cyrilzakka/clinical-trials huggingface dataset:
Long Term Foundation Knee Study

The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year 2000.
* Surgery must have been a primary knee replacement.
* Subject must have received only one primary knee replacement per hospitalization
* Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
* Subject is able and willing to sign the informed consent document

Exclusion Criteria:

* Subject must not have had any previous knee implants (unicondylar or total joint replacements)
* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms

Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.


Eligibility Criteria:
Inclusion Criteria:

* GPP patients with acute symptoms who are administered Spesolimab Intravenous (I.V.) Infusion in Japan
* Patients who have never been treated with Spesolimab I.V. Infusion before enrolment

Exclusion Criteria:

* None
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 \[NCT05162586\]).


Eligibility Criteria:
Inclusion Criteria:

* Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
* Have a Body Mass Index (BMI) within the \>= 40 kilograms per meter square (inclusive) at Screening
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants who experienced serious event(s) related to the study intervention during the WILLOW study
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
* Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 \[(SARS-CoV-2)\], bacterial or fungal infection, or any major episode of infection requiring hospitalization
* Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
* Participation in any other investigational drug study after the WILLOW study Week 24
* Other protocol defined exclusion criteria could apply
Taste Receptors Regulation in CF Patients

The project is intended to be realised in two phases. In the first stage, a case control study will be performed. In the second phase, double-blind, placebo controlled cross-over study will be conducted. The first stage it to compare innate immunity activation and Pseudomonas aeruginosa (Pa) expression between Pa positive and negative patients. In the second phase the effects of inhaled lactizole- TAS3R inhibitor will be assessed.

Three visits have been planned during the entire study. During the first visit, all patients included in the study will have the following procedures: questionnaire tests, lung function tests, taste perception tests (gustometry) and exfoliative cytology of the nasal mucosa.

Patients with confirmed Pseudomonas aeruginosa presence in the airways will be randomly assigned to the Lactizole-Placebo group and the Placebo-Lactizole group, with a recommendation to take laktizol (3 ml) for 3 weeks at the concentration determined during the preliminary examination, in the nebulization 2 times per day) or placebo (3ml 0.9% NaCl solution in nebulization 2 once a day). The first nebulization of the solution issued during the visit will take place during the visit; each patient will undergo a clinical and spirometric assessment after 20 minutes of observation from completed nebulization.

During the second visit (after 4 weeks from visit 1), the first visit procedures will be repeated for all patients. Patients in the Lactizole-Placebo group will be recommended to take a placebo for 4 weeks (3 ml of 0.9% NaCl solution in nebulization 2 once a day); on the other hand, patients from the Placebo-Lactizole group will be advised to take lactisol for 4 weeks (3 ml of the solution in the concentration determined during the preliminary examination, in the nebulization 2 once a day). The first nebulization of the solution issued during the visit will take place during the visit; each patient will undergo a clinical and spirometric assessment after 20 minutes of observation from completed nebulization.

During the third visit (after 4 weeks from visit 2), the first visit procedures will be repeated for all patients.

Eligibility Criteria:
Inclusion Criteria:

* ulmonary manifestations of cystic fibrosis

Exclusion Criteria:

* first positive result of inoculation from the airways, which according to the standard is associated with the need for antibiotic therapy
* contraindication to a biopsy of the nasal mucosa
* exacerbation requiring antibiotics
* diabetes, exposure to tobacco smoke
* other chronic diseases and clinical conditions which, according to the researcher, may influence the assessed parameters and the course of the study.

Temporary exclusion criteria

- acute respiratory infection within 2 weeks from 1, 2 and 3 visits of the study.
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS\<3;
* proven hepatocellular carcinoma with PVTT according pathological examination;
* not previous treated for tumor;
* tumor and tumor thrombosis were removed in operation;
* no recurrence occurence at 4 to 7 weeks after surgery;
* the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
* sign up consent;
* unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

* cannot tolerate TACE or TAI;
* CNS or bone metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy;
Feasability Study of Removing the Ovaries and Fallopian Tubes

The main reason for this trial is to show the feasibility of removing the ovarien and fallopian tubes through the gaster (transgastric adnexectomy). The background for it is to look for more indications of scarless surgery and we will show that the transgastric adnexectomy can be performed in an easy way. It is necessary that there is an indication for removing the ovaries and fallopian tubes and if the patient agree we will do it instead of through the belly through the gaster and maybe with an additional inzision in the vagina. All patients with indication for adnexectomy are potential candidates.

We will show the feasibility for transgastric adnexectomy in 10 patients. Patients for participating in the study suffer of benign adnexal deseases and there is an indication for removing them for diagnostic, prophylactic or therapeutic reasons. A flexible gastric scope is put transgastric into the abdomen, developing an pneumoperitoneum and removing the adnexes with a monopolar knife. The adnexes then are put out of the abdomen either transvaginally after colpotomy or even transgastric. We already performed an appendectomy in 24 patients and were able to show the feasibility in acute infectios situations.

Eligibility Criteria:
Inclusion Criteria:

* Indication for adnexectomy, agreement to take part in the study

Exclusion Criteria:

* No agreement in the trial; patients younger than 18 years of age
Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models

Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;

Exclusion Criteria:

* 1. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenetic factors;
* 2. Children with other major mental illnesses (e.g. schizophrenia) or organic diseases (e.g. congenital heart disease);
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients

This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease

Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Patients with vascular cognitive impairment according to modified Fazekas scale grade 2\~3 and/or more than 3 of lacunar infarction in Supratentorial
* Patients with Clinical Deterioration Rating(CDR) score of 0.5
* Patients with Korean-Montreal Cognitive Assessment (K-MoCA) score of 23 or less
* Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
* Written informed consent

Exclusion Criteria:

* Clinical diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis), Creutzfeld-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)
* Medication of dementia within the past 3 months. (e.g., donepezil, galantamine, rivastigmine, memantine)
* Medication of brain functional improvement medication within the past 6 weeks. (e.g., citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine)
* No studies (no regular school entrance), illiteracy
* Stroke within the past 3 months
* Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject
* Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
* Severe cardiovascular disease such as myocardial infarction, unstable angina or heart failure within the past 6 months
Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent.
2. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Infants whose parents or legal guardians can comply with study procedures including follow-up

Exclusion Criteria:

1. Previously received any meningococcal A, C, W and Y vaccines.
2. Previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth.
3. Progressive, unstable or uncontrolled clinical conditions.
4. A history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy.
5. Experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C \[100.4°F\]) within the previous 3 days.
6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
7. Received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth
8. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study.
9. Any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
10. Any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
11. Received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study.
12. Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops).
13. Relatives of site research staff working on this study.
Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block

Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.

In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old
* Patients with atrioventricular block and EF\>50% with a predicted ventricular pacing rate\>20%
* Patients with intraventricular septal diameter\>8mm
* Written informed consent

Exclusion Criteria:

* Indication for CRT or ICD device
* Patients with no subclavian approach, who are candidates for leadless devices
* Presence of severe tricuspid regurgitation
* Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers

The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.

Eligibility Criteria:
Inclusion Criteria:

* The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
* The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

* Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
* Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
* Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.
* Past or planned surgery affecting gastric acid secretion.
* Clinically significant hepatic or renal disorder.
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)
* No prior systemic therapy for ES-SCLC
* Major organs are functioning well
* Participant must keep contraception

Exclusion Criteria:

* Histologically or cytologically confirmed mixed SCLC
* Known history of severe allergy to any monoclonal antibody
* Known hypersensitivity to carboplatin or etoposide
* Pregnant or breastfeeding females
* Patients with a known history of psychotropic drug abuse or drug addiction
* Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment
Diagnostic Performance of Coronary Calcification Detection on CT Scan

thoracic pain is one of the most frequent reasons for consulting the emergency room. Chest pain can be a sign of different pathologies with a wide range of severity, from life-threatening aortic dissection or myocardial infarction to chest pain during an anxiety attack. Efficient triage of patients is therefore a crucial issue for emergency physicians in order not to ignore an acute coronary event requiring early and specific management.

The investigators seek to evaluate whether a diagnostic strategy based on a thoracic CT scan to rule out coronary calcifications and a single troponin assay can exclude an acute coronary event with sufficient accuracy compared to usual management.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Patient admitted to the emergency room of the Nouvel Hôpital Civil in Strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain \<30min or atypical symptoms but non-eliminable cardiac origin.
* Patient with an initial assessment within the norms (ECG not modified, first troponin negative) and having performed a chest CT scan
* Patient who has not expressed his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

- Patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery

The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.

Exclusion Criteria:

* surgery under laparoscope and other endoscopic operations
* clinical signs of deep vein thrombosis
* use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration
* severe hepatic disease or renal disease
* women of childbearing potential, pregnant or lactating.
Prevention Program to Reduce Injury Disparities Among Latino Day Laborers

The purpose of this study is to Identify intervention priorities using a corner-based needs assessment to document occupational and psychosocial risk and protective factors that increase Latino day laborers(LDL) risk for injury and to design a culturally responsive and context appropriate Occupational Safety and Health Administration (OSHA) 10-based safety intervention that also addresses psychosocial risks to reduce LDL injuries and collaboratively pilot a corner-level intervention and conduct an evaluation to assess the safety program's feasibility and acceptability as determined by the extent to which we can recruit, retain and follow-up LDL over the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* Latino
* identified at a "corner" located in the Houston metropolitan area
* currently looking for work at a corner

Exclusion Criteria:

* not of Hispanic/Latino background
* being unable to participate in the survey due to alcohol or drug use impairment.