cyrilzakka/clinical-trials huggingface dataset:
Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

Primay objective:

To evaluate the potential of the products in eliciting adverse skin reaction.


Eligibility Criteria:
Inclusion Criteria:

* Test area should have a healthy or normal skin
* Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction
* Not currently use of steroid or any medication during the test

Exclusion Criteria:

* History of Allergy or Allergic Reaction to:

  * Hey Fever
  * Asthma
  * Poison Ivy
  * Food
  * Cosmetics
  * Soap
  * Detergent
  * Metal
  * Jewelry
  * Lather
  * Fabric
  * Medication

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison of Antrum Surface Between Women With Operative Hysteroscopy or Planned Caesarean Section

Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of stomach and compare if divergence sizes can be observed between women with a operative hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be adapted to the population.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40
* Membership of a national insurance scheme
* Written consent
* Physical status score or American Society of Anesthesiologists (ASA) score = 1 or 2
* Planned caesarean section or operative hysteroscopy

Exclusion Criteria:

* Not able to give her written consent (not speaking French), under legal protection
* Insulin-dependant diabetes
* Hiatus hernia
* History of gastro-oesophageal surgery
* Contraindication to right lateral decubitus
* Treatments with anti-acids before ultrasounds.
Internet-delivered Psychodynamic Therapy for Depression

The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder
* 15 or more on MADRS-S

Exclusion Criteria:

* Severe depression (more than 35 on MADRS-S or based on interview)
* Severe psychiatric condition (e.g. psychosis or bipolar disorder)
* Suicidal (measured in diagnostic interview)
* Changed medication during the last three months
Correlation of Cervical Lordosis Degree Detected on Cervical X-Ray Image With Clinical, Demographic and MRI Findings

In this study we are investigating whether there is a relationship between the lordosis angle measured on cervical X-RAY images on the severity and level of cervical disc herniation detected by cervical MRI, demographic characteristics and the duration and posture of the person's daily life activities.

At least 125 patients between the ages of 18-65 who meet the inclusion criteria with cervical cervical X-RAY and cervical MRIs taken in the last 3 months will be included in the study.

The demographic characteristics of the patients such as age, gender, BMI, job, education level, marital status, as well as the time they spend on head flexion posture, and their screen time will be questioned. The presence of active trigger points in the cervical muscles will be determined by examination (levator scapula, trapeze, longus colli, splenius capitis).

Neck Disability Index will be filled in order to evaluate activities of daily life. Symptom duration and pain level will be evaluated by VAS.

Tangent and Cobb angles will be measured on cervical X-RAY images. Presence of effective lordosis will be recorded.

In cervical MR, disc herniation level, number, degree (bulging, protrusion, extruded disc) its level will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Axial neck pain and / or upper extremity radicular symptoms
* Existing MR and X-Ray radiographs taken within the last 3 months for cervical disc pathologies

Exclusion Criteria:

* A history of trauma,
* Patients with rheumatoid / autoimmune diseases such as rheumatoid arthritis or ankylosing spondylitis,
* A history of Cervical fracture or cervical spine surgery
* History of cancer history, neurological disease
* Muscle weakness
* Presence of Scoliosis
Enbrel Liquid Immunogenicity Protocol

The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis

The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must be able to self-inject or have someone who can do so for them
* Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value

Exclusion Criteria:

* Any prior biologic therapy for inflammatory disease
* Any prior cyclophosphamide therapy
* Not using adequate contraception
* Pregnant or breast-feeding or any significant concurrent medical condition
A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor use during the study period
* No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor use during the preceding 12 months including at index date
* Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other available data

Exclusion Criteria:

* Aged \<18 years on the first dispensation date or date of the first record of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use
* Type 1 diabetes mellitus
* Secondary diabetes
* Gestational diabetes
* Having a diagnosis of ESRD during the 12 months before the index date
* \<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period
* Missing or ambiguous data on age or sex
Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes

Determine the effects of tyrosine kinase Inhibitors on liver enzymes and electrolytes in relation to hematologic response in patients with chronic phase chronic meyloid leukemia.. Assiut University Hospital insight..

CML is a myeloproliferative neoplasm with unique biological and clinical features.

CML accounts for 15_20% of newly diagnosed cases of leukemias among adults. CML can present in three clinical phases : chronic phase, accelerated phase and blast phase.

CML is characterized by prodction of a breakpoint cluster region abelson(BCR-ABL) fusion protein with ABL kinase activity. This is due to reciprocal translocation between chromosome 9 and 22.

Imatinib \& Nilotinib, an ABL kinase inhibitors, which has revolutionized the CML therapy, are a selective tyrosine kinase inhibitors.

