cyrilzakka/clinical-trials huggingface dataset:
Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease

Von Hippel Lindau disease (VHLD) is an inherited syndrome characterized by vascular malformations, kidney cancer, adrenal gland and pancreas tumors. The VHL protein is not functional in the different disease associated lesions which results in production of high amounts of vascular endothelial growth factor (VEGF). Currently there are no clinical, radiographic or molecular markers that can predict the natural history of a given lesion. With 89Zr-bevacizumab positron emission tomography (PET) scanning, VEGF can be visualized and quantified.

The investigators hypothesize that 89Zr-bevacizumab PET imaging is a useful tool to predict the behaviour of disease associated lesions in patients with VHLD.

Adult patients with VHLD who have had routine magnetic resonance imaging (MRI) scans of central nervous system (CNS) and abdomen will undergo a 89Zr-bevacizumab PET scan. MRI will be repeated within 12 months.


Eligibility Criteria:
Inclusion Criteria:

* clinically or genetically proven VHLD
* at least 1 measurable, VHL associated lesion in the CNS
* routine MRI of the CNS ≤ 6 weeks before inclusion
* routine CT or MRI of upper abdomen ≤ 3 months before inclusion or planned ≤ 3 months after 89Zr-bevacizumab PET scan
* age ≥ 18 years
* written informed consent must be given according to good clinical practice (GCP), and local regulations

Exclusion Criteria:

* pregnancy
* any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, those conditions should be discussed with the patient before registration in the trial
Internet-based Stress Reduction Training for Students

The main objective of the current study is to evaluate whether a mindfulness based intervention delivered online can provide an effective resource for increasing psychological well-being among students. In addition, explore potential mechanisms through which the training lead to improvements by means of mediational analyses, with hypothesized variables like positive/negative affect and attention regulation.


Eligibility Criteria:
Inclusion Criteria:

* current student
* have an active e-mail account
* regular use of the internet

Exclusion Criteria:

* non-Swedish speaking
PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia

The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration will be approximately of 104 weeks per participant. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance treatment which will be followed by additional Extension phase 2 and long-term maintenance treatment. Efficacy of the participants will primarily be evaluated by Clinical Global Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
* Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
* Participants who are capable of and willing to fill out the questionnaire for themselves
* Participants who are compliant with self-medication or can receive consistent help or support
* Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

Exclusion Criteria:

* Participants with the past history of neuroleptic malignant syndrome (NMS)
* Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
* Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
* Participants who have been exposed to the study drug within one month before screening
* Participants with significant risk including suicide or aggressive behavior
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device

This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care

The study is an open-label observational study involving a minimum of 10 centers. A minimum of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV) treatment patients, will be enrolled. Enrollment will continue until all 3 of these conditions are met.

BAV-only patients will be followed through a 6-month post-treatment telephone follow up. Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or at 6 months post-BAV treatment, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic severe aortic stenosis (AS) patients who are not suitable candidates for aortic valve replacement surgery at the time of BAV procedure.
* Subject meets the Indication For Use.
* Probable survival to hospital discharge.
* Subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the Informed Consent Form. Alternatively, the legal guardian of the patient is able to give consent to participate.

Exclusion Criteria:

* Patient has undergone previous AVR
* Greater or equal to 3+ aortic insufficiency by echocardiogram obtained prior to planned BAV or intra-procedural predilation TAVR procedure
* Non-valvular AS
* Known congenital AV abnormality (e.g., bicuspid AV)
* Cardiogenic shock, as defined by a consistent systolic blood pressure \<80 mmHg off vasopressors or \<90 mmHg on vasopressors.
* Bacterial endocarditis ≤ 12 months prior to planned BAV procedure
* Unable to take aspirin (acetyl salicylic acid, ASA) or thienopyridine
* Any illness or condition which, in the Investigator's judgment, will compromise patient safety, or interfere with the interpretation of the treatment results
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial

We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.

This is a randomized, placebo-controlled, crossover, double- blind interventional study. Patients will receive 3.6 g of EPA and DHA fish oil and placebo oil for 6 months, randomly, in a crossover design, with a four month washout period between treatments.

Randomization will be stratified by ejection fraction (≤ 35% or \> 35%), and the type of the index arrhythmia (VT - spontaneous or inducible by electrophysiologic study (EPS), versus other - VF, SCD, Primary prevention - MADIT II).

Ischemia severity was chosen to be evaluated by Single Photon Emission Computed Tomography (SPECT) during stress (dipyridamol infusion).

