cyrilzakka/clinical-trials huggingface dataset:
App Teaches Doctors to Diagnose Skin Cancer

This study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. Secondarily the study aimed to investigate the time spent in reaching this change in proficiency.

Participants were given a questionnaire and an initial Skin Cancer Multiple Choice-Questionnaire (MCQ) to test their diagnostic skills regardining skin and mole cancer and the most common differential diagnoses.

Participants in the Intervention group was then given access to an educational mobile application (App) for 8 days and asked to diagnose 500 patient cases. The participants did so at their own leisure and time.

After 8 days they were asked to abstain from using the App for another 8 days (wash out period) and were then given a Final Skin Cancer Multiple Choice-Questionnaire (MCQ).

Participants of the control group received no intervention nor education during the 16 days of waiting before they took the final Skin Cancer Multiple Choice-Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Primary Care Physician who works in General Practice

Exclusion Criteria:

-
Physical Training and Health Education in Hospitalized Elderly

The Activity in GEriatric acute CARe (AGECAR) Plus Health Education is a randomized control trial to assess the effectiveness of an intrahospital exercise and health education program during short hospital stays for improving functional capacity of patients aged 75 years or older.

This research aims to investigate the effect of a training program using gait and muscle training and health education, over the functional capacity of elderly hospitalized patients.

The Randomized controlled trial with patients hospitalized in the Acute Care Unit of the Geriatric Department. Participants aged 75 years or older admitted for a short hospital stay will be randomly assigned in a four-week block, to either usual care (control) group or an intervention (training group). Participants allocated in the control group will receive standard hospital care. Participants allocated in the intervention group will perform during hospitalization, training program (30 minutes per session, two sessions per day, lower limb strength training, balance training, walking and inspiratory muscle training) and also health education. Health education consists of several informational activities. Each activity session will teach the patient and caregiver how to perform the exercises to ensure they will continue to be performed at home and before discharge the entire session will be devoted to reviewing the entire program. The type, frequency and progression of the exercises to be carried out will be reviewed; they will be explained how to do them at home and given personalized written instructions with illustrations of the exercises. Also, after one month and two months of discharge, the professional with whom they have completed the training will call them to insist on the completion of the program or to clarify any doubts that may exist.

Eligibility Criteria:
Inclusion Criteria:

* Participants will include people aged 75 years or older recruited from patients admitted into the Geriatrics Department of the Hospital General Universitario Gregorio Marañón (Madrid, Spain).
* Able to ambulate, with or without personal/technical assistance.
* Able to communicate.
* Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

* Duration of hospitalization \< 72 hours
* Any factor is precluding performance of the physical training program or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
* Terminal illness.
* Not capable of ambulation.
* Unstable cardiovascular disease or other medical condition.
* Severe dementia.
* Unwillingness to either complete the study requirements or to be randomized into control or intervention group.
Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)

Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.

This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with essential hypertension
2. Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly
3. Male and female adults aged 20 years or older
4. Voluntarily provided a written consent to participate in the study

Exclusion Criteria:

1. Patients with hypersensitivity to this drug or the ingredients of this drug
2. Pregnant or breast-feeding women
3. Patients on renal dialysis
4. Patients with moderate to severe hepatic impairment
5. Patients with biliary atresia
6. Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
7. Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator
8. Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)
Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

This is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all 3) Expectant management. Randomization will be 1:1:1 into these three arms. After randomization, they will be followed and treated clinically as is indicated by the progression of their condition. Primary outcome measures: uneventful decline of hCG to 5 IU/mL.


Eligibility Criteria:
Inclusion Criteria:

* Female with a persisting pregnancy of unknown location:
* A pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization.
* Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days), showing \< 15% rise per day, or \< 50% fall between the first and last value.
* Patient is hemodynamically stable, hemoglobin \>10 mg/dL
* Greater than or 18 years of age

Exclusion Criteria:

* Hemodynamically unstable in need of acute treatment
* Most recent hCG \> 5000 mIU/mL
* Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion)
* Diagnosis of gestational trophoblastic disease
* Subject unwilling or unable to comply with study procedures
* Known hypersensitivity to MTX
* Presence of clinical contraindications for treatment with MTX
* Prior medical or surgical management of this gestation
* Subject unwilling to accept a blood transfusion
Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy

Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18-year-old, diagnosed with cancer
* Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them

Exclusion Criteria:

* Patients who cannot complete a PET/CT scan
* Pregnant women
* Healthy volunteers
* Patients participating in other research studies

The subjects will not be paid to participate in this protocol. No costs will be charged to the subjects.
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.

Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight \>45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.

