cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effect of Lipikar Baume AP+M

Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.

It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.

A total of 20 subjects will be enrolled.

The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)).


Eligibility Criteria:
Inclusion Criteria:

* Male, female, diverse persons (\> 18yo) who are capable of giving consent
* Female patients are eligible if the subject is not a woman of childbearing potential (WOCBP) or if she is postmenopausal (cessation of menstruation \>12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, total hysterectomy)
* Signed informed consent
* Diagnosis of at least 4 actinic keratoses of the the forearm and/or back of the hand (each arm)
* Olsen grade I, II and/or III
* Subjects with similar severity and number of AKs on each side symmetrically
* The study participant is in good general condition for his or her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study

Exclusion Criteria:

* Known or documented intolerance to any of the ingredients of Lipikar Baume AP+M
* Any planned AK treatment during the study
* Treatment of actinic keratoses in the application area within the past 3 Months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
* Suspected invasive squamous cell cancer in the application area
* Chronic wounds, erosions, pre-existing infected skin or inflammation which, in the opinion of the investigator, are in need of treatment other than the study product
* Suspected non-compliance
* Current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil
* Any systemic immunosuppressant given within the 8 weeks prior to the study (e.g. systemic prednisolone, azathioprine etc.)
* Locally applied retinoids, steroids, or other prescribed externals in the 4 weeks prior to the start of the study that, in the opinion of the study physician, necessitate exclusion
* Products containing glycolic or alpha-hydroxy acids applied locally in the application area in the last 4 weeks
* Participation in another clinical trial
* Participation in a clinical study within the last 30 days
* Family members or colleagues of the investigator
* Participant is in a position or has a relationship with the investigator that presents a potential conflict of interest
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-II

This study is a prospective study aimed to validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 2935 female participants, including participants with gynecologic cancers patients and healthy participants.


Eligibility Criteria:
Inclusion Criteria for Cancer Arm Participants:

* Age 18 years or older
* Able to provide a written informed consent
* Confirmed diagnosis or highly suspicious cases of gynecologic malignancies within 42 days prior to blood collection
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer.
* previous history of malignant tumor;
* precancerous lesions or benign diseases confirmed by biopsy or surgical specimen;
* unknown or insufficient to determine the nature of the lesion by histopathological reports;

Inclusion Criteria for healthy control Arm Participants:

* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* No cancer related symptoms within 30 days prior to study screening.
* Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for healthy control Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 30 days prior to study blood draw.
* Recipient of anti-infectious therapy within 14 days prior to study blood draw.
* Have received or are undergoing curative cancer treatment within three years prior to study screening.
* With autoimmune or other diseases with severe comorbidities.
Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach

This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods

Purpose: This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods. Methods: A retrospective analysis of 1077 healthy laboring parturients receiving neuraxial analgesia was conducted. We compared a principal components regression model with treebased random forest, ridge regression, multiple regression, a general additive model, and elastic net in terms of prediction accuracy and interpretability for inference purposes.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Pregnancy requiring labor analgesia
* Active labor
* Request of neuraxial analgesia per patient and/or obstetrician
* Received combined spinal-epidural technique

Exclusion Criteria:

* Uterine tachysystole before neuraxial analgesia.
* Baseline blood pressure \<90/60 mmHg.
* Third trimester hemorrhage
* Eclampsia
* Allergies to local anesthetics or fentanyl.
* Maternal fever.
* Pruritus before performance of neuraxial analgesia
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.

