cyrilzakka/clinical-trials huggingface dataset:
Furosemide for Accelerated Recovery of Blood Pressure Postpartum

A randomized, double-blind, placebo-controlled single center investigation of furosemide's effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders of pregnancy

Hypertensive disorders of pregnancy are recognized causes of significant maternal/fetal morbidity and mortality, accounting for approximately 18% of maternal deaths worldwide. While significant research has been done on the evaluation and management of hypertension during pregnancy, studies of postpartum hypertension (PPHTN) are usually limited by their retrospective design and focus on inpatients in the immediate postpartum period (2-6 days), or patients who were readmitted due to complications related to hypertension. Few studies have investigated the incidence and proper management of hypertension in the postpartum period. Furthermore, in the United Kingdom, a review of maternal deaths determined that 10% were related to hypertensive disorders in pregnancy (HDP) in the postpartum period. Postpartum hypertension is also the cause of approximately 27% of readmissions to the hospital. These studies clearly show that PPHTN is associated with significant morbidity and that it is important to develop interventions that can reduce its effects.

In patients with HDP, postpartum blood pressure has been shown to decrease in the first 48 hours postpartum only to then increase in days 3-6 postpartum. This phenomenon is thought to be secondary to large fluid shifts, both secondary from fluid retention during the pregnant state as well as from fluids given intrapartum. Furthermore, large volumes of sodium are also mobilized into the intravascular compartment at this time. Given the latter, furosemide, a loop diuretic that mobilizes sodium and fluid excretion has been posed as a method to prevent severe range blood pressures and their associated maternal morbidity in the postpartum period.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum
* Gestational hypertension
* Pre-eclampsia with or without severe features
* Superimposed pre-eclampsia with or without severe features
* New diagnosis of HDP within 24 hours from delivery
* Postpartum, delivery ≥ 20 weeks estimated gestational age
* Age ≥18 years old

Exclusion Criteria:

* History of allergic reaction to furosemide
* High risk comorbidities for which treatment may be indicated or contraindicated: class C or higher diabetes mellitus, chronic kidney disease or baseline creatinine \>1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease
* Baseline labs with K \<3
* Use of furosemide or other diuretics antepartum or intrapartum
* Use of ototoxic agents including aminoglycosides (ie, Gentamicin for \>1 dose), cephalosporins (ie Ancef \>1 dose),
* Patient unstable for protocol per investigator's judgement
Tea and Forearm Blood Flow

The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar a placebo matched for taste and appearance in a blinded cross over design.

Epidemiological studies indicate that regular consumption of black tea reduces the risk of cardiovascular diseases. Tea consumption can result in improvements in endothelial function of conduit arteries as measured by flow mediated dilation.

Less is known however about its effects in other vascular beds. The study will test the hypothesis that tea affects endothelial function in the muscle microcirculation. This will be done by assessment of forearm blood flow using venous occlusion plethysmography after consumption of black tea against or placebo in a randomised, full cross-over study in 20 healthy middle-aged to elderly subjects

Eligibility Criteria:
Inclusion Criteria:

* Males and post menopausal (\> 1 years) females
* Aged ≥ 45 and ≤ 75 years
* Body mass index (BMI) of ≥ 18.0 and ≤ 35.0 kg/m2
* Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).
* Normal blood coagulation as assessed by routine lab tests

Exclusion Criteria:

* Strenuous exercise \> 2 hours per week. Strenuous exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation
* Current smoker or has stopped smoking less than 6 months before start of study
* Self reported alcohol intake of \> 21 units/week)
* Established cardiovascular disease or clinically significant arrhythmia
* Diabetes mellitus
* Blood pressure \> 160/100 mmHg
* Taking medication that might affect endothelial function (as judged by the PI)
A Useful Support System for Psychiatric Diagnostics and Follow-up in Adult Psychiatry and Primary Care (ASPP)

Psychiatric diagnostics involve collecting information about a patient's symptoms, age of onset, development over time, relation to external stress, and ability to function and experience suffering. This information is classified using ICD (World Health Organisation) and DSM (American diagnosis system). Currently, there is a lack of a scientifically evaluated system to support these diagnostics. This project seeks to develop and evaluate a set of self-assessment scales which collect and classify relevant data and serve as support for clinicians. These scales are made up of questions about typical psychiatric symptoms, which are assessed and evaluated using a statistical method (Item Response Theory). After testing and evaluation, a scale could consist of approximately 10 items or less. The scales are then tested together to see if the number of items and scales can be reduced further.

Psychiatric diagnostics are based on the systematization of information that can be collected about a patient's symptoms and behavior. The information typically concerns the symptoms a patient exhibits, the age of onset for the symptoms, how they have developed over time, whether they are related to any type of external stress, and whether the symptoms cause suffering and/or functional impairment. The collected information can then be classified using diagnostic manuals. The official one is the WHO's International Classification of Diseases (ICD). The American diagnostic system DSM is also used.

Today, there is a lack of a scientifically evaluated (validated) support system for psychiatric diagnostics. With this project, we aim to develop and scientifically evaluate a set of self-assessment scales that can collect and systematize relevant information about patients' symptom profiles, age of onset, long-term course, any possible relation to external stress, and function and suffering, which can serve as support for clinicians in the diagnostic process. Some of the scales are also intended to be used for follow-up.

Assessment scales consist of sets of questions or statements, which in this context are called "items." They describe deviant psychological symptoms (psychopathology) as gradually increasing phenomena (dimensions). In the project, we develop sets of items based on the most common diagnostic areas within psychiatry and general medicine. These are then tested on patients and evaluated using a modern statistical method specialized for developing scales, called Item Response Theory (IRT). The first sets of items contain between approximately 30 and 60 items. After evaluation, only the best-performing items are retained. Testing is repeated on new patient groups until they function optimally. The goal is for each scale to consist of approximately 10 items. Thereafter, the reduced scales are tested together and evaluated with IRT to, if possible, reduce the number of scales and items.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psychiatric problems

Exclusion Criteria:

* None
Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation

This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.

The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.

Eligibility Criteria:
Inclusion criteria:

* Patients plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (\>7 days) and longstanding persistent atrial fibrillation (\> 12 months, but ≤ 3 years) who are refractory to at least one class I or class III antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion.
* Subject is at least 18 and ≤ 75 years old.
* Subject is able and willing to give informed consent.

Exclusion criteria:

* Subject has paroxysmal atrial fibrillation (\< 7days) or persistent atrial fibrillation with duration \> 3 years.
* Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation.
* Subject has presence of an intracavitary thrombus.
* Subject has uncontrolled heart failure.
* Subject has severe valvular disease.
* Subject has the left atrial diameter \> 60 mm confirmed by echocardiography.
* Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants.
* Subject has known cryoglobulinaemia.
* Subject has severe renal dysfunction.
* Subject who is or may potentially be pregnant.
* Subject has unstable angina pectoris.
* Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
* Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.
Effectiveness of Module Based Learning and Mobile Application Based Learning Regarding Facility Based Newborn Care Among Nursing Students

The study evaluates the effectiveness of Module based learning and Mobile application based learning regarding Facility based newborn care among nursing students.Total 70 Nursing students were randomly allocated to MBL and MABL group . First 35 students received MBL based teaching and next 35 students received MABL teaching.

a comparative study was done to assess the effectiveness of Module based learning and Mobile application based learning regarding Facility based newborn care among nursing students.

MODULE GROUP

Day 1: Pre assessment of Knowledge through Structured knowledge questionnaire was done and practice through observation checklist by OSCE method .

Day 2: Module based Teaching administered to nursing students who were present on the data collection. Teaching and Hands on sessions were given to students by investigator. Introduction regarding Module and topics: Prevention of infection (Hand washing), Kangaroo Mother Care, Feeding of normal and low birth weight babies (Attachment during feeding, Paladai Feeding), Common Procedures (Oxygen administration, Insertion and Orogastric Tube Feeding, Weight Recording of a Newborn)

Day 15th = Post-test of Knowledge through Structured knowledge questionnaire was done in BSc. Nursing 3rd year classroom and practice through observation checklist by OSCE method Post-test of knowledge took 45 minutes.

MOBILE APPLICATION BASED GROUP

Day 16th = Pre assessment of Knowledge through Structured knowledge questionnaire was done in BSc. Nursing 3rd year classroom of M.M Institute of Nursing and practice through observation checklist by OSCE method

Day 17th = Mobile Application based Teaching administered to nursing students who were randomly selected. Teaching and videos were given to students by investigator in MM Institute of Nursing.

Introduction regarding Mobile Application and topics: Modules on Normal baby, At Risk baby, Sick Newborn, Videos on Attachment during feeding, Paladai Feeding, Oxygen administration, Kangaroo Mother Care, Insertion and Orogastric Tube Feeding, Weight Recording of a Newborn, Hand washing, Posters on Hand washing, Kangaroo Mother Care

Day 30th = Post-assessment of Knowledge through Structured knowledge questionnaire was done and practice through OSCE method

Eligibility Criteria:
Inclusion Criteria:

* BSc Nursing 3rd. Year students who were present at the time of data collection

Exclusion Criteria:

* BSc Nursing 3rd. Year students who were not having Android phone in MABL group
9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease

It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
* Patient age ≥ 6 years.
* If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent.

Exclusion Criteria:

- Absence of signed written informed consent and thus a patient unwilling to participate.
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity.

The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.


Eligibility Criteria:
Inclusion Criteria:

* Male and female babies with unilateral OBPP
* Age between 10 and 11 months
* Presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external ROM of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the AMS for shoulder external rotation and abduction, elbow flexion or supination)
* Signature of the consent form by (the) parent(s) over the age of majority

Exclusion Criteria:

* Bilateral OBPP
* Microsurgery or secondary muscle surgery planned between 12 and 18 months of age
* Contraindications to the use of botulinum toxin
* Contraindications to MRI
* MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints
* Parents inapt to provide consent for the participation of their child
* Parents under the age of 18 years
Evaluation of Respiratory Acoustic Monitor in Children After Surgery

The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).

