cyrilzakka/clinical-trials huggingface dataset:
Effects of an Augmented Reality Exercise Program in Older Adults

This research aims to examine the effects of an augmented reality (AR) exercise program on physical fitness (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory).


Eligibility Criteria:
Inclusion Criteria:

* Participants of both genders
* 60 years or older
* Autonomous community-dwelling older adults

Exclusion Criteria:

* Neurological disorders
* Cognitive impairment
* Health limitations related to exercise participation
Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.


Eligibility Criteria:
Inclusion Criteria:

Subjects with ES (including those with Down Syndrome) having completed the double-blind AC-055-305 / MAESTRO study as scheduled, i.e., who remained in the double-blind study up to Week 16 (whether or not they were still taking study drug at the end of this period).

Exclusion Criteria:

Subjects who prematurely discontinue double-blind study drug during the AC-055-305 / MAESTRO study due to:

* an AE assessed as related to the use of study drug,
* or elevated liver tests (related or unrelated to study drug).
Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.

The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.

In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.

The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 years, either sex
* Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Allergies to anesthetic or analgesic medications
* Contraindication to the use of locoregional anesthesia
* Chronic opioid use
* Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
* Necessity of major resection other than colorectal, palliative surgery
* BMI above 35 kg/m2
* American Society of Anesthesiologists (ASA) physical status above 3
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men or women age ≥20 years old
* Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
* HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
* HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
* Past or current history of severe diabetic complications
* Fasting plasma glucose \> 270 mg/dL before treatment start
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients requiring insulin therapy
Perceptions and Prevalence of Workplace Violence in Healthcare

Workplace violence includes physical and verbal aggression as well as threatening behavior. All types of workplace violence incidents in health care are often under-reported, especially if there is no lasting physical injury.

Research reveals that healthcare workers are three times more likely to experience workplace violence than any other occupation. The first step toward reducing the occurrence of violence is to understand the perceptions and prevalence of workplace violence.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be employed full-time, part-time, or per diem

Exclusion Criteria:

* Inability to read English will cause a staff member to be excluded from the study, as the survey is written in English.
A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone

The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Iran is uncertain. This study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult Iranian population.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed active liver disease due to Hepatitis B virus.
* Patients must have adequate blood \& liver functions.
* Female patients of child-bearing potential must be non pregnant and willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
* Patients who have serious concurrent illnesses other than hepatitis B like cancer, severe heart disease, uncontrolled diabetes mellitus or AIDS will not be eligible.

Exclusion Criteria:

* Persons allergic to lamivudine or suffering from hepatitis C, D or E infection or taking alcohol will not be eligible.
Telemedicine for Sleep Apnea Patients

Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.

Eligibility Criteria:
Inclusion Criteria:

* AHI \> 30/hr
* hypersomnolence
* agreement for the use of CPAP
* internet and GSM connection

Exclusion Criteria:

* central apnea \>20%,
* pneumothorax,
* severe nasal obstruction,
* previous pharyngeal surgery,
* severe COPD,
* heart failure,
* previous use of CPAP,
* no social security coverage,
* unavailability,
* no GSM and internet network
Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer

Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and majority of them were intolerable to combined chemotherapy in China. In the investigators phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy and safety of the combination.


Eligibility Criteria:
Inclusion Criteria:

1. Having signed informed consent Age more than 69 years old
2. Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy;
3. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
4. Sex is not limited
5. Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
6. Karnofsky performance status ≥80
7. Life expectancy of ≥ 3 month
8. WBC \> 3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet \> 100,000/mm3, Hb \> 9g/dl(within 14 days before enrollment),ALT and AST \< 1.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.0 times ULN
9. No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
10. Normal ECG and heart function
11. Fertile patients must use effective contraception Good compliance

Exclusion Criteria:

1. Previous treatment of palliative chemotherapy
2. Known hypersensitivity to Paclitaxel,Cisplatin
3. Only with Brain or bone metastasis
4. No measurable lesions, eg. pleural fluid and ascites
5. Suffer from severe heart disease or disease with other important organs Chronic diarrhea or renal dysfunction
6. Other previous malignancy within 5 year, except non-melanoma skin cancer
7. Mentally abnormal or disable cognition,including CNS metastasis
Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.

Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might cause higher myocardial oxygen consumption. As a result, combination of vasopressor / inotrope is still controversial.

The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments strategies (norepinephrine dose increasing or addition of dobutamine) in patients with cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine treatment.

The secondary objectives were :

* To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
* To evaluate the tolerance of the treatments
* To evaluate the dose and the admistration's kinetics of the treatments


Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiac index (CI) \< 2,2 L/min/m² or CI \< 2,5 L/min/m² under vasopressor/inotropic treatment and organ hypoperfusion signs : mottles, capillary refill time , urine output \< 0,5 mL/kg/hour during at least one hour ou renal replacement therapy, consciouness impairment, pulmonary oedema, hyperlactatemia (\> 2 mmoL/L)
* Mean arterial pressure \> 65 mmHg under norepinephrine treatment
* Patients with social coverage

Exclusion Criteria:

* \< 18 years old
* Pregnancy
* Inclusion in other drug study
* Poisonings with cardiotoxicants
* Patient with intra-aortic ballon pump, extracorporeal life support
* Patient under guardianship
Head Position Angles in Children

Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Designing a ventilating device that could indicate how to open an upper airway correctly may be beneficial. The head of children is randomly placed in different head positions by one investigator. A ventilating mask is then pressed gently on the child's face followed by measurement of the head position angles and pulmonary function. This information could be utilised to optimise assisted ventilation of an unprotected upper airway in children.

Ventilation during basic life support improves survival in cardiac arrest patients significantly. Unfortunately, this is in contrast to the willingness of potential rescuers to perform mouth-to-mouth ventilation. For example, although healthcare professionals would perform mouth-to-mouth ventilation on a 4-year old drowned child in \>90% of cases, this likelihood would decrease to \~10% in the case of a young male unconscious patient in a San Francisco public bus. Possibly, lay rescuers would perform assisted ventilation more often if a simple ventilation device were available. However, both the willingness to perform assisted ventilation plus the ability to open and to maintain the airway patent are necessary to ensure efficient ventilation in an unconscious patient with an unprotected upper airway.

Since retention of skills after basic life support classes are notoriously low, a resuscitation tool should incorporate self-explanatory features to improve applicability, and to provide built-in safety. Thus, an option could be to ensure an open airway by the use of a built-in indicator within a ventilating device to confirm correct head extension. One possible approach may be to determine head positions that make an open airway likely, and then extrapolate these angles to a scale that could be integrated into a ventilating device; however, safe head extension needs to be determined first to prevent harm. The purpose of this study is to determine head position angles reflecting neutral position and maximal extension in unconscious supine children in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II children, 1-10 years of age

Exclusion Criteria:

* Facial deformity
* Pathological airway or cervical spine
* BMI\>35
* History of gastric reflux
Telehealth-Enhanced Asthma Care for Home After the Emergency Room

The investigators propose a randomized controlled trial of Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) vs. enhanced care (EC). TEACH-ER includes: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (Zoom) when possible, featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. The investigators will enroll 430 children (ages 3-12 yrs) from the two dedicated pediatric EDs in our region, and follow all participants for a 12-month period. The investigators will call caregivers to complete blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge. The investigators will assess the effectiveness of TEACH-ER in reducing the need for additional asthma-related ED visits or hospitalizations in the 1-months after enrollment. Additional outcomes of interest include asthma symptoms, medication adherence, absenteeism from work and school, quality of life, and the delivery of care consistent with national asthma care guidelines.


Eligibility Criteria:
Inclusion Criteria (all criteria must be met):

* Physician diagnosis of asthma, based on review of medical records and/or caregiver report.
* Current emergency visit for an acute asthma exacerbation, requiring treatment with rescue medication.
* Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following:

  1. \>2 days/wk with asthma symptoms in the past month,
  2. \>2 days/wk with rescue medication use in the past month,
  3. \>2 days/month with nighttime symptoms in the past month (vs. 1-2 nights per month if 3-4 years old), or
  4. ≥1 other episode of asthma during the past year that required systemic corticosteroids (vs. during the past 6 months if 3-4 years old).
* Child age between ≥3 and ≤12 years.
* Child and caregiver live in Monroe County, NY.

