cyrilzakka/clinical-trials huggingface dataset:
Neurofibromatosis (NF) Registry Portal

The NF Registry is a database of patient-reported symptoms, treatments, and experiences with their neurofibromatosis disease. It is a contact registry to relay clinical trial opportunities to targeted patient subgroups, and to supply de-identified disease data to researchers. It has the potential to become a natural history resource.

Patients and parents of patients will be made aware of the Neurofibromatosis (NF) Registry through various non-commercial information sources such as the Children's Tumor Foundation (CTF) website, CTF-affiliated NF clinics, social media, CTF educational and fundraising events, and other nonprofit organizations and foundations such as the National Organization for Rare Diseases (NORD) and social media.

The NF Registry will be accessed by individual adult (over age 18) subjects via a web-based patient portal. The portal contains an IRB-approved informed consent form. Following consent, the registrant creates an account which is activated after email confirmation. An account can be created by an adult patient with the disorder, or by the parent or guardian of a child with the disorder. Account creators are required to enter identifiable contact and demographic data.

After the account is created, the account owner enrolls themselves or a minor family member (or both) and completes an on-line survey. There are separate surveys for NF1, NF2, and Schwannomatosis. The surveys ask about about the affected individual's medical and family history of the disease, testing and diagnosis, clinical manifestations (e.g., tumor types and locations) interventions and therapies, and quality of life. The account holder chooses whether to receive emails from the Registry with information about relevant clinical trials and studies for which they may be eligible.

Participant's responses are used to compile charts and graphics of de-identified aggregate data. Registered patients may view this data. Researchers may apply to our Data Use Committee for access to de-identified data or for subject recruitment emails to be sent to specific patient subgroups. Data capture and security for the NF Registry is done under contract by OpenApp (Dublin, Ireland), a web-based patient opt-in registry provider.Participants will be asked to update their information at least once a year. Their information will be stored in the NF Registry for an indefinite period of time. This longitudinal study is intended as a resource for patients and researchers. There is no specific outcome measure or anticipated endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with NF1
* Diagnosed with NF2
* Diagnosed with Schwannomatosis

Exclusion Criteria:

* Failure to complete account registration
Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis

The objective of this study is to evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS), as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA).

This is a 6-months retrospective study including patients with concomitant gonarthrosis and EHOA, defined as the presence of central erosion in at least two interphalangeal joints. Eligibility criteria are symptoms duration for at least 3 months, with a global hand pain score ≥40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score ≥6. The participants are stratified into two groups based on whether or not pCGS, at the daily dose of 1500 mg, was added to the conventional therapy for hand osteoarthritis (HOA). The latter consists of education and training in ergonomic principles, exercise and the use on-demand of acetaminophen or oral non-steroidal anti-inflammatory drugs. Patients are evaluated at baseline, after 3 and 6 months. Primary outcome measures are the change from baseline to month 6 in VAS and in FIHOA score. Secondary outcomes are duration of morning stiffness, health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36), symptomatic drugs consumption and percentage of treatment responders, according to the OMERACT/OARSI criteria.


Eligibility Criteria:
Inclusion Criteria:

* Erosive Hand Osteoarthritis, defined as the presence of the classical central erosion in at least two interphalangeal joints
* Treatment for at least 6 consecutive months with prescription-grade crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone.
* Symptoms duration for at least 3 months defined as global hand pain score superior to 40 mm on a 0-100 VAS and a FIHOA score of at least 6.

Exclusion Criteria:

* Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis
* Concomitant therapy with SYSADOAs, other than pCGS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months
* Concomitant treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months
* Contraindications or special warnings for pCGS presented in the data sheet.
The Effect of Trendelenburg Position on CCA Blood Flow

The investigators will evaluate the change of the common carotid artery blood flow according to patient's position and penumoperitoneum.

The study will include 20 patients undergoing gynecological surgery. The common carotid artery blood flow will be measured using Doppler US during the following conditions; supine position before induction of anesthesia, supine position immediately after induction of anesthesia, supine position with penumoperitoneum, head-down position with or without pneumoperitoneum.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I,II
* patients undergoing gynecology surgery under trendelenburg position
* Age ranges from 20 to 70

Exclusion Criteria:

* BMI \> 32
* Pregnancy
* Patients who did not agree to study
* Patients with allergies to the drugs used in this study
* Patients with anatomical variations or lesions in cervical or cranial vascular portion
* Patients with arrhythmia that may alter patient's cardiac output(e.g. artrial fibrillation)
Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis

Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
* Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
* Patients older than 18 years and younger than 75 years of age at the time of consent
* Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
* Patients willing and able to comply with study requirements for follow-up

Exclusion criteria:

* Patients who are treated with intragastric balloons
* Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
* Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
* Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
* Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
* Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy
* Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease
* Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer \>1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency,
* Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent.
* The patient refuses or is unable to provide written informed consent
* Prior bariatric treatment procedure
Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT

Multicentric, observational, registry-based study of 0.9 mg/kg i.v. thrombolysis in wake-up stroke or stroke with unknown onset based on non-contrast CT appearance only

Thrombolysis in wake-up stroke (WUS) or stroke with unknown onset (SUO) has been recently proven to be safe and effective using magnetic resonance imaging (MRI). However, in most of the thrombolyzing hospitals worldwide MR imaging is not available. We hypothesize that pragmatic non-contrast CT (NCCT)-based WUS/SUO thrombolysis may be feasible and safe.

Methods: TRUST-CT is an international multicenter registry-based study. WUS/SUO patients undergoing NCCT-based thrombolysis with NIHSS ≥ 4 and initial ASPECTS ≥ 7 are included and compared to propensity score matched non-thrombolyzed WUS/SUO controls. Primary endpoint is symptomatic intracranial hemorrhage (ICH); secondary endpoints include 24-hour NIHSS change of ≥ 4 and modified Rankin Score (mRS) at 90 days.

Eligibility Criteria:
Inclusion:

1. Ischemic stroke with NIHSS ≥ 4
2. Wake-up stroke or unknown onset stroke
3. Age ≥ 18 years
4. rtPA Bolus within 4.5h of awakening and/or within 4.5 of discovering symptoms
5. rtPA Bolus within 30 min. of admission CT

Exclusion:

1. Noncontrast cranial CT scan with ASPECTS \< 7
2. Evidence of intracranial or subarachnoid hemorrhage
3. Inability to control systolic BP \>185mm Hg, or diastolic BP \>110mm Hg with IV antihypertensive medication
4. Known coagulopathy or evidence of active bleeding
5. Surgical procedures, subclavian arterial puncture, trauma, and gastrointestinal or genitourinary bleeding within 14 days of the event
6. Patients taking oral anticoagulants and having an INR \>1.7
7. A platelet count \<100 000, venous glucose either \<50 or \>450
8. Premorbid mRS \> 3
Naloxone for Optimizing Hypoxemia Of Lung Donors

Brain-dead patients who provide authorization for organ donation will be randomized to naloxone or placebo if baseline arterial blood gas (ABG) after initiation of OPO (Organ Procurement Organization) management reveals hypoxemia, as defined by the ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) below 300 mm Hg, unless they have already been ruled-out for lung recovery. Investigators aim to assess whether naloxone improves oxygenation prior to organ recovery more than placebo.

Naloxone has been used by many OPOs for decades to improve the pulmonary status of brain-dead organ donors (based on anecdotal evidence and small uncontrolled studies). Its efficacy in this population has never been assessed in a controlled clinical trial. The rationale for its use appears to be that it blocks the increase in capillary permeability that occurs with herniation and brain death (as demonstrated in a single sheep study of herniation). Investigators aim to rigorously test this hypothesis in a randomized placebo-controlled trial in brain-dead organ donors who have baseline hypoxemia. The primary outcome will be the acute change in oxygenation (on first follow-up ABG after naloxone as well as the final ABG prior to organ recovery). Investigators will also assess whether treatment results in more lungs being recovered and transplanted, after correcting for baseline variables such as age, blood group, smoking history, and cause of death. This study will be performed under the auspices of the Organ Donation Research Consortium and be carried out by multiple OPOs across the country. Naloxone or blinded placebo (identical syringe filled with saline) will be given after the baseline ABG shows hypoxemia (PFR - PaO2 divided by FiO2, on positive end-expiratory pressure \[PEEP\] of 5 and usually 100% FiO2). Naloxone and placebo will both be co-administered with a neuromuscular blocking agent (e.g. vecuronium, per center protocol) to obviate any increase in spinal reflex movements that may be potentiated by naloxone treatment. All other protocols for organ donor management should be maintained at each OPO and no other study interventions are required. Transplant centers will be informed (through DonorNet) that the organ donor being considered for lung recovery has been enrolled in this blinded clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Brain-dead organ donor being managed by OPO (organ procurement organization)
* Lungs being considered for recovery and transplant
* Baseline ABG (after authorization) with P/F ratio \< 300

Exclusion Criteria:

* No authorization for research
* Lungs already excluded for transplant (e.g. known chronic obstructive pulmonary disease \[COPD\], human immunodeficiency virus \[HIV\] infection)
Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery

Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV preventive effect of palonosetron and combination of palonosetron and dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* patients who are undergoing minor orthopedic surgery.
* IV patient controlled analgesia

Exclusion Criteria:

* 1. minority (0\~19 year)
* patients who are belongs to ASA class 3 or more, and have underlying complicated cardiovascular or psychological disease.
* Steroid medication
* Diabetes Mellitus medication
A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation

The main aim of this study is to assess the safety profile of maribavir when treating refractory cytomegalovirus (CMV) infection after transplantation in adults with kidneys that are no longer functioning on their own (also called end-stage renal disease or ESRD) or have severe chronic kidney disease requiring artificial filtering of the kidney (dialysis) or the blood (hemodialysis).

In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.


Eligibility Criteria:
Inclusion Criteria

* Adults more than and equal to (≥) 18 years of age at index date
* Diagnosis of ESRD or severe chronic renal disease prior to the index date

  * If ESRD: participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (\<) 15 milliliter per minute (mL/min)
  * If severe chronic renal disease: participant diagnosed with severe chronic renal disease requiring peritoneal dialysis or hemodialysis; participant has an eGFR of 15 to \<30 mL/min at index
* Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before index date
* Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period
* Participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir
* Informed consent provided (where required by local regulations) before data collection commences

Exclusion Criteria

There are no exclusion criteria for this study
Compassionate Use of the Incraft® AAA Stent Graft System

To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of the clinical protocol through compassionate use.

In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths. The most significant complication of AAA is an aneurysm sac rupture from which more than 15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to 85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm repair (EVAR) and open surgical repair cases were performed in the year 2010 .

Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an alternative treatment of AAA for most patients. It is less invasive than open repair and carries lower rates of early mortality and morbidity . It has also extended treatment options to patients who cannot undergo conventional surgical procedures due to a high operative risk. As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the aortic neck and access vessels.

The InCraft ®AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, which assists the physician in deploying the device in a controlled, consistent, and precise manner within the aortic neck and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and the potential for aneurysm sac rupture.

Eligibility Criteria:
1. Obtain an independent assessment by an uninvolved physician.
2. Obtain informed consent from the patient or legal representative. The consent form used should provide information pertinent to the patient's specific situation. (If appropriate, the study consent form may be used with an addendum to inform the patient of concerns specific to their situation.)
3. Obtain clearance from the institution in accordance with their policies.
4. Notify the institutional review board and comply with their procedures.
Swedish Antibiotic Nursing Home Trial

Main aim and objective

The aim was to present the treatment of infectious diseases in elderly, especially in nursing homes and further to evaluate the effect of an intervention package aiming at improving treatment with antibiotics in Swedish nursing homes

Specific objectives

* Present the treatment patterns regarding infectious diseases, including gender aspects in elderly, especially in nursing homes.
* Through focus group discussions elucidate the decision making process in nursing homes and target the intervention.
* Based on the above information develop an educational intervention to contribute to the improvement of the prescribing of antibiotics in nursing homes
* Evaluate the effect of the intervention on quality of prescribing, knowledge and attitudes in relation to available guidelines


Eligibility Criteria:
Inclusion Criteria:

* nursing homes where residents have a common dining room and staff, and a self-assessed stable staff situation

Exclusion Criteria:

* specialised nursing homes or wards (e.g. oncology wards)
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients

The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.

This study will recruit approximately 100 CML patients under imatinib therapy in complete molecular remission with a history of at least 18 months of consecutive negative standard Q-RT-PCR as performed in their own centers. After signing the informed consent form (ICF), the patients will be tested for dPCR and will discontinue imatinib therapy. Then they will be monitored by standard Q-RT-PCR to assess the maintenance of the molecular remission; collection of data will be prospective as each center will collect the data for 36 months. At the end of this period, a peripheral blood sample for dPCR analysis will be obtained from those patients who will still have undetectable BCR-ABL transcripts by Q-RT-PCR to verify CML eradication. The maintenance of molecular remission by Q-RT-PCR and the survival will be monitored every six months during an additional follow-up of 24 months. Patients found to be positive to BCR-ABL transcripts by standard Q-RTPCR will repeat the test every 2 to 4 weeks until the loss of molecular remission, defined as two consecutive BCR-ABL positive tests with at least one with BCR-ABL/BCR value above 0.1%, or until the end of the study, whichever come first.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated IRB/IEC-approved Informed Consent
2. Age\>=18 years
3. Male or female patients with CML diagnosed in chronic or accelerated phase and who have been treated for more than 2 consecutive years with imatinib therapy
4. Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment
5. A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the list one performed within 3 calendar months prior to enrollment date
6. Willingness and ability to comply with scheduled visits laboratory tests and other study procedures

Exclusion Criteria:

1. Allogenic hematopoietic stem cell transplantation
2. Known active infections including human immunodeficiency virus (HIV) positivity
3. Current enrollment another clinical trial
4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results