cyrilzakka/clinical-trials huggingface dataset:
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.
* Obese (BMI ≥ 28 kg/m2) or overweight (24 kg/m2 ≤ BMI \< 28 kg/m2) with at least one comorbidity.
* Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
* Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).

Exclusion Criteria:

* Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.
* History of drug abuse prior to screening.
* History of alcohol abuse within 6 months before screening.
* Weight change of \> 5.0% within 3 months before screening (self-report).
* Presence of limb deformity or mutilation affecting height measurement.
The Correlational Study of PPV in Various VT in Mechanically Ventilated Patients

Mesquida, J et al showed there was a significant linear correlation between pulse pressure variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase of severe sepsis and septic shock. No study revealed the actual relationship between various PPV under different VT. So we hypothesized that there were relationship between various PPV in different tidal volume settings. The objective of this study was to examine the relationship between various PPV.


Eligibility Criteria:
Inclusion Criteria:

scheduled for elective abdominal surgeries ASA (American Society of Anesthesiologists) I or II BMI 18-25 preoperative examination is normal

Exclusion Criteria:

acute lung injure acute respiratory distress syndrome cardiovascular diseases neurological disease renal or hepatic disease diabetes mellitus BMI less than 18 kg/m2 or greater than 25 kg/m2
Breath Analysis Using an Electronic Nose in Non Alcoholic Fatty Liver Disease

The purpose of this is to analyse human exhaled breath by means of a device called electronic nose(eNose) in patients with non-alcoholic fatty liver disease (NAFLD) as a way to non-invasive assessment of liver disease.This device is medically adapted and clinically validated in patients with lung conditions.

Human exhaled breath contains over 3000 volatile organic compounds (VOCs) that vary in relative concentration in health and disease. Metabolic disorders affecting the liver, such as NAFLD, produce disproportionate organic compounds produced as a by-product of metabolism and thus expired in exhaled breath, excreted in urine and detectable in blood. NAFLD prevalence is increasing and has reached epidemic proportions affecting 90% of obese adults and 22%-53% of obese children.Liver biopsy is the gold standard in diagnosing NAFLD, but it is unpleasant and can lead to complications. There is an unmet need to develop a non-invasive method of assessing liver disease. Comon Invent (Delft, Netherlands) together with the respiratory department at the Amsterdam Medical Centre (AMC), University of Amsterdam, have adapted the electronic nose known as SpiroNose as a prototype device for clinical use. Sensitive electronic sensors detect molecules in breath and generate signals. Complex algorithms and analytical technics allow pattern recognition of breath samples from different subjects. Well charaterised patients will be selected into clinical categories of non-alcoholic fatty liver disease with and without cirrhosis and be compared with healthy individuals.

Edinburgh will be the only site conducting this study. In addition to exhaled breath analysis, blood and urine will be collected to study the end products of metabolism.Furthermore, stool and urine collected from some subjects will be analysed to understand the role of gut bacteria in fermentation, metabolic products as a result cause VOC production.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with no known or self declared medical illness with BMI (body mass index) within normal range (18.5-25)
* Non alcoholic fatty liver disease without cirrhosis
* Compensated (no evidence of ascites, encephalopathy) NAFLD cirrhosis; assessed by scoring system - Child's Pugh

Exclusion Criteria:

* Ongoing or recent (within last 6months) alcohol consumption more than 21 units per week for males and 14 units per week for females.
* BMI \> 40
* Chronic respiratory disease e.g. Chronic obstructive pulmonary disease (COPD), asthma, interstitial fibrosis
* Use of antibiotics within last 4 weeks of sample collection and inflammatory bowel disease, irritable bowel syndrome, celiac sprue, or other chronic inflammatory diseases of the intestines (for intestinal microbiome analysis)
* Other known liver disease e.g. Primary Biliary Cholangitis/cirrhosis (PBC), Alcoholic liver disease (ALD), Autoimmune and hepatitis
* Inability to provide informed consent.
* Participation in other clinical intervention/drug trial
Predicting Cerebral Palsy in Infants With White Matter Injury Using MRI

The goal of this study is to determin the MRI features associated with cerebral palsy and to develop prediction models of pediatric disorders by combining MRI with artificial intelligence.

The main questions it aims to answer are:

* How to achieve features on conventional MRI associated with cerebral palsy?
* How to predict the risk of cerebral palsy in infants aged 6 to 2 years based on conventional MRI and deep learning? Researchers will compare characteristics of periventricular white matter injury with cerebral palsy to those without cerebral palsy.

Participants will be asked to provide MRI data, clinical diagnoses information, and follow-up outcomes.

Cerebral palsy (CP) is a common group of movement disorders that often results in disability in children. In the context of CP, the importance of early diagnosis is crucial, but current diagnostic modalities often identify cases after the age of 2 years. After initial screening of infants at high risk for CP by behavioral scoring, magnetic resonance imaging (MRI) forms an integral part of the comprehensive evaluation. The training of conventional model of CP risk prediction requires a large investment of time and financial resources. The average sensitivity rate drops to 90%. Up to now, deep learning technology has been widely used in tasks related to image-based disease classification and has shown excellent performance.

Periventricular white matter injury (PVWMI) accounts for the largest proportion of various types of brain injuries in cerebral palsy, and the types of brain injuries in cerebral palsy are rich and complex, posing difficulties and challenges to deep learning models. Therefore, this study focuses on PVWMI, the most common type of cerebral palsy, and uses conventional MRI to develop a deep learning prediction model for CP in infants aged 6 months to 2 years old.

Eligibility Criteria:
Inclusion Criteria:

1. Infants and children at high risk of periventricular white matter injury (PVWMI) (gestational age \<35 weeks, birth weight \<2.6 kg, forceps-assisted delivery/fetal head attraction, Apgar score \<7, hypoglycaemia, sepsis, electrolyte disturbances, premature rupture of membranes);
2. Those who underwent MRI at 6 months of age-2 years, including at least T1WI and T2WI sequences;
3. Upon follow-up, the patient's clinical diagnosis: cerebral palsy, other diagnoses that did not develop into cerebral palsy, or inability to confirm the diagnosis).

Exclusion Criteria:

1. Incomplete MRI images or unreadable images due to motion artefacts;
2. Incomplete neurobehavioural assessment data (including: gross motor function).
Utility of PCD Diagnostics to Improve Clinical Care

This cross-sectional and longitudinal observational study is to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (PCD). There is new testing available, called nasal nitric oxide testing, that non-invasively measures nitric oxide levels in the sinus cavity. Individuals with PCD characteristically have low levels, but this testing does not have extensive data from everyday clinical practice. The objective of this proposal is to improve the diagnostic approach to children and adults with clinical concerns for primary ciliary dyskinesia (PCD).

This is an observational study to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (PCD). Participant selection will be on a referral basis for the consideration of a clinical suspicion for PCD. Participants will be identified by pulmonary providers that consider testing for PCD based on the clinical symptoms of the participant. These providers will then refer for enrollment in the study based on the clinical considerations for a diagnosis of PCD. Participants will be consented during the time of testing at the Pulmonary department. Any patient referred by a clinician for concerns for PCD, including those who have had PCD genetics sent, or a ciliary biopsy performed will be enrolled in the study. In addition, any participant who is referred for nasal nitric oxide testing and meets the inclusion and exclusion criteria for this testing, will also need to provide informed consent and be enrolled in the Nasal NO REDCap registry. This equipment is not currently FDA approved or CLIA certified for PCD diagnostic testing and therefore referring clinicians will be informed that the results of this test should not influence clinical decision making regarding the diagnosis of PCD. However, there is growing evidence that this testing has utility as a non-invasive screening tool for PCD and continued data from the general pediatric pulmonary population is needed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 2 years of age
* Must have two of the following clinical history points:
* Neonatal respiratory distress
* Chronic nasal congestion/runny nose
* Chronic cough
* Situs/laterality defects
* Bronchiectasis
* Ability to provide informed consent or consent of parent/guardian and ass

Exclusion Criteria:

* Recent history of sinus surgery or bloody nose in the past week
* Age \< 2 years of age
* Inability to tolerate probe in nose
* Sinusitis or other respiratory exacerbation currently being treated with antibiotics
* Admitted to hospital for respiratory exacerbation (inpatient status)
* Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by the IRB)
* Any other reason for which the study investigators feel the patient is not a good candidate to complete the testing
Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)

The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).


Eligibility Criteria:
Key Inclusion Criteria:

1. For patients with AMD:

   1. Active subfoveal choroidal neovascularization (CNV) secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA or OCT in the study eye, as determined by the investigator
   2. Men or women ≥50 years and older
2. For patients with DME:

   1. Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT)
   2. Men or women ≥18 years and older

Key Exclusion Criteria:

1. For patients with neovascular AMD:

   1. Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye
   2. Evidence of diabetic retinopathy (DR) or DME in either eye
2. For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
3. Prior IAI in either eye
4. IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an AE with any of these previous treatments that would preclude administration of drug in this study
5. Any prior treatment with angiopoietin inhibitors
6. Any prior systemic (IV) anti-VEGF administration
7. History of vitreoretinal surgery in the study eye
8. Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit
9. Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).
RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones

The goal of this observational study is to compare the safety and efficacy between RIRS with tip flexible pressure-controlling ureteral access sheath and mini percutaneous nephrolithotripsy（PCNL） for the treatment of 2-3-cm kidney stones.

Retrograde Intrarenal Stone Surgery (RIRS) has become one of the most common treatments for renal stones. The development of ureteral access sheath (UAS) is a significant advance in RIRS. In recent years, various improvements have been made to UAS, especially the emergence of a suction UAS and a tip flexible UAS. Using the advantages of suction and tip flexible technology, our team developed a tip flexible pressure-controlling UAS, which significantly improves the safety and effectiveness of RIRS. However, the current guidelines can recommend the indication of RIRS in kidney stones less than 2cm, and percutaneous nephrolithotomy(PCNL) is still preferred for kidney stones larger than 2 cm. Therefore, this study is the first to compare the safety and efficacy between RIRS with tip flexible pressure-controlling UAS and mini PCNL in the treatment of 2 to 3 cm kidney stones.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years
* American Society of Anesthesiology score 1-2
* Kidney stone diameter of 2-3 cm confirmed by CT
* Capable of giving written informed consent, which includes adherence with the requirements of the trial

Exclusion Criteria:

* Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit)
* Patients with uncontrolled UTI
* Patients with health or other factors that are absolute contraindications to RIRS or PCNL .Patients unable to understand or complete trial documentation.
Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders

The study aims to examine the effects of providing omega-3 supplements on young offenders' antisocial behaviour. Participants will be randomized into three groups: (1) Omega-3, (2) Placebo and (3) Treatment as Usual. Self report and correctional officer ratings of behaviour will be assessed at 0 months (baseline), 3 months (end of supplementation), 6 months and 12 months. The investigators hypothesize that omega-3 supplementation will reduce antisocial behaviour among the young offenders.

This study follows up on two prior omega-3 supplementation Randomized Controlled Trial (RCT) conducted on young offenders - one in the UK (Gesch et al. 2002) and the Netherlands (Zaalberg et al. 2009).

Eligibility Criteria:
Inclusion Criteria:

* Admission into young offender's institution

Exclusion Criteria:

* Allergy to fish and fish products
* Serious mental illness and intellectual disability
* Ability to read and write at the level required to complete self report questionnaires
A Study of BGM0504 Injection in Participants with Obesity or Overweight

This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.


Eligibility Criteria:
Inclusion Criteria:

* A male or female aged 18 to 65 years inclusive at screening
* BMI≥28 kg/m², or 24.0≤BMI\<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
* Weight change \< 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
* Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study

Exclusion Criteria:

* Diabetes mellitus
* Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
* Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
* Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
* History of pancreatitis
* Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
* Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt
Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum

Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.

Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.

Eligibility Criteria:
Inclusion Criteria:

* P.falciparum parasitaemia above 20/uL
* Resident in one of the four study villages

Exclusion Criteria:

* Fever
* Any other sign of clinical malaria
* Pregnancy
* Weight \<5kg
* History of hypersensitivity to any of the study drugs
* Treatment with any of the study drugs in the last 4 weeks
Bowel Preparation for Magnetic Resonance Enterography

Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. We present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for MRE in patients with Crohn's disease (CD).

This is a open label, multicenter, randomized controlled trial. 96 patients are planed to be 1:1 randomized into one of two groups: (1) Tube group, mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube; (2) Oral group, administer contrast solution orally, mid-gut tubing after the MRE examination. The primary outcome measures are: (1) grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention); (2) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring).

Eligibility Criteria:
Inclusion Criteria:

* Patients with CD need MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition);
* Age ≥ 14 years old.

Exclusion Criteria:

* Unable to understand or provide informed consent;
* Had difficulty in swallowing, or dysphagia;
* Allergic to laxative and/or contrast;
* Claustrophobia or implanted metal objects or cardiac pacemaker precluding performance of MRI;
* Known or suspected intestinal obstruction or severe stricture.