cyrilzakka/clinical-trials huggingface dataset:
Incidence of Neo-Aortic Insufficiency

The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated. These patients will be compared with an equal number of consecutive cases treated by classic Norwood stage I operation in order to determine the incidence of neo-aortic valve insufficiency and the clinical outcome of these patients.

Neoaortic valve insufficiency after Norwood type palliation of single ventricle patients has not been well studied. Patients with mild insufficiency tolerate it well; moderate to severe insufficiency however is poorly tolerated and can result in the death of the patient or at least require re-operation. Re-operation for neo-aortic insufficiency in this small size child is a difficult operation and the operative options are very limited. The introduction of the Sano modification of the Norwood procedure introduced a new set of variables due to the presence of a ventricular incision and possible distortion of the neo-aortic valve. It is therefore critical to determine the incidence of neo-aortic insufficiency and compare it to the standard Norwood operation, as well as to determine the clinical consequences of the presence of this phenomenon immediately postoperatively as well as long-term, up to completion of the stage II of the Norwood procedure (Glenn stage).

Eligibility Criteria:
Inclusion Criteria:

* patients undergone Norwood-Sano at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004
* equal number of consecutive patients undergone Norwood classic stage I at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004

Exclusion Criteria:

* those who do not meet the inclusion criteria
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery

The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.
* Age ≥18 years.

Exclusion Criteria:

* Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal).
* Women with a history of cirrhosis or other chronic liver disease.
* Women with a documented severe or life threatening allergy to iodine.
* Women with an allergy to ICG or severe allergy to iodinated contrast.
* Women undergoing any free flap (non-pedicled) reconstruction.
Comparison of the Effectiveness of Functional Training Versus Resistance Exercises in Patients With Psoriatic Arthritis

The aim of this study was to assess the effectiveness of Functional training versus resistance training in improving functional capacity, muscle strength, quality of life and disease activity in patients with PSA.

The Functional Training Group (FT) used elastic bands and the Resistance Exercise Group (RE) used weight training machines. The FT patients performed functional training and RE performed resistance exercises for the following muscles group: upper limbs, lower limbs and trunk. It was used a machine "leg extension" for the training on the lower limbs. For upper limbs the investigators used a pulley triceps machine and front pull in addition to free weights (dumbbells).

In order to perform the exercise program, the study followed all the recommendations established by the American College of Sports Medicine (ACSM) (Ratamess et al., 2009). It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises was 60% of one-maximum repetition (1RM).

The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteus: standing hips extension.

The patients were instructed to maintain their daily activities and to avoid any other nonpharmacological treatment.

Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of psoriatic arthritis, according to the CASPAR criteria

* Between 18 and 65 years of age, of both genders who agreed and signed the consent form.
* Patients should be-modifying drugs (DMARDs) on stable doses for at least three months and doses of non-steroidal anti-inflammatory drugs and corticosteroids stable for at least 4 weeks

Exclusion Criteria:

* Patients were excluded:

  * Uncontrolled cardiovascular disease
  * Decompensated diabetes mellitus; diseases
  * Severe psychiatric
  * Fibromyalgia
  * Other medical conditions that most disabling EA
  * History of regular exercise (at least 30 minutes 2 times per week) during the last 6 months
  * Arthroplasties of the hip and / or knee in the last 12 months; AND
  * Any other medical condition that prevents the patient from performing resistance exercises
Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels.

The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.


Eligibility Criteria:
Key Inclusion Criteria:

* People with HIV-1 (PWH) or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily B/F/TAF
* Currently virologically suppressed (HIV-1 RNA \< 50 copies/mL) on CAB+RPV IM injections every 2 months
* Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections
* Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV
* Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit
* No documented or suspected resistance to BIC, emtricitabine (FTC), or tenofovir (TFV).

Key Exclusion Criteria:

* History of B/F/TAF intolerance
* History of previous INSTI virologic failure including CAB+RPV
* Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug
* Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies)
* Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer

This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
* Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
* With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
* Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
* Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2.

Exclusion Criteria:

* Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
* Untreated or symptomatic brain metastases and leptomeningeal disease.
* History of hemoptysis within 3 months prior to first dose.
* History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
* Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months prior to start of dosing.
* Vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose.
* Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to start of dosing.
* Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment.
* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
* Chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose.
* Any biological therapy or immunotherapy within 3 weeks of start of first dose.
* Major surgery within 4 weeks of first dose.
* Infection requiring IV antimicrobials for management within 7 days of dosing.
* Known human immunodeficiency virus (HIV) infection, hepatitis C infection.
* Active autoimmune disease
Vaccination Against COVID-19 in Chronic Kidney Disease

This is a prospective, multi-center, observational study that will enroll patients receiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidney transplantation who will be vaccinated against COVID-19.

Patients on dialysis and kidney transplant patients infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) have an increased risk to develop a more severe course of disease or die from COVID-19 (coronavirus disease 2019). SARS-CoV-2 vaccination can increase protection against COVID-19. Kidney transplant patients and patients requiring dialysis suffer from an acquired immune deficiency. Due to the dysfunctional immune response, the general vaccine response in dialysis patients and kidney transplant patients is in many cases insufficient.

Until now, the vaccination response in dialysis patients and kidney-transplanted patients is unpredictable. Verification of vaccine response can provide important information on how to treat and protect these patients from a COVID-19. Therefore, there is a medical need to monitor vaccine protection after SARS-CoV-2 vaccination in clinical practice. In this observational study, data of the SARS-CoV-2 vaccination response collected in clinical routine will be analyzed from these patients. Based on this observational study, the investigators aim to get first evidence whether and to what extent vaccination against COVID-19 causes a vaccine response in immunocompromised patients with kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* receiving dialysis (hemodialysis or peritoneal dialysis)
* capable of giving consent
* age 18 or older

Exclusion Criteria:

- non-capable of giving consent
Electrical Activity of Diaphragm as a Means to Predict Extubation Success in Preterm Infants

Mechanical ventilation used to support the sick newborn infant is associated with many complications including the development of chronic lung disease. Limiting prolonged invasive ventilation remains an important strategy to decrease lung injury and prevent chronic lung disease. Currently, there is no objective measure available to predict readiness for removal of the endotracheal tube ("extubation") and discontinuing mechanical ventilation in this fragile population.

The investigators propose to predict extubation success by evaluating the electrical activity of the diaphragm (Edi), which provides important information about the "drive" to breathing coming from the brain and the function of the diaphragm, two essential factors determining extubation readiness and success.

In this observational study, very low birth weight preterm infants with RDS who require mechanical ventilation in first 24 hour of life will be recruited. A size appropriate nasogastric tube with multiple array of electrodes (Edi catheter) will be inserted in each eligible infant. The average EdI (Edi_avg) will be measured during mechanical ventilation just before extubation. All infants will be extubated to non-invasive positive pressure ventilation (NIPPV or CPAP) delivered through nasal cannula

The specific aim is to determine whether there is a relationship between Edi_avg before extubation and the extubation success in a sample of preterm infants with respiratory distress syndrome (RDS). We hypothesize that Edi-avg of infants with successful extubation will be significantly different from the infants who fail extubation

Eligibility Criteria:
Inclusion Criteria:

Preterm infants less than 35 week gestation, requiring intubation and mechanical ventilation for respiratory distress in the first 24 hours of life

Exclusion Criteria:

Infants with a non-intact esophagus (e.g tracheal-esophageal fistula or atresia), a non-functional diaphragm (e.g. phrenic nerve palsy), severe intracranial hemorrhage or structural CNS abnormality, severe birth asphyxia and critically sick infant needing paralysis or deep sedation.
Tobacco Approach Avoidance Training for Adolescent Smokers-2

This is a two part study. In Study 2, smokers who want to quit smoking will participate in a 4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach tendencies in the AAT test trials and the Implicit Association Task, when compared to adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have better abstinence rates compared to those who receive placebo AAT training with CBT.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Between ages 13-18 years
* Able to read and write in English.
* Smokers: Smoking 5 or more cigarettes daily for at least 6 months; Baseline urine cotinine levels \> 500 ng/ml
* Nonsmokers: Never smokers; Baseline urine cotinine levels \< 50 ng/ml

Exclusion Criteria:

* Current criteria for dependence on another psychoactive substance
* Current diagnosis of psychosis, major depression or panic disorder
* Regular use of any psychoactive drugs including anxiolytics and antidepressants unless the medication has been taken consistently for 2 months, is currently being monitored by a physician, and the condition for which the medication is taken is considered to be stable
* Pregnant or lactating girls, based on self report.
Parkinson's Disease and Experiences Throughout the COVID-19 Pandemic

The purpose of this research study is to examine the relationship between personal characteristics and satisfaction with care in those diagnosed with Parkinson's disease during the COVID-19 pandemic. Participants will take 4 different surveys regarding their satisfaction with care throughout the duration of the COVID-19 pandemic. The surveys in total should not take more than 30 minutes to complete


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with Parkinson's Disease
* Must be able to complete the surveys without any help

Exclusion Criteria:

* Under the age of 18
* Not diagnosed with Parkinson's Disease
* Unable to complete the surveys without help
Dental Implant Osteointegrated With The Residual Root

This case report presents the long-term prognosis of an implant resulting in late failure with an osteointegrated root remnant on the fixture 11 years after implant placement. A 68-year-old female patient experienced issues with a maxillary right 4-unit implant-supported bridge placed 11 years ago. During removal, an osteointegrated root remnant was discovered on the middle supporting implant, which had been inadvertently placed over it. Clinicians should be cautious with retained root remnants, as they may impact osteointegration. However, both the implant and root fragment were osteointegrated without adverse effects.

There is a growing demand for implant dentistry as the first rehabilitation choice for treating patients with missing teeth. Clinicians can encounter asymptomatic retained root fragments in edentulous spaces. This case report presents the long-term prognosis of an implant resulting in late failure with an osteointegrated root remnant on the fixture 11 years after implant placement. A 68-year-old female patient presented to the clinic with complaints of function related to a maxillary right 4-unit implant-supported bridge 11 years after the first insertion of the implants. After removal of the restoration, a root remnant was observed as osteointegrated on the fixture of the middle supporting implant. The implant was placed encroaching upon the mesial part of the residual root fragment left unintentionally, which was discovered accidentally during bridge removal. Clinicians should show ultimate attention when utilizing the retained root remnants in implant sites considering the potential risk of hindering osteointegration. However, osteointegration of the encroached implant and root fragment is plausible, with no observed adverse effects. A risk-benefit evaluation should be assessed individually.

Eligibility Criteria:
Inclusion Criteria:

* Patient with dental implants placed in contact with residual roots

Exclusion Criteria:

* Lack of retained root remnants
* Lack of dental implants
Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of esophageal cancer, stages I-IIIC, with no prior esophageal resection. Neoadjuvant therapy given prior to presentation at MSKCC will be accepted.
* Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, thoracoabdominal, or McKeown procedure) of esophageal cancer either by open or minimally invasive methods
* Chest and abdomen CT scan
* Ability to speak read and write English.

Exclusion Criteria:

* Inability to give informed consent
* Patients requiring a laryngectomy or colon interposition as part of their surgical resection.
* Patients with scleroderma.
The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis

This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis.

For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week.

Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy.

Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee osteoarthritis;
* Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) \> 4;
* Onset knee pain over 3 months prior to the inclusion;

Exclusion Criteria:

* Presence of psychiatric disease;
* Presence of fibromyalgia;
* Presence of systemic inflammatory rheumatic diseases;
* History of neoplasia;
* Presence of clinical diseases in other joints;
* Ongoing use of anticoagulant drugs.
Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy

Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS). Although recent advances in surgical techniques and perioperative management have made with established perioperative management have now made it possible to perform hepatectomies as a safe procedure with minimum mortality, the possibility of massive blood loss and resultant transfusion during hepatectomy still exist. The objective of this research was to identify the role of liver stiffness measurement for the prediction of intraoperative blood loss and postoperative recovery after elective right hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing right hepatectomy between August 2007 and July 2011

Exclusion Criteria:

* patients undergoing right hepatectomy without preoperative liver stiffness measurement
Clinical and Economic Assessment of a Pre-frail Screening Program

The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* More than 70 years consulting in primary care
* Non institutionalized
* Pre-frailty according to L.Fried criteria (1 or 2 criteria)
* Signed informed consent

Exclusion Criteria:

* Patient not able to stand by himself/herself
* Dementia
* Palliative care or life expectancy less than 6 months
* Blind patient
* unstable clinical situation
* Participation in other programs, studies or trials for elderly people