cyrilzakka/clinical-trials huggingface dataset:
PILI 'Āina Household

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and household levels compared to a Diabetes Prevention Program Lifestyle Intervention only group. The investigators will enroll 180 Native Hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (Type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). These index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month PILI Aina intervention or to a control group. Data collection will occur at baseline and 3, 9, and 12 months. Other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ (looking for older adults)
* Native Hawaiian resident in a participating homestead
* Overweight or obese (BMI ≥ 25 kg/m\^2)
* Prior diagnosis of T2D or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)
* Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week
* Willing and able to participate in all aspects of the individual and household-level intervention
* Fluent in written and spoken English

Exclusion Criteria:

* No children
* Pregnancy
* Serious illness such as cancer or chronic pain that may contraindicate full participation
Effect of Riociguat on Bone Metabolism

Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.

Clinical pharmacology

Eligibility Criteria:
Inclusion Criteria:

* Healthy male white subjects
* 18 to 45 years of age
* BMI between 18 and 28 kg/m2
* Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period

Exclusion Criteria:

* Relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis
* Resting heart rate in the awake subject below 45 BPM or above 90 BPM
* Systolic blood pressure below 100 mmHg or above 145 mmHg
* Diastolic blood pressure above 95 mmHg
* Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for males
* History of genetic muscle or bone disease of any kind
* Completely sedentary or extremely fit subjects
* Fractures in the preceding 12 months
* Psychiatric diseases
* History of peptic ulcers or relevant gastro-esophageal reflux disease
* Subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents
* Regular daily consumption of more than half a liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form, more than 1 L of xanthine-containing beverages, recent smoking history
* Use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine
* Subjects with a medical disorder, condition or history of such that would have impaired the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
The Observation About the Effects of Internal Carotid Artery Stenosis on Fundus Vessels and the Changes of Fundus Vessels After Interventional Therapy

The investigators plan to collect 30 participants with internal carotid artery stenosis to observed the relationship between the degree of internal carotid artery stenosis and fundus vessels （and blood flow）density before operation, and compared with participants without internal carotid artery stenosis.The fundus blood flow density will be observed after intervention operation in order to see whether the operation is effective to improve the density of fundus vessels and blood flow or not.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been diagnosed with carotid artery stenosis and need surgery;
2. Patients whose vision won't get worse soon;
3. Patients have not had any eye surgeries;
4. Patients with complete profile.

Exclusion Criteria:

1. Patients with severe systemic disease;
2. Patients with poor dioptric stroma;
3. Patients with nystagmus;
4. Patients with incomplete profile.
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 17 - 75 years of age
* Sustained recent, painful unilateral mild to moderate ankle sprain
* Meet baseline pain criterion

Exclusion Criteria:

* Open wound or infection at site of injury
* Evidence of severe injury or ankle fracture
* Use of oral NSAIDs or opioids within 12 - 24 hours of injury
* Presence or history of peptic ulcers or GI bleeding
* A history of intolerance to NSAIDs, acetaminophen, adhesives
* Positive pregnancy test
* Positive drug screen
A Self-Management Energy Conservation Program for Cancer-Related Fatigue

The purpose of this pilot study is to examine a 12-week self-management energy conservation program (ECAM)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and depression, self-efficacy, and beliefs about fatigue in a group of Thai women with breast cancer who are undergoing chemotherapy. We will also evaluate how well women like the intervention, how easy it is to use and whether women will do the activities.

Cancer-related fatigue is a distressing and multidimensional symptom. Research in the US has explored the efficacy of energy conservation interventions for fatigue and related symptoms but no previous ECAM programs have been tested in Thailand.

Eligibility Criteria:
Inclusion Criteria:

* Thai women are age 18 or older; are diagnosed with stage I-III breast cancer; are scheduled to receive at least four cycles of chemotherapy given in 21-day-intervals; report at least 4 out of 10 or higher on a fatigue scale in the past month; are able to read and write in Thai and can be contacted by telephone.

