cyrilzakka/clinical-trials huggingface dataset:
Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure

The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.

Udenafil (Zydena), a newly developed PDE-5 inhibitor, has been proved to have similar efficacy and safety profile, compared with other PDE-5 inhibitors. Also, laboratory data showed that udenafil inhibits ventricular hypertrophy and fibrosis in rat heart failure model. Based on these results, the investigators hypothesized that udenafil would improve symptom, exercise capacity and hemodynamic status in patients with systolic heart failure. In this 12-week, randomized, double-blind, placebo-controlled trial, patients with systolic heart failure will be enrolled according to the eligibility criteria. After randomization, study participants will be assigned to receive either 50mg of udenafil or placebo two times a day for 4 weeks, and then the dosage will be doubled to 100mg two times a day for next 8 weeks. Participants will attend study visits at baseline and weeks 4 and 12. Physical examination, medical history review, blood sample collection and electrocardiogram will be conducted on each study visits. At baseline and week 12, participants will undergo cardiopulmonary exercise test and exercise echocardiography. At every study visits,researchers will collect health information.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age, LV EF \< 40%

Exclusion Criteria:

* long-term use of medications that inhibit cytochrome P450 3A4.
* inability patients with exercise test
* primary pulmonary artery hypertension
* severe hypotension (\< 90/50mmHg) or severe hypertension (\> 170/100mmHg)
Vaccine Therapy for Patients With Stage III Melanoma

This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.


Eligibility Criteria:
* Must have Stage III melanoma
* Must have had all clinically-detectable disease surgically removed
* Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
* Cannot have HIV or Hepatitis A, B, or C
Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus

Objective: evaluation of effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus Outline: Among the patients with type 1 diabetes, the group with telemedicine and education using smartphone set as a experimental group and the group without those set as a control group, respectively.

Sample size: experimental group (n=50), control group (n=50) Inclusion criteria: patients with type 1 diabetes with A1c\>8.0% Exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics Method: We divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. We perform telemedicine and education with smartphone application to the experimental group every 2 weeks. We evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking A1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research.

Variables: A1c, satisfaction, knowledge, self-confidence, willing to continuing, quality of life, physical activity, drinking, smoking Primary endpoint: Improvement in HbA1c of experimental group Secondary endpoint: No improvement in HbA1c of control group


Eligibility Criteria:
Inclusion Criteria:

a. patients aged under 30 with type 1 diabetes b. patients who control glucose level with multiple daily injection of insulin pump c. Patients who agree the task to check glucose level during the experiment d. patients who has been diagnosed as type 1 diabetes more than 3 months e. patients whose A1c more than 8.0% within 6 months f. Patients who can use smartphone all day 2) exclusion criteria

1. chronic disease (except thyroid disorders with euthyroidism), psychological disease
2. Patients aged under 12 whose parents have psychological disease
3. Patients who cannot use smartphone app properly
4. athletics
5. Patients who use continuous glucose monitoring

Exclusion Criteria:

-
Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

This is a phase 1/2a study in dentin hypersensitivity patients to assess the safety, tolerability, efficacy and pharmacokinetics of single and multiple doses of KH001.


Eligibility Criteria:
\[Inclusion criteria\]

1. Subjects must be fully aware of the purpose and the content of the study, and the characteristics of the Investigational Product to sign written consent of their free will to take part in the study;
2. Subjects having at least 20 natural teeth and two teeth that could be assessed
3. Subjects is diagnosed with dentin hypersensitivity, has experienced dental symptoms of two or more teeth

\[Exclusion criteria\]

1. Subjects is allergic to the active substance or other excipients used in the Investigational Product
2. Subjects has any history of clinically significant allergy, such as drug allergy, asthma, eczema, or anaphylaxis
3. Subjects has any disease related to dentin hypersensitivity
4. Subjects taking anti-inflammatory analgesic drugs
Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural

As the dural puncture epidural (DPE) is increasing in popularity for labor analgesia, it is important to understand how it impacts outcomes in parturients. Prior studies have found epidural catheters placed via the combined-spinal epidural technique have greater success at surgical conversion for cesarean delivery than catheters placed via traditional techniques. The investigators aim to determine if epidural catheters placed by a DPE technique will also have an increased successful conversion for surgical anesthesia by conducting a retrospective review of all CD during the study period. If an association is found, this could be another benefit of DPE for labor analgesia.

Electronic medical records will be searched for all intrapartum cesarean deliveries performed from February 1, 2017 through May 30, 2021 (Mayo Clinic) and from January 1, 2022 to December 31, 2022 (BC Women's Hospital).

From this list, patients that had cesarean delivery with an epidural catheter will be identified and split into three groups based on the type of neuraxial block listed in the block document of the patient's medical record:

Group 1 - Dural puncture epidural Group 2 - Epidural Group 3 - Combined spinal-epidural

Failure of epidural catheter conversion to surgical anesthesia at cesarean delivery will be defined by requirement of a second anesthetic at the time of surgery, including spinal or repeat epidural techniques or general anesthesia at the time of cesarean delivery

Data Collection: All data will be collected retrospectively from the electronic medical record.

1. Type of neuraxial block
2. Size of needle used for DPE or CSE: 25 g or 27 g
3. Duration of time from epidural placement until CD (Time of epidural placement; time of delivery)
4. Number of epidural top-ups
5. Type and amount of medication used for conversion to surgical anesthesia
6. Urgency of cesarean delivery
7. Airway documentation indicative of general anesthesia (if applicable)
8. Length (time) of surgical procedure

Other data collected from patient electronic records will include:

1. Maternal demographics: Parity, number of prior cesarean deliveries, weight, height, BMI
2. Fetal characteristics (birthweight, Apgar scores)
3. Indication for cesarean delivery

   1. Fetal distress (NRFHT, fetal intolerance of labor)
   2. Failure of labor (Failure to dilate, failure to descend)
   3. Failed operative vaginal delivery
   4. Maternal comorbidity
   5. Emergency (cord prolapse, abruption, uterine rupture)
4. Anesthesiologist (Fellowship trained: Y/N) at time of cesarean delivery

Eligibility Criteria:
Inclusion Criteria:

1. Women with neuraxial labor analgesia (CSE, DPE, or Epidural) who have an intrapartum cesarean delivery
2. Singleton gestation

Exclusion Criteria:

1. No local anesthetic given in epidural for cesarean delivery (in emergency situation)
2. Inadvertent dural puncture
New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

The purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A.

The clinical study was conducted on the basis of the Voronezh city specialized Center for the treatment of patients with gastrointestinal bleeding. The study included 112 patients with ulcerative gastroduodenal bleeding. All patients were divided into two groups by random sampling: the main group (n=57 people) and the comparison group (n=55 people). In the treatment of patients of the main group (57 people), an individual approach was used with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, in the complex endoscopic treatment of bleeding-complicated gastroduodenal ulcers (Patent Russian Federation (RF) № 2632771). In the comparison group (55 people), traditional methods of endoscopic hemostasis were used.

Eligibility Criteria:
Inclusion Criteria:

* Gastroduodenal ulcers with bleeding

Exclusion Criteria:

* Bleedings of other etiology
Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Patients will be randomized to one of the following FDA-cleared devices that will be used to assess the workflow impact of fast identification (ID) and antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients: 1) Standard culture and AST of positive blood culture bottles plus the Verigene® Blood Culture Gram-positive/Gram-negative kit (BC-GP/GN); or 2) Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System.


Eligibility Criteria:
Inclusion Criteria:

* All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours
* All adult (≥18 years of age)

Exclusion Criteria:

* Identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
* Positive blood culture in the prior week with same Gram stain result
* Transferred from an outside hospital and had a history of a previously positive blood culture of the same Gram stain result
* Previously enrolled in the study
* Only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
* Died or were transitioned to comfort care within 24 hours of enrollment
* Negative Gram-stain
* Not admitted to hospital for ≥ 24 hours following blood culture positivity
Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension

The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.

This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).

Eligibility Criteria:
Inclusion Criteria:

* Black adults with an average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline.

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindication to beta-blocker therapy
Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial of Yiqi Wenjing prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy.

