cyrilzakka/clinical-trials huggingface dataset:
Steroid Withdrawal Immunosuppression After Renal Transplantation

The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3 months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and basiliximab. This study is an open-label, prospective, controlled clinical trial in a single center. Those patients who fulfill the entry criteria could enter in this prospective controlled trial of steroid withdrawal three months after transplantation.

Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation. The entry criteria include 1) no episode of clinically treated nor biopsy confirmed acute rejection up to entry; 2) serum creatinine level equal to or less than 2 mg/mL on three separate measurements; 3) no proteinuria (urine protein less than 1000 mg/24 hours; 4) tacrolimus trough level \> 5 ng/ml without signs of nephrotoxicity; 5) agreement to follow the study protocol.

For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation). The patients visit every week, and they are closely monitored with symptoms and signs, blood cell count, chemistry, and urinalysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 13 years who received a primary kidney transplant
* Subject who is using CNI ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)
* serum creatinine \< 2 mg/dL and the variation of serum creatinine \< 30% during the past 3 months
* Proteinuria ≤ 1g quantified by 24 hour urine or spot urine protein/creatinine ratio \< 1.0
* Subjects who agree with written informed consent

Exclusion Criteria:

* Subjects who received combined non-renal transplantation.
* Subject who received re-transplantation
* Deceased donor without a heartbeat
* Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or Mycophenolate Mofetil or to any of the excipients.
* Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferase) such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome.
* HLA-identical living related donor
* ABO blood group incompatible
* HIV, HBsAg, or HCV Ab tests (+)
* Abnormal liver function test (AST or ALT or total bilirubin\> upper normal limit x3) ANC \< 1,500/μL or WBC \< 2,500/μL or platelet \< 750,000/μL
* Women who are either pregnant, lactating, planning to become pregnant in the next 12 months.
* Subjects with history of cancer, except successfully treated, localized nonmelanocytic skin cancer Subjects with clinically significant infections within the past 3 months.
Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy

The purpose of the study is to examine the clinical safety, tolerability, and efficacy of clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with refractory epilepsy.

The study is designed to answer frequently asked questions when clinicians replace existing 1,4-benzodiazepine to Onfi, as follows:

1. What should be the optimal equivalent doses for conversion?
2. How quickly should it be converted?
3. Would there be significant improvement of seizure control?
4. Should we expect difference in tolerability? If so, what are common adverse events?
5. Would the tolerance to the therapeutic effect differ with Onfi after conversion?

Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to the initial study visit.
* Currently taking stable dosing regimen of clonazepam (0.5-4mg daily) for seizure control.
* Takes at least one additional Anti-epileptic drug besides benzodiazepine.
* Age 18-70 years, inclusive.
* In opinion of investigator, can be safely treated with Onfi.
* Minimum of 2 seizures, but no more than 24 complex partial or generalized seizures, during the 8-week baseline period prior to study entry.
* Able to communicate effectively with study personnel and considered reliable, able, willing, and cooperative with regard to complying with protocol-defined requirements, including completion of study diary.

Exclusion Criteria:

* Clinically relevant current illness or history of that may interfere with the subject's ability to complete the study as determined by the investigator.
* History of status epilepticus within 6 months prior to the initial study visit.
* History of suicidal attempts or suicidal ideation within 12 months of initial visit.
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound

Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound

This study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of Fespixon Cream for the treatment of pressure injury in sacrum wound. The duration of this study is: run in/ screen phase (2 weeks); treatment phase (16 weeks); follow-up phase (4 weeks), and visits are conducted every 2 weeks for a total of 12 visits. During the treatment phase, the Fespixon cream will be applied to the target ulcer once a day for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 4 weeks. During the follow-up phase, standard of care will be used for subjects who have unhealed or with recurrent wounds.

At each visit, the size and changes of the target pressure ulcer are recorded by photographing. The target pressure ulcer area in the photo is calculated using Image Pro® PLUS software.

Eligibility Criteria:
1. Main inclusion criteria:

1. At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter
2. NPUAP is classified as stage 2
3. No active infection, i.e., IDSA level 1
4. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment)
5. If an artificial ostomy is not performed, the distance between the target ulcer and the anus must be greater than 5 cm to prevent contamination

2. Main exclusion criteria:

1. Those who have an allergic reaction to the ingredients of this product, including those who have been allergic to sulfa drugs, Plectranthus amboinicus, Centella asiatica or excipients
2. Acute infection caused by wound ( WBC \> 12×10³/uL； or C-Reactive protein (CRP) \> 30 mg/dL)
3. Liver and kidney dysfunction ( defined as \[AST or ALT\] \> 3× the upper limit of normal; serum creatinine \> 3× the upper limit of normal)
4. Pregnant or lactating women
5. Infected with human immunodeficiency virus
6. Body mass index (BMI) less than 18.5 kg/m²
7. Unable to cooperate with changing of subject's position
8. Patients with anemia (Hgb \< 7.0 g/dL).
9. Unable to prevent contaminations such as feces or urinary incontinence
10. Malnutrition (Albumin\< 2.5 g/dL)
11. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer
12. In the opinion of the investigator, entering this trial may pose a threat to subject compliance.
EHR-integrated rUTI Texting Platform

The goal of this clinical trial is to compare a texting platform to usual care for managing recurrent urinary tract infections (UTI).

