cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Infection in Patients With Chronic Pulmonary Diseases.

This study aims to assess the clinical presentation, radiological patterns and outcome of COVID-19 infection in patients with chronic pulmonary disease.

Inter-relationship between the severity of COVID-19 infection and chronic pulmonary diseases.

The COVID-19 pandemic has led to many difficulties with the diagnosis and routine management of chronic pulmonary diseases such as COPD, Bronchial asthma, ILD and Bronchiectasis as well as raising concerns about the management and outcomes for patients with these diseases who develop COVID-19.

Although there is conflicting evidence on whether patients with chronic respiratory diseases are more susceptible to COVID-19, these patients exhibit a more severe presentation and higher mortality compared with those without chronic respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with confirmed diagnosis of COVID-19 infection by:

RT-PCR And Chest Computed tomography and laboratoty investigations. Patients with chronic chest disease including (COPD, bronchial asthma, ILD, bronchiectasis).

Exclusion Criteria:

* Those who are diagnosed with viral pneumonia caused by viruses other than COVID-19.

Those who are not confirmed to be COVID-19 with PCR or by radiological and laboratory investigations.
Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population

Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field.

Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of PCa who underwent transperineal PBx at our medical center, from 2011 to 2022

Exclusion Criteria:

* Patients with other cancers
Topiramate and Cerebrovascular Response in Migraineurs

The purpose of this study is to evaluate the effect of topiramate on cerebrovascular reactivity and mean flow velocity to photic stimulation in migraineurs.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 65 years
* newly-diagnosed patients with migraine without aura (International Headache Society classification)
* symptom frequency (at least 2 episodes of migraine attack/month)

Exclusion Criteria:

* prior use of preventive medication
* patients with cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, smoking)
* patients who take antihypertensive agent or antidepressant
* patients who were pregnant, breast-feeding or actively smoking
* patients with neurological or cerebrovascular diseases
Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic

Project rationale:

Since 2017, multiple sclerosis diagnosis should match the new McDonald criteria in which a "no better explanation than MS" should be fulfilled. However, many patients present with red flags that lead to a complex diagnostic work-up. There are no available biomarkers that permit to confirm or roll out MS diagnosis in such cases. Therefore, we lack biological markers that can help in the diagnosis of patients presenting with suspected MS.

Many studies have found that serum and cerebrospinal fluid (CSF) cytokines could help to differentiate MS from other diseases such as neuromyelitis optica spectrum disorders (i.e., IL-6) or neurosarcoidosis (i.e., sIL-2R). Serum and CSF kappa free light chains have also shown good diagnosis performance in MS. In daily practice, our MS tertiary center already perform the analysis of CSF concentrations of IL-1β, sIL-2R, IL-6, IL-10, and serum and CSF kappa and lambda free light chains to roll out other central nervous system (CNS) autoimmune diseases in patients presenting with white matter hyperintensities (WMH).

Objective:

To correlate CSF IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains with the final diagnosis in patients presenting to our MS tertiary center with suspected MS to identify a specific inflammatory biomarker profil involved in MS and other CNS autoimmune diseases.

The methodology:

This is an observational study. All patients ongoing a routine diagnostic work-up for suspected MS from june 2020 to june 2022 in our MS tertiary center will be analyzed. Cerebrospinal fluid IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains will be correlated with the final diagnosis to ultimately find MS associated biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to our center for the diagnostic work-up of White Matter Lesions
* Patients that need a routine blood analysis
* Patients that need a routine CSF analysis
* Non opposition to research consent

Exclusion Criteria:

* Patients with a contraindication to perform spinal tap (increase bleeding risk medicine or disease)
* Patients with a contraindication to MRI (metal prosthesis...)
Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Gestational Diabetes Mellitus

Exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise intensity and volume of aerobic exercise needed to produce the most wanted effects on targeted risk factors for subjects at risk of/with established type 2 diabetes, is still uncertain. In this study the investigators will investigate the acute effects of a single bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with and without gestational diabetes mellitus (GDM). The investigators think that very short bouts of high intensity exercise can be a way to reduce blood glucose in these women.


