cyrilzakka/clinical-trials huggingface dataset:
A Study to Analyze the Occurrence of Transformation From Myelodysplastic Syndrome to Acute Myeloid Leukemia in Patients With Myelodysplastic Syndrome Who Received Revlimid® 5 mg Capsules and Who Are Continuing or no Longer Continuing Revlimid Treatment

To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and who are continuing or no longer continuing Revlimid treatment.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end on the day when the appropriateness of enrollment is assessed for all del(5qMDS) patients in the all-case surveillance.
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.


Eligibility Criteria:
Inclusion Criteria:

* All del(5q)MDS patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as AML) has not been documented at the end of the observation period of the all-case surveillance.

Exclusion Criteria:

N/A
Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department

The purpose of this study is to determine the clinical utility of triage screening for anemia and carbon monoxide poisoning (COP) in the ED setting.This is a prospective, nonrandomized, multi-center study of the performance of simultaneous non-invasive testing for two common disorders (COP and anemia). We will determine the limits of agreement and performance characteristics of non-invasive carboxyhemoglobin (SpCO) and hemoglobin (SpHb) values compared to standard blood tests for measurement of carboxyhemoglobin and hemoglobin, in the emergency department setting.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 year or older.
* At least one digit has acceptable width as measured by study-provided digit gauge.
* Presenting to emergency department for any complaint.
* Potential for IV catheter and/or blood draw for CBC as standard of care.

Exclusion Criteria:

* Patients unable to consent for any reason
* Patients with fingernail polish, discoloration or trauma to fingers
Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.

Epidermal growth factor receptor(EGFR) is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon, breast, ovary, pancreas, and lung. EGFR tyrosine kinase inhibitor(TKI), gefitinib, erlotinib, and afatinib have been for the treatment of cancer associated with EGFR gene mutation. In addition, monoclonal antibodies to EGFR, such as cetuximab and panitumumab, have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer.

The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80%. Clinical features include acneform folliculitis, xerosis, paronychia, and itching. Of these, about 10% of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment, resulting in impaired therapeutic results.

There have been many attempts to prevent or treat such skin toxicity. However, there has been no scientifically proven treatment until now.

There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors, as a result of studies that improve acne significantly compared to placebo.

The purpose of this study is to evaluate the therapeutic efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor (TKI or monoclonal antibody).

Eligibility Criteria:
Inclusion Criteria:

* Patients who received EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) for malignant tumors
* Patients with EGFR inhibitor-associated skin reactions: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE V4.03) Grade 2, 3 Patients
* Patients who can understand and follow the protocol
* Patients who spontaneously agreed to the study

Exclusion Criteria:

* NCI-CTCAE grade 4 patients requiring systemic drug therapy
* Those with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks for reasons other than EGFR inhibitors
* Patients with existing acne history
* Patients who have already received anti-EGFR therapy
Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias

Cancer patients are among the most vulnerable individuals, whose health-related quality of life (HRQOL) may be substantially impacted by the COVID19 pandemic. We want to study how the COVID-19 pandemic influences the life of cancer patients and how these patients cope with the additional distress with the aim to facilitate the development of improved future interventional strategies to maintain resilience and HRQOL

In December 2019, the novel human pathogenic virus "SARS-CoV2" from the coronavirus family was identified, causing a respiratory disease known as "COVID19" (coronavirus disease 2019). COVID19 manifests itself primarily with influenza-like symptoms, but in special cases it can lead to severe conditions such as ARDS (acute respiratory distress syndrome). Compared to other pulmotropic viruses such as the influenza virus, SARS-CoV-2 is associated with a higher contagiousness and mortality.

Haematological and oncological patients are particularly vulnerable due to their advanced age, immunological restrictions in the context of the underlying disease and the treatment modalities (chemotherapy, radiation therapy, ...).

To evaluate the effects of the COVID19 pandemic on the perception of patients with malignant diseases, we aim to record so-called "patient-reported outcomes" (PROs) from patients at the University Hospital of Innsbruck at the Department of Internal Medicine V (Hematology and Oncology) and at the Department for Radiotherapy and Radiation Oncology. We use the validated EORT QLQ-C30 and a specially developed questionnaire for COVID19.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* validated hematological or oncological disease
* informed consent

Exclusion Criteria:

* Age \< 18 years
* Insufficient discernment
Deprescribing for Older Dialysis Patients

Aim 1 of the study is to identify the elements of a deprescribing intervention that address contextual factors specific to dialysis.

Aim 2 of the study, described in this record, is to determine the feasibility of a deprescribing intervention tailored for older dialysis patients.

Older adults receiving dialysis are often prescribed multiple medications. Some of these medications are used to treat symptoms, but they also can increase the chance of significant health problems. The purpose of this study is to identify if it is feasible to reduce the use of medications that have been identified as causing an increased risk for health problems.


Eligibility Criteria:
Inclusion Criteria (patients):

* an adult receiving dialysis for at least 6 months
* at least one active prescription for a potentially inappropriate medication (gabapentinoids, clonidine, alpha blockers, muscle relaxants, and Z-drugs)

Exclusion Criteria (patients):

* advanced dementia
* hospice care
* non-English speaking

Inclusion Criteria (providers):

* must be employed by Duke
* must see patients at a Duke affiliated DaVita hemodialysis (HD) clinic where Duke nephrologists serve as medical directors and rounding physicians

Exclusion Criteria (providers):

None
Telehealth-Based Exercise Program to Treat Fatigue in MS

This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.

This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis
* Veteran receiving services in VA VISN 20
* Fatigue
* Ability to ambulate
* cell phone or Household phone line
* Individual with multiple sclerosis verified by MS provider
* ambulatory

Exclusion Criteria:

* Current alcohol dependence or other substance dependence
* No working phone
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics

The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection. The investigators will also explore prevention and treatment through randomized controlled trials to initiate early intervention before clinical symptoms appear.

This is a single-center randomized controlled trial in which 100 patients treated with antineoplastic agents will be enrolled. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation. All patients will be randomly divided into test and control groups. Patients in the test group will receive oral Bifidobacterium trivium capsules for 6 months in addition to conventional treatment, whereas patients in the control group will receive conventional antitumor treatment only.

Eligibility Criteria:
Inclusion Criteria:

* With malignant tumors
* Will receive antitumor drugs
* Could receive regular follow-up for 6 months
* Written informed consent

Exclusion Criteria:

* Satisfactory echocardiographic images could not be obtained
* Cardiomyopathy
* Coronary artery disease
* Heart failure
* Arrhythmia requiring intervention
* Moderate or severe valvular disease
* Acute myocarditis
* Refractory hypertension
* Participating in other studies of drug intervention
Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder

The purpose of this study is to investigate the effect of red clover isoflavones in postmenopausal women with and without urge urinary incontinence and overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal (more than 5 years since last menstruation)
* Read and understand Danish

Exclusion Criteria:

* Participants receive treatment with estrogen both oral, transdermal, and topical within three months prior to inclusion in the study
* Participants take estrogen-like compounds (isoflavones) three months prior to inclusion in the study
* Participants take prebiotic and/or probiotic supplements within three months prior to study inclusion
* Receive antibiotics (any) within three months prior to inclusion in the study
* Recurrent urinary tract infections (defined as ≥ 2 infections in the last six months or ≥ 3 infections during the last year)
* Acute urinary tract infection defined as positive urine culture and symptoms of acute cystitis
* Previous or current diseases of the digestive and/or urinary systems evaluated by PI (including, but not limited to inflammatory bowel disease (IBD) and cancer)
* Current or prior suffering from breast, ovary, and/or endometrial cancer
* Use hormone spiral within the last 5 years if they are under 60 years
* Hysterectomy before cessation of menstrual periods if the women are below the age of 60
Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography

Right ventricular (RV) physiological remodeling in response to prolonged strength exercise remains poorly studied. This prospective, non-randomized, single-center study, proposes to follow 24 healthy sedentary volunteers who will benefit from a high-intensity pure resistance training program over a 6-month period. The volunteers, aged between 18 and 40 years old and male, will be recruited and evaluated at the University Hospital center of Caen Normandy. Cardiac remodeling in response to physical exercise will be analyzed by trans-thoracic echocardiography repeated during the follow-up. The physical impact of the training program will be assessed by a treadmill exercise test predicting maximal oxygen consumption (VO2max) before and after completing the training, and an isokinetic muscular test repeated every 3 months. Participants rest/activity cycles will be monitor before and after 3 months of training. The aim of the study is to demonstrate the existence of a physiologic RV remodeling in response to pure high-load resistance chronic exercise. The results will help to improve the understanding of the physiological RV response expected in strength athletes.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years
* Male gender
* Agree to participate in the study (signature of consent).
* Affiliated to an insurance scheme or beneficiary

Exclusion Criteria:

* Female gender
* Inability to express consent
* Moderate physical activity over than 150 minutes or intensive physical activity over than 75 minutes per week on a regular basis for more than 6 consecutive months, according to the World Health Organisation criteria.
* Participation in competitive sports of ≥ II and / or B according to Mitchell's classification in the last 3 years.
* Ischemic and non-ischemic heart diseases
* Family history of unexplained sudden death
* Personal or family history of elastic tissue disease (Marfan syndrome and related)
* Chronic diseases incompatible with physical exercise at high intensity
* Personal history of chemotherapy and / or radiotherapy
* ≥ 1 cardiovascular risk factors
* use of doping substances
* Body mass index \> 30 kg/m²
* Inclusion in another biomedical research protocol (during the present study or within 6 months before inclusion).
Australian Barrett's Cohort With Dysplasia and Early Cancer Study

The purpose of this study is to collect prospective observational data regarding endoscopic management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia and/or intramucosal carcinoma. To observe the natural history of patients with low grade dysplastic and non dysplastic Barrett's oesophagus


Eligibility Criteria:
Inclusion Criteria:

* Can give informed consent to trial participation
* Age greater than 18
* Barrett's oesophagus

Exclusion Criteria:

* Age less than 18
* Pregnant patients
Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient

Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.

IPL procedure is a device used for symptom relief and treatment of dry eye syndrome caused by meibomian gland dysfunction in adults, and its safety and long-term effects have been confirmed. The purpose of this study is to determine whether this procedure before cataract surgery is effective in improving the symptoms of dry eye syndrome after cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

1. A patient at the age of 21 cataract surgery
2. A patient has the visual potential of 20/25 or better in each eye after cataract removal
3. Dry eye patient by meibomian gland dysfunction
4. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Eye damage, active eye infection
2. Uncontrolled health problem
3. Wear contact lens within one month
4. Allergic reactions of fluorescein sodium or ophtalmic anesthetic
5. Eye surgery and trauma in the last six months
6. Eye disease, structural abnormality
7. If there is a cause of vision loss other than cataracts
8. Under 20/25 expect vision
9. Under the age of 20 years of age
10. Pregnant woman and lactating woman
11. Medical conditions in which IPL is contraindicated
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years old or older.
* Patient has a current diagnosis of NIDDM or IDDM.
* Patient's ulcer is present for a minimum of two weeks under the current Investigator's care
* The study ulcer has healed \<50% in size during the two weeks leading up to randomization
* The study ulcer is on the plantar surface of the forefoot
* The ulcer is \>/= 1.0 cm2 at Day 0 (the day of randomization).
* The ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.
* The ulcer is free of necrotic debris and clinical infection and is comprised of healthy, vascular tissue and is suitable for skin grafting.
* The patient's Ankle-Arn Index by Doppler is \>0.1
* There is adequate circulation to the foot to allow for healing.
* The patient's diabetes is under control as determined by the Investigator.
* Female patients capable of bearing children must test negative for pregnancy and must use an acceptable means of birth control.
* Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen.
* Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form.

Exclusion Criteria:

* Patient has clinical evidence of gangrene on any part of the affected foot.
* The ulcer is over a Charcot deformity.
* The ulcer has a nondiabetic etiology.
* The ulcer has tunnels or sinus tracts that cannot be completely debrided.
* The patient's diabetes is uncontrolled and could interfere with the completion of the study.
* There is a medical condition(s) that in the Investigator's opinion make the patient an inappropriate candidate for this study.
* Patient has/had a malignant disease not in remission for 5 years or more.
* Patient has acute or chronic hepatitis, cirrhosis, has a serum albumin of \<2.0 gms/dL, or has alkaline phosphatase or LDH at twice the upper limit of the normal range.
* Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
* Patient has Acquired Immunodeficiency Syndrome (AIDS) or is infected with Human Immunodeficiency Virus (HIV).
* Patient has participated in another study utilizing an investigational drug or device within the previous 30 days.
* The ulcer has cellulitis, osteomyelitis, or other clinical evidence of infection.
* Patient has any condition(s) which seriously compromises their ability to complete this study.
Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis

Sarcopenia can be easily observed in patients with hemodialysis. However, there were few studies on the precise concept and diagnostic criteria for sarcopenia in patients with hemodialysis. The investigators have already recognized the sarcopenia-associated mortality and morbidity in patients with hemodialysis. However, intervention studies on hemodialysis patients with sarcopenia have not been conducted until now. Here, The investigators aim a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis.

This is a prospective study with 60 patients with hemodialysis who were diagnosed as sarcopenia or frailty in our previous cohort study. Combined intervention will consist of resistance exercise and nutritional supplementation for 12 weeks. The primary outcome of this study is muscle mass and handgrip strength after 12 weeks' intervention. All functional outcomes will be measured at 0, 12, and 24 weeks after intervention. The data will be analysed using the intention-to-treat principle.

While feasible, inexpensive, and non radiation-exposed tools such as bioimpedance analysis have been used to measure appendicular skeletal muscle mass. In addition, isokinetic strength will be measured by a dynamometer for hand grip strength to evaluate sarcopenia. The main two axes of treatment of conventional sarcopenia are muscle resistance exercises and protein supplementation including branched chain amino acids. Therefore, it is necessary to confirm the clinical effect by intervention for resistance exercise and nutritional supplementation in patients with hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemodialysis
* Community-dwellers
* Able to walk with or without assistive devices for more than 100 meters

Exclusion Criteria:

* A person with cancer disease.
* People with psychiatric symptoms.
* A person who has an absorption disorder or has a history of resection of the small intestine or colon
* Pregnant women
* A person treated for acute bacterial infections
* A person who is in a wheelchair due to inconvenience in walking.
Final Height in Patients With CAH

Congenital adrenal hyperplasia (CAH) is the most common inherited disorder in the adrenal gland in children. Growth is usually affected in CAH patients either due to the disease itself or treatment consequences.

CAH comprises a group of autosomal recessive disorders caused by a deficiency of one of five enzymes needed for the synthesis of cortisol leading to defect in cortisol synthesis with or without aldosterone deficiency and an increase in the production of adrenocorticotropic hormone through negative feedback.

The most common form is 21-hydroxylase deficiency (21OHD), which forms more than 90 % of the cases.

In classic CAH, 75% of the patients have the salt wasting (SW) and 25% have the non salt-wasting phenotype (NSW).There are no clinical signs at birth in male infants and in female patients, CAH is suspected shortly after birth if there is genital ambiguity, ranging from slight clitromegaly to complete masculinization with acceleration of growth and pubertal development.

The non-classic (late onset) form of CAH is a less severe form of 21OHD, and is diagnosed later in life.

Final height in early and late onset patients has been reported as diminished (Hauffa et al, 1997).This could be attributed to androgen excess or treatment with steroids. Androgen excess can occur at any age leading to accelerated growth, early epiphyseal closure and compromised final adult height.

Despite that all forms of CAH differ in their degree of enzymatic deficiency, they all represent a therapeutic challenge to pediatric endocrinologists attempting to optimize growth.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a documented history of classical CAH.

Exclusion Criteria:

* Patients with non classical CAH.
* Patients treated with growth hormone.
* Chronic use of medications unrelated to CAH which may affect growth like immunosuppressive drugs like azathioprine and drugs that affect growth hormone release like octreotide, pegvisomant, bromocriptine and cabergoline.
* Other chronic diseases that may affect growth like heart disease, inflammatory bowel disease and renal disease.
* Other causes of adrenal insufficiency.