cyrilzakka/clinical-trials huggingface dataset:
TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure

TRANSFORM-HF is a large-scale, pragmatic, randomized, unblinded clinical effectiveness study comparing torsemide versus furosemide as treatment for heart failure. Approximately 6,000 patients with heart failure will be enrolled. The primary objective of the TRANSFORM-HF study is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized.

* This study will be a randomized, unblinded, two-arm, multi-center clinical trial of patients with heart failure who are hospitalized. Heart failure need not be the reason for hospitalization. Patients will be randomized 1:1 to either oral torsemide OR oral furosemide prior to hospital discharge. Oral dosing of torsemide compared to furosemide will be 1mg:2mg. The specific loop diuretic dose will be at the discretion of the treating physician with the above noted conversion.
* Trial enrollment occurs before hospital discharge, at the discretion of the healthcare provider.
* As appropriate, adherence to the randomized medication will be encouraged during the remainder of hospitalization and will continue post-discharge. Patients will receive follow-up per standard care without any additional study-specific visits.
* Patients will have 30-day, 6-month and 12-month follow-up phone contacts for assessments of vital status, interval hospitalizations, adherence, and quality of life. "Central follow-up" and collection of hospital discharge summaries via IRB-approved mechanisms. Subsets of patients enrolled early in the study have additional phone contacts beyond 12 months, up to 30 months, at six month intervals, to document vital status.

Eligibility Criteria:
Inclusion Criteria:

1. Patient hospitalized (≥ 24 hours or over a change in calendar date) with worsening of chronic heart failure, or new diagnosis of heart failure AND meets one of the following criteria:

   1. Has a left ventricular ejection fraction (EF) ≤40% within 24 months prior to and including index hospitalization by any method (with most recent value used to determine eligibility)
   2. Has an elevated natriuretic peptide level (either NT-pro-B-type natriuretic peptide or B-type natriuretic peptide) during index hospitalization as measured by local laboratory (with most recent value used to determine eligibility)
2. Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge with anticipated need for long-term loop diuretic use
3. ≥ 18 years of age
4. Signed informed consent

Exclusion Criteria:

1. End-stage renal disease requiring renal replacement therapy
2. Inability or unwillingness to comply with the study requirements
3. History of heart transplant or actively listed for heart transplant
4. Implanted left ventricular assist device or implant anticipated \<3 months
5. Pregnant or nursing women
6. Malignancy or other non-cardiac condition limiting life expectancy to \<12 months
7. Known hypersensitivity to furosemide, torsemide, or related agents
The Effect Of Self-Breast Examination Training On The Belief Of Breast Health

The aim of the present research was to detect the effect of self-breast examination provided to women between 18 and 49 years of age and practice on the belief of women on their breast health.

The aim of this study was to investigate the effect of breast self-examination training and practice on breast health beliefs. The study was a pretest-posttest randomized controlled experimental design. Women in the experimental group of the study will be provided with the training prepared by the researcher. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. In the presentation, the steps of breast self-examination were shown step by step using visual materials. In addition to the slide presentation about breast cancer and breast self-examination, women will be trained on breast self-examination with a breast examination model using the "show first, then do it" training technique, and the accuracy will be confirmed by asking women to do it. By using the model in breast examination, it will be determined what women do right and what they do wrong during the examination. Data will be collected with Personal Information Form and Champion Health Belief Model Scale.

Eligibility Criteria:
Inclusion Criteria:

* Fertility process to continue
* No communication problems
* Not having a disease that will affect perception

Exclusion Criteria:

* Having been previously diagnosed with breast cancer or receiving breast cancer treatment
* Being diagnosed with a medical mental illness and receiving treatment for this reason
* Being under active treatment in hospital due to any problem
An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites

The purpose of this study is to assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.

Study Design: Single institution, open-label, randomized study

Study Device: Pleurx Catheter

Treatment Plan: Cohort A: 15 patients treated with standard therapy (therapeutic paracentesis +/- diuretics)

Cohort B: 15 patients treated with peritoneal Pleurx catheter

Duration of Participation: Patients will be followed for one year, or until death, whichever comes first.

Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis

Secondary outcomes: Overall complications, quality of life, overall survival, and symptom control

Eligibility Criteria:
Inclusion Criteria:

(Patients can receive chemotherapy at the discretion of treating oncologist)

1. Patients with recurrent malignant ascites
2. Patients with refractory malignant ascites
3. Proven malignancy
4. Age \>= 18 years old
5. Eastern Cooperative Oncology Group (ECOG) performance scale =\< 2
6. Ability to understand and willingness to sign a written informed consent

Definitions:

Malignant ascites: One of the following criteria

1. Positive ascitic fluid cytology
2. Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites
3. Malignant Budd Chiari Syndrome with associated ascites
4. Hepatocellular carcinoma and ascites
5. Chylous ascites due to lymphoma
6. Peritoneal carcinomatosis and concurrent ascites
7. Proven abdominal malignancy with concurrent ascites

Refractory / Recurrent ascites: One of the following criteria

1. Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites.
2. Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician.
3. Intolerance or relative contraindications to diuretics: (serum sodium (Na) concentration of \<125 mmol per liter or serum creatinine \>1.5 mg/dl, hyperkalemia (potassium \>5.2 mEq/L or azotemia Bun/Creatinine ratio \> 20).
4. Removal of at least 5 L in the preceding two months for symptoms relief

Exclusion criteria:

1. Life expectancy less than one month
2. Coagulopathy (international normalized ratio \[INR\] \> 2 that does not correct with fresh frozen plasma)
3. Hepatorenal syndrome
4. Active skin infections at abdomen before procedures
5. Inability to provide inform consent
6. Platelet counts \< 50,000/mcL
7. Uncontrolled illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, that the physician feels would increase the risk of infection with the procedures or white blood cell (WBC) count \> 20,000/mcL
8. Absolute neutrophil count \<1000 / cu mm
9. Pregnant women
10. Multiloculated ascites
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)

Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial.

This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).

The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.


Eligibility Criteria:
Key Inclusion Criteria:

1. Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye
2. Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept

Key Exclusion Criteria:

1. Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past IVT injections with any agent in either eye
2. Treatment with any IVT injection in the study eye within the 25 days prior to day 1
3. Intraocular pressure (IOP) \>25 mm Hg in the study eye at screening
4. Any intraocular surgery in the study eye at any time during the past 3 months
5. Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye

NOTE: Other protocol Defined Inclusion/Exclusion Criteria Apply
Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method

To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:

* A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
* Consumables necessary for the implementation of the dressing,
* Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.

This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.


Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized into the dermatology unit
* patient with an evolutive leg ulcer since more than 1 month
* signed informed consent

Exclusion Criteria:

* known allergy to one of dressings used in this study
* patient with a non-treated osteomyelitis
* patient with tumoral tissues into the wound
* patient with raw organ or raw blood vessels
* patient with an anticoagulation treatment with a potentially hemorrhagic curative dose
* patient having hemostasis problems that can lead to hemorrhagic exudates
The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache

This study explores with the use of MSK Ultrasound imaging if the obliquus capitis minor and the rectus capitis major can be contracted with specific exercises.

This study explores if a subject with the neck in full maximal flexion is able to selective contract the the obliquus capitis minor and the rectus capitis major by head extension and rotation while maintaining the spine position. MSK Ultrasound imaging will be used to measure changes both in length and width.

Eligibility Criteria:
Inclusion Criteria:

* No history of surgery, No current neck pain, Being able to move the neck actively, being able to read English, between ages 18-65

Exclusion Criteria:

* Neck pain, History of surgery, unable to move the head into extension, outside age requirements, unable to read English
Celiac Disease Prevention

Celiac disease is an autoimmune disease induced by wheat gluten. Destruction of epithelial cells and microvilli on gut mucosa is causing a "flat mucosa" and an absorption defect. The diagnosis is based on typical microscopical finding in biopsy specimens but serum antibodies to tissue transglutaminase and certain gliadin peptides are strongly associated with the pathology. Severe diarrhoea associated with growth disturbance in infancy was historically characterising the disease but is nowadays rare. Clinically more mild forms including silent disease are very common. Studies based on antibody screening and biopsies done in autoantibody positive subjects have confirmed a frequency of about 1-2% in adult population. Undiagnosed disease is associated with deficiencies of nutrients and vitamins leading to various chronic symptoms like anaemia, osteoporosis and general fatigue. It has also been recently found that undiagnosed celiac disease may be associated with general underachievement in society probably associated with common psychological symptoms like fatigue and depression during the adolescence. The disease is treated by complete elimination of wheat, rye and barley in the diet, which is laborious and causing considerable extra costs in nutrition.

Much progress has been recently made in understanding of the genetic background and immune markers associated with the disease as well as in understanding those patterns of gluten introduction in infancy, which might be connected to a high disease risk. Our aim in this study is in the first phase to identify children at high genetic risk (around 10%) and in a follow-up study to define:

1. Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease?
2. Is it possible to decrease the frequency of celiac disease by nutritional counselling?
3. Is it possible to predict development of celiac disease by immunological tests before the development of mucosal lesion

If we can confirm, that optimising the conditions at the introduction of wheat gluten in infancy diet significantly reduces the disease incidence, will this have an important effect on the nutritional recommendations concerning the diet in infancy. Combining genetic screening and immunological tests might also offer a way to reduce the frequency of celiac disease and help in early diagnosis and organisation of an adequate treatment


Eligibility Criteria:
Inclusion Criteria:

* Presence of HLA-risk alleles DQA1\*05 and DQB1\*02

Exclusion Criteria:

* Lack of these HLA risk alleles
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).


Eligibility Criteria:
Inclusion Criteria:

* Men and women of age 18-65 years (Argentina minimum age will be 24 years of age)
* Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
* Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (Text Revision)\[DSM IV TR\] criteria. The current depressive episode must be \> 8 weeks in duration and \< 3 years duration.
* In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment.
* Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.

Exclusion Criteria:

* Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
* Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus

Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* written informed consent obtained
* good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria:

* evidence of a clinically significant cardiovascular, renal, hepatic, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
* any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study. as an exception paracetamol and ibuprofen for occasional pain are allowed
* known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
* pregnant or lactating females
Cyclosporine A in the Treatment of Juvenile Idiopathic Arthritis (JIA) Associated Chronic Anterior Uveitis

Juvenile idiopathic arthritis (JIA) is often associated with chronic anterior uveitis. Presence of vision threatening complications may indicate immunosuppressive therapy. In this study, the experience with cyclosporine A (CsA) as mono- or combination-therapy is analyzed.


Eligibility Criteria:
Inclusion Criteria:

* uveitis
* JIA
Impact of COVID-19 on Psychological Status in Case of IVF Interrupted or Postponed

Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments.

This study times to understand the changes in the psychological status of infertile patients who had in vitro fertilization (IVF) treatment interrupted or postponed because of the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* patients with IVF treatment interrupted or delayed during COVID-19 pandemic
* patients with signed informed consent
* patients with more than 18 years

Exclusion Criteria:

* patients with already diagnosed psychiatric disorders
Role of Anterior Segment Optical Coherence Tomography in Infectious Keratitis

To evaluate the role of anterior segment optical coherence tomography in follow up of infectious keratitis and assessment of response to treatment.

50 patients with proven infectious keratitis clinically will be included in the study.

The following will be performed for all patients in initial visit and follow up:

* Slit lamp examination and photography.
* Visual acuity assessment.
* Anterior segment optical coherence tomography.

  1. The central corneal thickness (CCT) (extracted from pachymetry map),
  2. Minimal corneal thickness (MCT) (extracted from pachymetry map)
  3. Corneal thickness at the site of the lesion (CTL) (extracted from pachymetry map or the sum of STL+ CETL)
  4. Stromal thickness at the center of the lesion (STL) stromal lesion (extracted from stromal map)
  5. Corneal epithelial thickness over the stromal lesion (CETL) at the center of the lesion (extracted from epithelial map)

Eligibility Criteria:
Inclusion Criteria:

* Any case with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.

Exclusion Criteria:

* Cases with healed infectious keratitis.
* Cases presented from the start with severe corneal affection and melting.
Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.

Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of concentration, motility and morphology, as well as in fertilization rate.

Minor data is available regarding the influence on male sperm.

Pomegranate contains a high concentration of vitamins ( C, B1, B2, B3, B5), potassium, Magnesium , Zinc and is a good source for polyphenols .Polyphenols molecules have been found to possess antioxidant properties and may effects the expression of different genes . Recent studies indicate that among foods that contain polyphenols, juice extracted from the pomegranate has the highest concentration of measurable polyphenols . Pomegranates have shown inhibitory effect on NF-κB and the MAP kinases JNK and ERK, which are critical steps in the cascade of events leading to inflammatory response. The NF- κB pathway is activated in response to bacterial infection and initiates the inflammatory cascade, which may explain the protective effect of Pomegranates on bacterial infections.

Eligibility Criteria:
Inclusion Criteria:

* TMC of less than 5 million spermatogonia in native sperm and morphology less than 4% by Kruger criteria.

Exclusion Criteria:

* sensitivity to Pomegranate
Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit

The study is examine the eye movements characteristics of patients with VOR gain deficits (overt and covert saccades) before and after physical therapy intervention program and examine the most effective physical therapy treatment program for patients with vestibulopathy.

The vestibular system receives and conveys information about head motion in space, and is the main human sensory system dedicated to detecting self-motion.The vestibular system plays a crucial role in static and dynamic balance control, stabilizing the head and trunk, especially on unstable surfaces . In terms of postural control and falls, the literature describes a direct association between VOR deficits, gait instability, and falls.The "gain" of the VOR is defined as the change in the eye angle divided by the change in the head angle during the head turn. Under ideal conditions, the gain of the rotational VOR is 1.0, meaning there is a compensatory eye velocity equal to the head velocity and in the opposite direction. In case of a positive vHIT, the VOR gain is decreased and refixating saccades are observed. The video Head Impulse Test measures eye velocity during head rotation. Instant feedback about every single head impulse allows the examiner to apply a set of standardized graded impulses. The system is easy to use in a clinical setting, provides an objective measure of the VOR, and detects both overt and covert catch-up saccades in patients with vestibular loss. Measurements are quick and noninvasive, and the automated analysis software provides instant results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with unilateral or bilateral vestibulopathy living independently in the community

Exclusion Criteria:

* cognitive state decline neurological disorder disease or disorders that can affect balance
Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

The purpose of this study is Safety, Pharmacokinetic Study of PRIC

1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup
2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup

Eligibility Criteria:
Inclusion Criteria:

* 19 to 45 years old healthy male subject at the screening
* Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study

Exclusion Criteria:

* Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
* Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions