cyrilzakka/clinical-trials huggingface dataset:
Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool

The present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO.

The organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the CEM@santé application (a French health care application) are reviewed by nurses from the platform and chemotherapy delivery is confirmed.

The study is planed in 2 steps.

1. st stage: the current circuit remains unchanged (with systematic medical or nursing validation to confirm chemotherapy administration. Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
2. nd stage: a short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation. Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Patient treated for solid malignancy
* Patient starting a new chemotherapy or immunotherapy protocol.
* Patient receiving one of the following intravenous antineoplastic treatments in day hospital: Nivolumab(1), Pembrolizumab(1), Folfox(2), Folfirinox(2), Xelox Carboplatin, EC chemotherapy (Epirubicin/Cyclophosphamide)
* Affiliated and beneficiary to a social security system
* Informed and written consent

Note1: may be used in combination with tyrosine kinase inhibitors (TKIs) Note 2 :may be used in combination with bevacizumab, cetuximab or panitumumab

Exclusion Criteria:

* Patient treated in neo-adjuvant situation for breast cancer
* Does not have a connected device (smartphone, tablet or computer)
* Does not have an internet connection
* Difficulty in filling out a questionnaire
* Protected adult or deprived of her liberty
* Pregnant or lactating woman
Effect of Dexmedetomidine on Gastric Emptying and Gastrointestinal Transit

The aim of the study is to determine the effect of dexmedetomidine infusion on gastric emptying and oro-caecal transit time in healthy volunteers, judged by measuring plasma paracetamol concentrations after paracetamol ingestion and pulmonary hydrogen measurement technique after lactulose ingestion. The effects of dexmedetomidine will be compared to the effects of morphine and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Normal cognitive function and fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel
* Age ≥ 18 years.
* Male gender.
* Weight ≥ 60 kg.
* Written informed consent from the subject.

Exclusion Criteria:

* Previous history of intolerance to the study drugs or related compounds and additives.
* Concomitant drug therapy of any kind except ibuprofen in the 14 days prior to the study days.
* Existing or recent significant disease.
* History of haematological, endocrine, metabolic or gastrointestinal disease.
* History of asthma or any kind of drug allergy.
* Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
* A positive test result for urine toxicology.
* A "yes" answer to any of the questions in a modified Finnish version of the Abuse Questions
* Donation of blood within six weeks prior to and during the study.
* Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results.
* BMI \> 30 kg / m2.
* Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* Smoking during one month before the start of the study or during the study period.
* Clinically significant abnormal findings in physical examination, ECG or laboratory screening \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].
Optimising Congestive Heart Failure Outpatient Clinic Project

This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.

Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.

Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years of age or older
* Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV
* Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography

Exclusion Criteria:

* An acute myocardial infarction or unstable angina pectoris within the last three months
* Valvular stenosis
* Dementia
* Severe concomitant disease
* Refusal to participate.
Reliability and Validity Study of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis

* To translate the Oxford knee score into Urdu language
* To evaluate the reliability and validity of Urdu Version of Oxford knee score for accessing pain and physical function in patients with knee osteoarthritis.
* To evaluate the correlation of Oxford knee score with Western Ontario McMaster universities osteoarthritis index and International Knee Documentation Committee

The original English version of Oxford Knee Score will be translated and culturally adapted as per previous recommendation. In patients with knee osteoarthritis, Urdu Version of Oxford Knee Score will be distributed among 100 participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of Oxford Knee Score will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. Third assessment will be carried out after 7 days of the Observer -1, for intra-observer assessment. Data will be entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient. Urdu Version of Oxford Knee Score will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed knee Osteoarthritis patients were included
* Both male and female patients were included
* Both unilateral and bilateral knee Osteoarthritis patients were included
* Patients were included who fulfilled the American college of rheumatology criteria
* Patients were included between the age of 35-80 Y old patients

Exclusion Criteria:

* Patients with any heart problem were excluded
* Patients with peripheral vascular injury were excluded
An Integrative Approach for Idiopathic Granulomatous Mastitis.

Collaboration is established between Turkish Holistic \& Integrative Medicine Association and Traditional \& Complementary Medicine Society of Istanbul Medipol University.

Study is carried out on idiopathic granulomatous mastitis patients who are followed in the Breast Clinic at Istanbul Medipol University Hospital for between September 2015 and September 2019. Hirudotherapy and medical cupping therapy were applied as traditional and complementary medicine integratively.

Following initial radiological imaging, microbiological- and histological testing, side effects and relapses are analyzed. Follow-up examination is also carried out at the end of the treatment, which consisted of clinical breast exam and radiological imaging.


Eligibility Criteria:
Inclusion Criteria:

* IGM patients, either ones newly diagnosed or had previously received different types of treatments, currently refusing conventional treatments with immunosuppressives etc, or/and surgical management, and now und

Exclusion Criteria:

* Patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.
Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease

The main objective of this study is to evaluate the prevalence and the clinical impact of Orthohepevirus C infection in different human populations, and to determine its zoonotic origin comparing the sequences obtained in both human and animal populations. This is an ambispective study where Orthohepevirus C infection will be evaluated in four high risk human population: i) patients with acute hepatitis, ii) patients with positive IgM antibody against Hepatitis E virus infection with undetectable viral load, iii) HIV infected individuals, and iv) solid organ transplant recipients. Furthermore, we will analyze three animal populations: i) suburban rodents, ii) domestic rodents, iii) wild carnivores. Viral sequences identified in both human and animal populations will be compared to evaluate the zoonotic origin of the infections.

To carry out the project a database will be created in electronic format, where the study team will integrate epidemiological, clinical and laboratory tests data of patients. Data will be anonymous and coded by a data manager.

Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin

Secondary objectives are:

1. To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
2. To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
3. To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
4. To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
5. To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
6. To evaluate the prevalence of infection by Ortho-C in wild carnivores
7. To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals

Eligibility Criteria:
1. HAOD cohort (Cohort of patients with acute hepatitis of unknown origin)

* Patients older than 18 years with acute hepatitis of unknown origin (HAOD)

  2. OrthoC-Tx cohort (HEV Screening Cohort in Transplant Patients):
* Kidney or liver transplant subjects

  3. Ortho-CoRIS Cohort (derived from the AIDS Research Network Cohort (CoRIS))
* HIV-infected patients being monitored by the Spanish AIDS Research Network (RIS)

  4. TrazHE Cohort (Traceability cohort of Hepatitis E infections)
* Patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA

  5. Ortho-C-Rodent Collection:
* Wild and peri-urban rodents (rats) from different areas of Spain

  6. Ortho-C-Domestic Rodent Collection:
* Domestic rodents and mustelids under follow-up in veterinary clinics of different Spanish municipalities.

  7. Ortho-C-Carnivore Collection:
* Wild carnivores that eat rodents collected by the research team since 2020 in 4 autonomous communities (Extremadura, Andalusia, Murcia and Castilla la Mancha)
Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)

Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice

This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. The patients will be observed up until Week 52.

Eligibility Criteria:
Inclusion Criteria:

* Patients in whom treatment with this drug is for CHF. The indications at approval for this drug are as follows. When using this drug, refer to the latest package insert of this drug.

Exclusion Criteria:

* Patients who were previously registered for this study. Patients who received eplerenone within the past three months regardless of the reason for use.
Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 10 years of age, and otherwise healthy
* Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
* In good health with no clinically significant disease that might have interfered with study evaluations
* Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

* History of hypersensitivity or allergy to ciclopirox
* Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
* Had a history of dermatophyte infection unresponsive to antifungal treatment
* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
* Was unwilling to sign the informed consent
* Female who was pregnant or lactating
Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients

Rationale: Research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia (CLL) without creating severe side effects in patients. In addition, studies have shown that rituximab, a therapy that targets the immune system, has the highest efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy drugs. Studies also show that rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin. This study offers the combination of immunotherapy with two promising chemotherapy agents against CLL.

Purpose: This study is evaluating the efficacy and safety of combination treatment with cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating the genetic and molecular components of CLL will also be performed. Some of these tests will be conducted before, during, and after treatments to assess changes resulting from the study drugs. Each patient's outcome will be assessed in relation to various aspects of their genes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of B-CLL (no mantle cell)
* Must have active disease
* Age \>=18 yo
* ECOG 0-3
* No radiation or surgery \<4 weeks

Exclusion Criteria:

* Any of the following comorbid conditions:

  * New York Heart Association Class III or IV heart disease
  * Recent myocardial infarction (\<1 month)
  * Uncontrolled infection
  * Active infection with the human immunodeficiency virus (HIV/AIDS) as further severe immunosuppression with this regimen may occur.
* Pregnant or nursing women
* Men or women of child bearing potential must use adequate contraception.
* Active primary malignancy requiring treatment or limits survival to ≤2 years.
* Any radiation therapy ≤4 weeks prior to study entry.
* Any major surgery ≤4 weeks prior to study entry.
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)

To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.

This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having \> 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon.

The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.

Eligibility Criteria:
Inclusion Criteria:

1. Failing mature upper limb AVF
2. Resistant stenosis (\>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
3. Patient is \>= 21 years of age
4. Ability to provide informed consent

Exclusion Criteria:

1. Thrombosed AVF
2. Target lesion has a sharp angle (\> 45 degrees)
3. Lesions requiring cutting balloon size \> 7 mm
4. Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
5. Contraindication to dual antiplatelet therapy
6. Severe allergy to contrast media that cannot be adequately managed for the procedure
7. Breast-feeding and/or pregnant females
8. Male patients who are planning to father children during the trial period
9. Unable to comply with follow up protocol (for instance, limited life expectancy)
Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection

This retrospective, multicenter clinical study evaluates the efficacy and safety of an AHCC®-based supplement derived from Lentinula edodes in promoting the negativity of persistent HPV infection lasting more than six months. The study involves three groups: unvaccinated participants receiving AHCC®, vaccinated participants receiving both AHCC® and the HPV vaccine, and vaccinated participants receiving only the HPV vaccine.

The study investigates the ability of AHCC® (Active Hexose Correlated Compound) to support immune modulation and promote negativity of persistent HPV infections, which are associated with an increased risk of cervical cancer. Participants are categorized into three groups based on vaccination and supplement use. Outcomes include the proportion of participants achieving HPV negativity and the safety and tolerability of the supplement over a 4-6 month period. The study aims to evaluate the potential of AHCC® as a complementary approach for managing persistent HPV infection.

Eligibility Criteria:
Inclusion Criteria:

* Female participants aged 18 years or older.
* Persistent HPV infection for at least 6 continuous months, confirmed by DNA-HPV testing.
* No prior treatment for cervical lesions via conization.
* No prior HPV vaccination

Exclusion Criteria:

* Current or planned pregnancy during the study period.
* Immunocompromised status, including known HIV infection.
* Severe or high-grade cervical lesions.
* Known allergy or hypersensitivity to AHCC® or vaccine components.
Current Status of Diagnosis and Treatment of Uroepithelial Carcinoma

A cross-sectional study describing the current status of diagnosis and treatment of uroepithelial cancer in hospitals of different grades in Henan Province

Patients diagnosed with uroepithelial carcinoma attending multiple research center hospitals in Henan Province from January 1, 2023 to December 31, 2023 A questionnaire was used to collect and analyze the treatment patterns of patients with early versus advanced uroepithelial cancer in different levels of hospitals in Henan Province.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age (at enrollment)
* Histologically confirmed uroepithelial carcinoma
* Patients with newly diagnosed or completed radical uroepithelial carcinoma in the early stages of uroepithelial cancer/advanced unresectable or with distant metastases of urothelial carcinoma
* Complete medical history information

Exclusion Criteria:

* Incomplete medical history and medical records
Effectiveness of Progressive Muscle Relaxation on Sleep Disturbance in Athletes

Literature supports that athletes have so many reasons for sleep disturbance in their day to day practice and during competition. This study is aimed to build familiarity with the significance of sleep for greatest athletic execution as well as providing Progressoive Muscle Relaxation(PMR),(A technique proposed by Jackobson to improve sleep and degrease the anxiety) as strategy to improve sleep prior to a significant competition during tournament

Adequate sleep is necessary to accomplish ideal athletic performance, cognitive functioning and overall well-being. Inadequate sleep is likewise connected to slow reaction time, delayed perception which can prompt impaired performance and increase risk of injury. A few investigations on sleep and athlete performance have additionally shown that sleep quality can be disturb for so many reasons.

A range of interventions are available that may be beneficial or are commonly utilized in athletes to enhance sleep quantity and quality in athletes. Drug strategies and hypnotics are related with side effects, for example, drug resistance and withdrawal symptoms. Thus, there has been increase in utilization of non-drug strategies for further developing sleep quality. Among such strategies are relaxation methods. It has been considered as one of the cost effective and simple methods for easing sleep. Progressive Muscle Relaxation (PMR) is a method that involved efficiently relaxing global muscles of body with the objective of mental and physical relaxation. PMR is widely used previously to improve sleep in general population however there is currently no evidence to support PMR to improve sleep quality during a competition/tournament as a non-pharmacological method to improve participating athlete's sleep.

The aim of this study is to build familiarity with the significance of sleep for greatest athletic execution as well as providing PMR as strategy to improve sleep prior to a significant competition during tournament.

Eligibility Criteria:
Inclusion Criteria: Participants falling in this category would be recruited into the study.

* Active athletes who are training for a competition.
* Age between 18 -36 years.
* Athletes score falling above 4 on "Athletic Sleep Screening Questionnaire"

Exclusion Criteria:

Participant failing to fall in this category would be excluded of the study.

* Athletes who are not performing for more than a year.
* History of metabolic diseases.
* Athletes taking sleeping aids i.e. sleeping pills.
* Having acute injury