The main question it aims to answer is:

• can a texting platform that integrates symptom triage and prevention education reduce the rate of unnecessary antibiotics for recurrent UTIs as compared to usual care?

Participants enrolled onto the texting platform will:

• receive evidence-based clinical guidance for the management of symptoms of UTI and receive educational videos on how to prevent UTIs. An important secondary outcome is to determine if the texting platform improves self-efficacy for the management of recurrent UTI.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Females who currently meet the criteria for recurrent UTIs
4. Age 18 years or older
5. Owns a mobile device with text messaging capability
6. Ability to read and write English
7. Currently receiving care from a provider in Penn Urogynecology or Penn Urology

Exclusion criteria:

1. History of known multidrug resistant UTIs
2. History of interstitial cystitis/bladder pain syndrome or current diagnosis of chronic pelvic pain
3. On continuous suppressive antibiotics currently
4. Currently pregnant or within 6 weeks of pregnancy
5. Transplant patient on immunosuppressive medication currently
6. Practice of chronic self-catheterization
Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

The objectives of this clinical trial are to assess the effects of dietary oils on blood lipids and other aspects of the fasting lipoprotein profile in healthy men and women with elevated cholesterol


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C level equal to or greater than 130 mg/dL and less than 200 mg/dL at visit 1
* Fasting triglycerides less than or equal to 350 mg/dL at visit 1

Exclusion Criteria:

* Has coronary heart disease or coronary heart disease risk risk equivalent, such as diabetes, atherosclerosis, etc
* Taking lipid medications intended to alter the lipids profile, including but not limited to statins, bile acid sequestrants, etc.
* Uncontrolled hypertension (systolic greater than or equal to 160 mm Hg or diastolic greater than or equal to 100 mm Hg)
A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)

To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoarthritis of the knee. To assess safety and tolerability of multiple doses of valdecoxib in patients with osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with symptomatic OA of the knee by the American College of Rheumatology (ACR) criteria and a Functional Capacity Classification (FCC) of I - III at Screening Visit and were walking
* At the Baseline visit, eligible patients were to have Patient's Assessment of Arthritis Pain VAS ≥ 40 mm and Patient's \& Physician's Global Assessment of Arthritis of "Poor" or "Very Poor"

Exclusion Criteria:

* Patients unable to walk generally
Head Circumference Growth in Children Who Develop Multiple Sclerosis Later in Life

Multiple sclerosis patients commonly develop generalized ventricular dilation with or without cerebral atrophy over time. Case studies in the literature have noted some multiple sclerosis patients develop the typical "normal pressure hydrocephalus" triad of dementia, gait disturbance and incontinence which were responsive to shunts.

Many patients with connective tissue disorders (Ehlers-Danlos Syndrome) develop Multiple Sclerosis and studies indicate that in the Multiple Sclerosis population, there exists over 10% more Ehlers-Danlos patients than in the normal population.

Because studies are indicating a form of external communicating hydrocephalus in the Ehlers-Danlos population, the author hypothesizes the same type of hydrocephalus may occur in the Multiple Sclerosis population.

To evaluate this hypothesis, investigators will retroactively evaluate the head circumference of Multiple Sclerosis patients between birth and 15 months (before the skull sutures have closed).

Multiple sclerosis patients commonly develop generalized ventricular dilation with or without cerebral atrophy over time. Case studies in the literature have noted some multiple sclerosis patients develop the typical "normal pressure hydrocephalus" triad of dementia, gait disturbance and incontinence which were responsive to shunts.

Many patients with connective tissue disorders (Ehlers-Danlos Syndrome) develop Multiple Sclerosis and studies indicate that in the Multiple Sclerosis population, there exists over 10% more Ehlers-Danlos patients than in the normal population.

Because studies are indicating a form of external communicating hydrocephalus in the Ehlers-Danlos population, the author hypothesizes the same type of hydrocephalus may occur in the Multiple Sclerosis population.

To evaluate this hypothesis, investigators will retroactively evaluate the head circumference of Multiple Sclerosis patients between birth and 15 months (before the skull sutures have closed).

High pressure on the brain (even if subtle) could be evidence of congenital CCSVI (cerebrospinal venous insufficiency), increased cerebrospinal fluid (CSF) production, the poor drainage of cerebral spinal fluid, or a combination of all. Retrospective examination of skull expansion is a necessary step to ascertain these possibilities, allowing for early treatment and the hope of avoidance of the neurological symptoms, and often disabling effects. It is the author's belief that "Benign External Hydrocephalus" is not a benign condition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis

Exclusion Criteria:

* Excludes CIS (clinically isolated syndrome)
Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis

We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic shock would decrease their functional disability and cognitive impairment. We plan to enroll patients with severe sepsis and septic shock who admitted an urban teaching hospital in Seoul, South Korea via ER. We will randomize those subjects into the intervention group which will take a standardized rehabilitation with routine clinical care for sepsis and the control group which will take routine clinical care for sepsis. And, we plan to assess their functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time of enrollment, 28 days, and 6 months later.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥20;
2. confirmed or suspected infection;
3. two or more among 1)-4) 1) body temperature \>38˚C or \<36˚C 2) heart rate \>90/min 3) respiratory rate \>20/min or PaCO2\<32 mmHg 4) WBC \>12000/mm3, \<4000/mm3, or band forms \>10%;
4. within 48 hours after arriving ER

Exclusion Criteria:

1. severe functional disability before admission;
2. central nervous system infection;
3. contraindication for exercise rehabilitation according to the investigators' decision;
4. severe medical illness or mental problem or laboratory abnormality which can confound the results;
5. pregnancy
Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study

The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.

The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.

Background Data: Iatrogenic bile duct injuries (BDI) following laparoscopic cholecystectomy (LC) result in major morbidity and incidental mortality. There is a lack of unselected population-based cross-sectional studies on the incidence, management, and outcomes of BDI. We hypothesised that due to improved imaging capabilities and collective laparoscopic experience, the BDI incidence will decrease over the study period and compare favourably with contemporary literature.

After IRB approval, all cholecystectomies performed at national public healthcare facilities between 2008 and 2018 were retrospectively reviewed. BDIs were classified according to the Strasberg classification. We hypothesized that due to improved imaging capabilities and collective laparoscopic experience the BDI incidence will decrease over the study period and compare favourably to contemporary literature.

Eligibility Criteria:
Inclusion Criteria:

* all patients with BDI during laparoscopic cholecystectomy (LC)

Exclusion Criteria:

* The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method
Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in children, is defined as arthritis persisting for at least 6 weeks with no known cause in a patient under the age of 16. The term JIA is an umbrella that includes very different diseases. The current International League of Associations for Rheumatology (ILAR) classification divides JIA patients into 7 categories based on number of involved joints and time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis. This classification groups together patients with different disease and divides patients with the same disease. In the first case, unifying distinct diseases could lead to undifferentiated therapeutic choices, moving away from the modern concept of therapeutic personalization. In the second case, similarities between paediatric and adult arthritis could not be found. This involves both a loss of collaboration with the adult rheumatologist and the difficulty in accessing possibly effective therapies approved only for adult arthritis.

In clinical practice, it is increasingly evident that the number of affected joints and the speed of joint involvement are not useful criteria for defining the type and severity of disease. Joint counts lead to underestimate the importance of joint distribution in the identification of distinct forms of arthritis. A recent study found that patterns of joint involvement represent prognostic features, so grouping patients by joint pattern and degree of localization may help clinicians tailor treatments based on predicted disease trajectories. Another important point to differentiate some forms of arthritis is the presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS) has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in patients with JIA. Recent studies underline the important role of MSUS findings to assess disease activity and assist disease classification. In recent years, the need has emerged to replace the ILAR criteria with a new nomenclature based on the disease biology. This approach could help clinicians to choose a personalized therapeutic strategy for patients with arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects under the age of 18 years
* Arthritis persisting for at least 6 weeks with no known cause

Exclusion Criteria:

* No consent from the patients' guardians
* Patients with Systemic onset Juvenile Idiopathic Arthritis
* Patients who developed arthritis on a pre-existing inflammatory disorder such as Inflammatory Bowel Disease, and had received previous treatments
Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women

the aim of the study was to investigate the effect of aerobic and resisted exercise program on lipid profile and quality of life in overweight breastfeeding women.

Although previous studies reported that exercise training during the postpartum period could improve the lipid profile and quality of life in overweight women and reduce the postpartum fatigue . None of them had investigated the effect of aerobic and resisted exercises on lipid profile and quality of life in overweight breastfeeding women.this trial will include 2 groups:

Group (A): was consist of 27 overweight breastfeeding women, who received nutritional recommendation and faradic current stimulation for 20 min on abdominal surface 2 times per week for 12 weeks.

Group (B): was consist of 27 overweight breastfeeding women, who received the same nutritional recommendation and faradic current stimulation for 20 min on abdominal surface 2 times per week plus exercise training (aerobic + resisted) for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. All of women were sedentary, non-smoking, breastfeeding women at their 3rd to 6th months postpartum
2. they had delivered a single, healthy, mature fetus with no complications through normal vaginal delivery.
3. Their age was ranged from 20 to 30 years old.
4. Their parity number was one or two.
5. They were overweight (body mass index (BMI) was ranged from 25 to 30 kg/m²).

Exclusion Criteria:

1. Having chronic disorders, heart disease, respiratory infections, diabetes mellitus, pelvic abnormalities, hormonal abnormalities, psychological problems, menstrual disorders or anemia of other pathological origins.
2. Receiving any type of physical exercise or sport.
3. Following a specific diet program.