cyrilzakka/clinical-trials huggingface dataset:
Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin

Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by suture repair when it is possible. Recently, the investigators have successfully developed and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the development of microvascularization and enables local and progressive delivery of growth factors providing unique properties for tissue remodeling and wound healing. The advantages of using PRF implantation include no transplant rejection and no need to perform second operation. Knee meniscal repair using PRF has not been reported before. The aim of this study is to investigate whether PRF implantation can facilitate regeneration process of meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal tears.

A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus) will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with surface coil at baseline before surgery, 3 months and 6 months and 12 months after surgery.

The investigators believe that PRF enables to facilitate regeneration of meniscectomized knee, and T2-map MRI enables monitoring healing process of meniscal tears.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 45 years old;
* time of injury to surgery within 8 weeks
* patients who will sign inform consent
* patients with clinical and MRI diagnosis of meniscal tears who will undergo arthroscopy
* patients who will make MRI diagnosis at 3, 6, 12 months

Exclusion Criteria:

* major trauma
* coexist ligamentous rupture
* knee dislocations
Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand

Objective

To assess both the short-term and the long term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA) in a single blind, prospective controlled, randomized trial.

Osteoarthritis is the most common form of joint disease and a major contributor of disability in older people. Current treatment of OA include pharmacological and non-pharmacological modalities. Spa therapy has a long history in the treatment of OA, but few articles have evaluated the effectiveness of thermal treatment in patients with primary OA of the hands.

The aim of this study is to assess the duration of the clinical effectiveness of mud-packs application and mineral bath in patients with primary OA of the hands in a single blind, controlled, randomized trial.

Our study will follow the patients for a longer period of time (12 months) than was done in previous studies.

60 outpatients will be enrolled; 30 patients will be treated with a combination of daily local mud packs and mineral bath water from the spa centre of Fonteverde Natural Spa Resort (San Casciano Terme, Siena, Italy) for two weeks; 30 patients will continue regular, routine ambulatory care. Patients will be assessed at baseline time, after 2 weeks, after 3, 6, 9 and 12 months following the beginning of the study and will be evaluated by VAS for spontaneous pain, Dreiser Algofunctional index, HAQ, AIMS1 and symptomatic drugs consumption.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from osteoarthritis of the hands according to the ACR criteria

Exclusion Criteria:

* Patients suffering from any other rheumatological disease other than osteoarthritis
* Patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months
* Contraindications to mud-packs and balneotherapy
Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section

1. Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).
2. Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;
3. Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease.

The placenta accreta spectrum (PAS) is defined as abnormal placental trophoblast adherence with a wide range of myometrial invasion. It is a serious pregnancy complication that can lead to severe postpartum hemorrhage, which may necessitate hysterectomy, and could ultimately lead to maternal death.Previous studies have shown that women with the highest risk of PAS disorders are those with a prior cesarean section (CS) who present in the second trimester of pregnancy with any degree of placenta previa or low-lying placenta.PAS patients without prior CS represent about one-third of the entire PAS population.The strategy to identify at-risk patients without a prior CS has yet to be defined. This may lead to under identification of PAS patients without prior CS and create a missed opportunity to plan the delivery and improve prognosis in these women. Established risk factors distinct from prior CS delivery include in vitro fertilization (IVF), intrauterine implants, endometritis, uterine artery embolization manual placental removal, uterine malformation, adenomyosis, submucosal fibroids, smoking, maternal weight, maternal age, parity, and multifetal pregnancy. Large clinical studies focusing on PAS disorders in women without prior CS are, indeed, scarce.This study aims to explore the risk factors and prognosis of PAS without a history of cesarean section and try to establish the prediction model.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women without prior cesarean section
* Pregnant women who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024

Exclusion Criteria:

* Pregnant women who did not terminate pregnancy at the Obstetrics Department of Peking University Third Hospital
* Pregnant women who gave birth at \<28 weeks.
Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded.

Randomization is stratified according to ventilatory support: non invasive or conventional ventilation.The major outcome is the ICU mortality rate in overall population and stratified according to ventilatory mode (noninvasive ventilation (NIV) versus conventional).

Secondary outcomes are superinfection necessitating a new antibiotic course, Length of mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency of gastric bleeding episodes that of frequency of hyperglycemic episodes.


Eligibility Criteria:
Inclusion Criteria:

* All COPD patients (according to the ATS definition) experiencing acute exacerbation originating in acute respiratory failure and requiring ICU admission will be included in the study.

COPD exacerbation is defined by the increased frequency of cough, volume and purulence of sputum and that of wheeze.

Acute respiratory failure is defined by the presence of hypercapnia with PaCO2 \>45mmHg associated with pH \> 7.35 and signs of respiratory muscle fatigue (contraction of accessory respiratory muscles, thoracoabdominal swinging ,..).

Exclusion Criteria:

* Asthmatic patients defined by a reversible obstructive disease following nebulized bronchodilators,
* Patients with uncontrolled left heart failure,
* AECOPD patients with a radiologically documented pneumonia,
* Systemic corticotherapy within 30 days before screening,
* contra-indication to corticosteroids (active gastroduodenal ulcer, uncontrolled sepsis, etc. ..)
Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo

This study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls.

For the primary analysis, this study examines the risk of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma in people diagnosed with vitiligo. It also examines actinic keratoses. In secondary analysis, this study examines the prevalence of skin cancer in people diagnosed with vitiligo compared to matched controls.

This study also examines whether the susceptibility to melanoma and nonmelanoma skin cancer may vary between different patient subgroups, e.g. ethnicity, those who undergo phototherapy or treatment with the new targeted biologic immunosuppressive therapies.

Eligibility Criteria:
Inclusion Criteria:

* All eligible adult patients (aged ≥ 18) registered with General Practioner (GP) practices contributing data to OPCRD between January 1, 2010 and December 31, 2020, were eligible for inclusion in the study. People diagnosed with vitiligo prior to the study period (prevalent vitiligo) and people newly diagnosed with vitiligo during the study period (incident vitiligo) are included as cases.

Exclusion Criteria:

* People actively registered with the GP practice at that date without a history of vitiligo require a minimum one-year registration with their GP practice.
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.
Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis

This study aims to determine the clinical characteristics, risk factors, and resistance mechanisms of patients with carbapenem-resistant P. mirabilis bacteremia.Patients with P. mirabilis growth in blood culture samples sent to bacteriology laboratory between 2018 and 2021 were retrospectively analyzed. Patients meeting the inclusion criteria were divided into carbapenem-resistant and carbapenem- susceptible groups. The investigators recorded demographic data, clinical features, and laboratory findings. Resistance genes were investigated in carbapenem-resistant isolates using PCR.

Patients with P. mirabilis growth in blood culture who met the study criteria were divided into two groups as carbapenem susceptible and resistant according to carbapenem antibiogram results. Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group and patients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group.

Demographic characteristics of the patients, concomitant chronic diseases, Charlson comorbidity index (CCI), hospital and intensive care unit (ICU) hospitalization and number of days in the last year, history and type of invasive intervention in the last three months (surgical-invasive), history of antibiotic use in the last three months and types of antibiotics used (Penicillin, cephalosporin, quinolone, carbapenem, tigecycline, colistin, aminoglycoside), hospitalization unit, total length of hospitalization, sample collection unit, growth result and antibiogram, clinical and laboratory data of the day of growth, sepsis and septic shock evaluated according to systemic inflammatory response syndrome (SIRS) criteria, 30-day mortality and patient outcome information were recorded.

Carbapenemase-producing gene regions were investigated by Polymerase Chain Reaction (PCR) in accessible samples of patients with carbapenem-resistant P. mirabilis growth in blood cultures.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients aged 18 years and older
* P. mirabilis growth in blood cultures

Exclusion Criteria:

* Samples taken in emergency departments, outpatient clinics, day treatment units
* Recurrent growths of the same patient
"Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection

It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion Criteria:

* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
* Decompensated cirrhosis
* History of liver transplantation
* History of hepatocellular carcinoma (HCC)
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer

The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
* Plans to proceed to surgery following pre-operative chemotherapy.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
* Has adequate organ function.
* Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
* Has life expectancy of greater than 12 months.

Exclusion Criteria:

* Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
* Known hypersensitivity to any of the study drugs or excipients.
* Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
* Congenital or acquired immune deficiency (e.g. HIV infected)
A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients

PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.


Eligibility Criteria:
Part I volunteers (single and multiple dose) - key inclusion criteria

* Healthy males
* Age 18 to 55 years
* Body mass index (BMI)18 to 32 kg/m2

Part II patients- key inclusion criteria

* Males, or females of non-childbearing potential
* Age 18 to 65 years
* Chronic hepatitis C, and absence of other known liver disease
* Seropositive for HCV antibody (HCV Ab) or HCV RNA at least once previously
* Seropositive for HCV Ab at screening
* Serum HCV RNA \> 5 log10 IU/mL at screening
* HCV gt-1
* Treatment-naïve for hepatitis C:
* BMI 18 to 35 kg/m2
* Otherwise in good health, without severe or clinically significant chronic or recurrent conditions requiring frequent medical intervention or continual pharmacologic management, except for anti-hypertensive use
* No medical or psychosocial conditions that would potentially interfere with the subject's ability to comply with the study assessments or visit schedule.

Part II patients - key exclusion criteria

* Seropositive for human immunodeficiency virus (HIV) antibody or hepatitis B virus (HBV) surface antigen (HBsAg)
* Signs or symptoms of decompensated liver disease
* Evidence of cirrhosis or hepatocellular carcinoma
* Diabetes Mellitus treated with insulin or hypoglycemic agents
* Asthma requiring hospital admission within the preceding 12 months
* History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements
* Any of the following laboratory values at screening

  * Haemoglobin (Hgb) \<11 g/dL in women or 12 g/dL in men
  * White blood cell count \<4,000/mm3
  * Absolute neutrophil count (ANC) \< 1800 per mm3
  * Platelet count \<100,000 per mm3
  * Serum creatinine \> upper limit of normal (ULN) at the central study laboratory
  * Serum albumin \<3.4 g/dL
  * Total bilirubin \>2.0 mg/dL
* Clinically significant abnormality in the electrocardiograms (ECGs) at screening
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation

Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and burden in clinical studies. However, lack of access to exercise programs has limited therapeutic adoption. The growth of technology-driven health care and diagnostics, recognized as an emerging priority by the American Heart Association, offers an opportunity for a pragmatic and patient-centered approach to meet this need. EASE-AF is a prospective, interventional study with a sequential run-in control to evaluate if a digital health-driven, patient-centered exercise intervention improves AF symptoms and burden. The research team will enroll 120 patients with symptomatic, paroxysmal AF. The main impact of this study will be the establishment of evidence for a novel, pragmatic paradigm for a patient-centered, digital technology-driven personalized exercise intervention for patients with AF.


Eligibility Criteria:
Inclusion Criteria:

* ≥40years of age
* Paroxysmal AF
* Electrocardiographic (or equivalent) documentation of AF within 12 months (would need to have evidence of AF after initial post-ablation blanking period if the patient had prior AF ablation)
* AF Severity Scale (AFSS) symptom score 13-26
* Self-report weekly moderate-vigorous physical activity (MVPA) 30-120 minutes

Exclusion Criteria:

* Unable to give consent
* ≤90 days from AF ablation, coronary revascularization, heart failure hospitalization
* Left ventricular ejection fraction (LVEF) \<50%, moderate to severe stenotic valvular heart disease or severe regurgitant valvular disease or history of mechanical valve replacement, presence of implanted pacemaker or defibrillator system
* Labile INR or unable to take anticoagulant despite indication
* Life expectancy \< 1 year
* Hemodialysis; severe pulmonary or liver disease
* Musculoskeletal, balance/gait issues, severe peripheral vascular disease, or neuropathy or other neurologic conditions limiting exercise
* Self-report MVPA \<30 minutes
* Upon initial screening, if the participant's baseline FitBit-measured MVPA ≥180 minutes/week (despite self-report range of 30-120 minutes), the participant will be further excluded.
Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4

This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days.

The purpose of this study is to collect performance data on the Integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older at time of screening
* Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
* Subject is currently using a Medtronic Paradigm Sensor Augmented insulin pump and has been so for a minimum of 3 months at time of enrollment.
* Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
* Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
* Subject is willing to wear the study devices for the duration of the study
* Subject is willing to perform frequent (min 7 per day) SMBGs during study device wear
* Subject is willing to keep a short diary during the device wear.

Exclusion Criteria:

* Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
* Female subject plans to become pregnant during the course of the study.
* Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
* Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
* The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.