cyrilzakka/clinical-trials huggingface dataset:
Ventricular and Pulmonary Vascular Reserve After the Fontan Operation

Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing.

Aim #2: Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology.

Aim #3: Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction.

Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing. Subjects with Fontan palliation will undergo cardiac catheterization during exercise. The investigators hypothesize that invasive hemodynamic assessment during supine exercise will enable identification of early stage pulmonary vascular disease and diastolic dysfunction that is not apparent from invasive studies performed at rest.

Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology. Transthoracic echocardiography will be performed at rest and during exercise simultaneously with catheterization in the subjects participating in Aim #1 to determine correlations between invasive and noninvasive hemodynamics and identify noninvasive alternatives to assess functional reserve.

Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction. Multi-organ function and patient reported outcomes will be evaluated at baseline, 12 months (optional), and 24 months (optional) in subjects participating in Aims #1 and #2. The investigators hypothesize that subjects with poorer ventricular-vascular reserve will display more clinical and end-organ deterioration in longitudinal follow up.

Eligibility Criteria:
Inclusion Criteria:

* Fontan Palliation
* Age ≥18 years

Exclusion Criteria:

-No clinical indication for cardiac catheterization
PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual

The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.


Eligibility Criteria:
Inclusion Criteria:

* Agree to all the purposes of the study by signing and dating the informed consent.
* Male, aged between 18 and 40 years, age disparity of each group should less than 10 years.
* Body weight ≥ 50kg, and body mass index (BMI) between 18 kg/m2 and 26kg/m2 at screening.
* Hemoglobin between 131g/L and 162g/L, hematocrit between 41% and 49%, and reticulocyte between 0.5% and 2%.
* Transferrin saturation and serum ferritin are in the normal range.
* Physical condition: vital signs, physical examination and laboratory tests ( including routine blood, biochemical tests, coagulation indicators, serum folic acid, vitamin B12, urine test, HBsAg, anti-HCV, anti-HIV, Immunoglobulin (IgA, IgM, IgG), thyroid function (T3, T4, TSH), autoantibodies), chest-X-ray, 12-lead ECG should all in normal range, or without significant clinically abnormal.

Exclusion Criteria:

* Presence of organic disease in heart, liver, kidney, brain; or presence of cardiovascular, pulmonary, gastrointestinal, urinary, neurological, endocrine, immunity, genitourinary or other systems disease.
* Subjects with familial genetic disease, mental illness, or physical disability.
* History of drug allergy.
* Orthostatic hypotension, systolic blood pressure \<90mmHg.
* Habitual medication, including Chinese herbal medicine.
* Poor inclusion conditions (e.g. infirm).
* Smoker (smoke everyday or more than 7 cigarettes per week)，alcoholics (more than 40g/day, equivalent to 100ml/day of 50 degree of white spirit).
* Participate in any other drug trials as the subjects within the previous 3 months.
* As blood donated within the previous 3 months, or experienced massive blood loss due to trauma or surgery.
* Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g. poor compliance).
Nuchal Cord Detection in Sonographic Evaluation by a First Year Resident.

The investigators aim to prove that minimal sonographic training for nuchal cord detection in an unexperienced first year medical resident is more than enough to detect the phenomenon. Patients undergoing elective cesarean section will undergo a routine ultrasound (that is performed to detect the fetal heart rate and the fetal presentation) during which the resident will attempt to detect nuchal cord. The resident will then attend the patient's surgery to verify the findings.

Patients undergoing elective cesarean section will undergo a routine ultrasound examination during which fetal heart rate, fetal presentation and nuchal cord presence will be documented. During surgery, after the fetus is delivered, presence or lack of nuchal cord will be documented.

The aim of the study is to show that minimal sonographic training may assist even an unexperienced sonographist in detection of such a subtle yet important phenomenon.

The study will be performed utilizing the newest resident in the OBGYN department.

Eligibility Criteria:
Inclusion Criteria:

* Any woman undergoing elective cesarean section.

Exclusion Criteria:

* None.
Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* age \> 17
* scheduled major foot and ankle surgery
* written informed consent
* fertile women in anti conceptive treatment
* fertile women not in anti conceptive treatment, but with negative urin-HCG on day of surgery

Exclusion Criteria:

* patients not able to understand or cooperate
* allergies to medicines involved
* daily buse of steroids
* daily use of opioids
Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD

Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease

The purpose of this study is designed to compare the therapeutic effect of chest mobility exercises and proprioceptive neuromuscular facilitation stretching on improving chest expansion and functional capacity in patients with chronicobstructivepulmonarydisease?

Eligibility Criteria:
Inclusion Criteria:

All patients will have the following criteria:

1. Age: 50-60 years old
2. All patients will be in mild to moderate of COPD. In accordance with criteria of Global Initiative for Chronic Obstructive Lung Disease (GOLD) (GOLD I-II).
3. BMI: obese class 1 (30-34.9).
4. Sex: male
5. They suffered from mild dyspnea, chronic cough and expectorations, with forced expiratory volume in one second (FEV1sec) from 50% to 80% of predicted value.

Exclusion criteria:

Patients with the following criteria will excluded from the study:

1. Severe psychiatric or cognitive impairments.
2. Progressive neuromuscular disorders.
3. Decreased level of consciousness.
4. Unstable fracture.
5. pacemaker inserted for fewer than 2 days
6. Deep-venous thrombosis (to minimize risk for pulmonary embolism from being in a prone position.
7. Mean arterial blood pressure of less than 65 mm Hg with or without vasopressors.
8. Tracheal surgery or sternotomy in the last 15 days.
9. Massive haemoptysis.
10. Intracranial pressure of more than 30 mm Hg or cerebral perfusion pressure of less than 60 mm Hg.
TEAS to Reduce Propofol Consumption During General Anesthesia

The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing minor surgeries including laparoscopic surgery and breast surgery under general anesthesia
* Patients with written informed consent

Exclusion Criteria:

* Patients with difficulty to communicate,including psychiatric disorder and Alzheimer's disease
* Patients with drug abuse
* Patients with disease of central nervous system
* Patients with renal or hepatic dysfunction
The Asian Transcatheter Aortic Valve Replacement Registry

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population

This registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site
Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD Probing Pocket Depth, Plaque Index, Bleeding Score, radiographic bone loss.

After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.

After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:

* Chlosite® gel application in the peri-implant sulcus
* Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.

The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).

In each time frame, indexes collection and nonsurgical debridement will be performed.

The present study is designed as a randomized clinical trial (RCT) to evaluate the clinical efficacy of two adjuvant gels in the treatment of perimplantitis.

Patients responding to the inclusion criteria will be included in the study. The following peri-implant indexes will be collected:

* BOP (Bleeding On Probing)
* GBI (Gingival Bleeding Index)
* Marginal Mucosal Conditions (swelling and erythema)
* Suppuration
* Mucosal margin migration
* PPD (Probing Pocket Depth)
* PI (Plaque Index)
* BS (Bleeding Score)
* Radiographic bone loss

After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.

After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:

* Chlosite® gel application in the peri-implant sulcus
* Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.

The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).

In each time frame, indexes collection and nonsurgical debridement will be performed.

Eligibility Criteria:
Inclusion Criteria:

- Presence of at least one peri-implant site with perimplantitis diagnosed according to the latest Classification of Periodontal and Peri-Implant Diseases and Conditions \[Berglundh et al., 2018\]

Exclusion Criteria:

* Patient with cardiac pacemaker
* Patients suffering from psychological, neurological or psychiatric disorders
* Patients suffering from systemic, metabolic or autoimmune diseases
* Pregnant women
S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT

The purpose of this study is to determine if Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.

Is extracorporeal treatment effective in the treatment of sepsis

Eligibility Criteria:
Inclusion Criteria

* Clinical diagnosis of Sepsis
* Mechanical ventilation due to acute pulmonary dysfunction
* One additional (second) acute sepsis-related organ dysfunction

Exclusion Criteria

* Pregnant women and nursing mothers
* Conditions or medications associated with an increased risk of bleeding/complications from anticoagulation
* Previous episode of sepsis during this hospitalization
* PaO2/FiO2 ratio \< 300
* Severe granulocytopenia (leukocytes \<500 / μl)
* Acute hepatic diseases or severe liver failure or cirrhosis
* Chronic cardiovascular disease precluding extracorporeal treatment
* Human immunodeficiency virus complicated by AIDS defining illness
* Evidence of active bleeding - uncontrolled hemorrhage
Guided Imagery in Hospitalized Pregnant Women

The study will be carried out in two different groups. Participants will be approached after being hospitalized for at least 24 hours. After the pregnant women are evaluated in terms of eligibility criteria for the research, the pregnant women who are eligible will be informed about the research and written informed consent will be obtained from the pregnant women who accept. The random distribution of pregnant women to the study groups will be carried out random.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Having no difficulties in understanding and speaking Turkish
* Being hospitalized for at least 24 hours
* Being in the second trimester of pregnancy (14-28 weeks)
* Having a medically stable condition
* Experiencing sleep disturbances
* Voluntarily agreeing to take part in the study

Exclusion Criteria:

* Having a hearing impairment
* Having ongoing severe vaginal bleeding
* Having a diagnosed psychiatric disorder and/or using psychiatric medication
* Having uncontrolled hypertension
* Presence of intrauterine fetal demise
* Premature rupture of membranes (PROM)
* Being in preterm labor
Epigenetics, Vitamin C and Abnormal Hematopoiesis - Pilot Study

This study evaluates whether vitamin C improves responses to epigenetic therapy with DNMTis. Half of the patients will receive vitamin C and DNMTi while the other half will receive placebo and DNMTi.

Recently, it was documented that hematological cancer patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) exhibited severe vitamin C deficiency. Vitamin C is an essential co-factor for ten-eleven translocation (TET) enzymes, which initiate DNA demethylation through oxidation of 5-methylcytosine (mC) to 5-hydroxy-methylcytosine (hmC). In-vitro studies show that vitamin C at physiological doses added to DNA methyltransferase inhibitors (DNMTis), induce a synergistic inhibition of cell proliferation and enhanced apoptosis. These effects are mediated via a viral mimicry response recently associated with cancer stem-like cell death and enhanced immune signals including increased expression of bi-directionally transcribed endogenous retrovirus (ERV) transcripts, increased presence of cytosolic double stranded RNAs, and activation of an interferon inducing cellular response to these transcripts. Data suggest that correction of vitamin C deficiency may improve responses to epigenetic therapy with DNMTis. In the EVITA pilot study, the investigators include MDS/AML patients and explore the potential role of restoring vitamin C within the normal physiological range in treatment of hematological cancer with DNMTis.

Eligibility Criteria:
Inclusion Criteria:

* MDS/AML patient in treatment with DNMTi

Exclusion Criteria:

* Intake of vitamin C as a dietary supplement including multivitamin
* Non-compliance
Compression Feedback for Patients With In-hospital Cardiac Arrest

A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.

A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (INOTECH, Nubberg, Germany) device. Randomization accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc., Madrid, Spain). Crossover was not allowed. The patient and data analyzer were blinded. The clinical provider was not blinded. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admitted to the intensive care unit (ICU)
* Full-code status
* Informed consent was obtained from the patient, legal guardian, or healthcare surrogate upon ICU admission (prior to cardiac arrest event)

Exclusion Criteria:

* Patients with any limitation of code status including but not limited to "no code" or"do not resuscitate" (DNR) and"do not intubate" (DNI), were excluded from study participation
Quality-of-Life Outcomes After Autologous Fascial Sling and TVT: a Prospective Randomized Trial

The objective of the study was to evaluate the impact AFS and TVT procedures on quality-of-life in incontinent women.

Between January 2001 to March 2002, 41 women with a principal complaint of stress urinary incontinence were studied in a prospective trial. Based on results of no numerical variables (including patient's perception of improvement and satisfaction with treatment), the statistical test demonstrated the need for equal sized groups for the comparison. So, the total size of sample groups was previously established as at least 40 women.

These patients were randomly distributed, in a single-blind study, into two groups. Group G1 (n=21) was submitted to AFS and Group G2 (n=20) to TVT implant. Average age in G1 was 49 years (range 26-69), and in G2, 52 years (range 26-79). This study was approved by the Bioethics Commission of the School of Medicine - UNESP, Botucatu.

All the women underwent preoperative urodynamic study, using a Dynograph R.611 recorder, which confirmed stress urinary incontinence in all of them. Patients with involuntary detrusor contractions or preexisting bladder outlet obstruction (BOO) during urodynamic study were excluded of the study.

The clinical follow up and a subjective success rate was performed at 1, 6, and 12 months and then annually after hospital discharge. A questionnaire was used to obtain personal data, obstetric, gynecologic, family history, and subjective analysis of urine loss. Cure was defined as complete dryness with no usage of pads.

De novo urgency was considered when patients had no problem with urgency symptoms preoperatively presented these complaints after surgery persisting more than 1 month. These symptoms were based on clinical evaluation.

Long-term patients' satisfaction and impact on QoL were performed at 36 months after surgery. To evaluate the QoL a validated questionnaire (11) (King's Health Questionnaire) was used. Follow up range from 36 to 54 months (median: 44 months).

Body mass index (BMI) was calculated and classified according to Garrow. All patients underwent physical examination including stress test. The degree of pelvic organ prolapse was assessed and graded according to Baden et al.

Basal laboratory investigations (serum creatinine, complete blood count, chemical and microscopic urinalysis, urine culture) were all routinely performed. In exceptional cases (lithiasis history, urinary infection ) renal ultrasound and plain x-ray of the kidney, ureters and bladder were carried out.

In the immediate postoperative, endovenous tramadol (10 mg/mL-1) was used in patient controlled analgesia (PCA) pump. After an i.v. loading dose of 0.07 mL/Kg-1 (administered over a period of 30 min).

The Physiotherapy Service at each surgical procedure was responsible for carrying out the random assignment of patients in accordance with the casualty.

Eligibility Criteria:
Inclusion Criteria:

* Stress Urinary Incontinence

Exclusion Criteria:

* Detrusor obstruction or hyperactivity
Accuracy Activity Monitors for Inhospital Activity Monitoring of Geriatric Patients

The focus of this study will be to determine the accuracy of the MOX, the Axivity and Fitbit, Empatica and Chill+ activity monitors (with both custom-made and available algorithms) for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in Acute Care for the elderly (ACE) and geriatric rehabilitation units.

In addition, the feasibility of the use of the activity monitors as a measurement tool in daily practice during hospitalization in the geriatric department will be investigated.

Adequate physical activity and exercise throughout the day are important to maximize independence and quality of life. To be able to optimize the physiotherapeutic interventions and to monitor how much geriatric patients move during hospitalization, it is desirable to follow up their activity by means of an activity monitor. In this study the investigators will determine the accuracy of three different types of activity monitors, the "MOX" placed on the thigh, the "Axivity" placed on the torso and the "Fitbit Sense", the "Empatica" and the "Chill+" placed on the wrist, for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in the geriatric department.

In this clinical study, 40 patients will participate of which 20 hospitalized in the geriatric rehabilitation unit at campus Pellenberg and 20 hospitalized in the acute care of elderly units at campus Gasthuisberg UZ Leuven, Belgium.

These activity monitors will remain attached for seven days so that activity can monitored during the week as well as on weekends. In an experimental test session a total of five activities (lying down, sitting, standing, walking and possibly climbing stairs) will be performed and observed, each lasting four minutes. The observations will be recorded by video where only the lower body will be in focus.

There will be daily checks to see if the activity monitors on the thigh, torso, and wrist stay in place, if the skin tolerates it well, if participants experiencing subjective discomfort, and if the measurements continue. At the end of the week, a short questionnaire will be completed on the user-friendliness of the different monitors.

The investigators will use the accuracy and patient satisfaction outcomes to decide the feasibility of using these activity monitors as a measurement tool in daily practice during hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the rehabilitation or acute ward of UZ Leuven
* walking with the use of a walkingaid
* a signed informed consent form
* an expected stay of at least 7 days

Exclusion Criteria:

* medically unstable