cyrilzakka/clinical-trials huggingface dataset:
The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children

This study is being conducted to determine the effect of EMLA cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years.

A chest tube is a device used to drain air or fluid from the pleural cavity under sterile conditions by inserting a thin or thick tube. Chest tubes adhere to the endothelium of the chest cavity after insertion and while in place. For this reason, the pulling force applied when they are removed breaks these adhesions and causes intense, localised and transient acute pain. Chest tube removal pain, defined as one of the patient's worst life experiences related to the surgical procedure, is an iatrogenic pain caused by an invasive procedure. Therefore, chest tube removal is a painful, anxious and frightening experience for the patient. There are few studies of pharmacological and non-pharmacological methods of pain control during chest tube removal in children. However, the management of pain associated with surgical procedures in childhood is very important for the management of pain, anxiety and fear that children will experience with future medical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Having two chest tubes (mediastinal/pleural) placed after open heart surgery
* Turkish literate
* With stable vital signs
* Willing to participate in the research

Exclusion Criteria:

* Experience with chest tube removal procedure
* Using analgesics other than routine procedures before the procedure
* Children receiving mechanical ventilation support
* Children who have complications in the postoperative period (heart and respiratory failure, repeated surgery, etc.)
* Children with a mental disability, perception problem, visual and hearing impairment
* Children with communication problems. • Children with cold allergies
Optimal Management of Vasa Previa Study - A Retrospective Study

This is a multicenter retrospective observational study of women diagnosed with a vasa previa during pregnancy or at delivery who delivered between 2000 and 2012. The study hopes to be able to describe techniques utilized to screen for and diagnose vasa previa as well as to describe the maternal characteristics and identify potential underlying risk factors that may provide a basis for future screening recommendations for vasa previa and treatment protocols.

This is a multicenter retrospective study of women identified as having a vasa previa during pregnancy or at the time of delivery who delivered between January 1, 2000 and December 31, 2012 at participating centers. The primary objective of the study is to describe techniques utilized to screen for and diagnose vasa previa.

* In those cases that were diagnosed antenatally, to describe the different management protocols utilized, correlate these management protocols with neonatal outcomes and support the management protocol that offers optimal outcomes for both mother and neonate.
* In those cases that were not diagnosed antenatally, to describe the clinical scenario surrounding delivery and the neonatal outcomes. Review the ultrasound reports and maternal characteristics to identify any potential risk factors for vasa previa that could have been identified antenatally in attempt to improve neonatal outcomes in the future.
* In all cases of diagnosed vasa previa (those diagnosed antepartum, intrapartum, and postpartum), to describe the maternal characteristics and identify potential underlying risk factors that may provide a basis for future screening recommendations and protocols. Due to the rarity of this diagnosis, the study hopes to include 100-250 participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosed of vasa previa made either during the pregnancy via ultrasound or at time of delivery via clinical and/or pathologic investigation.
* Patient delivered between January 2000 through December 2012

Exclusion Criteria:

* No diagnosis or confirmation of vasa previa
* Delivered either before January 1, 2000 or after December 31, 2012
Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.

Pelvic lymphadenectomy is associated with a significant risk of lower-limb lymphedema. In this study, we evaluate the feasibility of identifying the lower-limb drainage nodes (LLDNs) during pelvic lymphadenectomy for gynaecological cancers using an isotopic detection technique with a preoperative radiopharmaceutical injection into both feet Secondary objectives are to map lower-limb drainage, to assess the diagnostic value of our mapping technique, and to determine the incidence of lymphedema. LLDN mapping may allow the preservation of LLDNs, thereby decreasing the risk of lower-limb lymphedema and improving quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years of age or older with indication of pelvic lymphadenectomy for gynaecological malignancy:

  * High risk endometrial cancer (stage IB type I grade 3, stage I type II, stage\> IB) or with metastatic sentinel lymph node,
  * Early cervical cancer, or with metastatic sentinel lymph node,
  * Ovarian cancer.
* Must provide her signed and informed consent
* Beneficiary of a health insurance
* Having received a medical examination

Exclusion Criteria:

* Contraindication to pelvic lymphadenectomy
* Presence of lymphedema of the lower limbs
* Contraindication to radiomarkers (allergy or hypersensitivity to any component of the biomarker)
* Patient with dementia or altered mental status
* Pregnant or breast feeding patients
* Participation in any other clinical trial that could interfere with the study results
Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.

