cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Plasma Non-coding RNAs as Biomarkers in Coronary Heart Disease

The purpose of this study is to determine whether the expression level of miR-320a are effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. the most recent symptoms of coronary heart disease within 7 days;
3. meet one of the following conditions: A. clinical history of typical ischemic chest pain (more than 5 minutes of persistent chest pain); B. serum cardiac biomarkers positive (TnT/I or creatine kinase peak greater than 99% of URL); C. Electrocardiogram changes of myocardial ischemia.

Exclusion Criteria:

1. pregnant women or plan to;
2. participate in any drug clinical trials within 3 months;
3. patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
4. serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
5. previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
6. patients refused to comply with the requirements of this study to complete the research work;
7. according to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).
Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
* Good general health.
* Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
* Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
* Administration of any investigational drug or device within 14 days of study initiation.
* Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
* Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
* Post-refractive surgery.
* Currently pregnant or lactating by case history.
* Other protocol-defined exclusion criteria may apply.
A Prediction Model for 1-year Mortality After Valvular Heart Surgery

The investigators aimed to develop a predictive model for mortality incorporating nutritional, inflammatory, and perioperative factors in patients undergoing valvular heart surgery. In this retrospective study, the investigators aimed to establish a comprehensive prediction model to predict the risk of 1-year mortality in valvular heart surgery patients through the identification of the inflammatory index most associated with 1-year mortality and developing a prognostic nomogram model incorporating perioperative risk factors with nutritional and inflammatory indices that would be verified by validation cohorts.


Eligibility Criteria:
Inclusion Criteria:

1) patients who presented for surgery primarily due to valvular heart disease, including those who required concomitant coronary artery bypass surgery, aortic procedures, or other cardiac procedures.

Exclusion Criteria:

1. patients aged \<18 years
2. undergoing transcatheter valve replacement, combined congenital heart surgery, or implantation of ventricular assist device, 3) lacking data required for calculating inflammatory indices, or 4) follow-up loss.
Risk Factors and Impact of Anesthesia Techniques on Myocardial Infarction Following Transurethral Resection of the Prostate

This study examined the risk factors and the influence of the type of anesthetic used during transurethral resection of the prostate (TURP) on subsequent incidence of myocardial infarction (MI).

This study utilized a population-based, nationwide dataset to evaluate the risk factors of MI for patients with benign prostate hypertrophy (BPH) who received TURP. Besides, The study also compared the different effects of general anesthesia (GA) and neuraxial anesthesia (NA) on the incidence of MI within 6 and 12 months after TURP.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving TURP surgery (1998-2012)

Exclusion Criteria:

* Patients without anesthesia records
* Patients receiving both general and neuraxial anesthesia
* Mortality within 12 months of TURP
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)

The main purpose of this study was to evaluate safety and efficacy of a single injection of MIJ821 in addition to standard of care (SoC) pharmacological anti-depressant treatment in participants with treatment-resistant depression (TRD)

The trial included a screening period of up to 28 days. On Day 1, after screening, eligible participants were randomized to one of the treatment arms (1 mg, 4 mg, or 10 mg of MIJ821) or placebo and received study treatment administered as a single subcutaneous injection. Participants remained at the clinic for at least 4 hours after administration of study treatment for safety observation including assessment of local tolerability by visual inspection of the injection area. Post-dose clinic visits occurred 24 hours post dose (Day 2), Days 8, 15, 22 and 29 to evaluate efficacy and safety. Efficacy assessments included the Montgomery-Asberg Depression Scale (MADRS) and other clinical outcome assessments (COAs). Safety assessments included laboratory tests, ECGs, vital signs and physical examinations. In addition, phone calls were conducted 3 days after each on-site clinic visit with the exception of the End-of-study (EOS) visit. EOS visit was completed on site on Day 29. Including screening, participants were in the study for up to 8 weeks (57 days).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained prior to participation in the study
* Male and female participants, 18 to 65 years of age (inclusive) at screening
* DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE)
* MADRS score ≥ 24
* Failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants

Exclusion Criteria:

* Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
* Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening
* Participants with current borderline personality disorder or antisocial personality disorder
* Current clinical diagnosis of autism, dementia, or intellectual disability
Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel

The FilmArray Meningitis/Encephalitis (ME) Panel (hereinafter referred to as FilmArray ME Panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.


Eligibility Criteria:
Inclusion Criteria:

* Residual cerebrospinal fluid samples after routine tests;
* Samples obtained by lumbar puncture;
* Sample volume is not less than 0.5 mL;
* Samples that have not been centrifuged;

Exclusion Criteria:

* Samples from repeatedly enrolled patients;
* Samples that have not been preserved as required
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm

This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with benign essential blepharospasm
* Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
* Combined Jankovic Rating Score of \>2

Exclusion Criteria:

* Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
* Profound atrophy of the muscles in the target area(s) of injection.
* Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
* Known significantly impaired renal and/or hepatic function
The Effect of Vitamin D on Urinary Calcium Excretion in Kidney Stone Formers With High Urinary Calcium

The investigators hypothesize that a 3 month course of vitamin D supplementation to treat 25(OH)D deficiency in stone formers with high levels of 24-hour urinary calcium will not increase urinary calcium excretion by greater than 10%.

