cyrilzakka/clinical-trials huggingface dataset:
Optimal EGM Configuration for Morphology Discrimination

The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.

Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.
2. Patients must be willing to sign an informed consent form.
3. Patients must have frequent PVCs (minimum of 30/hour)

Exclusion Criteria:

1. Known history of slow VT (under 160 bpm).
2. Patients under the age of 18 years.
3. Pregnant women.
4. Pacemaker dependent rhythm.
5. Ongoing angina pectoris.
6. Current NYHA Class 3-4 heart failure.
Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression

Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no treatment has been shown to be superior. The investigators wish to study the effectiveness of syndactyly versus digital splint when comparing joint mobility. The investigators also wish to study the effectiveness of finger compression in reducing edema and therefore allowing a greater arc of motion.

Proximal interphalangeal joint (PIPJ) injuries of the fingers are a common occurrence. They may be treated various ways: strict immobilization in a finger splint for one to three weeks, syndactyly, no immobilization. Immobilization is often responsible for joint stiffness whereas immediate mobilization might produce pain.

Injuries to the joints of the hand produce edema that is responsible for additional stiffness. Compressive garment may be worn to limit the extent of the edema and help its resorption.

Although PIPJ injuries are frequent, their treatment does not benefit from a consensus. Most studies are retrospective or aimed at a pediatric population. The investigators wish to evaluate the outcome of PIPJ injury after different treatments: either strict immobilization in a rigid splint for three weeks, of relative immobilization in a syndactyly for three weeks.The investigators also wish to study the effect of finger compression on edema resolution and finger motion. Therefore there will be four treatment groups: syndactyly with and without compression, rigid splint with and without compression.

The study will be conducted in the hand surgery unit of a university hospital in a prospective way. The assignment to a particular treatment group will be randomly performed. Patients will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* proximal interphalangeal joint injury with or without dorsal or lateral luxation
* less than seven days after injury
* injured joint stability
* fracture of the palmar rim of the intermediate phalanx less than 30% of articular surface

Exclusion Criteria:

* palmar luxation of the proximal interphalangeal joint
* fracture of the palmar rim of the intermediate phalanx greater than 30% of articular surface
* injury to the central band of the extensor tendon
* fracture other than palmar rim of the intermediate phalanx less than 30% of articular surface
* non reducible luxation
Assessment of Patients Quality of Life Treated With Three ARTHRUM H 2% Joint Injections

The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.

This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of life treated by intraarticular injections, eventually for several years, by difference of usual clinical trials.

This open, prospective, multicentric study aims to analyse, in patient care, the impact of three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months (D180) in the symptomatic treatment of knee osteoarthritis.

Parameters used to determine treatment outcomes include: "Short-Form 12 Health Survey" (SF-12), Pain score of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC A)

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged over 40;
* Suffering from symptomatic knee osteoarthritis radiologically confirmed less than 12 months ago and stage I, II or III according to KELLGREN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale
* Patient able to understand the trial procedure and give his/her consent to take part, in writing;
* Patient geographically stable during the trial;
* Patient affiliated to the French social security regime or benefiting from such a French regime.

Exclusion Criteria:

* Inflammatory arthritis;
* Progressive infectious condition of the knee being studied;
* Previous treatment with viscosupplementation for at least one year;
* Injection of corticoids into the knee studied for less than two months;
* Known hypersensivity to hyaluronic acid or substances with similar activity;
* Pregnant or breast-feeding women;
* Patient under guardianship or tutorship or under juridicial protection;
* Patient currently taking part in another clinical research study.
Enhancement and Restoring of Low Dose Abdominal CT Images

Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post processing filters can improve and restore grainy and noisy low dose CT images by enhancing structure and reducing image noise. In our study of 10 patients, the investigators perform a preliminary evaluation of a novel post processing filter, which does picture element correlations in all three spatial dimensions. By comparing normal dose pictures with unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three dimentional (3D) filters,the investigators will be able to assess the possible clinical value of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, Male or female,Age above 60 years, Referred to our department for an abdominal CT with intravenous contrast.

Exclusion Criteria:

* Abdominal diameter less than 80cm or larger than 100cm, Gross pancreatic pathology, Gross anatomic anomalies in the investigated region, Intolerance of intravenous contrast
Electronic Health Record (EHR) Decision Support to Improve Outpatient Asthma Care

To determine whether an innovative clinical decision support system embedded in an existing electronic health record (EHR) will improve provider adherence to the existing National Asthma Education and Prevention Program (NAEPP) guidelines.

12 primary care pediatric practices at The Children's Hospital of Philadelphia(both urban and suburban sites) will be randomized to receive either a passive EHR (control sites) or an interactive decision support system (intervention sites).

After receiving a standardized education module based on NAEPP guidelines, 12 primary care pediatric practices (both urban and suburban sites) will be randomized to receive either a passive EHR (control sites) or an interactive decision support system (intervention sites).

The primary outcome of interest will be the proportion of patients on appropriate asthma controller medication compared over time. Secondary outcomes include the proportion of asthma patients with: 1) an updated asthma action plan 2) documentation of spirometry performed (6 to 17 yrs) and 3) an updated problem list reflecting current asthma severity. After hours calls to providers and types of office visits related to asthma will be tracked. 4) In addition, measurement of asthma-related quality of life and missed school and work in a sample of 200 subjects from each group will be performed. Contextual factors at the clinic and patient level will be examined to assess their association with outcomes of interest.

If shown to be successful, this type of clinical decision support, embedded within the EHR, has the potential to be a powerful tool to improve the implementation of asthma guidelines and clinical practice guidelines for other conditions and illnesses in the primary setting.

Eligibility Criteria:
Inclusion Criteria:

* Known patients with asthma

Exclusion Criteria:

* None
A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Volunteers

A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344

A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening.
5. Those who agree to contraception during the participation of clinical trial.
6. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeletomuscular, immune, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood within 8 weeks or blood components within 4 weeks prior to the first dose of the investigational product.
6. Those who exceed an alcohol and cigarette consumption than below criteria. A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week B. Smoking: 20 cigarettes/day
7. Those who exceeds 2 times the upper limit of the reference range of AST(or ALT) or 1.5 times the upper limit of the reference range of γ-GTP.
8. Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions.
9. Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.)
10. Those who were deemed inappropriate to participate in the study by the investigator.
11. Those who have a pregnant or nursing woman.
Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors

This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent, progressive, or refractory melanoma or other solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.

Study DAY101-102 (master study) and sub-studies will consist of a screening period, a treatment period, a safety follow-up period, and a long-term follow-up period where survival, status and subsequent anticancer therapies are collected.

Tovorafenib will be evaluated alone or combined with a different targeted therapy in each sub-study. The Phase 1b part of each applicable sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate anti-tumor activity.

Substudy A will enroll patients with recurrent or progressive melanoma or other solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.

Substudy B will enroll patients with recurrent or progressive melanoma or other solid tumors with alterations in the key proteins of the MAPK pathway.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by patients ≥ 18 years of age and, assent for patients ≥ 12 up to \< 18 years of age
* Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1)
* Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required
* If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging

Substudy A-specific inclusion criterion:

* Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.

Substudy B-specific inclusion criterion:

* Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.

Exclusion Criteria:

* Known presence of concurrent activating mutation
* Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)

Substudy A-specific exclusion criterion:

* Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy
A Study to Evaluate the Effectiveness of Intravitreal Aflibercept in Patients With Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion, Which Either Have or Have Not Been Pretreated for Their Disease

AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO).

The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries.

Additionally, utilization and treatment regimens in routine clinical practice will be described.

Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* For DME

  -- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to DME
* For macular edema secondary to RVO

  -- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to macular edema secondary to RVO
* Patient for whom the decision to initiate treatment with aflibercept is made prior to and independent from study participation
* Signed informed consent.

Exclusion Criteria:

* Any contraindications as listed in the local intravitreal aflibercept SmPC (summary of product characteristics)
* Current participation in any other clinical (interventional) study or in any other anti-VEGF study
* Receipt of systemic anti-VEGF and pro-VEGF treatment
* Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema or any other condition expected to permanently limit VA outcomes over the course of the study
* Patients with prior retinal surgery
* Any prior treatment with aflibercept
* History of stroke or transient ischemic attacks within the last 6 months
* Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
* For patients with prior treatment (i.e. patients that previously have been treated with intravitreal anti-VEGF or steroids):

  * Previous treatment of the study eye with anti-angiogenic drugs or laser within the last 3 months and patients with ocular surgery of the study eye within the last 3 months
  * Intravitreal dexamethasone or triamcinolone in the study eye within the last 3 months
  * Fluocinolone implant within the last 3 years
  * Dexamethasone implant within the last 6 months
* For DME

  -- Concomitant therapy with any other agent to treat DME in the study eye.
* For macular edema secondary to RVO

  * Patients who have received or who require pan retinal photocoagulation due to neovascularization
  * Concomitant therapy with any other agent to treat macular edema secondary to RVO in the study eye.
The Risk Stratification of Papillary Thyroid Cancer With AUS/FLUS by FNA

Purpose: To investigate the clinical characteristics of papillary thyroid cancer (PTC) with Bethesda category III (AUS/FLUS) by fine needle aspiration (FNA) and to assisted the precision treatment.

Methods:A total of 290 patients who underwent thyroidectomies or thyroid lobectomies from August 2015 to September 2020, following a diagnosis of Bethesda category III (AUS/FLUS) from preoperative thyroid FNA were investigated.

Groups: In order to investigate the clinopathologic characteristics, the patients, were grouped according to Cytology,Gender, Tumor size.

Purpose: To investigate the clinical characteristics of papillary thyroid cancer (PTC) with Bethesda category III (AUS/FLUS) by fine needle aspiration (FNA) and to assisted the precision treatment.

Methods:A total of 1739 cases diagnosed with Bethesda category III (AUS/FLUS) by FNA from August 2015 to September 2020 were reviewed, and 523 patients received thyroidectomy or lobectomy. 290 patients were diagnosed with PTC and investigated retrospectively.

Groups: In order to investigate the clinopathologic characteristics, the patients, were grouped according to Cytology,Gender, Tumor size.as follows:AUS and FLUS\&AUS/FLUS;male and female; tumor size≤1cm and\>1cm.

Eligibility Criteria:
Inclusion Criteria:

Clinical cytology diagnosis of Bethesda category III (AUS/FLUS) pathological confirmation of thyroid malignancy after surgery.

Exclusion Criteria:

1. pathological confirmation of other thyroid carcinomas, including follicular carcinoma ,medullary carcinoma ,undifferentiated Spindle cell carcinoma and lymphoma were excluded
2. female who were pregnant were excluded
3. patients with mental disorders were excluded
4. patients without the complete clinical data were excluded
Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures

To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

In order to minimize the amount of distending media infused during hysteroscopic procedures, investigators used manual syringe method for delivering of distending media during hysteroscopic procedures from June 2010 to November 2013 in our institute. The aim of this study was to evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

The medical records of all women who received hysteroscopic procedures by manual fluid-infusion method or convention pump fluid infusion method between June 2010 and November 2013 will be reviewed. In order to reveal the superiority/inferiority of clinical outcome of women receiving manual fluid infusion method, perioperative outcomes will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.
* Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose from June 2010 to November 2013 in Department of Obstetrics \& Gynecology in Far Eastern Memorial Hospital.

Exclusion Criteria:

* Female patients of less than twenty years-old.
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

This clinical trial was performed to assess the clinical efficacy and safety of two 4 week treatment courses of daily intravenous administration of Cerebrolysin (20mL \[milliliter\] IV \[intravenous\] per day). The study was performed as prospective, randomised, double-blind, placebo-controlled, parallel group, multicentre study with 2 study groups.

Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo (0.9% NaCl \[sodium chloride\]) and 100 mg acetylsalicylic acid The study drug was given once daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive days per week. This treatment regimen was repeated after a two-month treatment-free interval. Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.

Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24 were necessary.


Eligibility Criteria:
Inclusion Criteria:

* Men or post-menopausal women between 50 and 85 years
* Clinical diagnosis of vascular dementia according to NINDS-AIREN criteria
* CT or MRI results compatible with clinical diagnosis
* MMSE score between 10 and 24, both inclusive
* Modified Hachinski Ischemic Score \>4
* Hamilton Depression Scale score of less than or equal to 15
* Adequate visual and auditory acuity to allow neuropsychological testing
* Informed consent given by the patient and/or the next-of-kin

Exclusion Criteria:

* Gastric ulcer associated with intolerance of acetylsalicylic acid treatment
* Severe psychotic features, schizophrenia, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
* Any severe systemic illness or unstable medical condition that could lead to difficulty complying with the protocol or significantly limits life span.
* Patients who in the investigator's opinion, would not comply with study procedures
* Any significant neurological disease other than vascular dementia, such as Parkinson's disease, epilepsy, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis
* History of alcohol or substance abuse or dependence within the past two years
* Patients with a history of systemic cancer within the past two years
* Severe congestive heart failure or malignant, uncontrollable hypertension
* Participation in a clinical trial with an investigational drug in the past four weeks
Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)

The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.


Eligibility Criteria:
Inclusion Criteria:

* Melasma
* Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
* Age at least 18 years
* Subject is willing and able to give written informed consent

Exclusion Criteria:

* use of bleaching creams during the past six weeks
* history of keloid
* active eczema
* suspected hypersensitivity to lidocaine or triple therapy
* use of isotretinoin in the past six months
* high exposure of the lesion to sunlight or UV light (UVA or UVB).