cyrilzakka/clinical-trials huggingface dataset:
Semaglutide to Reduce Atrial Fibrillation Burden

Atrial fibrillation (AF) is the most common arrhythmia worldwide. AF is associated with obesity and the co-morbidities of obesity, including hypertension and obstructive sleep apnea (OSA) which increase left atrial (LA) size and decrease LA function. Semaglutide, a Glucagon-like peptide receptor 1 agonist (GLP-1 RA), is currently approved by the Food and Drug Administration for weight loss for individuals with and without diabetes. The effects of pharmacologic weight loss with Semaglutide on AF are unknown. The investigators plan on conducting a randomized controlled trial of semaglutide versus placebo in individuals with paroxysmal or early persistent AF (\>10% AF burden on ambulatory monitoring, a previous electrical cardioversion, or AF lasting ≥ 7 days but \< 3 months who have a body mass index ≥ 27.0 kg/m2. The trial will last for 52 weeks. The primary outcome will be the change in AF burden for 2 weeks, immediately before starting the medication or placebo to two weeks starting at week 50, as determined by an implantable loop recorder or two week ambulatory Additional outcomes will be change in epicardial adipose tissue as determined by chest/abdomen/pelvis computed tomography scan at enrollment and at week 52, change in apnea-hypopnea index from baseline sleep study to week 52 sleep study, change in LA longitudinal strain from baseline echocardiogram to echocardiogram at 52 weeks, and change on symptom surveys.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old with a BMI ≥ 27 kg/m2 who have paroxysmal AF with a ≥ 10% burden on ambulatory monitoring or a previous electrical cardioversion or early persistent AF (≥ 7 days, \< 3 months) who are willing to attempt rhythm control.

Exclusion Criteria:

* Unable to consent
* A personal or family history of medullary thyroid carcinoma
* A personal or family history of multiple endocrine neoplasia syndrome type 2
* History of allergic reaction to Semaglutide or any of its components
* Currently pregnant or planning to become pregnant
* Currently breastfeeding
* History of acute pancreatitis
* History of pancreatic adenocarcinoma
* Previous or current GLP-1 RA use
* Previous or current use of alternative pharmacologic weight loss agents (phentermine, diethylpropion, orlistat, phentermine-topiramate, bupropion- naltrexone, gelesis100, or setmelanotide)
* Unable to tolerate anticoagulation
* History of bariatric surgery
INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer

This proposal seeks to further understand the contribution of the PIK3CA mutations in colon cancer, by correlating the type of hotspot mutation with the development of metastases in stage II and stage Ill patients.

In order to do this, DNA will be extracted from either frozen or paraffin embedded colon cancer tissues to sequence PIK3CA, KRAS and BRAF. Clinical outcome data will be gathered to include metastases and survival to correlate with PIK3CA, KRAS and BRAF mutational status. Patients with stage II and stage Ill colon cancers will be identified in the University of New Mexico Human Tissue Repository and the NIH PLCO prevention trial biorepository.

Existing banked tissues of stage II and Ill colon cancers will be collected. There will be no direct contact with living individuals. Epidemiological factors such as age, race, gender and outcome data of metastases and survival will be collected.

This proposal aims to identify PIK3CA mutations as a biomarker for metastasis.

In order to do this, DNA will be extracted from either frozen or paraffin embedded colon cancer tissues to sequence PIK3CA, KRAS and BRAF. Clinical outcome data will be gathered to include metastases and survival to correlate with PIK3CA, KRAS and BRAF mutational status. Patients with stage II and stage Ill colon cancers will be identified in the University of New Mexico Human Tissue Repository and the NIH PLCO prevention trial biorepository.

Existing banked tissues of stage II and Ill colon cancers will be collected. There will be no direct contact with living individuals. Epidemiological factors such as age, race, gender and outcome data of metastases and survival will be collected.

Specific Aims:

1. To develop and standardize methods for high throughput DNA extraction and analysis from colon tumors of patients with stage II and stage III disease harboring PIK3CA exon 9 and exon 20 mutations.
2. To determine the correlation between wild type and PIK3CA, PIK3CA exon 9 and PIK3CA exon 20 mutations and development of metastatic disease and overall survival in stage II and stage III patients with colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Specimen from patients with stage II and stage III colon cancer.