The aim of the study is to determine the changes of liver enzymes and electrolytes in relation to hematologic response during treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with CML
* Chronic phase CML
* Normal hepatic and renal functions

Exclusion Criteria:

* Blastic phase CML
* Accelerated phase CML
* Hepatic \& renal impairment
A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants

Main Objective of this study is to compare the single intravenous (IV) infusion pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference formulation.

Participants will be randomized 1:1:1:1 and dosed with either of the 4 treatments: A, B, C, or D; followed by review of safety and tolerability data during and after the infusion. The study will proceed with treatments A, and C unless one or more of these treatments shows poor tolerability; in which case the study may proceed with treatment B or D in the follow-up cohorts. Additional participants will be randomized equally to each of the treatments the study will proceed with.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be willing to participate in the study and sign the informed consent form (ICF).
* Participants must be willing and able to complete all study-specific procedures and visits.
* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator.
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 45 kg and ≤ 110 kg, at screening.
* Heart rate \> 45 bpm and \< 95 bpm at screening or baseline (within 30 minutes prior to randomization).
* Systolic BP \> 110 mmHg and \< 140 mmHg at screening or baseline (within 30 minutes prior to randomization).
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate \> 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
* Males and females, ages 18 or local age of majority to 40 years, inclusive.

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Diagnosis of fibromyalgia
* History of syncope, orthostatic instability, or recurrent dizziness
* History or family history of ocular disorders (eg, glaucoma)
* History of bleeding diathesis (unusual susceptibility to bleed \[hemorrhage\] mostly due to hypocoagulability)
* Personal history or strong family history of sudden cardiac death, myocardial infarction, or other heart disease considered to be clinically significant by the investigator
* Any major surgery within 4 weeks of study drug administration
* History of Gilbert's Syndrome
Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).

Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.


Eligibility Criteria:
Inclusion Criteria:

* Patient was an adult at surgery,
* Patient implanted with HYPE® acetabular cup and HIPER liner,
* Patient was followed-up at least once on retrospective part of the study,
* Patient's current social security affiliation is valid.

Exclusion Criteria:

* Patient refuses the use of his/her personal data,
* Patient is unable to follow surgeon's instruction or unavailable for follow-up,
* Patient with contraindication to x-rays,
* Patient not implanted with HYPE® acetabular cup and HIPER liner.
Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.

A prospective, randomized, active-controlled clinical trial was conducted to initially evaluate safety of sericin-chitosan cream in comparison with a commercially available cream containing dimethicone for pressure sore treatment in healthy volunteers. The results of this study provided preliminary safety profile of sericin-chitosan cream before conducting the further clinical trial in specific population (pateints with early-stage pressure sore).

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers at the age of 20 - 65 years
* voluntarily sign inform consent

Exclusion Criteria:

* Diagnosed with chronic skin conditions (e g. eczema and psoriasis) and immunocompromised diseases
* Allergic to silk sericin and chitosan, and dimethicone
* Received immunosuppressive therapy, antihistamine, and corticosteroid drugs two weeks before study enrollment.
Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.


Eligibility Criteria:
Inclusion Criteria:

1. Rutherford Stage 2-5.
2. At least 90% stenosis or occlusion of the femoropopliteal artery.
3. Eluvia stents are used for target lesions.
4. Agree and sign the informed consent form

Exclusion Criteria:

1. Life expectancy is less than 1 year.
2. Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened.
3. Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life.
4. Patients with in-stent restenosis of the femoral popliteal artery.
5. Patients with acute arterial thrombosis.
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials

The overarching goal is to develop a mHealth App that can use smartphone embedded sensors to objectively collect physical function data in individuals with knee osteoarthritis (KOA) in the context of daily life.

The goal is to develop a mHealth App using smartphone embedded sensors to objectively collect physical function data in individuals with knee osteoarthritis (KOA) in the context of daily life. It will be performed technical development of an internet-interactive App to collect, analyze and transfer the subjects' data. As a proof-of-concept, the mHealth App will execute algorithms that automate deployment of three well-established physical function tests. In a laboratory setting, it will be evaluated usability, acceptability and reliability of the mHealth App compared with traditional performance tests among focus groups of individuals with KOA. It will then evaluate its usability and acceptability when used in the participants' home environments. As an early indicator of construct validity, it will be examined if the physical function test measurements can detect diurnal variation in the impact of KOA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 50 years old with symptomatic knee osteoarthritis
* English Speaker
* Be able to walk 20 meters without an assistive device, such as a cane, walker or crutches.
* Have an iPhone 6 or higher with internet connection. \* Confirmation of knee osteoarthritis will be based on American College of Rheumatology (ACR) classification criteria:

Exclusion Criteria:

* Prior surgery on either knee within 6 months of enrollment
* Received corticosteroid injection in the knee within 3 months of enrollment
* Evidence or history of any other inflammatory arthritis (rheumatoid arthritis, gout, psoriatic arthritis).
Magnetic Resonance-Guided Adaptive Radiotherapy (MRgART) Using an Integrated Magnetic Resonance Linear Accelerator (MRL)

This study is being done to help further understand how MR-guided adaptive RT in conjunction with the Integrated Magnetic Resonance Linear Accelerator (MRL) can improve patient outcomes. This study will include participants who will be receiving radiotherapy using the MRL machine to target their cancer more precisely. Participants will be asked to have a few extra MR scans taken during their RT planning and to complete a few quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older with a diagnosis of cancer, regardless of clinical site or stage
* Planned to receive a course of MR-guided adaptive RT using the MRL
* Ability to provide informed consent

Exclusion Criteria:

* Patients under 18 years old
Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months

This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.

This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of NBP607-QIV compared to Agrippal which are indicated for active immunization for the the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled. Each subject is administered with single or two doses of vaccines depending on previous vaccination history, and randomly assigned in 2:1 ratio.

Stratified randomization for trial site and age strata is used to achieve the balance of treatment assignment.

Total of three or five visits are scheduled depeding on dosing schedule. For subjects assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity assessment before and 4 weeks after single vaccination at Visit 1 and 3 respectively. Safety is monitored 3 days, 4 weeks after vaccination through Visit 2\* and 3 (\* telephone contact). For subjects assigned to two-dose vaccination schedule, blood sampling is conducted before first vaccination and 4 weeks after second vaccination at Visit 1 and Visit 5 respectively. Safety is monitored 3 days, 4 weeks after each vaccination through Visit 2\*, 3, 4\*, and 5 (\* telephone contact)

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 35 months
* Those who were normal gestational age at birth (for children aged 6 months to \<1 year)
* Those who have provided written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study

Exclusion Criteria:

* Those with any immunodeficiency disease or malignancy
* Those with hypersensitivity to vaccination
* Those who are contraindicated for intramuscular injection due to thrombocytopenia or other coagulopathy
* Those with history of treatment with any of immunosuppressants or immunoregulators within 12 weeks prior to screening
* Those with history of receiving blood product or treatment with immunoglobulin within 24 weeks prior to screening
* Those with history of influenza vaccination within 24 weeks prior to screening
* Those with any severe chronic conditions that interfere with study participation
Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay

Patients of age \>18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups:

1. Patients admitted to the ICU in the first 3-4 months will have their bed head elevated to 15 degrees + H2 blockers administration + mouth wash BID
2. Patients admitted to the ICU in the following 3-4 months will have their bed head elevated to 30 degrees + H2 blockers administration + mouth wash BID
3. Patients admitted in the last 3-4 months will have their bed head elevated to 45 degrees + H2 blockers administration + mouth wash BID.

All patients will have their vital signs, BMI, and fluids ins and outs measured every 24 hours until the discharge from the ICU or death. All patients will be evaluated for GI functions (no vomiting, flatus+, bowel movement +, bowel sounds+, and KUB with normal gas distribution pattern) prior to oral intake.

Patients in the three groups will be matched by age, sex, and BMI with historical controls with broncho- aspiration (BA) (positive controls) and without BA events (negative controls) from a pool of 20,032 ICU admissions (01JAN2010 to 31DEC2019).


Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* All the patients admitted to ICU by surgery department.
* Development of aspiration pneumonia in patients admitted to ICU department of VA hospital.
* Aspiration Pneumonia development during hospital stay and treating physician indicated the diagnosis of aspiration pneumonia in history and physical exam notes.

Exclusion Criteria:

* Age \<18
* Patient transferred or admitted to the hospital as a primary diagnosis of aspiration pneumonia (development of aspiration pneumonia prior to admission).
* Treating physician not documented aspiration pneumonia in history or physical exam notes.
* Drug overdose, seizure or cardiopulmonary arrest prior to hospital admission.
Wideband Tympanometry in Otitis Media With Effusion

The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.

Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.

Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.

Eligibility Criteria:
Inclusion Criteria:

* All patients were diagnosed by ear examination, pneumatic otoscopy, and type B tympanogram with 226 Hz tympanometry. They were followed for 3 months with proper medication. After 3 months if there was no change with ear examination and 226 Hz tympanometry, surgical ventilation tube insertion was offered.

Exclusion Criteria:

* The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.
Evaluation Of Periodontal Health After Treatment With Hall Technique Versus Atraumatic Restorative Treatment in The Management of Carious Primary Molars

This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \&amp; ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to achieve better treatment for caries with pain-free procedures in developing countries that have high caries index and low income.


Eligibility Criteria:
Inclusion Criteria:

* Age: From 4 to 6 years.
* Caries in primary molars within enamel/dentin with vital pulp.
* Healthy children.
* Cooperative children.

Exclusion Criteria:

* Presence of signs and symptoms of necrosis.
* Root caries.
* History of Spontaneous pain.