cyrilzakka/clinical-trials huggingface dataset:
Limitations of Using a Sheimpflug Image-Based Device for Measuring Anterior Chamber Depth in Pseudophakic Eyes

There have been numerous studies comparing various ACD measurements in phakic eyes,while researches comparing ACD in pseudophakic eyes are less extensive. With the recent popularity of presbyopia correction, measuring the ACD will facilitate differentiating pseudophakic accommodation from pseudoaccommodation. It is thus mandatory to verify the accuracy of ACD measurement of these devices since the innovation of various IOLs in the recent decade makes this task more complicated. In this study, we will assess the limitations of using Pentacam for ACD measurement in pseudophakic eyes and compare Pentacam measurement with IOLMaster and A-scan measurements.

In this prospective study, ACD was measured in 90 phakic and 94 pseudophakic eyes by Pentacam, IOLMaster and A-scan. Correlations and differences between the three measurements were investigated. The accuracy in detecting the anterior lens surface in pseudophakic eyes was also assessed.Differences in ACD-Pen, ACD-IOLM, and ACD-A were analyzed using one-way analysis of variance (ANOVA). When an overall significance of P\< 0.05 was obtained, pair-wise comparisons were made using Tukey's multiple comparison t tests. The association between ACD-Pen, ACD-IOLM, and ACD-A was assessed using Pearson's correlation test. The distribution of erroneous ACD-Pen measurement for the three IOLs was analyzed with the chi-square test. In all analyses, P \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Phakic group: randomized
* Pseudophakic eyes : the cases accepted cataract surgery

Exclusion Criteria:

* Previous ocular trauma or intraocular surgery other than cataract surgery;
* Contact lens use in the past two months;
* Use of medication that might affect the pupil; corneal disease or ocular infection;
* History of ocular disease, such as

  * Dry eye syndrome
  * Uveitis
  * Glaucoma
  * Ocular tumor
* Cases with any surgical complications were also excluded.
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis

This study will evaluate the use of microwave radiometry in a population of patients diagnosed with acute appendicitis and treated with appendectomy. The main purpose of the study is to report the results of microwave radiometry as a diagnostic tool in acute appendicitis and compare those results with the commonly used ultrasonography.

Patients diagnosed with acute appendicitis from the emergency department of Hippocration General Hospital and treated with appendectomy will be evaluated with microwave radiometry for changes in the temperature of the appendix before its removal.

Subsequently, the results of microwave radiometry for the patients confirmed by the histopathology report to have acute inflammation of the appendix, will be compared with those of the ultrasonography used for the diagnosis of acute appendicitis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of appendicitis
* Surgical removal of appendix
* Pathological confirmation of appendicitis

Exclusion Criteria:

-
Effects of Action Observation and Motor Imagery on Orofacial Sensorimotor Variables

The main objective of the present study was to evaluate the effects of different dosages of action observation (AO) and motor imagery (MI) combined with an orofacial exercise program on pain pressure thresholds, lingual endurance and perceived exertion in asymptomatic subjects.


Eligibility Criteria:
Inclusion Criteria:

1. healthy individuals with no pain
2. aged between 18 and 65 years
3. subjects with correct masticatory function and labial and lingual mobility

Exclusion Criteria:

1. individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
2. underage individuals
3. individuals with orofacial pain or temporomandibular disorders at the time of the study
4. subjects' complaint of toothache or tenderness to percussion.
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

What is the visible light protective effect of dihydroxyacetone in individuals with erythropoietic protoporphyria? This will be tested in this randomized blinded placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with erythropoietic protoporphyria
* At least 18 years of age
* Obtainment of written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Use of dihydroxyacetone at the treatment or placebo fields within the last two week
* Sun exposure of the treatment or placebo fields within the last two week
* Use of suncreen or other local treatment on the treatment or placebo fields during the study period (two days)
* Allergy to adhesive bandages, dihydroxyacetone or lotion
A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation

The knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation.

A randomized controlled study comparing pulmonary vein antrum isolation with and without the knowledge of the real-time contact force. In both groups, a catheter, which is able to measure contact force (SmartTouch, ThermoCool catheter, Biosense Webster) will be used. In the control group, the operator will be blinded to the measured contact-force. In all patients, the ablation will be guided by a circumferential mapping catheter (Lasso, Biosense Webster), CARTO 3 mapping system and ablation of adenosine-induced reconnection will be performed in all patients. Follow-up will be performed by continuous monitoring using an implantable loop recorder (Reveal XT, Medtronic Inc, Minneapolis, Minn)

Eligibility Criteria:
Inclusion Criteria:

* Patients \<75 years of age with atrial fibrillation who have had at least two episodes of symptomatic paroxysmal or short-lasting persistent atrial fibrillation in the foregoing 12 months undergoing the first pulmonary vein antrum isolation can be included.
* Patients having also persistent episodes of atrial fibrillation of shorter duration (the longest atrial fibrillation episode 3 months) on top of paroxysmal episodes will be included

Exclusion Criteria:

* Contraindication to anticoagulation treatment with vitamin K antagonists Amiodarone therapy Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease NYHA III-IV Left ventricular ejection fraction \< 35% Left atrial diameter \> 5 cm Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism) Age \< 18 years
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines for subject therapy management.

The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of Heart Failure related events associated with signs and symptoms of pulmonary congestion and in the subject HF therapy management.

The OptiVol feature is based on the measurement of daily intrathoracic impedance values, measurements that can be used to track changes in the subject's thoracic fluid status over time. An Alert warns the patient whenever a programmable threshold has been reached.

The study is divided into three phases.

The first phase is double-blinded and designed to determine the sensitivity and positive predictive value of the OptiVol Fluid Trends data for the detection of Heart Failure related hospitalizations with signs and/or symptoms of pulmonary congestion.

In the second phase of the study, the Alert is turned ON and the positive predictive value of the first OptiVol Patient Alert for the development of signs and/or symptoms of pulmonary congestion will be evaluated.

The third phase of the study allows for remote subject therapy management using the OptiVol Patient Alert. The patient management strategy is then based on the experience gained in the second study phase Physician actions taken in the occurrence of a Patient Alert will be summarized.

Eligibility Criteria:
Inclusion Criteria:

* Successfully implanted InSync Sentry device (\< 34 days post implant or pocket revision)in the pectoral region;
* At least one HF-related hospitalization that required administration of IV medication (inotropes, nitrates, diuretics) within the last 12 months
* The Subject has a market released, transvenous, high voltage Right Ventricular lead
* The Subject is able to detect a Patient Alert signal

Exclusion Criteria:

* \<18 years of age (or under a minimum age required by local law)
* Moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
* Post heart transplant or awaiting heart transplantation
* Primary pulmonary hypertension
* Renal insufficiency requiring dialysis

Amendment to the inclusion criteria (Jul 06):

* Inclusion of patients with Concerto/Virtuoso devices.
* At least one HF-related hospitalization that required administration of IV (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 months
Post-market Clinical Trial of the Dominus® Stent-Graft

Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use

The multicenter study aims to collect post-market clinical data on the Dominus® Stent-Graft in the treatment of thoracic aortic diseases. With the goal of assessing safety and efficacy, the prospective follow-up study will include 100 patients undergoing Endovascular Treatment of Thoracic Aortic Diseases, following the product's Instructions for Use

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use;
3. Patient available for appropriate follow-up times for the study duration;
4. Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.

Exclusion Criteria:

1. Patient currently participating in another clinical study of drug or medical device;
2. Life expectancy less than 12 months.
Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)

The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)

Exclusion Criteria:

* Familiar or personal history of diabetes
* History of drug or alcohol abuse within the 2 years prior to the study
* A smoking habit greater than 10 cigarettes per day
* History of allergy to the study drugs
* Intercurrent disease
* Intercurrent treatment with any drug
Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children

The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.

Most patients with functional gastrointestinal disorders complain of gas-related symptoms which can negatively affect quality of life, even in pediatric age.

Dietary and life-style changes, administration of simethicone, activated charcoal and probiotics may reduce intestinal gas but often results are unsatisfactory.

Literature shows that α-galactosidase is effective to reduce gas production and related symptoms in adults.

Eligibility Criteria:
Inclusion Criteria:

* pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.

Exclusion Criteria:

* suspected episodes of hypersensitivity or allergy;
* chronic organic disorders (by clinical history, physical examination, laboratory tests);
* use of drug affecting the GI motility during the previous 4 weeks;
* inability of the parent to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator.
Brief Skills Training Intervention for Suicidal Individuals

A significant percentage of individuals who die by suicide do not seek mental health services in the time preceding their death. This population is underserved and it is unclear what barriers keep them from seeking treatment. In order to begin a line of research aimed at addressing this high-risk population, this proposal rests on the hypothesis that suicidal individuals who do not seek treatment prior to attempting suicide experience the same psychopathological difficulties as suicidal individuals who do seek treatment - namely, severe emotion dysregulation. However, these non-treatment-seeker s will likely require more creative recruitment strategies and briefer interventions than treatment-seeking individuals. As such, this application proposes to use wide-reaching recruitment efforts throughout the community to locate and enroll individuals who are suicidal but not seeking treatment. Further, there is a paucity of empirical support for interventions targeting suicidal individuals. Dialectical Behavior Therapy (DBT) is one of the few treatments that have been demonstrated to be effective with a suicidal population and is the only treatment whose effectiveness has been replicated. Previous research has suggested that an abbreviated version of the skills that are taught in DBT skills training have effectively reduced emotion dysregulation (i.e., depression and anxiety) in problem drinkers and the format of the proposed intervention is derived from this evidence-based emotion dysregulation intervention. As such, the proposed research is a randomized, controlled pilot trial of a very brief, one-time, skills-based intervention targeting difficulties in emotion regulation and distress tolerance.

