cyrilzakka/clinical-trials huggingface dataset:
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations

The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. 18-75 years old (inclusive of both ends)
3. ECOG score of 0 or 1.
4. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
5. Subjects with central laboratory- confirmed functional HER2 mutations
6. No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
7. Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
8. Protocol-defined adequate organ function including cardiac, renal, hepatic function

Exclusion Criteria:

1. Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
2. Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
3. Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
4. With poorly controlled tumor-related pain.
5. previous or current with other malignancies.
6. Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
7. Subjects with active or previous autoimmune diseases.
8. Subjects with uncontrolled or severe cardiovascular diseases.
9. Subjects with active hepatitis B or hepatitis C.
Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache

The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.

The secondary objectives of this study are to:

A. To evaluate the number of blood patches needed for each patient during her hospital stay B. Assessing the intensity of all headaches every 24H C. Evaluate the complications occurring during the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* The patient was informed about the implementation of the study, its objectives, constraints and patient rights
* The patient has signed the informed consent
* The patient must be affiliated or beneficiary of a health insurance plan
* The patient is available for follow up concerning her hospital stay
* The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency.
* The patient has an indication for a blood patch

Exclusion Criteria:

* The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47).
* The patient is in an exclusion period determined by a previous study
* The patient is under guardianship, curatorship or under judicial protection
* The patient refuses to sign the consent
* It is not possible correctly inform the patient
* The patient is pregnant
* The patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study
* The patient was delivered by cesarean section
Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety: A Cross-Sectional Study.

This study aims to evaluate the association between Molar-Incisor Hypomineralization, Maternal Stress and anxiety in a group of pediatric patients.

Molar incisor hypomineralization is a medical global condition characterised by a qualitative defect in the enamel mineralization affecting the first permanent molar teeth predominantly, and with or without the involvement of incisor teeth. MIH have various and major clinical challenges. Clinically the lesion appears with well demarcated opacity and porous with a color that ranges from white, creamy or yellow to brownish. Thus differ in its severity from mild to severe. The OHRQoL is a fundamental part of our children's general health and well-being but with the condition mentioned above their eating, sleeping, social interaction, self-esteem is being minimized and so the analysis of the etiological factors should be carried out.

Worldwide the prevalence of this condition, MIH was found to be from 2.4 to 40%, the reason behind this huge range difference is the use of different indices, diagnostic criteria, variability between examiners, lack of standardized methods of recording lesions and different age groups, while recent studies in Egypt reported 2.3% of MIH in a group of Egyptian children from 8 to 12 years in Cairo. Moreover, 878 million people across the world were MIH-affected and 17.5 million new cases are identified each year according to a study published 02 August 2022 in Egypt.

Despite the worldwide increasing interest in the causes of MIH, there is still insufficient evidence to verify the etiological factors of this condition, especially stress and anxiety. There is a potential relationship between stress and MIH, as glucocorticoids mainly cortisol have receptors on ameloblasts and so further research and population-based studies are urgently required to evaluate the prevalence of MIH and its association with stress.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric Patients with completely erupted at least one first permanent molar with MIH, based on a validated diagnostic criteria
* Children age range from 8 and 12 years
* Parents who agree and signed the consent for their children participation

Exclusion Criteria:

-Enamel defects only limited to the Permanent incisors; as the term MIH was chosen to always highlight the fact that molars are involved regularly in this condition, opacities on incisors only may relate to another origin of the defect and should not be referred to as MIH.
A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia

The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 \~ 79
* People who have not reached LDL-C targeted level in accordance with the guidelines for hyperlipidemia management released by Korean Society of Lipidology and Atherosclerosis
* In case of female participants taking combination HRT or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.
Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost

Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age

  * Diagnosis of open-angle glaucoma or ocular hypertension
  * IOP \> 16 mm Hg in each eye at the latanoprost -treated baseline evaluation
  * Presently on latanoprost monotherapy for at least 6 weeks
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication or allergy to brimonidine or any of its components

  * Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2%
  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator.
  * Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed).
  * Corneal abnormalities
  * History of intraocular surgery within the last 3 months
  * Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control
  * Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.
Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation

Many drugs have an influence on neuromuscular transmission. In clinical practice, neuromuscular blocking agents are commonly used, but even in the absence of neuromuscular blocking agents, anesthetic drugs can influence neuromuscular transmission. Especially volatile anesthetic agents have a clinical impact on neuromuscular transmission, they have been shown to prolong and deepen the effect of neuromuscular blocking agents. But even in the absence of neuromuscular blocking agents, volatile anesthetics can impair neuromuscular transmission. One mechanism of action is the desensitization of the acetylcholine receptors by shifting them from a normal to a desensitized state. This effect can weaken neuromuscular transmission by reducing the margin of safety that normally exists at the neuromuscular junction, or can cause an apparent increase in the capacity of neuromuscular blocking agents to block transmission.

In this study, the influence of sevoflurane and propofol on the maximum force, maximum speed of contraction and relaxation will be measured at the adductor pollicis in patients having general anesthesia without the use of neuromuscular blocking agents. Maximum force and speed of contraction and relaxation will be measured before and after anesthesia by either sevoflurane or propofol. Primary outcome is the influence of either anesthetic agent on maximum muscular force and speed of contraction - relaxation, and if this influence is greater for volatile anesthetic agents than for intravenous anesthetic agents.


Eligibility Criteria:
Inclusion criteria

* Patients (male or female) from 18 - 80 years
* Scheduled for surgery without the use of neuromuscular blocking agents
* Health care insurance in Belgium
* Written informed consent

Exclusion Criteria:

* Any pathology involving neuromuscular transmission
* Confirmed neuropathy of any origin
* Expected anesthesia duration \< 30 min
* Renal insufficiency defined as a glomerular filtration rate \< 40 mL/min/m2
* Hepatic insufficiency defined as an increase \> 1.5 \* normal value of hepatic enzymes
* Confirmed or suspected pregnancy
* Language barrier
* Any patient which will receive unplanned neuromuscular blocking agents during surgery
* Any history of personal or familial suspected malignant hyperthermia
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID-19 vaccination rates for pregnant people overall.

Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve COVID-19 vaccination rates for pregnant people. To address this, the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM COVID-19 intervention and the other half to standard of care. The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Eligibility Criteria:
Inclusion Criteria:

Patient criteria:

* Sex is female
* Pregnant
* Identified as being eligible for COVID-19 vaccine

Practice personnel criteria:

\*Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites

Exclusion Criteria:

\*None
Pharmacogenomic Research in Korean Patients With Hepatitis C

The aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C virus infected patients

Exclusion Criteria:

* Patients who infected Hepatitis B virus or Human immunodeficiency virus
* HCV infected patients previously treated with antiviral drugs
* Patients had a history of autoimmune hemolytic anemia
Efficacy and Safety of Polylevolactic Acid Injection Combined With 1565nm Non-ablative Fractional Laser in the Treatment of Striae Distensae

1. Striae distensae (SD), also known as stretch marks, are common, permanent dermal lesions that can be symptomatic and are considered aesthetically undesirable; thus, they pose a significant psychosocial and therapeutic challenge. SD arise in areas of dermal stretching and most commonly occur on the abdomen, breasts, buttocks, and thighs. Most literature has described SD during pregnancy(striae gravidarum) and puberty, with reported prevalences varying from 11% to 88%. Hormonal influences, reduced genetic expression of fibronectin, collagen, and elastin, and mechanical stretching of the skin have all been postulated to contribute to SD formation. In the acute phase, SD appear as red/violaceous lesions (striae rubrae; SR) that can be raised and symptomatic. The chronic form (striae albae; SA) exists as hypopigmented dermal depressions.
2. Polylevolactic Acid(PLLA) is at present one of the most promising biodegradable polymers (biopolymers) and has been the subject of abundant literature over the last decade. PLLA can be processed with a large number of techniques and is commercially available (large-scale production) in a wide range of grades.
3. Previous studies have found that 1565-nm laser can promote the synthesis of types I, III, and VII collagen and elastin, as well as the remodeling of dermal collagen. According to previous studies, dermal collagen deposition and remodeling may be related to the mechanism by which 1565-nm laser improves SD.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-50 years old, regardless of gender;
2. The clinical diagnosis was atrophic stria;
3. Patients with normal blood routine, liver and kidney function, and preoperative infection;
4. Able to communicate well with researchers and comply with the overall test requirements;
5. Willing to take and retain photos before and after treatment;
6. Volunteer and sign an informed consent form.

Exclusion Criteria:

1. Scar constitution;
2. Acute or chronic skin infections (including bacteria, viruses, and fungi) exist near the treatment area;
3. Those who are allergic to any component of the product;
4. Those who have been injected with anticoagulant drugs;
5. Those who have used other drugs, other substances, and other implant agents;
6. Patients with severe primary and psychiatric disorders such as heart, brain, liver, kidney, hematopoietic system, endocrine system, etc;
7. History of peripheral vascular disease, long-term alcoholism, diabetes, immunosuppression, disorder, drug abuse, etc;
8. Pregnant and lactating women;
9. Those who are critically ill and difficult to accurately evaluate the effectiveness and safety of the product.
Reducing Risk of Stroke and DementIa in PatientS with COVert CERebrovascular Disease

The purpose of the DISCOVER study is to pilot acceptable approaches to people with covert cerebrovascular disease (CCD) and their follow-up. This is the first step in designing efficient randomised trials of treatments to reduce the risk of stroke or dementia in people with CCD.

DISCOVER is a prospective cohort involving individuals with covert cerebrovascular disease (CCD) in NHS Lothian. Participants will be recruited through electronic health records and clinician collaborators. Participants will be monitored at 3 and 6 months and where possible 12 months to assess cognitive, functional, and vascular event outcomes.

Eligibility Criteria:
Inclusion Criteria:

* People who, at the time the letter is prepared or are identified by a clinician

  * Age ≥ 65 years
  * Have no known history of:

    * Stroke or TIA
    * Dementia
    * Parkinson's disease
    * Multiple sclerosis
    * Metastatic cancer (or non-meningioma brain tumour).
  * A CT or MRI scan report ≤5 years before study start date with of one or more of:

    * Cerebral small vessel disease
    * Deep old ischaemic stroke
    * Cortical old ischaemic stroke

Exclusion Criteria:

* Text of brain scan report unreadable
* Do not consent to take part in study procedures
* Unable to consent
* Unable to communicate by email, letter or telephone through language, speech disability or lack of address
* Unlikely to survive one year past enrolment in judgement of the study investigator
Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor

Objective of the study: to obtain new data on the dynamics of the labor process, cervix dilatation and head station on the labor process and to develop a new progress indices.

Background: the best method used today to supervise the labor process is to follow cervix dilatation and head station. Today, the physician or the midwife use manual examination to estimate cervix dilatation and head station. This examination is perform many times in a normal labor process, and even more if there is any delay. The information from these examinations is inaccurate and non-continuous. In case of delay in the labor process, the delay will diagnosed late, because the frequency of the manual examination is about once an hour.

With the assistance of the BirthTrack device we can get continuous data on the labor process and get indices to estimate the labor process progress without the use of vaginal (manual) examination.

40 women in an active labor will take part in the study.

Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we follow the cervix dilatation and the fetus head station.


Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous women 18 years or older admitted to the labor and delivery unit in active labor (3cm dilatation and contractions).
2. Parturients with epidural anesthesia
3. Singleton fetus in vertex presentation
4. Gestational age 37 or more
5. Reassuring fetal heart tracing
6. The woman is able to read and understand the consent form

Exclusion Criteria:

1. Parturients in natural birth without epidural anesthesia
2. Low lying placenta
3. Known or suspected fetal or maternal infection
4. Maternal thrombocytopenia
5. Maternal bleeding disorder
6. Known major fetal malformation
7. Suspected fetal growth restriction
8. Subjects with significant psychiatric history
9. Subjects with indication for immediate delivery
10. Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes
Clinical Efficacy of the Drug Ster® Compared With Predfort® in Control of Postoperative Inflammation in Cataract Surgery

Is the primary objective of this investigation to compare the clinical efficacy of the drug test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator - Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of postoperative inflammation in cataract surgery by phacoemulsification through periodic measurement of efficiency scores (number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds).

The secondary objective is to compare the safety data observed during the study period, ie will be assessed the frequency and intensity of adverse reactions and compared statistically between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all study procedures and sign, by his own free will, IC;

  * Adult patients, regardless of gender, ethnicity or social status, with good mental health;
  * Patients who present at screening visit, a clinical diagnosis of cataract with an indication for corrective surgery with phacoemulsification technique.

Exclusion Criteria:

* Patients with a history or clinical diagnosis of other eye diseases such as glaucoma, corneal ulcers, scarring, and uveitis;

  * Patients with known hypersensitivity to any component of the drug under investigation;
  * Patients who have made use of systemic corticosteroids within 15 days before surgery;
  * Patients who have made use of topical corticosteroids in the 7 days before surgery;
  * Patients who have made use of systemic antibiotics in the 15 days preceding surgery;
  * Patients who have made use of topical antibiotics in the 7 days before surgery;
  * Patients presenting abnormality, at the discretion of the principal investigator in the following ophthalmic examinations Preoperative slit-lamp examination, measurement of intraocular pressure (applanation tonometry) and examination of background, other than the underlying disease (cataract);
  * Pregnant or lactating women.