cyrilzakka/clinical-trials huggingface dataset:
Effect of Tele-exercise on Cardiorespiratory Fitness in Paediatrics

The goal of this clinical trial is to learn if telemedicine exercise programme can improve the cardiorespiratory fitness (how well your body delivers oxygen to muscles and organs) and insulin resistance in Asian children with low cardiorespiratory fitness levels. The main questions it aims to answers are:

* Does telemedicine exercise programme improve the number of 20-metre laps the participant is able to run?
* Does telemedicine exercise programme improve the insulin sensitivity using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) formula?

Researchers will compare the telemedicine exercise programme to current active lifestyle programme (e.g., daily step count monitoring) to see if telemedicine exercise programme is more effective in improving cardiorespiratory fitness.

Participants will:

* participate in weekly telemedicine exercise programme or adhere to current active lifestyle recommendations through daily step count reporting for 10 weeks
* visit the clinic for pre- and post-programme cardiorespiratory fitness assessments and blood taking

This study is to investigate the effectiveness of delivering exercise intervention programme to improve cardiorespiratory fitness through telemedicine for paediatric patients with low cardiorespiratory fitness levels. Conventionally, exercise programme for these patients are conducted within hospital premises. However, some challenges may deter patients from enrolling into these programmes, such as long travelling distance, lack of available caregiver and unsuitable timings. Understanding the impact of a shorter-term programme (i.e., 10-week programme) on cardiorespiratory fitness and glucose metabolism also allows us to customise programmes of appropriate length to deliver the require health impact instead of subjecting all patients to a lengthy programme. Therefore, evaluating the effectiveness of telemedicine-based exercise programme will enable us to fine-tune our programme and provide an alternative mode of exercise intervention so as to cater for a wider range of paediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 17 years (secondary school students)
* able to participate in school physical education lessons

Exclusion Criteria:

* less than 12 years or older than 17 years (non-secondary school students)
* has medical or musculoskeletal condition(s) preventing participation in school physical education lessons or exercise
INTO-HLH: A Disease Registry for Patients With Hemophagocytic Lymphohistiocytosis (HLH)

The purpose of this observational study is to collect data on the natural history of disease of patients with Hemophagocytic Lymphohistiocytosis (HLH) including diagnosis, treatments, responses, and outcomes.

Hemophagocytic Lymphohistiocytosis (HLH) is a complex, hyperinflammatory syndrome resulting from the interplay of genetic predisposition and various environmental factors. Despite available treatment options for HLH, approximately 30% of patients do not respond to therapy. Moreover, the standard therapy is constrained by its toxicities, and safer treatments are pursued.

There is an unmet need for a deeper understanding of the natural history, clinical/etiologic diversity, complications, and treatment outcomes of patients with HLH, specifically from North America. The proposed study, a collaboration between Cincinnati Children's Hospital Medical Center (CCHMC), Texas Children's Hospital, and Sobi Inc. aims to establish a robust registry that will enable investigators to better define the natural history of HLH.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically suspected or confirmed HLH, including those meeting the HLH-2004 diagnostic criteria (primary or secondary forms, including malignancy) and other forms of HLH (macrophage activation syndrome \[MAS\], cytokine release syndrome \[CRS\], etc.)
* Signed and dated informed consent and assent (adolescents)

Exclusion Criteria:

* None
Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients with serological evidence of Chagas infection and positive PCR real time

Exclusion Criteria:

-
Prevalence of Latent Tuberculosis (TB) Infection Diagnosed by Interferon-gamma Release Assay and Tuberculin Skin Tests in Patients With Old Healed TB

We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma release assay and tuberculin skin tests in patients with old healed TB.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years
* Patients with TB sequelae in their CXR

Exclusion Criteria:

* Patients on immune-suppressants
Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men

The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 45 years;
* In urinary retention and catheterized (indwelling or intermittent) for less than 180 days;
* Documented diagnostic history (within 180 days of study) of detrusor contractility (\>= 15 cmH2O) confirmed via pressure-flow test;
* Negative Urinalysis on Visit 1;
* Not a candidate for pharmacologic, minimally invasive or surgical treatment of the prostate;
* Charlson Weighted Index of Comorbidity Score \>= 1;
* Willing and able to sign the Informed Consent Form;
* Willing and able to complete the follow-up protocol requirements;
* Experiencing catheter-induced discomfort.

Exclusion Criteria:

* Current use of a urinary catheter daily for greater than 180 consecutive days immediately preceding entering into the study;
* Positive Urinalysis on Visit 1;
* Current or recent (within the last 6 months) urinary tract disease including urethral stricture, bladder stones, and other significant urological conditions or surgery;
* Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affect the function of the lower urinary tract;
* History of conditions associated with neurogenic bladder, including spinal cord injury, multiple sclerosis, or Parkinson's disease;
* Use of anticholinergic medication;
* Gross hematuria when catheter is removed on Visit 1;
* Known or suspected prostate cancer;
* Prior pelvic irradiation therapy;
* Prostatic urethral length \< 4 cm or \> 9 cm (combined length from the top proximal side of the bladder neck to the bottom distal side of the external sphincter);
* Intravesical enlargement of the median lobe of the prostate.
Prediction of Sepsis After Percutaneous Nephrolithotomy

We aim to determine the preoperative predictors of sepsis after percutaneous nephrolithotomy (PCNL) in patients with unilateral, solitary and proximal ureteral stones.


Eligibility Criteria:
Inclusion Criteria:

* (1) PCNL was performed to treat unilateral, solitary, and proximal ureteral stones; and (2) age ≥18 years

Exclusion Criteria:

* anatomical renal abnormalities (horseshoe kidney, solitary kidney, transplant kidney and kidney duplication)
Integrating Reminiscence Technology Into Exercise Programs in Subacute Care

This study evaluates the feasibility of a randomized controlled trial to evaluate the impact of motivating reminiscence-based therapy on exercise adherence, mood and physical health within a subacute rehabilitation population. The jDome BikeAround technology displays user-specified Google Earth images onto a domed screen as the user pedals on a stationary bike, which fosters the experience of bicycling through that given environment. Participants will use the technology for 12 weeks during their regularly scheduled therapy sessions.

Adherence to physical activity in older adults and those in a low-intensity rehabilitation program is important with respect to achieving the demonstrated benefits in mobility, physical function and overall health maintenance. Physical activities that incorporate motivational strategies can improve long-term adherence to therapy programs. The jDome BikeAround technology is one example, as it involves reminiscence therapy coupled with stationary bicycling. Participant's are able to visit any familiar locations or places they have wished to visit, thus providing a positive and interactive experience as they engage in physical activity.

Participants will be enrolled for a total of 12 weeks. They will have three 10 minute weekly sessions with the jDome BikeAround during their regularly scheduled therapy sessions. Feasibility will be evaluated by participant recruitment, program completion, rate of adverse events and staff acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the LIR (Low-intensity rehabilitation) or CMP (complex medical program) unit/floor where the research study is being conducted. Of note, both units receive low intensity rehabilitation services at baseline.
* Participants capable of providing informed consent or have a SDM capable of providing consent on their behalf
* Sufficient visual abilities to observe images on the domed screen
* Able to comprehend and communicate in English or French
* Minimum height requirement of 5'2" or 157cm in order to successfully fit the BikeAround system's stationary bike.

Exclusion Criteria:

* Physical limitations (as determined by the SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround. This includes:
* 1) Inability to coordinate/move lower limbs effectively to complete pedaling task
* 2) The pedaling exercise causes discomfort/pain greater than expected with physical activity
* 3) Medical treatment prevents usage of the system (i.e. continuous ventilatory needs for patients admitted within the CMP unit)
* Cognitive impairment (as determined by the SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround, such as:
* 1) Inability to sustain attention to focus on pedaling task
* 2) Inability to follow one-step commands.
* Known behavioral abnormalities (e.g. overly aggressive behavior) that in the opinion of the clinical care team might impede any meaningful participation in the project
* Those who are in the opinion of, the attending physician or clinical team, too unwell to participate in the project
Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation

The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
* ≥2 Symptomatic atrial fibrillation episodes
* At least 1 paroxysmal atrial fibrillation episode documented by an ECG or device recording system in the 6 months prior to enrollment AND
* At least 1 additional (for a total of ≥2) paroxysmal atrial fibrillation episode documented by an ECG or device recording system, OR, at a minimum, a physician's note indicating recurrent symptomatic atrial fibrillation
* No episode \>7 days
* Failed to respond to or is intolerant of ≥1 Class I, II, III or IV antiarrhythmic drug
* Able and willing to provide informed consent and Health Insurance Privacy and Portability Act (HIPAA) authorization
* Able and willing to meet all study requirements, including attending all post-ablation procedure assessments and visits

Exclusion Criteria:

* Left atrium ≥50 mm
* Chronically used amiodarone in the 3 months prior to enrollment
* Previous left atrial ablation or surgical treatment for atrial fibrillation
* Left ventricular ejection fraction (LVEF) \<35 %
* New York Heart Association (NYHA) Class III or IV heart failure
* History of myocardial infarction (MI) or unstable angina in the 6 months prior to enrollment
* Multiple other exclusion criteria to establish overall good health and likely study compliance
Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients

Pegylated liposomal doxorubicin (PLD) was an anthracycline nanomedicine to be approved for advanced breast cancer and other solid tumor therapy and showed a good disease control rate (57%). PLD could induce hypersensitivity reaction (HSR). There are about 9-25% patients got infusion reaction or HSR. Severe HSR could lead to allergic shock even presyncope or threat to life. To our knowledge, there were no sensitivity biomarker to predict the PLD induced HSR. And the mechanism of PLD induced HSR is unknown yet. Therefore, to analyze and discuss the biomarkers and mechanism of PLD induced HSR in advanced breast cancer, we design this prospective, observational, biomarker study.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old; Breast cancer confirmed with histological or molecular diagnosis; Advanced breast cancer diagnosis according to American Joint Committee on cancer eighth edition cancer staging manual; Treatment with liposomal doxorubicin; No pregnancy plan and voluntary use of effective contraceptive measures during treatment

Exclusion Criteria:

* Subjects who discontinued treatment due to previous severe adverse reactions to liposomal doxorubicin or doxorubicin; poor compliance.
Medicinal Plant Use for Treating Inflammation Among Dominicans in New York City and the Dominican Republic

The purpose of this study is to investigate and compare the use of herbal medicine among Dominicans in New York City and the Dominican Republic.

According to the 2000 U.S. Census Report, Dominicans constitute the largest Hispanic immigrant group in New York City. Studies have shown that immigrants' use of traditional and herbal medicine is close to that of native-born Americans. However, minority immigrants often have limited access to traditional health care; as a result, they may be more likely to consult with traditional healers and use medicinal plants than nonimmigrants. This study is designed to increase knowledge about immigrants' health and to contribute to more culturally-sensitive health care. The purpose of this study is to determine medical plant knowledge and use among Dominican traditional healers and patients in New York City and in the Dominican Republic.

This study will comprise two parts. In Part I, Dominican medicinal plant users and Dominican traditional healers in New York City will be questioned about the medicinal plant species they know and how they are used for prevalent illnesses. The same number of participants will be interviewed in the Dominican Republic, allowing for detailed comparisons between the two study sites.

In Part II, the most frequently-cited medicinal plant species will be subjected to a thorough literature review on their pharmacologic activity and the chemical composition of their active constituents. Two in vitro assays will be used to measure the anti-inflammatory activity of certain plant extracts, and their anti-inflammatory compounds will be isolated and characterized for the purpose of standardization of active extracts. On the basis of these results, recommendations will be formulated for future studies and community use of selected medicinal plant species.

Eligibility Criteria:
Inclusion Criteria:

* Dominican ethnicity
* Have knowledge of Dominican medicinal plants
Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to achieve "optimal surgical space condition".

this difference in the pressure of intra-abdominal CO2 insufflation due to different strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in patient's respiratory pattern and cerebral oxygenation. Although previous study (studies) showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and cerebral oxygenation, so far.

The present study determines and compares the changes CO2 absorption and cerebral oxygenation (cerebral perfusion) after applying CO2 insufflation with different intra-peritoneal pressure 8 vs 12 mmHg during deep-NMB.