This research aims to evaluate the safety of the intervention, the feasibility of the research methods (including the appropriateness of the relaxation training control condition), and to preliminarily estimate the immediate (one week) and long-term (one and three month) changes resulting from the DBT Brief Skills Intervention (DBT-BSI) relative to a relaxation training control on the primary outcomes of suicide ideation and emotion dysregulation as well as a number of secondary outcomes. These results will inform the design of a subsequent full-scale randomized controlled trial of the DBT-BSI.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* Suicidal ideation in the last week
* Live within commuting distance to research office
* Have not been engaged in mental health treatment in the past month
* Consent to assessment

Exclusion Criteria:

* Non-English speaking
* Significant cognitive impairment
CKD-337 Drug Interaction Study

The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male volunteer between 19 and 55 years old.
* BMI between 18.5 and 27.
* Able to participate in the entire trial
* Signed the informed consent form prior to study participation.

Exclusion Criteria:

* Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
* sit SBP \< 100mmHg or sit SBP ≥ 150mmHg or sit DBP \< 70mmHg or sit DBP ≥ 100mmHg
* Have acute infection history within 14 days
* Have a allergic disease of need to treat
* Have hypersensitivity reactions history for IP or any specific drugs.
* AST, ALT or Total bilirubin \> UNL \* 1.5
* Estimated GFR \< 60 ml/min
* Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* A heavy smoker (cigarette \> 10 cigarettes per day)
* A heavy alcohol consumer (alcohol \> 140g/week)
* A heavy grapefruit consumer (more than 1cup per a day)
* Have a history of drug abuse or showed a positive for urine drug test.
* Administrated IP within 60 days prior to screening
* Rhabdomyolysis include of having a history or family history of genetic muscle diseases
* Positive for HIV antibody, HBsAg, HCV antibody test
* Previously donate whole blood within 60 days or component blood within 30 days
* Subject takes ethical drug or herbal medicine within 30 days
* Clinically significant laboratory test result
* An impossible one who participates in clinical trial by investigator's decision including other reason
Metabolic Effects of Early Time-restricted Carbohydrate Consumption

In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* both males and females
* type 2 diabetes

Exclusion Criteria:

* type 1 diabetes
* insulin treatment
* pharmacological treatment for weight loss
* pregnancy
* other acute or chronic conditions influencing body weight and glucose metabolism
Trauma Reception and Resuscitation Project

Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients.

Demonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria: All injured patients \> 15 years old who are brought or present to the The Alfred Trauma Centre during the study period.

Exclusion Criteria: Stable Trauma patients (ie Pulse rate \<100/minute, MAP \>70mmHg, Hb \>70, temperature \>35 and \<37.5, Spo2 \>92%, GCS \>13) undergoing secondary transfer from another hospital, where trauma occurred \>6hrs prior to arrival.
High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

The study is designed to compare the effectiveness and safety of high-voltage Pulsed radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients with ineffective conservative treatment and explore better non-surgical treatment methods for Trigeminal Neuralgia patients.

Trigeminal neuralgia (TN) is a paroxysmal, lightning-like, severe pain in the facial area innervated by trigeminal nerve. Patients who have failed to achieve benefits from drug treatment could try to undergo nerve block, a traditional conservative treatment. Pulsed radiofrequency (PRF) is a noninvasive pain intervention technique for the treatment of TN. However, its treatment effectiveness has rarely been reported and remains controversial among scholars. A recent single-center preliminary clinical study showed that high-voltage PRF had significant effectiveness in the treatment of TN. However, whether high-voltage PRF treatment can become an optional treatment for TN patients who have failed to achieve benefits from drug treatment still needs to be confirmed with standardized clinical studies by utilizing conservative nerve block treatment as a control. The study is designed to compare the effectiveness and safety of high-voltage PRF and nerve block for the treatment of primary TN patients with ineffective conservative treatment and explore better non-surgical treatment methods for TN patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
* 18-75 years old.
* Response to drug treatment poorly or unable to tolerate the side effects of drugs.
* A BNI pain intensity scale score of IV-V.
* Supposed to undergo neurosurgical intervention according to Trigeminal Neuralgia treatment guidelines.
* Agree to participate in this trial and have signed the informed consent.

Exclusion Criteria:

* Abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders.
* Abnormal electrocardiogram or chest X-ray results.
* Severe cardiopulmonary dysfunction.
* Infection at the puncture site.
* History of mental illness, or history of narcotic drug abuse.
* Allergy to local anesthetic drugs or steroids.
* Cannot cooperate with the treatment.
* History of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or microvascular decompression.
Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role.


Eligibility Criteria:
Inclusion Criteria:

* 25-75 years old

Exclusion Criteria:

* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
* Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
* Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides greater than 300 mg/dL
* Fasting glucose greater than 126 mg/dL
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
* Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
* Use of any tobacco products in past 3 months
* Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
* Known (self-reported) allergy or adverse reaction to blackberries or other study foods
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol