cyrilzakka/clinical-trials huggingface dataset:
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery

Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.

The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)

Eligibility Criteria:
Inclusion Criteria:

* patients\>18 years
* Candidate for primary total hip replacement with femoral stem and acetabular cup
* if ostheoarthritis patients aged 18 to 85 years
* if femoral neck fracture patients aged 18 to 90 years
* patients with social security scheme
* patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation
* patients who gavee consent to partecipare in the clinical investigation

Exclusion Criteria:

* \<18 years
* if female, pregnant
* patient who has already had primary hip surgery on the same side
* local or disseminated neoplastic disease
* inability to understand the study and agree to partecipate
* patients cancelling partecipation before surgery
* patients under guardianship or curatorship
* patients without a social security scheme
* patients refusing to partecipate
Helicobacter Pylori Eradication Study

The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.

Purpose of Study\>

1. To evaluate the efficacy of tailored therapy compared to concomitant therapy.
2. Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
3. To evaluate the compliance of tailored therapy compared to concomitant.
4. To analysis of factors which influence to the eradication rate.

Patients\>

; Target disease

* peptic ulcers(gastric ulcer, duodenal ulcer),
* gastric MALToma,
* Endoscopic therapy state of early gastric cancer or gastric adenoma,
* Patients who require H. pylori testing by clinical judgment, such as chronic gastritis.

Method\>

Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. In concomitant treatment group, lansoprazole 30 mg, amoxicillin 1.0 g, metronidazole 500 mg and clarithromycin 500 mg were administered twice a day for 2 weeks, regardless of 23S ribosomal RNA point mutation. In tailored treatment group, In the case of 23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. In tailored treatment group, In point mutation positive cases, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. For each treatment group, at least 4 weeks after completion of drug administration, confirm the sterilization and confirm the compliance and adverse effects of the drug.

Eligibility Criteria:
Inclusion Criteria:

* H. pylori infection diagnosed patient, between 18 years old and 80 years old
* No history of H. pylori eradication therapy
* No antibiotic use for more than 3 days within 1 month of treatment

Exclusion Criteria:

* History of taking antibiotics for more than 3 days in the last 1 month
* History of subtotal or partial gastrectomy
* Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality
* Pregnant and lactating women
* Disagree with the survey or do not respond to the questionnaire
* Contraindications for each medications
LUME BioNIS: a Biomarker Study in Patients With NSCLC

At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of this NIS is to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict OS in NSCLC patients eligible for treatment with Vargatef®. The investigations in this study are exploratory in nature and considered to be hypothesis generating. The results from these investigations may help to expand our understanding of the disease and the response to Vargatef®.

Purpose:

Eligibility Criteria:
Inclusion criteria:

* Age = 18 years.
* Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma.
* Signed and dated written informed consent.
* Vargatef ® is initiated and administered in accordance with the SPC.
* Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or at re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5µm thickness).

Exclusion criteria:

* Any contraindication to Vargatef® or docetaxel as specified in their respective labels.
* Vargatef® initiated more than 7 days prior to inclusion in this NIS.
* Patients participating simultaneously in a clinical trial.
A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>_ 18 years of age with vitreomacular traction

Exclusion Criteria:

* PVD present at baseline
* Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
* Vitreous hemorrhage
* Patients who have had a vitrectomy in the study eye at any time
PLANNED VISUAL EDUCATION ABOUT SKIN CANCER

This study aimed to evaluate the effect of planned visual education based on the Health Belief Model on university students' attitudes and beliefs toward skin cancer. The planned visual education based in Health Belief Model has possitive effects on univestiy students' attitudes and beliefs toward skin cancer.

This study aimed to evaluate the effect of planned visual education based on the Health Belief Model on university students' attitudes and beliefs toward skin cancer. Planned as a cluster-randomized controlled experimental study conducted on two groups (n=116). The study was carried out in Faculty of Economics and Administrative Sciences (FEAS) and Hasan Ferdi Turgutlu Faculty of Technology (HFTFT) from the faculties of Manisa Celal Bayar University (MCBU) between February-Semptember 2019. Among seven departments in FEAS and four departments in the HFTFT, simple random sampling was used to draw lots again. The Department of Econometrics from the FEAS was assigned as the intervation groups (n=58) and Mechatronics Engineering from HFTFT was assigned as the control group (n=58). Data were collected using The Student Introduction Form and The Health Belief Model Scale in Skin Cancer.

Eligibility Criteria:
Inclusion Criteria:

* who Registered and continuing department courses
* who agreed to participate in the study
* who had formal education
* who been second year students

Exclusion Criteria:

* Registration and absence of the student in the department courses
* Refusal to participate in the study
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).

Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were completed in the Western countries and market authorization of adalimumab was approved in United States (US) and European Union (EU) for the treatment of subjects with HS. The differences between this study and global studies include sample size, study design, duration, and race.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have a diagnosis of HS;
* Participant must have any HS symptom at least 6 months prior to Baseline;
* HS lesions must be present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III;
* Participant must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit;
* Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.

Exclusion Criteria:

* Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or participation in adalimumab trial;
* Any other active skin lesion or condition that may interfere with assessment of HS;
* Participants received antibiotic treatment for HS within 28 days prior to the Baseline visit other than those allowed per protocol. Participant on permitted oral antibiotic treatment (doxycycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;
* Participants received prescription topical therapies for the treatment for HS within 14 days prior to the Baseline visit;
* Participants received systemic non-biologic therapies with potential therapeutic impact for HS less than 28 days prior to the Baseline visit;
* Participants received oral concomitant analgesics (non-opioids and opioids) for HS-related pain within 14 days prior to the Baseline visit.
Research of Biomarkers in Duchenne Muscular Dystrophy Patients

The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* FOR PATIENTS:
* Diagnosis of DMD confirmed by genetic testing
* Age over 3 years
* Weight over 15 kg
* Informed consent signed
* FOR CONTROLS:
* Age over 3 years
* Male gender
* Weight over 15 kg
* Subjects with national health insurance coverage
* Informed consent signed
* Nonacute or chronic muscular, allergic, infectious, endocrine or inflammatory disorder in the 3 weeks preceding inclusion

Exclusion Criteria:

* FOR PATIENTS:
* Concomitant chronic or acute muscular, endocrine, infectious, allergic or inflammatory disorder in the three weeks preceding the blood test
* Intake of medicines other than angiotensin-converting enzyme inhibitors, beta blockers, dietary supplements, vitamins, alendronate and methylphenidate. Steroids (and medicines prescribed with them such as calcium supplements and proton pump inhibitors) will be discussed
* Mental retardation or autism
* Vaccination or treatment with immunoglobulins within the three months preceding inclusion
* FOR CONTROLS:
* Concomitant chronic or acute muscular, neurological (including mental retardation and autism), infectious or inflammatory disorder in the three weeks preceding the blood test
* Vaccination or treatment with immunoglobulins within the three months preceding inclusion
SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes

Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are in high demand.

The medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal.

For this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type I diabetes.

The main task of participants is to wear the investigational device during one week.


Eligibility Criteria:
Inclusion Criteria:

* patients with type I diabetes
* male and female patients aged 18 to 50 years
* wearing a FreeStyle Libre CGM and giving the access of collected data
* using insulin pump or insulin pen and giving the access of collected data
* willing to wear the investigational device continuously throughout the study (24h/24h)
* affiliated with French Social Security
* having signed the informed consent form

Exclusion Criteria:

* any skin disease (inflammatory diseases of skin, cancer of skin, infectious diseases of skin, change in skin color...)
* any serious disease that could interfere with the study
* body mass index (BMI) \> 30kg/m2
* scars or tattoos on the upper side of the wrist wearing the investigational device
* who may have an allergy to one of the material used in the device
* who have magnetic resonance imagery (MRI), computed tomography (CT) scan or high frequency electrical heat (diathermy) treatment during the study
* persons mentioned in articles L1121-5 to L1121-9 of the public health code (Pregnancy or Lactation ; Females with childbearing potential, defined as a premenopausal female and not using an effective form of birth control\*; Person deprived of liberty by judicial order ; Person under guardianship or curatorship ; Minors ; Adults who are incapable or unable to give their consent ; Cross-over situations)
* who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
* who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of language problem, poor mental development
Comparison of ABLLS-R and Portage Guide in the Development of Receptive Language Skills Autism Spectrum Disorder.

Language is the system someone uses to communicate with another person. This covers the origins and construction of words, their definitions, and the use of language in various contexts. In normally developing children, receptive language skills are typically much more advanced than expressive language skills. However, some studies found that toddlers and kids with ASD had a relatively greater impairment in receptive language skills than in expressive language skills. The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder (N=12).

The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABLLS-R protocol and other will receive Interventions under portage guide protocol. The data will be analysed by using SPSS 22 statistical software. The results of the study of both the groups will be compared and conclusion will be made on the basis of results. Receptive language skills are crucial for communication and social interaction. Research comparing these assessment tools can contribute to the development of more effective early intervention programs for children with ASD. By identifying the most appropriate assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes. By understanding the strengths and limitations of each assessment tool, professionals can create more individualized treatment plans for children with ASD


Eligibility Criteria:
Inclusion Criteria:

* Children with autism spectrum disorder with mild to moderate severity level will be included in the study.
* The age range of the children will be from three years to seven years.

Exclusion Criteria:

* Children with other neurological disorders or any comorbid conditions will be excluded from the study.
* Children who are not participated in any kind of other intervention.
Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor

The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home.

Women participating in the study will be asked to regularly record data with the Bloomlife sensor, from inclusion in the study until delivery. In addition, clinical information related to their pregnancy and delivery will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Gestational age between 20 weeks and 0 days and 30 weeks and 0 days
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* History of allergies to silicone-based adhesives
* Any health condition resulting in higher chance of C-section (meeting one of these criteria is sufficient to be excluded): previous history of C-section, placental abnormality, being primipara and older than 40
French Validation of an Interview Guide to Cancer Announcement : the Psycho Oncology Basic Documentation

Validation of the PO-BADO in its short and long versions that need a standardized validation process with the inclusion of 450 Patients

In the case of confirmation of the PO- Bado long version, that means for 240 patients a caregiver support time longest 15 minutes than usually suggested, since in 6 items of the Po- Bado usually explored in the caregiver support time, add 6 other additional items provided in the long version. This further time, can be considered as an additional contribution to the free expression.

For the 120 patients seen during the validation of the short version , there is no change in the duration of the caregiver support time.

Eligibility Criteria:
Inclusion Criteria:

* cancer
* having a caregiver support time
* Aged 18 years and over

Exclusion Criteria:

* without known psychiatric history
Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery disease and diagnostic yield of different non-invasive methods in patients with type 2 diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest, and perfusion after vasodilatation stress will be used in the study. A subpopulation will in addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise training.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Age at diagnosis \> 30 years
* Age at inclusion 40-75 years

Exclusion Criteria:

* Angina pectoris
* Coronary angiography/stress-test diagnostic of coronary artery disease last 3 years
* Previous myocardial infarction, coronary bypass operation/PCI or heart failure
* Clinical indication for stress -testing
* Active bronchospasm excluding use of adenosine
* eGFR \< 30 ml/min/m2
* short estimated life expectancy due to cancer, chronic liver/renal diseases
CCHS Secure Health-hub Advancing Research Efforts (CCHS SHARE)

The purpose of this study is to capture longitudinal natural history data in Congenital Central Hypoventilation Syndrome (CCHS). This will include capturing standardized clinical data from standard of care assessments at several CCHS referral centers. Funding source-FDA OOPD

The natural history of a disease is how a disease progresses over time and impacts the lives of patients and their families. In Congenital Central Hypoventilation Syndrome (CCHS), as in all rare diseases, collecting enough information to understand disease natural history is challenging. Knowledge and data sharing is a key to overcoming this challenge. Investigators at Lurie Children's are collaborating with teams at other CCHS medical and research centers and patient advocacy groups to build a shared resource called the CCHS Secure Health-hub Advancing Research Efforts (CCHS SHARE). CCHS SHARE will advance knowledge of CCHS natural history and guide future research studies and clinical trials. The purpose of this study is to collect and store CCHS natural history data over the course of many years in CCHS SHARE. Collected information will include patient and family self-reports surrounding their health and its impact on daily life, information collected during standard clinical care (medical records), family history, and other related information from patients. Information in CCHS SHARE will be used for medical research to better understand CCHS and to develop new treatments.

Eligibility Criteria:
Inclusion Criteria:

Participants with a confirmed CCHS diagnosis (confirmed alveolar hypoventilation and PHOX2B mutation testing results), of all ages and genders, who are followed clinically.

Exclusion Criteria:

An unconfirmed diagnosis of CCHS or unconfirmed PHOX2B mutation or not followed clinically
MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD

This randomized controlled trial will investigate the clinical impact of Myxovirus Resistance A (MxA) and C-Reactive Protein (CRP)-guided antimicrobial treatment compared to usual care in outpatients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD).

Respiratory viral infections are a leading cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). However, there is currently a lack of rapid diagnostic methods to differentiate the cause of AECOPD, resulting in insufficient attention to viral-induced exacerbations, with antibiotic treatment remaining the primary treatment.

Myxovirus resistance protein A (MxA) has been identified as a potential biomarker to distinguish respiratory viral infections, while C-reactive protein (CRP) has been confirmed as a useful guide for antibiotic therapy in AECOPD.

This randomized controlled trial aims to investigate the clinical value of MxA and CRP-guided antimicrobial treatment in outpatients with AECOPD, with the goal of reducing antibiotic overuse and improving patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥40 years old；
* Current or former smoker with a minimum smoking history of 10 pack years, clinical diagnosed with mild-to-severe COPD;
* Presenting with an acute exacerbation of COPD
* The severity of AECOPD is mild to moderate.

Exclusion Criteria:

* Required urgent hospitalization
* Received interferon therapy within 30 days before screening
* Had an active systemic inflammatory condition within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery
* Received vaccine in the past 30 days
* Active tuberculosis
* Immunocompromised
* Presenting with current respiratory failure
* Clinical suspicion of pneumonia or pulmonary edema.
* Coexisting bronchiectasis, cystic fibrosis, or asthma
* Had a concurrent infection at another site, such as urinary tract infections or sinusitis;
* Contraindications to antibiotics and/or antivirals
* Known etiology of the present exacerbation
* Pre-treatment with corticosteroids (cumulative dose of methylprednisolone ≥ 80 mg or equivalent dose) for the present exacerbation.