cyrilzakka/clinical-trials huggingface dataset:
Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)

It is generally estimated that 5 % of patients with thyroid cancer will develop distant metastases, and most of them had an advanced stage of the disease at presentation. Thirty per cent of them are resistant to radio iodine therapy and are called "refractory". Their long term survival is estimated to be less than 10 %.

The objective of this study is to identify the factors associated with poor outcome in a cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and medullary thyroid carcinomas were excluded.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman ≥ 18 years.
* Thyroid cancer differentiated from follicular origins (papillary, vesicular or poorly differentiated carcinoma).
* TNM classification: stage pT3 (≥2 cm), or pT4 or M1 at diagnosis.
* Patient after post operative radioiodine therapy.

Exclusion Criteria:

* Patient who can not be followed during the protocol.
* Patient who does not consent.
Efficacy of Magnesium Sulfate as an Adjuvant in Erector Spinae Plane Block as an Anesthetic Post Operative After Modified Radical Mastectomy

efficacy of magnesium sulfate as an adjuvant in erector spinae plane block as an anesthetic post-operative after modified radical mastectomy


Eligibility Criteria:
Inclusion Criteria:

* 1. ASA I-II. 2. Female patients aged 18-65 years. 3. Scheduled for a modified radical mastectomy with axillary dissection for breast cancer.

Exclusion Criteria:

1. ASA \< II.
2. more than 65 years old
3. Patients with known allergies to the study drugs
4. Skin infection at the site of needle puncture.
5. Coagulopathy

5. Drug or as that would interfere with perception and assessment of pain. 6. Uncooperative patients.
Improving Patient Reported Outcome Measures in Catheter Ablation

This study will assess whether more frequent measurement of patient reported outcome measures (PROMs) - specifically health related quality of life (HRQL) - can improve the evaluation of the clinical effectiveness and cost-effectiveness of catheter ablation of ventricular tachycardia (VT) in patients with an Implantable Cardioverter Defibrillator (ICD).

It is designed to have feasibility outcomes which contribute to answering the above.

Patients who have been implanted with an ICD are at risk of suffering from dangerous arrhythmias such as VT.

Patients can experience clinical events including worsening of any underlying heart failure regardless of either VT ablation or medical therapy treatment strategy (anti-arrhythmic drugs (AAD)). VT ablation is a specialist procedure which has been proven in randomised clinical trials (RCTs) to confer symptomatic relief from VT, reduced hospitalisations and reduced shocks from ICDs. However, there is no effect on mortality.

The frequent nature of clinical events in this group of patients may affect their health status quite dramatically and yet based on current trial evidence, only 3 out of 6 randomised trials in VT ablation reported PROMs. This can lead to brittle conclusions about the overall cost-effectiveness profile of a procedure such as VT ablation.

This study will assess for the feasibility of more frequent HRQL monitoring and its impact on whether it is able to better capture the clinical narrative and quality of life changes of patients with severe heart failure and an ICD. And thus the assessment of both clinical effectiveness and cost effectiveness of catheter ablation of VT or continuing anti arrhythmic drug therapy.

METHOD \& SETTING Single centre study at St Bartholomew's Hospital London. Patients will be identified through established local pathways - there are traditional outpatient specialist clinics where Consultant Cardiologists receive referrals of patients for consideration of managing patients with VT, including ablation. In addition, there are joint VT clinics operated by Consultants as well as by cardiac physiologists. In the outpatient VT clinic, 85 patients were seen in a 10-month window - it is assumed that this scale will allow feasible identification of patients to be recruited to the both the groups of this study.

Eligibility Criteria:
Inclusion Criteria:

Adults (\>18 years) With an Implantable Cardioverter Defibrillator (ICD) implanted \>3 months from time of recruitment and a previous episode of documented VT requiring therapy from the ICD.

And impaired LV/RV function Willing and able to give written informed consent

Exclusion Criteria:

Patients who are planning to move away from study site within 12 months of enrolment who wished to use postal method to complete their HRQL Patients who are unable to give informed consent
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission

The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;

To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent and complying with the examination program of the protocol;
* Participants with axial SpA fulfilling the Assessment of Spondyloarthritis international Society 2009 (ASAS) axial SpA classification criteria;
* Participants must fulfill the criteria of maintaining remission of aSpA, defined as ASDAS\<1.3；
* Participants must fulfill the criteria of remission of aSpA defined as ASDAS\<1.3，then continuous to evaluate every four weeks for three times and ASDAS\<1.3 each time.
* Laboratory results must fulfill following requirements: Hb≥85g/L；3.5×109/L≤WBC Count ≤10×109/L；Platelet count ≥ Normal lower limit; Liver function (ALT、TBIL) ≤Twofold of normal upper limit; Renal function (SCr) ≤Normal upper limit;
* The pregnancy test must be negative for women of childbearing age; Efficient contraception must be taken for both male and female participants during the trial period and within three months after the end of the trial.

