cyrilzakka/clinical-trials huggingface dataset:
Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients

The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline (PTF), a nonspecific phosphodiesterase inhibitor, on kidney function in patients at high-risk for progression to end-stage renal disease. The investigators hypothesize that therapy with Pentoxifylline will slow progression of kidney disease over time.

The treatment objective for chronic kidney disease (CKD), regardless of etiology, is to slow or halt progression of renal dysfunction and reduce proteinuria (in those patients with proteinuric renal disease). Multi-drug medical regimens remain the cornerstone of therapy for medical-renal disease, often with an angiotensin converting enzyme inhibitor and/or an angiotensin receptor blocker. These therapies, though often efficacious, have not been shown to halt disease progression entirely, and the medical therapy of renal disease remains suboptimal.

PTF is a safe, generally well-tolerated drug currently indicated for symptomatic and functional relief of intermittent claudication presumed due to chronic occlusive arterial disease of the limbs. A number of small studies in patients across a range of renal disease states show that PTF can reduce proteinuria, an important component of treatment of CKD. It is not known, however, if the drug will slow progression of CKD as measured by glomerular filtration rate.

Comparisons: subjects randomized to receive PTF compared with those randomized to receive placebo

Eligibility Criteria:
Inclusion Criteria:

Patients 18 years of age or older currently being treated with an ACE-I or ARB and with one of the following conditions:

1. Non-nephrotic range proteinuria (between 1 and 3 grams/day by 24-hr collection), hypertension (blood pressure \>130/80 or current use of antihypertensive drug therapy), and an eGFR of less than or equal to 40 ml/minute but greater than 20 ml/minute.

   OR
2. Nephrotic range proteinuria (\>=3 grams/day proteinuria) by 24-hr urine collection, and an eGFR greater than 20 ml/minute

Exclusion Criteria:

1. Acute renal failure: defined by \>25% decrease in eGFR over one month
2. Pregnancy or currently breast-feeding
3. Current use of cytotoxic drug therapy (cyclophosphamide, cyclosporine, mycophenolate mofetil, prednisone, chlorambucil) or a current indication for, and plan to implement, such therapy.
4. Current use of PTF
5. Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage
6. Current use of theophylline
7. Contraindication to ACE-I or ARB.
8. Fewer than 2 measured serum creatinine values separated by 6 months prior to potential enrollment
Adipocytokines in Endometrial Cancer

Endometrial cancer incidence rates were increasing in the past two decades with a continuous rising trend in Taiwan. Uterine cancer was attributable to obesity based on their association with excess body weight in most epidemiological cohort studies. However, the prevalence of obesity was lower in Taiwan.Therefore, we will study if adipose tissues depots in different locations of body could reflect or correlate the pathogenesis of endometrial cancer.

Besides lipid metabolism, adipose tissue plays import roles in regulation of hormones, adipokines, cytokines and immunocytes. Adipose tissue is now known as endocrine organ which to express and secrete a variety of bioactive peptides, known as adipokines. We will evaluate the difference various adipocytokines between visceral and subcutaneous adipose tissues between women with benign lesions and endometrial cancer. We will study the inter-individual differences in adipocytokines between two types of adipose tissues and their correlation with image quantification.

Eligibility Criteria:
Inclusion Criteria:

Women diagnosed with primary endometrial cancer and undergo surgery, with or without adjuvant therapy in our hospital (EmCa group); women received surgery for benign pelvic lesions in our hospital (control group)

Exclusion Criteria:

Women with an underlying malignancy or any concomitant malignancy, prior chemotherapy or radiation before diagnosis of endometrial cancer, history of autoimmune diseases or immunosuppressive agent use
Pain and Convalescence After Laparoscopic Groin Hernia Repair

The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* planned laparoscopic inguinal or femoral herniorrhaphy
* ASA class I-II
* speak and read danish

Exclusion Criteria:

* converting to open operation
* low compliance (dementia, psychiatric disorder)
* use of morphine or similar drugs daily in the last month
* complications to the operation
Low Sodium Cooking Study

The purpose of this study is to evaluate the acceptance of a salt restricted diet cooked with a controlled amount of salt in patients with heart disease. Verifying if there is difference in the acceptance of the standard and hyposodic diets cooked with controlled amount of salt.

