cyrilzakka/clinical-trials huggingface dataset:
Changes in Eye Shape With Myopia Management Interventions

The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:

* do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
* are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?

Participants will:

* have multiple different types of photos taken
* have their prescription for glasses/contacts checked
* have their eye health checked, including the use of dilating eye drops
* be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
* will complete five study visits over the course of 12 months

Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.


Eligibility Criteria:
Inclusion Criteria:

* best corrected visual acuity of 20/25 or better in each eye
* nearsighted
* current contact lens wearer
* normal binocular vision (to be determined by an examiner at the first study visit)

Exclusion Criteria:

* eye diseases (including lazy eye or eye turn)
* pregnant, nursing, or planning a pregnancy in the next 12 months
* history of refractive surgery (e.g., LASIK)
* history of myopia control treatment
* sensitivity to anesthetics or preservative in eye drops
* difficulty with pupillary dilation
The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis

Scoliosis specific exercises have been shown to improve curve progression but there have been few studies that compare the different exercise approaches in adolescent idiopathic scoliosis (AIS). The objective of this study was to compare the effects of Core stabilization (CS) exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to brace wearing in patients with AIS. It is important to compare different exercise methods on different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation, body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.

The aim of this study was to investigate whether adolescent with idiopathic scoliosis receiving scoliosis specific exercise approach, such as SEAS exercises, in accordance with the bracing approach for moderate curves would have greater improvement in curve progression, trunk deformity, body symmetry and quality of life than adolescent receiving exercise therapy based on the general core stabilization approach with similar intensity. Thirty female patients with AIS aged 12 to16 years, who have moderate curves (20 to 45 degree) randomly divided into two groups. One group received CS exercise, while other received SEAS exercise for forty-min once weekly for four months. Both groups underwent full-time bracing (23 hours per day) intervention. Outcome was based on Cobb angle, angle of trunk rotation, body symmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Walter Reed Visual Assessment Scale) and quality of life (Scoliosis Research Society - 22 Questionnaire) measured at baseline and after intervention period. Results were analyzed using the paired sample t-test to compare repeated measurements and independent sample t-test to compare the groups.

Eligibility Criteria:
Inclusion Criteria:

* The patients included in the current study were consecutive adolescents with idiopathic scoliosis seen in our department who were referred to receive both brace and exercise treatment conservatively. Additional inclusion criteria included the following: female gender; at least age 12 years; primary curve magnitude between 20 and 45 degrees of Cobb angle; double curve (right thoracic-left lumbar) or single thoracolumbar curve having an apex in the main thoracic region; Risser 2-3 and no previous treatment.

Exclusion Criteria:

* Exclusion criteria for both groups were as follows: evidence of congenital curve; neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases or surgical correction history.
Evaluation of Virtual Reality in Hazmat Training

Type of study: Two-group comparison.

Main question it aims to answer:

Does the use of virtual reality emergency scenarios provide a practical and effective tool to supplement traditional instructor-led training for first responder trainees?

A. For the traditional hazmat response training group; Traditional training will be held in the classroom environment for 45 minutes in the form of a lecture, then the training session will be terminated.

B. For VR hazmat response training group; After the traditional classroom session has ended, the participants will complete the additional VR training scenario, online content, and question-answer session. Once completed the session will be closed.


Eligibility Criteria:
Inclusion Criteria:

* currently enrolled in a hazmat training course

Exclusion Criteria:

* under the age of 18 or over the age of 65
Customized Orthosis for Children With Clubfoot

This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti casting, the implementation of customized AFOs with Ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with Mitchell shoes.


Eligibility Criteria:
Inclusion Criteria:

* less than 12 months old (no age minimum)
* no neuromuscular disease involved
* treated by Ponseti casting
* idiopathic bilateral or unilateral clubfoot
* no other congenital foot deformity
* no previous open surgeries to treat the deformity

Exclusion Criteria:

* patients with prior surgical treatment
* not treated by Ponseti casting
* an underlying syndrome
* neurological disorder
The Effect of Nutrition and Fluid Intake in the First Stage of Labor

Birth is a process that requires large amounts of energy. As a result of skeletal and smooth muscle contractions at birth, the body's basal metabolic rate, energy requirement, hydration requirement, and insensible fluid loss are significantly increased. Information regarding the safety and effectiveness of increased hydration during labor is still controversial. There is no consensus on whether this hydration should be given with intravenous solutions or orally. The study aims to determine the effect of fluid intake in labor on the delivery process, maternal-fetal outcomes, and postpartum satisfaction of the mother.

Method of Study: The study was planned as a randomized controlled experimental study to evaluate the effect of fluid intake during labor on mothers and babies.

Location and Characteristics of the Research: The research will be conducted in the delivery room of Sakarya Training and Research Hospital.

Population and Sample of the Study: The research will consist of pregnant women who apply to Sakarya Training and Research Hospital with signs of the onset of labor and will have an expected vaginal delivery in the delivery room. Annually, 7000-8000 women give birth in the hospital, and approximately 50% have an expected vaginal delivery. All pregnant women who met the sampling criteria and volunteered to participate in the study during the study's implementation will be included. The research will be carried out in 3 groups experimental and control groups. The study will be conducted with a total of 90 pregnant women, 30 of whom are in each group.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research
* Agreeing to abide by the protocol
* Being able to read and write,
* Ages 18-35 years
* 37-40 Pregnancy weeks
* First pregnancy,
* Single fetus
* BMI ≤ 28,
* Head presentation
* Cervical dilatation of \<6 cm or less (latent phase)
* Height ≥ 1.50 cm

Exclusion Criteria:

* Communication barriers (speech, hearing, mental),
* Disability (physical or mental problem, drug use),
* Chronic diseases (hypertension, diabetes, etc),
* Gastrointestinal problems before and during pregnancy
* Comply with the fluid intake protocol during labor,
* Pregnant women who are scheduled for elective cesarean section
* Pregnant women considered to be at immediate cesarean risks, such as diabetic pregnant women with cephalopelvic incompatibility, multiple pregnancies, preeclampsia, and macrosomic fetus
Efficacy of Near-Assisted Learning (NAL) in Improving Students' Objective Structured Clinical Examination (OSCE) Grades

This study aims to evaluate the impact of near-assisted learning (NAL) on first-year medical students' objective structured clinical examination (OSCE) grades in a problem-based learning (PBL) environment.

In this randomized controlled trial, 1st year medical students were recruited in the study along with selected highly-performing, trained peer-instructors. The participants were randomly allocated to two groups, an intervention group supervised by the instructors and the control group that had to practice independently. They would attend OSCE sessions and had their performance evaluated, later on, in an exam. In addition to comparing their performance with each other, scores of the previous batch were considered in the comparison.

Eligibility Criteria:
Inclusion Criteria:

* 1st year medical students.
* Medical students of Sulaiman Alrajhi Colleges.
* Males.

Exclusion Criteria:

* Students of other academic levels.
* 1st year medical students of other universities.
* Females.
Psychometric Qualities IPAQ-SF

This is an observational, prospective multicentric study designed to develop medical knowledge.

The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb amputee patients.

The questionnaire is administered twice to each patient, once during the consultation and again when they return home. Patients also undergo a 6-minute walk test.

This is an observational, prospective multicentric study designed to develop medical knowledge.

The IPAQ is an internationally validated questionnaire for measuring physical activity in healthy subjects.

The IPAQ-SF (short format of the IPAQ) assesses overall physical activity and sedentary time during the last seven days. The IPAQ-SF has been used in a population of lower limb amputees on several occasions, but no study of its psychometric qualities in application to this population has been performed to date.

The main objective of the study is therefore to gather a set of arguments allowing the IPAQ-SF to be used in the follow-up consultation of patients with lower limb amputations who are fitted with a device.

This would help health professionals to assess the physical activity of this population and to develop physical activity promotion interventions adapted to their needs.

This study is part of the standard management of patients with lower limb amputations and devices. In addition to the clinical data and the result of the 6-minute test from the classical management, the IPAQ-SF questionnaire will be completed twice by the patients included in this study:

* Once during the consultation,
* Once at home.

For the only center equipped (center 01) with inertial sensors, the gait parameters during the 6-minute test will be collected in order to extract fatigue indices.

Upon completion of the IPAQ-SF questionnaire a second time, the patient's participation in the study ends.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone a major lower limb amputation: transtibial, transfemoral, hip or knee disarticulation or trans-iliolumbar
* Fitting more than 1 year old
* Age 15-69 years (IPAQ-SF not validated outside these ages)
* All causes of amputation (vascular, traumatic, tumor, infectious...)
* Patient having given their informed consent
* Patient affiliated to a social security system

Exclusion Criteria:

* Subjects with bilateral amputations
* Inability to fully and adequately understand the questionnaire (i.e., cognitive impairment, patient does not speak French)
* Contraindication to the 6-minute walk test (chest pain, palpitations, mental confusion or lack of coordination and balance, dizziness or malaise, intolerable dyspnea, leg cramps or extreme leg muscle fatigue, any other clinically justified reason).
* Patients under legal protection (under guardianship, under curatorship, safeguard of justice)
* Pregnant or breast-feeding woman
A Volunteer Study to Collect Imaging Data for the Development and Validation of ScanNav Anatomy PNB

This is a single-centre, prospective, non-randomised volunteer study to be undertaken in Intelligent Ultrasound's offices at Hodge House, 114-116 St Mary Street, Cardiff, CF10 1DY, UK.

This is a single-centre, non-randomised, prospective study involving up to 100 participants. The data collected in this study will augment the data collected in ML2018_AG_01, ML2018_AG_02, IU2019_AG_03, and IU2020_AG_04.

Phase I Collect data from participants for each indicated block area. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.

Phase II Validation will proceed by feeding the videos into the ScanNav AnatomyGuide system and recording the output anatomy highlighting, overlaid on the original ultrasound image. The overlaid video will be examined by experts to identify safety and performance issues.

Eligibility Criteria:
Inclusion Criteria:

Potential participants who meet the following criteria will be considered eligible for the study:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

Potential participants who meet the following criteria will NOT be eligible for the study:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent;
3. Previous surgery or trauma to the affected area.
Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥22 years of age)
* Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.
* Admitted or intended to be admitted to the ICU
* At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of the earliest diagnosis of sepsis or septic shock.

Exclusion Criteria:

* Prisoners or imprisonment at time of enrollment
* Prior enrollment into this study
* Informed consent as approved by IRB is unable to be obtained.
Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer

RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse and death in women with operable breast cancer.In the North American Inter-Group factorial trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals (supported by the use of granulocyte-colony stimulating factor) were better than the conventional inconvenient weekly intervals.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-70 years female operable breast cancer patients
2. Patients were required to register within 60 days from the final surgical procedure required to adequately treat the invasive primary tumor.
3. women who had operable,histologically confirmed adenocarcinoma of the breast with a. histologically involved positive lymph nodes b. or histologic diagnosis for three negative patients; c. or lymph node negative, HER2 positive(if HER2 + +, FISH (fluorescence in situ hybridization method)/CISH tests confirmed HER2 amplification is positive),but unable or intolerant to herceptin combined chemotherapy.
4. Karnofsky points greater than or equal to 70.
5. Postmenopausal women or HCG test results were negative, Women of child-bearing potential willing to use effective contraception during the study.
6. PATIENT CHARACTERISTICS:

Hematopoietic:

* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal
* TBIL no greater than 1.5 times upper limit of normal
* AKP no greater than 2.5 times upper limit of normal
* AST no greater than 2.5 times upper limit of normal
* ALT no greater than 2.5 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

* No history of myocardial infarction
* No congestive heart failure
* No significant ischemic or valvular heart disease

Other:

* No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)

Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

-
Study of Jitongning Tablet to Treat Spondyloarthritis

This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage.

Jitongning Tablet is a kind of traditional Chinese medicine(TCM), consists of Cortex Eucommiae, Duhuo(Radix Angelicae Pubescentis), Zhichuanwu(Radix Aconiti) , Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Puerariae and Radix Glycyrrhizae. This study is being conducted to evaluate the efficacy and safety of Jitongning Tablet in patients with active axial spondyloarthritis (SpA) (Syndrome Of Kidney Yang Deficiency and Biood Stasis Stagnation), when compared with placebo and to explore the optimal dosage.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 65 years old (including 18 and 65) ;
* Meeting the diagnostic criteria for active axial SpA according to the the ASAS classification 2009, defined as satisfied 2 of the following:

  1. BASDAI score ≥ 4;
  2. In the assessment of pain numerical rating scale (NRS), spine pain NRS ≥ 4;
* Meeting the standard of TCM syndrome diagnosis for kidney yang deficiency and biood stasis stagnating syndrome;
* Sacroiliac arthritis of CT categories I(A)\~Ⅲ(B) (including I(A) and Ⅲ(B));
* Human leukocyte antigen B27 (HLA-B27) is positive;
* C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate raised;
* Voluntary signing of informed consent.

Exclusion Criteria:

* Those who use NSAIDs in the first 2 weeks of randomization;
* In the first 4 weeks of randomization, take disease-modifying antirheumatic Chinese herbal medicine or Chemical drugs (such as sulfasalazine ,methotrexate, leflunomide, Chloroquine, Total glycosides of Tripterygium, Cyclophosphamide, Azathioprine, etc),opioid analgesics(Methadone, Morphine, etc.) ,systemic glucocorticoid therapy;
* In the first 3 months of randomization, take biological agents that have been used for spinal arthritis;
* Those who have undergone spinal surgery or joint surgery within 8 weeks before randomization;
* Patients who received intra-articular injection, spinal or paravertebral injection of corticosteroids within the first 6 months of randomization;
* The spine is completely stiff (fused);
* Any Other rheumatic immune system diseases or immunodeficiency syndromes such as ulcerative colitis, psoriasis, uveitis, etc.
* Those who have a fertility requirement within 6 months;
* Women during pregnancy and lactation;
* Suspected or indeed drug use, substance abuse, alcoholism;
* In the first 3 months of randomization, take the test or in progress;
* Serious cardiovascular, Liver , kidney, brain, mental, neurological disorders that affect informed consent and/or adverse event expression or observation;
* Abnormal liver function(the AST or ALT value is above the upper limit of the normal); Abnormal renal function (serum creatinine is above the upper limit of normal);
* Due to other circumstances, the investigator considered it inappropriate for the participants.
AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT

National, retro- and prospective, observational, multicenter clinical research platform to connect clinical and genomic data of patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) with results from multi-gene next-generation sequencing (NGS) panels (\>30 genes)

The AIO-BNHO CONNECT research platform is a clinic-genomic database collecting data on NGS results and corresponding clinical outcomes in patients with advanced solid tumors (excluding NSCLC, SCLC, and mesothelioma). Data of deceased patients will be included. The platform will provide insight into the current state of precision oncology in Germany by compiling real-world data encompassing a broad spectrum of care providers including but not limited to practice-based oncologists, community hospitals, and university hospitals. The platform also comprises a decentral tissue repository with clinically annotated tumor specimens retrieved within routine clinical care that can be used in future collaborative research projects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced (i.e., locally advanced, inoperable, or metastatic) solid tumor, ineligible for curative surgery and/or curative systemic therapy
* Available results of commercial or non-commercial RNA- and/or DNA-based multi-gene NGS panels with \>30 genes analyzed; for non-commercial panels a list of all tested genes and multiple gene biomarkers (e.g., tumor mutational burden (TMB), microsatellite status) must be provided
* Age ≥ 18 years
* Signed and dated informed consent form (not applicable for inclusion of deceased patients)

Exclusion Criteria:

* Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)
* NGS results older than two years at the date of patient inclusion
Comparison of HES 130 in Balanced and in Unbalanced Solution

The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.


Eligibility Criteria:
Inclusion:

* Male or female (non pregnant) patients; between 18 and 70 years
* Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer
* General anesthesia
* Voluntary consent

Exclusion:

* Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV
* BMI \< 18 or \> 29
* Patients with daily urine output \< 1L
* Patients on hemodialysis
* Abnormal liver or renal function (i. e. above upper limit of normal range)
* Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal)
* Hgb \< 10g/dl or HCT \< 30%
* Potassium, sodium or chloride above the upper limit of normal of the laboratory
* History of diabetes mellitus
* Known history of a mental or neurological disorder, such as epileptic seizures.
* History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation
* Patients with known hypersensitivity and with contraindications to HES or any of the excipients