Eligibility Criteria:
Inclusion Criteria:

* cholecystitis
* provision of written informed consent

Exclusion Criteria:

* COPD
* asthma
* low LV ejection fraction
A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged ≥18 to ≤75
* Body mass index (BMI) ≤ 40 kg/m2
* Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
* Serum triglyceride levels at screening \< 400mg/dL (\< 4.52 mmol/L)

Exclusion Criteria:

* Any significant acute medical illness, significant cardiovascular history
* Current or history of hepatic or hepatobiliary disease
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema

To show efficacy of Zarzenda in the treatment of hand eczema

The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate hand eczema for at least 3 months
* At least 4 weeks have passed since use of systemic treatment for eczema
* At least 4 weeks have passed since any vaccination
* At least 1 week has passed since last topic treatment on hands with corticosteroids
* Agree to use adequate contraceptive method if of childbearing potential
* Willingness to avoid excessive exposure to sunlight and avoid skin irritants

Exclusion Criteria:

* Pregnancy, breast feeding
* Severe excoriations on the hands
* Need for systemic treatment for atopic dermatitis
* Known sensitivity to Zarzenda and/or to extract of nut butyrospermum parkii (shea)
* Known immune deficiency
* Concomitant infection on hands
Defining the Intestinal Microbiota in Premature Neonates

The investigators will collect daily faecal samples from premature (\<32 weeks) infants in the intensive care unit from the day of birth until they are discharged. By using newly developed molecular detection techniques the investigators aim to define more precisely than has ever previously been attempted, all the species of bacteria present in the faeces. This will enable comparison of the pre-morbid and post-morbid intestinal microbiota (all the bacteria in the gut) in premature neonates.

Highly premature infants are susceptible to serious infections such as necrotizing enterocolitis (NEC) and late-onset blood stream infections (BSIs).

NEC is a poorly understood, potentially life-threatening bowel disorder. It is thought that bacteria proliferating abnormally in the bowel may play an important part in its cause, but no single pathogen has yet been identified.

BSIs are commonly caused by gut bacteria. As the highly premature gut is fragile and has increased permeability, poor motility and decreased immune defences, localised inflammation caused by abnormal bacterial growth may allow 'bystander' microbes to translocate through the gut into the blood stream leading to systemic infection.

In a small proportion of infants who develop NEC, surgery will be required as part of treatment of the condition. In these infants the investigators will seek consent to collect a small part of the diseased bowel which has been removed. Similar analysis will be performed on these samples. The analysis of the tissue samples will give us an indication of how well the faeces act as a proxy for the intestinal microbiota.

In this ecological study of the evolution of the intestinal microbiota in preterm infants, by comparing samples from babies who develop NEC or late-onset BSI with those of well babies the investigators will be able to look for differences characteristic of the conditions. This information will help aid design of prevention or treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* All premature babies born at less than 32 completed weeks gestation who are admitted to an Imperial College NHS Healthcare Trust Neonatal Intensive Care Unit (St. Mary's Hospital or Queen Charlotte's \& Chelsea Hospital), and whose parents/guardians have given their consent will be eligible to enter the study.

Exclusion Criteria:

* All babies born at more than 32 completed weeks gestation will be excluded from the study.
Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
* Confirmed TTTS patients, who by definition meet the following sonographic criteria:

  * Single placenta.
  * Polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to amniodrainage.
  * Oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to amniodrainage.
  * Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic).
  * Same gender, if visible.
  * Quintero Stages 1-4.
* Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included.
* Patients with an anterior placenta may be included.
* Triplet gestations with two or three fetuses sharing the same placenta may be included.
* Patients must be able to give written informed consent.

Exclusion Criteria:

* Patients unable or unwilling to participate in the study or to be followed up.
* Patients unable to give written informed consent.
* Presence of major congenital anomalies that may not warrant surgery.
* Known unbalanced chromosomal complement.
* Prior intentional septostomy (purposely making a hole in the dividing membrane).
* Ruptured membranes.
* Chorioamnionitis.
* Abnormal intracranial ultrasound findings of either fetus to include, but not limited to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, Dandy-Walker syndrome, holoprosencephaly and agenesis of the corpus callosum. Isolated ventriculomegaly (atrium 10-19 mm) may or may not be used as exclusion criteria.
* Placental abruption.
* Active labor.
* Patient unwilling to receive blood products.
* Recipient twin with a middle cerebral artery peak systolic velocity \> 1.5 multiples of the median (indicative of fetal anemia).
* Any other patient deemed inappropriate for the study by the principal investigator.