Exclusion Criteria:

* Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
* Participants who are intolerant of NSAIDs;
* Participants who are in active axSpA episodes;
* Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
* Participants who were in acute infection or acute attack of chronic infection during screening period;
* At the time of screening, participants who were in the acute stage of acute infection or chronic infection, and if the acute infection had improved, they could be re-screened.
* Participants who suffer from invasive fungal infections (e.g. histoplasma, coccidiosis's, candida, aspergillus, blastomyces, pneumocystis, etc.) within the first 6 months of screening; Or opportunistic bacterial infections (e.g. bacterial, viral or other infections, including Legionella and Listeria);
* Participants with other autoimmune diseases which are expected to influence the evaluation of experimental medications, such as inflammatory enteritis, psoriasis, uveitis, etc.
* Participants with previous or currant congestive heart failure, coronary heart disease, serious arrhythmia;
* Participants with severe, progressive, uncontrolled vital organ and systematic disorders, and other conditions that are considered inappropriate to participate in this trial;
* Participants with circumstances that may affect the compliance (e.g. prolonged travel or leave, planned relocation, mental illness, lack of motivation to participate, etc.).
Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation

The Parkinson TELEREHABilitation-NET pilot study (Parkinson TELEREHAB-NET) is designed to observe and monitor PD patients in their initial phase (which includes the period from the onset of motor symptoms until the onset of motor fluctuations) and to assess the feasibility of an integrated multidimensional approach in treating and managing PD patients in a local clinical setting (ASL CN1). Chiefly, through this pilot study, feasibility and acceptability of the general experimental plan, as well as the potential for positive effects of physiotherapy in early PD patients will be assessed.

So, this pilot study primarily aims at:

1. validating the feasibility of the study protocol, assessing participants' inclusion and exclusion criteria, testing instruments/procedures used for home rehabilitation (both for the Telerehabilitation Exercise group - TrE arm and for the Home Self-Exercise group - HSE arm), testing the suitability of the method for data collection;
2. obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms;
3. evaluating appropriateness of the consent form, recruitment potentials, time needed to receive written consent, and the required number of researchers/medical specialists/physiotherapists needed to cover the whole study path;
4. assessing patients' acceptability of the intervention, through the evaluation of the adherence to rehabilitation process (in both arms), the completeness of proposed measurements, and compliance at follow-up.

Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales, after completing the whole rehabilitation path (described below) compared to baseline level, and maintenance of results over time.


Eligibility Criteria:
Inclusion Criteria:

General:

* adults, aged 18 or older;
* medical diagnosis of idiopathic PD according the most recent Movement Disorder Society diagnostic criteria;
* disease stage ≤ 2 on the Hoehn\&Yahr scale;
* Montreal Cognitive Assessment score \>25;
* ability to read, understand and provide a written informed consent, in accordance with good clinical practice and local regulations;
* motivation and possibility to show up for planned controls and to comply with the requested study procedures.

Specific for TrE arm:

* wireless internet access at home;
* adequate room to place telerehabilitation device (about 2 meters in front of device monitor).

Exclusion Criteria:

* \<18 years of age;
* Any atypical, iatrogenic, or secondary Parkinsonism;
* Disease stage \> 2 on the Hoehn\&Yahr scale;
* Any severe orthopaedic, vascular, respiratory, or cardiac problems or any other medical condition that, in the principal investigator's opinion, could limit participation in moderate exercise or the study protocol.
Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).

The objetive of this study is to explore the efficacy and safety of a triple combination of ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients


Eligibility Criteria:
Inclusion Criteria:

1. TMD dysfunction syndrome patients of RDC/TMD Groups Ia and/or Ib (+/- IIIa and/or IIIb); with moderate to severe pain (VAS \>4), refractory to conservative treatment (including splint / local prosthesis)
2. Subjects between 18 and 65 years.
3. Body weight within the normal range (IMC index between 19 and 30) expressed as weight (kg) /height (m2).
4. Physical condition according to ASA I or II (American Society of Anesthesiologists)
5. Having not participated in previous clinical trial during the three months preceding the setting-up of this study.
6. Free acceptance to collaborate in the study, expressed by signature of written informed consent by the participant

Exclusion Criteria:

1. Patients who are pregnant or breastfeeding.
2. Patients who have a consumption of enzyme-inducing drugs within the 30 days prior to the study: carbamazepinam, nevirapine, phenobarbital, rifampin, secobarbital and St. John's wort.
3. Patients who are consuming: acetaminophen, acetyl salicylic acid, bemiparina, clonixidina, oral anticoagulant, heparin and derivatives, systemic corticosteroids, pemetresed, digoxin, phenytoin, lithium, methotrexate, Salicylates, NSAIDs, antacids containing aluminum, such as algeldrato, magaldrate, morphine and its derivatives.

   Patients who have been medicated with NSAIDs or Morphic derivatives for the treatment of pain of TMD prior to attending the consultation will be included whether, they meet a washout period of 8 to 12 hours (depending on the medication taken) before being included in the study.
4. Patients with underlying systemic pathology candidate to receive drug treatment with analgesic.
5. In patients with a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs. Peptic ulcer / active or recurrent gastrointestinal hemorrhage (two or more episodes of ulceration) or proven hemorrhage.
6. Patients with active Ulcerative colitis or Crohn's disease. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
7. Patients with urolithiasis by oxalate
8. History of alcoholism or drug dependence within 3 months prior to the screening visit, and / or, History of psychotropic drugs consumption within 3 months prior to the screening visit.
9. Heavy consumer of stimulating beverages (\>5 coffees, teas, or cola drinks per day).
10. History of drug allergy, idiosyncrasy or hypersensitivity. 11 Patients with cerebrovascular bleeding or other active bleeding 12 Patients with bleeding diathesis or other bleeding disorders .
A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation

The goal of this clinical trial is to compare the crossability of novel spherical tip versus regular noncompliant balloon in CHD population with tortuous coronary artery leisions that requiring postdilation after stent implantation.

The main question it aims to answer is:

•Wether the spherical tip balloon have advantages in terms of crossability compared to regular noncompliant balloons Participants will sign an informed consent form, collaborate with data collection, and accept the intervention measures from corresponding groups. Researchers will compare spherical tip balloon with regular noncompliant balloon to see if there is any difference in crossability.

The tortuous lesion increases the difficulty of coronary intervention treatment, especially when there is still a large angle after stent implantation. The ability of the non compliant balloon to pass through the stent segment becomes the key to complete the operation.

The spherical tip noncompliant balloon is an original design by our center, which reduces its resistance to stent struts through the spherical structure of balloon tip, and is committed to increasing the crossability of the balloon.This study is a multicenter, randomized, single blind design with the aim of truly revealing the differences in parameters such as success rate of crossing, times of attemptation, and time consumption between the novel spherical tip and regular non compliant balloon.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old, regardless of gender
* Patients with indications for coronary artery stent implantation
* The vascular curvature angle\<120 ° after coronary artery stent implantation
* Noncompliant balloon postdilation is required
* Voluntarily participate and sign an informed consent form

Exclusion Criteria:

* Pregnant women or patients who are attempting to get pregnant
* Patients participating in clinical trials of other drugs or medical devices
* Patients deemed unsuitable by the researchers to participate in this clinical trial
Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.

An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.

Open-label, non-comparative, non-interventional study

Eligibility Criteria:
Inclusion Criteria:

* Must have at least one eye which was diagnosed with neovascular degeneration

Exclusion Criteria:

* Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis
Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury

Currently, most patients with an anterior cruciate ligament (ACL) injury undergo surgery. There is a general belief that surgical reconstruction is necessary to return to sport safely and to limit premature knee osteoarthrosis or additional meniscal damage. However, there is unsufficient scientific evidence for this belief. Moreover, several studies show that a reconstruction does not guarantee successful return to sports or the prevention of osteoarthritis or meniscal injuries at all. Therefore, an immediate surgery after an ACL injury is more and more questioned. The only qualitative RCT that exists (KANON trial) could not demonstrate that an immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or incidental meniscal damage) compared to a conservative approach consisting of progressive rehabilitation and delayed surgery if there was persistent knee instability.

In a future multicenter RCT the investigators want to 1) verify these results and 2) search for predictors that predict which patients from the conservative group do well without delayed surgery. This information is invaluable to physicians as it allows them to decide which treatment is best for the patient.

Before performing a large, adequately-powered RCT that compares both treatment options, the investigators will run a pilot study that assesses the feasibility to recruit ACL patients for such RCT. This seems necessary, as many patients still believe that timely surgery is a prerequisite for restoring knee function, for returning to sports and for preventing cartilage degeneration. These preferences for surgery might affect recruitment and adherence to the protocol. Therefore, a pilot study will performed that demonstrates whether a large RCT is feasible with regard to 1) participant recruitment, 2) adherence to the treatment arm they were allocated to and 3) protocol feasibility. The findings of this pilot study will help deciding about progressing to a future definitive RCT.


Eligibility Criteria:
Inclusion Criteria:

* Rotational trauma to a previously uninjured knee within the preceding 4 weeks
* Medical diagnosis of ACL insufficiency including MRI (both partial and complete ruptures)
* Minimum of 18 years

Exclusion Criteria:

* Patient has history of a previous ACL injury or knee surgery to the index knee.
* Indication for acute surgery because of related injuries to the knee
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Female who is pregnant. Since MRI assessment cannot be performed.
Oncology Episode Payment Model in Hawaii

The HMSA Cancer Episode Payment Model (CEM) is a payment model designed to test the effects of better care coordination on health outcomes and costs of care for Hawaii Medical Services Association (HMSA) members with cancer who receive chemotherapy.

The CEM is designed to improve community health, to improve care coordination, quality, and appropriateness of care, to improve patient experience, and to implement a value-based incentive structure that appropriately rewards oncologists for cost-savings and sustained of improved quality of care.

Eligibility Criteria:
Inclusion Criteria:

* Any oncologist who practices with Hawaii Oncology and is a participating provider.

Exclusion Criteria:

* Any provider who does not practice with Hawaii Oncology.
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's Disease.
* MMSE 12-26 inclusive.
* If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
* If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Exclusion Criteria:

* Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region \[e.g., thalamus, hippocampus\]).
* Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
* Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
* Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.