Exclusion Criteria:

* Any other stage or type of disease outside of stage II and stage III colon cancer.
The Comparative Effectiveness of Alprostadil,Sodium Ferulate and Dopamine in Pediatric Acute Kidney Injury

Acute kidney injury (AKI) is a pervasive clinical event in children.It has been independently associated with prolonged hospital stays, risk of in-hospital death and future progression to chronic kidney disease. Except for removal of nephrotoxic agents and optimization of supportive care,there are still no other effective therapeutic options recommended by recent guidelines. Renal ischemia is the main mechanism of AKI, the improving microcirculation therapy would be the effective management to improve the outcome of AKI in children.

Dopamine is a vasodilating drug that in small doses improves renal circulation. Alprostadil have been used in chronic arterial occlusion and Sodium Ferulate in ischemic cerebral vascular disease,they have a similar therapeutic effect of anti-platelet aggregation and vasodilation. Recent research shows that alprostadil might be associated with a significant reduction in postcontrast Scr, blood urine nitrogen (BUN) and Cystatin C (CysC) level and decrease the incidence of contrast-induced nephropathy.The investigators speculate that Alprostadil,Sodium Ferulate and dopamine would be effective in treating AKI in children.

This is a prospective, multicenter, randomized, double-blind, 52-week study. The purpose of this study is to evaluate the comparative effectiveness and safety of Alprostadil,Sodium Ferulate and dopamine in improving the outcome of AKI in children.

This study aims to explore the effective treatment of pediatric AKI and improve the outcome. It is a 52-week multicenter, randomized, double-blind,prospective study to evaluate comparative effectiveness and safety of alprostadil injection,sodium ferulate and dopamine injection. This study plans to recruit 8 to 10 centers, with 300 participants randomly divided into 3 groups and given respectively Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d,Sodium Ferulate2\~6mg/kg.d,iv,14d,Dopamine3\~5ug/kg .min,iv,3h/d,14d.Time of outcome measurement is 1w,2w,4w,24w,52w. Primary Outcome Measures is The change of Serum creatinin from baseline, estimated glomerular filtration rate (eGFR) and urine volume in the participants after the use of the study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Provide informed consent signed and dated by participants and/or their guardians
2. male or female, Asian.
3. Aged from 1 to 18 years.
4. Patients meet the AKI diagnosis criteria of 2012 Kidney Disease: Improving Global Outcome (SKDIGO) Guideline

Exclusion Criteria:

1. prerenal or postrenal failure
2. Patients need renal replacement therapy
3. Patients with hemorrhagic disorders
4. Patients in shock
5. Patients with multiple organ failure
6. History of Alprostadil or Sodium Ferulate or dopamine sensitivity
7. Patients with heart failure
8. Patients with peptic ulcer
9. Patients with glaucoma
10. Patients with interstitial pneumonia
A Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen.

The aim of this non-interventional study is to extend the knowledge on effectiveness of Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.


Eligibility Criteria:
Inclusion Criteria:

* Women with a medical indication for an ovarian stimulation therapy for the purposes of an IVF or ICSI.
* First-time ovarian stimulating therapy for an IVF or ICSI.
* Ovarian stimulation therapy exclusively with Ovaleap®.
* GnRH antagonist protocol.
* Body-Mass-Index (BMI) \< 30 kg/m2.
* Duration of menstrual cycle 24 - 35 days.

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Combined application of IVF and ICSI
* Ovarian hyperstimulation with Ovaleap® with a consecutive "social freezing".
* Polycystic ovary syndrome (PCOS).
* Endometriosis (AFS (American Fertility Society) grade 3 and 4).
* Uterine myoma (intramural \> 4 cm, submucosal).
* Hydrosalpinx (on one side or both sides).
Expression of Erythroid Differentiation Regulator 1 (Erdr1) in Vitiligo

Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo


Eligibility Criteria:
Inclusion Criteria:

* Patients with generalized non-segmental vitiligo.
* Both sexes.
* Age \>18 years old.
* New cases or cases not receiving any medication for at least 3 months ago.

