cyrilzakka/clinical-trials huggingface dataset:
The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.

Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.


Eligibility Criteria:
Inclusion Criteria:

* The BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereo vision is less than 80 seconds, far exotropia is less than 10 prism degrees, far esotropia is less than 6-8 prism degrees, and astigmatism is equal to or less than - 2.50 D;
* Myopia progressed more than 0.5D in the past year;
* Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
* Written informed consent of guardian and child.

Exclusion Criteria:

* Diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma, fundus diseases; present situation with anterior segment or posterior segment inflammation, such as acute conjunctivitis, iridocyclitis;
* Systemic diseases affecting drug use: albinism, epilepsy, serious mental and neurological diseases, congenital heart disease, arrhythmia;
* Atropine allergy;
* Very low birth weight infants with birth weight less than 1500g;
* Receiving other treatment to control the development of myopia, including anticholinergic drugs such as atropine, or participated in other functional frame lens, multifocal soft lens in the past one year;
* Other situations that not suitable for participating in the trial as judged by the researcher
Prevention of Infection in Indian Neonates - Phase I Observational Study

India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.

Invasive bacterial infections encompass clinical diagnoses of septicemia, pneumonia, and meningitis. Together, these infections are termed "neonatal sepsis" and account for over half of the newborn deaths at the district and sub-district level in India. Sepsis is the most common (80-90 percent) primary diagnosis for admission in Indian hospitals. Phase 1 of this study is a prospective, epidemiologic study involving over 1,000 community-based and hospital populations of newborn infants. It includes identifying all infants born in study hospitals and those brought to the hospitals with suspected sepsis; obtaining blood cultures from these infants and identifying the sepsis-causing bacteria; screening of all bacterial strains isolated from blood cultures for antimicrobial resistance; collecting basic demographic, risk factor, and treatment data on each case; and developing a computer-based system/network for data management. A village-level surveillance system was put in place to identify women during their pregnancy; monitor pregnancy outcomes; and establish a mechanism for referral of all potentially septic infants to participating clinics or hospitals for evaluation, including the collection of blood cultures. Potential sources of bacteria causing sepsis will be identified using molecular epidemiologic techniques. This involves matching septic infants' blood isolates with other colonizing isolates obtained from screening skin, throat, and stool cultures in the infant and skin and vaginal cultures from their mothers.

Eligibility Criteria:
Inclusion Criteria:

* Age \<60 days
* A diagnosis of suspected sepsis/pneumonia, based on the presence of at least one of the following symptoms at admission: poor feeding/poor sucking, decreased activity/lethargy, fever, hypothermia, cyanosis, diarrhea, abdominal distension, seizures, apneic spells, sclerema, bleeding, jaundice, tachypnea, chest wall retractions, shock.
* Born in one of the participating hospitals or in village inside catchment area If the screening physician does not suspect sepsis, even in the presence of one or more of the above signs, the baby should not be enrolled.

Exclusion Criteria:

• The presence of major congenital anomalies A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
Glucose-dependent INsulinotropic Polypeptide: Effect on Bone Remodelling and Cell Activity (GINEBRA)

Glucose-dependent insulinotropic polypeptide (GIP) is released by the intestines in response to food intake and increases insulin secretion. Although short-term (\< 3 hours) stimulation with GIP decreases bone resorption in humans, the effect may vanish following continuous administration within 24 hours, at least in patients with type 1 diabetes. Whether the anti-resorptive effect of GIP can be maintained if the hormone is non-continuously administrated is unclear. As the first GIP receptor (GIPR) agonist, tirzepatide was recently approved for the treatment of obesity and type 2 diabetes in the USA and type 2 diabetes alone in the EU, there is a need to establish knowledge about the long-term effects of GIP on bone health, including if different exposure times to GIP have different skeletal effects.

This project will investigate whether GIP maintains its anti-resorptive potential if given as intermittent compared to continuous infusion in healthy men and women aged 18-40 years. Administration cycles involve intermittent (8 hours daily) and continuous (24 hours daily) injection of GIP for three days each. The effect of GIP will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells (osteoclasts and osteoblasts) using bone marrow aspirates and bone marrow biopsies. Each participant will receive both administration cycles using a crossover design with a 14-28 days washout period between administrations of GIP.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pre-diabetes or diabetes (HbA1c \>42mmol/mol)
* BMI \>28
* fractures with \< 6months
* comorbidities/treatments that may influence bone metabolism or procedures - -- pregnancy
* inability to provide informed concent
Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.

The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.

Secondary objectives

1. To evaluate patient compliance over the entire duration of the screening program
2. To assess patient smoking cessation
3. To describe radiation doses received during CT scans
4. To identify organizational constraints for general practitioners
5. To compare stages at diagnosis before and after implementation of screening program

Conduct of research Eligible patients will be identified by general practitioners. Patients included will require a low-dose thoracic CT scan to be performed by a radiologist of their choice. Smoking cessation will be systematically proposed, and will be carried out by the general practitioner or a tobaccologist.

The radiation dose from thoracic CT scans should not exceed 100 mGy.cm Product Dose Length (i.e. \< 1.5 mSv). Imaging reports will be forwarded to the general practitioner.

If the first CT scan is negative (T0): a second scan will be scheduled 1 year later (T1). If this second scan is also negative, in the absence of lung cancer risk factors other than smoking, scans will then be performed every two years. In the presence of a risk factor for lung cancer (other than tobacco), screening will remain annual.

In the event of a result classified as uncertain: a follow-up scan is scheduled at 3 months ; if the follow-up scan is negative, the next screening will be scheduled 1 year after this follow-up scan. If the screening performed 1 year later is also negative, subsequent screenings will be performed annually.

In the event of a positive result: the general practitioner will refer the patient to a pneumologist of his/her choice for further examinations; data from these additional examinations will be collected.

The screening protocol may evolve in line with recommendations issued by the French National Authority for Health (HAS).

For participants undergoing CT scan at the imaging department of Emile Muller hospital in Mulhouse (GHRMSA), a blood sample will be collected (optional) for subsequent biomarker assays.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 to 74 years
* Smoking OR having smoked (withdrawal of \<15 years): ≥15 cigarettes/day for ≥25 years OR ≥10 cigarettes/day for ≥30 years
* Affiliated or beneficiary of a social security scheme
* Written informed consent

Exclusion Criteria:

* Inability to walk up two flights of stairs without stopping
* BMI \> 35 kg/m²
* Recent chest CT scan \< 1 year
* Personal history of lung cancer \< 5 years or under treatment
* Personal history of cancer being monitored by chest CT scan
* Contraindication to lung cancer treatment or diagnostic investigations
* Current or recent respiratory symptoms immediately suggestive of lung cancer
* Pregnant or breast-feeding woman
* Person under court protection, guardianship or curatorship
* Person deprived of liberty by judicial or administrative decision.
The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia

Aim: This study was planned for comparing physical activity levels, nutrition quality and quality of life of the individuals that are diagnosed with and without metabolic syndrome (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).

Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic characteristics of the individuals that participated the study were registered with a survey form. The long form of the International Physical Activity Questionnaire was used for determining physical activity levels of the individuals; whereas total numbers of daily steps were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS) was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for the assessment of health-related qualities of life of individuals and Beck Depression Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis and anthropometric measurements of individuals were also taken.


Eligibility Criteria:
Inclusion Criteria:

* Patients among the ages of 35-70,
* Suffering from LBP for at least 3 months,
* Diagnosed with LDH having at least 1 active trigger point that can be cooperated .

Exclusion Criteria:

* Those with LDH that show neurological symptom,
* Having any orthopaedic problem at lower extremity and lower back region,
* Having sacroiliac joint problem, diagnosed with lumbar spondylolisthesis,
* Having any neurologic, rheumatic, oncologic problem,
* Who received any physiotherapy program at least 6 months before, patients having any corticosteroid treatment or oral medication
* Those having needle phobia were not included in the trial.
Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury

The purpose of this study in patients suffering from acute lung injury is to determine whether positive end-expiratory pressure (PEEP) setting guided by electrical impedance tomography (EIT) influences pulmonary gas exchange, lung mechanics, ventilation/perfusion matching and homogeneity of regional ventilation when compared to other PEEP setting strategies such as the open lung concept or the ARDSnet protocol.


Eligibility Criteria:
Inclusion Criteria:

* acute lung injury, need for optimization of ventilatory settings

Exclusion Criteria:

* preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical instability, increased intracranial pressure
A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

The purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of uncomplicated malaria.

Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to malaria control. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is an evaluation of the phased introduction of combination anti-malarial therapy (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of effective regional drug policy and provide a database for decision-making on the implementation of CAT, it is essential that the in vivo response to CAT be investigated. This will be achieved through the SEACAT 01 protocol which is a component of the SEACAT evaluation described in another file on this website. However, in selected Mozambique sites where the intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate, AS, plus SP) will be conducted according to a specific amendment (Amendment 4) to the SEACAT 01 protocol. Amendment 4 is presented in this separate file on the website for clarity.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, older than 12 months.
* Weight \> 10 kg.
* Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.50C or history of fever.
* Documented informed consent.
* Lives close enough to the health centre for reliable follow up.

Exclusion Criteria:

* Has received anti-malarial treatment in the past 7 days.
* Is infected with other malarial species (such subjects will be excluded retrospectively).
* Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated).
* Has received cotrimoxazole or chloramphenicol in the past 7 days.
* History of G6PD deficiency.
* Is pregnant.
* Has a history of allergy to any sulphonamide (for SP) or artemisinin derivative (for artesunate and co-artemether).
Topical Treatment and Prevalence of P. Acnes

This study is about preventing surgical site infections of the shoulder. We hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of Propionibacterium acnes in the dermal layer.

P. acnes are skin pathogens known to cause surgical site infections despite proper preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the application of Choraprep prior to sampling. However, this study was limited as it failed to utilize a control group and only investigated one preparatory technique. Meanwhile, there remains to date no study investigating the effect of topical treatments. The purpose of this study is to investigate how specific topical treatments affect growth in the dermal layer. 12 volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch biopsies from their back above the scapular spine, with each biopsy taken from a region of the skin treated with a different topical (topical clindamycin alone, topical benzoyl peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df overall test of the treatment indicators will test for any differences in positivity for P Acnes among the treatments; pairwise comparisons among the treatments will adjust for multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of 0.05, and analyses will also be performed based on hemolytic subtypes.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer
* age \> 18

Exclusion Criteria:

* history of antibiotic use in the last month
* active acne on the back
* non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)
Immune Modulation by Exosomes in COVID-19

Following whole blood stimulation with mesenchymal stem cell derived exosomes, immune phenotype, cytokine release and mRNA expression patterns from critically ill patients with COVID-19 will be determined.

Critically ill patients with COVID-19 may develop lung failure and require extracorporal oxygenation due to hyperinflammation and progressive lung fibrosis. The anti-inflammatory and immune modulatory function of mesenchymal stem cells will be investigated by whole blood stimulation experiments using stem cell derived exosomes. Exosome preparations have been characterized by miRNA and protein expression patterns and suggest their tissue regenerative capacity.

The hypothesis of the present study is that mesenchymal stem cell derived exosomes attenuate inflammation and support anti-fibrotic pathways.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill COVID-19 patients with lung dysfunction
* COVID-19 WHO severity degree \>= 4, ARDS (WHO Definition 13 March 2020)
* Body weight \> 50 kg
* Informed consent

Exclusion Criteria:

* Pregnant or breast feeding women
Neurophysiologic Biomarkers in Rett Syndrome

The goal of this observational study is to identify candidate biomarkers in individuals with Rett Syndrome (RTT). The main questions it aims to answer are:

* Do these biomarkers change during clinical changes in individuals with RTT?
* Are biomarkers stable over time in clinically stable individuals?
* Do these biomarkers correlate with severity of RTT?

Participants will be asked to undergo an electroencephalogram (EEG) with measurements of Evoked Potentials (EP) to measure electrical activity in the brain.

Researchers will compare findings in individuals with RTT to those in typically developing individuals to see if there are differences between the two groups.

The main goal of the project is to identify potential biomarkers that can become measures for intervention and other translational studies and, at the same time, provide insight into abnormal synaptic activity and pathogenesis of RTT. Therefore, the proposed assessments will be performed with females with RTT and age matched typically developing females. These electrophysiological assessments will be compared to established clinical outcome measures from previous work in the NIH funded Rett and Rett related disorders natural history study. The neurophysiological parameters for RTT will be correlated with each other and also to disease staging, overall clinical severity scores and through exploratory analyses with specific clinical features. The investigators will also be testing procedures to perform the recordings, electrode types and placement, and ways to reduce movement and artifact within the data to establish best practices.

Eligibility Criteria:
Inclusion Criteria:

1. Rett Group: Females ages 3-18 (inclusive) with a clinical diagnosis of RTT with a likely pathogenic or known pathogenic variant in MECP2.
2. Likely Rett Group: Females from 1 year to \< 5 years of age with MECP2 variant if regression has not yet occurred or child is within 6 months of last skill loss.
3. Typically developing (TD) Group: Females age matched to RTT population (1-18) with no developmental or cognitive concerns as assessed using the Child/Adult Behavioral Checklist, Survey of Well-Being of Young Children (\<5yo), or the Wide Range Achievement Test-4 (\>5 yo).

Exclusion Criteria:

Rett and Likely Rett Groups:

1. Presence of a duplication in MECP2 or any other identified pathogenic mutation in another gene.
2. Active medical conditions not typically found in RTT.

Typically Developing Group:

1. Score below norms on the performance tests
2. Have a known neurological disorder (excluding migraine)
3. Being on neuroactive medications.
Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections.


Eligibility Criteria:
Inclusion Criteria:

* Planned cesarean section
* American Society of Anesthesiologists Class I-II

Exclusion Criteria:

* Patients refusing to enroll in the study
* Serious coagulopathy
* Serious systemic disease
* Story of allergy to drugs being used in the study
* Morbid obesity (Body mass index \> 30)
A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies

The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years old，Male or female;
2. Patients with pathologically confirmed advanced solid tumors who did not respond to standard treatment, did not tolerate standard treatment, or were determined by the investigator to be unsuitable for standard treatment;
3. ECOG PS score of 0-1;
4. Life expectancy of ≥3 months;
5. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Receiving chemotherapy, targeted therapy, immunotherapy, radical radiotherapy or surgical treatment for less than 4 weeks before study therapy (excluding tyrosine kinase inhibitors or other small molecule targeted drugs \< 2 weeks); Four weeks prior to the start of study treatment (patients who have entered the follow-up period measured by the time of last use of the experimental drug or device) were enrolled in another clinical study;
2. Drugs that affect the activity of metabolic enzyme CYP3A have been used in the past, and the eluting period from the end time to the first administration in this study is within 5 half-lives;
3. Patients with active TB within 1 year prior to the start of drug therapy or with a history of active TB infection more than 1 year prior to the start of drug therapy without proper treatment were studied;
4. Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.