cyrilzakka/clinical-trials huggingface dataset:
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial


Eligibility Criteria:
Inclusion Criteria:

* GMFCS level III, IV, V of the Cerebral palsy
* 20-45 degree of Cobb's angle

Exclusion Criteria:

* less than 20 degree or more than 45 degree of Cobb's angle
* Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
* Acute lumbar pain
* Fixed scoliosis
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension

Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* msDBP ≥ 90 mmHg and \< 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201)
* msDBP ≥ 95 mmHg and \< 110 mmHg at Visit 3 (Day 1 / randomization).
* All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* Previous or current diagnosis of heart failure (NYHA Class II-IV).
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
* History of malignancy within 5 years
* History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

Cataract surgery will be performed in subjects who have signed an informed consent form. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation
* Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
* Preoperative pupil dilation in mydriasis ≥ 6.5 mm

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Recurrent intraocular inflammation of unknown etiology
* Uncontrolled glaucoma
* Uncontrolled systemic or ocular disease
* Blind fellow eye
* Microphthalmus
* Corneal abnormality
* History of uveitis/iritis
* Iris neovascularization
* Pseudoexfoliation
* Proliferative diabetic retinopathy
* Pregnancy
* Lactation
* Females of childbearing age: not included
Chest Pain Observation Unit Risk Reduction Trial

The purpose of this study is to determine whether a brief counseling intervention initiated in the chest pain observation unit has a significant impact upon the health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking) of emergency department patients.

Increasingly, emergency department patients for whom a non-ischemic etiology of acute coronary syndrome (ACS) symptoms cannot be identified undergo further evaluation to rule out myocardial ischemia and appraisal of cardiovascular risk factors (CRFs) in chest pain observation units (CPOUs). CPOU admission may represent a "teachable moment," but there has been little research on the effectiveness of brief, practical interventions for cardiovascular risk reduction in this population, despite the fact that the vast majority of these patients have at least one modifiable CRF and many do not receive regular primary care follow-up. The purpose of this study is to determine whether a brief counseling intervention initiated in the CPOU has a significant impact upon health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking). Based on the Health Belief Model (HBM), the intervention is designed to provide patients with tailored information on their cardiovascular risk, to negotiate goals for change, and to build problem-solving skills. All participants who are admitted to the CPOU for evaluation of ACS symptoms will be randomized to brief intervention (face-to-face counseling in the CPOU, coupled with telephone counseling at 4 weeks) or to minimal intervention (booklet with general information on CRFs) after a negative initial troponin measurement. We will conduct a baseline survey and follow-up telephone interviews at 2- and 6-month to assess stage of change and CRF-related behaviors. Linear mixed models and logistic regression (with generalized estimating equations) will be used to compare continuous and dichotomous behavioral outcomes across treatment arms, respectively. The proposed trial will evaluate the feasibility and effectiveness of delivering brief interventions for cardiovascular risk reduction in the CPOU setting, will provide insight into mechanisms of behavior change in these patients, and will guide the development of future case management interventions.

Eligibility Criteria:
Inclusion Criteria:

* At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity)

Exclusion Criteria:

* Patients who "rule-in" for myocardial ischemia at initial testing
* Terminally ill (expected to survive less than 3 months)
* Unavailable for 6-month follow-up
* Cannot be contacted by telephone
* Institutionalized persons (prisoners, nursing home residents)
* Unable to provide informed consent (impaired mental status, unable to speak English)
Nicotinic Agonist Effects on BMI and Neuronal Response

Obesity is a serious and growing health problem in the United States. Obesity is associated with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased quality of life and increased mortality. Given the health and quality-of-life effects of obesity, developing effective treatments clearly is an important goal.

This study plans to learn more about the effects of an investigational new drug (DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to affect appetite, the investigators are interested in studying effects of the study drug, which has some similarities to nicotine, on how your brain responds to such things as pictures of food. The study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese (BMI \> 27)
* Between 21-65 years old

Exclusion Criteria:

* Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension
* Women capable of conception (must be post-menopausal, surgically sterilized, or have adhered to an anti-contraception birth control regimen for at least 1 year)
* Nicotine use
* Significant endocrine/metabolic disease
* Kidney disease
* Neurological illness
* Liver disease
* Medication use affecting appetite and/or metabolism
* MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
Complex Decongestive Applications in Patients With Lipedema

Lipedema is a rare condition which almost exclusively affects women. The disease is characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is often mistaken for simple obesity. In most patients, the hips, buttocks, thighs, knees, and lower legs are affected. Upper extremity involvement has been reported to be present in 80% patients. The hands and feet are never affected. The accumulation of subcutaneous fat and edema results in tenderness, sensitivity to touch and pressure and also pain. Patients also tend to bruise easily even after a minimal trauma. It has been reported that the complaint of pain increases with aging.There is no known cure for lipedema. However, conservative treatment with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy is used worldwide as a standard treatment regimen . The aim of this study is to investigate the effect of complex decongestive applications on lower extremity limb circumference and volume in patients with lipedema.

All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy Each patient received;

1. 45 minutes of manual lymph drainage on both lower extremities,
2. Moisturisation of the lower extremities,
3. Bandage application

Alongside this routine, the patients were advised to exercise (walk) regularly every day.

This treatment routine was continued until the patients were discharged from the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Being willing to participate in the study
* Being 18-65 years old
* Having a diagnosis of lower extremity lipedema

Exclusion Criteria:

- Having edematous disease in the lower extremity such as lymphedema or chronic venous insufficiency
Explore the Association Between Neuropsychological Functions and ADHD Diagnosis and Comorbid Using Longitudinal Study in Preschool Children

The current study using the longitudinal study in preschool children to exam three study issues: 1) using the neuropsychological functions (ie. Behavioral inhibition, delay aversion, the variability of reaction time) among the preschool children predict the ADHD diagnosis and behavior symptoms in 1.5 years later. 2) using the behavior inhibition, delay aversion and the variability of reaction time (using the parameter among Gaussian distribution and ex-Gaussian distribution) explore the association between attention and motor inhibition problems. 3) explore the transaction effect between the neuropsychological functions and family function and parenting to predict ADHD comorbidity with oppositional defiant disorder.4) explore the association between the internalizing/ externalizing problems of ADHD and temperament. The current study has opportunity to describe and to answer the complicated problems for heterogeneous neuropsychological deficits in ADHD, and to elucidate the core issues for ADHD have comorbid with ODD. The most important contribution is to offer the empirical evidence to make a clean suggestion in ADHD diagnosis and intervention in preschool age.

The current study would follow the same participants for 1.5 years, time 1 is around 4-5 years old, and time 2 is around 6-7 years old.

Participants:

* 100 typical developmental control
* 120 ADHD high risk preschool children at time 1

The diagnosis at time 2 to have three groups in this study:

* ADHD persistent
* ADHD remission
* typical developmental control

The measurements were included

* the different neuropsychological test (ie. behavioral inhibition, delay aversion, and vigilance task)
* the ADHD behavioral rating scales and diagnosis interview
* the scaling for family function and parenting
* intellectual assessment

This study could offer the suggestion for the further intervention in ADHD.

Eligibility Criteria:
Inclusion Criteria:

1. Control group

   * The subjects without ADHD.
   * Ages range from 4 to 5
   * Full scale IQ ≥ 80
   * The subjects who and whose parents consent to this study.
2. ADHD high risk group

   * Patients who have clinically diagnosis of DSM-IV ADHD confirmed by the Psychiatrists or have the risk of becoming ADHD confirmed by the ADHD behavioral rating scales.
   * Ages range from 4 to 5
   * Full scale IQ ≥ 80
   * Patients who and whose parents consent to this study.

