cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®

The primary objective is to compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life) of using foam silver dressing (Mepilex® Ag) to a Silver sulfadiazine 1% cream (Silvadene®) from the perspective of the health care provider.

The secondary objectives are to investigate the safety, the tolerance and the performance on burn status including pain.

In- and/or out-patients at ten centers in the United States were included in this investigation. Subjects included were 5 years of age and older who suffered from partial thickness burns. Every patient was followed for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated)
* Burn of thermal origin
* Both gender with an age ≥ 5 years at randomization
* Signed informed consent
* Subjects who are younger than the legal consenting age must have a legally authorized representative

Exclusion Criteria:

* - Burns equal to or older than 36 hours
* Burns of chemical and electrical origin
* Clinically infected Burn (as judged by the investigator)
* Treatment of the burn with an active agent before study entry, SSD is allowed up to 24 hours prior to randomization
* Patients with necrotising leucocytic vasculitis or pyoderma gangrenosa.
* Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
* Patients with insulin dependent diabetes mellitus
* Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolon/day or equivalent.
* Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days.
* Known allergy/hypersensitivity to any of the components of the investigation products.
* Patients with physical and/or mental conditions that are not expected to comply with the investigation.
* Participation in other clinical investigation(s) within 1 month prior to start of the investigation
* Pregnancy
* Previously randomised to this investigation
Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI

Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.


Eligibility Criteria:
Inclusion Criteria, Breast Cancer Patient Participants:

* Females with a diagnosis of invasive non-metastatic breast cancer (stage I-IIIC)
* Scheduled to begin a course of chemotherapy with Adriamycin and Cytoxan
* Chemotherapy naïve
* Able to speak and read English
* 21 years or older
* Give written informed consent

Exclusion Criteria, Breast Cancer Patient Participants:

* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
* Must not be diagnosed with a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
* Must not have any Central Nervous System disease (e.g., movement disorder, multiple sclerosis)
* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms
* Must not be scheduled to receive concurrent radiation treatment while receiving chemotherapy.
* Must not be colorblind

Inclusion Criteria, Control Participants:

* Must be female and within 5 years of the age of the subject receiving chemotherapy
* Able to speak and read English
* Give written informed consent
* 21 years or older

Exclusion Criteria, Control Participants:

* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
* Must not be diagnosed with a neurodegenerative disease (e.g. Alzheimer's disease, Parkinson's disease)
* Must not have Central Nervous System disease (e.g., movement disorder, multiple sclerosis)
* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms
* Must not have been diagnosed with cancer or previously have received chemotherapy
* Must not be colorblind

For optional sub-study: MR safety assessed via Rochester Center for Brain Imaging Magnetic Resonance (MR) Safety Screening Form to confirm eligibility to participate
Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders

The purpose of this study is to obtain bone marrow and peripheral blood samples, along with clinical data from patients with Multiple Myeloma (MM), Waldenstrom's Macroglobulinemia (WM), Smoldering MM, and other lymphoplasmacytic lymphomas (LPL) including but not limited to MGUS and IgG or IgA LPL. These samples will become part of a tissue bank and will be used in ongoing studies to find out more about the causes and biology of MM, WM and LPL; to identify what factors result in normal cells becoming cancer; to determine how to improve treatment options; to study how the immune system identifies abnormal cells; and to evaluate the immune function in these diseases. The investigators will also study the tumor cells at the level of the participant's genes to develop treatment strategies as well as to better understand how biologic differences affect patient outcomes.

* Participants will be asked to complete a medical survey which includes demographics, diagnosis, and treatment history, medical history, lab results and symptoms experienced.
* Participants will then receive instructions for the tissue banking procedure, which involves donating bone marrow and blood samples. These will be collected only at times when necessary clinical bone marrow samples are obtained and will not require an extra visit to the doctor.
* The investigators are also requesting permission to collect medical information from the participant's record and link this information to the specimens so that we may better understand the participant's response to treatment. For samples obtained prior to beginning therapy, this information might allow us to develop new ways of predicting response to therapy. The investigators are also requesting permission to store samples of blood and bone marrow to establish a tissue bank for future research to these diseases. These samples will be de-identified; any of the participant's personal health information identifiers will be removed.
* The tumor sample may be obtained at diagnosis, during treatment and/or as the time of relapse. The timing of sample collection will coincide with other bone marrow tests required to assess the response to therapy or any other clinical purpose.

Eligibility Criteria:
Inclusion Criteria:

* Any individual diagnosed with Multiple Myeloma, Waldenstrom Macroglobulinemia, MGUS, smoldering MM or other lymphoplasmacytic lymphomas
* Signed informed consent
* 18 years of age or older
Diabetes and Depression Text Messaging Intervention

The main aim of the "Diabetes and Mental Health Adaptive Notification Tracking and Evaluation" trial (DIAMANTE) is to test a smartphone intervention that generates adaptive messaging, learning from daily patient data to personalize the timing and type of text-messages. We will compare the adaptive content to 1. a static messaging intervention with health management and educational messages and 2. a control condition that receives a weekly mood message. The primary outcomes for this aim will be improvements in physical activity at 6-month follow-up defined by daily step counts.

We utilized user-centered design (UCD) methods to iteratively develop the DIAMANTE content and text messaging system through three iterative phases of UCD with ten patients each (total n=30). The first phase consisted of 1.5-hour individual semi-structured interviews. Findings from phase 1 were used to inform content and information delivery decisions of the final intervention, including selecting the thematic message categories and the design. In the second phase, patients tested out an early prototype of the mobile application through usability testing. Patients tested the final DIAMANTE intervention including thematic message content and the application in the third, final UCD phase, in order to address any user-related issues prior to launching the randomized control trial.

In the DIAMANTE Randomized Controlled Trial, we aim to examine the effect of a smartphone app that uses reinforcement learning to predict the most effective messages for increasing physical activity. We will recruit 276 low-income minority patients with depression and diabetes within he San Francisco Health Network. We will compare this intervention to static messages with health management content, and a control group that only receives a weekly mood message.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c (Hemoglobin A1c) \> 7
* PHQ-8 (Patient Health Questionnaire-8) \> 5

Exclusion Criteria:

* high levels of physical activity (\>30 minutes of moderate to vigorous activity per day)
* pregnancy
* inability to exercise due to physical disability
* serious mental illness
* unable to read and write in English or Spanish
* plans to leave the country for extended periods of time during the trial
Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

All subjects:

* Male and female Caucasian subjects 18 to 70 years of age
* At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
* CYP2C9 wild-type (CYP2C9\*1 homozygous carriers)

Hepatic impairment:

- Subjects must have either mild, moderate or severe hepatic impairment

Exclusion Criteria:

All subjects

* Hepatic impairment due to non-liver disease.
* Use of other investigational drugs within certain timelines
* Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
* History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR \< 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles \>100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
* History of cardiac catheter ablation.
* Women of child-bearing potential
* History of malignancy of any organ system
* Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
* History or presence of symptomatic postural hypotension or syncope.
* Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count \< 30,000/μL at screening or baseline.
* Clinically significant infection or recent vaccination with live-attenuated vaccines.
* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
* History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.

Hepatic impairment:

* History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
* Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
* Treatment with certain drugs

Healthy subjects:

* History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.
Symptom Care at Home Heart Failure Pilot Study

This project aims to adapt a computer-interface telephonic interactive voice response system that monitors symptoms and provides real-time, self-management coaching messages based on heart failure patient-reported outcomes. This system has the strong potential to be widely disseminated into clinical practice leading to improved patient outcomes through better self-management behaviors.

Keeping heart failure (HF) patients at home with a low symptom burden after hospital discharge is challenging. Evidence shows that delay in HF symptom recognition and poor self-management are associated with unplanned emergency department visits and rehospitalizations. Clinical trials aimed at preventing rehospitalization using telemonitoring have shown limited utility suggesting that monitoring physical changes alone may not be sufficient to maintain stability of HF patients at home. A recent cancer study has demonstrated that patients receiving cancer chemotherapy achieved a 40% reduction in symptoms using Symptom Care at Home (SCH), a computer-interface telephonic interactive voice response system pairing patient-reported symptoms with automated real-time, self-management coaching. While a few HF studies have used interventions that monitored symptoms, no studies have tested a system that monitors and provides real-time, self-management coaching tailored to specific patient-reported outcomes(PRO). The objective of this study is to pilot an adaption of the SCH system to HF resulting in preliminary data to support a fully-powered randomized control trial to test an adapted SCH-HF system that could be widely disseminated. Specific Aims over two-parts are: Aim 1\] Tailor the real-time self-management coaching system to integrate HF symptom monitoring and self-management coaching into the SCH-HF system; and Aim 2\] Conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and preliminary efficacy of the SCH-HF system. This study is significant because it expands our understanding into HF symptom monitoring and management using PRO in the home setting. The proposal is innovative because it integrates HF clinician and patient perspectives to develop a daily home monitoring and real-time self-management coaching system.

Eligibility Criteria:
Inclusion Criteria:

* ICD-9-coded (402.01; 402.11; 402.91; 404.01; 404.03; 404.13; 404.91; 404.93; or 428.XX) or ICD-10-coded (150.1-150.9) medical diagnosis of HF
* New York Heart Association (NYHA) class I - IV
* ability to read, understand, and speak in English
* will be discharged home
* have daily access to any type of telephone

Exclusion Criteria:

* a score of 0 or 1-2 with an abnormally drawn clock on the Mini-Cog
* discharged home on hospice care
* end-stage renal failure:End-stage renal failure patients will be excluded because they receive clinical interaction with providers a few times per week while they are on hemodialysis.
* Wait list for transplant
Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by familes.


Eligibility Criteria:
Inclusion Criteria:

* Infantile hemiplegia
* Age from 9 months to 18 months.
* No use of the affected upper limb

Exclusion Criteria:

* Associated pathologies
* Epilepsy no controlled with medicins
* No collaborated families
Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration.

The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS.

Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.


Eligibility Criteria:
Inclusion Criteria (in healthy individuals):

* Age above 18 years old.
* Non-pregnant women.
* Healthy or controlled chronic diseases.
* Examination at the Oral Medicine Clinic

Inclusion Criteria (in RAS patients):

* Age above 18 years old.
* Non-pregnant women.
* Clinical diagnosis of RAS.
* Examination at the Oral Medicine Clinic

Exclusion Criteria:

* Oral lesion suspected to be malignant.
* Ulcerative oral lesion other than RAS.
* Another experimental oral intervention within the last 24 hours.
* Pregnant women.
* Allergy to components of the Pro-pe adhesive tablet
Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion

In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.


Eligibility Criteria:
Inclusion Criteria:

1. Patient's age is 18 or above
2. Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms.
3. Patient able to understand,read and sign informed consent.
4. Patient is not participating in other medical trials at present or in the past 30 days

Exclusion Criteria:

1. Age under 18 years
2. Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma
3. Subjects which their biopsy in the pre operating process will include high risk cell types:

   * Grade 3 endometrioid adenocarcinoma,
   * clear cell carcinoma
   * papillary serous carcinoma
   * carcinosarcoma
Optimizing Fidelity of Interpersonal Psychotherapy

The study is designed to develop and validate an instrument to measure quality and adherence to IPT for research and training purposes. The measure is now being used to evaluate training in IPT.

The study is a randomized trial comparing 4 different methods of follow-up training in IPT. Following initial 2-day training, participant therapists will be randomized to either individual supervision, group supervision, an internet-based training program, or autodidactic training. Participants will be followed for a year to determine their use of IPT, outcomes with patients, and adherence and quality of IPT in 4 case portfolios. The adherence measure for IPT developed in Phase I of the project is being used as the gold standard measure of IPT fidelity.

Eligibility Criteria:
Inclusion Criteria:

* Active and licensed therapist conducting psychotherapy treatment; naïve to training in IPT

Exclusion Criteria:

* Inactive or not treating patients
The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

Psychosocial risks are significant in the management of patients with cardiovascular disease and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled, clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of life in ICD patients. The specialized, real-time data, collected by the device provides a unique look at the electrophysiological parameters of each patient's heart.

All intervention data will be analyzed to determine the statistical significance of the data, and to accept or reject the hypothesis. In addition, the researcher will conduct supplemental interviews with patients who have lived with the implantable cardioverter defibrillator (ICD) device for at least six months and who are not in the intervention. The qualitative data gathered from these interviews will document concepts of illness and healing and general beliefs about mind-body interventions.

Eligibility Criteria:
Inclusion Criteria:

* Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
* Must be 18 or more years of age

Exclusion Criteria:

* Patients requiring more than 48 hours of hospitalization for implantation
* Mental Incompetence (Dementia)
* Physician's contra-indication
Biomarkers of Acrylamide, Glycidol, POPs, PFAS and Disease Outcomes and OMICs Signatures

The aim of the project is to assess the associations between biomarkers of acrylamide and glycidol exposure and disease outcomes in a case-cohort study based on two prospective cohorts with biobanks. The investigators also aim to assess the exposure-affected OMICS signatures and molecular pathways underlying disease development (specifically cardiovascular diseases such as myocardial infarction and stroke and cancer such as breast-, endometrial and colorectal cancer) for these exposures along with persistent organic pollutants (POPs) and per- and polyflouroalkyl substances (PFAS) using a prospective cohort study utilizing and integrating various 'OMICs' technologies.


Eligibility Criteria:
Inclusion Criteria:

* 60YO: Men and women of 60 years old residing in Stockholm
* SMC-C: Women residing in Uppsala

Exclusion Criteria:

* Subjects will be excluded if they had the outcome under investigation at baseline