Patients will be randomized into two groups. Patients in group 1 will receive on the first day the standard hyposodic diet - cooked without salt, with 2g of salt (sachet) to be added by the patient at each meal (lunch and dinner). After the first day dinner, these patients will respond to the diet acceptance questionnaire. On the second day, patients in this same group will receive the hyposodic diet cooked with controlled amount of salt at lunch and dinner. The hyposodic diet cooked with controlled amount of salt is cooked with 2 grams of salt that is divided for all the preparations, according to standardized recipes. After dinner, the patients will respond again to the diet acceptance questionnaire, however referring to the diet received in this day.

Patients in group 2 will receive the same intervention, however changing the order of reception of the diets, so, on the first day they will receive the cooked hyposodic diet with controlled amount of salt and on the second day the standard hyposodic diet (salt sachet).

The questionnaire applied refers to the reasons for not accepting the diet. The same questionnaire will be applied twice for each patient, after each of the diets offered - standard hyposodic and hyposodic cooked with controlled amount of salt.

The amount of food that was ingested by the patients, for both diets, will be evaluated by weighing the food that remains in the thermal of each meal. Leftovers of the preparations should be stored properly in plastic bags, separated by patient and properly identified, to be weighed in an electronic scale and immediately discarded in an appropriate place. It will be noted how much the patient refused from each preparation, in grams. The value obtained will be subtracted from the quantity, in grams, of the same preparation offered to the patient. The result of this operation (amount in grams of the preparation accepted / ingested by the individual) will be converted into percent. To determine the weight of the sended food, a thermometer will be weighed, which will be sent on the day, according to the standard home measure used.

Eligibility Criteria:
Inclusion Criteria:

* cardiac patients hospitalized in a clinical unit with prescription of hyposodic diet

Exclusion Criteria:

* prescription of diet with restrictions or changes in consistency;
* patients who prefer to receive soup or other non-standard food in the diet;
* pacients without unable to respond to the questionnaire.
Community Health Workers Against COVID19

Randomized controlled trial among patients from family practices at risk of psychosocial suffering due to social distancing measures. Patients from the intervention group receive support from community health workers. contacted at least 8 times by community health workers. Evolution of psychosocial wellbeing is evaluated by questionnaires at time 0 and after 6 weeks of intervention. Psychosocial outcomes are compared between control and intervention groups. Process evaluation will be done through in-depth interviews.

Patients vulnerable for psychosocial suffering due to social distancing measures are recruited by family practitioners in the City of Ghent. The recruited patients are randomly selected into a control and intervention group. Based on the validated Promis instruments, all participants are interviewed face to face on their mental and social health at time 0 and after 6 weeks of intervention. Patients from the intervention group are contacted by Community health workers after the first interview. Community health workers offer emotional support to the patients through at least 8 contacts over 6 weeks. The control group receive care as usual and are offered support by community health workers after the second interview. In depth interviews (qualitative study) will be conducted among community health workers and patients after finalizing the post-intervention questionnaires.

Research questions: What are the psychosocial consequences of social distancing for at-risk groups? Can community health workers reduce the psychosocial impact of physical distancing measures isolation?

Relevance: Understanding community-based psychosocial support for vulnerable people during and after health crises.

Keywords: Community health workers, psychosocial, health crises

Eligibility Criteria:
Inclusion Criteria:

* patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures

Exclusion Criteria:

* Patients with severe psychiatric diseases (psychosis, severe depression)
CORE Study COVID-19

This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.

The study will be conducted at multiple sites (to be determined by the spread of disease and availability of resources). It is appreciated that settings will vary in terms of clinical infrastructure, resources and capacity. This study will enrol eligible patients (adults) with confirmed or suspected infection with a pathogen relevant to the study objectives. Recruitment of patients with Day 1 (enrolment) data and biological samples is the priority.