Exclusion Criteria:

* Mental Retardation
* Schizophrenia, Schizoaffective Disorder
* Mood Disorders
* Organic Psychosis
* Learning Disorder
* Pervasive Developmental Disorder
* The subjects of control group if have a history of the following condition as defined by DSM-IV: ADHD in addition to the above exclusion criteria will be excluded.
Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

The hypothesis is that in acute exacerbated Chronic Obstructive Pulmonary Disease (AECOPD), personalized variable dose glucocorticoid treatment will result in superior clinical outcome when compared to fixed dose therapy.

Treatment with glucocorticoid for acute exacerbations of COPD results in the improvement of clinical outcomes. However, the optimal doses of glucocorticoid for each individual patient has not been determined. According to GOLD Report 2014, a dose of 40 mg prednisone per day for 5 days is recommended (Evidence B), although there are insufficient data to provide firm conclusions concerning the optimal duration of corticosteroid therapy of acute exacerbations of COPD. The purpose of the current study is to compare clinical outcomes of personalized or fixed dose of glucocorticoid in patients with acute exacerbations of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Exacerbation of COPD as defined by the presence of at least 2 of the following: change in baseline dyspnea, cough, or sputum quantity or purulence.

Exclusion Criteria:

* Signs of severe exacerbation (arterial pH \< 7.26 or PaCO2 \> 9.3 kPa)
* History of asthma
* Significant or unstable co-morbidity
* Participated in another study 4 weeks before admission
* Previously randomized to this study
* Known hypersensitivity to prednisolone
* Inability to give written informed consent
* Radiological diagnosis of pneumonia
* Estimated survival of less than 6 months due to severe comorbidity
* Use of glucocorticoid within 1 month before admission
Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

This study evaluate the effect of radical prostatectomy on involuntary pelvic floor muscle contraction

Radical prostatectomy may cause stress urinary incontinence (SUI). That poses problem in terms of quality of life. There are many treatment options available for patients with SUI, but the exact mechanism is not known. We compared, in continent and incontinent men post-radical prostatectomy, the correlation between the temporal course of pelvic floor activation during cough.

Simultaneously, recordings of electromyographic activity of external anal sphincter (EAS EMG) and external intercostal muscle (EIC EMG) during coughing will be made with a pair of pre-gelled electrodes. Cough effort cause an involuntary pelvic contraction. Intercostals muscles recording was chosen because they are one of the muscular components of cough initiation with diaphragm muscle. 24h pad-weighing test is used to quantify urinary incontinence. We will measure the latency between the onset of the EIC EMG and the EAS EMG (RT3), during a cough effort. We will also measure the duration of the contraction, the maximum EAS EMG activity and the area under the curve.

Eligibility Criteria:
Inclusion Criteria:

* Follow in neuro-urology for lower urinary tract symptoms
* Radical Prostatectomy

Exclusion Criteria:

* Perineal Radiotherapy
* Surgery for stress urinary incontinence
Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction

Hypothesis:

Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels \>15 g/dl in patients with ST-segment elevation myocardial infarction (STEMI)

Design:

Prospective, open label single center pilot study

This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform representative statistics of expected Hb kinetics in response to Mircera®.

Eligibility Criteria:
Inclusion Criteria:

* Patients (age 18 - 80 years) with acute STEMI undergoing PCI

Main Exclusion Criteria:

* Hemoglobin levels \>15g/dL
* history of a myeloproliferative syndrome
* thrombolysis for index infarction
* anticipated additional revascularization within 3 months
* cardiogenic shock
Power of Liquid Biopsy Tracking in Immunotherapy Treated Stage IV Melanoma

The advent of immune ICI has remarkably improved survival in advanced melanoma patients in the last decade. Long term responders following 2 years of treatment with immunotherapy go on to surveillance with frequent radiological imaging every 3-6 months up to 5-10 years. This not only exposes patients with a relatively low risk of recurrence to significant amounts of ionising radiation, but also increases the burden and cost on already stretched radiology departments. Therefore, this study aims to assess the feasibility and patient experience of using ctDNA with minimally invasive liquid biopsy assays as a biomarker for detecting disease relapse or progression at the point of radiological progression. Data from this pilot study will help to design a future validation study for establishing optimal liquid biopsy for surveillance in advanced melanoma patients.

This prospective study will measure ctDNA in a simple plasma sample and using a dried blood spot assay, collected at the time of radiological disease progression. We will investigate the use of tumour informed and tumour naïve approaches, assessing targeted sequencing, copy number variations using whole genome low depth sequencing, fragmentomics and methylation as potential methods to improve molecular recurrence detection. We will also collect urine samples to investigate the use of cfDNA to detect relapse in the brain, which has been noted to be more challenging to detect using ctDNA in the blood than other sites of relapse.

In addition, we will investigate the use of novel immunophenotyping technology through a collaboration with MelioHealth (IMU) in the same setting. The IMU platform combines high resolution cellular analysis and machine learning to enable high-content, high-throughput and real-time cellular immunophenotyping from less than 2ml of whole blood. We hypothesize that disease relapse following immunotherapy may detectably trigger a patient's immune system memory, which may be particularly important for those patients who do not shed ctDNA.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven melanoma
* Unresectable stage III or stage IV disease, with confirmed radiological disease progression within 1 month of recruitment
* Patient has received at least 1 cycle of immunotherapy with checkpoint inhibitors for melanoma
* Undergoing standard of care active treatment with regular interval imaging or routine imaging surveillance following treatment completion/cessation
* Age over 16
* Not previously diagnosed with HIV, Hepatitis B or C (does not need testing)

Exclusion Criteria:

* Not on routine surveillance with interval imaging per standard of care
* Unable to provide informed consent due to psychological, medical or cognitive conditions.
* Unable to comply with schedule of study samples to be collected. Concurrent active malignancies needing treatment
Rezafungin Pharmacokinetics in Patients on ECMO

Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum echinocandin, Rezafungin, in critically ill patients receiving ECMO

This is a prospective, open-label, Phase 1b, pharmacokinetic study of Rezafungin in 8 critically ill patients receiving ECMO support at Hartford Hospital. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive other antibiotics as necessary to treat any current infection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Receiving venovenous or venoarterial ECMO support.

Exclusion Criteria:

* Females who are pregnant or breast-feeding
* History of any moderate or severe hypersensitivity or allergic reaction to any echinocandin antifungal
* Receiving rezafungin to treat documented or suspected infection within 14 days of screening, or expected to receive rezafungin during the study intervention phase
* Receiving or likely to require intermittent hemodialysis
* A hemoglobin less than 7.2 gm/dl at baseline
* Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal
* Patients expected to have ECMO discontinued within the next 24 hours
* Any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
* Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls

The investigator hypothesize that low-dose MDMA (3,4-methylenedioxymethamphetamine) will produce a sufficiently strong oxytocin stimulation in healthy controls and no relevant increase in patients. This study will confirm previously published data and provide important safety data with low-dose MDMA stimulation testing.


Eligibility Criteria:
Inclusion criteria patients:

1. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency

Inclusion criteria healthy controls:

1. Adult healthy controls
2. Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
3. No medication, except hormonal contraception

Exclusion Criteria:

1. Participation in a trial with investigational drugs within 30 days
2. Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months
3. Consumption of alcoholic beverages \>15 drinks/week
4. Tobacco smoking \>10 cigarettes/day
5. Cardiovascular disease (coronary artery disease, heart failure Left ventricular ejection fraction \<40%, stroke in the last 3 months, atrial fibrillation/flatter, Wolff-Parkinson-White-Syndrome)
6. Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (\<85mmHg)
7. Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
8. Psychotic disorder in first-degree relatives
9. Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase inhibitors
10. Pregnancy and breastfeeding
11. Diagnosed Chronic Kidney Disease \> grade III (glomerular filtration rate \< 30ml/min)
12. Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range