cyrilzakka/clinical-trials huggingface dataset:
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients

The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims of the study are to develop a hospital cost minimization analysis and a cost effectiveness analysis based on direct estimation of costs and quality of life deriving from remote follow-up (performed with Merlin@home and Merlin.net) compared to standard follow-up in the management of ICD implanted patients.

TARIFF is a prospective observational study aimed to measure direct, indirect costs and quality of life of all participants for the duration of the observational timeframe. Purpose of cost collecting is to include a complete set of medical services and productivity loses that could be directly affected by the different clinical Follow-Up (FU) pathway. The study consists of 2 phases: firstly standard follow up costs will be collected for 100 pts, then all costs associated to remote follow ups will be collected for other 100 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients already implanted with ICD
* Patients able to be followed in the same centre during all the study
* Patients with age \> 18
* Patients able to understand and to answer to EuroQoL Group 5-Dimension (EQ-5D) Questionnaire

Exclusion Criteria:

* Patients pregnant
* Patients unable to connect Merlin@home transmitters with Website Merlin.net (i.e.without telephonic analogic line or Global System for Mobile Communication (GSM)/Universal Mode Telecommunication System (UMTS) connection)
Nurse-led Educational Intervention on Heart Failure Patients

A randomized controlled study to examine the effect of a nurse-led, home/telephone or telephone-only educational intervention on outcomes of heart failure patients and their caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Men or women aged ≥18 years old.
* Hospitalized for new-onset or decompensated chronic heart failure.

Exclusion Criteria:

* Any severe neuromuscular disease or other disability or mobility problems that preclude performance of six-minute walk test.
* Any severe cognitive dysfunction or psychiatric disease that limit ability to receive education.
* Patients unable to be contacted by phone or other means.
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.


Eligibility Criteria:
Inclusion Criteria:

* Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107

Exclusion Criteria:

* Other protocol-defined inclusion/exclusion criteria may apply.
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia

Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.


Eligibility Criteria:
Inclusion Criteria:

* Be 40 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent.
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Have no active ocular disease or allergic conjunctivitis.
* Not be using any topical ocular medications.
* Be willing and able to follow instructions.
* Have signed a statement of informed consent.

Exclusion Criteria:

* Participating in a conflicting study.
* Considered by the Investigator to not be a suitable candidate for participation.
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.

After the peeling, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Eligibility Criteria:
Inclusion Criteria:

* Phototypes I and II according to the Fitzpatrick scale;
* Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.

Exclusion Criteria:

* Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
* Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
* Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
Short Versus Long Wire ERCP Systems

This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing ERCP.

Exclusion Criteria:

* Age less than 18 years, pregnant women, patients unable to provide informed concent, prior surgery causing a significant change in the anatomy of the papilla (Billroth II or Roux-en-Y)
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.
How Does Early Age Life Style Affect Bone Strength and General Health Parameters at Middle Age?

The purpose of this study is to evaluate the effect of vigorous physical activity versus extremely sedentary life style during young age on the bone mineral density and general health in later life.

Bone strength and peak bone mass are preliminary determined by genetic factors. Life style, especially exercise, is also considered to have an important effect on bone strength. Bone has the ability to strengthen itself according to Wolff's Law. When bone is subjected to strains and/or strain rates higher than the usual, it responds by remodeling, strengthening its architecture. The ability is greatest in young individuals and decreases with age. In the elderly this ability is largely non-existent and bone mass is lost. Whether this loss leads to osteoporosis is largely a function of the peak bone mass achieved before the decline. 11% of males and 44 % of females over 50 suffer from osteoporosis in later life. To what extent vigorous exercising beginning at a young age can increase bone strength is not known.

The purpose of the proposed research is to quantify the effect of life style on bone strength and general health parameters by comparing two male populations, one sedentary and the other that has done demanding physical training: (1) Elite infantry recruits who were inducted into the I.D.F. in Feb 1983, did their basic training at Sanur and were part of the 1983 stress fracture project who completed three years of elite infantry service and continued to serve as combat soldiers in the reserves; (2) Yeshiva students who had profiles of 82 or 97 and received deferment from their military service in 1983 and since then have continued their studies and never served in the army.

