cyrilzakka/clinical-trials huggingface dataset:
Enriching Clinical Trials Requiring Amyloid Positivity With Practice Effects

The primary objective of this study is to demonstrate that individuals with low short-term practice effects (STPE) on cognitive testing are more likely to be identified as "positive" on amyloid imaging than individuals with high STPE. STPE may also inform us about other AD-related biomarkers, including hippocampal volumes, functional connectivity, and APOE status. By realizing the aims of this pragmatic study, we hope to be able to offer more economical and efficient screening of potential participants for clinical trials, which would reduce participant burden and financial costs.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Identified as intact, Mild Cognitive Impairment, or Alzheimer's disease
* Able to complete study procedures
* All participants must have a collateral source (e.g. spouse, adult child, caregiver, close friend) available to briefly comment on the cognitive abilities and daily functioning of the participant. If the participant is diagnosed with probable AD dementia, a legally authorized representative (e.g. spouse, adult child) must be available to provide informed consent for the participant.

Exclusion Criteria:

* History of major stroke, head injury with loss of consciousness of \>30 minutes, or other neurological/systemic illness that may affect cognition
* Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder)
* History of substance abuse
* Current use of antipsychotics or anticonvulsant medications
* Known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
* Need for monitored sedation or anesthesia during PET or MRI scanning.
* Claustrophobia to a degree that the individual cannot undergo PET or MRI imaging
* History of metal injury which precludes the individual from undergoing MRI imaging
* Evidence of stroke or mass lesion on a CT or MRI scan
* History of radiation therapy to the brain
* History of significant major medical illnesses, such as cancer or AIDS.
* Inadequate vision, hearing, and manual dexterity to participate in the cognitive assessments.
* 15-item Geriatric Depression Scale score of \>5
* Clinical Dementia Rating score of \>1
* Mini Mental State Examination score of \<20
Effect of Woodsmoke on Vascular Function

Exposure to air pollution is a well established risk factor for the development of heart disease. Firefighters are exposed to excess air pollution in the form of wood smoke during the extinguishing of forest or woodland fires. Heart attacks in on-duty firefighters have been linked to specific duties and in particular fire suppression, but the reasons for this increase in risk are not well understood. Exposure to wood smoke may alter blood vessel function and increase blood clot formation to explain the link between fire suppression and heart attacks.

The investigators wish to determine the effect of exposure to wood smoke at concentrations found at the perimeter of a woodland fire on blood vessel function and clotting in healthy non-smoking male professional firefighters or volunteers. Volunteers will be studied before and after inhalation of wood smoke or clean air for one hour in a purpose built whole-body exposure chamber. The investigators will perform comprehensive vascular assessments thereafter.

Understanding the effects of wood smoke on the blood vessels and clotting will be an important first step in helping to protect firefighters from heart disease. Through research, the investigators hope to identify methods to minimise the risk of heart attacks in firefighters and understand the health effects of a major source of air pollution that is relevant to the general population.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking healthy male firefighters or volunteers

Exclusion Criteria:

* Current smoker or regular users of snus
* History of lung or ischaemic heart disease
* Malignant arrhythmia
* Systolic blood pressure \>190mmHg or \<100mmHg
* Renal or hepatic dysfunction
* Previous history of blood dyscrasia
* Unable to tolerate the supine position
* Blood donation within the last 3 months
* Recent respiratory tract infection within the past 4 weeks
* Routine medication including aspirin and NSAIDs
Case Series Assessing TissuGlu® Surgical Adhesive in Flap Surgery for Decubitus Repair

To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.

A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.

Eligibility Criteria:
Inclusion Criteria:

* undergoing a procedure for decubitus repair
* be 22 years of age or older

Exclusion Criteria:

* expected flap size less than 5 sqcm
Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma

This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.


Eligibility Criteria:
Inclusion Criteria:

* Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy.
* Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts: subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy or newly diagnosed subjects who are not candidates for anthracycline-based therapy.
* At least 1 measurable disease lesion that is \> 1 cm in the longest transverse diameter, with a product of the diameters \> 2.25 cm2 by CT or magnetic resonance imaging (MRI).