This study is a randomized, placebo-controlled, double-blind, and multicenter clinical trial. Three hundred sixty postoperative patients with colon cancer stage IIa-IIIc will be randomly assigned into treatment group I, treatment group II and placebo-control group, taking Huangqi Guizhi Wuwu granules, Danggui Sini granules and the mimetic granules of Yiqi Wenjing granules respectively. All subjects will receive mFOLFOX6 or FOLFOX4 or XELOX chemotherapy regimen along with traditional Chinese medicine(TCM) or placebo treatment per day for at least three months and one year follow up. EORTC QLQ-CIPN20 will be used to assess the degree of peripheral neuropathy as the primary outcome measure. Grades of OIPN evaluated by NCI-CTCAE 5.0, quality of life evaluated by EORTC QLQ-C30, chemotherapeutic efficacy evaluated by RESIST 1.1, and the number of completed chemotherapy cycles are selected as the secondary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Subject diagnosed with colorectal cancer stages IIa-IIIc, confirmed by histopathological examination, according to CSCO guidelines for diagnosis and treatment of colorectal cancer.
* Subject suitable for receiving FOLFOX4 or mFOLFOX6 as adjuvant chemotherapy after radical resection of colorectal cancer, receiving each dose and cumulative dose of oxaliplatin are 85mg/m2 and ≥540 mg/m2 respectively.
* Subject with Karnofsky performance status scale (Schag et al.1984) index ≥60 points and an expected survival time ≥6 months.
* Subject over 18 years of age, men or women.
* Subject without severe damage of the heart, liver, kidney or hematopoietic system.

Exclusion Criteria:

* Subject with any grade of peripheral neuropathy.
* Subject who has ever received treatment of neurotoxic chemotherapeutics, such as oxaliplatin, cisplatin, taxanes, or vinca alkaloids.
* Subject who is receiving agents with potential preventive or therapeutic effects to neuropathy, such as duloxedine, carbamazepine, venlafaxine, gabapentin, pregabalin, phenytoin, valproate, milnacipran, or tricyclic antidepressant.
* Subject who is participating or have participated in other clinical trials.
* Subject with a family history of hereditary/familial neuropathy.
* Subject who cannot take drugs orally.
* Subject with mental illness who cannot cooperate.
* Pregnant or lactation period women.
Feasibility in Identification of Breast Cancer Candidates for Elimination of Axillary Surgery

Preoperative identification of patients with pathologic complete response or residual disease in axilla can aid in tailoring subsequent axillary surgery including omission of axillary surgery based on tumor biology and response to neoadjuvant chemotherapy.

OBJECTIVE:

To determine the accuracy of on-treatment core needle biopsy in breast to predict nodal response after neoadjuvant chemotherapy.

OUTLINE:

Early breast cancer patients aged above 18 and below 70 years with biopsy-confirmed, clinically T1-4, N1-3, and M0 disease are eligible for this study. Breast cancer is proven pathologically in all patients using the baseline core needle biopsy, and the skin of all patients is tattooed at the baseline. Metastatic lymph nodes are diagnosed with core needle biopsy or fine needle aspiration. All the patients undergo clip placement into node with biopsy-confirmed metastases at the time of diagnosis. For patients who were not evaluated as progressive disease by the latest imaging measurement, repeated CNB (RCNB) was performed after 2-4 cycles of NAC, depending on the total cycles of NAC., repeated core needle biopsy is conducted within the baseline tattooed area after 2 to 4 cycles of neoadjuvant chemotherapy, depending on the total cycles of chemotherapy. Tissue is acquired from different sections of the lesion from different angles to minimize the impact of tumor heterogeneity. For each patient, 3 to 4 tissue specimens are collected and sent for pathological review to examine whether there is residual malignancy (residual cancer, pleomorphic tissue) in the tumor site that is tattooed.

All the patients receive planned axillary surgery after completion of neoadjuvant chemotherapy. the surgical approach was determined by the treating breast surgical oncologist including targeted axillary dissection (TAD) or axillary lymph node dissection, mainly based on the intraoperative TAD results

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study within 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical stage T1-4 N1-3M0 breast cancer at diagnosis (prior to neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition
2. Aged above 18 and below 70 years
3. No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
4. Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry \[IHC\] and/or in situ hybridization \[ISH\]) evaluated on core needle biopsy prior to starting neoadjuvant chemotherapy
5. Completing all planned cycles and regimens of neoadjuvant chemotherapy followed by axillary surgery

Exclusion Criteria:

1. Nonrepresentative core needle biopsy in the breast during neoadjuvant chemotherapy
2. Inflammatory breast cancer
Effects of Energy Density on Self-served Snacks in Preschool Children

The purpose of the study is to determine whether the energy density of snack foods affects the amounts that preschool children serve themselves and then consume. We will serve snacks that vary in energy density to preschool children in their childcare centers and measure the amount they serve themselves and consume. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.


Eligibility Criteria:
Inclusion Criteria:

* Children who are enrolled in a scheduled classroom of the participating childcare centers
* Children who are between the ages of 4 and 6 years old at the time of enrollment

Exclusion Criteria:

* Children who have tested positive or are showing symptoms of COVID-19, or have recently had potential exposure with a person with COVID-19
* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who are absent from the childcare center on the acclimation day or both study days
* Children who are not able to serve themselves the two foods that are provided during the acclimation day
Atorvastatin as Adjunctive Therapy in COVID-19

Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.

COVID-19 is caused by SARS-CoV-2, a β-coronavirus that binds to the zinc peptidase angiotensin-converting enzyme 2 (ACE2). No drug is licensed to treat COVID-19, but adjunctive pharmacologic interventions have been proposed for their immunomodulatory effects, including statins. About 5% of cases are considered critical, with severe respiratory failure as well as myocarditis, and thromboses, and are associated with high fatality rate. Statins affect endothelial dysfunction and have anti-inflammatory and immunomodulatory effects.

This prospective, randomized, open-label trial of atorvastatin as adjunctive treatment of COVID-19 in hospitalized patients aims to study:

1. Will atorvastatin reduce progression to severe or critical COVID-19 disease and death compared to standard care?
2. Will atorvastatin lead to improved clinical outcome of COVID-19 disease at 30 days compared to standard care?

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18-85 years, admitted with suspected COVID-19 disease based on clinical criteria (typical upper respiratory symptoms, e.g. runny nose, sore throat, dry cough, associated with COVID-19 infection).

Exclusion Criteria:

* already on chronic statin therapy, known hypersensitivity or adverse events to statins, negative nasopharyngeal (NP) swab for SARS-CoV-2, pregnancy and lactation, need for ICU admission, ALT or AST \>2X upper limit of normal; CPK \> 5x upper limit of normal; and creatinine clearance \<50%, chronic treatment with colchicine, cyclosporin, digoxin, fusidic acid, azole antifungals, niacin.
ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)

This post-market, interventional, prospective, single arm, the United States (US) based multi-center study will assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 or type 2 diabetes for greater than or equal to (\>=) 6 months
* Currently using insulin as a component of the diabetes therapy
* Allow and be able to provide self-monitoring of blood glucose (SMBG) data at least 1 month prior to study start
* SMBG frequency as confirmed by site SMBG data download of participants meter(s): Basal insulin treated participants - SMBG \>=5 times per week and Multiple dose insulin participants - SMBG \>=2 times per day
* Glycosylated hemoglobin (HbA1c) of \>=7.5 percentage (per local laboratory obtained less than or equal to \[\<= 3\] months of Baseline)
* Able to read and write in English language
* Currently using a Smartphone and have experience with downloading at minimum one application
* Smartphone compatibility; must be able to download the ACCU-CHEK Connect system application accordingly
* Naive to the ACCU-CHEK Connect system
* Willing to comply with study procedures

Exclusion Criteria:

* Treatment with insulin pump therapy
* Any use of continuous glucose monitoring (CGM) to manage their diabetes during the course of the study
* Visually impaired
* Women who are pregnant, lactating or planning to become pregnant during the study period
* Diagnosed with any clinically significant condition (for example anemia, major organ system disease, infections, psychosis or cognitive impairment)
* Participant requires chronic steroid in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
* Participant is the investigator or any sub-investigator, general practitioner, practice staff, pharmacist, research assistant or other staff or relative of those directly involved in the conduct of the study and design of the protocol