The goal of the study is to learn:

* What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial.
* About the safety of sotatercept and if people tolerate it


Eligibility Criteria:
Inclusion Criteria:

* Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
* Has symptomatic PAH classified as WHO Functional Class II or III

Exclusion Criteria:

* Has a weight of \<35 kg
* Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
* Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
* Has uncontrolled systemic hypertension
* Has a history of pneumonectomy
* Has a history of known pericardial constriction
* Has a history of restrictive cardiomyopathy
* Has history of atrial septostomy (within 180 days prior to study start)
* Has personal or family history of long QT syndrome
* Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
* Has a cerebrovascular accident (within 3 months prior to study start)
* Has significant (\>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
* Has untreated more than mild obstructive sleep apnea
* Has known malignancy that is progressing or has required active treatment within the past 5 years
* Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
* Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device
Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion

A total of 75 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into 3 groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography and fluoroscope only respectively (allocation ratio 1:1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. All patients underwent transesophageal echocardiography before and 3 months after operation, and the results were explained by two experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. All patients were examined by transthoracic echocardiography 3 months after operation to evaluate new pericardial effusion, pericardial tamponade, instrument embolization / displacement and so on. The baseline clinical and surgical features and hospitalization outcomes of patients guided by ICE and TEE and fluoroscopy only were recorded and compared. Clinical endpoints include death, new pericardial effusion that does not require pericardiocentesis, tamponade with pericardiocentesis, instrument embolism / displacement, bleeding at the entry site, thromboembolic events (stroke / transient ischemic attack \[TIA\]). The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided and fluoroscopy only-guided left atrial appendage occlusion combined with radiofrequency ablation. The average follow-up time is 3 months.


Eligibility Criteria:
Inclusion Criteria:

AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2 and HAS-BLED score ≥3, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria:

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.
Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke

Administration of cell-free exosomes derived from mesenchymal stem cell (MSCs) can be sufficient to exert therapeutic effects of intact MSCs after brain injury. In this study we aim to assay the administration of MSC derived exosome on improvement of disability of patients with acute ischemic stroke

Exosomes derived from multipotent mesenchymal stromal cells (MSCs) promote neurovascular remodeling and functional recovery after stroke. Animal study has shown that Exosome treatment markedly increased the number of newly formed doublecortin (a marker of neuroblasts) and von Willebrand factor (a marker of endothelial cells) cells. Based on previous literature, intravenous administration of MSC-generated exosomes post stroke improves functional recovery and enhances neurite remodeling, neurogenesis, and angiogenesis and represents a novel treatment for stroke. Also some studies have presented which miR-124-Loaded Exosomes ameliorate the brain Injury by promoting neurogenesis. So in present study we aim to assess improving patients with acute ischemic stroke who received MSC derived exosome

Eligibility Criteria:
Inclusion Criteria:

* Male or female acute ischemic patients aged 40-80 years with symptoms of acute cerebral infarction of less than 24h from stroke onset.
* Patients with infarct size 3\*3
* Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement.
* Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.
* Patients must have a score on the NIH Stroke Scale 8-24, and mRS ≤ 1
* Women of childbearing age should have a negative pregnancy test performed prior to inclusion
* Obtaining informed consent signed

Exclusion Criteria:

Comatose patients.

* brain tumour, cerebral oedema with compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage.
* alcohol use Active infectious disease, including HIV, hepatitis B, Hepatitis .
* patients with dementia.
* Specify clinical conditions
* Patients who are participating in another clinical trial.
* Inability or unwillingness of individual for giving written informed consent.
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV-infection prior to study enrollment
* Screening laboratory result indicating HCV genotype 2 infection
* Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening
* Voluntarily sign an informed consent

Exclusion Criteria:

* Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir
* Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease
* Clinically significant laboratory abnormalities
* Uncontrolled clinically significant disease, disorder or medical illness
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.

The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.

This study was designed as a randomized, double-blind, multi-center Phase III trial, with a placebo-controlled treatment period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300 mg s.c. in participants aged 18 to 75 years with a low or moderate ASCVD risk and fasting LDL-C value of ≥ 130 mg/dL but \< 190 mg/dL who were not on any lipid lowering therapy.

The study consisted of 3 parts:

* Screening: the screening period was up to 14 days to allow adequate time for the eligibility evaluations.
* Core Part: a double-blind, placebo-controlled treatment period of 180 days in which eligible participants were randomized 1:1 to receive either inclisiran sodium 300 mg s.c.

