cyrilzakka/clinical-trials huggingface dataset:
Implementation of an Asthma Program to Improve Asthma Identification and Education in Children

The primary objective of this study is to document the prevalence and associations between asthma, hypertension, and obesity in children living in Pittsburgh, Pennsylvania and its surrounding regions.

The secondary objective is to determine the impact of various educational interventions on child and caregiver knowledge of asthma.

The Asthma Program will consist of six screenings and three camps each year, for two consecutive years. Screenings will be conducted in areas where populations are known to be at increased risk for asthma and its complications, such as inner-city, lower socioeconomic, African-American populations. Screenings will be conducted at churches or schools in these areas one month prior to each camp in an effort to identify children with undiagnosed or uncontrolled asthma and refer them to the camps. Camps will also be conducted in areas where populations are known to be at increased risk for asthma and its complications to improve ease of access. Asthma and smoking cessation education will be provided at each camp to children and caregivers. Baseline data will be collected at each camp and assessed. Longitudinal clinical outcomes will be assessed in children attending multiple camps.

Eligibility Criteria:
Inclusion Criteria:

* Children, ages 5- 17 years attending the asthma camps and screenings.

Exclusion Criteria:

* Children younger than 5 years of age and adults 18 years of age and older.
Influence of PET/CT Radiomic Features on the Outcome of Lung Cancer Patients

Radiomics is an attractive field in objectively quantifying image features, and may overcome the subjectivity of visually interpreting computed tomography (CT), or positron emission tomography (PET). It is reported that the features related to treatment response, outcomes, tumor staging, tissue identification, and cancer genetics. Therefore, the investigators try to explore the key features for the outcome of lung cancer patients.

Radiomic Features:

PET/CT images, including other kinds of CT serials, were transported into a personal computer. Using the open source software of 3D-Slicer, volumes of interest (VOIs) for primary tumor, or even lymph nodes, was semi-automatically or manually segmented. And then, radiomic features were extracted.

PET Parameters:

Using combined CT VOIs, corresponding PET standard uptake value (SUV, no unit) were measured. For a foci (either tumor, or lymph node), mean, sum and maximum SUV were documented, and were used for training and validating models alongside radiomic features.

Feature Selection:

Data were analyzed by deep learning or random forests method, and top 20 variables were scored by their contribution to the regression (variable importance, VIMP). The generalized features were identified as the same ones between two kinds of image serials (for example, ordinary and thin-section CT, or PET and CT). Additionally, when three or more features met the criterion, a lower value of Akaike information criterion (AIC) which measures the relative quality of statistical models was used to find appropriate features with lower overfitting possibility.

Model Validation:

The developed model was validated internally and externally. The internal indices for independent continuous variable were accuracy (bias and absolute bias) and precision (correlation coefficient and R square), and that for independent classified or survival variable was c-index. The patients enrolled from another medical center were used for external validation.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed as lung caner.
2. Accepted PET/CT scans at the hospitals either affiliated to Shanxi Medical University or Anhui Medical University
3. Both PET and CT serials can be obtained
4. Can be followed for treatment modalities (including chemotherapy regimens, radiotherapy dose, and et al), survival time and status, and other related information.

Exclusion Criteria:

1. Simultaneously suffering from the cancers from other tissues and organs
2. Have a history of diabetes, chronic heart diseases, or chronic renal failure
Posture Analysis for Patients With Haemophilia

Hemophilia A and B are inherited disorders characterized by deficient or missing coagulation factors VIII or IX, respectively, of which the main long-term clinical manifestation is joint damage. Patients with haemophilia (PwH) are susceptible to clinical joint bleeding that may cause irreversible joint damage. Some degree of damage may already occur after the first haemarthrosis or even in children who never experienced clinically evident joint bleeds. Joints are mechanical systems with a structure strictly related to functioning. Therefore, any alteration in structure may have an impact on function (starting from the primary level of posture and anti-gravity muscles), which might in turn stress the joints and increase the risk of bleeding.The primary aim of this study is to investigate the changes in posture and the mechanical properties of anti-gravity muscles of adolescent PwH. The secondary aim is to determine the effect of joint dysfunction on posture in adolescent PwH.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent boys with haemophilia A or haemophilia B (for experimental group) and healthy adolescent boys (for control group).

Exclusion Criteria:

* To be with another congenital coagulopathy such as von Willebrand syndrome.
* To be unable to stand without support due to hemophilic arthropathy.
* To be having another musculoskeletal problem.
* To be having factor VIII or IX level in the plasma above 6%
The SALMANTICOR Study

The SALMANTICOR study will obtain data on the prevalence and incidence of structural heart disease in a population setting. A cross-section survey of randomly selected residents of Salamanca (Spain) will be performed. A total of approximately 2400 individuals, stratifies by place of residence (rural and urban) and by age and sex will be studied. The variables to analyzed will be obtained from the clinical history, different surveys including social status, Mediterranean diet, functional capacity, electrocardiogram, echocardiogram and biochemical and genetic analysis. Surviving participants are expected to return for a 5 and 10-year follow-up visit.

The objectives of this study are: to obtain data on the prevalence and incidence of structural heart disease in a population setting; to show the spatial distribution different patterns of structural heart disease through the spectrum of age and sex and between urban and rural; and to generate new hypotheses which might serve to healthcare research and to political commitment to obtain resources and support effective public health program implementation.

The SALMANTICOR study is a cross-sectional descriptive population-based study of the prevalence of structural heart disease and their risk factors that will enroll a total of 2400 individuals, stratifies by place of residence (rural and urban), by age and by sex, in a Spanish community: Salamanca. Cohort participants will undergo a basal examination visit between 2015 and 2018. Surviving participants are expected to return for a 5 and 10-year follow-up visit. Institutional review committee approval was obtained and all participants will provide informed consent. The SALMANTICOR study is designed to provide echocardiographic parameters characterizing cardiac structure and function in all individuals. Medical history, surveys completion, and examinations will be obtained at the subject´s primary care referral center and will be analyzed and interpreted centrally at University Hospital of Salamanca. A complete medical history, physical examination and the surveys completion checkout will be performed by a cardiologist in a separate office to where examinations and blood sample extraction will be performed. Echocardiographic measures will be initially performed. Participant blood pressure and VASERA measures will be taken within 30 minutes of starting the echocardiographic exam and after the subject will be resting for 10 minutes. ECG will be performed after VASERA to finalize with the blood sample extraction. A magnetic resonance substudy and and a details analyses in diabetic individuals will also performed. SALMANTICOR participants will undergo surveillance for cardiovascular events, including heart failure, incident coronary heart disease, and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

* Any individual willing to participate

Exclusion Criteria:

* Death people not identified in the community records
* Not able to attend the visit
Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care

The purpose of this study is to assess the psychometric properties of a brief screening questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians' offices, and to pilot test a personalized, computer-facilitated brief intervention delivered on a tablet computer and by the provider based on screening results.

The primary goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There is substantial evidence supporting the effectiveness of screening and brief intervention among adult primary care patients, primarily in the reduction of harmful drinking. However, there have been few studies of alcohol screening and brief intervention conducted among adolescents seen in busy primary care settings. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program which incorporates the age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because tobacco use is the leading cause of cancer-related mortality in the US as well as screening for marijuana and other drug use so as to create a comprehensive screening instrument that includes all major substances that adolescents use.

Additionally, the NIAAA guide recommends that providers deliver a brief intervention in response to the screening results. Therefore, a secondary aim of this project will be to pilot-test a computer-facilitated Brief Intervention component using a randomized design comparing three groups: 1) screening with treatment as usual \[cASCA/TAU\]; 2) screening with the computer-facilitated brief intervention \[cASCA/BI\]. The BI component consists of patients viewing on the computer, immediately after the screening, their score and level of risk for a substance use problem, as well as several interactive pages of science and true-life stories about the health risks of substance use. Clinicians are then given the screen results and suggested talking points for a few minutes of brief counseling during the visit.

Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

* access to computer and email address
* available and willing to complete all follow ups by email or phone
* medically and emotionally stable
* can read and understand English

Exclusion Criteria:

* Patient has already participated in this study
Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer

This is an observational study for patients with breast cancer that will be treated with doxorubicin (Adriamycin) and/or trastuzumab (Herceptin). The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 15 years.