Exclusion Criteria:

Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA


Eligibility Criteria:
Inclusion Criteria:

* Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits \>10 swollen joints, \>12 tender joints.
* Subjects must have failed prior treatment with one or more DMARDs.
* A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
* Body weight less than or equal to 100 kg

Exclusion Criteria:

* A history of, or current, acute inflammatory joint disease of different origin from RA.
* Prior treatment with any TNF antagonist, including adalimumab.
* Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
* Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
Hepatic Safety of Statin Use in Neurology Inpatients

This research employs a cross-sectional study and a retrospective cohort study to analyze the liver safety of statin use among inpatients in the neurology department in China from different perspectives. The aim is to supplement evidence-based medicine and provide guidance for the clinical use of statins.


Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized in the Department of Neurology of Yueyang Hospital from June 2020 to February 2023.
2. Age ≥18 and ≤85 years old, both sexes.
3. Meet the diagnostic criteria of cerebrovascular disease (L1-8B0), headache disease (L1-8A8) and dizziness and vertigo (MB48) in ICD-11.

Exclusion Criteria:

1. Incomplete medical history.
2. 1 days ≤ patients with \< 7 days of prior statin use.
3. Patients with malignant tumors (ICD-11 code L1-2A0, L1-2A2, L1-2B5, L1-2E6 diseases) and hematological diseases (ICD-11 code L1-3A0, L1-3B1, L1-3B8 diseases).
Effect of Diet Composition on Liver Fat and Glucose Metabolism

This study is designed to determine if the amount of fat and saturated fat in the diet contributes to the development of a condition called fatty liver disease in the absence of changes in weight.

A condition called non-alcoholic steatohepatitis is characterized by fat accumulation in the liver and associated inflammation. This condition is strongly associated with obesity, insulin resistance and type 2 diabetes. Diets high in saturated fat result in fatty liver, insulin resistance and liver injury in animal models. Dietary composition may contribute not only to hepatic fat accumulation and insulin resistance but may also promote inflammation leading to chronic liver disease in humans. This study will test the hypothesis that a diet high in fat and saturated fat contributes to liver fat accumulation, insulin resistance and inflammation by comparing the effects of a four-week, weight stable high fat/high saturated fat diet (55% calories from fat/25% saturated fat) with a four-week, weight stable low fat/low saturated fat diet (20% fat/8% saturated fat) in overweight and obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years old, men and women, otherwise in good general health, BMI \>27 kg/m2

Exclusion Criteria:

* Abnormal glucose tolerance, fasting glucose\>100 mg/dl or diabetes
* History of liver condition or alanine aminotransferase (ALT) above the upper limit of the normal range
* Use of medications that cause insulin resistance or fatty liver: niacin, glucocorticoids, estrogens, tamoxifen, amiodarone, accutane, sertraline, atypical antipsychotics, anti-HIV medications
* Chronic use of anti-inflammatory medications (aspirin, ibuprofen, naprosyn, steroids, etc)
* Average alcohol intake \>20 grams/day
* Tobacco use
* Creatinine \>1.5 mg/dl for men and \>1.4 mg/dl for women
* Hematocrit \<33%
* Pregnancy or lactation
* Significant weight loss within the past 6 months (\>5% body weight)
* Claustrophobia or any contraindications to being placed in the magnet for the MRS scan such as pacemakers, defibrillators, brain aneurysm clips, etc.
* Other serious medical conditions or inflammatory conditions such as cancer, inflammatory arthritis, etc.
* History of multiple food allergies or intolerances or severe food allergies
* History of coronary artery disease, history of or treatment of hyperlipidemia, LDL \>200 mg/dl, fasting triglycerides \>300 mg/dl
* Weight \>300 pounds
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.

The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled.

Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* is at least 21 years of age and skeletally mature
* must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis;
* must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
* must score at least 15/50 (30%) on the Neck Disability Index
* is willing and able to follow the post-operative management program
* must understand and sign the informed consent document

Exclusion Criteria:

* symptomatic cervical DDD at more than one level
* axial neck pain as the primary diagnosis without evidence of neural compression
* neck or arm pain of unknown etiology
* any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible
* severe spondylosis at the target level
* prior surgery at the target level
* fused level adjacent to the target level
* osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
* active infection or surgical site infection
* is using any medication known to interfere with bone/soft tissue healing
* diabetes mellitus requiring daily insulin management
* any terminal, systemic, or autoimmune disease
* medical conditions or mental incompetence which may interfere with study requirements
* BMI \>40 or a weight more than 100 lbs over ideal body weight
* chemical dependency problem that may interfere with study requirements
* current smokers
* history of any invasive malignancy unless treated and in remission for at least two years
* documented allergies to metal or plastic
* currently pregnant, or interested in becoming pregnant during the study follow-up
I3LTE4: Intensive Insulin Therapy and Production of LTE4 in Patients With Diabetes

The primary objective of the study is to assess the effect of a 3-month intensive insulin therapy on urinary leukotriene E4 (LTE4) excretion in patients with diabetes.

