cyrilzakka/clinical-trials huggingface dataset:
Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics

Low intensity physical activity by half squat of the elderly people with hemiplegia significantly slow down the pulse wave velocity of the arteries of the lower limbs of the paralyzed side within 8 weeks.

Measurement of aortic pulse wave velocity (PWV) is a noninvasive method for assessing arterial stiffening in atherosclerosis. In hemiplegics, disuse of the affected limb is associated with the muscle wasting leading to development of local atherosclerosis. The brachial-ankle aortic PWV (baPWV) is an indicator of early stage disuse syndrome, and is measured with a device that is particularly useful in elderly hemiplegics.

The LIPA regime was designed to result in an increase of 3.3% (about 40 kcal/day) of daily energy consumption compared to their individual baseline values. This included aerobic exercises and half squats (70° knee flexion) for altogether about 20 minutes, once daily. In addition, the subjects performed passive ankle dorsiflexion-plantar flexion, 30 times/minute for 10 min, once daily. The LIPA was aimed at affecting the passive range of motion in ankle, knee, and hip, and weight bearing on the affected leg in standing position.

Eligibility Criteria:
Inclusion Criteria:

* age above 65 years
* male
* hemiplegic
* onset of stroke within 5 years
* some of them required walking aid indoors
* all of them required a walking aid outdoors

Exclusion Criteria:

* severe functional limitations that precluded any increase in PA
* presence of associated cardiovascular conditions such as uncontrolled hypertension or angina
* presence of undiagnosed or untreated health conditions that manifested as abnormal findings in laboratory test and contraindicated exercise tests
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients

The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.

The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (NIV). NIV is standard therapy for patients with nocturnal hypoventilation.

The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.

Patients over the age of 18 referred to, or under follow up at, the Royal Brompton Hospital who require domiciliary NIV but are inexperienced with use of NIV will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. At the end of one month the patient will be swapped to the alternative NIV for a further one month of domiciliary NIV treatment. At the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous CO2 monitoring and 24 hour Holter monitoring.

Eligibility Criteria:
Inclusion Criteria:

* new clinical diagnosis of nocturnal hypoventilation
* requirement for long-term domiciliary non-invasive ventilation
* no previous experience with domiciliary non-invasive ventilation

Exclusion Criteria:

* uncontrolled cardiac failure
* acute exacerbation of respiratory failure
* daytime resting PaO2 \< 7.5kPa
* moderate or severe bulbar weakness
* inability to understand rationale and/or consent form for study
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.

Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms).

This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in prolonging the time to the first symptomatic arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart failure and/or ischemic heart disease) and those without these conditions. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase. The follow-up phase of the study is designed to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.


Eligibility Criteria:
Inclusion criteria:

* History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities
* History of congestive heart failure and/or ischemic heart disease
* Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study
* At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm.
* Sinus rhythm immediately prior to dosing

Exclusion criteria:

* Previously unsuccessful cardioversions within 60 days of screening period
* Failed to respond to any Class III antiarrhythmic drugs
* Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
* Previously in an azimilide study
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma

This first-in-human study is designed to establish the safety and tolerability of ATR-101 in patients with advanced adrenocortical carcinoma whose tumor has progressed on standard therapy. Information will also be collected to determine how long ATR-101 stays in the blood, and if any effect on tumor progression is seen. Biomarkers (blood and urine tests) will determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen and testosterone) are seen.


Eligibility Criteria:
Inclusion Criteria:

18 years;

* Clinical confirmation of adrenocortical carcinoma that is locally advanced or metastatic and not amendable to surgical resection;
* Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based chemotherapy regimen;
* Able to understand and comply with the protocol requirements;
* Willing and able to provide informed consent.

Exclusion Criteria:

* Mitotane level \> 5
* Use of contraindicated concomitant medications
* Unstable medical condition that, in the judgment of the investigator, could interfere with study procedures or data interpretation.
Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method

The main goal of the study is to determine the physiological parameters of sublingual microcirculation in children in different age categories using Sidestream Dark-Field Imaging Method. No significant differences are expected to be found between measurements in healthy volunteers in different age categories.

After recording the basic anthropometric parameters, pressure, pulse and O2 saturation, each volunteer who meets the inclusion criteria will have their microcirculation measured using a Sidestream Dark-Field (SDF) probe placed sublingually by one examiner using the SDF method. The measurement will be performed in supine position in a disease-free period, with normal diets, at least 2 hours after the last meal in the afternoon, for girls outside the menses period. Premedication or analgesia will not be used. A total of 3 video clips will be recorded from different parts of the sublingual area with a minimum length of 20 seconds in a row, unless the child needs a short break between measurements. The recorded videos will then be processed offline by one evaluator who is trained and experienced in microcirculation evaluation, three best and most stable parts of each video clip will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* healthy child
* informed consent of parents

Exclusion Criteria:

* inability to cooperate
* acute illness
* chronic illness
* chronic medication
* substance abuse
A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits

Purpose: Using a novel oxygen blender prototype with modified bCPAP to manage children 1 month to 5 years of age hospitalized with respiratory distress due to lower respiratory tract infection (LRTI) in low-resource settings is not associated with clinical failure within 1 hour of use.

Aim: To investigate if this novel oxygen blender is safe to use among children 1 month to 5 years old hospitalized for respiratory distress from lower respiratory tract infections in a low-resource setting.

The study will be a prospective cohort feasibility and safety trial. Patients admitted to Chenla Children's Healthcare who meet eligibility criteria will be asked for consent and then enrolled. Once enrolled, the participant will be treated per hospital protocols and stabilized on bCPAP respiratory support. Once stable for 2 hours, the blender will be incorporated into the bCPAP circuit. At this point, the study nurses will begin recording data for the study as well as providing standard medical care per hospital protocols.

Eligibility Criteria:
Inclusion Criteria:

* Admitted for lung disease and require hospitalization
* Admission diagnosis is lower respiratory tract infection or pneumonia or bronchiolitis (any infectious microbe including bacterial, viral, fungal, parasitic)
* Have respiratory distress on presentation to the hospital (cough or trouble breathing plus at least one of the following: \<92% despite low flow oxygen, central cyanosis, tachypnea, chest indrawing, nasal flaring, grunting, head nodding, convulsions, lethargy, inability to breastfeed or drink)
* A bCPAP (electronic) machine is not available to use

Exclusion Criteria:

* History of asthma
* Upper airway obstruction
* Diaphragmatic hernia
* Pneumothorax
* Acute Glasgow Coma score \<4
* Cleft Palate
* Cyanotic heart disease
* Bleeding disorders
* Imminent death within 2 hours
* Have had abdominal or thoracic surgery
Ultrastructural Changes of Trabeculectomy Specimens in Patients With Uveitic Secondary Glaucoma

Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary glaucoma.

To evaluate morphological changes and to compare to primary open angle glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* secondary uveitic glaucoma
* IOP \> 24 mmhg with topical and/or systemic therapy
* need for surgical intervention to control IOP
Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

The investigators are trying to investigate the coagulation status of idiopathic (immune) thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von Willebrand factor level, thromboelastography.

In patients with chronic coagulation disorder, laboratory model and clinical data have shown evidence for a rebalanced hemostasis. Previous study showed that the platelet count may not predict the risk of bleeding since the platelet count is not an indicator of platelet function. Thromboelastography may be the choice of investigation when platelet function is in question especially in patients with idiopathic (immune) thrombocytopenic purpura (ITP). Previous study have shown that maximum clot formation is the most important thromboelastography parameter in predicting bleeding in ITP patients that makes thromboelastography superior to other hemostatic tests. The investigators are trying to evaluate the rebalanced hemostasis in patients with ITP by comparing the value of platelet count, von Willebrand factor antigen level, and thromboelastography parameters.

Eligibility Criteria:
Inclusion Criteria:

* Those who visits the outpatients clinic of Samsung Medical Center with a diagnosis of idiopathic (immune) thrombocytopenic purpura (ITP)between March, 2012 and February, 2013.
* Those with age between 20 and 70 yrs old

Exclusion Criteria:

* Those with other causes of thrombocytopenia other than ITP
Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

This research program will improve the care and treatment outcomes of dually diagnosed veterans who receive inpatient psychiatry care, and decrease their use of VA inpatient mental health services. It will increase the use of substance abuse outpatient care and 12-step groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.

Background:

Substance use disorders (SUDs) are highly prevalent among veteran psychiatry inpatients. Dual substance use and psychiatric disorders are related to poor outcomes and rehospitalizations, which are quite costly. However, relatively little is known about how to effectively help dually diagnosed psychiatry inpatients. Telephone Monitoring (TM) is effective among SUD patients at increasing SUD continuing care and self-help utilization and improving SUD outcomes. This study will build on these findings and contribute important new clinical knowledge by determining whether TM is similarly effective when adapted for dually diagnosed veteran psychiatry inpatients. It will evaluate the effectiveness of a manual-guided TM intervention.

Objectives:

Primary hypotheses are that patients in the TM condition, compared to patients in usual care (UC), will attend more SUD continuing care sessions and 12-step group meetings, and have better SUD and psychiatric outcomes. Secondary hypotheses are that TM patients will have fewer and delayed rehospitalizations, and their better outcomes will be mediated by SUD outpatient treatment and 12-step group participation.