Fit for surgery is a randomized clinical trial of multimodal prehabilitation prior to colon or rectal cancer surgery. Participants will either receive

The study is a part of the PREHAB study which is performed in collaboration with international centers.

The full protocol are published BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective colorectal cancer surgery
* WHO performance status I and II
* Signed consent

Exclusion Criteria:

* Known metastatic disease
* Unable to perform baseline test or basic training e.g. paralytic or completely immobilized patients, orthopedic impairments.
* ASA 4 or 5 (American Society of Anesthesiologist Classification)
* Neoadjuvant chemo- or radiation therapy
* Renal failure III B or higher
* Illiteracy or unable to write or understand Danish
* Cognitive disabilities, which affects adherence e.g. severe dementia (MMSE score ≤17).
* Withdrawal of consent.
Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility

The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from relatives of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding clinical and laboratory data on disease characterization, treatment, and outcome; and to serve as a source of human biological samples and corresponding laboratory and clinical data.

There is no study design for this protocol. Samples obtained under IRB/IEC-approved protocols that clearly permit storage of patient material at SJCRH will be banked, provided proof of informed consent is available. Such samples will be tagged accordingly and will be only released to fulfill the aim(s) of the protocol under which they were obtained, or to investigators that apply to the St. Jude Children's Research Hospital Tissue Resources Committee to use the samples.

Eligibility Criteria:
Inclusion Criteria:

* Patients (and their relatives) and control populations treated or studied at SJCRH and SJCRH affiliates and collaborating sites that have IRB approval for TBANK with malignant and non-malignant conditions.
* Patients from institutions that do not have Institutional Review Board (IRB) approval for TBANK, and at which a banking mechanism may not be established, who provide samples for research at St. Jude and from whom consent for TBANK is obtained by the TBANK principal investigator (PI).

Exclusion Criteria:

* Patients from institutions that do not have IRB approval for TBANK, and who have not provided consent for TBANK, or patients not enrolled on SJCRH protocols that incorporate consent for tumor banking.
Seaweed-derived Rhamnan Sulfate and Vascular Function

The primary aim of the proposed investigation is to examine the hypothesis that a relatively short period of rhamnan sulfate supplementation would improve key markers of vascular dysfunction in middle-aged and older adults with at least one risk factors for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* at least one risk factor for cardiovascular disease (e.g., dyslipidemia, hypertension, obesity, impaired fasting glucose)
* a BMI of \<40 kg/m2

Exclusion Criteria:

* gastrointestinal disorders and/or renal disease
* pregnancy or lactation
* strenuous physical activity (\>3 times/week)
* alcohol abuse
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Eligible participants for this study must have had a diagnosis of probable AD and must have had clinically meaningful agitation secondary to AD.

This was to be a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment.

Approximately 380 participants were to be enrolled at approximately 60 centers in North America.

Study medication was to be administered orally twice-daily from Day 1 through Day 85. Screening was to occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were to be randomized into the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
* The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
* The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
* Either out patients or residents of an assisted-living facility or a skilled nursing home
* Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is \>= 4 (moderately ill) at screening and baseline
* Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
* Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

* Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participant with myasthenia gravis
Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥19 years old
2. Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina
3. Provision of informed consent

Exclusion Criteria:

1. Age\> 80 years
2. Increased risk of bleeding, anemia, thrombocytopenia
3. A need for oral anticoagulation therapy
4. Pregnant women or women with potential childbearing
5. Life expectancy \< 1 year
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition

Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab. Doses to be tested will be 7.5 mg, 15 mg and 30 mg subcutaneous monthly compared to placebo for six months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Stage 3-5 CKD
* hs-CRP \> 2.0 mg/L
* Comply with contraception

Exclusion Criteria:

* Low neutrophil count
* Low platelet count
* Spot urine protein to creatinine ration \> 4000 mg/g
* ALT/AST \>2.5x ULN
* TSAT \< 10%
* Positive TB test
* Evidence of HIV, hepatitis B
* Blind or illiterate
* Expected to require blood transfusion
* Thromboembolic event within 12-weeks
* Evidence of active infection
* Peptic ulcer disease, diverticulitis, inflammatory bowel disease
* Uncontrolled hypertension
* Planned coronary revascularization
* Major cardiac surgery, CHF
* Active malignancy, bone marrow or organ transplant
* Allergy to study drug
* Treatment with investigational drug, treatment with HIF stabilizer or ESA
* Use of immunosuppressive drugs, systemic antibiotics
* Breastfeeding, any other significant medical history
FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents

The purpose of this study is to find out whether an Internet-supported FeetEnergy approach and two home works integrated in three health education lessons can increase adolescents' active commuting to school and leisure-time physical activity and decrease their screen time.


Eligibility Criteria:
Inclusion Criteria:

* student's informed consent and an approval from his/her parent

Exclusion Criteria:

* no informed consent from the student and no approval from his/her parent
Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis

All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults ≥ 18 years of age.
2. Diagnosis of chronic plaque-type scalp psoriasis.
3. IGA of mild or greater (scalp only) determined at screening
4. Scalp surface area of 30% or greater determined at screening
5. Able to give written informed consent prior to performance of any study related procedures.
6. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom, diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
7. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. \<30% scalp surface area
2. Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
3. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
4. Pregnant or breast feeding, or considering becoming pregnant during the study.
5. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
6. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
7. Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
8. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
9. Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
10. Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of Baseline.
11. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or through information that is given at the baseline appointment. Participants will be randomly assigned to a group.


Eligibility Criteria:
Inclusion Criteria:

* Not currently exercising for at least 100 minutes per week
* Have a Body Mass Index (BMI) of 25 or greater
* Has a physician in one of the three participating practices

Exclusion Criteria:

* Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery

It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed supratentorial WHO grade II gliomas;
2. Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
3. Karnofsky performance score (KPS) ≥ 60;
4. No more than moderate neurologic symptoms and signs;
5. The interval between surgery and randomization is less than 12 weeks;
6. Have signed the consent form. -

Exclusion Criteria:

1. WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
2. Have received prior radiation therapy to the head and neck region;
3. Have received prior chemotherapy;
4. Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
5. Prior malignancy's disease-free survival less than 5 years;
6. Have active infection;
7. Patients are pregnant or breast-feeding. -
Effect of Peer Mentoring and Blood Pressure Self-monitoring on Hypertension Control.

Cardiovascular diseases are increasing throughout the developing world and are the cause of almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries. As more than three fourth of the global burden of cardiometabolic diseases are related to risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low physical activity, and harmful consumption of alcohol. This burden could be dramatically reduced by changing individual behaviors. This study is focused on interventions that are aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based on a Behavioral Economics approach. Most of public policies targeted to tackle Noncommunicable diseases utilize a rational economic model of behavior.

Behavioral economics, by using insights from cognitive psychology and other social sciences, has drawn a lot of attention for its potential to increase healthy behaviors. Interventions informed by Behavioral economics principles seek to rearrange the social or physical environment in such a way to 'nudge' people towards healthier choices and behaviors. This is an individual controlled randomized trial which will be conducted to assess whether the implementation of two strategies, blood pressure self-monitoring plus signing a "contract of commitment", and peer mentoring are effective to reduce blood pressure values over a period of 3 months, compared to usual care. This randomized trial will enroll 430 patients from 10 public primary care clinics in Argentina.


Eligibility Criteria:
Inclusion Criteria:

* Adults (21 years and older) who only have public health coverage, and have high blood pressure (SBP ≥140 mmHg and / or DBP ≥90 mmHg)

Exclusion Criteria:

* Pregnant women, bed-bound, and patients who cannot give informed consent.