Exclusion Criteria:

* Candidate for potentially curative therapy such as stem cell transplantation.
* Prior allogeneic hematopoietic stem cell transplantation (HSCT).
* Prior autologous transplantation, radioimmunotherapy, or other anti CD22 immunotherapy \<= 6 months before the first dose of investigational product.
* More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer regimens.
"Pharmacokinetic Study of Nicotinamide Riboside"

Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®, ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for NR have not been reported in humans. This study will use a recently-developed, whole blood assay for NR to assess the pharmacokinetics of NR at a maximum dose of 1000 mg twice daily, and will collect history, physical examination and laboratory data to determine the safety and tolerability of NR in eight, healthy volunteers. In addition, whole blood nicotinamide adenine dinucleotide (NAD) levels will be measured at each time point, to determine whether this NR dose significantly raises whole blood NAD levels.

1. On Day 1, participants will have a baseline assessment, including blood pressure and heart rate, as well as baseline assessment of "safety" labs: complete blood count with white blood count differential and platelets, serum chemistry panel (sodium, potassium, chloride, glucose, blood urea nitrogen and creatinine), uric acid, creatine kinase, aspartate aminotransferase and alanine aminotransferase, and lactate dehydrogenase.
2. Participants will receive 250 mg nicotinamide riboside (NR) by mouth daily on Days 1-2, 250 mg NR by mouth twice daily on Days 3-4, 500 mg NR twice daily by mouth on Days 5-6 and 1000 mg NR twice daily by mouth on Days 7-8.
3. On Day 2, a blood sample will be obtained from each participant to measure serum chemistry panel to assess for the possibility of hyperkalemia and hyperglycemia. In addition, an instant read potassium will be measured using a point-of-care device available on the University of Washington (UW) General Clinical Research Center (GCRC). If the potassium is greater than 5.5, a repeat value and an ECG will be performed and the Study Investigator. If it is greater than 6.0, the Study Investigator will evaluate the subject for admission.
4. On Day 9 prior to receiving their morning dose, participants will be admitted to the UW GCRC for an overnight stay.

   1. In the UW GCRC, the participants will receive the last 1000 mg dose of NR at time=0.
   2. Blood samples will be collected at time = 30 minutes and at 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours.
   3. Whole blood samples will be frozen at -80 degrees C until assayed for NR and NAD+.
   4. "Safety labs" performed on Day 1 will be repeated

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult (age 21-50 years), male or female
* Willing and able to provide informed consent

Exclusion Criteria:

* Current smoking
* Receiving concurrent medications or supplements
* History of liver, renal, cardiovascular, endocrine, or neurological disease
* Known allergy to niacin or nicotinamide ribosome
* Unwilling to refrain from drinking alcohol during the duration of the study
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction

The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular implantable electronic device (CIED) leads during transvenous lead extraction (TLE) procedures in a multi-center study. IVUS should identify the location and severity of these adhesions, which the investigators will then correlate to difficulty of the extraction procedure using metrics like pulses of laser energy delivered and time required to traverse an area of fibrosis or ILA. The investigators will be focusing primarily on the section from innominate vein (INNV) down through the superior vena cava (SVC) to the right atrium.

Using IVUS to view blood vessels and the heart structure is approved by the Food and Drug Administration (FDA). Using it as described in this study is off label because of the manner in which it is advanced to the SVC, through the right atrium. While it is not restricted from use in this way, it is not specifically on-label. It should be noted that the use of IVUS during TLE procedures as proposed in this study is routine at the University of Chicago and patients will undergo this procedure regardless of participation in this study. The EP physician team regards the use of IVUS during TLE to be nonsignificant risk.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 21 years of age
* Patients with at least one lead over 1 year dwell time requiring extraction

Exclusion Criteria:

* Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
* Venous occlusion to the extent that the IVUS catheter cannot pass
* Leads \< 1 year dwell time requiring extraction
Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Background:

Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses.

Objective:

Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.

Hypothesis:

SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed.

Methods:

All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally.

Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports.

Randomization will be performed before surgeries after patients have given their informed consent to the study.

No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent.

Endpoints:

* Morbidity
* Body image and Cosmetic results
* Post-operative pain (opioid sparing effect)
* Operative time
* Hospital stay


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years

Exclusion Criteria:

* Contraindication to laparoscopy
* Liver disease
* Cognitive trouble
Efficacy And Safety Of Unfractionated Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass

The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients over the age of 18 years;
* Patients with indication for cardiac surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb \<11.0 g / dL, platelets \<100,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (APTTr\> 1.40);
* Patients with renal impairment (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with a history of heparin-induced thrombocytopenia;
* infection (eg endocarditis, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet agents (clopidogrel and ticlopidine) for less than 7 days;
* Use of aspirin for less than 5 days;
* Use of heparin, low molecular weight less than 24 hours;
* Use of unfractionated heparin for less than 12 hours.
Beverage for Immune Support

Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be able to understand and provide informed consent
2. Males and Females ≥18 to 65 years of age;
3. Have diagnosis of EG/EGE
4. Have histologically confirmed active disease \> 30 eosinophils/hpf
5. Symptomatic (have experienced symptoms within the last one months prior to enrollment).
6. Female subjects of childbearing potential must have a negative pregnancy test upon study entry
7. Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study-specific methods may be listed, if applicable

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Secondary causes of gastrointestinal and peripheral eosinophilia
3. Eosinophilic infiltration isolated to the esophagus.
4. Pregnancy
5. Immunodeficiency states
6. Have been treated with topical swallowed steroids within the last 6 weeks or systemic steroids within the last 2 months unless repeat endoscopy is performed and shows active inflammation on these therapies in which case these medications will be allowed to be continued without dose escalation.
7. Have taken immunosuppression medication or immunomodulators within 2 months of the study unless the recent/baseline endoscopy has active histologic inflammation while on these medications. In this case, these medications will be permitted to be continued as long as the dose is not escalated during the treatment phase.
8. Have been on an elemental diet previously for six weeks with follow up endoscopy completed.
9. Have participated in any investigative drug study within 6 weeks prior to study entry.
10. Unable to complete study procedures including endoscopy.
11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Effect of Yellow Pea Protein and Fibre Added to a High-carb Meal on Glycemic Response and Food Intake

The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* No metabolic disease
* BMI 20 - 25 kg/m\^2
* male
* age 20-30

Exclusion Criteria:

* Intolerance to treatments
* on appetite-modifying medications
* restrictive eating
* smoking
* over or underweight
* breakfast-skipping
Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC.

With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above.

In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible.

This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, biopsy-proven World Health Organization (WHO) types II or III NPC; Stage I disease (American Joint Committee on Cancer 7th edition); Between 18 and 70 years old; Adequate bone marrow, liver and renal function; Satisfactory performance status: a score of 0 or 1 using the Eastern Cooperative Oncology Group System; Patients provided signed informed consent.

Exclusion Criteria:

* Evidence of relapse or distant metastasis; History of prior malignancy or previous treatment for NPC; The presence of uncontrolled life-threatening diseases; The investigator considered the patient unable to complete the study.
Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO.

One hundred and ten patients with macular edema (ME) secondary to BRVO are randomized (1:1) to treatment with intravitreal injections of aflibercept or ranibizumab. An initial loading dose of at least three monthly injections is given in the study eye until the ME is resolved. Then patients are observed at regular intervals, initially every four weeks until study completion. Total follow-up time is nine months from baseline to completion. If ME recurs, patients are treated according to a treat-and-extend algorithm.

At every visit, visual acuity (VA) is measured with an ETDRS chart at 4 m. The fundus is examined by indirect ophthalmoscopy and by optical coherence tomography (OCT). Macular ischemia is evaluated with OCT angiography (OCT-A), visual field status with computerised perimetry and retinal sensitivity with microperimetry. Choroidal thickness is evaluated with enhanced depth imaging (EDI) OCT. Vision related quality of life (QoL) with NEI VFQ25.

Eligibility Criteria:
Inclusion Criteria:

* BRVO naïve patients, disease duration 1-6 months, BCVA 23-73 ETDRS letters (20/40-20/320), macula edema with intraretinal cysts and CRT \> 300 micrometers (Cirrus)

Exclusion Criteria:

* BRVO with neovascular component, intraocular surgery during the previous 3 months, earlier vitreoretinal surgery, vascular retinopathy of other cause, intraocular infection/inflammation, myocardial infarction och cerebrovascular stroke during the last 3 months.
Clinico-demographic Features of Patients With Acne Vulgaris

The Global Burden of Disease Study 2010 found that acne vulgaris is the eight most common skin disease, with an estimated global prevalence (for all ages) of 9.38%.(1) Furthermore . Acne is a chronic inflammatory process that presents with two types of lesions clinically; non-inflammatory (closed and open) and inflammatory lesions (papules ,pustules ,nodules and post inflammatory pigmentary changes).


Eligibility Criteria:
Inclusion Criteria:

* patients of both sexes with clinical evident acne vulgaris
* any age

Exclusion Criteria:

* no exclusion criteria