Observational analyses will be stratified according to available data. Outcome data for primary and secondary objectives will be derived from data from routine clinical and laboratory assessments performed as part of standard inpatient medical management at the treating site, documented using proportionate case report forms (CRF; either paper or web-based electronic 'eCRF'). Clinical and laboratory data will be collected throughout the acute illness period according to local resources. Priority at all times will be given to the collection of clinical information. Research data will be integrated as much as possible with information available from hospital and regulatory files.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or proven Coronavirus infection (COVID-19)

Exclusion Criteria:

* Confirmed diagnosis of a pathogen unrelated to the objectives of this study (or other non-infectious diagnosis) and no indication or likelihood of co-infection with a relevant pathogen.
Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study

PrEP (pre-exposure prophylaxis) is an effective prevention strategy in which HIV-negative individuals take antiretroviral drugs (tenofovir disoproxil fumarate and emtricitabine - TDF/FTC) to reduce HIV acquisition. Clinical studies have shown that the TDF/FTC combination protects MSM and transgender women against HIV infection. According to the PROUD study, PrEP can decrease the risk of HIV infection among MSM by 86% (90% CI 64-96). The international community recognizes that PrEP can be an additional tool in the framework of a combination prevention package for those most at risk of contracting HIV. Data on HIV incidence among MSM and trans women are largely unknown. In Brazil, Mexico and Peru, data on the incidence of HIV among MSM and trans women are very scarce, limited to small cross-sectional studies.Current methods used to determine HIV-1 incidence have many limitations. These methods include mathematical modeling, retrospective calculations of AIDS case reports, age-based prevalence determinations, and prevalence determinations with multiple rounds of longitudinal surveys to estimate HIV incidence, which require numerous assumptions and inputs and can pose additional challenges in the era of expansion of antiretroviral therapy (ART) and increased survival of HIV-1 infected individuals. On the other hand, prospective longitudinal cohort studies of high-risk individuals can be used to estimate incidence; however, they are often labor-intensive, complex, very expensive, difficult to implement in most countries, and have recruitment biases. Laboratory methods can be unbiased and do not require complicated assumptions and case-by-case weighting. The cross-sectional use of Recent HIV Infection Tests (TRIs) based on biomarkers offers, in principle, accessible, reliable and low risk of bias options for estimating incidence.


Eligibility Criteria:
Inclusion Criteria:

* MSM and transgender women
* aged 18 years or older
* willingness and ability to sign an informed consent form.

Exclusion Criteria:

* Individuals currently using PrEP, PEP or receiving antiretroviral therapy;
* Individuals unable to understand the study or who do not agree to sign the consent form;
* Individuals who are participating in a clinical trial of antiretroviral medication or any investigational product to prevent the acquisition of HIV infection (for example, monoclonal antibodies such as PEP or PrEP)
Calm Athlete: Feasibility of App-based Mindfulness Training on Collegiate Student-Athletes' Mental Wellbeing

The goal of this clinical trial is to evaluate the feasibility of a mobile app-based mindfulness training program in collegiate student-athletes. The main questions it aims to answer are:

* Is a app-based mindfulness program feasible for use with collegiate student athletes?
* What, if any, benefits are seen in the mental wellbeing of collegiate student athletes following mindfulness training?

Participants will use the Calm app to complete semi-structured program of 21 mindfulness sessions over 6 weeks. Participants will complete each 8-15 minute sessions at a location and time of their choosing.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old
* NCAA athlete academically eligible to practice and compete in sport, and physically cleared by university sports medicine staff for participation
* Not a regular user of mindfulness meditation in the last 6 months (\<4 sessions/month)
* Willingness to create an account on the Calm app and share usage data with researchers
* Fluent in English

Exclusion Criteria:

* Regular mindfulness meditation practice (\>4 sessions/month)
* Not currently an NCAA eligible athlete
* Hospitalization or intensive outpatient treatment for mental illness within the past 2 years
* Not cleared by sports medicine staff to participate in sport due to injury at time of enrollment
* Not willing to download the Calm app and/or create an account
* Not willing to share app usage data with researchers
* Not fluent in English
Delayed or Immediate Local Treatment of Veins

Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.

This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.


Eligibility Criteria:
Inclusion Criteria:

* Ultrasound verified insufficiency of great saphenous vein (GSV)
* GSV diameter 5-10 mm
* C2-C4 varicosities
* Most proximal insufficient branch in the distal thigh
* Written and signed informed consent

Exclusion Criteria:

* Peripheral arterial disease
* Body mass index \>40
* Lymphoedema
* Known allergy to sclerosant
* Any known coagulopathy or history of deep vein thrombosis
* Severe illness
* Pregnancy
Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections

This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.


Eligibility Criteria:
Inclusion Criteria:

1. Be ≥ 21 years of age
2. Have an ankle-related infection
3. Is skeletally mature, as evidenced by closed epiphyses.
4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
6. If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion.

Exclusion Criteria:

1. Infections that do not involve the ankle
2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
3. Affected limb is dysvascular
4. Where adequate soft-tissue coverage cannot be achieved
5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
7. Are currently a prisoner
8. Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
9. History of vancomycin or gentamicin allergy
10. Are implanted with other antibiotic eluting products.
Liquid Biopsies for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer

Activating somatic mutations and methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper G-I endoscopy.

Carriers of germline pathogenic variants in the CDH1 and CTNNA1 genes have the Hereditary Diffuse Gastric Cancer Syndrome. Asymptomatic carriers have at high lifetime risk of diffuse gastric cancer (30-70%). Screening upper gastrointestinal endoscopy, even with multiple random biopsies, misses signet ring cell cancer foci. Invasive cancers can thus go undetected. There is therefore a recommendation of total risk-reducing gastrectomy, at least in carriers with a family history of gastric cancer. Novel screening strategies are needed. In this pilot project, the investigators will perform liquid biopsies of both blood and gastric fluid in asymptomatic carriers who refuse gastrectomy and in controls. The investigators aim to show that somatic mutations in a panel of genes involved in gastric cancer and methylation profiles are detected in a subset of carriers, and not in controls. These could be indicative of invasive cancer undetected by endoscopy, and would thus be a strong argument for risk-reducing gastrectomy. On the contrary, in the absence of somatic mutations in liquid biopsies, endoscopic surveillance could continue.

Eligibility Criteria:
Inclusion Criteria:

Case:

* Patient ≥ 18 years old
* CDH1 or CTNNA1 germline pathogenic variant.
* No history of diffuse gastric cancer.
* French social security.
* Ability to understand and willingness to sign a written informed consent document.

Volunteers:

* Patients ≥ 18 years old
* Patients with no oncological history
* Patients with macroscopically normal oeso-gastroduodenal fibroscopy
* French social security.
* Ability to understand and willingness to sign a written informed consent

Exclusion Criteria: for both arms

* Patients with cancer being treated
* Patients with metastatic cancer
* Medical contraindication to general anesthesia or FOGD (bleeding disorder, pregnant women )
* Patients under guardianship or curator
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study

Self-medication of pain by consuming alcohol and marijuana is common. However, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. The study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users. This will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years;
* English-speaking
* Self-identify as White/Caucasian or Black/African American
* Own a smartphone with cellular/data plan
* Regularly co-use alcohol and smoked marijuana as indicated by scores of ≥3 on item 1 of the CUDIT-R and AUDIT.
* Willing and able to give informed consent

Exclusion Criteria:

* Participation in biceps-specific conditioning program in the past 6 months\*
* Self-reported wrist/hand, elbow, or shoulder pain the past 3 months
* Chronic medical condition that may affect pain perception (e.g. diabetes, fibromyalgia, headaches)
* Self-reported kidney dysfunction, muscle damage, or major psychiatric disorder
* Medical marijuana prescription
* Consumption of marijuana using only non-inhalational methods (e.g. edibles, tinctures, or cannabidiol oil)
* Score of ≥ 10 on Patient Health Questionnaire-9 (moderate depression)
* Women who are pregnant, trying to become pregnant, or breastfeeding