The study seeks to determine the reliability and accuracy of the acoustic respiratory monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring (TI) and manual counting of respiratory rate in postoperative pediatric patients at risk of adverse respiratory events.

Eligibility Criteria:
Inclusion Criteria:

* Male or female children 2 to 16 years of age
* In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by patient controlled analgesia for post-operative pain control
* Child weighs at least 10 kg on day of surgery

Exclusion Criteria:

* Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites that would interfere with sensor or electrode applications.
* Patient is admitted to the Intensive Care Unit
* Patient has tracheostomy
* Patient is on non-invasive ventilator support
Memory Enhancement Using Transcranial Alternating Current Stimulation

The 32 million Alzheimer's disease (AD) and 69 million prodromal AD patients worldwide contribute to a large economic burden. Effective and safe therapies that slow or prevent the progression from mild cognitive impairment (MCI) to AD are therefore of high priority. Transcranial alternating current stimulation (tACS) is a safe and patient-friendly non-invasive brain stimulation technique that serves as a potential candidate for reducing and/or slowing cognitive impairment. Application of tACS in the gamma frequency range, specifically around 40 Hz, has been studied in patients with AD and MCI due to AD. In these patients, a single session of 40 Hz tACS at the precuneus showed to improve episodic memory and to increase gamma power, as measured with electroencephalography. These findings will be replicated in the current study in patients with MCI due to AD, using magnetoencephalography (MEG) recorded before, during and after tACS. In this way, brain activity and network changes that underlie this improvement in episodic memory can be studied with greater temporal and spatial detail.


Eligibility Criteria:
Inclusion Criteria:

* Recent (not more than 6 months ago) amnestic MCI diagnosis, which consensus is obtained in a multidisciplinary meeting after an extended multidisciplinary test battery at the memory clinic, including confirmation of AD pathology with cerebrospinal fluid biomarkers: abnormal p-tau/Aβ42 ratio of \> 0.023

Exclusion Criteria:

* Suffering from serious neurological, psychiatric or somatic comorbidity
* Suffering from epileptic seizures or severe claustrophobia
* Intensive use of psychoactive medication
* Having a cardiac pacemaker, internal cardiac defibrillator or other intracorporeal device that interferes with MEG recordings
Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercise With Knee Osteoarthritis

Osteoarthritis (OA) is a chronic disease process characterized by degeneration and inflammation in the joint cartilage and subchondral bone, synovial fluid and joint capsule. One of the most affected joints in OA is the knee joint, and the incidence of OA increases with age.

Different treatment approaches are used in the treatment of osteoarthritis. The aim of the study is to examine the effectiveness of Mulligan technique and core exercises applied to female patients with knee osteoarthritis. In addition, the investigators did not find any study examining the effect of Mulligan technique on static balance in the treatment of OA. This is the secondary aim of the study.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with knee osteoarthritis
* To be in the age range of 40-70
* No lower extremity surgery in the last 6 months.
* Agree to participate in the study

Exclusion Criteria:

* Having had hip-knee replacement surgery
* Surgery planned in the last 6 months
* Having received physical therapy in the last 6 months
* Having uncontrollable hypertension and cardiac problems
* Having been diagnosed with rheumatoid arthritis
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects

This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 in Healthy Male Subjects.

CT-P43, containing the active ingredient ustekinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Stelara. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 will be evaluated in Healthy Male Subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, between the ages of 19 and 55 years, both inclusive.
* Subject has a body weight between 60 to 90 kg, both inclusive, and a BMI between 18.5 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth.

Exclusion Criteria:

* A medical history and/or condition that is considered significant
* Clinically significant allergic reactions, hypersensitivity
* History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
* Active or latent Tuberculosis
* History of malignancy
* Previous exposure to ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23
Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy in Non-valvular Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4-5-fold. The prevention of complications is based on oral or antiplatelet anticoagulant treatment. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). Contraindication to VKA or poor control of the International Normalized Ratio leads to the administration of direct-acting oral anticoagulants (DOACs). There is a trend towards inadequate AT in non-valvular AF (NVAF) patients.

The Objective of the study is evaluate the impact of the implementation of a decision support tool linked to digital clinical history on the adequacy of AT, the incidence of complications and the mortality in patients with NVAF in primary health care of the Catalan Institute of Health (ICS).


Eligibility Criteria:
Inclusion Criteria (all criteria must be met):

* Patients diagnosed with NVAF one year prior to the implementation of the computerized tool;
* Patients receiving anticoagulant treatment with DOACs or VKAs;
* Patients followed in primary care (with at least 6 INR controls during the year prior to the intervention).

Exclusion Criteria:

* Patients with INR control in the reference hospital;
* patients with valvular AF (mitral stenosis);
* patients with a prosthetic heart valve;
* change to another primary care center.