cyrilzakka/clinical-trials huggingface dataset:
Factors to Affect the Provision of Health Data of Users Through PHR App

An experiment to determine if the incentive message affects people's active health data sharing.

Researchers send a weekly message to participants asking them to share their step data on their personal health records(PHR) applications. (4months in total)

(Baseline, 1month) For the first month, researchers send the same data request message to both counties.

1. term, 1 month) The researchers added a message saying, 'Incentives are provided for data sharing' only to the experimental group.
2. term, 1 month) Excludes incentive message for both groups
3. term, 1 month) The researchers added a message saying, 'Incentives are provided for data sharing' only to the control group.

   * For equity in both groups, an incentive message was provided to the control group in the last month under the same conditions as the experimental group.
   * Only the first 3 months of data were used for the study.

Hypothesis

* In 1-term, the number of data sharing in the experimental group is higher than that in the control group.
* In 1-term, the number of data sharing in the experimental group is more active than baseline period.
* In 2-term, the number of data sharing in the experimental group is still higher than in the baseline period.
* Over the next 1 month, the number of sharing in the experimental group was maintained, which was still higher than that of the control group.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 to 70
* A person who has no difficulty in installing and using PHR app under study
* A person who has expressed his/her willingness to participate voluntarily

Exclusion Criteria:

* Children/Adolescents under the age of 18 or Seniors over 71 years of age
* Those who do not have a smartphone or who are not proficient in using a smartphone
* Persons who are uncooperative and difficult to understand the research method due to cognitive decline
Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...

The investigators have shown that sleep health education and sleep disorders screening improve health and safety of employees. There is potential to increase the benefits of the sleep health education and screening program if more firefighters are evaluated, diagnosed and referred for treatment. Investigators will evaluate whether firefighters in stations randomized to participate in the Sleep Health and Education Program (SHEP) intervention will have improved health and safety outcomes as compared to firefighters in stations randomized to the control condition.


Eligibility Criteria:
Inclusion Criteria:

* Firefighters working in one of the two fire departments selected for study

Exclusion Criteria:

* None
Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia

This clinical trial studies bioelectrical impedance measurement for predicting treatment outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as bioelectrical impedance measurement, may help predict a patient's response to treatment for acute leukemia.

PRIMARY OBJECTIVES:

I: To determine the feasibility of obtaining standardized phase angle measurements (bioelectrical impedance measurement) on patients hospitalized for treatment of newly diagnosed acute leukemia.

II. To evaluate the association between standardized phase angle measured at the start of therapy and treatment-related outcomes including treatment related mortality (defined as 60-day mortality) III. Evaluate the association of the day 14 standardized phase angle and treatment related outcomes, 30-day mortality, length of hospitalization, transfer to intensive care unit during induction, treatment response (14 day bone marrow response, complete remission), receipt of post-remission therapy, overall survival.

IV. An exploratory analysis investigating associations with the primary and secondary outcomes using different ways to categorize the baseline standardized phase angle and, for acute myeloid leukemia (AML) patients, the standardized phase angle measure obtained just prior to the nadir marrow.

OUTLINE:

Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, peripherally inserted central catheter \[PICC\] line placement, etc.).

After completion of study treatment, patients are followed up for two years.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for newly diagnosed acute leukemia
* Receiving induction treatment while hospitalized
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of a pacemaker or defibrillator
* Patients pregnant at the time of enrollment
* Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
* Unable/unwilling to follow protocol requirements
Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria

This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen administration supplemented with dehydroepiandrosterone sulfate against drug-resistant malaria.

Worldwide progression of Plasmodium falciparum chloroquine (CQ), amodiaquine and sulfadoxine-pyrimethamine resistance leaves few alternative for the control of malaria, particularly in Africa. For some strains of P. falciparum and P. berghei, the resistance to CQ and AQ is linked to an increase in reduced glutathione (GSH) levels and GSH-related enzyme activity, such as glucose 6-phosphate deshydrogenase (G6PD). The pro-hormone dehydroepiandrosterone sulphate can be used to potentiate the antimalarial action of CQ on drug resistant P. falciparum strains, by inhibiting parasite G6PD activity. This hormone has a second advantage: it is metabolised in human into a series of potent immunomodulatory steroids which may be in the causal pathway that allowed the induction of protective immune responses against several infections, included malaria. This first study evaluated the tolerance and efficacy of a standard CQ regimen supplemented with dehydroepiandrosterone sulphate for the treatment of drug resistant uncomplicated falciparum malaria.

Eligibility Criteria:
Inclusion Criteria:

* signing an informed consent (informed consent was given by legal guardian for children);
* age egal or more than 15 years;
* fever (axillary temperature egal or more than 37.5 °C and less than 40°C) or a history of fever within the last 24 hours;
* no sign suggestive of other febrile illness;
* absence of signs of complicated malaria (WHO criteria);
* willingness to participate in follow-up for 14 days
* a positive thick blood film for P. falciparum without other detectable infectious microorganisms

Exclusion Criteria:

* patients taking glucocorticoids or other immuno-suppressive drugs, or indicating recent antimalarial drug history (verbal questionnaire);
* severe malaria;
* mixed infections;
* women using contraceptives;
* pregnant women;
* breast-feeding women.
A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa

The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio.

The study will comprise:

1. A Screening Period which will last up to 28 days.
2. A Treatment Period up to 16 weeks.
3. A Follow-up period of 6 weeks after the last dose of study drug.

The maximum clinical trial duration for each participant is 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening.
2. At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3.

Exclusion Criteria:

1. Has a draining fistula count of ≥ 20.
2. Has another active skin inflammatory condition, infection (viral, bacterial, or fungal), or another active ongoing inflammatory disease (other than HS) that requires treatment with a prohibited medication, which could interfere with the assessment of HS.
3. History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic lung infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers (not related to HS).
4. Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.
Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement

An alternate perioperative pain control protocol composed of intravenous ketorolac and oral acetaminophen for patients who underwent total knee replacement was designed with the aim to determine its efficacy when compared to pain control with intravenous morphine and oral oxycodone combined with acetaminophen. In addition, the study will evaluate the differences and similarities in the Hispanic population that could predict protocol efficacy.

Acute pain after a surgical procedure may occur secondary to trauma from the procedure itself or from procedure-related complications. Appropriate peri-operative acute pain management is an important phase of patient's recovery since it's under-treatment can lead to adverse outcomes such as: thromboembolic and pulmonary complications, additional time spent in an intensive care unit or hospital, hospital readmission for further pain management, needless suffering, impairment of health-related quality of life, and development of chronic pain. Furthermore, it's over-treatment with opioid medications is associated with an increased risk of thromboembolic, infectious and gastrointestinal complications as well as increased length of hospital stay, cost of care and risk of opioid addiction.

Perioperative administration of intravenous (IV) non steroidal anti-inflammatory drugs (NSAID), such as ketorolac, has been shown to effectively decrease opioid requirements and pain levels while demonstrating tolerable side effects. Its use after total knee replacement has been associated with a 27% decrease in the use of morphine. When NSAID is combined with acetaminophen 1000mg every six hours, an additional benefit in terms of improved pain scores on post-operative day three was shown in patients who underwent total hip or knee arthroplasty. Therefore, the purpose of this study is to provide an effective alternative for pain management in Hispanic patients who underwent total knee replacement and evaluate the role of ketorolac and acetaminophen.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic American patients undergoing primary total knee arthroplasty
* Older than 21 years of age
* Classified with an American Society of Anesthesiologist Classification (ASA) of I or II.

Exclusion Criteria:

* Hypersensitivity to any components of analgesic drugs
* Impaired renal, cardiac, or hepatic function
* Baseline serum creatinine level higher than 1.2mg/dL
* History of gastrointestinal bleeding
* Neuromuscular deformities
* Inability to consent
Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury

Traumatic brain injury (TBI) is a leading cause of death and disability around the world. The social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1 billion per year in Canada- $650 million in care and $580 million in lost productivity. Novel interventions aimed at TBI-linked molecular targets have been successful in limiting injury and improving neurologic recovery in animal models, thus providing compelling evidence that effective intervention is possible after injury. This study proposes to investigate traumatic microvascular injury (TMI) and specifically blood-brain barrier dysfunction (BBBD) as a candidate biomarker and therapeutic target in TBI.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 85 inclusive
* Clinically diagnosed TBI or evidence of TBI
* For mild TBI, as defined by the American Congress on Rehabilitation Medicine (1993), clear evidence and/or documentation of blunt head injury and any one of the following:

  * any loss of consciousness up to 30 min
  * any loss of memory for events immediately before or after the injury as much as 24 h
  * any alteration of mental state at the time of the injury
  * focal neurologic deficits that might or might not be transient

but where the severity of the injury does not exceed oss of consciousness exceeding 30 min, posttraumatic amnesia longer than 24 h, a Glasgow Coma Scale score falling below 13 after 30 min.

* For moderate TBI (GCS 9-12) and severe TBI (GCS 4-8) CT evidence of TBI-linked abnormality (intracranial lesion including traumatic SAH, contusion, extra-axial hematoma). For patients who are intubated, use best documented GCS within first 48 hours of injury.
* Stable respiratory or hemodynamic status allowing MRI within 2-4 days of TBI as determined by the attending physician
* Patient or substitute decision maker can provide consent

Exclusion Criteria:

* Pre-existing known neurologic, psychiatric disease (dementia, prior severe TBI, schizophrenia, uncontrolled epilepsy, major depressive disorder, stroke, multiple sclerosis, brain tumor)
* Serious infection, complications (sepsis, multilobe pneumonia, etc.) \< 4 days after TBI
* Acute ischemic heart disease (MI or unstable angina)
* SBP \< 100 mm Hg, DBP \< 60 mm Hg
* MRI contraindications; patient has metal implant, pacemaker, biostimulator, neurostimulator, internal defibrillator, history of metal in eye, inner ear implant, cerebral aneurism clip, joint replacement, any known metal in their body, or are pregnant or breast feeding
* History or evidence of active malignancy
* History or evidence of serious kidney (GFR =\<60) , heart, or liver disease
* Pregnant or breast-feeding women
* Inability to complete follow up visits (e.g. tourists)
Beliefs and Attitudes for Successful Implementation in Schools (BASIS)

The goal of this study is to adapt and test the feasibility and potential efficacy of a theory-driven pre-implementation intervention to address individual-level barriers to EBP implementation - Beliefs and Attitudes for Successful Implementation in Schools (BASIS) - designed to improve school mental health providers' implementation of EBPs. BASIS is intended to be a feasible and scalable first-line or adjunctive implementation enhancement intervention that is facilitative of other efforts (e.g., organizational interventions) that target high quality EBP implementation. Aims of this study are to: (1) Adapt an existing, theory-driven implementation intervention (BASIS), previously used with educators, to improve the EBP implementation behaviors of school mental health providers; and (2) Assess the viability of a later clinical trial by: (a) establishing the feasibility, acceptability, and appropriateness of the BASIS intervention among school mental health providers, and (b) Pilot testing BASIS, as compared to an Attention Control, delivered as pre-implementation intervention prior to training in a specific, existing EBP. Key organizational factors (e.g., implementation climate) will also be evaluated and included as covariates and we will explore trends in the data to inform the design of a larger trial. Ultimately, BASIS offers an innovative and scalable approach to improving school mental health providers' uptake and use of EBPs in order to increase the number of youth with mental health problems who receive high quality services.


Eligibility Criteria:
Inclusion:

School mental health providers (school psychologists, school social workers, etc.) recruited from middle and high schools in two economically and ethnically diverse districts in the Seattle area.
The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies

The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.

The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.This study was planned as randomized controlled experimental single-blind.

The population of the research will be 2-6 months old babies who come to Giresun Güce District State Hospital Family Health Center to receive DaBT-IPA-Hib vaccine between the dates of the research. The sample of the study will consist of infants who met the case selection criteria, accepted to participate in the study and were vaccinated between the specified dates.

As a result of the power analysis, it was determined that a total of 99 infants, 33 of whom were to be applied cold massage, 33 to be administered ShotBlocker©, and 33 to the control group, who were 2-6 months old to be administered DaBT-IPA-Hib vaccine, met the case selection criteria and agreed to participate in the study. Considering the possibility of case losses, a total of 108 babies, 36 in each group, are planned to be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* The baby is 2-6 months old,
* DaBT- IPA- Hib vaccine will be administered,
* The baby does not have a chronic disease,
* Parents must be at least primary school graduate,
* Parent's willingness to participate in the study.