The investigators propose a prospective longitudinal cohort of breast cancer patients treated with anthracyclines and/or trastuzumab to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine whether associations between SDOH and cardiotoxicity risk differ according to race. Patients will be followed with serial echo, blood draw, and surveys every 3 months for the first year, then annually for two years. After 3 years following start of cancer therapy, patients will have study visits every other year for up to 15 years.

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years of age
* Breast cancer with treatment plan that includes doxorubicin and/or trastuzumab
* Ability to provide written informed consent

Exclusion Criteria:

* Pregnancy at enrollment
* Inability or unwillingness to provide consent
Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury

The main objective of this pilot study is to obtain information, which will be used for the design of a main randomized controlled trial (RCT) with a larger size based on feasibility, validity and sample size estimation as well as the potential effects of pre- and probiotic intake on intestinal microbiota. A larger trial will then be designed to test the hypothesis that adding probiotics or prebiotics may improve gut microbiome composition, gastrointestinal symptoms as well as cardiometabolic health indices in mid-term and possibly lead to improved sports performance over a longer-term period in athletes with a Spinal Cord Injury.

In this pilot crossover randomized controlled trial, twenty (N = 20) para-athletes will participate in an intervention consisting of a four-week intake of probiotic, using the commercially available multistrain probiotic preparation "BactoSan pro FOS" from Mepha (Basel, Switzerland), followed by a four-week wash-out period, and a four-week prebiotic intervention using "Naturaplan Bio Oat Bran" (Coop, Switzerland). Total duration of the study will be 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* athletes with a spinal cord injury shortlisted as potential participants for major international events, such as the Paralympic Games 2021 in Tokyo and World Championship qualification

Exclusion Criteria:

* Chronic inflammatory bowel diseases (i.e. ulcerative colitis, Crohn's disease)
* Taking antibiotics and/or other medication to alleviate gastrointestinal complaints at recruitment time point
* Pregnancy
Prevention of Postoperative Nausea and Vomiting

We designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with dimenhydrinate undergoing plastic surgery.

A total of 60 voman patient, ASA status I-II , aged 18-65 year and scheduled for elective rhinoplasty were enrolled in the study. Exclusion criterias hypersensitivity or contraindication for the studied medications, received an antiemetic drug or steroid within 24 hours before anesthesia, have history of diabetes history of motion sickness (MS) or PONV, or pregnant and lactating females.

Patients were informed on how to use the patient controlled analgesia device during the postoperative period. The risk criterias for PONV were recorded for each patient.Patients were randomly assigned to two study groups of 30 patients. All patients were premedicated with intravenous (iv) midazolam (1-2 mg). On arrival in the operating room, standard anesthetic monitors were applied. Anesthesia was induced with iv propofol (2-3 mg/kg) and fentanyl (1-1.5 μg/kg). Tracheal intubation was facilitated with rocuronium (0.6 mg/kg). After tracheal intubation all patient received iv 8 mg dexamethasone. Normocapnic mechanical ventilation was performed after intubation. General anesthesia was maintained with sevoflurane (1 minimum alveolar concentration) in oxygen / air mixture and remifentanil (0.1-0.3 μg/kg/min) infusion.Four mg ondansetron and for each patient 1 mg/kg dimenhydrinate in the 5 ml syringe solution were prepared by pharmacy department, and given to the blinded investigators. The patients, anesthesiologists (with the exception of the primary author), statistician, and observes were all blinded.

Dimenhydrinate was administered in group DD (1mg/kg), and ondansetron was administered in group DO (4mg), and all patients received tramadol (1.5mg/kg) and tenoksikam (20mg) half an hour before emergence.

Postoperative analgesia was provided with a patient controlled analgesia system by using iv tramadol (5mg/mL) (2 ml bolus and 10 minutes lockout interval without basal infusion).

After the surgery, muscle relaxation was reversed by administering neostigmine (0.05mg/kg) and atropine (0.015mg/kg). Patients were extubated and transferred to the recovery unit.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

18 Years to 60 Years woman

ASA (American Society of Anesthesiologist) physical status I or II

Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy

Exclusion Criteria:

Hypersensitivity or contraindication to the study medications,

Antiemetic drug or steroid use within 24 hours before anesthesia,

History of diabetes mellitus,

History of motion sickness or postoperative nausea and vomiting,

Pregnancy,

Breast feeding
Single Ascending Dose Study of MYK-461 in Healthy Volunteers

The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, single ascending (oral) dose study in healthy volunteers aged 18-55 years.


Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index (BMI)
* Normal LVEF
* Normal electrocardiogram (ECG)
* Females must not be breastfeeding and must be permanently sterilized or are postmenopausal.

Exclusion Criteria:

* Any structural abnormalities on echocardiography
* Positive results of HIV test and/or seropositive for HCV or HBV.
Figure-of-Eight Walk Test in Parkinson

The aim of study is to assess validity and reliability of Figure-of-Eight Walk Test in people with Parkinson's Disease


Eligibility Criteria:
Inclusion Criteria:

* at least 40 years of age
* neurologist-diagnosed Parkinson's Disease
* Hoehn \& Yahr (H\&Y) stages 1 to 3
* able to walk at least 20 meters

Exclusion Criteria:

* other neurologic disorder
* visual, auditory, orientational problems that could affect study results
* any orthopedic problem that prevents walking and standing
* have a cardiovascular, pulmonary or hormonal disorder
Neural Correlates of Psychiatric Disorders

This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037. The participant data originally acquired from IRB# 202370 will be included in this new record:

This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing SEEG monitoring at Vanderbilt University Medical Center
* At least 18 years of age
* English speaking

Exclusion Criteria:

* Age \<18
* Not able to complete questionnaires (e.g., unable to comprehend instructions or follow directions)
Association Between Helioderma and Response to Immunotherapy in Patients With Metastatic Melanoma

Melanoma is one of the most aggressive forms of skin cancer, representing only 5% of all skin cancer but 80% of all death by skin cancer. Diagnosis and treatment of melanoma must be early because prognosis depends on stage disease.

Immunotherapy is used in metastatic melanoma. However, all patients not respond to immunotherapy.

Helioderma (photoaging) is a marker of exposure to UV rays and therefore of mutagenesis. Thus, helioderma could be associated with the response to immunotherapy.

The detection and management of melanomas must be very early because the prognosis largely depends on the extent of the disease at the time of diagnosis.

For patients with melanoma, immunotherapy or dual therapy is used as treatment in unresectable and metastatic (AJCC stage IV) cases, depending on mutation status. Primary immunotherapy is possible in mutated patients in the absence of threatening progression.

However, not all patients respond well to immunotherapy, so biomarkers that predict treatment response are needed to optimize patient benefit.

The onset, development, and course of melanoma are based on the accumulation of genomic changes, including high loads of ultraviolet-induced mutations, which make melanoma the most immunogenic tumor. In several tumor types, tumor mutation load (TMB) and immune infiltration have been reported to predict response to immunotherapy. Indeed, the higher the TMB, the more the tumor is likely to produce a neo-tumor antigen, target of the reactivation of the immune system.

No threshold value of TMB has been determined to date, having a predictive value in melanoma. The degree of helioderma could be a potentially discriminating marker of the degree of UV exposure and therefore of mutagenesis. Preliminary results have reported the interest of this approach but must be confirmed because it was a small study (Russo et al).

UV-induced DNA damage results in clinical signs of heliodermia or photoaging: more or less deep wrinkles, loss of elasticity, thinning of the skin, lentigo pigmentary disorders, yellowish color of the skin, telangiectasias, on the skin areas exhibited. Helioderma could therefore be an easily accessible clinical predictor of a good response to immunotherapy.

The aim of the study is to study association between helioderma and response to immunotherapy in patients with metastatic melanoma.

Eligibility Criteria:
Inclusion Criteria:

* metastatic melanoma
* Whatever the mutation BRAF status
* treated by immunotherapy or specific therapy
* aged more than 18
* agreeing to participate to the study

Exclusion Criteria:

* Patient whose treatment by immunotherapy has already started
* Patient who have had a radiotherapy or chemotherapy treatment
* Patient with an unknown primary melanoma, choroidal melanoma
* Patient with other cancer (except basal cell and squamous cell skin cancer)
* Patient with genetic predisposition for melanoma
* aged less than 18
* Adult not agreeing to participate to the study