cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension

Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.

Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). It is a frequent complication of the liver disease, affecting up to 80% of tested patients. MHE affects severely the lives of patients by altering their quality-of-life and their socioeconomic status and is strongly associated to the development of overt HE. Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). Their presence has been associated with recurrent or persistent HE. The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known.

Patients with compensated cirrhosis and portal hypertension will be considered for inclusion. After written inform consent, the serum ammonia, psychometric hepatic encephalopathy score (PHES) and the animal naming test (ANT) will be performed to evaluate the presence of MHE. Patients diagnosed with MHE will be treated and a new evaluation will be performed 6 months later.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cirrhosis and portal hypertension older than 18 old
* Patient who underwent a CT scan or MRI in the last 3 months
* The Mini-Mental State (MMS) test \>25.
* Patient capable of receiving and understanding information relating to the study and of giving his written informed consent.
* Patient affiliated to the French social security system

Exclusion Criteria:

* Cirrhotic patient with overt HE or history of persistent or recurrent HE.
* Hepatocellular carcinoma beyond Milan criteria.
* Portal vein thrombosis.
* Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt.
* Presence of neurological or psychiatric disorder.
* Patient with treatment by benzodiazepines or opioid substitution.
* Pregnant or nursing women
* Patient in exclusion period of a previous study
* Patient under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study

TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter tricuspid valve replacement (TTVR) devices. This substudy of the main registry will focus on those with post-procedural acute hemodynamic instability (AHI).

TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® software. Patients with AHI will be compared to a control group without AHI, composed of individuals implanted with TTVR at Columbia University Irving Medical Center. In this substudy at Columbia, the investigators aim to describe AHI incidence, its clinical presentation, its impact on prognosis, and the predictors of its occurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And
* Patients presenting an AHI, defined by the need for inotrope and/or vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator's judgement).

Exclusion Criteria:

* Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )
* Patients started on inotrope/vasopressor either as part of a routine post-interventional protocol or preventively for "right ventricular (RV) support" without sign of hypoperfusion.
Conversations as a Means to Delay the Onset of Alzheimer's Disease

Past epidemiological studies have demonstrated that larger social networks, or more frequent social interactions, could have potential protective effects on the incidence of Alzheimer's Disease (AD). However, in those studies, indicators of social interactions were often broad, and included distinct elements that affected cognition and overall health. This project will examine whether conversation-based cognitive stimulation has positive effects on domain-specific cognitive functions among the elderly. Face-to-face communication will be conducted through the use of personal computers, webcams, and user-friendly simple interactive Internet programs to allow participants to have social engagement while staying at their home and also for the cost effective execution of the study.

Participants are randomized into the control group (weekly 10 minutes phone check-in only) or experimental group (30 minutes daily video chat with standardized/trained conversational staff). User-friendly equipment and internet are provided.

Eligibility Criteria:
Inclusion Criteria:

* Non-demented participants
* Willing to participate in daily conversation using internet/webcam with interviewers for 6 weeks
* Willing to monitor daily conversational amount using a digital recording device
* Willing informant who has frequent contact with the participant

Exclusion Criteria:

* have major illness or disabilities which interfere with interacting using the audio/video technology
* diagnosed as dementia
* MMSE \< 24 at screening
* Geriatric Depression Scale (15 items) \>4 at screening
Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels

The purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum IgE levels.


Eligibility Criteria:
Inclusion Criteria:

* Atopical dermatitis
* Total serum IgE level above 5000 kU/l
* IGA score of 3 or above
* No sufficient response to topical corticosteroids/calcineurin inhibitors, UV therapy (at least 4 weeks of therapy), systemic corticosteroids and cyclosporin A (at least 8 weeks of therapy) or no possibility of a prolonged use of this therapy due to adverse events/contraindications
* 18 years of age or above
* Effective contraception during therapy
* Informed consent

Exclusion Criteria:

* Unfavorable conditions for peripheral venous access
* Known hypersensitivity or allergy towards materials used in the adsorber columns
* Adequate anticoagulation not possible (e.g. multiple allergies towards various anticoagulants)
* Extreme bleeding tendency during anticoagulation
* Hypercoagulability
* Severe cardiovascular disease forbidding extracorporeal circulation
* Severe systemic infection
* Serum IgG level below 250 mg/dl
* Severe immunodeficiency (e.g. AIDS)
* Treatment with an ACE inhibitor (discontinue drug at least 72 h before treatment)
* Pregnancy
* Lactation
* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism or mental dysfunction)
A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation

The investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical treatment for patients currently enrolled in the Mayo Clinic Stroke Rehabilitation Unit.

The objectives of this study are to measure the effects of a therapy dog embedded in stroke rehabilitation sessions on the patients' functional recovery, depression, anxiety, motivation, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older.
* Patient must be in the comprehensive in-patient stroke rehabilitation program.
* Patient must have a stroke from any cause.
* Patients must be able and willing to give informed consent.
* Patients must be able to speak English as the questionnaires being used are only available in English.

Exclusion Criteria:

* Patient who has a pacemaker.
* Patient who is pregnant.
* Patient who is deemed inappropriate to the study by the medical professional.
* Patient who is unable to give informed consent.
* Patient who is unable to speak English.
Ventilation Strategy During General Anesthesia for Orthopedic Surgery

The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.

This is a non-randomized alternating intervention cohort study in which all orthopedic surgery operating rooms will alternate amongst four designated ventilation settings which include two tidal volumes and two PEEP levels. At the end of the four-week sequence, the entire sequence will be repeated 26 times over a 2-year period. Thus, ventilator settings will not be randomized on a per-patient basis, or even among study weeks.

Ventilation parameters will be designated at the beginning of each study week. However, clinicians will be free to adjust to whatever ventilation settings they believe is optimal in individual patients to ensure oxygenation and patient safety.

Eligibility Criteria:
Inclusion Criteria:

* Surgery in orthopedic operating rooms 32-37
* General anesthesia with endotracheal intubation.

Exclusion Criteria:

* Non-orthopedic procedures;
* Intubation before induction of anesthesia.
Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance.

In previous studies it was found that substitute benzamide derivatives with higher selective binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in Israel, there are four medications which belong to substitute benzamide derivatives group: amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect is universal for the whole group of benzamide.

The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an additional possibility for management of CIH.

The pilot study will be conducted in two mental health centers. In order to examine our hypothesis, we will use an add-on design. Into the study will be enrolled 50 patients with schizophrenia and schizoaffective disorder (males and females, 19-60 years old), according to the DSM-IV criteria, treated with clozapine and suffering from hypersalivation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years, male or female
* DSM-IV criteria for schizophrenia
* Clozapine treatment
* At least 2 scores on the Nocturnal Hypersalivation Rating Scale (NHRS)

Exclusion Criteria:

* Evidence of organic brain damage, mental retardation, alcohol or drug abuse
Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness

The study investigates the effects of animal-assisted therapy on patients with severe disorders of consciousness. The focus lies on the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 10 patients during 16 therapy sessions.

While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients in a minimal conscious state are recruited.

This pilot study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable "standard" therapy session without the presence of an animal.

Over a period of four weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 16 therapy sessions (8 experimental, 8 control) for each patient.

Each therapy session lasts about 20 minutes.

The study takes place at REHAB Basel. Animal-assisted therapies are held in a special room at REHAB Basel in the presence of one or more small animals that will be selected by the therapist.

Patients are allocated randomly to start with either the experimental or the control condition.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients of REHAB Basel
* Disorder of consciousness: minimal conscious state defined via:
* CRS Score (Coma Remission Scale) of auditory 3-4 or visual 2-5 or motor 3-5 or oromotor/verbal = 3 or communication = 1
* BAVESTA Score of 2.8

Exclusion Criteria:

* Enrolment of the investigator, his/her family members, employees and other dependent persons
* medical contraindications for contact with animals as allergy, phobia etc.
* If the patient's medication changes radically during the time of data collection
Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure

Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure.