Eligibility Criteria:
Inclusion Criteria:

* pregnant
* Gestational diabetes mellitus or normal glucose tolerance
* able to exercise

Exclusion Criteria:

-
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have had a diagnosis of Crohn's disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria.
* Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m2), or overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:

  * hypertension
  * Type 2 diabetes mellitus (T2DM)
  * dyslipidemia
  * obstructive sleep apnea, or
  * cardiovascular disease.
* Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
* Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
* Have a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
* Have an inadequate response to, loss of response to, or intolerance to:

  * at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
  * at least one advanced therapy for CD (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrin antibodies, Janus kinase (JAK) inhibitors such as upadacitinib, or anti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).

Exclusion Criteria:

* Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
* Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
* Currently have or are suspected to have an abscess.
* Have a stoma, ileoanal pouch, or ostomy.
* Have a history of more than 3 small bowel resections, diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
* Have had more than 5% body weight change in the past 3 months
* Have a current or recent acute, active infection.
Per-oral Endoscopy Pyloromyotomy (G-POEM) in the Treatment of Refractory Diabetic Gastroparesis : Prospective Evaluation of Efficacy

The objective of the study is to document the clinical efficacy and complications of endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are close to the placebo.

Gastroparesis is a functional disease affecting 4% of the population, which is consecutive to diabetes in 30% of cases and considerably alters the patients' quality of life. The diagnosis is based on gastric fullness symptoms, endoscopy and gastric emptying scintigraphy. The therapeutic alternatives including drug therapies (Metoclopramide, Erythrocin), surgery (Electric gastric stimulation) or endoscopy (Botulinic toxin), are insufficiently effective. Two surgical series suggested an interesting efficacy of laparoscopic pyloroplasty, which remains invasive for a motility disorder. More recently, an US team performed the first case of G-POEM with an excellent outcome and no adverse event. This promising result was confirmed by a Brazilian case, a short retrospective series (7 patients) and the first European case performed and published by our team that has performed 5 cases since. Based on experience, it is proposed a prospective monocentric study to evaluate the efficacy of the G-POEM technique on refractory gastroparesis. This study will include 40 patients on a period of three years, whom suffer from refractory gastroparesis, confirmed by clinical evaluation (GCSI and analogic visual scale), upper GI endoscopy and gastric emptying scintigraphy at the inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Presenting a clinical refractory gastroparesis for\> 1 year, that is to say whose functional nonspecific symptoms persisting despite medical therapy (prokinetic) optimal.
* Having a calculation before inclusion GCSI score (Gastroparesis Cardinal Symptom Index) and a scan of the pathological gastric emptying finding gastroparesis older than 3 months.
* No history of gastric surgery (partial gastrectomy Sleeve gastrectomy, ...) or esophageal surgery
* Not having endoscopic gastric lesions (ulcers antro-pyloric cancer).
* Having no indication against anesthetic.
* Having consented to participate in the study.
* Affiliated with a social security scheme (beneficiary or assignee).

Exclusion criteria:

* Minors.
* Pregnant or breastfeeding
* Having an anesthetic against indication.
* Scan the normal gastric emptying
* Under curative dose anticoagulants whose suspension is inappropriate.
* Under dual anti-platelet aggregation whose suspension is inappropriate.
* Being unable to give informed consent
Bracing or Kinesio Taping in The Management of Lateral Epicondylitis

Lateral epicondylitis is an overuse syndrome of the forearm, which is associated with pain and sensitivity in the lateral elbow region.

The aim of the study was to find out about is there any difference between the effects of traditional orthotic devices and adhesive taping, in the management of lateral epicondylitis. Therefore, the forearm counterforce brace, which was widely used in daily clinical practice for lateral epicondylitis, was compared with kinesio tape, a new technique of adhesive taping which has become increasingly popular. The study investigated and compared the effects of the two interventions (the forearm counterforce brace and kinesio tape) on pain severity, functional status and disability of patients with lateral epicondylitis.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65 years
* presence of elbow pain lasting for less than three months

Exclusion Criteria:

* history of acute trauma or fracture on forearm
* congenital or acquired elbow deformities
* demyelinating diseases
* patients who had diagnosed as fibromyalgia
* presence of skin lesion on lateral aspect of the elbow
* presence of rheumatic disease
* presence of systemic infection
* presence of pregnancy
* presence of malignancy
ACP Video Intervention for Patients With Life-Limiting Illness

The goal of this research is to increase patients' knowledge about advance care planning (ACP) discussions and hospice care for patients with serious illness receiving home-based care.

ACP is a process that allows patients to communicate their wishes and preferences or medical care, when they are seriously ill, to their medical providers. The study investigators would like to assess whether a home-ACP video can improve patient-clinician communication about patients wishes for their medical care and lead to more patient-centered care.

This study is a randomized clinical trial of a Home-ACP intervention among 500 adult patients with serious illness receiving medical care at home with the Clover Health House Calls Program. Study participants will be assigned to one of two groups. In one group, participants will continue to receive usual care with their home-based care team. In the second group, participants will continue to receive their usual care with their home-based care team and also view an ACP video that helps them understand ACP and provides education about ACP and hospice care.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 or over
* Have a one-year prognosis or less as determined by Clover Health's validated algorithm
* Speak either English or one of the other 25 languages in which the video intervention is available

Exclusion Criteria:

* Visually impaired beyond 20/200 corrected
* Acute psychiatric illness or other comorbid condition that impairs cognitive ability to participate in advance care planning discussion as determined by the primary House Call Provider.
Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses

The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe

Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline.

The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings.

Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 30 years
* Uncircumcised
* Wants to be circumcised
* Agrees to be circumcised by any of the study methods ,PrePex or Surgical as appropriate
* HIV sero-negative
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total)
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
* Subject agrees to anonymous video and photographs of the procedure and follow up visits
* Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours

Exclusion Criteria:

* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
* HIV sero-positive
* Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
* Known bleeding / coagulation abnormality
* Uncontrolled diabetes
* Subject that to the opinion of the investigator is not a good candidate
* Subject does not agree to anonymous video and photographs of the procedure and follow up visits
* Refusal to take HIV test.
Financial Toxicity in Cancer Patients

This study will seek to generate the early data needed to understand the relationship between constructs and measures of patients' coping resources and psychological response and measures of patients' financial toxicity. To collect this early descriptive data, the overall goal of this study is to identify social, behavioral, and knowledge factors associated with financial toxicity outcomes. Identifying these factors will ultimately help elucidate targets for behavioral, psychosocial, and/or educational and coaching interventions.

PRIMARY OBJECTIVES:

1. Examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity.
2. Identify the feasibility of collecting these measures in a Spanish-speaking cancer patient population.
3. Describe the relationship between financial toxicity and clinical outcomes (survival and disease status). This is an exploratory aim.
4. a) Describe the correlation between measures of self-efficacy, quality of social support, financial literacy and clinical and demographic patient characteristics with outcome measure of financial toxicity, by tumor type and age subgroups. b) Describe response rate to the financial toxicity measure (\>50% completed items on the survey instrument), by tumor type and age subgroups. This is an exploratory aim.

OUTLINE:

Participants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be able to read and speak English or Spanish
* Participant must have diagnosis of cancer within the past 365 days; all disease sites and all stages are eligible for enrollment

Exclusion Criteria:

* Unable to give consent
Advanced MR Imaging in Sarcoma Patients

We intend to investigate the clinical application of two emerging imaging modalities for which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study will involve multi-disciplinary contributions from nationally recognized sarcoma experts in Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and Pathology.

Patients will undergo additional magnetic resonance (MR) imaging at the same time as the standard imaging.

The ability to compare several imaging modalities within a single cohort of patients maximizes the potential of the study to impact the future management of sarcoma patients. The collaborative nature of this study, with essential contributions from many departments will undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the advanced imaging experience that is acquired.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 7 years.
* Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing Sarcoma, Rhabdomyosarcoma or Soft tissue Sarcoma.
* Tumors \> 5 cm in diameter.
* Planning to receive RT or surgery with or without adjuvant radiotherapy (RT) at Mayo Clinic Rochester.
* Provide informed written consent if ≥ 18 years. If \< 18 years, provide informed written assent and parent or legal guardian provide informed written consent.
* Patients must have measurable disease as defined in Section 11.0.
* Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester.
* Baseline MRE information deemed as acceptable for assessment
* Baseline perfusion MRI deemed as acceptable for assessment

Exclusion Criteria:

* Co-morbid conditions that would result in expected survival to be less than 5 years
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures.
* Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.

Exclusion Criteria:

* For those undergoing bunionectomy, other painful conditions involving the surgical foot.
* Positive lab values for Hepatitis B or C or HIV