cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis

The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male and non-pregnant female patients ≥18 years and \<65 years
* Clinical diagnosis of tinea pedis
* Positive baseline KOH
* Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)
* Patients must be able to swallow capsules intact
* Use acceptable birth control methods

Key Exclusion Criteria:

* Major organ system disease or clinical infection
* Poorly controlled diabetes mellitus
* Pregnant or lactating
* Confluent, diffuse moccasin-type tinea pedis
* Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail
* Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot
* Recent use of systemic corticosteroids or antifungal therapy
* Known(HIV)infection
* Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.
A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study，the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ)adenocarcinoma.
2. HER2 overexpression or amplification negative.
3. Female or male, 18 years of age or above.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
5. Patients who are willing and able to provide the signed informed consent form, willing and able to comply with all the scheduled visits, study treatment, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer.
2. Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic active CNS metastases ，leptomeningeal disease, and/or rapid progression.
3. Presence of uncontrolled pleural effusion or ascites despite puncture drainage within 14 days prior to randomization.
4. More than 20% weight loss within 2 months prior to randomization.
5. Diagnosed with other malignant tumors within 5 years prior to enrollment.
6. Presence of any active, known or suspected autoimmune disease.
7. Prior treatment with TGF-β inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies.
8. Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
Analysis of Current Situation and Evaluation of Trauma Treatment Training in China

This study will rely on the training course of CTCT project to conduct standardized training for trauma practitioners in China. And the quality of training will be stratified research; Continuously improve the quality of trauma treatment and improve the prognosis of trauma patients.


Eligibility Criteria:
All CTCT participants from different administrative districts of China registered for standardized and procedural CTCT curriculum . All trainees have finished the general survey of personal background, trauma care status in local hospitals and pre-training tests of trauma knowledge. After CTCT curriculum and hifidelity trauma simulation training, they were also needed to finish post-training test about the initial evaluation of various kinds of traumas. The pre- and post-training examination were constantly about trauma evaluation of major trauma patients.

Inclusion criteria: Trainees who attended on CTCT curriculum. Exclusion criteria: Rejection for supplying training information, in-completed CTCT training information, lack of pre- and/or post-training scores.
Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

The manipulation of blood pressure in acute cerebral ischemia has been a matter of debate until now. The investigators are clearly in need of more detailed data on how antihypertensive treatment affects outcome in acute phase of stroke.

This study will assess the effects of modest blood pressure (BP) lowering manipulation in acute period of ischemic stroke on death or dependency at 90-day.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patients admitted within 24 hours and can be enrolled within 48 hours after qualifying ischemic stroke onset
* Patients with systolic blood pressure above 150 mm Hg and no more than 185 mm Hg at least twice of 3 or more times at 5 minutes intervals after resting
* Baseline NIHSS score at least 2 points, not more than 21 points
* Full functional independence prior to the present stroke indicated by an estimated premorbid mRS score of 0 or 1
* Informed consent from the patients or authorized representatives must be obtained in writing enrollment into the study

Exclusion Criteria:

* Patients who received thrombolytic therapy (intravenous or intraarterial)
* Patients with acute Intracerebral hemorrhage diagnosed by neuroimaging
* Patients with moderate or severe cardiac failure (New York Heart Association class III and IV)
* Patients with medical condition which need urgent or special antihypertentive therapy, such as hypertensive encephalopathy, aortic dissection, acute renal failure, acute pulmonary edema, or acute myocardial infarction
* Comatose at screening
* Known or suspected cerebral aneurysm or arteriovenous malformation
* Any other clinical relevant serious disease, including uncontrolled Diabetes, severe liver disease, or severe renal disease at the time of randomization
* Life expectancy of less than 3 months due to comorbid conditions, such as malignancy
* Participation in another drug trials or planned use of vascular interventions within the previous 30 days
* Women who are pregnant, breast feeding, or of child bearing potentials
* Contraindication to ARBs, such as history of angioedema to ARBs, renovascular hypertension
Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade

The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap.

Silicone oil is the first choice treatment for long-term vitreous replacement in complicated cases of retinal detachment. However, it will cause various problems for permanent tamponade, such as keratopathy, glaucoma, cataracts, and silicone oil emulsification3. In addition, silicone oil has the potential to cause retinal toxicity. Moreover, the gravity and mechanical pressure of the silicone oil on the retina may influence retinal blood flow and, and the presence of silicone oil in the vitreous cavity may block the oxygen exchange between the retinal surface and the vitreous humor, resulting in the metabolic disturbance of the retina. In this study, the investigators utilized a noninvasive measurement (Oxymap, Reykjavik, Iceland) to evaluate the effect of silicone oil tamponade on oxygen saturation and diameter in retinal vessels in complicated retinal detachment cases.

Eligibility Criteria:
Inclusion Criteria:

* initial silicone oil tamponade duration of more than 3 months
* transparent reflecting media
* intraocular pressure (IOP) between 11 and 21mmHg
* complete retinal re-attachment
* healthy contralateral eye.

Exclusion Criteria:

* severe refractive media opacity (serious keratoleukoma and cataracts)
* silicone oil emulsification
* ocular hypertension
* retinal detachment
* retinal scar within the main vascular arch
* any ocular disease and any history of surgery in the contralateral eye
* any type of systemic disease
* pregnancy
Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing. CPAP is a treatment widely used in the NICU in preterm infants right after they are born to help keep their lungs open/inflated. Although the benefit of CPAP after birth has been well studied, no one knows how long a stable preterm infant should stay on CPAP. The primary outcome of this study is to compare the lung volumes in the infants at 6 months of age by pulmonary function testing who were randomized to 2 extra weeks of CPAP in the NICU versus CPAP discontinuation, usual care. During the same pulmonary function test the investigators will also measure and compare how the infant's lungs diffuse gas.

Eligibility Criteria:
Inclusion Criteria:

1. Infants born at \>24 to ≤ 32 weeks gestation
2. Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation)

Exclusion Criteria:

1. Significant congenital heart disease
2. Major malformations
3. Chromosomal anomalies
4. Culture proven sepsis at consent
5. Complex maternal medical conditions
6. Clinical instability
7. Multiple gestations \> twins
8. \<3rd or \>97th percentile for weight85
9. Participating in another neonatal randomized clinical trial with a competing outcome
10. Mother/legal guardian without stable method of communication
Bogota School Children Cohort

This observational study investigates the associations of nutritional indicators, biomarkers, sociodemographic conditions, and infections with child health, as well as physical, behavioral, and cognitive development. Investigators recruited a random sample of 3202 children from primary public schools in Bogota, Colombia in February 2006 and followed them for a median of 6.5 years. Investigators hypothesized that poor nutritional status at the time of recruitment in middle childhood would be related to adverse health outcomes through adolescence.


Eligibility Criteria:
Inclusion Criteria:

* Primary public school enrollment in February 2006

Exclusion Criteria:

* None
The Effect of Increasing Dietary Protein on the Gut Microbiome and Its Metabolites

This study will determine the effect of dietary protein not absorbed in the small intestine on the bacteria in the large intestine and the metabolites those bacteria produce when they break down the protein. The three specific goals are:

1. Determine if increasing dietary protein increases the purine breakdown product, allantoin, as observed in our previous study.
2. Establish a model to examine the effect of dietary protein on the gut microbiota and metabolites.
3. Identify gut bacteria and metabolite changes that occur with increased consumption of animal (whey) or plant (pea) protein sources.

Healthy male and female participants were recruited following specific inclusion/exclusion criteria. Participants were excluded if they 1) were less than 25 years of age, 2) consumed pre or probiotics in the last week, 3) had taken any antibiotics in the last three months, 4) were taking any prescribed medicines for a chronic disease such as diabetes, hypertension, cancer, anxiety, depression, or GI-related diseases. and 4) had taken any laxatives or antidiarrhea inhibitors in the last week. The study design was pre/post, with each person serving as their own control. Interested participants were randomly assigned to one of two study groups: 50 g whey protein supplement or 50 g pea protein supplement. They were asked to consume the supplement along with their usual dietary intake. Participants were located within the contiguous USA and were sent a fecal collection kit, the protein supplement, and a shaker bottle using overnight shipping. We used the fecal collection kit developed by the Biocollective. A fecal sample was collected before and after the participant consumed the protein supplement daily for seven days. At both time points, the participants were asked to recall the foods they ate during the previous 24 hours using ASA24-2020, provide information on their physical activity (International Physical Activity Questionnaire, IPAQ), and answer questions about the stool sample they collected. The stool sample will be analyzed for the microbes and metabolites present. These will be correlated with the dietary protein they consume.

Eligibility Criteria:
Inclusion Criteria:

* 25 years old or older
* male or female
* located in the contiguous United States

Exclusion Criteria:

* Taken any prebiotics in the last week
* Taken any probiotics in the last week
* Taken any prescription medications other than oral contraceptives
* Taken antibiotics sometime in the last three months
* Taken any diarrhea inhibitors in the last week
* Taken any laxatives in the last week
* Taken any dietary supplement(s)
* Diagnosed with cancer
* Diagnosed with an inflammatory disease of the GI tract, such as irritable bowel disease
* Experienced long-haul COVID fatigue
* Were physically inactive (\&lt;600 METS per week)
Effect of Virtual Reality Glasses in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction

This research was conducted as a randomized controlled experimental study aiming to determine the impact of virtual reality glasses used in the AVF process on the pain felt by patients and patient satisfaction.

