cyrilzakka/clinical-trials huggingface dataset:
Pressure Support During Chest Wall Compression

The purpose of this study is to compare two physiotherapy techniques: chest wall compression versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.

1. After being placed in the supine position in bed, with head angle elevation at 30°, patients were randomized to:group 1 (G1): chest wall compression for ten minutes in chest or group 2 (G2): chest wall compression plus increase of 10 cmH2O in IP in PSV for ten minutes in chest.
2. Clinical variables and APACHE II were registered.
3. Parameters analyzed at the beginning (1) and at the end (2) of the protocol were: variation of peak pressure (ΔPp=Pp2-Pp1),variation of tidal volume (ΔVT =VT2-VT1), variation of dynamic compliance (ΔCdyn= Cdyn2-Cdyn1).
4. The amount of variation of mucus secretion aspirated (ΔSa= Sa2-Sa1) at the end was also measured

Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation over 48 hours
* With ventilatory drive
* Hemodynamically stable MAP\> 60 mmHg
* With treatment of respiratory therapy

Exclusion Criteria:

* Contra indication of increased positive inspiratory pressure
* Peak pressure in the upper airway \> 40 cmH2O
* Osteoporosis diagnosis
* Deny to participate in the study
The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.

This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Persistent AF;
3. nonresponse or intolerance to ≥1 antiarrhythmic drug. -

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease and/or prosthetic heart valve(s);
3. With myocardial infarction or stroke within 6 months of screening;
4. With Significant congenital heart disease;
5. Ejection fraction was \<40% measured by echocardiography;
6. Allergic to contrast media;
7. Contraindication to anticoagulation medications;
8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
10. Having any contraindication to right or left sided heart catheterization;
11. Previous atrial fibrillation ablation;
12. Presence of an implanted cardioverter-defibrillator;
13. Any cardiac surgery within the past 2 months;
14. Poor general health;
15. Life expectancy less than 6 months.
Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery.

Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.


Eligibility Criteria:
Inclusion Criteria:

* children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)
* children undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* refusal of blood products
* end-stage renal disease
* planned avoidance of CPB
* use of non- heparin anticoagulants
* participation in an experimental drug or device protocol within 30 days
* existing hemoglobinopathy
* allergy requiring washed RBCs
* immunocompromise requiring special blood product treatment.
Telehealth Home-monitoring for Frailty in Cardiac Surgery

Cardiac surgical interventions are increasingly offered to vulnerable patients or patients living with frailty. Unfortunately, frailty has been shown to be an independent predictor of poorer outcome and increased health care resources in terms of readmission to hospital or visit to the ER after discharge. We hypothesize that the use of a comprehensive Telehealth home-monitoring program could reduce emergency room visits and re-hospitalization after heart surgery.

Frailty in all patients will be determined using the Edmonton frailty scale (EFS) as is part of the current standard of care for all patients at the NBHC since 2018. We plan to implement the Telehealth intervention on all 120 consecutively enrolled patients identified as vulnerable and/or frail and discharged from hospital within 10 days of their surgery. The primary outcome of interest will be rates of ER visit and readmission to hospital within 30 days of discharge compared to propensity score matched historical control patients. A power calculation suggests that 120 patients per group are necessary explaining why the intervention group will be 120 patients. We chose to compare our intervention to a matched group of 240 individuals from historical data which already captures follows patients 30 days after surgery but is limited in its Telehealth intervention. Duration of the study is 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients, aged 55 years or older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement, mitral valve repair/replacement or combined CABG/valve procedures.
2. Patients defined as pre- vulnerable, vulnerable or frail based on the Edmonton frailty scale (\> 4 considered pre- vulnerable) as defined prior to surgery

Exclusion Criteria:

1. Medical reasons for exclusion

   1. Patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery
   2. Acute endocarditis who are at higher risk for adverse events
2. Dialysis dependent who are at higher risk for adverse events
3. Patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention
4. Patients who do not have any support or potential caregivers to help facilitate their transition home
5. Patients undergoing minimally invasive surgery which has been shown to enhance recovery
6. Patients unable to be discharged home within 10 days of their surgery. The average length of hospitalization is 5 days with frail patients often requiring additional time but usually within 10 days unless some major barrier exists in allowing discharge home.
7. Patients who are transferred to another hospital for recovery or care.
Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers

The present study will evaluate the safety in healthy people aged 1- 45 years (male and female) after single intramuscular (IM) dose of trivalent subunit inactivated influenza vaccine till the 30-days follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy people with aged 1 to 45 years;
2. Previous history of not being vaccinated by any flu vaccines;
3. Women of childbearing potential agree to apply the contraceptive measures during the study period;
4. Do not have any acute or chronic diseases by screening;
5. Having the abilities of understanding and conforming the study plan;
6. Volunteer to the study;
7. Agree to vaccinate completely and conform the follow up procedure within 30 days after the first vaccination.

Exclusion Criteria:

1. Having the suspected symptoms of infecting flu: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat;
2. A prior history of allergy to any components of candidate vaccine;
3. Sensitive to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80;
4. Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
5. Being immuno deficiency due to treatment;
6. Using immunosuppressive drugs (belong to steroid group) within 06 months before vaccination;
7. Being sickness or cancer or HIV (+);
8. Participating in other study on drug or vaccination;
9. Receipt of other vaccine within 04 weeks before participating in the study;
10. Congenital malformation, mental disorder or members of family having the mental disorder;
11. Using immune globulin or blood products within 03 months before vaccination;
12. Having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation;
13. Body temperature over 37.5 degree Celcius within 01 week before vaccination;
14. History of alcohol or drugs addicted within 05 years;
15. Planning to travel away from the study site among the visits.
Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* Clinically diagnosed CHC with detectable virus replication
* Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.

Exclusion Criteria:

* Any contraindications for peginterferon alfa-2a or ribavirin treatment
* Pregnant or breast-feeding
Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. The study is only to observe the patients before, during and after their usual treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Female between 20 and 50 years of age, inclusive, on the day of enrolment.
2. Has a BMI between 20 and 30 kg/m2.
3. Is to be treated in the posterior thigh / saddlebag area using the MC1.
4. Has never been treated with the MC1 before.
5. Females who are post menopausal or using a medically acceptable form of birth control prior to study enrollment and during the course of the study. (i.e., condoms with spermicide, oral contraceptives contraceptive implants etc.)

Exclusion Criteria:

1. Subject is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female subjects of child-bearing potential), or intends to become pregnant during the study.
2. Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
3. Keloid scars, hypertorphic scars or a history of abnormal healing.
4. Any known bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants.
5. Tissue ischemia in the area to be treated.
6. Suffering from concurrent conditions such as liver or kidney disorders, Hypertension or abnormally high blood pressure.
7. High cholesterol and/or diabetes.
8. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
9. Epilepsy.
10. Tuberculosis.
11. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
12. Suffering from Endocrine syndromes or thyroid hyperfunction.
13. Active skin infection, any infection in the treated area within the last 30 days or skin disease in the area to be treated (e.g. eczema, psoriasis, urticaria, dermographism).
14. Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
15. Malignancy in the area to be treated.
16. Laminectomy in the area to be treated.
The Clinical Difference Between the Nonfatal Patients and the Fatal Patients With Severe COVID-19

To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to compare the clinical information (laboratory and radiologic characteristics)of nonfatal participants and fatal cases. The investigators wish figure out the clinical character of the fatal participants. The result may help the physician to find the fatal patients with COVID-19 more easily. The fatal patients with COVID-19 could be treated early.


Eligibility Criteria:
Inclusion Criteria:

* The patients with Coronavirus Disease 2019
* Positive result on real-time reverse-transcriptase-polymerase-chain-reaction
* Positive result on chest computed tomography

Exclusion Criteria:

* No
Appropriate Inhaler Use of Tiotropium As Add-on Therapy in Symptomatic Asthma

This pragmatic, two-arm, randomized controlled trial study aim to survey the inhaler errors of add-on tiotropium therapy with ICS+LABA in real-world practice of asthma patients and the efficacy of recheck stratage of inhaler skills. Patient characteristics and inflammatory features will be evaluated prospectively for association of asthma control by add-on tiotropium.

1. The clinical efficacy of tiotropium as add-on treatment to ICS with a LABA have been demonstrated in clinical trials in adult patients with symptomatic asthma.
2. Certain patients of daily care, like patients with smoking asthma, late onset asthma or asthma with chronic airway obstruction are often excluded from clinical trials.
3. Studies have shown the cognitive function of patients with COPD is impaired. When mixed types of inhaler devices are prescribed, the multiple steps of different devices may ensure complexity and confusion for patients, which may compromise the efficacy of add-on therapy. The inhaler error of add-on tiotropium treatment in real-world asthma treatment is unknown.
4. The improvement of step errors after varieties of teaching intervention is around 30\~50%. Strategy of recheck inhaler technique recommended by the treatment guideline may optimized inhaler use. (https://ginasthma.org/gina-reports/).
5. Factors like responseness of short-acting bronchodilators and cholinergic tone have been reported as predictors of a positive clinical response of add-on tiotropium. However, more specific physiological or inflammatory factors. e.g. exhaled nitric oxide test (FeNo), and para symptomatic function and cardiac-pulmonary interaction have not been evaluated prospectively.
6. This pragmatic, two-arm, randomized controlled trial study aim to survey the inhaler errors of add-on tiotropium therapy with ICS+LABA in real-world practice of asthma patients and the efficacy of recheck stratage of inhaler skills. Patient characteristics and inflammatory features will be evaluated prospectively for association of asthma control by add-on tiotropium.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20 to 75 years old asthmatic patients under regular treatment
2. Received medium to high dose ICS with LABA at least 3 months
3. Persistent asthma related symptoms: asthma control questionnaire (ACQ-7\>1.5)
4. Physicians in charged prescribed Tiotropium as add-on therapy according to clinical judgement.

Exclusion Criteria:

1. Refuse to provide inform consent
2. Pregnancy or breastfeeding women
3. Patients with chronic obstructive pulmonary disease
4. Using other Long-acting Muscarinic Antagonists e.g. Sebree, Ultibro, Anoro and Spiolto
A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia

A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Hyperopia with or without astigmatism.

Exclusion Criteria:

* Contraindications to LASIK.
Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Effectiveness Study

The purpose of this study is to test the effectiveness of a new clinical decision support tool, Placement Success Predictor (PSP), in a naturalistic setting. PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type at a behavioral health center using machine learning algorithms.

The primary hypothesis is that clients in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success will have better outcomes than the clients who were not.

The secondary hypothesis is that clients' level of improvement over time will be positively correlated with the number of days they are in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success.

In 2017, a total of 669,799 children were confirmed victims of maltreatment in the United States; of the 442,733 children in foster care, 34% have been in more than one placement and 11% are in a group home or institution. Stakes are extremely high for making the best out-of-home placement choice per child because some placement types and multiple placements are associated with poor outcomes. In the past few years, legislation has been created to guide placement decisions for children. Federal law 42 U.S. Code 675 requires that children in the care of the state are placed "in a safe setting that is the least restrictive (most family like)." In addition, the Family First Prevention Services Act signed into law by the U.S. Congress in 2018 includes measures to reduce the number of children in long-term residential settings. This effectiveness study is to assess and improve the usage of PSP in a behavioral health setting.

Sample. Clients at Children's Hope Alliance (CHA) who completed the TOP, CHA's standard behavioral health assessment. The target recruitment goal is 700 clients.

Methods. PSP results will be available for all clients with recent behavioral health assessment data.

Eligibility Criteria:
Inclusion Criteria:

* Completed TOP CS assessment

Exclusion Criteria:

* None
Step Into Support for Endurance and Strength (SISTERS)

The Step into Support for Endurance and Strength (SISTERS) research study is evaluating whether a mobile health game designed to increase physical activity is feasible and acceptable in patients with gynecologic cancers.

-SISTERS is testing a mobile health intervention can help increase physical activity. Participants will be randomized to receive either 1) a Fitbit or 2) a Fitbit + a game + help from a friend or family member whom you chose will help the participant reach their goals. (i.e. a Teammate).

This study is a two-arm randomized controlled pilot study designed to test the feasibility and acceptability of using a wearable accelerometer (Fitbit) vs. a wearable accelerometer (FItbit) + a game designed to help participants increase physical activity + social support improves participants' average daily step counts.

Eligible Participants will be randomly assigned into 1 of 2 groups

1. Fitbit (wearable accelerometer) or
2. Fitbit (wearable accelerometer) + game + help from a self-selected teammate

The study interventions involved in this research are:

* Surveys/Interviews
* Fitbits (also known as a wearable accelerometers or fitness trackers)
* Way to Health Platform
* Help from a Teammate (i.e. a friend or family member that participants choose to help them reach their goals)

It is expected that about 50 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with a gynecologic cancer (ovarian, fallopian tube, primary peritoneal carcinoma, uterine, or cervical) who have completed cancer treatment ≥ 6 weeks prior.
* Own a smartphone (Android or iOS).
* Can read and provide informed consent in English.
* Do not have cognitive, visual, or orthopedic impairments that preclude participation, as evaluated by the research staff or oncology provider.
* Insufficiently active, as indicated by a score of \<14 on the Leisure Score Index of Godin Leisure-Time Exercise Questionnaire (LSI).
* No future chemotherapy planned (except maintenance treatments; e.g. PARP inhibitors or endocrine therapy)

Exclusion Criteria:

* Patients already participating in a mobile health intervention.
* Patients who do not own a smartphone or computer to transmit data from the wearable tracker.
* Self-reported inability to walk 2 blocks (at any pace).
* Patients who are unable to identify a social support partner (i.e. family member, friend, or partner) to participate in the study (if selected for the intervention arm).
* The following special populations will be excluded from this research:

  * Adults unable to consent
  * Individuals who are not yet adults (infants, children, teenagers)
  * Pregnant women
  * Prisoners