Exclusion Criteria:

* Thai women have a history of severe psychiatric illness, or have other illnesses that could be responsible for the fatigue other than cancer such as iron deficiency anemia, multiple sclerosis, congestive heart failure, chronic fatigue syndrome or fibromyalgia. With regard to anemia, women must have a certain hemoglobin in the normal range at baseline. They also cannot have acute or chronic bone, joint, or muscular abnormalities that would increase the risk of falls and injury. Women scheduled to receive concurrent radiation therapy are not eligible.
Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence. Very often, the figures put forward are underestimated. Improving the knowledge of these situations would make it possible to develop targeted primary and secondary prevention programs. In this study, is proposed an innovative method of exploiting existing national databases, the PMSI and SNIIRAM, with the aim of 1) approaching an order of magnitude of the frequency of physical abuse in children and 2) evaluating its contexts and consequences. The PMSI is a high-quality database that has been used for many years for medical research purposes. It provides a large amount of epidemiological information and can be used to create cohorts large enough to detect rare events. The SNIIRAM/EGB data allows the recovery of all data on reimbursed consumption, such as drug treatments, biological examinations carried out or consultations (with general practitioners or specialists).


Eligibility Criteria:
Inclusion Criteria:

* All children aged 0 to 5 years hospitalized in France between 2007 and 2014.
* Based on ICD-10 codes generated within the PMSI, 3 groups of children were defined:

  1. those with at least one code dedicated to physical abuse,
  2. those with at least one code or "combination of codes" suspected of physical abuse, and
  3. all other hospitalized children, control group.

Exclusion Criteria: NA
An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses

This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 and older
* Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:

  * Crystalens
  * Crysalens HD
  * Tecnis One monofocal
* Patients must have a healthy cornea and macula
* Patients must have 20/25 or better best corrected vision
* Able to provide written informed consent

Exclusion Criteria:

* BCVA of less than 20/25
* On oral medications that could potentially block accommodation:

  * First generation antihistamines
  * Anticholinergic agents
  * Anti-psychotic medications
  * Antidepressant medications
Clinical Frailty Assessment and Postoperative Adverse Outcomes and Quality of Life in Elderly Patients

The frailty index may represent a useful decision support tool to optimize modifiable drivers of the quality and cost of digestive surgery care. However, classical indices are cumbersome to compute and often require unavailable data. The number of operations in the elderly is gradually increasing, and the prevention and treatment of adverse postoperative outcomes has become the focus of clinical attention. More recently, clinicians have focused more on the association between frailty and adverse postoperative outcomes, but this has not been rigorously applied to long-term prospective studies in older patients.

As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Advanced age and comorbid diseases render the elderly at increased risk of postoperative morbidity and mortality. The incidence of postoperative complications is twice as non-elderly patients, and mortality rates are five times higher than non elderly patients. Thus, it is a significant challenge to safely and stably ensure the elderly in an optimal perioperative period.

Elderly patients continue to pose a major threat to the world's rapidly ageing population due to high rates of surgery and postoperative complications in elderly patients. Therefore, optimizing perioperative management strategies for elderly patients remains one of the biggest challenges facing clinicians.

Frailty is a multidimensional clinical syndrome characterized by vulnerability to dependence and increased mortality when exposed to stressors. It is often clinically described as a lack of physiological reserve, manifested as a loss of physical ability, metabolic function, and cognitive abilities. A systematic review of studies of patients in general surgery reported that the prevalence of prefrailty was estimated to be between 11.3% and 45.8%, while the prevalence of frailty was estimated to be between 10.4% and 37.0%.

Although clinicians or relatives may be aware of frailty, there is currently no standardized clinical gold-standard assessment tool to widely use and quantify frailty.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric surgical patients ≥65 years old
* non-selective cardiac surgery

Exclusion Criteria:

* Missing or incomplete patient follow-up records
* ASA degree V
* Delirium before surgery
* Patient refused to enroll
Pain After Cesarean Section - A Danish Multicenter Cohort Study.

Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and found that 45% of 861 patients had experienced very severe pain during recovery.

This result was surprisingly high but also unspecific. Therefore, the investigators aim to investigate the intensity of pain experienced by patients at specific time intervals after the cesarean section e.g., every 6th hour. Additionally, the investigators will examine whether the pain has an impact on important functions for both the patients and the newborns, as well as assess the overall morphine consumption.