Chronic kidney disease (CKD) is a progressive, irreversible renal disease in which the ability of the body to maintain the balance of metabolism, fluid and electrolytes fails. Chronic kidney disease (CKD) is one of the major health problems with an increasing prevalence in the World. Hemodialysis as one of the most common methods of renal replacement therapy is a stressful procedure despite to maintain the survival of patients with chronic kidney disease that permanent and safe vascular access is one of the requirements of a successful hemodialysis. The pain of AVF puncture is common among the patients undergoing HD as acute and chronic pain which reported in more than 82% and 92% of them, respectively. Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Receiving HD treatment
* Open to communication
* Fully oriented
* Without vision, hearing and perception problems
* Without any psychiatric illness
* Without a history of seizures such as epilepsy
* HD treatment administered via AVF
* İn the last day, no injection was made into any artery or vein from the place where the intervention will be performed
* Without any signs of infection such as redness, swelling, open wound in the area where the intervention will be performed
* Standardized Mini Mental Test value is 24 points and above
* One-time needle attempt from AV

Exclusion Criteria:

* Refusing to participate in the study
* under the age of 18
* Can't speak Turkish
* Closed to communication and not fully oriented
* Visual, hearing and perception problems
* Any psychiatric illness
* Having a history of seizures such as epilepsy
* HD treatment not administered via AVF
* Injection into any artery or vein from the place where the intervention will be performed in the last day,
* Any signs of infection such as redness, swelling, open wound in the area to be operated
* Using any pain medication before the procedure on the same day
* SMMT value below 24 in patients over 65 years of age
* Cannulation procedure not performed with a 16 G AVF needle
* Patients with multiple injections from the AVF
Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads

The Family Sodium Watcher program in this study is designed to improve adherence to a sodium restricted diet in patients with HF using strategies that educate both patients and family caregivers about sodium monitoring and that stress a gradual progressive adaptation to low sodium food for both patients and family caregivers.

Heart failure (HF) emerged as a significant public health threat in the 1990s and has now reached epidemic proportions. Despite advances in the medical treatment of HF, patients with HF face frequent hospitalizations for acute exacerbations. Inadequate self-care strategies, in particular non-adherence to a sodium restricted diet (SRD), is a main cause of these rehospitalizations. Prior interventions to increase adherence have focused on increasing knowledge about restricting sodium in the diet have met with limited success. Unaddressed by these interventions are the major barriers of measuring and tracking daily sodium intake, family members who continue to eat high sodium diets, and a preference for salty foods-particularly in the elderly who have a decreased sense of taste. It is possible to retrain the taste buds to enjoy low salt foods by gradually reducing the amount of sodium in foods over the course of 16 weeks. This retraining works best with direct involvement and support from family members. The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a SRD by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods.

Eligibility Criteria:
Inclusion Criteria:

Eligible patients will:

* have diagnosis of chronic HF with either preserved or reduced ejection fraction
* have a dedicated primary family caregiver
* be able to speak and write English

Eligible caregivers will:

* be a primary caregiver identified by the patient
* the spouse, committed partner, or family member living with the HF patient
* be able to speak and understand English
* have no obvious major clinical cognitive impairment that would impair ability to give informed consent
* have no major co-morbidities (i.e. HF, cancer, renal/liver failure, or uncontrolled diabetes as determined by self-report).

Exclusion Criteria:

Patients will be excluded if they have:

* major clinical cognitive impairment (i.e., dementia, Alzheimer disease, and severe stroke)
* a co-existing terminal illness (e.g., cancer)
* a referral for heart transplantation
* a dietary prescription that prevents following a 2-3 gram sodium diet (e.g., clinician does not support use of a SRD).
* no dedicated caregivers
Pathogen Identification of Bacterial Pneumonia Via DNA Detection

Pneumonia is a common cause of morbidity and mortality. The diagnosis of pneumonia from the microbiology perspective has been challenging. Recent reports suggest the utility of nuclear acid detection for rapid and accurate diagnoses of these pathogens and their antibiotic-resistant spectrum. Extracted bacterial nucleic acid in sputum specimen will be identified by Nuclear acid detection assay kit with Microfluidic Pumping Chip and LAMP methods

Sputum specimens normally collected from the patients with pneumonia for routine microbiologic testing and extra specimens will be evaluated via nuclear acid assay developed in our laboratory. The assay will be directed at variety of both pathogens, including Streptococcus pneumoniae, Hemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma pneumonia, Chlamydia pneumoniae and Legionella pneumophila, and common antibiotic-resistant genes, such as ESBLs genes, MecA, OprD. The ultimate goal is to have an available panel of highly accurate and rapid (same day) assay, which will be carried out in several hours for identification.

The extracted pathogen nucleic acid in sputum specimen will be identified by Nuclear acid detection assay with Microfluidic Pumping Chip and LAMP methods. The species of bacteria and their antibiotic-resistant gene to be detected are as listed above. As nucleic acid extracts will be archived, other pathogens can be investigated in the future if the correlated assay is developed. All results obtained by nuclear acid detection will be compared to results for conventional testing as listed above. Sensitivity, specificity and predictive values will be calculated. In cases where discordant results occur, additional testing and or medical history review will be properly conducted.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age.
* Cough present greater than one day
* History of fever
* X-ray evidence of pneumonia.

Exclusion Criteria:

* Pneumonia caused by TB, fungi and virus