cyrilzakka/clinical-trials huggingface dataset:
The Early High Risk Period for Patients With Heart Failure

Many people with heart failure either die or are admitted to the hospital in the first few months after the condition is diagnosed. The reasons for this are currently unclear- but may be due to worsening heart failure or other medical conditions such as angina, heart attack or sudden electrical problems of the heart. The investigators propose to recruit and follow-up 450 people, with a new diagnosis of heart failure for a minimum of six months in a multi-centre observational study at two hospital sites: The Hillingdon (Uxbridge) and The Conquest (Hastings) hospitals. The total study duration will be two years. People will be recruited after a diagnosis of heart failure is made and the study will assess reasons for death or admission to hospital and the psychological impact of the condition on both patients and their carers. This is an observational study and no change will be made to patients' conventional treatment.

Hypotheses:

1. The high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or
2. The high mortality in the early period after the diagnosis of heart failure is related to co-morbid events- principally major coronary events such as myocardial infarction or acute coronary syndrome.

This research should help to identify ways of improving the outlook for people with newly diagnosed heart failure. The analysis of the data generated by this study will be supervised by a statistician. Clinical and demographic data will be described using mean + standard deviation, for continuous variables, and absolute numbers and percentages for categorical variables. Group differences will be examined by t-tests for continuous variables and Chi-square (x2) test for categorical variables. Survival will be reported in terms of Kaplan-Meier curves with differences analysed by Cox proportional hazards.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of heart failure

Exclusion Criteria:

* Under age of 18 years
* Unable to give consent
Metacarpophalangeal Joint Prostheses in Hand Surgery.

The primary working hypothesis of this study is whether KeriFlex® metacarpophalangeal joint prostheses provide an equivalent result to Swanson finger joint implants in patients with rheumatoid arthritis or post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Metacarpophalangeal Joint Prostheses between 2014 and 2022 using Swanson or KeriFlex implant system at Hospital Waldfriede

  * rheumatoid Arthritis or post-traumatic osteoarthritis of Metacarpophalangeal joint

Exclusion Criteria:

* post surgery bone fracture of the same limb
* Pregnancy, lactation
* active malignant tumor
Active Vitamin D and Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy

Traditionally MCN is treated with a high dose of prednisolone, which induces remission in 60-90% of patients. Prednisolone treatment contains numerous side effects and the current dose is empiric. Given the lack of efficacy evidence and the risk associated with the currently accepted treatment regimen there is a need to characterize the outcome in MCN further, and to establish new, and potentially less toxic treatment regimens.

The aim is to examine if treatment with reduced dose of prednisolone in combination with activated vitamin D is as effective as standard high dose prednisolone in achieving remission and preventing relapse in MCN, and if reduced dose prednisolone is associated with fewer side effects compared to standard dose. Furthermore, the study will examine the influence of prednisolone metabolism on the efficacy and side effects of prednisolone in the treatment of MCN.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven minimal change nephropathy
* If earlier minimal change: No relapse in 5 years, and earlier only treated with prednisolone
* Nephrotic syndrome
* Age more than 18 years

Exclusion Criteria:

* Cancer except from basal cells carcinoma
* Lymphoproliferative disease
* Pregnancy
* eGFR \< 30 ml/min/1,73m2 (CKD-EPI)
* Allergy
* No danish language
* No ability to give informed prove
Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction

Assessment of duration of action, safety \& toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Erectile Dysfunction

Exclusion Criteria:

* Alpha blockers and Nitrates of any preparation
An in Vivo Bioequivalence Study of 2 Loxoprofen Sodium Products in Vietnamese Healthy Male Volunteers

This study aims to investigate whether FABALOFEN 60 is bioequivalent to JAPROLOX® TABLETS after a single oral administration of each loxoprofen formulation in healthy subjects by assessing of pharmacokinetic properties including AUC, Tmax and Cmax and to evaluate the safety of test drug FABALOFEN 60 and reference drug JAPROLOX® TABLETS during drug administration.

This study is a randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study in 24 fed healthy subjects with an at-least-6-day washout period. The drug level in serum is detected by High-performance Liquid Chromatography (HPLC) to determine Cmax, AUC0-t and Tmax. Safety are evaluated during drug administration, blood sampling time, washout period and 1 week after the end of blood sampling for any adverse drug reactions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males.
* 18 to 55 years old.
* BMI in the range of 18 - 27 kg/m2, according to 1983 Metropolitan Index for adults.
* No present or history of hypertension, diabetes, respiratory or digestive problems, hepatic or renal deficiency, genetic problems nor tuberculosis (all inclusive).
* Laboratory results (hematological, biological) within normal range; negative HIV-test and HbsAg.
* No abnormalities on ECG.
* Willing to participate in the study.

Exclusion Criteria:

* Legal incompetency.
* Drug, alcohol or tobacco abuse.
* Allergic history to loxoprofen or any other excipients of the study products, or heparin.
* Abnormalities in cardiovascular, digestive, immunity, hematological, endocrine, neurological or psychiatric system determined by clinical physicians.
* Suspected positive HIV-test or HbsAg by quick test or electrochemiluminescence Immunoassay (ECLIA) or enzyme-linked immunosorbent assay (ELISA).
* Any illness determined by clinical physicians within 2 weeks prior to the first dosing.
* Use of any over-the-counter drug within 1 week or prescription drug within 2 weeks prior to the first dosing.
* Donation or loss of more than 450 ml of blood within 28 days prior to the first dosing.
* History of dysphagia or digestive diseases affecting drug absorption.
* History of difficulty in accessibility of veins in arms.
Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.

The investigators primarily aim to observe the number of attacks from initiation of baricitinib treatment.

The secondary outcomes are to determine: The safety profile of baricitinib in participants with NMO and whether baricitinib improves Expanded Disability Status Scale (EDSS), et al.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years old;
2. Diagnosis of NMO or NMO spectrum disorder according to the 2015 International Panel for Neuromyelitis Optica Diagnosis criteria;
3. Clinical evidence of either at least one attack requiring rescue therapy (intravenous corticosteroids, intravenous immunoglobulin, plasma exchange, or a combination of these therapies) in the year before screening or at least two attacks requiring rescue therapy in the 2 years before screening;
4. EDSS \<=6.0;
5. Patients were seropositive for AQP4-IgG;
6. Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

1. Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc);
2. Participation in another interventional trial within the last 3 months Tumor disease currently or within last 5 years;
3. Pregnant, breastfeeding, or child-bearing potential during the course of the study Clinically relevant heart, liver, kidney or bone marrow function disorder.
4. Have a history of venous thromboembolism (VTE), or are considered at high risk for VTE by the investigator.
New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon

1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies.

Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.

Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon.

The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm

Exclusion Criteria:

Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters
Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.

This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
* Measurable disease and adequate organ function as specified in the protocol

Key Exclusion Criteria:

* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with bendamustine.
* Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day 1.
* Prior autologous stem cell transplant within 3 months
* Active Hepatitis B or Hepatitis C
Perfluorooctyl Bromide Which Empowers the Liquid to Flat the Detached Retina and Displace the Underneath Fluids Anteriorly

Perfluorohexyloctaneis Essential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset


Eligibility Criteria:
Inclusion Criteria:

* - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;

Exclusion Criteria:

* Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;
Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of PNH patients experience a clinically evident TE and 60% of patients without clinically diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk in most patients with PNH. Much of these data come from PNH patients from European descent. To understand the impact of TE in patients with PNH from non-European regions, we performed this study to evaluate the clinical characteristics of Korean patients with PNH.

To evaluate the clinical characteristics in Korean PNH patients

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data

Exclusion Criteria:

* Patients have no Flow cytometry data
Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients

Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.

Although effective methods of secondary prevention after stroke or TIA are available, adherence to recommended evidence-based treatments is often poor. Programs for supported secondary prevention after cerebrovascular events with improved health education are promising but have not been evaluated regarding recurrent event reduction so far.

A prospective randomized trial has been started to assess the effectiveness of a patient centered structured support program intending a reduction of recurrent vascular events. Usual care consists of structured information given at discharge as well as regular outpatient care by general practitioners. The support program additionally employs a stepwise intensified support program with up to eight appointments over two years in outpatient clinics. Results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. They are also offered assistance in finding appropriate physical activities or smoking cessation programs.

Patients are randomized to regular care or regular care plus support program and will be followed-up until the total number of 317 primary endpoints has been reached. The composite primary endpoint consists of stroke, major coronary event and vascular death.

Eligibility Criteria:
Inclusion Criteria:

* Acute cerebrovascular event (either TIA or minor Stroke within 14 days before study inclusion) according to the following definitions:
* TIA (clinical restitution within 24 hours and ABCD2-Score ≥3) or visible DWI-lesion in MRI
* Minor stroke (mRankin ≤2 at time of inclusion)
* Patients with at least one of the following treatable risk factors:
* Arterial Hypertension
* Diabetes mellitus
* Atrial Fibrillation
* Smoking
* Written informed consent prior to study inclusion
* Realistic perspective in keeping the outpatient appointments

Exclusion Criteria:

* Distance from home to study center not in suitable range for keeping the outpatient appointments
* cognitive impairment jeopardizing adherence to the support program
* Modified Rankin Score \>2 at time of study inclusion
* Malignant disease with life expectancy of less than 3 years
* relevant alcohol or other substance abuse (except for nicotine)
* Stroke or TIA etiology without options for evidence based secondary prevention (e.g. dissection or vasculitis)
Sleep Assessment in CML

Patients with CML report on fatigue, and many of them report on sleep disturbances. The investigators wish to objectively assess the patient's sleep using a sleep "wrist watch" (Actigraph) , and correlate data with their perception of sleep quality. A matched participants group will serve as control. the Control group is defined as participants not having CML or any other malignancy and without any known sleep disturbances.

The investigators will contact the CML patients cohort (about 50) and ask them to join the study. Those consenting will be briefed on the use of an Actigraph wrist device, which the patients should wear for a week. In addition, patients will fill quality of life, depression and anxiety questionnaires.

During the assessment week they will be asked to fill in a short "sleep diary" to be correlated with the objective Actigraph results.

The investigators will analyze objective data and compare to the subjective report of patient's sleep and compare these results with a matched cohort of the control participants. The investigators will analyze the quality of life, anxiety and depression scores also.

The main objective of the study is to try and find a correlation between CML and sleep disturbances, several previous studies found sleep disturbances in reported questionnaires, but the sleep parameters were never studied objectively. Also most of the studies concentrated on the fatigue as the main symptom, in our study the investigators will focus on sleep quality and quantity as a primary symptom.

The quality of life questionnaire will be WHOQOL-BREF questionnaire. The anxiety questionnaire will be Hamilton Anxiety Rating Scale. The depression questionnaire will be Beck Depression Inventory.

The sleep watch that will be used is called Actigraph/Actiwatch and it is FDA approved device, this device will help the investigators assess and observe the objective sleep parameters like length of sleep, time to fall asleep, number of awakenings at night.

There will be no intervention in the study, the results will not alter the treatment the patients receive. But if some patients will be found to have a severe depression or anxiety they will be referred to psychiatric consult.

the study will be with the collaboration of Professor Iris Haymov, sleep researcher from the Max Stern Academic College of Emek Yezreel.

Eligibility Criteria:
Inclusion Criteria:

* CML patients
* Without known sleep disturbances that are not related to the disease

Exclusion Criteria:

* Malignancy other than CML
* Known sleep disturbances
* Pregnant women
Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit

The clinical finding of skin rashes which appear after a vitamin C deficiency in Long Term Care Unit leads us to believe that the institutional diet could predispose to this kind of deficiency. Vitamin C has a key role into the struggle against oxidant stress and is involved into the connective tissue formation of the skin and the vascular endothelium. Vitamin C deficiency affects currently 15 to 25% of the elderly over 65 years old reaching 15% women and 20% men after 65 according to Johnston and Al. It concerns mainly the people in precarious situations (persons without fixed homes, ethyl-smoking persons) and elderly over 65 years. Hypovitaminosis C, defined by plasma level between 5 mg/L and 15 mg/L (28.41 to 85.23 µmol/L), is currently undiagnosed, especially with people with a risk of food deficiency and its prevalence increases with age. The treatment consists of a daily oral supplementation of 1 gram of vitamin C/d for 15 days. A minimum intake of 10 mg/D of vitamin C is required to prevent scurvy and maintain a total pool of 350 mg. A diet modification by a systematic intake of 2 glasses of fresh orange juice and/or the consumption of raw fruits and vegetables would prevent the appearance of scurvy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 65 years old
* living in the Unit of Long Term Care without any limit time.
* with a system of social insurance
* Who gave its consent by his own , or with help of his representant or his tutor or curator.

Exclusion Criteria:

* rejection of the blood sample
* patient feeding with articial nutritional feeding (stomach tube feeding)
* person close to death, who is not able to feed himself and / or with life-threatening in short time.
* Patient with personal history of vitamin C deficiency.
Dapagliflozin Effect on Rheumatic Mitral Stenosis

Rheumatic mitral stenosis remains a health problem in developing countries. Progressive fibrosis of the valves and myocardium is the main pathophysiology that plays an important role. Dapagliflozin has various beneficial effects on the heart by reducing fibrosis, reducing inflammation, and improving patient quality of life. However, the role of this therapy is unknown in patients with rheumatic mitral stenosis.

This study is an open-label study on Rheumatic Mitral Stenosis patients, carried out at Sebelas Maret University Hospital Sukoharjo, Panti Rahayu Hospital Purwodadi, and Permata Bunda Hospital Purwodadi. Researchers divided 36 Rheumatic Mitral Stenosis patients sequentially into two groups, the first was the dapagliflozin group which would receive dapagliflozin 10 mg once a day and standard treatment. And the second group will only get standard treatment. Each patient will be examined on PICP, MMP-1, MMP-1/TIMP-1 ratio, TGF-β, Net atrioventricular compliance index, NT-pro BNP, and Kansas City Cardiomyopathy Questionnaire on day 1 and one month after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Severe mitral stenosis by echocardiographic examination of the planimetric method with morphology that supports the etiology of rheumatic
* Heart failure in functional class II-III
* Dapagliflozin naive

Exception Criteria:

* Other significant valve diseases
* Pregnant or breastfeeding
* Unstable hemodynamic conditions including cardiogenic shock
* history of mitral valve replacement/repair or mitral balloon valvuloplasty
* history of hypoglycemia
* eGFR below 25 mmHg
* diffuse pulmonary fibrosis