50 subjects will be reviewed in each group. Measurements of weight, height, waist and abdominal girth, resting pulse and blood pressure will be made. The brachial/ankle blood pressure index will be recorded. MRI of the right knee to study potential degenerate changes will be done using a 1.5 Tesla General Electric Signa MR scanner. Quantitative Computed Tomography (QCT), one of the most popular and effective methods utilized for osteoporosis screening, will be performed to determine volumetric BMD, BMC, bone geometric properties and strength indexes of the tibia and lumbar spine.

Comparisons:

Group I: 50 males (age 41-45), former elite Israeli infantry soldiers, selected randomly from those recruits who did their infantry basic training at Sanur in Feb. 1983 (all profiled 82 or 97) and completed their military service as combat soldiers will be compared to:

Group II: 50 age-, profile- and ethnically-matched Israeli citizens whose military service was deferred in 1983 because of Torah studies and who did not do army service and were not involved in any kind of physical training.

Eligibility Criteria:
Inclusion Criteria:

* Israeli military profile 82 or 97 at age 17-22

Exclusion Criteria:

* Israeli military profile less than 82 at age 17-22
* Former soldiers with shrapnel injuries will be excluded from MRI studies
Study of Medication Patch to Treat Children Ages 6-12 With ADHD

The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 6 to 12 years of age.
* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
* Participation in structured morning routine (e.g. school, camp, or other organized activities).

Exclusion Criteria:

* Mental retardation (IQ \<75).
* Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
* Subjects with moderate to severe dermatological atopy.
* Subjects with known structural cardiac abnormalities.
* Organic brain disorders.
* Seizure Disorder.
* Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder.
* Subjects with current comorbid psychopathology that in the investigator's opinion will warrant immediate treatment or will interfere with the safe execution of the protocol (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI).
* Subjects with a history of intolerable adverse effects or non-response to methylphenidate.
* Pregnant or nursing females.
Apply Machine Learning to the Interpretation of Urinary Crystal Morphology.

The goal of this observational study is to developing an image-based artificial intelligence software that can automatically interpret the types and sizes of crystals in urine. The main question\[s\] it aims to answer are:

* Allowing healthcare professionals to input urine images and receive real-time reading results on crystal types and sizes.
* This aims to provide a faster, more objective, and accurate analysis of crystals.

We anticipate delivering an image AI software suitable for practical applications, promoting the automation and accuracy of urine crystal analysis.

Kidney stones are primarily formed due to the supersaturation of ions in urine, leading to the formation of crystals. An assessment of the risk of kidney stones is based on a patient's medical history, biochemical urine tests, and various laboratory examinations. Combining these with imaging studies such as CT scans, ultrasound, and X-rays helps in diagnosing the type of kidney stones, though imaging results for smaller stones may be less accurate. Stone formation is common with a high recurrence rate, and there is a strong correlation between urine crystals and stone composition. Therefore, the analysis of urine crystals is meaningful for the diagnosis, evaluation of treatment strategies, and prevention of stone recurrence in kidney stone disease.

Microscopic analysis of urine crystals allows the observation of smaller crystals. However, manual urine microscopy is slow and time-consuming. To address this, we aim to develop artificial intelligence software to assist in the interpretation of urine crystals, providing a faster analysis. We will retrospectively analyze urine crystal images stored from previous research (Chang Gung Memorial Hospital Internal Project Research No. 107123-E) to identify crystal types. Subsequent image preprocessing and category labeling will be done to train and infer machine software. The results will be compared with manual interpretation to establish the accuracy of the software.

Eligibility Criteria:
Inclusion Criteria:

* Retrospectively analyze the urine crystal images preserved from the previous study 107123-E for crystal type analysis. Subsequently, conduct image preprocessing and label categorization for machine software learning and inference. The interpreted results will then be assessed for accuracy using statistical analysis software.

Exclusion Criteria:

* Not applicable
Study Using Pregnenolone to Treat Bipolar Depression

Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.

Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, pregnenolone showed a strong signal on depression scores.

Secondary

1. Determine if pregnenolone supplementation is associated with greater improvement in anxiety symptoms in persons with BPD, depressed phase. Data from prior studies suggests that pregnenolone may decrease symptoms of anxiety. Anxiety is a common and clinically important feature of BPD. Therefore, we will examine anxiety symptoms in this trial.
2. Determine if pregnenolone supplementation is associated with improvement in manic symptoms as compared to placebo in persons with BPD, depressed phase. Our pilot study suggested that pregnenolone may be associated with improvement in manic symptoms. Although the current study targets bipolar depression we will also examine manic symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women of all races age 18-75 years
* Diagnosis of bipolar I, II or not otherwise specified (NOS) disorders currently meeting criteria for a major depressive episode
* English speaking

Exclusion Criteria:

* Active suicidal ideation with plan and intent
* Treatment resistant depression
* Vulnerable population (i.e. pregnant, cognitively impaired, incarcerated)
* Severe or life threatening medical condition
* History of allergic reaction or side effects with prior pregnenolone use
* Current substance use disorder defined as meeting criteria for abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM)(SCID) interview and self-reported use within the past 3 months or a positive baseline urine drug screen
* Removal or addition of concomitant psychiatric medications within 10 days prior to randomization
* Current Warfarin therapy
* Current use of oral contraceptives
* Current hormone replacement therapy
* History of heart disease or arrhythmias
* Current (past 7 days) systemic
Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

It has been shown that insulin might be involved in the pathogenesis of thyroid growth.

Objective To evaluate the impact of IR and metformin use on the volume of benign thyroid nodules (TNs).

Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle aspiration confirming the diagnosis is necessary to inclusion. Patients will receive similar tablets of MTF and placebo and instruct to take 3 tablets/day of MTF (500mg/tablet). Thyroid volume, as TN volume, will be assess by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. Blood samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h fasting.

It has been shown that insulin might be involved in the pathogenesis of thyroid growth. Previous studies suggest that metformin (MTF) therapy decreased thyroid volume and nodule size in subjects with insulin resistance (IR).

Objectives To evaluate the impact of IR and metformin use on the volume of benign thyroid nodules (TNs).

Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle aspiration confirming the diagnosis is necessary to inclusion. Exclusion criteria were: nodules with a predominantly cystic pattern, pregnancy, diabetes, acromegaly, previous use of MTF, levothyroxine, corticoid or any weight loss medication in the past six months, hepatic or cardiac insufficiency, creatinine levels \> 1.4 mg/dL and MTF intolerance doses \>1.0 gram/day. Patients will receive similar tablets of MTF and placebo and will be instructed to take 3 tablets/day of MTF (500mg/tablet). Thyroid volume, as TN volume, will be accessed by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. Blood samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h fasting.

Eligibility Criteria:
Inclusion Criteria:

* patients with benign nodules diagnosed by fine needle aspiration biopsy (FNAB)

Exclusion Criteria:

* Nodules with a predominantly cystic pattern
* Eggshell calcification
* Coalescent thyroid nodules (not suitable for size analysis)
* Pregnancy
* Diabetes
* Acromegaly
* Previous use of MTF, levothyroxine, corticoid or any weight loss medication in the past six months
* Hepatic or cardiac insufficiency
* Creatinine levels \> 1.4 mg/dL
* MTF intolerance doses \< 1.0 gram/day
Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.


Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis
* over 19 years
* Eastern Cooperative Oncology Group 0-1
* Proper organ function
* more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)
* Who should sign on the Informed consent form before participate the trial.

Exclusion Criteria:

* Metastasis in other organ except liver
* Chronic active hepatitis or cirrhosis
* History of treatment for metastatic colorectal cancer
* Subject pregnant or breast feeding
* Uncontrolled disease
* Have had adjuvant therapy
* Uncontrolled peripheral nerve infection
* Alcoholic or drug addict
* Subject currently is enrolled in or ≤30 days from ending other clinical trial.
* History of other type of cancer except resolved from skin cancer and cervical cancer.