cyrilzakka/clinical-trials huggingface dataset:
Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)

The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB) mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia (CDH).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CDH between 20 and 36 weeks estimated gestational age (EGA)
* Only one of the following fetal criteria and one of the following postnatal criteria must be met for enrollment. Fetal criteria: an ultrasound (US)-obtained observed to expected lung to head ratio (o/e LHR) less than or equal to 35% or 2) a fetal magnetic resonance imaging (fMRI)- obtained observed to expected total fetal lung volume (o/e TFLV) less than or equal to 35%. Postnatal criteria: 1) Cord blood gas (CBG) with potenital hydrogen (pH) \<7.0, 2) Arterial blood gas (ABG) with pH \<7.2 on 2 gasses within the first 24 hours, 3) Preductal oxygen saturation (O2 sat) \<90% x 2 total hours (not necessarily consecutive) within the first 24 hours, or 4) Oxygenation Index (OI) \>20 x 2 total hours (not necessarily consecutive) within the first 24 hours.

Exclusion Criteria:

* Genetic/chromosomal abnormality: Trisomy 21, Trisomy 18, Trisomy 13 or other, significant genetic abnormality. Microdeletions or other mild genetic abnormalities are not considered exclusionary.
* Severe/major cardiac anomaly: coarctation of the aorta, combined atrial and ventricular septal defects, hypoplastic left heart syndrome, tetralogy of fallot, double outlet right ventricle, atrioventricular canal defects, or other hemodynamically significant defects.
* Moderate/severe neurologic / intracranial abnormality: Grade III or IV intraparenchymal hemorrhage, space occupying mass or lesion, or clinically significant traumatic lesion such as a subdural or epidural hemorrhage.
* Prematurity \<30 weeks estimated gestational age (EGA): Birth at 29 6/7 weeks or before
* Participation in an alternative prenatal intervention study: Fetoscopic Endotracheal Occlusion (FETO)
* Unwillingness / inability to return for follow-up evaluation and assessment
Neuropathic Pain and Quality of Life in ICU Survivors

Previous research on intensive care unit (ICU) survivors shows that rehabilitation is challenging, because of patients experiences of disease related problems both under and after treatment. Approximately 20 % of patients die within hospital, up to 80% suffer from hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other symptoms and disability (Angus et al 2004; De Letter et al 2001; Ely et al 2001; Nelson et al 2006; Van den Berghe et al 2001; Van den Berghe et al 2003) . A recent study shows that 28% of intensive care survivors have chronic pain that reduce their health related quality of life (Boyle et al 2004).

The aim of this study is to perform a survey about prevalence of pain type, and which consequences this causes when it comes to function and quality of life up to 12 months after the ICU stay.

1. What type of pain has ICU survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development?
2. What is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and PTSD in these patients?
3. What is these patients largest obstacle for good QoL after discharge from hospital?

A prospective and longitudinal survey 3 time points for data collection:

1. ICU - background data about the patients ICU stay (days on ventilator, medication, treatment, SAPS II, SOFA etc).
2. 3 months after ICU discharge - survey about pain, QoL, sleep, fatigue, Post traumatic stress disorder (PTSD), anxiety and depression.
3. One year after ICU discharge - the same as 3 months.

Survey instruments:

Pain - Brief Pain Inventory, Neuropathic Pain Syndrome Inventory, Pain diary QoL - SF 12, Sleep - General Sleep Disorder Scale Fatigue - Lee Fatigue Scale Anxiety and depression - Hospital Anxiety and Depression Scale PTSD - PTSS 10 Social Provision - Revised Social Provision Scale

Eligibility Criteria:
Inclusion Criteria:

* ICU stay longer than 48 h
* 18 years old or older
* Patients must write and understand Norwegian well.

Exclusion Criteria:

* Dying patients
* No acceptance form next of kind
* No concent from the patients
* Other that the researcher thinks should be excluded f. ex Patients with very bad prognosis
* Patients with low probability for self report after ICU stay
Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth

This study involves drawing blood samples from men before and after they perform 30-minutes of moderate-intensity aerobic exercise. The investigators will evaluate whether adding the exercise serum to colon cancer cells in a dish can reduce the growth of the cells compared to the resting serum.

Note: serum is the liquid part of the blood that carries hormones and metabolites around the body.

Regular exercise is associated with a reduced risk of developing colon cancer. However, the mechanisms underpinning the anti-cancer effect of exercise are not yet fully understood. A recent theory suggests that each time you exercise, the short-lasting spikes in circulating hormones can suppress the growth of cancer cells. Hence, every exercise bout could have a direct anti-cancer effect.

This study will recruit men with an increased of colon cancer and explore whether incubating colon cancer cells with serum collected after a bout of moderate-intensity aerobic exercise influences cell viability in vitro.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* BMI ≥ 25 kg/m2 and/or waist circumference of ≥ 94 cm
* Male
* Participating in less than 30 min of planned, structured, moderate to vigorous-intensity physical activity on three or more d·wk-1 for the last three months

Exclusion Criteria:

* Any absolute or relative contraindication to exercise testing, as determined by the American College of Sports Medicine
* Any sign/symptom of cardiovascular, metabolic or renal disease
* Known cardiovascular, metabolic or renal disease without written medical clearance from physician
* Resting hypertension (≥160 mmHg systolic and/or ≥90 mmHg diastolic)
* Chronic obstructive pulmonary disease and/or asthma with peak respiratory flow \< 300 l/min
* Previous stroke or transient ischemic attack
* Epilepsy or aneurysm (large vessel or cerebral)
* Previous or current treatment for malignancy
* Clotting disorder
* Taking beta-adrenergic blocking agents
* Resting heart rate ≥ 100 bpm
* Musculoskeletal, neurological, anthropometric, or rheumatoid conditions that makes it not possible to pedal a bicycle and/or would be worsened due to exercise
* Body mass \> 150 kg
Clinical Study on BiHapro Total Hip System With Different Surface Coatings

This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.

The efficacy of the prosthesis will be evaluated comparing the pain, the function and the range of motion measured preoperatively and postoperatively using recognized clinical outcomes Harris Hip Score. The secondary efficacy measurement is based on X-rays to measure the mineral bony thickness in the areas of Gruen zones of the proximal femur.

Eligibility Criteria:
The patients who are selected for this study must fit the following criteria.

* Candidate for a Total Hip Arthroplasty
* Less than 80 years of age.
* A pre-operative level of pain and function the same as for conventional joint replacement.
* A likelihood of obtaining relief of pain and improved function.
* Full skeletal maturity.
* Ability to follow instructions.
* Good general health for age.
* Willing to return for follow-up evaluations.
* No bias to sex.
Foundation Knee Study - Retrospective

The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.


Eligibility Criteria:
Inclusion Criteria:

* Have knee joint disease related to one or more of the following

  * osteoarthritis
  * post-traumatic arthritis
  * inflammatory tissue disorders
  * arthritis secondary to other diseases
  * Avascular necrosis of the femoral condyles;
* Skeletal maturity
* Less than 70 on the Knee Society Score (rating score)
* Sufficient bone stock, as judged by radiographs, to support primary knee implant
* Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant
* No infection present
* No known materials sensitivity

Exclusion Criteria:

* Skeletal immaturity
* Greater than or equal to 70 on preoperative Knee Society Score (Rating Score)
* Post-patellectomy
* Insufficient bone quality which may affect implant stability
* Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture.
* Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity)
* Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Prisoners
* Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity)
* Patient is pregnant
* Infection present
* Materials sensitivity
Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum

This study will evaluate the pharmacokinetic disposition of raltegravir in pregnant HIV-1 infected women. These results will be compared to pharmacokinetic data obtained following pregnancy as well as to studies previously carried out in nonpregnant women and male patients. By determining the disposition characteristics for this specific patient population, antiretroviral (ARV) dosing can be optimized during pregnancy. Appropriate dosing is necessary to minimize adverse effects, slow progression of disease, and further reduce the risk for vertical transmission. Data will also be obtained on genital tract penetration and placenta transfer of raltegravir to the newborn.

The subjects enrolled in this study will take an antiretroviral based regimen containing raltegravir twice daily both during and after their pregnancy. The specific regimen will be chosen by their own primary care provider based on their antiretroviral history and resistance testing. They will undergo a series of blood sampling for pharmacokinetic analysis over 12 hours on two occasions; a) during their 3rd trimester and b) approximately 3 months postpartum. Concentrations of raltegravir in the infant will be assessed by cord and infant blood sample at delivery and a blood sample at approximately 3 months of age.

Hypothesis: The pharmacokinetic exposure of raltegravir as measured by the 12 hour area under the plasma concentration versus time curve (AUC0-12h) during third trimester pregnancy is similar to the AUC0-12h estimated three months post-partum.


Eligibility Criteria:
Inclusion Criteria:

* Female, 16 years old or older
* Pregnant, at least 14 weeks gestation in order to initiate raltegravir treatment if decided by their pregnancy health care provider. The first pharmacokinetic study visit occurs no sooner than 26 weeks gestation (3rd trimester)
* Normal fetal heart motion by ultrasound, vital signs and brief physical exam as conducted by their primary pregnancy health care provider within two weeks of study entry (part of their standard prenatal care)
* Intolerance or resistance to at least two classes of antiretroviral agents
* Availability of a raltegravir-optimized background regimen based on referring provider's selection and resistance testing
* English or Spanish speaking

Exclusion Criteria:

* Inability to follow study protocol or drug administration
* Women who are planning to breastfeed (this is not recommended for HIV-infected women to reduce HIV transmission to the baby)
* Women unable to sign informed consent
* Women with a history of anaphylaxis or other life threatening adverse event associated with antiretroviral therapy
HEALing Communities Study

This study will test the impact of implementing the Communities That Helping to End Addiction Long-term (HEAL) intervention on opioid overdose deaths within 67 highly affected communities with the goal of reducing opioid overdose deaths by 40%.

The HEALing Communities Study (HCS) is a multi-site, parallel group, cluster randomized wait-list controlled trial to test the impact of the Communities That HEAL (CTH) intervention, which is designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. The intervention will include 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence-based practices to address overdose and opioid use disorder. Communities receiving the intervention will be engaged to reach individuals who are at highest risk of overdose death (e.g., out of treatment, leaving jail) and: (1) expand access to and receipt of medication for opioid use disorder (MOUD) and behavioral treatment, (2) increase the number of individuals retained in treatment beyond 6 months, (3) reduce the risk of fatal overdose through expansion of overdose education and naloxone distribution, and (4) improve prescription opioid safety. In addition, the study will determine (1) the factors that contribute to or impede successful implementation of the CTH intervention, (2) the factors that contribute to or impede sustainment of CTH intervention, and (3) the incremental costs and cost effectiveness of the CTH intervention.

Eligibility Criteria:
Inclusion Criteria:

* The community must be located in one of the four participating states: Kentucky, Ohio, Massachusetts, or New York.
* At least 30% of the communities selected within each state must be rural.
* Across all the HCS communities within each state, there must be a minimum of 150 opioid-related overdose fatalities (with at least 22 opioid-related overdose fatalities experienced by the rural communities) and a rate of at least 25 opioid-related overdose fatalities per 100,000 persons, based on 2016 data.
* The community must express willingness to address in their response strategy the implementation of MOUD, overdose prevention training, and naloxone distribution across their community.
* The community must express willingness to develop partnerships across health care, behavioral health, and justice settings for evidence-based practices to address opioid misuse, OUD, and overdoses.

Exclusion Criteria:

* Communities that did not meet the aforementioned inclusion criteria were excluded from the HCS.
The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care

The purpose of the research is to evaluate and test the usefulness of the mobile application forDiabetes to improve the self-care of individuals with diabetes type 1. The investigators want to obtain the missing evidence from the field of application operation and their impact on individuals' self-care and study the acceptance of applications among healthcare staff, which plays an essential role in patient education.

The investigators will conduct a randomized study in which individuals included in the intervention group will use the forDiabetes app to self-care for their type 2 diabetes throughout the study. A randomized controlled trial will be conducted in family medicine clinics throughout Slovenia. At the start of the observation and the first control visit, the investigators will assess self-care and disease perception of individuals with the help of validated questionnaires. Measurement of body weight, blood pressure, blood sugar monitoring, and glycated hemoglobin will also be performed at the observation and a first control visit. For individuals who will use the forDiabetes application during the research, the investigators will also assess the frequency of using the mobile application in the home environment at the first control visit.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years;
* with regulated and diagnosed type 2 diabetes;
* patients who are managed in a family medicine clinic;
* patients who have the option of using a mobile phone and a blood sugar meter in the home environment.

Exclusion Criteria:

* patients diagnosed with type 1 diabetes;
* patients who have chronic complications as a result of diabetes.
Efficacy of Intracavernous Platelet-rich Plasma Injection in the Treatment of Erectile Dysfunction

Investigation of the efficacy of autologous platelet-rich plasma administration on the potency of patients with vasculogenic and/or neurogenic erectile dysfunction


Eligibility Criteria:
Inclusion Criteria:

- 1)40-70 years old male, sexually active heterosexual, 2) Patients with a diagnosis of mild to moderate erectile dysfunction (IIEF score between 8-21) according to the International Index of Erectile Function (IIEF) for at least 3 months, 3) Patients who cannot achieve an erection despite peroral PDE5 inhibitor and intracavernous alprostadil injection therapy

Exclusion Criteria:

1. Patients with psychogenic erectile dysfunction, 2) Patients with a history of priapism, penile fracture, peyronie, penile curvature 3) Patients with a history of radical prostatectomy, 4) Patients with a history of major pelvic trauma, surgery, radiotherapy, 5) Patients with a history of malignancy affecting survival, 6) Patients with severe psychiatric illness that impairs adherence to treatment, 7) Patients with any bleeding disorder or on anti-aggregants/coagulants.
St. Jude Cancer Education for Children Program: The Feasibility of Teacher Delivery (Pilot Study)

-The St. Jude Cancer Education for Children Program was created in 2006 as part of the outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research Hospital. The curriculum is designed to teach schoolchildren about cancer and dispel common misconceptions, inform students about healthy lifestyle choices that can translate to reduced cancer risk in adulthood, and to inspire an interest in science and scientific careers. In the 2010-2011 school year, researchers examined the impact of the program in regard to knowledge.

It has always been clear that St. Jude personnel are limited to visiting a small number of schools in person each year so in 2011, a teacher's kit to the education program was created. The kit includes all the lesson plans needed to complete the program without the presence of St. Jude staff members. As a result, researchers at St. Jude Children's Research Hospital want to test the feasibility of the intervention by schoolteachers, and how this mechanism of delivery will affect student knowledge, attitudes, and health behaviors associated with cancer and healthy living.

Teachers who agree to participate will use the teacher's kit developed by the St. Jude International Outreach Program to deliver the St. Jude Cancer Education for Children curriculum to 4th grade students over the course of 1 week. Pre and post survey data will be collected from students to measure knowledge, beliefs, attitudes, perceptions of vulnerability, intentions, and behaviors associated with cancer and healthy living. Rates of compliance and feedback about the curriculum will be collected from teachers via curriculum checklist, survey, and interviews.

Primary Objective:

* To determine if it is feasible for classroom teachers to implement the St. Jude Cancer Education for Children Program.

Secondary/Exploratory Objectives:

* To determine factors that may contribute to the program's feasibility such as school and teacher characteristics.
* To measure the impact of the intervention on student knowledge, beliefs, attitudes, perceptions of vulnerability, intentions, and self-reported health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Located in the United States or United States territories
* District \& school provide permission
* 3rd, 4th, or 5th grade student with cognitive capacity to complete questionnaires (as determined by the teacher)
* Assents to study participation

Exclusion Criteria:

* Located outside of the United States or United States territories
* Student does not assent to participation
* Student without cognitive capacity to complete questionnaires (as determined by the teacher)
* Parent or guardian refuses consent
WISE Project - Women's Involvement in Steady Exercise

The general objective is to assess adherence to a HIIT-type exercise program, complemented with nutritional plans and other health-related advice, which will be administered through a mobile application in sedentary girls.

The project is aimed at encouraging participation in sport and physical activity, especially by supporting the implementation of the Council Recommendation on health-enhancing physical activity and being in line with the EU Physical Activity Guidelines, since its main objective is to determine the influence of exercise and healthy lifestyle on body composition of young women aged 15-24 and to define a specific WISE Exercise Programme - a multidimensional model of dependence between body composition, lifestyle and nutrition which would enable the programming of optimal patterns of behaviour in life habits as a planned corrective measure and stimulate the young women in EU countries to avoid the drop out of sports.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged between 15 and 24 years.
2. Sedentary participants who do not comply with the WHO physical exercise recommendations and with a low IPAQ, which means that they do not perform at least:

   * 3 or more days of vigorous activity for at least 20 minutes a day.
   * 5 or more days of moderate-intensity activity.
   * Walk at least 30 minutes a day every day.
   * 5 or more days of combined moderate or vigorous intensity activities or walking achieved a minimum of 600 METs(min/week).

Exclusion Criteria:

1. Participants with diabetes.
2. Participants with possible heart problems or other type of contraindication that does not allow physical exercise (for this, the PAR-Q survey will be passed)
3. Participants who are not willing to wear the watch during the 6 months that the intervention lasts.
4. Participants who have contracted severe COVID-19 in the last 3 months. If the patients suffer from COVID-19 during the study, then they will stop exercising, but the measurements will be taken at the end of the study.