All Danish regions have approved the REDCap database as a secure way to collect and store data. REDCap can also send encrypted links that can be converted into SMS messages sent to the participants' mobile phones at fixed intervals, allowing participants to enter data directly into the secure system. The investigators also aim to feasibility test the system.

When a child is delivered by cesarean section, it is an expectation that the mother can take care of herself and the baby a few hours after the surgery. However, severe pain can hinder this. Therefore, it is important to investigate whether pain relief for our patients is sufficient.

Based on response rates and the frequency of outcomes, data from this observational study can support the design of a future national multicenter randomized controlled trial (RCT) with a focus on postoperative pain intervention. The incidences of binary outcome measures and standard deviations of continuous outcome measures will support the sample size calculations for our RCT.


Eligibility Criteria:
Inclusion Criteria Patients who undergo planned cesarean section under spinal anesthesia. Patients must be able to answer a Danish questionnaire via SMS on their phone and provide consent.

Exclusion Criteria:

Age \< 18 years
Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

This laboratory study is looking into genes in samples from younger patients with acute megakaryoblastic leukemia (AMKL). Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Cryopreserved mRNA Study Population Description: Samples from AAML0531 Sampling Method: Non-Probability Sample

OBJECTIVES:

I. To determine whether NUP98/JARID1A expression is a recurrent translocation in NUP98-rearranged cases in pediatric acute megakaryoblastic leukemia (AMKL).

II. To screen the Children Oncology Group (COG) samples for genetic aberrations in pediatric AMKL.

OUTLINE:

Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or mixed-lineage leukemia (MLL)-rearrangements, and other gene expression profiling by reverse transcriptase polymerase chain reaction (RT-PCR) and karyotyping or fluorescence in situ hybridization (FISH). Results are then compared with each patient's outcome data.

Eligibility Criteria:
Inclusion Criteria:

* Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia
Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD

This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined.

This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. The primary endpoint was the incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection

Eligibility Criteria:
Inclusion Criteria:

1. Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation.
2. Patients who receive Posaconazole tablet as primary prophylaxis of invasive fungal disease.
3. Patients developing or developed acute gastrointestinal GVHD which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors.

   Gastrointestinal GVHD grades (I-IV) were recorded according to the Glucksberg criteria.
4. Patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent

Exclusion Criteria:

1. refuse to enroll
2. patients have known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study medication used.
3. pregnant or lactating females
4. take drugs known to interfere with azole antifungal agents, including terfenadine, cisapride and ebastine, within 24h before Posaconazole application; astemizole at enrollment or within 10 days before Posaconazole application; or cimetidine, rifampin, carbamazepine, phenytoin, rifamycin, barbiturates, isoniazid, catharanthine and anthracyclines within 24 h before Posaconazole application
5. have an ECG with a prolonged QTc interval (QTc greater than 500 ms);
6. have severe renal insufficiency, alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin levels more than two-times the upper limit of normal;
7. patients are expected to survive no more than 72 h;
8. Those with evidence of active fungal infection within 3 weeks prior to enrollment
Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen

The purpose of this study is to compare the preoxygenation efficacy of tidal volume breathing and vital capacity breathing.


Eligibility Criteria:
Inclusion Criteria:

-Adult patients 20 years of age or older who are planning to undergo surgery under general anesthesia

Exclusion Criteria:

-basal skull fracture, 2번 - facial anomaly, 3번 - consciousness disorder, 4번 - Risk of aspiration
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:

1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.
3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be in atrial fibrillation confirmed by 12 lead EKG.
* blood pressure \> 90 mmHg
* Patient without cardiopulmonary symptoms
* 18+ years of age

Exclusion Criteria:

* Contraindiction to warfarin
* Recent (within 6 months) MI or cardiac revascularization
* Recent (within 6 months) CVA or TIA
* NYHA Class IV CHF
* Active thyroid disease
* Major hepatic dysfunction
* Renal dysfunction (\>2 mg/dL)
* Hyperkalemia (\>4.6 mEq/L)
* Hyponatremia (\<130 mEq/L)
* Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug
* History of ARB intolerance
* Contraindication to ARB therapy
* Pregnancy
* Female of childbearing age
* Age \< 18 years of age
* Inability to give informed consent
* Other medical conditions calling 1 year survival into question