Our group has recently reported the results of a preliminary cross-sectional study, which demonstrated that the urinary LTE4 excretion is increased in patients with type 1 diabetes. With regard to recent human genetic studies showing that polymorphisms in the 5-lipoxygenase (5-LO) promoter and FLAP haplotypes is linked to cardiovascular disease susceptibility our data suggested the potential interest of LTE4 as a non-invasive biomarker of cardiovascular risk. In diabetes mellitus, further studies are required to evaluate the 5-LO pathway after improvement of glucose control and concomitantly with established inflammatory cardiovascular biomarkers.

The secondary objectives are:

Before and after 3-month intensive insulin therapy- Relationship between a marker of platelet activation (urinary 11-dehydro-thromboxan B2 :11-dehydroTXB2) and urinary LTE4- Relationship between inflammatory plasma markers of cardiovascular risk (hs-CRP and fibrinogen) and urinary LTE4- Relationship between a plasma marker of endothelial dysfunction (sICAM-1) and urinary LTE4- Changes in LTE4 according to patient subgroups (patients with type 1 and type 2 diabetes mellitus)

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus (type 1 or type 2)
* \> 18 year-old
* subject has given free, informed written consent
* subject entitled to health insurance cover
* medical follow-up at the department of Diabetology, Grenoble University Hospital
* inappropriate glucose control (HbA1c \> 8.5%) requiring an initiation, or revision, of insulin therapy

Exclusion Criteria:

* legal incapacity or limited legal competence
* pregnant women
* heart failure
* impaired renal function,defined by a creatinin clearance \< 60 ml/mn according to Cockroft formula
* asthma
* respiratory failure
* IV, IM, SC or oral treatment with cortico-steroids for the last 2 months prior to baseline
* current smoking \> cigarettes / day
* any infectious disease for the last 2 months prior to baseline
* baseline CRP \> 20 mg/l
A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus

The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
* Fasting Plasma Glucose between 126 and 240 mg/dL
* Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
* Fasting C-peptide \> 0.8 ng/mL

Exclusion Criteria:

* Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
* Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
* BMI \> 42 kg/m2
* Presence of any diabetic complications requiring chronic therapy
* Presence or history of any form of hepatic disease
* Serum creatinine \> 1.8 mg/dL
* History of cardiac arrhythmias or abnormal cardiac electrophysiology
* Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol
Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

Since the first successful percutaneous closure under transoesophageal echocardiographic (TEE) guidance, many centres explored transcatheter procedures without fluoroscopy. This single centre study aims to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under echocardiography-only guidance during our one-year experience. Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or echocardiography-only in National Cardiovascular Center Harapan Kita. Patients were evaluated clinically and radiologically using TTE at 6, 24 and 48 hours after the procedure. Primary endpoint was the procedural success. Secondary endpoints were the procedural time and the rate of adverse events. Echocardiography-guided PDA closure is non-inferior to fluoroscopy-guided PDA closure, with similar procedural times. However, this method is operator-dependent and requires an experienced team for it to be performed successfully.

From March 2019 to April 2020, a total of 60 patients with PDA were recruited as participants for this prospective, single-centre, non-randomized clinical trial. They were divided equally into two groups: the fluoroscopy group who underwent percutaneous PDA guided by fluoroscopy and the echocardiography group who underwent percutaneous PDA closures guided by transthoracic echocardiography (TTE) and TEE at the National Cardiovascular Centre Harapan Kita, Jakarta, Indonesia. Patients with stable hemodynamic and clinically asymptomatic PDA were evaluated and considered for transcatheter PDA closure. Significant chamber enlargement and mild to moderate pulmonary hypertension were also indications for transcatheter closure. Ductal morphology was evaluated using multiplanar TTE and TEE imaging.

After the procedures, patients were evaluated and followed-up after 6, 24 and 48 hours to observe any residual shunts and complications. This study protocol conforms to the ethical guidelines of the Declaration of Helsinki and the Nuremberg Code with approval from the Research Ethics Committee of National Cardiovascular Center Harapan Kita No LB.02.01/VII/475/KEP076/2020. Written consent to perform the procedure and to use the patients' medical records for this study was obtained from the patients or their parents.

Eligibility Criteria:
Inclusion Criteria:

* PDA, age \<= 18yo

Exclusion Criteria:

* \>= 18yo, Eisenmenger syndrome, coexistence of other associated congenital heart disease