Exclusion Criteria:

* Having a congenital or neurological health problem,
* Have taken an analgesic drug in the last 4 hours,
* Babies with a body temperature above 37.5 will not be included in the study.
BM Collection From NICU Infants for Composition

The primary objective of this study is to collect feces from premature infants over a five weeks period to characterize its composition. Metabolomics, Proteomics, Genomics and Microbiome analyses and cell-based assays will be performed to identify individual components present in feces, which may contribute to the onset of irritation in the diapered area of premature infants.


Eligibility Criteria:
Inclusion Criteria:

* Infant's parent(s)/legal guardian(s) must be fluent in English or Spanish, willing and able to read, understand, and sign the informed consent form (ICF).
* Infants (male or female) who are equal or less than a gestational age of 30 weeks + 4 days.

Exclusion Criteria:

* Any medical condition which, in the opinion of the principal investigator, may compromise infant's safety.
* Any underlying chronic skin conditions. However, infants may participate in the study with a rash in the diapered area if, in the opinion of the principal investigator, this does not compromise infant's safety.
Actinic Keratoses Treatment With Metvix® in Combination With Light

The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in subjects with mild actinic keratoses (intra-individual comparison)


Eligibility Criteria:
Inclusion Criteria:

* Male or female above 18 years;
* Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria:

* Subject with clinical diagnosis of at least one severe AK on TAs
* Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
* Subject with pigmented AK on the TAs
The Effect of Pain Neuroscience Education and Behavioural Graded Activity on Chronic Pain in Breast Cancer Survivors

Chronic pain in breast cancer survivors (BCS) is of considerable concern as it impacts the health-related quality of life (HRQoL) and activities of daily living negatively. Over the past decades, awareness has raised the value of pain neuroscience education (PNE) in chronic pain. However, pain education remains underused in oncology and is often restricted to a biomedical management, which falls short in explaining persistent pain following cancer. Since PNE alone has rather small effect sizes, it should ideally be combined with a physical part, 'behavioural graded activity' (BGA). Therefore, the purpose of this study is to investigate the effectiveness of PNE with BGA compared to usual care on chronic pain in BCS.

A multi-centre, parallel, two-arm, double-blinded superiority with a three months intervention and two years follow-up will be conducted in 200 BCS with chronic pain. These will be randomly assigned to the intervention or usual care group. The intervention group will receive 6 sessions, in which PNE and BGA will be integrated. Whereas, the usual care group will receive an information leaflet regarding "Pain in and after cancer".

The primary objective of the present study is to examine whether the combination of PNE and BGA has an added value in decreasing the pain intensity compared to the usual care in BCS with chronic pain. The secondary objectives are to investigate whether the combination of PNE and BGA has the ability to reduce endogenous hyperalgesia and improve HRQoL compared to the usual care in BCS with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* To meet the definition introduced by the National Cancer Institute's Office of Cancer Survivorship, in which a cancer survivor is a patient with a history of cancer that is beyond the acute diagnosis and treatment phase. Patients need to be cancer-free and should have finished their primary treatment with a curative intent for at least 3 months prior to study participation. Adjuvant hormonal therapy and immunotherapy form the exception to the rule and are tolerated.
* To report a pain severity of at least 3 out of 10 on pain visual analogue scale.
* To be able to speak and read in Dutch in order to give informed consent and to complete the assessment tools. Written and signed consent will be obtained from all participants.

Exclusion Criteria:

* Suffering from dementia or cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score \<23/30).
* Suffering from severe psychological or psychiatric diseases.
* Diagnosis of new neoplasms or metastases.
The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)

The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).


Eligibility Criteria:
Inclusion Criteria:

* Participant is 18 to 36 months of age
* Participant's current weight and height within the 10th to 90th percentiles
* Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis
* Participant lives at home with parent(s) or other family member(s)
* Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI)

Exclusion Criteria:

* Participant who is receiving any breast milk at time of randomization
* Participant with an active infection.
* Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant.
* Known or suspected intolerance to cow's milk protein
* Participant diagnosed with diabetes
* Participant is from a multiple birth and the sibling(s) are still living
* Participant with a sibling that has participated in this study.