As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established.

The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2\<=200 mmHg) PaCO2\<45 mmHg pH\>7.30

Exclusion Criteria:

Need for urgent endo-tracheal intubation Exacerbation of asthma or chronic obstructive pulmonary disease Documented pneumothorax Clinical diagnosis of Cardiogenic pulmonary oedema Do-not-intubate order Altered neurological status that requires immediate intubation and/or making the patient uncooperative Thoracic or abdominal surgery in the previous 7 days Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient's face
The TENDERA Multicenter Clinical Trial

TENDERA is a multicenter randomized controlled trial to compare traditional entry point in the radial artery for TRI and distal puncture at the anatomical snuffbox area for transradial Interventions. The Investigators hypothesized that novel entry point in radial artery may lessen vascular access site complication rate and especially the radial artery late occlusion rate.

the forearm access will be made using traditional technique what was well described previously in the literature. The novel puncture site is located in the snuffbox area distal to the traditional radial access point. Thanks to surrounded anatomical conditions in anatomical snuffbox area vascular access site complications may be lessened comparing to forearm radial access site.

Eligibility Criteria:
Inclusion Criteria:

age 18-75 primary radial artery puncture radial artery diameter \>1,5mm by ultrasound stable coronary disease less than 6F sheath needed patient height \>185cm

Exclusion Criteria:

ACS AMI critically ill patients previous TRI procedure Raynaud's disease
Transpyloric Feeding in Severe Bronchopulmonary Dysplasia

Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with birth weight \< 1000g. BPD is associated with multiple long-term adverse outcomes including chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the development of these impairments. Gastroesophageal reflux (GER) contributes to these mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately, clinically available methods to diagnose GER in infants are unreliable. Moreover, acid suppressive agents are both ineffective and carry high risk of serious life-threatening morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.

This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway complications of GER and and whether this methodology can aid in identifying individual infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.

Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and improve a validated BPD severity score (secondary outcome).

The investigators hypothesize that 80% percent of enrolled infants will have significantly fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and will have this feeding method formally recommended.

Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared to gastric feeds reduce airway complications of GER in infants with severe BPD.

The investigators hypothesize that transpyloric compared to gastric feeds will be associated overall with a 15% reduction in number of daily intermittent hypoxemic events.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≤ 32 weeks
* Severe BPD (FiO2 ≥ 30% and/or mechanical ventilation or non-invasive positive pressure respiratory support at the time of enrollment)
* Post menstrual age of 36-45 6/7 weeks at enrollment
* Parent and/or guardian permission (informed consent)

Exclusion Criteria:

* Prior intolerance to transpyloric feeds
* History of surgical anti-reflux procedure
* Congenital heart disease (not including patent ductus arterioles and hemodynamically insignificant ventricular septal defect or atrial septal defect)
* Structural abnormalities of the upper airway, lungs, or chest wall
* Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
* Parent, guardian, or subject who, in the opinion of the investigators, are unlikely to participate for the duration of the study
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological findings on biopsy consistent with UC.
* Subject is capable and willing to comply with all study procedures.

Exclusion Criteria:

* Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
* Subject has participated in an investigational drug or device study, other than a previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30 days of entering the current study.
* Subject discontinued from a previous balsalazide disodium tablet study due to study drug-related AE(s), including UC flare or associated symptoms that were perceived by the subject/investigator as being caused by study drug.
* Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.
* Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.
* Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
* Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C). Subjects with a history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.
Insulin Resistance in Primary Hyperparathyroidism

The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.

To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos \>6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients.

The test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* primary hyperparathyroidism and fb-glukos\>6,1 and/or HbA1c \> 39 mmol/mol

Exclusion Criteria:

* Treatment with insulin, sulfonylurea or metformin