Exclusion Criteria:

* Segmental or Universal vitiligo
* Autoimmune diseases
Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection

The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection.

The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with persistent Helicobacter pylori infection.
* Patients with previous Helicobacter pylori eradication therapy for one or two times.

Exclusion Criteria:

* Patients unable or unwilling to receive gastroscopy.
* Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Clinical and Radiographic Evaluation of Intra Coronal Bleaching of Primary Anterior Teeth

clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique

This study will be conducted for the clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 3-5 years.
* Parents/caregivers acceptance.
* Traumatized anterior teeth with sensitivity to percussion and palpation with gray discoloration.
* Discolored anterior teeth indicated for intracoronal bleaching.
* Traumatized anterior teeth no response to an electric pulp test.
* Discolored teeth with satisfactorily previously obturated root canal .
* Absence of preapical lesions or apex resorption.

Exclusion Criteria:

* Teeth with signs tooth mobility indicated for extraction.
* Teeth with vertical root fracture.
* Teeth with preapical lesions or apex resorption.
* Teeth with discolorations from restorative materials.
* Children with lack of cooperation for post-operative recall and follow up.
Antibiotics Study in Preterm Premature Rupture of the Membranes

The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality, and to review the evidence and provide recommendations on the use of antibiotics in PPROM.

Despite major advances in perinatal care, preterm delivery is still the predominant cause of perinatal mortality and a major cause of neurological morbidity and mortality. Although the determinants of preterm labor and delivery are uncertain, evidence suggests intrauterine infection is a contributing factor. Antibiotic therapy for women in preterm premature rupture of membranes has been a routine practice. However the optimal regimen remains unclear and the choice of latency antibiotic regimen is at the discretion of admitting physician. The group 1 is treated only with cefazolin (1.0mg iv every 6 hours for 7 days). The group 2 is given a combination of cefazolin(1.0mg iv every 6 hours for 7 days) and erythromycin(250mg p.o. four times a day for 7 days). In group 3, clarithromycin (500mg p.o. 4 times a day for 7 days) was treated with cefazolin(1.0mg iv every 6 hours for 7 days). This study is designed to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality and to review the evidence and provide recommendations on the use of antibiotics, especially by comparing the combination regimen in PPROM.

Eligibility Criteria:
Inclusion Criteria:

* PPROM, PA 23+0\~33+0wks
* ROM \<48 hrs before randomization
* singleton
* Cervical dilatation \<3cm
* uterine contraction less than 4 times per 1 hr

Exclusion Criteria:

* Major fetal malformation
* Multifetal pregnancy
* Rupture of the membrane \>8hrs before randomization
* Prior antibiotics use at local clinic before referral
* Vaginal bleeding
* IIOC (incompetent internal os of cervix)
* Placenta previa
* Gestational diabetes or overt diabetes
* Hypertensive disorders in pregnancy
* Liver cirrhosis
* Acute renal failure
* IUGR(Intrauterine growth restriction)
Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.

Eligibility Criteria:
Inclusion Criteria:

* equal to or older than 40 years
* under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
* risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
* signed informed consent

Exclusion Criteria:

* under 40 years
* history of HCC
* patients with pregnancy or nursing
* any contraindication of MRI
* any contraindication of CT
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors


Eligibility Criteria:
Inclusion criteria:

* Advanced or metastatic cancer
* 18 years and above

Exclusion criteria:

* Previous treatment with 4 or more cycles of carboplatin;
* Previous treatment with 2 or more courses of nitrosourea or mitomycin;
* Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
* Severe and/or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply
Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients

Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity.

Patients will sign an informed consent and assent to participate. Skin and both nares will be cultured for S aureus. A blood sample and two 2 mm skin biopsies will be obtained one from non-lesional skin and another one from lesional skin). The patients will be instructed in the use of the three-week S. aureus decolonization regimen and provided with the medications (sulfamethoxazole/trimethoprim and Mupirocin ointment) and Chlorhexidine. The second visit will take place immediately at the end of the three-week S. aureus skin decolonization regimen. Disease severity will be assessed, the skin and nares will be re-cultured, and skin biopsies and blood will be obtained.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants ≥6 yrs of age
2. Meet atopic dermatitis Standard Diagnostic Criteria
3. SCORAD \> 40.

