cyrilzakka/clinical-trials huggingface dataset:
HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program

The purpose of this implementation trial is to execute a nurse-led, home-based cardiac rehabilitation (HBCR) program, evaluate the program's impact on patient outcomes over 6 months; and compare outcomes of HeartHome (HH) participants to a group of participants in traditional cardiac rehabilitation (CR).

Despite being recognized as a class 1 recommendation by the American Heart Association (AHA), traditional CR is underused: only 20% of patients who need CR are referred, and only half of those referred enroll in the program. The primary barriers to enrollment in CR include the failure of providers to refer patients; systems that lack a clear, streamlined referral process; and patients who face multiple barriers, including knowledge, transportation, cost, time, and social-family support.

The HeartHome program is adapted from MULTIFIT, an evidence-based, interdisciplinary model of care developed at Stanford University was originally designed to provide coronary risk factor modification in post-MI patients, and later modified to implement consensus guidelines for providing HBCR to individuals with CVD using nurse managed care via telephone follow-up. HeartHome will combine nurse home visits with telephone and electronic supports for participants in a HBCR program that allows them to engage in cardiac rehabilitation programs at home.

In this trial, nurses will deliver the 12-week educational program to 150 participants. Participants will then complete follow-up assessments at the end of the program (3 months post enrollment), and then at 6-months post enrollment. The data collected will be compared to a control group that contains de-identified data from 150 patients that attend the traditional cardiac rehab program.

Eligibility Criteria:
Individuals are eligible for the HeartHome study if they meet all the following inclusion criteria:

* Diagnosed with one of the following conditions: myocardial infarction (MI)/acute coronary syndrome (ACS), ST-elevation myocardial infarction (STEMI), non-STEMI, percutaneous coronary intervention (PCI) or stable angina;
* Decline traditional cardiac rehab or do not respond to traditional cardiac rehab enrollment methods;
* Willing to have a nurse visit them in their home and receive follow-up phone calls and text messages for a 12-week intervention period;
* Understand the requirements of participation in and consent to the HeartHome program;
* Live within a 75-mile radius of the study site.

Individuals are not eligible for the HeartHome study if they meet any of the following exclusion criteria:

* Diagnosis of heart failure
* Diagnosis of valvular heart disease
* Presence of cardiac disease requiring surgery or other invasive procedure
* Impaired mental capacity resulting in an inability to understand or follow directions and study protocol
* Impaired functional abilities that prevent them from participating in physical activity
* Presence of any serious medical conditions that are likely to cause premature death or to impair functional capacity
* No access to a telephone
Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Embolism

to detect the incidence of CTEPH patients.

Primary outcome To predict CETHP in symptomatic patients after pulmonary embolism episode.

Secondary outcome:

On Echocardiography revealed RV dysfunction which are peak TR Velocity , the RV/LV basal diameter ratio, flattening of the IVS, RV acceleration time and/or midsystolic notching, IVC diameter with decreased inspiratory collapse and RA area.

Chronic thrombo embolic pulmonary hypertension(CTEPH)is a progressive pulmonary vascular disease characterized by chronic obstruction of major pulmonary arteries with flow-limiting organized thrombi. In the clinical classification of the 6thWorld Symposium on Pulmonary Hypertension, CTEPH/chronic thromboembolic pulmonary disease(CTED)are in group4, labeled as PH due to pulmonary artery obstruction. CTEPH should be considered in PE patients if:(1)they report symptoms that could be related to CTEPH or with frank right heart failure,(2)the CTPA used to diagnose acute PE shows signs indicative of CTEPH,(3)they have risk factors or predisposing conditions for CTEPH. Recurrent venous thromboembolism(VTE),post-thrombotic syndrome, bleeding ,and functional limitations as important outcome measures of acute PE treatment , Dyspnea ,anxiety, chest pain ,post-thrombotic panic syndrome, and depression that lead to persistent functional limitations and/or decreased quality of life have been labeled as post-PE syndrome(PPS),includes CTEPH. Early diagnosis of CTEPH is important ,as it is the only form of PH that is potentially curable , but also challenging because signs of right heart failure only become evident in advanced disease stages and earlier disease stages are characterized by non specific or even absence of symptoms. The diagnostic work up of suspected CTEPH ,starts with trans thoracic Doppler echocardiography, In addition to the peak tricuspid regurgitation velocity , the right ventricle/left ventricle basal diameter ratio, flattening of the interventricular septum, right ventricular acceleration time and/or mid systolic notching, inferior vena cava diameter with decreased inspiratory collapse and right atrial area are used echocardiographic signs to assess the probability of PH.

Eligibility Criteria:
Inclusion Criteria:

Any patient diagnosed as acute pulmonary embolism ,aged between 18-80 years old which Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1,

Exclusion Criteria:

Secondary causes for pulmonary hypertension Severe kidney injury(eGFR\>30 mg/dl/1.7m2) Hepatic affection Contraindication to anti-coagulation
Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments

Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.

