cyrilzakka/clinical-trials huggingface dataset:
Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function

The goal of this pilot study is to effectively treat hypertension in subjects with either known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due to the unique properties of nebivolol, it is hypothesized that there will be improvements in left ventricular (LV) systolic and diastolic function manifesting as increase exercise capacity in this patient population with primarily LV diastolic dysfunction. The present study was performed to determine the effects of nebivolol on blood pressure, exercise tolerance and parameters of left ventricular systolic and diastolic function in a group of hypertensive patients with echocardiographic evidence diastolic dysfunction.

Prior to the initiation of Nebivolol and after 10 weeks of Nebivolol therapy, subjects underwent a resting 2D echocardiogram including routine sampling of mitral valve (MV) inflow and LV tissue Doppler imaging as well as a symptom limited exercise treadmill stress test with echocardiographic imaging. Primary endpoints were 1) changes in systolic blood pressure before and after 10 weeks of treatment and 2) changes in exercise capacity as determined by exercise duration and metabolic equivalent (MET) level before and after treatment. Secondary endpoints were changes in exercise hemodynamics and Doppler echocardiographic parameters of LV systolic and diastolic function and quality of life before and after 10 weeks of nebivolol treatment. Subjects completed an EuroQol (EQ-SD) Quality of Life questionnaire which is a standardized measure of health status developed by the EuroQol group as a simple general measure of health at baseline and at conclusion of the 10 week trial period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis (new or established) hypertension, defined by serial measurements \>/= 140/90
* Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler

Exclusion Criteria:

* Severe bronchospastic disease/ reactive airway disease
* Inability to tolerate beta blocker therapy including: \>1st degree atrioventricular (AV) block, symptomatic hypotension, symptomatic bradycardia,
* Subjects with physical limitations that would prevent them from participating in an exercise treadmill test
* Age \<18 or \>90 years
* Those with life expectancy \<1 year
* Subjects with class III/IV New York Heart Association (NYHA) heart failure symptoms
* Chronic Kidney Disease 3 or greater (CrCl \<30 cc/min)
* Subjects with active ischemia or evidence of ischemia on initial stress echocardiography
Global Atrophie Biomarker Evaluation Study (GABiE)

To investigate the use of microperimetry and SS-OCT in assessing the natural changes of retinal sensitivity and anatomy in the perilesional zone of geographic atrophy areas in patients with dry age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the study
* Age \>=60 years
* Ability (including a sufficient general health status according to investigators judgement) and willingness to undertake all scheduled visits and assessments including predefined methodology and standards utilizing microperimetry GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in the study eye
* GA lesion in the study eye must reside completely within the FAF imaging field (Field 2- 30 degree image centered on the fovea)
* BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m in the study eye
* Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV in the study eye

  * The total GA lesion size \>=1.2 mm\^2 (approximately \>=0.5 disc area \[DA\]) and \<=17.78 mm\^2 (approximately \<=7 DA) and must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)
  * If GA is multifocal, at least 1 focal lesion must be \>=1.2 mm\^2 (approximately \>=0.5 DA)
* Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye

Exclusion Criteria:

* GA in either eye due to causes other than AMD (for example, monogenetic macular dystrophies \[e.g., Stargardt disease, cone rod dystrophy\] or toxic maculopathies \[e.g., chloroquine/hydroxychloroquine maculopathy\])
* Receiving active treatment in any studies of investigational drugs for GA/dry AMD in the study eye
* Mean sensitivity difference \> 3 dB between the two microperimetry examinations in the screening visit.
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
* Prior treatment with Visudyne ®, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
* History of prophylactic subthreshold laser treatment for AMD in the study eye
* Further criteria apply.
Three Anaesthesic Method in Electroconvulsive Theraphy

To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.

The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.

Eligibility Criteria:
Inclusion Criteria:

* Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
* Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia)

Exclusion Criteria:

* Involuntary patient status
* Patients with known or self-declared needle or mask phobia
* Pregnancy
* Asthma
* Cerebrovascular disease,
* History of myocardial infarction in the previous 6 months,
* Atrial fibrillation or flutter,heart block,
* A known or family history of reactions to the study drugs.
Evaluation of Modification in VO2 Max After Performing the "Physical Activity and Health Course (PAPS) 53" Program

Physical inactivity is the leading cause of preventable death in developed countries, ahead of smoking. It is responsible for 5.3 million (9%) of the 57 million deaths worldwide in 2008 and 10% of deaths in Europe.

Encouraging regular physical activity in the general population is a public health priority.

Cardiorespiratory capacity, measured during an exercise test, expressed as maximal oxygen consumption (VO2 max) or Metabolic Equivalent Task (MET) = oxygen consumption at rest \[3.5 ml/kg/min\], is an excellent indicator of individual exercise capacity and is increased by regular physical activity (PA).

Any gain in cardiorespiratory capacity of 1 MET is accompanied by a 12% reduction in mortality whether the subjects are free of any cardiovascular pathology or have a chronic pathology, regardless of their age.

As physical activity is an integral part of the management of many diseases, it seems essential to evaluate specific protocols oriented towards the maintenance or development of strength or endurance, or even mixed protocols.

The PAPS 53 (Physical Activity and Health Pathway), set up in Mayenne, responds to the demand for prescription of adapted physical activity. It is a 3-month program with 2 one-hour sports sessions per week (30 minutes of endurance and 30 minutes of muscle strengthening).

The National Sport and Health Strategy 2019-2024 expert group recommends better defining the characteristics of physical activity (intensity, frequency, etc.) to determine the effect (dose-response) on different at-risk populations and according to the type of pathology.

Investigators proposed to study by comparison the VO2 max values obtained during the two exercise tests (at inclusion and after 3 months of physical activity program). The hypothesis is that, after completion of the PAPS program, the VO2 max value of a patient will be significantly increased.

The control group is represented by the patients who have not yet followed the adapted physical activity program. The intervention group is therefore composed of the same patients. The aim is to compare the same group of eligible patients, before and after having followed the "PAPS 53" protocol


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years)
* Patient integrating the PAPS 53 with an indication to perform a stress test
* Person affiliated or benefiting from a social security plan
* Patient having signed an informed consent beforehand

Exclusion Criteria:

* Contraindication to the performance of the stress test
* Patient unable to understand the objectives or instructions of the study
* Poor understanding of the French language
* Pregnant, nursing or parturient woman
* Person deprived of liberty by judicial or administrative decision
* Person under forced psychiatric care
* Person admitted to a health or social institution for purposes other than research research
* Person subject to a legal protection measure
* Person unable to express his or her consent
* Person in a period of exclusion relative to another intervention research
Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease

By doing this study, researchers hope to learn about the feasibility of using a mobile application to help overweight or obese adults with PAD increase their walking distance and lose weight.

Peripheral artery disease (PAD) or poor leg circulation affects 8 to 12 million Americans including non-Hispanic Whites, African Americans and Latinos. Having PAD can limit how far you can walk. Many patients with PAD are also overweight or obese. Weight loss among overweight or obese adults with PAD may improve walking distance. Given how common obesity or being overweight is among persons with PAD, interventions are needed to address weight loss in this population.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese (body mass index \>=27 kg/m2)
* Have symptomatic PAD
* English speaking
* Have 24 hour access to a cell phone

Exclusion Criteria:

* Cannot tolerate fruits and vegetables, fiber, and/or a low fat diet, as informed by a physician and/or registered dietician
* Restricted intake of water
* Pregnancy
* Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
* Use of supplemental oxygen
* Heart attack within preceding 3 months
The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction

By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to increase surgeon satisfaction.

After obtaining approval from our university and the Turkish Ministry of Health's pharmaceutical and medical device agency and written consent from the patients, 100 patients who underwent middle ear surgery using controlled hypotension under general anesthesia will be included in the study.

The study will be conducted in a randomized controlled, double-blind manner. Patients between the ages of 18-65 and with American Society of Anesthesiologists (ASA) Scores I and II will be included in the study. Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes. At the end of the operation, the operator's quality of vision of the surgical field will be recorded by questioning the surgeon's satisfaction with the Boezaart Score and the Surgeon Satisfaction Score.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-65
* Individuals with ASA I (no additional disease) or ASA II (mild systemic disease)
* Those who do not have a disease such as thrombophilia or bleeding diathesis will be included in the study

Exclusion Criteria:

* Patients with ASA III (those with uncontrolled chronic disease) or above
* Patients with cardiovascular disease, congestive heart failure, coronary artery disease, cerebrovascular insufficiency, renal or hepatic failure
* Patients with thrombophilia, bleeding diathesis, coagulation defects
* Pregnant patients
* Those with a history of any allergic reaction to tranexamic acid and its derivatives will be excluded from the study
The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection

The direct oral anticoagulants (DOACs) and particularly the FXa inhibitors are a concern in patients presenting with type A aortic dissection as this may contribute to severe bleeding complications. The antidote andexanet alfa (Ondexxya®) can interact with the heparin- anti-thrombin III (ATIII) complex which may neutralize the anticoagulant effect of heparin and the use of andexanet alfa before surgery necessitating heparin-anticoagulation has been reported to cause unresponsiveness to heparin. The investigators have preliminary in-vitro data demonstrating the ability to remove apixaban from reconstituted blod by hemadsorption and are now analyzing if aFXa inhibitor levels may be reduced by hemadsorption in the clinical setting analyzing this in patients using FXa inhibitors being operated acutely for type A aortic dissection.


Eligibility Criteria:
Inclusion Criteria:

* Indication for urgent surgery for proximal aortic disease
* Treatment with FXa inhibitor for more than 2 weeks
* Measured concentration of FXa inhibitor in therapeutic range (\>50 ng/mL) at the time of admission.
* Intraoperative use of Cytosorb® hemadsorber.

Exclusion Criteria:

• Low FXa inhibitor concentration (\<50 ng/mL) at the time of admission
Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery

Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after being sutured sometimes dehisced after days up to a few weeks and this study will investigate whether it is better to resuture early or leave the rupture for secondary healing.

140 women will be included in the trial, 70 women will be randomized to resuturing and 70 women will be randomized to expectant management. The investigators will follow the women with clinical investigations after 2 and 4 weeks. After two weeks the healing will be measured using the REEDA scale and the women will be asked whether they breastfeed or not. The psychological wellbeing will be measured using the EPDS (Edinburgh Postnatal Depression Scale).

After four weeks the above will be done again as well as collecting of the daily pain diary that the women have filled in since being included in the trial.

After one year the women will be seen again and the investigators will do a clinical investigation including ultrasound of the perineal body, measurement of the perineal body, POP-Q ( Pelvic Organ Prolapse Quantification System) as well as multiple validated scales as EPDS, FSFI ( Female Sexual Function Index), PFIQ (Pelvic Floor Impact Questionnaire) and PFDI (Pelvic Floor Distress Inventory). These scales will help the investigators to find out if the women have moderate to much trouble with vaginal wideness and/ or moderate to much problems during defecation and therefore, if the perineal body is palpated smaller than 2 cm, there will be indication for a perineal reconstruction.

The primary outcome will be to investigate whether early resuturing is reducing the need of a later secondary reconstruction of the perineal body compared with conservative management concerning dehisced perineal wounds.

The secondary outcomes will be to investigate whether early resuturing is reducing the risk of having symptoms from the perineum and/or sexual problems one year after delivery.

The healing of the wound and the estimated pain will be compared between the two groups.

Certain questions concerning secondary fear of childbirth will also be asked and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Woman over 18 years old who had a vaginal delivery and suffered from a perineal rupture, grade 2 (spontaneous or episiotomy).
* No longer than two weeks has passed since delivery.
* The woman must be able to give informed consent.

