cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Histopathology in Thyroid Nodule

A thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are benign, with only 10% to 15% harboring cancer. This is a prospective study conducted at the department of Ear, Nose and Throat - Head and Neck Surgery (ENT-HNS) of Shree Birendra Hospital , a tertiary heath care centre of Nepal. Individuals visiting ENT-HNS outpatient department with thyroid nodules had undergone Ultrasonography (USG) of neck followed by Fine-Needle Aspiration Cytology (FNAC) from the thyroid nodules. USG was reported by Thyroid Imaging Reporting and Data System(TIRADS) and FNAC by Bethesda system. Thereafter patients were planned either for surgery either total thyroidectomy or hemithyroidectomy. Post operative histopathology was correlated with preoperative FNAC and USG reports.

The main objective of this prospective cohort study is to know the correlation between pre- operative Bethesda with post- operative histopathology , pre - operative TIRADS with post operative Histopathology and comparison of combined scoring of Bethesda and TIRADS with histopathology report. It is of utmost importance to deep dive into thyroid nodules workup to detect malignant nodules, as the management aspect of benign and malignant nodules has a vast difference. Thyroid ultrasonography is useful for risk stratification of nodules, and American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) classification provides recommendations for fine-needle aspiration cytology (FNAC) based on objective ultrasonography features of these nodules. To maintain uniformity in reporting system FNA sample are categorized according to the Bethesda system. Total 42 participants who met the inclusion criteria were included in the study. Statistical Analysis was done using Statistical Package for the Social Science (SPSS) version 25. Analysis was done in the form of percentage and proportion and represented as table wherever necessary. Spearman's correlation coefficient was used to evaluate the correlation between Bethesda and TIRADS. Bethesda and histopathology and TIRADS and Bethesda system. The P value was set at \< 0.05 for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients presenting to Ear Nose and Throat, Head and Neck Surgery Department with thyroid nodules undergoing hemithyroidectomy or total thyroidectomy within the study period

Exclusion Criteria:

* 1.Patients refusing to give consent for the study. 2.Patients with already known case of thyroid malignancies proven by histopathological reports.
Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

This study will examine the combination of myoelectric computer interface (MyoCI) training with targeted memory reactivation (TMR) in chronic stroke survivors. The study aims to determine whether this training-plus-sleep combination will generalize to improve arm motor function over an extended training protocol in stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment is 21 or older
* Hemiparesis from first ever stroke affecting arm movement at least 6 months prior to screening
* Severe to moderate motor impairment (FMA-UE of 7-40)
* At least some voluntary shoulder and elbow muscle activation

Exclusion Criteria:

* Inability to follow instructions of the MyoCI task
* Visual impairment (such as hemianopia) preventing full view of screen
* Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest)
* Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
* Inability to understand or follow commands in English due to aphasia or other reason
* Diffuse or multifocal infarcts in both hemispheres
* Substantial arm pain preventing participation for 90 minutes a day
* Spasticity treatment (pharmacological or Botox) within last 3 months
* Ferromagnetic implants that are MRI incompatible
Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina Severity in Patients With Chronic Angina in the Absence of Obstructive Coronary Artery Disease.

The aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7).

After administration of unfractionated heparin (100UI/Kg), a special pressure guide (Pressure Wire X, Abbott), equipped with a distal sensor capable of measuring pressure and temperature, will be introduced inside the anterior descending branch (IVA) of the left coronary artery and hyperemia will be induced by intravenous infusion of adenosine. The IMR will be calculated using the thermodilution technique, and is given by the product between the mean distal pressure, in the left anterior descending coronary artery, and the mean transit time (Tmn) during maximal hyperemia.

During the procedure, additional coronary physiological indices will be calculated such as:

* Quiescent full cycle flow ratio (RFR), - Fractional flow reserve (FFR),
* Coronary flow reserve (CFR)

In order to identify different phenotypes of microvascular dysfunction, as follows:

* Phenotype A: Patients with IMR\>25, CFR \<2 and FFR\>0.80 (concordant pure-microvascular pathological results)
* Phenotype B: patients with IMR\>25, CFR\>2 and FFR\>0.80 (increased microvascular hyperemic resistance, maintenance of microvascular reactivity)
* Phenotype C: Patients with IMR 25, CFR 2 and FFR\>0.80 (normal hyperemic resistance and reduced reactivity) All these phenotypes can also be combined with pathological FFR measures (\<0.80) (phenotypes A1, B1, C1).

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria will be considered for study participation:

Age ≥18 and \<85 years. Chronic coronary syndrome (including patients with anginal equivalents) Angina CCS class II-IV Evidence of inducible reversible ischemia in noninvasive trials

Availability of the following measurements:

* Microvascular resistance index (IMR)
* Quiescent full cycle flow ratio (RFR),
* fractional flow reserve (FFR),
* Coronary flow reserve (CFR) Willingness to participate and sign the informed consent document prior to the procedure.