Exclusion Criteria:

1. . Enrollment in another clinical trial
2. Hypersensitivity to an agent used for the skin decolonization protocol
3. Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, azathioprine, methotrexate)
4. Phototherapy for AD within 4 weeks
5. Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
6. Use of topical steroids, topical calcineurin inhibitors within 7 days
7. Bleach baths within 7 days of the first Visit
8. Use of oral or topical antibiotics within 21 days of the beginning of the study
9. Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
10. History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
11. Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
12. Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
13. Febrile illness at time of visits
14. Suspected immune deficiency or family history of primary immunodeficiency
15. Pregnancy
The eCALM Study - An Online Mindfulness-Based Stress Reduction Program for Individuals Living With Cancer in Alberta

For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation can decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal growth and spirituality, and improve quality of life and sleep. Online MBSR may improve the accessibility of MBSR programs to underserved cancer patients who are unable to attend available in-person groups. This study will examine whether patients are willing to participate and complete the program, and also whether the online program improves mood and stress.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Speak and read English sufficiently to complete questionnaires
* Women and men who have been diagnosed with any type of cancer, at any time in the past with no restriction on tumor site
* Pre or post primary cancer treatment, up to having completed primary cancer treatment within the last 36 months
* Exhibiting moderate distress
* Willing to participate in the intervention requirements; able to participate in the intervention (2 hrs per week for 8 weeks and a full day online retreat)
* Internet access
* Resident of Alberta, who has limited access to in-person cancer-specific MBSR programs

Exclusion Criteria:

* Presence of major self-reported psychiatric disorder not in remission, current substance abuse/dependence, and psychotic symptoms
* Previous participation in a MBSR program
Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term

The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.


Eligibility Criteria:
Inclusion Criteria:

1. term,
2. singleton
3. no contraindication to prostaglandins
4. vertex
5. no exposure to vaginal prostaglandins in the index pregnancy

Exclusion Criteria:

1. parity \> 3
2. severe PIH: BP\> 160/100, abnormal LFT's, proteinuria \>1g/day
3. previous uterine surgery
4. regular uterine contractions
5. maternal age \> 45
6. twins
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical picture of oropharyngeal candidiasis
* Confirmation of oropharyngeal candidiasis by candida culture positive
* HIV-positive patients
* Patients 18 years of age

Exclusion Criteria:

* Patients with signs or symptoms of systemic candidiasis
* Patients with signs or symptoms of esophagitis
* Pregnant or breast-feeding women
* Patients who have taken systemic antifungals within the past 30 days
* Patients who have taken local antifungals within the past 7 days
MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

This project, mySmartSkin (MSS), includes an innovative Type 1 hybrid effectiveness-implementation trial designed to enhance the effects of MSS and simultaneously assess key implementation outcomes (e.g., cost, adoption) as well as contextual factors important for scale-up in community and health care settings where melanoma survivors receive follow-up care. A type 1 hybrid effectiveness-implementation design allows us to engage multilevel stakeholders throughout this process, evaluate the effectiveness of the enhanced MSS, and identify critical factors for wide-scale implementation. Aim 1 will focus on enhancing the previous version of MSS by collaborating with multi-level stakeholders in qualitative interviews and usability testing. Aim 2 will evaluate the effects of enhanced MSS on thorough skin-self examinations (SSE) in a randomized-control trial (RCT) and examine its impact on the diagnosis of new/recurrent melanomas. Aim 3 will focus on assessing selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation.

This is a type one hybrid effectiveness-implementation study consisting of three aims. Aim one (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim two (Months 16-60) involves the longitudinal randomized control trial (RCT) comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage. Aim three (Months 16-60) will assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
* Three months to five years post-surgery
* No current evidence of cancer
* Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
* ≥ 18 years old
* Internet access
* Able to speak/read English
* Able to provide informed consent

Exclusion Criteria:

* Children