cyrilzakka/clinical-trials huggingface dataset:
Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software

The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.

The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms.

The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for Contoura excimer laser vision correction
* Gender: males and females.
* Age: 20 or older
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Good ocular health, with no pathology that compromises visual acuity (other than refractive error)
* Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye being treated
* Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up to -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D
* Desire good vision at distance in both eyes

Exclusion Criteria:

* Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, Fuchs' dystrophy, etc.)
* Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or corneal transplant, DSAEK, DMEK, lamellar keratoplasty)
* Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
* Desire for good uncorrected near vision in one or both eyes
* Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial
* Unsuitability for the trial, in the opinion of the investigator, for any reason
* Pregnancy or desire to become pregnant during the trial
* Intraoperative complications.
Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients

Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes

This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a 1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period. All study procedure will be conducted after obtaining informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with type 2 diabetes.(World Health Organization classification) \> 20 years of age.
* Patients who have received stable doses of any OADs for at least 12 weeks prior to the screening visit.
* treatment with basal insulin plus OADs \>3 months with suboptimal glycemic control (HbA1c \>7%)
* FBG \<130 mg/dl or FBG ≥130 mg/dl, but daily insulin dose \>0.7U/kg or had history of nocturnal hypoglycemia
* Patients who are willing and able to cooperate with study and give signed informed consent.

Exclusion Criteria:

* Patients with type 1 diabetes.
* History of severe hypoglycemia or hypoglycemia unawareness within prior 6 months.
* Patients who had received any investigational insulin for more than 3 months or who have received investigational insulin treatment within 4 weeks prior to screening visit.
* Patients hypersensitive with insulin analog or its excipients.
* Patients who are currently pregnant/lactating, or who are preparing for pregnancy or lactation.
* Renal dialysis patients, patients with severe liver disease or congestive heart failure
* BMI \>40kg/m2
* Excessive insulin resistance (total daily insulin dose\>2.0unit/kg)
Fremanezumab Compassionate Use Program for Pediatric Patients

This is a Compassionate Use Program (CUP) based on a licensed physician's unsolicited request. Specifically, this CUP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).

Patients must have successfully completed the clinical trial according to the 30084 protocol, without any major protocol violations or tolerability issues, or who are anticipated to complete this trial within the next 2months, and whose Requesting/Treating Physician is requesting continued supply of the investigational medicinal product (IMP) known as TEV-48125 (fremanezumab) on behalf of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures
* In the opinion of your physician/investigator are able to continue IMP (fremanezumab) in a safe and compliant way.

Exclusion Criteria:

* Additional criteria may apply, please contact your physician/investigator for more information.
Metagenomic Sequencing in Clinical Infectious Diseases

Progress in the diagnosis of infectious pathogens depends on the development of effective methods and the discovery of suitable biomarkers. There are several kinds of methods that have been used in diagnosis of various pathogens, such as microscopic examination, culture, serologic diagnosis or molecular approaches, etc. However, these methods have similar limitations, that is, the single detection of reagents. More importantly, physicians seldom consider infections with rare pathogens. Recently developed metagenomic next-generation sequencing (mNGS) has the capability to overcome limitations of traditional diagnostic tests. This new technology could identify all pathogens directly from sample with a single run in a hypothesis-free and culture-independent manner. Studies have shown that mNGS is more sensitive than traditional culture method in clinical conditions such as blood stream, respiratory and general infections. More importantly, due to unbiased sampling, mNGS is theoretically able to identify not only known but also unexpected pathogens or even discovery novel organisms. It should be noted that mNGS also has some limitations such as human genome contamination and possibly environmental microbial contamination. The vast majority of reads in mNGS are derived from human host. This would impede the overall analytical sensitivity of mNGS for pathogen detection. Host depletion methods or targeted sequencing may help to partially mitigate this disadvantage. As mNGS could not, by itself, define whether the detected microbe is the causative pathogen or environmental microorganism, a multidisciplinary discussion by clinicians, microbiologists as well as the lab technicians is required to interpret the result.


Eligibility Criteria:
Inclusion Criteria:

* All the patients have received mNGS testing in clinical practice.

Exclusion Criteria:

* Interruption of patient treatment process and incomplete information
Intestinal Transport of Microbial Metabolites in Chronic Kidney Disease

Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Mechanisms governing their intestinal uptake and metabolism, however, are currently unknown. The investigators aim to explore these transport characteristics in depth. Therefore, colonic biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to available data of healthy controls. Insights in the mechanisms controlling intestinal transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it might lead to novel therapeutic targets in the treatment of chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 85 years
* Chronic kidney disease ≤ stage III (KDOQI), i.e., estimated glomerular filtration rate (MDRD) \< 60 ml/min/m² or need of dialysis therapy 27
* Scheduled colonoscopy for diagnostic purposes
* Written informed consent

Exclusion Criteria:

* History of gastro-intestinal disease (e.g., inflammatory bowel disease)
* History of colon surgery
* Recipient of a renal or other solid organ transplant
* Exposure to antibiotics or drug therapy with a known influence on intestinal transporters (e.g., P-gp) or enzymes during 2 weeks before colonoscopy
Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)


Eligibility Criteria:
Inclusion Criteria:

-Male and female patients aged 20 to 60 years;Presence of mono-infection of P. falciparum or P. vivax; Weight between 40 kg to 90 kg.

Exclusion Criteria:

* Patients with signs and symptoms of severe/complicated malaria
* Infection with more than one parasite species
* Women of child-bearing potential; pregnant or nursing women
* Those who have taken any anti-malarial treatment in the preceding 14 days or other investigational drugs within 30 days or 5 half-lives
The Morphology and Parameter Estimation of Cranial Ultrasound Spectrum Based on Cerebral Artery

1. Observe the changes of TCD/TCCD spectrum shape before and after lumbar puncture in patients with severe neurological disease.
2. Discuss the TCD/TCCD spectrum shape and parameters of cerebral arteries and neurocritical patients Correlation of intracranial pressure.

After entering the ICU, the subjects who meet the standards will undergo a full-body physical examination and basic vital signs assessment and monitoring, which mainly include specialized examinations of the nervous system, multimodal brain function testing, respiratory system monitoring and management, hemodynamic monitoring, and APACHEⅡ Score, GCS score, and perform routine general circulation, breathing management, sedation and analgesia management, temperature management, osmotic pressure management, lumbar puncture pressure measurement

Eligibility Criteria:
Inclusion Criteria:

Aneurysmal subarachnoid hemorrhage (aSAH), traumatic brain injury (TBI), acute deficiency Blood stroke (AIS), acute cerebral hemorrhage (ICH), hypoxic ischemic encephalopathy (HIE), Sepsis-associated encephalopathy (SAE), intracranial tumor surgery; older than 18 years old, \<85 Years old; patients who need lumbar puncture.

Exclusion Criteria:

1. Age \<18 years old;
2. Pregnancy;
3. The condition of the temporal window is limited and the image cannot be obtained;
4. The frequency spectrum of bilateral cerebral arteries shows stenosis;
5. Patients with cerebral artery stenosis
6. Patients who have not obtained informed consent;
Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia

A randomized, open-label, multicenter study to compare the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).

This is a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed, treatment naïve ITP patients
2. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
3. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received first-line and second-line ITP-modifying therapy (any previous dose of corticosteroids or other immune-suppressive agents);
2. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
3. Active or a history of malignancy;
4. Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
5. Pregnancy or lactation;
6. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN);
7. Current or recent (\<4 weeks before screening) clinically serious viral, bacterial, fungal, or parasitic infection;
8. A known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
9. Patients who are deemed unsuitable for the study by the investigator.
Quantifying Congestion by Ultrasound

The investigators will determine the feasibility of identifying and quantifying changes in interstitial and intravascular congestion by imaging in participants with heart failure. The investigators will either continue or temporarily suspend both loop diuretics and mineralo-corticoid antagonists (MRA) for 48 hours in participants with heart failure that is both stable and mild and compare measurements of interstitial (B-lines) and intra-vascular fluids (IVC and JV diameter and renal venous flow) by ultrasound and, in a subset of participants without contra-indications, by cardiac MRI.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of heart failure
* Plasma NT-proBNP \>125ng/L or BNP \>35 ng/l
* Left ventricular ejection fraction (LVEF) \<50% on prior imaging test
* Treated routinely with a daily dose of loop diuretic
* Receiving other guideline-indicated therapy for heart failure
* Willing to sign the informed consent form
* Greater than 18 years of age

Exclusion Criteria:

* Chronic Kidney Disease Stage 4 or worse (eGFR \<30 mL/min/1.73 m²)
* Atrial fibrillation
* Significant valve disease (investigators opinion)
* Breathlessness or chest pain at rest or minor exertion
* Patients unable to lie flat
* Patients deemed too unstable to miss treatment with diuretics for 48 hours
* Patients taking part in another interventional trial
* Any other concomitant condition that in the opinion of the investigator would not allow a safe participation in the study (ie:-pregnancy, significant frailty)
* Patients unwilling or unable to consent
* For patients willing to undergo MRI; contraindication to MRI including claustrophobia, metalworkers, and intra-orbital or intracranial metal (eg:- stents), and non-MRI compliant device.
Maternal Betaine Supplementation During Breastfeeding

Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Our previous results in humans demonstrate that lower breast milk betaine levels were associated with faster infant postnatal growth, a strong and potentially modifiable risk factor of future obesity. Betaine is a trimethylated derivative of glycine, which is present in multiple foods and occurs naturally in breast milk. In this study, we will perform a double-blind randomized placebo-controlled pilot clinical study, in which maternal diet will be supplemented with betaine for 3 months during breastfeeding; infant's growth and adiposity will be monitored until 12 months of age, and breast milk composition and gut microbiota analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Maternal Pre-pregnancy BMI between 25 and 40.
* Willing to exclusively breastfeed for ≥ 3 months
* Infant gestational age at birth \> 37 weeks
* Infant birth weight \> -1 standard deviations
* Absence of infant disease or malformations at birth

Exclusion Criteria:

* Multiple pregnancy
* Lactose intolerance
* CBS deficiency (inherited disease)
Prevention of Seasonal Affective Disorder

This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).


Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.

Exclusion Criteria:

* Patient has a current or past history of seizure disorder or brain injury.
* Patient has a history or current diagnosis of anorexia nervosa or bulimia.
* Patient has recurrent summer depression more frequently than winter depression.
* Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
* Patient has initiated psychotherapy within the last 3 months.
Knee Registry (Knieregister)

Rationale: In view of patient care, patient characteristics and treatment parameters are registered for all patients visiting the Mobility Clinic of the University Medical Center Utrecht for orthopaedic knee treatment. Patients also fill out questionnaires for function, pain and mobility of the knee, before and after treatment.

Objective: The main objective of this registry is to collect patient characteristics and treatment parameters together with data from the questionnaires in a database. This knee registry can be used for future research questions.

Study design: This is a longitudinal observational registry.

Study population: All patients that visit the Mobility Clinic will be asked to participate in the knee registry. Patients that meet one or more of the following criteria will be excluded: are below the age of 16, not able or willing to sign the broad consent form, not being able to read and understand Dutch language, or receiving medical treatment for their knee elsewhere.

Main study parameters/endpoints: Data will be collected for future research for which the purpose is not known at this time. When new research will be conducted, study parameters will be set. A study application has to be submitted to the institutional ethical review board of the University Medical Center Utrecht. Patients do not need to be asked permission for the use of their data for each study individually. Only when additional information is needed.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for patients to participate in this registry is minimal and consists of time. Any future results may be beneficial for patients. Participation or refusal to participate in the registry has no consequences for their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Receives orthopaedic knee surgery or conservative knee treatment (advice, physiotherapy, injections etc) at the UMC Utrecht;
* Able to read and understand Dutch language;
* Is able and willing to signs the broad consent form.

Exclusion Criteria:

* Receives no treatment (refusal of surgery or treatment);
* Receives treatment elsewhere.
Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism

A substudy of TMC114FD2HTX4004 that will perform glucose tolerance testing, adipose testing and MRI scan at baseline, 12 and 24 weeks post switch of ART medications.

Synopsis Full study title: Assessing the impact of integrase strand transfer inhibitors (INSTI) to protease inhibitor (PI) switch on insulin sensitivity and fat metabolism (ADIPOSITY): a sub-study of DEFINE

Endpoints and objectives:

The following endpoints will be determined 12 and 24 weeks after switch from an INSTI-based antiretroviral therapy (ART) regimen to a PI-based regimen:

Primary endpoint: Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).

Secondary endpoints: 1) Change in insulin sensitivity (SI) at 24 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT); 2) Change in insulin secretion during the fsOGTT assessed by using C-peptide deconvolution; 3) Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI); 4) Change in adipocyte size by the osmium tetroxide fixation technique; and 5) Change in expression of genes associated with adipose tissue development, lipogenesis, inflammation and endocrine function by RNA sequencing.

Hypothesis: Insulin sensitivity will improve following switch from INSTIs to PIs

Eligibility Criteria:
Inclusion Criteria:

* • Must be enrolled in the DEFINE study TMC114FD2HTX4004

  * Must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study.

Exclusion Criteria:

* • Contraindication to magnetic resonance imaging as determined by institutional policy.

  * Current diagnosis of diabetes mellitus