Exclusion Criteria:

* An inability to speak and understand English. Parents (and children) with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.
* No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible location). If a subject does not have access to an appropriate device for Zoom visits at home, we will provide a device with required data plan.
* Other significant medical conditions, including cystic fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
* Children in foster care or other situations in which consent cannot be obtained from a legal guardian.
Quality of Cardiopulmonary Resuscitation Without and With Defibrillator Feedback

Quality of bystander cardiopulmonary resuscitation (CPR) affect patient survival. Quality of professional CPR on patients has not been studied in detail, but it is regularly reported that the quality when tested on manikins deteriorates dramatically within months after training. Automated direct feedback on CPR quality from manikins brings quality back within a couple of minutes. Similar feedback has been incorporated into a defibrillator which also monitors quality of CPR. We hypothesise that quality of professional clinical CPR improves with such feedback

Defibrillators which monitor quality of CPR via changes in thoracic impedance (for ventilation) and movement of the sternum employing an accelerometer (for chest compressions) will be employed in ambulances in Akershus county (Norway), Stockholm (Sweden) and London (UK). During phase 1 quality of CPR will be monitored without feedback from the defibrillator. During phase 2 the ambulance personnel will receive feedback via the defibrillator. During phase 3 the ambulance personnel will be retrained with particular attention to the quality problems that became apparent in phase 3.

Quality of CPR will be continuously recorded by the defibrillators and the data collected and sent via internet to Laerdal Medical. All other cardiac arrest data including survival will be recorded using standard datasets for cardiac arrest research as developed by a task force with members from the organisations in International Liaison Committee on resuscitation (Utstein guidelines). The data will be annotated and analyzed in detail by researchers at University of Oslo

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest out-of-hospital

Exclusion Criteria:

* \< 18 years old
Continuation Treatment Protocol for Patients Who Participated in the Adagio TVP 1012/501 Clinical Trial

the purpose of the study is to extend the use of Rasagelin Mesylate 1mg per day by subjects who participated in the Adagio TVP 1012/501 according to form 4a for additional three years.


Eligibility Criteria:
Inclusion Criteria:

* subjects who are willing to contiue this treatment.
* subjects who took part in the TVP 1012/501 clinical trail.

Exclusion Criteria:

* subjects who didn't take part in the TVP 1012/501 clinical trail.
Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia

The objective of this clinical study is to evaluate the influence of the Great autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular system in patients with resistant hypertension. The primary endpoint is the change in mean blood pressure after 10 treatments .

In addition, data are collected on the immune system as well as for food and sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Resistant Hypertension \> 140 / \> 90mmHg
* Inclusion age : 45 +
* Regular monitoring of blood levels considered
* pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent
* Men and Women

Exclusion Criteria:

* derailed diabetes
* renal impairment , renal creatinine clear \<50 ml
* Non - austherapierte cancer / tumor patients
* Non - adjusted thyroid dysfunction
* BMI\> 35
* LVEF \<limit ( " 35% " )
* Peripheral AVK ( ABI - measurement ) \> Stage II
* regurgitation \> Stage I
* abdominal aneurysm
* infections
* acute febrile infections with temperature \> 38.5 ° C
* COPD and asthma to stage III
* dyspnea NYHA \> Stage III
* z.n. Stroke shorter than 12 weeks
* Acute liver failure
* Acute Apoplexy
* Severe poisoning
* drug addiction
* hyperthyroidism
* Hypotension
* hypocalcemia
* hypoglycemia
* ozone allergy
* pregnancy
* clotting problems ( hemophilia )
* pre-existing condition with hemoglobin \< 9mg/dl
* Fresh myocardial infarction
* Internal bleeding
* thrombocytopenia
* Acute alcohol
* Citrus allergy when using sodium citrate