Exclusion Criteria:

At least one of the following:

Pregnancy or breastfeeding. Medical or psychological conditions that would compromise proper and orderly participation.

Left ejection fraction less than 30% Prior coronary artery bypass surgery (CABG) Decompensated congestive heart failure (CHF) Chronic or acute renal failure with creatinine \>2mg/dl Severe valve disease Patients with comorbidities limiting life expectancy to less than one year.
Functional Magnetic Resonance Imaging (fMRI) Exploration of Neurocognitive Processes Involved in Food Addiction (FA) in Obese Patients: Towards New Phenotypic Markers for an Optimized Care Pathway

Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making

Obesity is a worldwide epidemic associated with many complications. The treatment of obesity is a failure if it does not take into account eating disorders. Among them, food addictions seem to be frequent among obese patients. Clinical diagnosis and therapeutic approaches depend on presence of these FA. Moreover, eating disorders are associated with visible brain abnormalities in fMRI but the cerebral fMRI phenotype of FA is not known.

Eligibility Criteria:
Inclusion Criteria:

* female
* right-handed
* grade 1 and 2 obesity
* aged between 20 and 50
* no other addictions including smoking
* no contraindications to fMRI
* affiliated to French Social Security
* having given a written informed consent

Exclusion Criteria:

* abdominal circumference + upper limbs along the body \> 200cm
* addiction to alcohol or other psychoactive substances
* daily smoker
* sleep Apnea Syndrome paired
* psychotic psychiatric disorders
* history of bariatric surgery
* medical care in the nutrition unit
* inability to comprehend or complete questionnaires
* pregnant or breastfeeding woman
* persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.


Eligibility Criteria:
Inclusion Criteria:

* History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)
* ≥ 6 months post-stroke
* Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
* Stable concomitant medication therapy regimen within 4 weeks of screening visit

Exclusion Criteria:

* History of seizures, except simple febrile seizures
* Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
* Botulinum toxin use within 2 months prior to the Screening Visit
* Orthopedic surgical procedures in any of the extremities within the past 6 months
* Diagnosis of multiple sclerosis
Association Between Obstructive Sleep Apnea and Bruxism

The objective of this retrospective observational study will be to investigate the between the Obstructive Sleep Apnea Syndrome (OSAS) and Sleep Bruxism (SB), in individuals diagnosed through polysomnography (PSG).

The SB and OSAS are sleep disorders with great importance for dentistry. The OSAS is characterized by partial or total obstruction of the upper airways. SB is defined as a repetitive activity of the mandibular musculature characterized by the tightening or grinding of the teeth and/or by the retrusion or propulsion of the mandible. This study retrospective observational will be evaluation to investigate the association between OSAS and SB. Data from PSG and medical records (n=640) will be collected from January 2012 to July 2018 at "Instituto do Sono de Pelotas (ISP)".

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who was undergone PSG at the "Instituto do Sono de Pelotas (ISP)";
* Have completed all the respective PSG reports.

Exclusion Criteria:

•Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.
Effects of High Functional Resistance Training Program on Arterial Stiffness

Study examined the effects of CrossFit training on blood vessels. The results indicate long term CrossFit training does not harm blood vessel function.

Arterial stiffness is a systemic loss of elastic properties that significantly augment cardiovascular disease risk in adults. Chronic aerobic and anaerobic exercise activity has consistently been shown to attenuate or not affect markers of arterial stiffness in adults with chronic disease and otherwise healthy adults. Chronic high functional resistance training's effect on vascular compliance is less understood. The study aimed to determine the impact of a chronic high functional resistance training program on pulse wave velocity and beta-stiffness index. Accordingly, participants (18-40 years old) were placed in a non-randomized fashion into high functional resistance training (HIB) group (n = 9; \>6 months of CrossFit experience; 4 female) or control (CON) group (n = 8; \< 6 months of exercise experience; 6 female). Participants in the HIB group trained at the same local facility 4 -5 days a week, utilizing the same training program. CON group refrained from exercise during the study period. Body composition, 1,000-meter rowing test, deadlift 1 repetition maximum (1 RM), hemodynamic assessments, and vascular compliance were assessed at baseline and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* body weight stability with no more than ± 2.5 kg fluctuations in last six month

Exclusion Criteria:

* hypertension
* heart disease
* cancer
* diabetes
* renal disease
* hepatic disorders
* history of tobacco use.
Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital

To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital

Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured through already placed Foley's catheter simultaneously with patients's data record. If patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8 hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU or removal of Foley's catheter. After completion of data collection, data will be analyzed accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative patient admitted to surgical ICU
* Age \>/= 18
* Foley's catheter in place

Exclusion Criteria:

* Patient refusal
* Underwent neo-bladder procedure
* Need continuous bladder irrigation
Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy

A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy


Eligibility Criteria:
Inclusion/Exclusion Criteria:

* High or intermediate grade of soft tissue sarcoma; Low grade tumours allowed provided there is disease progression.
* Metastatic and measurable disease (RECIST);
* Subjects can have received maximum of 4 prior lines of systemic therapies (including up to 2 combination regimens) for advanced disease. (Neo) adjuvant/maintenance treatments are not counted for this criterion;
* Last dose of prior therapy can be given upto 14 days prior to start of study if all ongoing toxicity from prior anticancer therapy are grade 1 or resolved (except alopecia).
* Must have failed anthracycline-based therapy and available standard chemotherapies at the treating institution except if medically contraindicated or refused by patient;
* No treatment with anti-angiogenesis inhibitors;
* Age \> 18 years
* WHO PS 0-1;
* No leptomeningeal or brain metastases, normal bone marrow, liver, renal and cardiac functions;
* No prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix or breast or the patient has been free of any other malignancies for \> 3 years)
* Adequate bone marrow function; adequate blood clotting results; adequate hepatic and renal function;
* No poorly controlled hypertension;
* Clinically normal cardiac function;
* No clinically significant gastrointestinal abnormalities including malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
* No cerebrovascular accidents 1
* No transient ischemic attack, deep vein thrombosis or pulmonary embolism within past six months;
* No active bleeding or bleeding diathesis;
* No hemoptysis within six weeks of study drug;
* No major surgery or trauma within 28 days of therapy treatment;
* Concomitant medication restriction;
* No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
* Ability to swallow \& retain oral medication
* Adequate contraception must be used;
* No Psychological familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.
Clinical Evaluation of PoreSkin

PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine, Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a permanent dermal substitute aiming to reduce skin contracture. The objective of this study is to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* 18-60 years with burn scar contracture and hypertrophic scar

Exclusion Criteria:

* Undergoing immunosuppressive therapy
* Immunocompromise host (DM, HIV infected)
* Evidence of malnutrition
* Active malignancy
Clinical Evaluation of a New Printable Denture Base Material

This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 84 years
* informed consent signed and understood by the subject
* full edentulous patients
* a digital design of the dentures is already existing.
* ability to visit the clinic in person until the baseline recall

Exclusion Criteria:

* patient does not wear the dentures regularly
* mental health status does not allow reliable feedback
* patients with a proven allergy to one of the ingredients (methacrylates) of the materials used
* patients with severe systemic diseases
* poor oral / denture hygiene
* pregnancy
A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants

The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed Product (FVP) (IV) to create the IV solution.


Eligibility Criteria:
Inclusion Criteria:

* Be healthy on the basis of physical examination, medical history, vital signs and electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
* Must be a non-user or light user of tobacco products (not smoke more than 10 cigarettes or equivalent a day for at least 6 months prior to screening), including all nicotine use, example, cigarettes (including e-cigarettes or the equivalent of e-cigarettes), cigars, chewing tobacco, patch, gum
* Participant is considered eligible according to the following tuberculosis (TB) screening criteria: (a) have no history of latent or active TB before screening; (b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; (c) have had no recent close contact with a person with active TB; (d) have a negative QuantiFERON-TB test result within 28 days prior to the administration of study intervention

Exclusion Criteria:

* History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Has a current chronic infection, prior history of recurrent infection, or an active infection
* Received any systemic immunosuppressant agent (other than a short course of corticosteroids for minor inflammatory conditions) within 6 months before and during screening and administration of study intervention
* Has a positive urine drug or alcohol screen during screening or at admission (Day -1)
Brain Effects of Escitalopram and Citalopram Using fMRI

Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake inhibitors that alter blood flow to the amygdala and other brain structures involved in regulating mood. Escitalopram consists of S-citalopram while citalopram contains both S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may block the effects of S-citalopram. The hypothesis being tested is that because of the antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood circuit than racemic citalopram when equal doses of S-citalopram are administered. The study design consists of a two week medication period followed by blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 21 to 50 years.
* Capable of providing informed consent.
* Has an established residence and phone.

Exclusion Criteria:

* Meets DSM-IV criteria for an Axis I or II disorder.
* History of substance dependence or abuse within the past month.
* Use of NSAID's, beta blockers, calcium channel blockers, antidepressants, antipsychotic medications, lithium or other medication which in the opinion of the investigator would alter vascular responsivity.
* Regular use of sedative hypnotic or narcotic medication, or other medication that might affect the individual's perception of visual stimuli.
* History of cataracts or significant visual impairment.
* A medical condition, which in the opinion of the investigator is likely to affect the individual's perception of the visual stimuli or vascular response.
* Participation in a research protocol that included administration of medication within the past 3 months.
* Cigarette smoking.