cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions

The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.

The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DCB currently available on the market.

The present study is designed as a prospective, open label, observational study.

The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.

Patients elected for endovascular revascularization with DCB will be asked their written consent to the use of their personal data.

Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days), 24 and 36 months (±30 days). Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

1. Documented obstructive ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4
2. Target lesion consists of a single solitary or multiple adjacent de novo or re-stenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm
3. Target vessel is the superficial femoral artery and/or popliteal artery (P1-2-3)
4. Life expectancy \>1 year in the Investigator's opinion
5. Written informed consent

Exclusion Criteria:

1. Patient unwilling or unlikely to comply with FU schedule
2. Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure
3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
4. Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure
5. ≥15 cm long inflow lesion (≥50% DS)
6. Failure to successfully treat \< 15 cm long inflow lesion in the ipsilateral Iliac artery
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of JYP0061 in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of JYP0061 in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with JYP0061 orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.

This study will be an double-blinded, single-center phase I clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be administered for single-dose treatment or 10-day multiple-dose treatment and 5-day safety follow up after the last dose of treatment. The safety and pharmacokinetic measures will be conducted according to the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years old (including both endpoints), healthy males or females;
* Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28kg/m\^2 (including both endpoints);
* No significant abnormal clinical symptoms, normal physical examination, vital signs, 12-lead electrocardiogram (ECG), chest CT, ultrasound, and laboratory examination important indicators do not show clinically significant abnormalities;
* The participants (including partners) have no plans for childbearing from screening to 90 days after the last administration of the study drug, and are willing to take appropriate effective contraceptive measures (non-oral contraceptives);
* Fully understanding the study, voluntarily participate in the trial, and willingly sign the written informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* Individuals with special dietary requirements that cannot comply with a uniform diet;
* Suspected or confirmed allergy to any ingredients similar to the study drug or any ingredient in the study drug, or individuals with a history of allergic reactions;
* Past or current severe illness/abnormality (including but not limited to cardiac/cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, malignant tumors, hematological, immune, rheumatological, neurological or psychiatric diseases), or any acute or chronic disease or physiological condition that could interfere with the trial results;
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody; Participated in a clinical trial within the past 3 months;
Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer

External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks. The sensitivity of different tissues to fractionation changes can be quantified through the α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC is lower than for most other tumors and approaches a value characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of patient convenience and treatment cost are obvious. There is level I evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation RT schedules.

Results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. In this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. The study will be performed in 2 stages. For stage 1, sample size was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI complications with an expected rate of 25%. When including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.


Eligibility Criteria:
Inclusion Criteria:

* patients with T1-4 N0 M0 prostate cancer

Exclusion Criteria:

* other no skin cancer diagnosed within 5 years prior to enrolment
* no informed consent
Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.


Eligibility Criteria:
Inclusion Criteria:

* Desire and willingness for correction of asymmetry or volume enhancement of his/her lips
* Females and males ≥ 18 years of age
* Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results

Exclusion Criteria:

* Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use
* Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies


Eligibility Criteria:
Inclusion Criteria:

1. Age18-60.
2. Both genders.
3. abdominal surgery.
4. ASA I-III.

Exclusion Criteria:

1. Drug allergy.
2. Morbid obesity (BMI \>40 kg/m2).
3. Psychiatric disorder.
4. Opiod dependence.
5. patient refuse.
Analysis of TPE Treatments With multiFiltratePRO

Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.

The study is a retrospective, open, non-comparative, multi-centric PMCF study. The investigational device has CE approval. The investigation involves the retrospective collection of treatment data for the TPE treatment mode from the medical records. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the TPE mode of the multiFiltratePRO system.

The site will document the treatment data of patients with an indication for the TPE treatment who had been treated with the investigational devices under the TPE treatment mode between 2019 and October 2023 in chronological order.

Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥40kg irrespective of the age
* Patients with indication for TPE treatment according to ASFA guideline
* Patients have been treated with TPE between January 2019 and October 2023
* Availability of at least 50% of the parameters to be documented for the patient

Exclusion Criteria:

* Participation in an interventional clinical study during the retrospectively collected TPE treatment data
* Previous documentation within this study
* Simultaneous use of another filter for additional therapy form
Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study

REALIZE was a single-arm retrospective cohort study which described treatment patterns with brolucizumab, including treatment intervals between anti-vascular endothelial growth factor (VEGF) injections before and after a switch to brolucizumab.