Subcutaneous adipose-tissue biopsy, a biomarker considered the gold-standard for the objective assessment of long-term habitual dietary intake of fish and marine omega-3 PUFA (EPA and DHA) will be obtain.

Compliance will be monitored by counting returned capsules or bottles and by measuring the omega-3 PUFA composition in red blood cells (RBC).

Three different types of questionnaires will be used in this trial to obtain more information as to the additional potential benefit of omega-3 PUFA supplementation:

1. The newly Israeli Food Frequency Questionnaire (FFQ) will be used to examine dietary intake of other nutritional habits/patterns and its relationship to the study outcomes.
2. The Hebrew language SF-36 health survey will be used to examine general health status.
3. The Back questionnaires will be use to examine possible beneficial effects of fish oil supplementation on depressive symptomatology.

Eligibility Criteria:
Inclusion Criteria:

* post-MI patients.
* Both single and Dual chamber ICD recipient.
* implanted more than 3 months ago.
* Agree to give written informed consent.

Exclusion Criteria:

* Less than 18 years of age.
* ICD implantation as a 'bridge' to heart transplantation.
* Stable antiarrhythmic medication over the last month prior to enrollment.
* Patients taking class I antiarrhythmic medication.
* A projected lifespan less than one year.
* Participation in another trial (during or within 90 days before the study).
* Use of supplemental n-3 fatty acids during the last 3 months.
* Women who are pregnant and of childbearing potential who do not use adequate contraception.
* Patients known to have a history of recent drug or alcohol abuse. 10) History or current intestinal or hepatic disease.
Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis

Gastric cancer with para-aortic lymph node (PAN) involvement is regarded as advanced disease, and only chemotherapy is recommended from the guidelines. In unresectable cases, neoadjuvant chemotherapy could prolong survival if conversion to resectability could be achieved.


Eligibility Criteria:
Inclusion Criteria:

1. Gastric or gastroesophageal adenocarcinoma proven histologically .
2. Has para-aortic lymph node metastasis(PAN was defined as nodes in the region between the upper margin of the celiac artery and the upper border of the inferior mesenteric artery (stations no. 16a2/16b1))
3. Eastern Cooperative Oncology Group performance status of 0 to 1.
4. Life expectancy ≥12 weeks.
5. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).

   Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN , ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L。 Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
6. Female subjects should not be pregnant or breast-feeding.
7. No serious concomitant disease that will threaten the survival of patients to less than 5 years.

Exclusion Criteria:

1. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
2. History of another malignancy in the last 5 years with the exception of the following:

   Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer.
3. Any other metastatic disease will render patient ineligible according to AJCC staging manual(such as liver，lung，etc）.
4. Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
5. Poorly controlled diabetes mellitus with fasting blood sugar \> 18 mm. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
6. Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
7. Previous surgery on primary tumour; Prior palliative surgery (open and closure, passage operation)
8. Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated -
Does an Active Range of Motion Monitor Improve Outcomes/Decrease Cost for Patients Undergoing Total Knee Arthroplasty?

The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA.

The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA. Patients will be given the opportunity to participate, and enrolled and consented participants will be treated and followed by physicians from OSI Orthopedic \& Sports Medicine. Upon consent, patients will be randomized to receive the active range of motion monitor (the knee glider) two weeks prior to surgery, near day of surgery to use postoperatively, or standard of care (no knee glider). All patients enrolled in the study will have access to Force Therapeutics, patient engagement and outcome collection system utilized by OSI Orthopedic \& Sports Medicine. Enrolled subjects will be followed from the time of consent, through 6 months following surgery. Patients who are randomized into groups receiving the knee glider will receive the knee glider for up to 4 weeks following surgery, and compliance will be monitored. The hypothesis of this study is that patients who utilize an active range of motion monitor (the knee glider) will have improved clinical outcomes over patients receiving standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have undergone Total Knee Arthroplasty (TKA) and have agreed to participate in this study.

Exclusion Criteria:

* Individuals who have not undergone TKA.
Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After CABG

The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG.

The main question it aims to answer is:

Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG .

Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works.

Participants will

1. Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG.
2. Clinical follow-up at Week 1, 4, 12, and 24 after CABG.
3. Protocol-driven CCTA at Week 24 after CABG.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years old，
* Any sex，
* Signed informed consent，
* Within 3 days after primary isolated CABG using RA graft

Exclusion Criteria:

1. Allergy to isosorbide mononitrate or amlodipine.
2. Hypotension (systolic BP \<90 mmHg or diastolic BP \<60 mmHg)
3. Acute myocardial infarction or cardiogenic shock
4. Contraindications for CCTA examination (eg., iodine allergy)
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.


Eligibility Criteria:
Inclusion Criteria:

* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
* Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
* Any intraocular inflammation in the study eye present during the screening slit lamp examination
Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

Glutamine is considered a conditionally essential amino acid during critical illness. After severe trauma, glutamine supplementation into the gastrointestinal tract may help maintain bowel function. We hypothesize that for the major torso trauma patient, high dose glutamine given enterally during resuscitation from shock and continued during enteral nutrition support is absorbed, available systemically and preserves gut integrity.

In this prospective, randomized, controlled trial of patients with major torso trauma, high-dose enteral glutamine and enteral nutrition will be given to research subjects while controls will receive isocaloric, isonitrogenous enteral support. Enteral tolerance, bowel integrity and permeability will be evaluated. The systemic appearance of glutamine will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Adult trauma patients meeting criteria for shock resuscitation
* Major torso trauma
* Admission to the Shock/Trauma Intensive Care Unit

Exclusion Criteria:

* Age \<18 years
* Pregnant
* Expected survival \< 24 hours
* Bowel in discontinuity
* Renal failure: baseline serum creatinine\>3.0 and/or dialysis
* Admission total bilirubin \>10 mg/dl
* History of cirrhosis or cirrhosis apparent on exploratory laparotomy
* Asystole or CPR required
Evaluating Adult Patient Temperatures During Lower Spinal Surgery

The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not. The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.

Patients were randomly assigned to either the treatment group or the control group prior to surgery. Prior to induction, patients in the control group were given inspiratory gas at ambient air temperature (20-22 degrees Celsius) and patients in the treatment group were given inspiratory gas at warmed temperatures (40-41 degrees Celsius). All patients were induced with general anesthesia in the supine position and repositioned prone following endotracheal intubation and placement of an esophageal stethoscope with a temperature sensor, as per usual hospital practice. Esophageal temperatures were recorded within 30 minutes of the baseline esophageal temperature and every 10 minutes thereafter for the first hour post-induction. All patients had a blanket and forced air warming applied to their lower extremities and upper back at 43 degrees Celsius after draping. All patients had esophageal temperature measurements recorded every 30 minutes until the patient was repositioned supine. Core temperatures were recorded four hours post-induction for those patients reaching that timeframe.

Eligibility Criteria:
Inclusion Criteria:

* Elective spine surgery anticipated greater than three hours in duration
* Posterior approach
* An operative site between lumbar one and sacral one
* Involving two or more levels with fusion and/or instrumentation and/or revisions
* American Society of Anesthesiologists (ASA) Status of I-III

Exclusion Criteria:

* Patients with a tracheostomy
* Preoperative temperature \>38°C or \<36°C on the day of surgery
* Active infection or erythema to the back
* White blood cell count greater than 10,500/microliter (mcL)
Knowledge, Attitude and Practice of Gastrointestinal Endoscopists Toward PPE in COVID-19 Era

Assessing the knowledge and practice of GIT endoscopists toward the use of PPE.

An online questionnaire assessing the knowledge and practice of GIT endoscopists toward the use of PPE will be used.

Eligibility Criteria:
Inclusion Criteria:

* GIT endoscopists

Exclusion Criteria:

* Refuse to participate
Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).

A 26 week maintenance study of CDP870 in Crohn's disease


Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3)\*. \* Vienna Classification (1998)
* Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.
* Patients aged 18 years or above at screening.

Exclusion Criteria:

* Crohn's Disease Related
* Fistula abscess present at screening.
* Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
* Short bowel syndrome.
* Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
* Positive stool laboratory results for enteric pathogens.
Lifestyle Changes in Older Adults With Metabolic Syndrome and Tinnitus

The problem of tinnitus (subjective type) is prevalent in obese older adults with different diseases such as metabolic syndrome. The changes of lifestyle are very important to lose weight, improve tinnitus and metabolic syndrome

Sixty older adults (with metabolic syndrome with chronic subjective tinnitus) with obesity were selected in a equal random manner to be classified into the first group that administered changes in their lifestyle (exercise applied on treadmill and low caloric diet) for twelve successive weeks and second group that was not administered lifestyle changes

Eligibility Criteria:
Inclusion Criteria:

* obese person (class one obesity)
* patients with metabolic syndrome
* patients with chronic subjective tinnitus (bilateral complaint from more than six months).
* older adults aging 65 years and more
* both sexes will be included

Exclusion Criteria:

* respiratory insult
* cardiac insult
* liver insult
* kidney insult
* lower limb insult
* neurological insult