4 separate days

   * OR

     (b) In the past year, adolescent has had one or more of the following: (i) 2 or more exacerbations requiring oral systemic corticosteroids; (ii) 2 or more emergency department visits; (iii) 1 hospitalization; (iv) 2 or more urgent medical care visits due to asthma
   * OR

     (c) Adolescent scores 19 or lower on the Asthma Control Test

Exclusion criteria are -

Families will be excluded if:

1. The family is currently involved in an asthma management intervention above and beyond usual care, OR
2. Adolescent is unable to complete study procedures independently.
RNA Cloning and Visualization in Human Atherosclerosis

The research objectives of this project are as follows:

1. Obtain high-quality human atherosclerotic arterial samples from diseased donors.
2. Perform biochemical analysis to determine the abundance, localization and activity of Dicer and double-stranded RNAs in these diseased tissues.

Participants enrolled in to this pilot study will not be randomized and will not receive any investigation medication.

In collaboration with Dr. Sibu Saha, Professor of Surgery, University of Kentucky, the investigator will obtain freshly isolated human atherosclerotic tissue from patients undergoing carotid endarterectomy. The surgical process by which the tissue is obtained is not part of this research project. These tissues are surgically removed from patients as a treatment for atherosclerosis of the carotid arteries and typically sent for pathological examination.

After the the clinical pathology has been completed, the investigator will obtain and analyze a small amount of discarded (200mg) tissue. Subsequent analyses will be performed on the basis of the pathological grading provided by UK Pathology (e.g do readouts of the Dicer pathway correlate with pathological plaque characteristics). Tissue will be anonymized, with only information with respect to drug history, age, gender and pathological grade of the tissue.

The will extract protein and RNA. Dicer abundance will be assessed by western blot, quantitative RT-PCR and northern blot. Dicer related RNAs will be measured by quantitative RT-PCR and northern blot. The invesigator will inspect the tissue for evidence of altered Dicer activity by measuring the relative levels of abundant canonical Dicer substrates/enzymatic products (i.e. the ratio of pre- to mature micro-RNA) via northern blot. The investigator predicts that Dicer levels and activity are reduced in human atherosclerotic tissue compared to healthy arteries.

Next, the investigator will assess whether downstream mediators of Dicer dysregulation are activated in these tissue samples by comparing levels and activation of the inflammasome (caspase-1, NLRP3, ASC), cytokines (IL-1β, IL-18) and signaling intermediates (MyD88, IRAK1/4) between healthy and diseased tissues. The investigator predicts that atherosclerotic plaques will exhibit evidence of Dicer dysregulation.

Next, the investigator will co-stain tissue sections with antibodies recognizing Dicer as well as cell-specific markers (CD31 for endothelium, SMA for smooth muscle, MAC-1 for macrophages) to assess whether Dicer dysregulation displays cell type-specific patterns.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 and older
* Undergoing carotid endarterectomy

Exclusion Criteria:

* Under 18 years of age
* Not undergoing carotid endarterectomy
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration.
* vulgaris total body surfae area involvement of at least 10%
* Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate.

Exclusion Criteria:

* Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study.
* Functional class (V (ACR) RA or amyloidosis)
* Active vasculitis (except for subcutaneous rheumatoid nodules).
* Subjects with a history of asthma, angioedema or anaphylaxis.
* Subjects with evidence of active or latent bacterial or viral invedtions.
* Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma).
* body weight \> 100 kg (or 220 lbs.)
ZOOMit-fMRI Identifies Motor Functional Cortex

This study was designed to collect a series of patients with gliomas which were involved in motor cortex to analyze difference accuracy of motor cortex localization between BOLD-fMRI and ZOOMit-fMRI.

Gliomas will lead motor dysfunction when they are involved in motor cortex. However, tumor resection also have risk to lead postoperatively motor function deficits if destroy patients' motor cortex when tumor removed. Hence, it is important for neurosurgeon to realize the situation of patients' motor cortex locations in order to determine personal operative protocol.

The blood oxygen level dependent fMRI (BOLD-fMRI) is a prevalent preoperative method to localization motor cortex. It shows motor relevant cortex by the change of blood oxygen level when patients cooperate to finish motor tasks. The advantage of BOLD-fMRI includes higher time and spatial resolution, higher sensitivity, non-invasive. However, its accuracy of localization has not been satisfactory because neurovascular uncoupling. The ZOOMit-fMRI is a novel technic which is evolved from conventional BOLD-fMRI to localize motor functional cortex.The advantage of ZOOMit-fMRI is smaller field of view (FOV) and higher spatial resolution comparing with BOLD-fMRI. That helps to reduce other region of brain interference and elevate accuracy of localizations.

In this study, the investigators plan to enroll 60 patients, whose gliomas are involved in motor cortex, to acquire their BOLD-fMRI and ZOOMit-fMRI data in order to analyze their difference in the accuracy of motor cortex localization.

Eligibility Criteria:
The inclusion criteria were as follows: 1) age ≥ 18 years; 2) no history of surgical treatment or radiotherapy; 3) no contraindication to MRI scanning; 4) agreeable to receive the fMRI scanning and awake craniotomy with DCS.

The exclusion criteria were as follows: 1) basing on the anatomic MRI, the distance from the tumor to the hand-knob area lower than 20 mm; 2) disable to finish the task of clenching fist during fMRI scanning.
Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention

The scar site was divided into 3 sites; combined IPL/fractional Er:YAG laser treatment site, fractional Er:YAG laser treatment site and untreated control site. At baseline, three lesions were randomized to IPL / fractional Er:YAG laser combination therapy site, fractional Er:YAG laser treatment alone site, and untreated control site. The laser treatment was conducted total three sessions, immediately at suture removal (baseline), 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment (20 weeks after suture removal).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of postoperative scars on the abdomen
* scars were symmetrical shaped in a line of 3cm or more

Exclusion Criteria:

* uncontrolled systemic or chronic disease
* hypersensitive to the ingredients
* a history of other laser treatments within the past 6 months
* pregnancy
* lactation
* Recent sun exposure
In Patients With Hip Dysplasia, Mid-Term Lower Extremities and Spine After Hip Arthroplasty Natural Course

Patients with developmental hip dysplasia often present to the outpatient clinic in adulthood with hip pain due to progressive hip osteoarthritis. However, they may have complaints such as limping, lumbar lordosis, lower back pain, and leg length difference. Today, the best treatment option for these patients is hip arthroplasty. Hip arthroplasty causes a high rate of functional improvement and pain relief. According to the hip arthroplasty technique applied, improvement in lameness, leg length difference and spinal curvatures is expected. The aim of our study is to show the change in postoperative spine and lower extremity curvatures after hip arthroplasty in patients with advanced developmental hip dislocation.

Developmental hip dysplasia (DDH) describes the spectrum of anatomical changes in the acetabulum and proximal femur; these can cause limping, lower back pain, lumbar lordosis, and leg length variation. DDH is the main cause of degenerative arthritis of the hip and valgus deformity of the knee. The best treatment option for DDH is total hip arthroplasty (THA). During THA, the distorted anatomy of the acetabulum and proximal femur poses great difficulties. Additionally, the soft tissue can be released and the femur can be shortened while correcting the placement of the acetabulum to prevent neurological damage (sciatic nerve paralysis). Postoperative evaluations focused on assessing joint function and alleviating preoperative clinical symptoms. Some studies have examined changes in lower extremity and knee alignment after THA in patients with DDH. In patients with DDH, THA may cause genu valgus deformity due to increased lower extremity length and Q angle immediately after the operation. THA extends the lower extremity, affecting the patellofemoral joint and anterior knee pain. However, the long-term effects of THA on the alignment of the lower extremity are unclear, especially in patients with Crowe type III and IV DDH, which involves femoral shortening osteotomy. There are few studies examining changes in the knee and lower extremities as a result of THA in patients with DDH. The aim of this study is to evaluate the mid- and long-term alignment of the spine and lower extremity after THA with or without femoral shortening osteotomy in patients with unilateral DDH (Crowe type III-IV).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral Crowe type 3 hip dysplasia
2. Patients with unilateral Crowe type 4 hip dysplasia

Exclusion Criteria:

1. Patients with unilateral Crowe type 1 hip dysplasia
2. Patients with unilateral Crowe type 2 hip dysplasia
3. History of previous surgery on the hip for which surgery is planned
Sestrin-2 Levels and Insulin Resistance

The aim of this study is to evaluate sestrin-2 levels in children with obesity


Eligibility Criteria:
Inclusion Criteria:

Obese adolescents Body mass index above the 95th percentile BMI Z-score above 2

Exclusion Criteria:

Primary hyperlipidemia Primary liver disease Hypothyroidism Diabetes
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years age;
* type 2 diabetes receiving pioglitazone (\>= 30 mg/day) and metformin (\>= 1500 mg/day) for at least 12 weeks prior to screening;
* HbA1c \>=7.0% and \<=10.0% at screening;
* BMI \>= 25 (\>23 for Asians) and \<=45 kg/m2 at screening;
* stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

* history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
* evidence of clinically significant diabetic complications;
* clinically symptomatic gastrointestinal disease;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer

Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Single arm, open label, prospective, observational study of gefitinib treatment for locally advanced (stage IIIB) or IV (metastatic) or relapsed NSCLC patients.

Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced stage IIIB not suitable for curative therapy or stage IV (metastatic) disease or relapsed NSCLC
* ECOG Performance status 0\~2.
* Written Informed Consent
* Female or male patients aged 18 years or over, eligible for treatment for NSCLC

Exclusion Criteria:

* Previous exposure to EGFR-TKI
* Concomitant use of other anti-cancer drugs with EGFR-TKI
* Patients without available Tumor DNA
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
* Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers

This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118

This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years (Parts A and B) or 65 and 85 years (Part C), inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Female subjects of non-childbearing potential must meet at least one of the following criteria:

  1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
  2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
* Screening supine blood pressure \>= 140 mm Hg (systolic) or \>=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.
Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker

The impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme inhibitors.

The impact of sodium intake on plasma drug concentrations concentrations obtained after a single oral dose of RAS blocking drugs (ramipril 10 mg, valsartan 160 mg, candesartan 8 mg) or a blocker as control (ATENOLOL 50 mg) will be compared in healthy normotensive men randomly assigned to a 6-day replated-sodium diet or a sodium depletion.

Eligibility Criteria:
Inclusion Criteria:

* 64 (16 per treatment goup) non-smoking healthy male volunteers
* Aged between 18 and 35 years after a complete clinical examination
* Safety laboratory measurements
* Having given written informed consent.

Exclusion Criteria:

* hypertension
* known disease
* diabetes mellitus
* known hypersensitivity
* contraindication to ACE inhibitors
* history of cardiac or pulmonary disease or asthma conditions which do not permit medical follow-up and compliance with the study protocol.
Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction

The overall objective of this study is to compare the clinical benefit and safety of two different surgical techniques of primary reverse total shoulder arthroplasty for the treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres minor dysfunction. The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group) and the second technique does not include a concomitant latissimus and teres major transfer (control group).


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pseudoparalysis due to chronic rotator cuff dysfunction with or without glenohumeral arthritis.
* Chronic rotator cuff tear with severe retraction, atrophy, fatty infiltration.
* Active forward elevation of less than 90 degrees
* Teres minor dysfunction
* Positive lag and hornblower sign
* Grade 2 or greater fatty infiltration of the teres minor and infraspinatous seen on MRI
* Able to attend scheduled office visits
* Meet all criteria to have a latissimus and teres major transfer

Exclusion Criteria:

* Revision arthroplasty
* Previous shoulder infection
* Neuro-muscular disorder (ie: Parkinson's)
* Advanced dementia
Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects.

Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with head/neck cancer and starting radio therapy treatment
* age between 18 and 80 years (both included)
* able to talk, read and understand Danish
* ability to give informed consent

Exclusion Criteria:

* known hypersensitivity towards bupivacaine or other local anesthetics of the amide type
* pregnancy
* women breastfeeding a child
Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure

The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure.

The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure. Heart Smart will provide synchronous virtual group education to homebound people with heart failure receiving services from Penn Medicine at Home. The primary clinical goal is to improve self-efficacy for heart failure self-management and improve their knowledge of heart failure self-management strategies. Secondary outcomes will explore the feasibility of the program by exploring technology, adherence and satisfaction with the program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of heart failure
* Receiving home health care from Penn Medicine at Home at time of screening.
* Technology capabilities to participate in the program (laptop or tablet with a camera, internet access).
* Able to read and write in English.
* Cognitive ability to participate in the program if the participant is able to score12/15 on the Montreal Cognitive Assessment (MoCA) 5 Minute Phone Test.

Exclusion Criteria:

* Hearing impairment that impacts communication.
* Previous experience receiving occupational therapy services from the principal investigator.