The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.

Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained.


Eligibility Criteria:
Inclusion Criteria:

The patient presented with successful endodontically treated maxillary 1st premolar.

* Patients having class I occlusion.
* Good oral hygiene with no signs of periapical pathology or periodontal disease(24).
* Patient having natural teeth as opposed to dentition.

Exclusion Criteria:

* Pregnancy, which prevents the use of diagnostic x-rays.
* Parafunctional habits.
* Mobility in the abutment teeth more than grade 1.
* Patient presenting allergy to materials being used.
Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration

Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive servoventilation on cardiac function, exercise tolerance and quality of life in patients with chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure with ejection fraction ≤45%
* optimal medical treatment for at least 1 month
* clinical diagnosis of Cheyne-Stokes respiration

Exclusion Criteria:

* unstable heart failure
* stroke
* transient ischemic attack in last 6 months
* pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance
* severe chronic obstructive pulmonary disease
Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection

Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.

The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection

Exclusion Criteria:

* chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications
Recto-Anal-Repair in the Treatment of Advanced Haemorrhoidal Disease

Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal disease.


Eligibility Criteria:
Inclusion Criteria:

* Stage III or IV hemorrhoidal disease (Appendix A)
* Patient age 18-80 years old
* Patient fit for general or local anesthesia
* No prior surgical treatment for hemorrhoidal disease
* No prior surgical treatment for anorectal sepsis
* Signed informed consent

Exclusion Criteria:

* Stage I or II hemorrhoidal disease (Appendix A)
* Patient unfit for surgery
* Clotting disorders
* Anal or colorectal malignancy
* Secondary hemorrhoidal disease
* Pregnancy
* Unwilling or unable to sign informed consent
Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model

The purpose of this study is to understand how a stepped-care model of Parent-Child Interaction Therapy (Step-Up PCIT) addresses child behavioral problems among children between the ages of 2 and 7 with a traumatic brain injury (TBI).


Eligibility Criteria:
Child Inclusion Criteria:

* Child is between the ages of 2 and 7
* Child has a mild to moderate TBI

Primary Caregiver Inclusion Criteria:

* Primary caregiver is 18 years or older
* Primary caregiver speaks and reads in either English or Spanish

Child Exclusion Criteria:

- Children with major sensory impairments (e.g., deafness, blindness)

Primary Caregiver Exclusion Criteria:

- Primary caregiver with major sensory impairments (e.g., deafness, blindness)
Extubation in Pediatric Patients: Proactive or Passive?

Smooth extubation process can reduce the complications in recovery time. This study aimed to investigate what is the better time to extubation when children is breathing spontaneously and adequately: waiting until children have movements or wakefulness (passive extubation）or removing endotracheal tube directly (proactive tracheal extubation).

This is a randomized, controlled cross-over trial. The hypothesis of this study is that the different extubation protocol can impact recovery quality in children in post-anaesthesia care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned off and patients all delivered into PACU for recovery. Patient was positioned on his or her lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the patients regained spontaneous respiration. After spontaneous breathing turn to regular and sufficient（tidal volume \>6-8 ml/kg, respiratory rate \>10 times per minutes , end tidal carbon dioxide concentration \>7.19 mmHg）, the trachea tube could be removed. In Group A, patients were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex. In Group B, tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups. Patients were transported to the ward until they breathed air with a patent airway. The extubation time, recovery characteristics and respiratory complication were recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status aged 3-7 years

Exclusion Criteria:

* a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index\>30 kg/m2
Long-term Outcomes of Implants in Patients with Periodontitis

The aim of the study is to examine potential influencing factors on the changes in the periodontal parameters probing pocket depth (PPD), bleeding on probing (BOP), and alveolar bone loss (ABL) on implants and control teeth (using a split-mouth design) over five (T-5), 7.5 (T-7), and ten years (T-10) of supportive periodontal care (SPC). For this purpose, 150 patients with periodontitis and implants are re-examined cross-sectionally (T0), and the changes in the main peri-implant and periodontal target parameters are compared retrospectively at the specified observation time points (T-5, T-7, T-10).

Potential influencing factors to peri-implant conditions include patient-related factors, therapy-related factors and implant-related factors. In addition, patients will be surveyed using validated questionnaires on oral health-related quality of life (OHIP-G14), and a number of common risk factors for periodontits and peri-implant conditions.


Eligibility Criteria:
Inclusion Criteria:

Patient-related:

* At least one dental implant present
* Age ≥ 18 years at the beginning of the observation period
* Verbal and written consent
* Complete periodontal and dental status at one of the defined observation time points with 6 probing sites per tooth/implant and bleeding on probing (BOP) recorded during the periodontal maintenance phase

Locally:

* a contralateral control tooth to the implant is present at the first defined observation time point
* BOP recorded on the implant

Exclusion Criteria:

* No written and verbal consent
* Younger than 18 years
An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.

