cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk.

The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.

The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.

We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.

The patients will be proposed to perform the following tests and to fill in questionnaires:

- Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.

Tests:

* Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value \<56)
* Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value \>12 seconds).
* 6 minute walk test evaluating endurance to submaximal exercise.
* Isokinetic maximal force of the quadriceps at 60°/s
* Balance control: posturography consisting in measuring variations when standing on a force platform.
* Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.
* Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.

Analysis of the results:

We will calculate the sensitivity of the TUG test (abnormal test) to detect fall risk as assessed by an abnormal BBS score.

Moreover, in fallers, we will search for predictive factors. More specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease).

Perspectives:

When validated as a screening test for the risk of falling in COPD patients, the TUG test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.

Eligibility Criteria:
Inclusion Criteria:

* COPD confirmed by pulmonary function tests
* Long term oxygen therapy since at least 3 months in the LOT+ subgroup

Exclusion Criteria:

* Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks
* Pulmonary rehabilitation in the last 3 months
* Any neurological disease affecting balance control.
* Inability to perform a walk test
Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)

The purpose of this study is to monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm.


Eligibility Criteria:
Inclusion Criteria:

* wrist circumference: 14 cm-25 cm

Exclusion Criteria:

* none
An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis

The purpose of this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study
Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep Quality in Young Adults With Insomnia

Sleep deprivation, which is a universal necessity, has serious physiological consequences.

Sleep disorders are among the most common health problems, and yet they are often neglected. The osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes. Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Humans spend about a third of their lives sleeping, but most individuals know little about sleep. Sleep deprivation, which is a universal necessity, has serious physiological consequences.

Based on behavioral and physiological criteria, human sleep is divided into two phases: Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM).

NREM sleep corresponds to 75% to 80% of sleep and REM approximately 20% to 25% of sleep, existing between four to six episodes.

Sleep disorders are among the most common health problems, and yet they are often neglected. It is estimated that millions of people suffer chronically from a sleep or wakefulness disorder, impairing their health and longevity.

According to the International Classification of Sleep Disorders (ICSD) there are eight categories of sleep disorders and clinical history is essential for diagnosis, including family history, medical, psychiatric, neurological or substance abuse disorders.

Insomnia is a sleep disorder defined by difficulty falling asleep, staying asleep, or both. It can cause significant distress and impair daily tasks. The symptoms of insomnia are expressed by having difficulty falling asleep, waking up frequently during the night, waking up very early on a daily basis, and tiredness already present upon waking up.

Osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes (Henley, Ivins, Mills, Wen, \& Benjamin, 2008). Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Eligibility Criteria:
Inclusion Criteria:

* Have sleep disorders (insomnia);
* Volunteers between 18 and 30 years of age.

Exclusion Criteria:

* Attending the 3rd or 4th year of the Osteopathy Course;
* Present fever (axillary or oral temperature higher than 37.5º C);
* Have a history of skull fracture;
* Have a history of bleeding and intracranial hemorrhage;
* Have a diagnosis of convulsion.
Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury

This is a multi-center randomized clinical trial study. The purpose of this study is to examine safety, feasibility and efficacy of automated peritoneal dialysis as compared with intermittent hemodialysis for AKI patients with indications for dialysis.

The incidence of acute kidney injury (AKI) is rapidly increasing worldwide. This is a common and devastating disorder, especially in critical illnesses, affecting 5-8% of all hospitalized patients and up to 30% of those in intensive care units, with high mortality. About 50-80% critical patients with AKI needed dialysis treatment. Intermittent hemodialysis (IHD) might be the most-commonly modalities applied in AKI patients requiring dialysis. However, no data of randomized study concerning renal recovery and treatment efficiency of AKI patients treated with APD is available in Chinese adult patients. This study is a 2-armed randomized controlled non-blind non-inferior trial to explore the feasibility, efficacy, and safety of APD in AKI patients as compared with intermittent hemodialysis. Base on the sample size estimation, 100 subjects (n=50 in each arm) should be enrolled in this study. The primary outcome is the rate of renal recovery (independence of dialysis) in the first 21days after initiation of renal replacement.

Eligibility Criteria:
Inclusion Criteria:

* AKI patients according to Acute Kidney Injury Network criteria
* Rapidly rising serum creatinine level (a sudden increase of at least 30%)
* Meeting the indications for dialysis

  * Uremia or azotemia (BUN\>80 mg/dl)
  * Fluid overload (after diuretics use)
  * Electrolyte imbalance (K\>5.5 mEq/L after clinical treatment)
  * Acid-base disturbance (pH\<7.2 and bicarbonate\<10mEq/L after clinical treatment)

Exclusion Criteria:

* Age under 18 years, or older than 80 years
* Urinary tract obstruction; acute interstitial nephritis or rapidly progressive glomerulonephritis needed immunoinhibitory therapy
* Previously received renal replacement therapy(RRT) of any type/presence of dialysis access during the current illness.
* Pre-existing severe chronic kidney disease (baseline serum creatinine\>4mg/dl) more than 10 days prior to initiation of first RRT.
* Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (\<1month), multiple abdominal surgeries.
* Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure \<80mmHg).
* Pregnant.
Frequent Ballgames Training for 9-11 Year Old Schoolchildren

Inactivity among schoolchildren is a challenge to public health and for the municipality in particular. This study´s aim is to evaluate the cognitive and physical as well as social and fitness adaptations, and learning outcomes of short- and long term ball training for 9-11 years old girls and boys, and to determine to what extend the organisation (5x12 minutes og 3x40 minute a week) and type of training (ball games, circuit training or running) influence the magnitude of response.


Eligibility Criteria:
Inclusion Criteria:

* 9-11 years old girls and boys in 3rd grade in schools in Frederikssund and Copenhagen

Exclusion Criteria:

* Children with severe mental or physical disabilities
QVA Mechanistic Efficacy Study (Receptor Effects, Etc)

The purpose of this study was to assess global ventilated lung volume in moderate to severe COPD patients using MRI lung imaging after treatment with QVA149 compared to placebo.

The MRI approach represented an opportunity to better understand the impact of a potent dual bronchodilator on the small and central airways and thereby increasing ventilated lung volume, gas exchange, and ventilation-perfusion deficits.

The study investigated the effect of QVA149 on global and regional lung ventilation using MRI lung imaging to enhance the understanding of QVA pharmacology in COPD patients.

Eligibility Criteria:
Key Inclusion Criteria:

Males and females with COPD aged 40 years and above, weighing ≥45 kg and ≤100 kg, who were smokers and ex-smokers who had a smoking history of at least 10 pack years, and diagnosed with moderate to severe COPD according to GOLD 2015 criteria were included in the study. Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC \< 0.70 and by a post-bronchodilator FEV1 ≥ 30 % and \<80 % were included in the study. Post-bronchodilator refers to 1 hr (+/- 5 minutes) after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol/360 µg albuterol (or equivalent dose).

Key Exclusion Criteria:

Patients with conditions which could compromise patient safety and compliance (as judged by the investigator), as well as conditions that required oxygen therapy for chronic hypoxemia, ≥25% emphysematous changes on a scan within 6 months to screening, those with lower respiratory infections within 6 weeks of screening, and patients with concomitant pulmonary disease were excluded from the study. Patients with asthma were also excluded from the study.

Pregnant or nursing (lactating) women, patients with poorly controlled Type I or Type II diabetes, patients with poor renal function, and those who were unable to use a dry powder inhaler or perform spirometry, and had contraindications to MRI were also excluded.
Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke

Stroke remains one of the leading causes of death and adult disability worldwide. Yet, currently, the only accepted treatment for acute ischemic stroke(AIS) is recanalization of occluded arteries. Thrombolysis with tissue plasminogen activator, limited by its narrow therapeutic time window and the concern of hemorrhagic complication, is still uncommon in use. The other approach is to try to impede the ischemic cascade by targeting various components of the cascade that are deemed to be of importance, namely, a neuroprotection strategy.

Nerve growth factor (NGF) plays extensive roles in preventing ischemic injury. Besides that, it is also involved in neurogenesis of the central nervous system (CNS). In addition, the levels of NGF protein and messenger RNA significantly decreased in the CNS at the first few hours and returned to normal levels several days later after middle cerebral artery occlusion (MCAO) in animal models. These observed results suggested that NGF was demanded in ischemic brain injury, but endogenous NGF is insufficient for the requirement and delivering exogenous ones will be blocked in entering into the CNS by the blood-brain barrier (BBB). Intracerebroventricular or intracerebral injection of NGF or grafting of NGF-producing cells may be less practicable due to invasiveness and safety concerns.

Intranasal (IN) administration is a noninvasive and acceptable delivery strategy for drugs bypassing BBB and can deliver NGF to the CNS, which has been proved to show neuroprotective effects on brain injury.

The effects of intranasal NGF in human ischemic stroke is still controversial that need further evaluation.

The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post acute ischemic stroke, continuing for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18years;
2. Acute ischemic stroke consistent within 72 hours;
3. Written informed consent from patient or surrogate, if unable to provide consent.

Exclusion Criteria:

1. Premorbid mRS ≥ 3 points;
2. Currently in pregnant or lactating;
3. Allergy to NGF;
4. Current participation in another investigation drug or device study;
5. Life expectancy less than 1 year.
Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients

The thromboembolic risk is increased during the nephrotic syndrome (NS) with an incidence of deep vein thrombosis 15%, pulmonary embolism of 10-30% and renal vein thrombosis of 25-37%. There is a hemostatic imbalance with urinary leakage of anticoagulant factors and increased hepatic synthesis of procoagulant factors, platelet hyperaggregability and a decrease in fibrinolytic activity. However, the identification of patients requiring anticoagulant prophylaxis remains imprecise.The thromboembolic risk is higher when the NS is related to extramembranous glomerulonephritis comparatively to others glomerulopathies. The reason of this difference is not still known. This risk increase with SN's severity and therefore with the decrease of albuminemia. Moreover, few studies have evaluated anticoagulant treatment efficacy during a NS, which clinical benefit depends also on hemorrhagic risk specific of each patient. Thus, the determination of the thrombotic risk and the modalities of anticoagulation are variable and perfectible during the NS.

We propose to use the thrombin generation test (TGT) to quantify the thromboembolic risk in patients with a NS and to follow its evolution during prophylactic anticoagulation and after remission of NS.

Thrombin generation test will be performed prospectively in nephrotic patients with various diseases (Minimal Change Disease (MCD), Malignant Nephrosclerosis (MN), Focal Segmental GlomeruloSclerosis (FSGS), diabetic glomerulopathy...) at diagnosis, during anticoagulant treatment (D8±3) and after disease remission (M6).

Eligibility Criteria:
Inclusion Criteria:

* Nephrotic syndrome
* Known cause of nephrotic syndrome (renal biopsy and/or positive anti-PLA2R)

Exclusion Criteria:

- Active anticoagulation treatment before TGT
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to treat viral infections that may happen after solid organ transplant (SOT). VSTs are cells specially designed to fight viral infections that may happen after a solid organ transplant. These cells are created from a blood sample collected from the study participant.

Solid organ transplant and the use of immunosuppressive medications reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Reduction of immunosuppression may put the organ at risk of rejection. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections and minimize complications.


Eligibility Criteria:
Inclusion Criteria:

* Blood adenovirus PCR ≥1,000
* Blood CMV PCR ≥ 500
* Blood EBV PCR ≥ 1,000
* Plasma BKV PCR \>1,000
* Plasma JC Virus PCR \> 1,000
* Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
* Evidence of invasive CMV infection, e.g. pneumonitis, retinitis, colitis.
* Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.
* Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy
* Evidence of PML or other CNS infection due to JC virus
* Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent, or a clinically acceptable steroid dose at the discretion of the PI
* Age \> 1 day
* Must be able to receive VST infusion in Cincinnati

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer

The goal of this observational study is to evaluate the role of the USTC diagnostic model in risk-adaptive strategies for biopsy decision-making in patients with low-risk suspected prostate cancer in order to reduce unnecessary biopsy. Based on the USTC diagnostic model (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) and serum PSA levels, patients with low-risk suspected prostate cancer are enrolled and received active surveillance rather than biopsy. The main questions to be answered is:

• The safety and feasibility of conducting biopsy-free active monitoring in patients with low-risk suspected prostate cancer accessed by the USTC diagnostic model and serum PSA levels.

Participants will be required to undergo serum PSA testing every 3 months, mpMRI testing every 6 months, and reassessment of the probability of developing prostate cancer using the USTC model every 3 months. Patients who do not meet the inclusion criteria and are at increased risk will no longer receive active surveillance and will be advised to undergo biopsy. Dynamic changes in PI-RADS score and biopsy results will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinically suspected PCa have indications for prostate biopsy;
2. Complete serum PSA testing and mpMRI examination in the outpatient department;
3. 4 ng/ml ≤ serum total PSA ≤10 ng/ml;
4. The probability of prostate cancer calculated by USTC diagnostic models is less than 0.05;
5. There is no family history of prostate cancer and no history of other malignant tumors.

Exclusion Criteria:

1. The patient has previous history of prostate biopsy;
2. Lack of complete clinical information, such as failure to perform mpMRI;
3. Patients with serum total PSA \< 4ng/ml or \> 10ng/ml.
4. According to USTC diagnostic model, the probability of prostate cancer is equal or more than 0.05.
Three-dimensional Assessment of Craniofacial Structures

The goal of this project is to reduce the radiation exposure in orthodontic patients by the use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital dental models, three-dimensional photograph) The first step in this process is to develop and validate an orthodontic analysis able to assess craniofacial proportions, dental, skeletal, and facial soft tissue. The investigators working hypothesis is that data from three-dimensional facial photographs and from digital dental casts can be registered accurately and consistently, and the diagnostic information about tooth position and facial soft-tissue derived from them are comparable to x-ray derived data


Eligibility Criteria:
Inclusion Criteria:

* Full permanent dentition
* Complete set of digital orthodontic records
* Must be able to follow directions

Exclusion Criteria:

* Incomplete orthodontic records
Psychopathology of Dissociative Disorders

The goal of the project is to investigate the prevalence of dissociative disorders in psychiatric inpatients in Taiwan. Relevant clinical issues, including common psychiatric comorbidity (e.g., positive psychotic symptoms), associated psychosocial factors (e.g., negative life events, perceived parenting style), and neuro-cognitive underpinning (e.g., executive functions) were also targeted. Standardized interview schedules, self-report scales, and cognitive tasks will be applied. The investigators hypothesized that dissociative disorders would be associated with positive psychotic symptoms, a history of early interpersonal adversity, and enhanced executive functions.

Though formally included in the Diagnostic and Statistic Manual of Mental Disorders since 1980, dissociation had once been considered as a rare psychiatric disturbance. With standardized structured interview, however, recent empirical studies showed that in average 9 percent of participants in general population, 10 percent in psychiatric outpatients, and 15 percent in psychiatric inpatients receive the diagnosis of a dissociative disorder. In Taiwan few attempts have been made for systematic investigation of dissociative disorders. Little has been known about the characteristics, prevalence, and associated features of Taiwanese patients with a dissociative disorder. The goal of the project is to investigate the prevalence of dissociative disorders in psychiatric inpatients in Taiwan. Relevant clinical issues, including common psychiatric comorbidity (e.g., positive psychotic symptoms), associated psychosocial factors (e.g., negative life events, perceived parenting style), and neuro-cognitive underpinning (e.g., executive functions) were also targeted. Standardized interview schedules, self-report scales, and cognitive tasks will be applied and the assessment will be held by the licensed clinical psychologist who receive training on the assessment and treatment of dissociative disorders. The results may enhance the understanding about the clinical features of dissociative disorders in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* being stable and appropriate for interviews

Exclusion Criteria:

* with organic syndromes
* mentally retarded (FIQ \<80)
* cannot communicate in Mandarin Chinese