cyrilzakka/clinical-trials huggingface dataset:
Assessment of Acute Disease to Reduce Imaging Costs

Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation, intravenous contrast and anticoagulation. This project addresses question of whether quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients with charted evidence of chest pain and dyspnea. After a validation phase, the main study will randomize patients to either the Standard care group or the Intervention group, which will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.


Eligibility Criteria:
Inclusion Criteria

* Adult (\>17 years) ED patient reports a history of chest discomfort and new or worsened shortness of breath or breathing difficulty, documented in the written history of present illness or review of systems.
* Patient must understand English or have a certified translator present.
* Physician has ordered or plans to order a 12-lead electrocardiogram.
* Patient indicates the site hospital was his or her "hospital of choice" in the event of return visit within 14 days.

Randomization Exclusions

* Positive urine cocaine test.
* Incarceration within 14 days of enrollment.
* Patient elopement from medical care (i.e., patients who leave against medical advice).
Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla

Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.


Eligibility Criteria:
Inclusion Criteria:

* Indication of Esophagogastroduodenoscopy independent from the study
* Written informed
* Age ≥ 18 years

Exclusion Criteria:

* Absence of written informed consent
* Contraindication or absence of informed consent regarding sedation with Propofol
* Postoperativ changes of the upper GI-tract
* Intention of endoscopic intervention
* Suspicion of upper GI-bleeding
* Suspicion of stenosis of the esophagus
* Stent in the papilla duodeni major
* ASA (American Society of Anesthesiologists) classification ≥ 3
A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris

To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne vulgaris.

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, Adapalene Gel 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and to Differin® Gel (Adapalene 0.1%, Galderma) and both active treatments to a placebo control in the treatment of acne vulgaris

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
* Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
Radiofrequency Female External Genital Region: a Clinical Trial

OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29 sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a week. The instruments of evaluation were photo (taken before the first session and eight days after the last session), which were evaluated by the patient and by three health professional (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged, satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The patients' satisfaction and the health professionals' evaluation were analyzed by the chi-squared test and by binomial comparison inter-group and intra-group.


Eligibility Criteria:
Inclusion Criteria:

* were included women aged between 18 and 60 years with unsatisfied the appearance of the external genital, attending the clinical physiotherapy, Bahia, Brazil

Exclusion Criteria:

* Pregnant women, women that were using copper IUD, as well as other with skin lesions in the genital region were excluded from this trial.
The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

Nosebleeds (epistaxis) are a frequent cause of emergency department visits, reportedly inciting 1 in 200 visits. They are most common in those less than ten and older than seventy, often occurring in the winter months secondary to dry indoor heating. Epistaxis is associated with elevated blood pressures, but it is controversial whether hypertension is actual a contributing cause.

In non-life-threatening epistaxis, the first step in management is commonly the application of a topical vasoconstrictive medication. In many cases this will lead to cessation of the bleeding or facilitate the exam in those that continue to bleed. Frequently used medications include phenylephrine, oxymetazoline, and lidocaine with epinephrine.

Classic teaching has been to avoid the use of these medications in patients with elevated blood pressures due to concerns of inducing hypertensive crisis. Strict avoidance of topical vasoconstrictors in this patient group with epistaxis severely limits the treatment options for a many patients given the association between the two conditions.

Though universally taught, the actual effect of these agents on blood pressure remains unquantified. Studies investigating the prevention of nose bleeding during nasotracheal intubations suggest that the effect might be minor with little variation between agents.

Clinical question:

What is the effect of commonly used intranasal vasoconstrictors on blood pressure in volunteers without a history of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers over the age of eighteen that have been recently dismissed from the Emergency Department at Mayo Clinic Hospital, Saint Marys Campus.
* We will recruit a convenience sample of 100 patients from the Emergency Department who have completed their Emergency Department evaluation and treatment and are being discharged to home with non-painful conditions.

Exclusion Criteria:

* We will exclude persons under the age of eighteen
* Vulnerable populations (pregnant patients and prisoners)
* Those with an allergy to any of the study agents
* Those with acute pain
* Those using antihypertensive or antiarrhythmic agents
* Those with significant cardiopulmonary comorbidities (namely history of arrhythmia, coronary artery disease, hypertension, and heart failure)
* Those with concomitant use of Monoamine oxidase A (MAO) Inhibitors
* Those with a diagnosis of angle closure glaucoma or benign prostatic hyperplasia (BPH)
* Those with a history of cerebrovascular disease
* As well as those with a history of previous nasal surgery or known nasal anatomic abnormalities.
Validation of Sleep Apnea Diagnosis Device

Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for OSA diagnosis are necessary. The overnight oximetry with the oxygen desaturation index (ODI) has been largely investigated as a diagnostic test for OSA but its accuracy remains undefined. The aim of our study is to evaluate if an wireless polygraph (Oxistar) is accurate to diagnosis OSA in patients referred to a Sleep Lab.

Consecutive patients referred to the sleep laboratory with suspected diagnosis of OSA underwent in-laboratory polysomnography (PSG) and simultaneously wireless polygraph. The PSG oximeter and the wireless polygraph were worn on different fingers of the same hand. All sleep studies were reviewed by one blind investigator according the 2017 American Academy of Sleep Medicine recommendations. The number of desaturations from wireless polygraph at the 3 predefined threshold levels (of ODI-2%, ODI-3%, or ODI-4%) was derived automatically using proprietary algorithm. Moderate to severe OSA was defined as AHI ≥ 15 events/h. The diagnostic accuracy of ODI-2%, 3%, and 4% for the diagnosis of moderate-severe OSA were calculated for cut-off values from 1 to 20 desaturation events/h. The sleep actimetry was compared with the sleep stages from PSG, most of the statistical metrics applied for diagnosis were used to evaluate the applicability of this proposed method. Finally, the snoring events computed by the smartphone application were compared with the events heard by a specialist and the statistical comparison metrics were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* referred by medical staff for an overnight assessment for suspected sleep apnea

Exclusion Criteria:

* polysomnography for the CPAP titration
Study on the Accessibility and Feasibility of Intelligent Applet for Health Intervention of Cancer Patients

In the 5G era with the revolutionary improvement of network speed, digital medical care has brought great convenience to health services. There is a lack of mobile medical data on cancer care worldwide. We designed an applet based on mobile intelligent electronic devices with a doctor-patient dual interface for the perioperative management of cancer patients and verified its applicability in the general population. This study aims to specifically improve the applet according to the characteristics of cancer patients, use it to accurately manage and intervene cancer patients, and establish a rapid doctor-patient communication platform, hoping to improve prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Sign and date informed consent;
* Commit to abide by the research procedures and cooperate with the implementation of the whole research process ;
* Can adhere to and cooperate with research intervention;
* Tumor patients;
* Patients/family members can use smart phones to access the Internet;
* Patients/family members have sufficient cognitive and reading ability;
* No mental illness;
* No serious visual impairment

Exclusion Criteria:

* Equipped with specific devices (such as cardiac pacemaker);
* Those who do not meet the conditions listed in the inclusion criteria.
MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors

What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Minor subject (\<18 years old)
* Operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020
* Having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.
* Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject (or his parents) who expressed his (their) opposition to participating in the study
* Lack of pathological or MRi results
* Subject under guardianship, curatorship or safeguard of justice
Comparison of Conservative and Operative Treatment of Jones Fracture

The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.

The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.

The study proposes a supposition of recommending the active operational approach, which shortens the period of healing by 6 weeks, limitation of physical activity by 4 weeks, and sick leave by 2 months. It also completely eliminates the need to perform a rigid fixation of the extremity for 8-12 weeks.

Eligibility Criteria:
Inclusion Criteria:

- Jones fracture

Exclusion Criteria:

* combined injury
* recurring injury
* diabetes mellitus
* chronic renal insufficiency
* osteopathy
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment

The purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-HIV treatment: 1) lamivudine (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir (APV)/ritonavir (RTV).

Patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups. Within each group they are stratified based on HIV-1 plasma RNA levels.

Group 1: Patients receive 3TC/ABC/d4T; Group 2: Patients receive 3TC/ABC/EFV; and Group 3: Patients receive 3TC/ABC/APV/RTV.

Treatment continues for 96 weeks. Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly. In the event of incomplete viral suppression or virologic failure, patients will be switched to secondary therapy.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this trial if they:

* Are HIV-positive.
* Are at least 18 years old.
* Have a viral load of at least 5,000 copies/ml.
* Have a CD4 count of at least 50 cells/mm3.
* Agree to practice effective methods of birth control while on the study, if a woman.

Patients are not eligible for this trial if they:

Are pregnant or breast-feeding. Have ever taken anti-HIV drugs. (Less than 2 weeks of prior anti-HIV treatment is allowed.) Have a history of AIDS-defining opportunistic illness (except for Kaposi's sarcoma involving skin) within 45 days of the screening visit. Treatment for the illness must have been completed at least 30 days prior to screening.

Are enrolled in another study where the medication may interfere with the control of viral load in this study.

Have a serious medical condition such as diabetes or heart problems that would make it unsafe to be on this study.

Have a history of a severe nerve disease of the type that may cause muscle weakness.

Have had pancreatitis (inflamed pancreas) or hepatitis within 6 months of starting the study.

Have had radiation treatment or chemotherapy within 4 weeks prior to study entry, or think those treatments may be needed during the study period. Local treatment for Kaposi's sarcoma is allowed.

Have used certain medications, including vaccines, that interfere with the immune system within 4 weeks prior to study entry.

Have taken an HIV vaccine within 3 months prior to entry. Are taking St. John's wort. Have a history of being allergic to any of the study drugs.
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects

A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.

Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and subpopulations (regulatory T cell \[T regs\], TH-17 and TH1) after treatment initiation with Raltegravir based regimens and their relationship with functional CD8 T cells and if Raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.

A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects.

HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC 200 mg/TDF 300 mg QD (Arm B).

Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry and entry. The average of these measurements will be used to establish their baseline values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV Infection
* Genotypic resistance without major resistance mutations within 30 days
* Antiretroviral drug-naïve
* Screening HIV-1 RNA ≥5000
* Women of reproductive potential
* Negative pregnancy test within 48 hours

Exclusion Criteria:

* Acute or recent HIV-1 infection
* Currently breast feeding
* Use of immunomodulators
* Evidence of major resistance mutations
* HBsAg positive
* Acute hepatitis of any etiology or clinically significant liver disease
* Current imprisonment or involuntary incarceration
Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy

The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.

Previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. Moreover, the local control was not responsible for survival benefit. Adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. However, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. At present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. Besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.

Eligibility Criteria:
Inclusion Criteria:

* The lesion must be within 12 cm of the anus as measured by endoscopy
* Histologically confirmed diagnosis of rectal carcinoma
* CT, MRI and EUS verified as clinical stage III rectal cancer without involvement of other organs
* Without multiple primary cancer
* Sufficient organ function
* Able to provide written informed consent

Exclusion Criteria:

* Younger than 18 years or older than 75 years
* Synchronous or metachronous malignancy within 5 years.
* Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
* Patients with a history of pelvic irradiation.
* ASA grade IV or V.
* Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding.
* Severe mental illness.
* Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
* Patients who received steroid therapy within one month.
* Patients or family members misunderstand the conditions and goals of this study.
A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

pNENs still have a risk of recurrence after radical resection, and the overall recurrence and metastasis rate is as high as 13.7%-36.2% in China. At present, there is no standard adjuvant therapy for pNEN, and prospective studies are still lacking. This study was a randomized, double-blind, placebo-controlled, multicenter clinical trial to explore the efficacy and safety of surufatinib in the adjuvant treatment of pNET, in order to further improve the prognosis of patients and to provide high-quality research evidence for adjuvant therapy.


Eligibility Criteria:
Inclusion Criteria:

* pNETs lesions pathologically classified as WHO grade 1/ 2/ 3;
* G2/3-NET with at least one high-risk postoperative recurrence factor, including but not limited to lymph node metastasis, neurovascular invasion, pancreatic duct dilation, tumor \>4cm, positive resection margin, etc.; or G1-NET with lymph node or remote transfer;
* Complete surgical resection (R0 or R1 was achieved) ;
* Adjuvant treatment was performed within 6-12 weeks after surgery;
* Have received whole-body 68Ga PET-CT examination within the past six months;

Exclusion Criteria:

* Urinalysis shows urine protein ≥ 2+ and 24-hour protein quantity test shows urinary protein ≥1 g;
* Under anti-hypertension treatment, still uncontrolled hypertension, defined as: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg;
* Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris or coronary artery bypass grafting, congestive heart failure according to the New York Heart Association (NYHA) classification ≥ 2; ventricular arrhythmias which needs drug treatment; LVEF (LVEF) \<50%;