This study consisted of 2 periods: a 12-week treatment period and a 48-week post-treatment period (for all participants who received study drugs). All participants who received at least 1 dose of study drug were to be followed for 48 weeks post-treatment to monitor for safety, HCV RNA, the emergence and/or persistence of resistant viral variants, and assessment of patient-reported outcome (PRO) instruments.

Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile.
* Chronic HCV infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced.
* Subjects must be on a stable opioid replacement therapy of methadone or buprenorphine ± naloxone for at least 6 months prior to screening.

Exclusion Criteria:

* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
* Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug.
* Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of \>3 or Ishak score of \> 4.
Myoglobin Removal With CytoSorb in Rhabdomyolysis

The aim of this observational study is to assess whether myoglobin removal with CytoSorb® ameliorates endothelial damage in severe rhabdomyolysis patients who are admitted to the intensive care unit. The primary objective of the study is:

- Does myoglobin removal with CytoSorb® reduces glycocalyx degradation markers?

Patients with severe rhabdomyolysis will receive the intervention and blood samples will be obtained in regular intervals.

Rhabdomyolysis is characterized by destruction of muscle by various causes and is diagnosed by increased creatine kinase concentrations in the blood. Myoglobin released into the blood may cause acute kidney injury in up to half of these patients. The mortality caused by severe rhabdomyolysis is also high (32%). Extracorporeal modalities, such as CytoSorb (CS) can effectively eliminate the myoglobin from the bloodstream.

In addition to ischemic and inflammatory damage, myoglobin also causes direct endothelial cell injury. Degradation of the endothelial glycocalyx layer can be assessed by several biomarkers such as Syndecan-1, Heparan sulfate, cadherin

However, it is not fully known whether myoglobin elimination improves the outcomes or it is irrelevant of the outcome.

The investigator hypothesized that myoglobin elimination with CS alleviates the damage inflicted upon the endothelium and may have a role in improving patient outcomes in severe rhabdomyolysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Creatine Kinase \> 5000 IU/L.
* Myoglobin results can be obtained only after 5 working days after sampling in our center, therefore it cannot be used as an inclusion criteria.
* GFR below 40 ml/min.

Exclusion Criteria:

* High dose vasopressor requirement
* Not expected to survive \> 24 h
* Lack of consent to participate
CRD007 for the Treatment of Duchenne Muscular Dystrophy, Becker Muscular Dystrophy and Symptomatic Carriers

This is an investigation of the efficacy and safety of CRD007 in Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD) and symptomatic carriers.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dystrophinopathy

Exclusion Criteria:

* Severe functional impairment
Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy

Objective: To observe the effect of Ningmitai capsule on ureteral calculi after lithotripsy and evaluate the safety of treatment.

Study Design: A multicenter, prospective, randomized, controlled clinical study design was adopted

Interventions:

control group: Give antibiotics or diclofenac sodium suppository as needed. Ningmitai group: Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day.

combination group (Ningmitai plus tamsulosin).: Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group.

Sample size: 230

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as upper urinary calculi by B-ultrasound, kidney and upper bladder (KUB), intravenous urogram (IVU) or computerized tomography (CT) before surgery with the ages between 20 and 70 years.
2. Having ureteral residual fragments post URL and the diameter more than 5mm.
3. The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications.
4. Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.

Exclusion Criteria:

1. Pregnancy, severe diabetes, or renal insufficiency.
2. Ureteral stricture and lower urinary tract obstruction.
3. Concomitant treatment with α1-receptor antagonists, or Chinese traditional medicines who can be used to relieve stranguria and expel stone, or any other treatment that might interference the efficacy evaluation.
4. Unwilling or unable to comply with the administration regimen described in the protocol, or having an incomplete profile, hence their efficacy and safety couldn't be evaluated.
5. Severe adverse events and need to withdraw from the study.
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease

* Assess the differences between flow and volume responses after bronchodilator reversibility testing in patients over different clinical chronic obstructive pulmonary disease stages (GOLD stage I to GOLD stage IV).
* Study the Correlation between the bronchodilator response and the severity of the disease.

chronic obstructive pulmonary disease is a common preventable and treatable disease characterized by persistent airflow limitation that is usually progressive. The diagnosis requires an evidence of obstructive pattern by spirometry measured before and after bronchodilators.

The degree of reversibility of airflow obstruction differs between patients, and does not predict the response to bronchodilator therapy. It can be seen in terms of forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1),or Inspiratory capacity (IC) or residual volume (RV).

Eligibility Criteria:
Inclusion Criteria:

* Patients Clinical diagnosis of Chronic Obstructive Pulmonary Disease
* Must be able to do pulmonary function test
* Age more than 40 years
* Stable Chronic Obstructive Pulmonary Disease patients

Exclusion Criteria:

Any patients with a diagnosis of:

* Bronchial asthma
* Bronchiectasis
* Respiratory failure
* Decompensated core pulmonale
* Chronic Obstructive Pulmonary Disease combined with any other respiratory disease