We plan to conduct a clinic-based interventional study of 30 patients followed at Brigham and Women's Hospital with history of nephrolithiasis, urinary calcium excretion between 200 and 400 mg/day, and 25-vitamin D deficiency (defined as serum level ≤ 25ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks \[1\], and each participant will serve as his own control. The outcome is the change in urinary calcium excretion. The planned study duration is 3 months. We will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium

Eligibility Criteria:
Inclusion Criteria:

* History of nephrolithiasis
* 25(OH)D deficiency (defined as serum level ≤ 25ng/ml) within 3 months of enrollment
* 24-hour urinary calcium excretion \> 199 mg/day and \< 400 mg/day (measured less than 6 months prior to study enrollment)

Exclusion Criteria:

* Non-Caucasian
* Women of child-bearing age (age \< 50)
* Known uric acid, cystine, or struvite stone disease
* Hypercalcemia (serum calcium \> 10.4 mg/dl within the past 12 months)
* Gross hematuria within the past 6 months
* Acute stone event within the past 2 months
* Recent stone intervention within the past 1 month
* Suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer)
* Addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

As part of this study, to avoid surgery, the doctor will use a 3-dimensional (3D) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patient with indication for implantation of a classic multisite pacemaker;
* New York Heart Association II/IV patient despite optimal medical treatment;
* Patient with left ventricular ejection fraction ≤35%;
* Patient with a widened QRS \> 120ms;
* Patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed);
* Patient with failure of resynchronization via the endovenous route due to difficulty in accessing the coronary sinus or instability in the coronary sinus;
* Patient having been informed and having signed an informed consent form;
* Patient able to understand the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), and to complete questionnaires.

Exclusion Criteria:

* Patient with resynchronization failure due to occlusion of the superior vena cava;
* Patient with no usable lateral coronary sinus vein;
* Patient with a life expectancy \< 3 months;
* Patient wearing a vena cava filter;
* Patient with active sepsis;
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.

This is a Phase 3, parallel group, multicenter, rollover study in participants with CF who are homozygous or heterozygous for the F508del CFTR mutation and who previously participated in Study 103 (Study VX12-809-103, NCT01807923), Study 104 (Study VX12-809-104, NCT01807949), or Cohort 4 of Study 102 (Study VX09-809-102, NCT01225211).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF), and where appropriate, signed assent form.
* Participants entering the Part A Treatment Cohort: Completed 24 weeks of study drug treatment in Study 103 or Study 104 and elect to enroll in Part A treatment cohort.
* Participants entering the Part B Treatment Cohort: Completed 56 days of study drug treatment in Cohort 4 of Study 102 and elect to enroll in Part B treatment cohort.
* Participants entering the Part A Observational Cohort: Completed 24 weeks of study drug treatment in Study 103 or Study 104, but do not elect to enroll in the Part A Treatment Cohort or do not qualify to enroll in Part A treatment cohort.
* Willing to remain on a stable CF medication regimen through the end of study (Part A and Part B Treatment Cohorts only).

Exclusion Criteria:

* Any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant (e.g., cirrhosis with portal hypertension).
* Pregnant and nursing females. Females of childbearing potential must have a negative pregnancy test at the Day 1 Visit.
* History of drug intolerance in the prior study that would pose an additional risk to the participant in the opinion of investigator or Vertex.
* History of poor compliance with study drug and/or procedures in the previous study as deemed by the investigator.
* Participation in an investigational drug trial (including studies investigating lumacaftor and/or ivacaftor, or studies requiring blood collections with or without administration of study drug)
Orthodontic Archwire Effectiveness Trial

This study protocol is for a randomised clinical trial which aims to test two materials used as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi) archwires. Both professional and patient related outcome measures are to be used to fully evaluate performance.

This is a randomised clinical trial of Firewire and CNiTi as orthodontic aligning archwires. A two group single blind parallel multicentre study design in a National Health Service primary care setting in England will be used.

Patients will be recruited from those attending the practices for orthodontic treatment that meet the inclusion and exclusion criteria. Online randomisation will allocate to one of the two groups, stratified by centre and age group (adolescent / adult).

Sample size calculation indicates a total sample size of 42, but allowing for dropouts and missing data the investigators will recruit 64, 32 to each group.

Patients will be treated according to a strict clinical protocol including customised Damon Q fixed appliances and defined archwire sequence. Participants will be seen at initial 5 week intervals for data collection after new archwire placement, and otherwise at routine 10 week intervals.

Primary outcome data (rate of alignment) will be collected over the initial 10 weeks and secondary outcomes over the duration of the treatment (18 months approx).

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older
* Class 1 Incisor relationship (British Standards Institute Classification)
* Labial segment crowding in upper and / or lower arch \>4mm
* Little's Irregularity Index in upper and / or lower arch \>4mm
* Eligible for NHS orthodontic treatment
* Planned non-extraction upper and lower fixed appliance orthodontic treatment

Exclusion Criteria:

* Previous fixed appliance orthodontic treatment
* Previous functional appliance treatment
* Planned use of fixed auxiliary appliances (e.g. quadhelix, Trans Palatal Arch)
* Cleft lip and palate or other craniofacial anomalies
* Hypodontia (excluding third molars), or missing teeth due to previous extraction
* Abnormal root morphology on pre-treatment radiographs
* Confirmed history of nickel allergy
* A medical history resulting in them taking analgesics for a chronic condition
* Limited mouth opening or other contra-indication to intra-oral scanning
Adverse Events in Dry Needling

The purpose of this prospective cohort survey study is to further explore the incidence of adverse events with dry needling by physical therapists - as well as any differences or similarities between patient-reported vs therapist-reported incidence of AEs.

The study design will comprise of an observational study, where practicing clinicians will log data from dry needling sessions and patients will report via online surveys. Clinician logs will be collected weekly via an online REDCap survey . Patients will be instructed to complete an online REDCap survey in the event that an adverse event occurs. Data will be collected for a period of 4 mo.

Descriptive statistics will be used to calculate frequencies of various AE's and rates of occurrence per 100 treatments. Adverse events will be classified on how frequently they occur, ranging from very common (\>1/10 treatments) to very rare (\<1/10,000 treatments).

The investigators will then examine for differences between patient-reported and clinician-reported incidences and also explore for any correlations between adverse events and other various reported factors.

Eligibility Criteria:
Inclusion Criteria:

* Any patient that receives dry needling as a part of their care by a physical therapist and consents to provide information

Exclusion Criteria:

* Does not receive dry needling or does not consent to provide information
Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.

Metformin is a safe, well-tolerated oral biguanide widely used as first-line therapy for type 2 diabetes for over 50 years. In addition to its glucose-lowering effects, metformin modulates inflammatory and metabolic factors resulting in weight loss and reduced inflammation and plasma lipids. Data from animal studies suggest that metformin could limit OA development and progression, possibly through activating AMPK.

Retrospective cohort study of participants with OA and type 2 diabetes reported that patients receiving a combination of cyclooxygenase-2 inhibitors and metformin therapy had a lower risk of joint replacement than those receiving cyclooxygenase-2 inhibitors alone .

These findings shed light on possible therapeutic potential of metformin in treatment of OA.

Eligibility Criteria:
Inclusion Criteria:

* Patients have symptomatic and radiological evidence of OA in one or both knee joints.
* Age ≥ 45 years.
* Both obese male and female will be included (BMI ≥ 30 kg/m²).

Exclusion Criteria:

* Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA.
* Patient with hypertension or diabetes mellitus.
* Patient with hepatic or renal impairment.
* Patients who have active peptic ulcer.
* Patients with positive malignancy.
* Steroid injection into the affected knee joint within 3 months of recruitment for the study.
* Pregnant or lactating female patients.
Using Chronobiology to Improve Lenvatinib Efficacy

The goal of this proof-of-concept clinical trial is to assess the efficacy and safety of chronobiology implementation into lenvatinib treatment regimens of thyroid cancer patients, via a mobile application.

Participants will use a mobile application to follow variability-based physician approved drug administration schedules.

Systemic treatments for thyroid cancer have emerged in the past decade, accompanied by a deeper understanding of its underlying molecular mechanisms. Among these, lenvatinib, a multi-targeted tyrosine kinase inhibitor, was approved as a monotherapy for treating locally advanced or metastatic radioactive iodine refractory differentiated thyroid cancer. Despite its efficacy, lenvatinib is associated with a spectrum of adverse events (AEs), including hypertension, fatigue, proteinuria, and gastrointestinal disturbances, which often necessitate dose reduction, interruption, or permanent discontinuation. To overcome these challenges, the investigators address to the Constrained Disorder Principle (CDP), an innovative approach that emphasizes the exploration of constrained variability in treatment regimens to optimize drug effectiveness and minimize AEs. In other disease contexts, such as congestive heart failure, multiple sclerosis, and chronic pain, the integration of CDP-based second-generation artificial intelligence (AI) systems into treatment regimens has shown promising results in enhancing therapeutic outcomes by dynamically adjusting treatment parameters. The investigators hypothesize that a personalized dynamic adjustment of lenvatinib dosages and administration timing, guided by an AI-driven approach via a mobile application, may reduce AEs, improve adherence, and enhance overall treatment efficacy. In this proof-of-concept study, the investigators aim to evaluate the feasibility and efficacy of utilizing a CDP-based second-generation AI system to optimize the therapeutic regimen of lenvatinib in patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. Lenvatinib treated cancer patients, who suffer from loss of response of dose-limiting adverse effects.

Exclusion Criteria:

1. Current or history of drug abuse
2. Pregnancy/lactation/planned pregnancy
3. The subject is currently enrolled in or has not yet completed at least 60 days since ending another investigational device or drug trial.
4. Unable to comply with study requirements.