This study was conducted using German patient-level prescription data and the prescription date was used as a proxy for anti-VEGF injection date.

The study period was defined from the date of the first available anti-VEGF injection in the dataset to 30 November 2021. The index date for each patient was the date of the first brolucizumab injection, which could be anytime between 01 March 2020 (since brolucizumab became available in Germany for use outside of clinical trials in March 2020) and 30 November 2021. The date of the patient's first neovascular age-related macular degeneration (nAMD) diagnosis was assumed to be the date of the first anti-VEGF prescription in the database for that patient, from January 2015 onwards.


Eligibility Criteria:
Inclusion Criteria:

• Patients aged ≥50 years with a nAMD diagnosis, who received ≥1 brolucizumab prescription regardless of prior anti-VEGF treatment, and had a minimum of 12-month follow-up from index date.

Exclusion Criteria:

* Patients without a record of prescription of any drug in the six months before the index date (pre-index period).
* Patients with evidence of bilateral treatment with brolucizumab.
Effects of Hi-maize Resistant Starch on Insulin Sensitivity

The purpose of this study is to determine the effects of a dietary fiber, resistant starch, on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including type 2 diabetes and heart disease. This study will show if consuming resistant starch can help improve insulin sensitivity in overweight and obese people.


Eligibility Criteria:
Inclusion Criteria:

* Stable body weight
* No serious health conditions
* Waist circumference \> or = to 89 cm (females) and 102 cm (males)

Exclusion Criteria:

* Diabetes
* other serious illnesses
* use of medications that affect outcomes
* BMI \> or = 35.0 kg/m2
End-of-Life Patient Identification Assistance in Acute GEriatric Medicine

The main objective of this project is to build a tool, adapted to the French geriatric population, that will predict the risk of death at three months after hospitalization in acute geriatric medicine. This tool will be built using selected items via a review of the literature published in 2015.

The 8 items of the CriSTAL tool will be collected prospectively in all patients hospitalized successively in the 2 post-emergency geriatric services (PUG) of the University Hospital of Toulouse, over a period of 9 months, by a dedicated clinical research associate. Patient survival will be assessed by obtaining the vital status of the cohort via CépiDC

As the population ages, the prevalence of chronic diseases increases. Let's take the example of cardiovascular, respiratory or neurological diseases, including Alzheimer's disease. These pathologies are at the origin of decompensations requiring sometimes multiple hospitalizations. It is clear that the goals of care (curative or palliative) are not always related to life expectancy. Decision making, especially in an acute context, is often tricky. The use of a tool with certain parameters of the patient could help to guide the reflection. The present study propose a tool proposed by an Australian team (CriSTAL), which lists items described in the literature as a risk factor for the death of elderly patients. This tool is currently being studied in several types of populations around the world (general population, cancer patients, hospitalized etc.).

This is a prospective study aimed at evaluating routine, single-center care, conducted at Toulouse University Hospital.

The successive inclusion of hospitalized patients in Post Emergencies Geriatric (PUG) unity will be carried out over a period of 9 months.

The primary outcome will be the vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.

Eligibility Criteria:
Inclusion Criteria:

* Any geriatric patient hospitalized via emergencies at Post Emergencies Geriatric (PUG) unity
* Oral agreement of non-opposition to the use of the data relative to their hospitalization and relative to their evolution within 3 months following the hospitalization

Exclusion Criteria:

* Patient having expressed his opposition to the use of data related to his hospitalization
Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a healthy diet following macronutrient recommendations for Americans will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same.


Eligibility Criteria:
Inclusion Criteria:

* Generally, good health status based on one routine physical in the past 15 months, current health status
* Normal HbA1C, weigh 110 lb or more
* Age 65 years or more, generally healthy, all races and both sexes
* Generally practicing a meat-based dietary pattern, do not have any special dietary requirements, and
* Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

* Medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment, and do not intend to lose weight
* Impaired kidney functions
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* Major gastrointestinal disorders in the past 3 months
* History of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition affecting the ability to provide written informed consent
* If they had not had a routine health checkup 12 months before recruitment.
* If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverages during the study period.
FRESHAIR4Life: Building the Case for Action

The goal of this observational study is to understand the burden and determinants of tobacco use and air pollution (AP) exposure among mid- to late adolescents in Greece, the Kyrgyz Republic, Pakistan, Romania, and Uganda. This context-specific knowledge will be crucial for selecting, adapting, and implementing preventive interventions in the next phase of the project.

The main questions the investigators aim to answer are:

* What is the perceived burden of tobacco use and AP exposure among adolescents?
* What are the contextual drivers and behavioral determinants contributing to (prevention of) these risk factors?
* How do the dynamics between stakeholders influence prevention efforts?

In this study, data will be collected through interviews, focus group discussions, photovoice, document analysis, observations, personal exposure monitoring, and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents: mid- to late-adolescents (14 to 21 years) within the target population;
* Family members: relatives in the first or second degree of (not necessarily participating) adolescents;
* Providers: any relevant stakeholder that is connected to adolescents through profession (e.g. school teacher, youth worker) and/or providers of (public) healthcare;
* Stakeholders: any relevant stakeholder with either a specific expertise, in-depth knowledge or overall overview on the subject, and in direct contact with the community (e.g. community member/leader, policy maker). Due to the community- and individual-level focus of this research, individuals associated with the tobacco industry are deliberately not included as stakeholders.

Exclusion Criteria:

- People living outside the target area or not in direct contact with the target population.
A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer

Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. Therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.

Nausea and vomiting remain two of the most distressing symptoms to children being treated for cancer. Nausea and vomiting are directly associated with the administration of chemotherapy, due to effects of the chemotherapy on the gastrointestinal mucosa, and certain chemotherapeutic agents, such as cisplatin, are known to be particularly emetogenic. In addition, anticipatory anxiety has been identified as an important patient factor in the development of post-chemotherapy nausea and vomiting. Many drugs have been developed in an effort to diminish nausea and vomiting in children receiving emetogenic chemotherapy and these agents, particularly the 5-hydroxytryptamine receptors, have vastly reduced the amount of nausea and vomiting experienced in this population. However, approximately 50% of children and adolescents still suffer from nausea and/or vomiting even after maximal pharmacological intervention. This suggests that other interventions are needed to further reduce the experienced nausea and vomiting seen in children undergoing chemotherapy. As such, many patients and providers have turned to complementary and alternative medicine (CAM) for the relief of nausea and vomiting. Aromatherapy is one such modality that has demonstrated some degree of effectiveness in adults suffering from nausea and vomiting due to chemotherapy, motion sickness, or postoperatively.

Aromatherapy is an inexpensive and easy therapy to administer to children, and many children can self administer aromatherapy depending on their age and the form of aromatherapy. Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. Therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy.

Exclusion Criteria:

* Patients allergic to peppermint, ginger or lavender
The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

The objectives of this study is

* To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment.
* To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

Eligibility Criteria:
Main Inclusion Criteria:

* Fasting triglycerides 500-1500 mg/dl
* Not on other lipid altering therapy, OR on stable lipid altering therapy

Main Exclusion Criteria:

* Type I diabetes or uncontrolled type II diabetes
* Recent cardiovascular or coronary event
* History of pancreatitis
* History or evidence of major and clinically significant diseases that would interfere with the conduct of the study or interpretation of data
* Uncontrolled hypertension
Medical Staff: Higher Risk for Gastrointestinal Polypoid Lesions

This is a single center, retrospective, propensity score-matched analyzed study. Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital of Shandong University, China, from January 2017 to September 2018, were retrospectively reviewed to compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians and general population.

This is a single center, retrospective, propensity score-matched analyzed study. Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital of Shandong University, China, from January 2017 to September 2018, were retrospectively reviewed.To compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians and general population.

Eligibility Criteria:
Inclusion Criteria:

- Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital from January 2017 to September 2018

Exclusion Criteria:

- Subjects who had a history of gastrointestinal surgery or subjects who did not finish the endoscopic examination were excluded