cyrilzakka/clinical-trials huggingface dataset:
International Extranodal NK/T-cell Lymphoma Project

This study is to explore risk factors for poor progression-free survival (PFS) and overall survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with non-anthracycline based treatment.

This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (1) Patients diagnosed with ENKTL, nasal type between January 1, 1995 and December 31, 2014; (2) Patients treated with non-anthracycline based therapy as an initial treatment. The pathology of initial diagnosis was reviewed by designated pathologists.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ENKTL, nasal type
* Patients diagnosed between January 1, 1995 and December 31, 2014
* Patients treated with nonanthracycline-based therapy as the initial treatment after diagnosis
* Nonanthracycline-based therapy includes the following treatments:
* Radiotherapy including concurrent chemoradiation
* Chemotherapy not including anthracycline such as doxorubicin (e.g. SMILE, VIPD) The type of salvage treatment will not be a criterion for exclusion. Thus, patients who had received various kinds of salvage treatment including anthracycline-containing regimens can be included. Patients who had undergone autologous or allogeneic stem cell transplantation can also be included in the analysis if they satisfy the above-mentioned inclusion criteria.

Exclusion Criteria:

* Patients who had received anthracycline-based therapy, such as CHOP or CHOP-like regimens, as the initial treatment.
* Patients who do not have pathology slides available for central review.
Evaluation of the Intraoperative Accuracy of 3D-planned and Guided Osteotomies of the Hand and Forearm

Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies that are performed with patient-specific instruments.

Due to the higher accuracy achieved it is expected that complaints can be resolved or effectively revealed. The Research hypothesis to prove is "The medical product permits the surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus, carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and 2º. Secondary outcome is an assessment of the surgical outcome using the "Disabilities of the Arm, Shoulder and Hand" (DASH) and the "Patient related wrist Evaluation" (PRWE) scores.


Eligibility Criteria:
Inclusion criteria

* Posttraumatic or congenital bone deformity or pseudoarthrosis in the field of hand Surgery requiring correction by corrective osteotomy
* Clinical indication for a computer tomography scan of the forearms
* \> 18 years old
* written informed consent

Exclusion criteria

* pregnant or nursing women
* other clinical significant accompanying symptoms (Tumor, infection)
* non-compliance of the patient to follow the clinical study protocol, drug or alcohol abuse
* Participation in a different clinical trial within the last 30 days before inclusion or during the study
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

A study of infliximab in patients with Fistulizing Crohn's Disease

This is a medical research study for patients with Crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). Fistulas are a common complication of Crohn's disease. Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohn's disease. This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas.

Subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab.

Eligibility Criteria:
Inclusion Criteria:

* Single or multiple draining fistulas
* Crohn's disease of at least 3 months' duration,

Exclusion Criteria:

* Crohn's disease complications for which surgery might be indicated
* Positive stool culture
Hypertension and Sleep Disordered Breathing in Pediatrics

The primary objective is to determine the prevalence of sleep disordered breathing in children with primary hypertension or pre hypertension. The secondary objectives are to determine any association factors for children with primary hypertension or prehypertension to have sleep disordered breathing be it gender, age, body mass index (BMI), family history (hx) or ethnic group.

This is an exploratory, cross sectional study involving identification of the children of the age between 10 years and 17 years diagnosed with primary hypertension who have not been previously diagnosed and or treated for sleep disordered breathing with the revised pediatric sleep questionaire (PSQ) for sleep disordered breathing. The subjects that have shown interest will be mailed the informed consent/assent form to tbe reviewed. The consent/assent form will be handed to the child and all their questions and concerns will be answered in a comprehensible manner.

Eligibility Criteria:
Inclusion Criteria:

* aged 10 to 17 years old diagnosed with primary hypertension

Exclusion Criteria:

* refused to participate in the study
* children to secondary hypertension
* previously diagnosed with sleep disordered breathing
Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort

The purpose of this study is to investigate features of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).

This retrospective chart review study will analyze the demographics, medical history, clinical features, and pathological data of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an EGID including EG, EGE, and/or EC. Subjects with EoE can be included if they also have another EGID.
* Clinical symptoms of gastrointestinal dysfunction.
* Findings of increased eosinophils on tissue biopsy at the time of diagnosis, before treatment initiated.
* Exclusion of other causes of gastrointestinal eosinophilia.

Exclusion Criteria:

* Gastrointestinal eosinophilia caused by another disorder.
* Diagnosis of EoE without another EGID.
* Insufficient medical record or pathology data available to support an EGID diagnosis.
Intravenous Oliceridine and Opioid-related Complications

The investigator will evaluate the side effects of oliceridine.

The investigator will evaluate the side effects of oliceridine. Limited information suggests that oliceridine may cause fewer side effects than the standard opioids given post surgery. Oliceridine is effective for treating acute pain, and is approved by the FDA. Patients will wear a device that continuously monitors breathing. Data from this monitor will be blinded to the clinical staff. Primary Aims include: The investigators will evaluate the proportion of patients having an adjudicated meaningful respiratory compromise with a specified precision of 0.15 using a 95% confidence interval at 24 hours post first study dose.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* American Society of Anesthesiologists physical status 1-4
* Scheduled for major noncardiac surgery expected to last at least 2 hours
* Expected to remain hospitalized at least two postoperative nights
* Scheduled for general endotracheal, spinal anesthesia, or the combination
* Expected to require substantial opioid analgesia, defined as ≥20 mg morphine equivalents
* Expected to have patient-controlled intravenous analgesia.

Exclusion Criteria:

* Are demented or otherwise cannot provide valid consent
* Have contraindications to oliceridine
* Used legal or illegal opioids chronically, defined as \>15 mg morphine equivalents for \>15 days during the month before consenting by history
* Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring
* Have planned epidural anesthesia/analgesia
* Planned spinal morphine administration
* Are designated Do Not Resuscitate, hospice, or receiving end of life therapy
* Are expected to require postoperative mechanical ventilation or ICU admission
* Are expected to receive intrathecal opioids
* Are expected to receive gabapentin, pregabalin or other analgesic adjuvants
* Use oxygen at home
* Are unwilling or unable to comply fully with study procedures (including not tolerating the capnography cannula)
* Are known to be pregnant or breastfeeding
* Use CPAP at home
* Have previously participated in the trial
COMPARISON OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY

The purpose is to compare the effects of piezosurgery and conventional rotary instruments on postoperative pain, swelling, trismus and patients' comfort after mandibular third molar surgery.

The investigators plan a prospective and split mouth study. Thirty patients will be randomly selected. Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.

One side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery. The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.There will at least one month between two surgeries. The investigators will compare postoperative pain, swelling, trismus and patients' comfort.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.

Exclusion Criteria:

* Exclusion criteria were as follows: Alcohol abuse, smoking, pregnancy, and presence of acute severe periodontitis.
Investigating Immune Escape by SARS-CoV-2 Variants

The purpose of this protocol is to investigate the ability of pre-existing immunity by natural infection or vaccination to prevent infections by emerging SARS-CoV-2 variants.

Several variants of the SARS-CoV-2 virus were identified in 2020 including the United Kingdom variant (known as 20I/501Y.V1, VOC 202012/01, or B.1.1.7), South Africa variant (known as 20H/501Y.V2 or B.1.35), and Brazil variant (known as P.1), with more variants still being discovered. There is concern that these variants, due to mutations in spike protein and receptor-binding domain of the spike protein, can be more infectious, lethal, and potentially escape the immune responses from vaccination or prior infection. Research is needed to understand the risks associated with currently known variants of SARS-CoV-2 as well as investigate if there is potential for new mutations to form that would allow SARS-CoV-2 variants to partially or entirely escape the immune mechanisms developed from vaccination and/or prior infection from the wild-type strain of SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

* People who have been fully vaccinated for COVID-19 2-12 weeks prior to enrollment or individuals \<3 months post-COVID-19 infection.
* Collection of samples for blood samples will be done only from healthy, nonpregnant adults who weigh at least 110 pounds.
* Participants must be able to provide informed consent.

Exclusion Criteria:

-Subjects considered vulnerable including children, pregnant women, nursing home residents, or other institutionalized persons, fetuses, prisoners, and persons without decisional capacity.
Fast Food Photo Study 2

Participants will be exposed to a hypothetical fast food menu, asked to place a hypothetical lunch order, and will then be exposed to a second menu with several changes made to the menu. Participants will be asked to identify as many changes as possible on this second menu, and then complete a survey about their eating tendencies and demographics.

The menu with changes will feature changes to both calories and prices, allowing for measures of whether participants notice such changes and the order in which changes are noticed.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older,
* agrees to consent form

Exclusion Criteria:

* N/A
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.

Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352.


Eligibility Criteria:
Male and female patients, 12-17 years of age, who have at least a six-month history of Crohn's disease and who are currently experiencing moderately to severely active Crohn's disease. Females must not be breastfeeding or pregnant, and must not become pregnant during the study.
Evaluating the Infant Complex Congenital Heart Disease by Multidetector Computed Tomography

To test the ability of multi-detector spiral CT in evalting the infant complex congenital heart disease.

To test the ability of multi-detector spiral CT in evalting the infant complex congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

complex congenital heart disease

Exclusion Criteria:

-
Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

THe main goal of our randomized controlled trial with blinded observer will be to compare four pediculicide products acting mechanically, Paranix Spray, Paranix Lotion, Paranix Mousse and Hedrin against a reference product acting chemically, Prioderm, during a non-inferiority (20% equivalence). THe randomization will be balanced every 10 families. The secondary objective will be to compare the lenticide efficacy of the products and their local tolerance and cosmetic acceptibility.


Eligibility Criteria:
Inclusion Criteria:

* Subject-male or female, child \> 3 years and adult
* Pediculosis of scalp, confirmed by the identification of minimum 5 live lice with a fine-tooth comb
* Negative urine pregnancy test before inclusion for women of childbearing potential
* Use of a contraceptive method by hormonal contraceptives or IUDs or tubal ligation or condoms for women of childbearing potential
* Subject agreeing to participate in the study with written informed consent for participation
* Written consent of both parents for the minor patients.

Exclusion Criteria:

* Children under 3 years.
* Woman pregnant or lactating or without contraception
* Use of a pediculicide or lenticide treatment within 2 weeks before entry into the study
* Subject with known hypersensitivity to any component of the tested products
* Subject who participated in a clinical study in the 3 months prior to inclusion
* Ongoing treatment potentially interacting with the treatment under study (other pediculicide products)
* Subject undertreatment susceptible to influence the evaluation of the trial (including trimethoprim-sulfamethoxazole).
* Severe medical or psychiatric illness considered by the investigator as potentially dangerous to the subject or incompatible with the conduct of the study
* Asthma
* Subject unable for linguistic or psychiatric reasons to understand the information and give informed consent
* Subject refusing to give written consent
* Subject deprived of his liberty by administrative or judicial decision, or guardianship
* Patient hospitalized in a medical or social facility for another reason that biomedical research
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock

The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death

While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for sudden death prevention in high risk individuals, reduction of device associated morbidity remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown modest benefits of atrial pacing in preventing atrial fibrillation, however right ventricular (RV) pacing was not limited, thus any favorable effects associated with atrial prevention and treatment may have been offset by the RV pacing. New algorithms to prevent RV pacing are now made available in our current devices. The choice of dual chamber versus single chamber ICD for primary prevention warrants re-assessment of atrial prevention and termination therapies, without the potentially adverse effects of RV pacing.

This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50 to dual chamber ICDs. Patients will be followed for one year.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for ICD for primary prevention according to American Heart Association/American College of Cardiology (AHA/ACC) guidelines who have a clinical indication for ICD implantation for ventricular arrhythmia or sudden death prevention.
* The ability to understand the scope of the study, provide written informed consent, and a willingness to complete all study visits and associated procedures.

Exclusion Criteria:

* Pregnant women
* Age \<18 years old
* Inability to provide consent
* On a heart transplant waiting list
* Life expectancy \<1 year
* Indication for pacing
* Atrioventricular (AV) node ablation
* Permanent atrial fibrillation or atrial flutter
* Indication for cardiac resynchronization
* Preexisting, separate pacemaker pulse generator that won't be explanted
* Intra-aortic balloon pump or other device
* Inotropic drug (not digitalis) necessary for hemodynamic support
* Chronic serious bacterial infection
* Inability to receive pectoral non-thoracotomy lead ICD
* Inability to program device according to protocol
* History of Out of Hospital Cardiac Arrest (OHCA) or sustained Ventricular Tachycardia as an indication for ICD (secondary prevention indication)
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine

The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Is between the ages of 18 and 55 years.
* Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura.
* Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months).
* Has age of onset of migraine less than 50 years old.
* Is able to give written Informed Consent

Exclusion Criteria:

* Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
* Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site.
* Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), coronary artery disease or recent myocardial infarction.
* Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people.
* Has had a previous bilateral or right cervical vagotomy.
* Has a clinically significant irregular heart rate or rhythm.
* Has uncontrolled high blood pressure.
* Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
* Has a history of carotid endarterectomy or vascular neck surgery on the right side.
* Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore™ stimulation site.
* Has a recent or repeated history of syncope.
* Has a recent or repeated history of seizure.
* Has a history or suspicion of narcotic abuse.
* Takes medication for acute headaches more than 10 days per month.
* Is pregnant, nursing, thinking of becoming pregnant in the next 3 months, or of childbearing years and is unwilling to use an accepted form of birth control.
* Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
* Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
* Is a relative of or an employee of the investigator or the clinical study site.
Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome

This study will begin to evaluate personalized preventative dementia treatments for Veterans at risk for developing dementia. The investigators will target Veterans with Motoric Cognitive Risk syndrome (MCR), which is characterized by slow gait speed and cognitive concerns (e.g., problems with memory or concentrations).

This study will involve therapeutic exercise treatments for Veterans with pre-clinical dementia syndrome. Participants will either participate in functional power training, music-based walking training, or a combination of both. The study will use a sequential multiple assignment, randomized trial (SMART) design. Successful completion of this study will lay the foundation for subsequent research trials, contributing to valuable evidence for personalized rehabilitation medicine for older Veterans.

Eligibility Criteria:
Inclusion Criteria:

1. Age 65
2. Receiving VA primary care
3. Community-dwelling
4. Motoric Cognitive Risky Syndrome i. Slow gait speed ii. Subjective cognitive concerns/complaints

Exclusion Criteria:

1. Non-English speaking
2. Presence of a terminal disease
3. Major medical problem
4. Myocardial infarction or major surgery in the previous 3 months
5. Use of a walker
6. Dementia diagnostic
7. Mobility disability