(inclisiran group) or matching placebo s.c. (control group) on Day 1 and Day 90. The end of core part (EOC) visit was conducted on Day 180. The database lock for the core part was planned to occur after all randomized participants have completed the EOC visit (or have discontinued from the study before EOC). The primary analysis was conducted after the database lock for the core part.

• Extension Part: an extended treatment period of 180 days. In the extension part, participants originally randomized to inclisiran in the core part were to continue the inclisiran treatment while participants initially randomized to placebo were to transit to the inclisiran. The extension part was to start from the Day 180 treatment dose (placebo in the inclisiran group and inclisiran for participants originally randomized to the control group).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Fasting LDL-C of ≥ 130 mg/dL but \< 190 mg/dL
* Triglycerides ≤ 400 mg/dL
* Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline

Exclusion Criteria:

* Use of any LLT within 90 days prior to screening visit
* History of ASCVD
* Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
* Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome

Other protocol-defined inclusion/exclusion criteria may apply.
VIRal Hepatitis and GAllstone Disease Study

The study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease.

Patients seeking care at emergency room at Sahlgrenska University Hospital, Gothenburg, Sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. If they agree, a serum sample will be draw for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA. The proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection).

Eligibility Criteria:
Inclusion Criteria:

* Acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at Sahlgrenska University Hospital, Gothenburg
* Written informed consent
* Ability to obtain 9 mL serum for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA

Exclusion Criteria:

* Not willing to give written informed consent
* Age below 18 years
Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects

A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.

This was an observational, multicenter study conducted to investigate the long term follow-up of subjects who had been exposed to study drug (either SKY0402, bupivacaine HCl, or both) in prior SKY0402 breast augmentation studies. Specifically, the protocol was designed to elicit any changes in the response of the silicone shell of the implant after exposure to study drug.

Eligibility Criteria:
Inclusion Criteria:

* Participated in either Pacira SKY0402-C-210 or Pacira SIMPLE Breast Augmentation 315 and received a dose of SKY0402, bupivacaine HCl, or both
* Able and willing to comply with all study visits and procedures.
* Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments.
* Able and willing to provide written informed consent

Exclusion Criteria:

* Did not receive study drug in either Pacira SKY0402-C-210 or SIMPLE Breast Augmentation 315.
* Has a clinically significant systemic or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments.
Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

Dentin hypersensitivity (DH) is a common clinical problem frequently seen in dental patients. According to Splieth et al., the prevalence of dentin hypersensitivity is 3-98% in adult population.DH is described as a short, sharp pain or discomfort that responses to certain stimuli, typically thermal, tactile, osmotic or chemical, due to exposed dentinal surface which can be explained by the hydrodynamic theory.

The laser is a narrow, focused beam of light emitted to vaporise, fuse, melt, or seal dentinal tubules using laser heat to induce hydroxyapatite crystals for recrystallisation of the mineral component of dentine. The obliteration of dentinal tubules is caused by heat generated by laser beam which inhibits the transmission of the stimulus in the dentinal tubules.

Grape seed extract contains proanthocyanidins (PA) which is able to bind to proline-rich proteins, like collagen, and contributes in enzyme proline hydroxylase activity that is essential for the biosynthesis of collagen in the dentin. The cross-linking action of collagen fibrils in dentin also able to prevent mineral loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least three sensitive tooth by gingival recession or tooth wear \>2 scores on the VAS scale.
* Tooth wear index score \<3 (Smith and Knight tooth wear index)
* Systemically healthy patient.
* 20-50 years of age.

Exclusion Criteria:

* Teeth with caries, cracked teeth, mobile teeth and pulpitis.
* Deep periodontal pockets (probing depth \>6 mm), periodontal surgery within the previous 3 months.
* Recent desensitizing therapy
* systemic diseases and gastric diseases (GERD)
* Allergy to active ingredients.