Methods:

This study will take place at two VAs: Palo Alto (VISN 21) and Ann Arbor (VISN 11). Dually diagnosed patients in psychiatry inpatient treatment will be randomly assigned to UC or TM. Patients in the TM condition will receive an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment if a relapse occurs, and encourage 12-step self-help group participation. Patients will be assessed at baseline, end-of-intervention, and six months and one-year post-intervention for primary and secondary outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and TM groups on course of primary and secondary outcomes over time; Cox regression models will compare groups on time to rehospitalization; and sequential regression analyses will examine whether outcomes associated with TM are mediated by more SUD continuing care and 12-step group participation.

Status:

As of this time, this project is in the follow-up data collection phase.

Eligibility Criteria:
Inclusion Criteria:

* Dually diagnosed veteran in VA inpatient psychiatry treatment

Exclusion Criteria:

* Current diagnosis of schizophrenia or schizoaffective disorder
* too psychiatrically unstable or cognitively impaired to understand informed consent and other study procedures
* does not have ongoing telephone access
An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
* Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
* Available tumor tissue for biomarker analysis

Exclusion Criteria:

* Must not have squamous cell or undifferentiated GC or GEJ
* Untreated known central nervous system (CNS) metastases
* Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply
On-line Treatment for Conduct Problems

The research evaluates the use of online versions of delivering an effective psychological treatment for children clinically referred for serious oppositional, aggressive, and antisocial behavior. The goal is to develop models of delivery that reach families in need that are not being served by in-person treatment. The project has immediate implications for the treatment of children but more generally addresses several issues critical to treatments that are based on Internet, telepsychiatry, and related technologies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Conduct Disorder of Oppositional Defiant Disorder (for the child)
* Residence in the state of CT
* Access to a computer and high-speed Internet access
* English fluency (at least one parent)
* No history of significant developmental delay (for the child)
* Parental consent

Exclusion Criteria:

* Participation in another form of psychotherapy or counseling that is directed toward the reduction of social, emotional, or behavioral problems
* Evidence of recent suicidality (for the child)
* Current or lifetime diagnosis of a Pervasive Developmental Disorder
* Primary diagnoses of a mood or anxiety disorder
* Acute family crisis
* Parent or guardian who can participate in treatment shows current psychosis or an uncontrolled medical condition
Cognitive and Behavioral Dysexecutive Syndrome in Multiple System Atrophy

The main objective of the study is to compare the score to the Behavioral Dysexecutive Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 7 years) and sex .

Multiple system atrophy (MSA) is a rare neurodegenerative disorder which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. According to the consensus criteria for the diagnosis of MSA, the presence of dementia is considered an exclusion criteria. However, several studies have reported cognitive impairment in patients with MSA, dominated by a dysexecutive syndrome. Some studies have compared the cognitive profile of MSA-P patients and MSA-C but any have studied the behavioral dysexecutive syndrome in this population. In 2010, the GREFFEX has established criteria for dysexecutive syndrome and described two distinct parts: the dysexecutive syndrome and cognitive behavioral dysexecutive syndrome. Our clinical impression is that according to the type of MSA, the dysexecutive syndrome seems to be different : the MSA-P patients seem to have a cognitive dysexecutive syndrome and the MSA-C patients a behavioral dysexecutive syndrome.

We want to compare the BDSI score between MSA-P patients and MSA-C patients matched on disease duration, age and sex The specific involvement of the cerebellum in behavioral disorders could explain the behavioral differences experienced by clinicians caring for these patients but never demonstrated. The presence of these disorders could have an impact on the relationship between the patient and the caregiver. In addition, few studies have correlated with cognitive imagery data. Therefore, the exact areas involved in cognitive and behavioral MSApatients remain poorly understood.

Eligibility Criteria:
Inclusion criteria:

* Patients suffering from "probable" MSA according to clinical consensus criteria (Gilman et al, 2008),
* Age \>30
* Written informed consent
* Patient covered by the national health system
* The presence of an informant
* Blood negative dosage of the hormone béta-hCG for the women old enough to procreate

Exclusion criteria:

* UMSARS IV score \> 4 points
* Pregnant woman (blood positive dosage of the hormone béta-hCG) or breast feeding
* Patient under tutelage
* Patient unable to give consent
* Against indication to perform an MRI
The Human Blastocyst Secretome and Implantome

The aim of this study is to identify the protein secretion and consumption profile of the human blastocyst (secretome) and the implanted blastocyst (implantome) using the protein array technology.


Eligibility Criteria:
Inclusion Criteria:

* Conditioned medium of blastocytes
Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

The study has been designed as a prospective, non-randomised, single centre study to determine the predictive utility of Short Term Variation (STV) of the Fetal Heart Rate (FHR)from the intrapartum FHR data collected using the portable fetal ECG monitor (Monica AN24) in women requiring continuous monitoring during labour due to antenatal or intrapartum risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Singleton term pregnant labouring women during established labour (cervix \>3cm dilated, regular uterine contractions \>3:10 minutes)
* Written informed consent
* At least 18 years of age

Exclusion Criteria:

* Preterm labouring women
* Multiple pregnancy
* Involved in another study using a device or medicinal product