Exclusion Criteria:

* Perineal rupture grade 3 and 4.
* Woman suffering from connective tissue disease.
* Ongoing treatment with oral cortisone or other immunosuppressive disease.
* Diabetes treated with insulin.
* Suspicion of occult damage of the anal sphincter.
* Earlier surgery of the perineum.
A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures

The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

From January 2011 to September 2012, 157 patients with distal radial fractures were allocated into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long incision, and patients in group B were treated through the conventional flexor carpi radialis approach. All fractures were fixed with volar plates. Patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were analyzed with the Statistical Package for Social Sciences 13.0. A P \< 0.05 was statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Fernandez type II-IV radial fractures.

Exclusion Criteria:

* Fernandez type I radial fracture.
* Fernandez type V radial fracture.
* Open radial fractures.
* Surgery using K-wires or screws alone.
* The use of external fixators.
* multiple fractures, pathological fracture.
Impact of the Use of New Complete Denture on the Oral Health Related to Quality of Life (OHRQoL)

The aim of this project was to evaluate the impact before and after (3, 6, 9, and 12 months) of oral rehabilitation with conventionalof the insertion of new complete dentures (CD) in the oral health-related quality of life (OHRQoL) in total edentulous patients compared to dentate individuals. This is a clinical trial study approved by the Research Ethics Committee (nº 31105714.7.0000.5626 ) which was conducted on 122 patients who attended the clinics of Federal Fluminense University, with the necessity of CD. The eligibility criteria were: healthy patients without disabilities; aged up to 50 years; complete upper and or lower jaw edentulism for a minimum 5 years; the presence of adequate healthy tissue to support the prosthesis; adequate cognitive ability and understanding to respond to the questions posed. It will be excluded patient with motor disabilities, cognitive impairment and people with special needs. After the installation of the CD a follow-up of one week, three, six, nine, twelve and eighteen months will be performed. The Oral Health Impact Profile (OHIP-Edent) instrument will be applied (in form of an interview) to evaluate the impact of CD on OHRQoL. The scores of the OHIP-Edent index will be calculated using the additive method, summing the numeric response codes for each item. Shapiro-Wilk test revealed nonparametric distribution of data. Chi-square, Mann-Whitney U, and Kruskal-Wallis tests were performed for comparing groups according to sociodemographic data. Kruskal-Wallis test was per- formed for comparing groups and treatments throughout time. A significance level of 5% was adopted, and all analyses were performed on Statistical Analysis System (SAS) version 9.3 software. The responsiveness was assessed by analyzing the change of the scores on the scales and subscales. The changes was calculated by subtracting the post-treatment scores from the before-treatment scores. Positive change scores will indicate an improvement in OHRQoL, while negative scores will indicate deterioration.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients without disabilities;
* aged up to 50 years;
* patient with complete upper and or lower jaw edentulism for a minimum 5 years;
* patient with presence of adequate healthy tissue to support the prosthesis;
* patient with adequate cognitive ability and understanding to respond to the questions posed

Exclusion Criteria:

* patient with motor disabilities;
* patient with cognitive impairment
* people with special needs.
Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis

This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.

All patients with chronic pancreatitis will be considered for participation in this study. Patients selected for participation will be evaluated 4 weeks prior to the first one-on-one therapy session. A baseline pain score will be assessed using the visual analog pain scale. Narcotic dosage and frequency as well as anti-emetic usage will be evaluated at this time. A pre-treatment quality of life score will be recorded using the SF-12® Patient Questionnaire. Patients will also be queried about the presence of nausea and reflux.

After the pre-intervention evaluations are complete, patients will be randomized into one of two arms: treatment with cognitive behavioral therapy and narcotics as needed or treatment with conventional narcotic analgesics alone. Patients undergoing CBT intervention will participate in eight weekly therapy sessions. Follow-up assessments will be conducted six months and nine months after the last therapy session is completed. The patients will be evaluated based on pain score, narcotic dosage and frequency, anti-emetic usage, quality of life assessment, and pain related hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be18 years of age
2. Diagnosed with chronic pancreatitis
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study

Exclusion Criteria:

1. Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.

Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (\>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).


Eligibility Criteria:
Inclusion Criteria:

* cardiac surgery treatment of TR, isolated or in conjunction with other procedures on the left heart
* patients operated on between January 1998 and December 2004

Exclusion Criteria: