cyrilzakka/clinical-trials huggingface dataset:
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP)

The primary objective of this study is to investigate the anti-angiogenic effect of bevacizumab measured by CTP as a predictive marker for efficacy measured by progression-free survival (PFS) in mCRC patients under first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy

So far, CTP has provided non-invasive imaging of tumor biological response to anti-angiogenic and vascular targeting agents in a number of clinical trials with increasing clinical application. CTP can be examined with a variety of commercially available CE-certified CT scanners and imaging post-processing is possible with commercially available CE-certified software from different vendors, too. In several studies, anti-angiogenic effects have been detected with CTP but further evidence for its clinical validation has to be proven in clinical trials.

Changes in tumor vasculature measured by CTP will be correlated to the clinical efficacy parameters progression-free survival, overall survival and response rate, thus identifying a group of patients who profit most from the anti-angiogenic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, male or female
* Signed written informed consent
* Patients with histologically confirmed diagnosis of colorectal cancer with hepatic metastases who are candidates for systemic treatment.
* Confirmation of metastatic liver disease within one month prior to inclusion in one of the following radiological procedures:

  * Contrast-enhanced spiral computed tomography showing at least one liver nodule ≥ 20 mm in longest diameter according to RECIST 1.1 criteria
  * MR imaging of the liver with liver lesions suspicious for metastases
  * PET computed tomography (PET/CT) with liver lesions suspicious for metastases
* Patient is eligible and designated for treatment with standard-of-care first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy.
* ECOG performance status ≤ 2 (see appendix)

Exclusion Criteria:

* Inability or unwillingness to comply with the participation requirements
* History of untreated hyperthyreosis
* History of intolerance of or allergy to iodine contrast media according to CTCAE V4.03
* Calculated creatinine clearance \< 45 ml/min
* For fertile women: positive urine pregnancy test or lactation.
* Known or suspected non-compliance, drug or alcohol abuse
* Life expectancy of less than 3 months
* Participation in another interventional trial with an investigational medicinal product (IMP) and within 30 days prior to screening
Long Term Health Outcomes of Women Veterans' Service During the Vietnam Era

Little is known about the long-term health and mental health status of women Vietnam veterans. For many of these women, the effects of this war are still present in their daily lives. As these women approach their mid-sixties, it is important to understand the impact of wartime deployment on health and mental health outcomes nearly 40 years later. The investigators propose to assess the prevalence of posttraumatic stress disorder (PTSD) and other mental and physical health conditions for women Vietnam veterans, and to explore the relationship between PTSD and other conditions and the Vietnam deployment experience. The investigators are interested in studying women Vietnam veterans who may have had direct exposure to traumatic events. For the first time, the investigators also want to study those who served in facilities near Vietnam. These women may have had similar, but less direct exposures. This cross-sectional study will seek to contact approximately 10,000 women for participation in a mailed survey, telephone interview and a review of their medical records. Women identified as serving in Vietnam, near Vietnam (in Asia during the Vietnam Ware) and in the U.S. during the Vietnam War will be identified from an established cohort and sent a survey on demographics, behaviors, disability, health-related quality of life, and medical conditions. Women agreeing to be contacted will also be interviewed by study investigators using the modified CIDI to ascertain current and lifetime mental health conditions (including PTSD) and exposure to traumatic events. A more extensive chart review will be conducted by a clinician to validate self-report of key medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Women alive as of survey receipt who were active duty military personnel in one of the four Armed Services between July 4, 1965, and March 28, 1973, with a 30 day minimum period of service.
* This will include those who served in Vietnam, near Vietnam (Guam, the Philippines, Japan, Korea, Okinawa, or Thailand), or in the 50 United States.

Exclusion Criteria:

* Unable or unwilling to provide informed consent
ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial

This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\].

The main questions it aims to answer are:

* Does ESPB provide superior analgesia than PIFB
* Do patients who receive ESPB have better recovery outcomes

Regional nerve blocks, including Pecto-intercostal block (PIFB) and Erector spinae plane block (ESPB), can provide a certain level of analgesia for thoracic and cardiac surgeries. This study focuses on patients undergoing their first conventional sternotomy for cardiac surgery. They are randomly assigned to receive either PIFB or ESPB for pain relief. Comparisons are made between the two groups for postoperative 48-hour analgesic medication requirements, static and dynamic postoperative pain scores, improvements in postoperative respiratory function, quality of life index (QoL15), and other clinically relevant prognostic indicators.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients, elective and first-time cardiac surgery patients undergoing traditional sternotomy. Procedures include coronary artery bypass surgery, valve repair or replacement surgery, atrial and ventricular septal defect repair surgery, and other open-heart surgeries.

Exclusion Criteria:

* 1. Emergency surgery 2. Anticipated combined major aortic vascular surgery 3. Already admitted to the ICU or on a ventilator before surgery.
A Study of TAK-994 in Adults With Narcolepsy

Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study.

The main aim of this study is to check if participants have side effects from TAK-994.

Participants will take one of 3 different TAK-994 dose for 8 weeks.

Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo.

The study doctors will check for side effects from TAK-994 and placebo throughout the study.

Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

The drug being tested in the study is called TAK-994. TAK-994, is being tested to treat participants with NT1. Participants who completed Part B of TAK-994-1501(NCT04096560) will be eligible for enrollment in this study.

This study will enroll approximately 112 patients to receive one of three different TAK 994 dose for 8 weeks (active drug extension period). Participants will be randomly assigned to one of these different TAK 994 doses which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

Following the 8-week Active Drug Extension Period, participants will continue into a 4-week Double-blind Randomized Withdrawal Period and will receive TAK-994 or Placebo.

Participants randomized to TAK-994 will continue to receive the same dose as before.

This multi-center trial will be conducted worldwide. The duration of treatment in this study is 12 weeks plus a 2 week safety follow up period. Participants will visit the clinic 10 times after the first dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB

The goal of this study is to test a volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, specifically in patients who have an immediate implant placement for teeth #5-#12.

The main question this study aims to answer is does the recombinant human platelet-derived growth factor-BB accelerate the formation of blood vessels and augment tissue volume around the immediate implant.

Participants will be asked to undergo immediate implant placement using volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, as well as attend 11 study visits over the course of 1.25 years.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-95
* Has a single hopeless tooth in the maxillary esthetic zone (i.e., first premolar to first premolar, tooth #5-tooth #13)
* Adequate oral hygiene (i.e., full-mouth bleeding score (FMBS) and full mouth plaque score (FMPS) of less than 25%)
* Adequate tooth space to support an immediate implant placement (i.e., adequate mesiodistal space of greater than or equal to 6 mm and interocclusal space to support a non-occluding provisionalization).
* Postextraction vertical bone defect of the buccal socket wall was less than or equal to 3mm

Exclusion Criteria:

* patients taking long-term (more than 3 months) medications affecting bone metabolism
* generalized untreated periodontitis with greater than of 30% of sites with greater than 5mm pocket depths and bleeding upon probing with a dental probe
* medical contraindications for having a surgical procedure (i.e., ASA Status of III, patient with a severe systemic disease that is not life-threatening; ASA Status of IV, a patient with a severe systemic disease that is a constant threat to life).
* history of radiotherapy in the head and neck region
* heavy smoker (greater than 10 cigarettes per day)
* pregnancy
* gingival recession before extraction in relation to the contralateral tooth
Consumers' Emotional Reaction to Sustainability Cue

This will be a randomized control trial (RCT) to examine whether the three priming interventions (health priming, environmental sustainability priming, and co-benefits priming) work to change consumers' sustainable food choice through their effects on changing consumers' emotional reaction when seeing foods with cues of environmental sustainability, which will be indicated by measuring consumers' facial expression, eye movement and pupil dilation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should be aged 18 years or above
* Subjects should be Hong Kong residents
* Subjects should be able to read Chinese

Exclusion Criteria:

* Subjects who have vegan or vegetarian diets will be excluded
* Subjects who have to follow special diets due to illnesses will be excluded
* Subjects domestic helpers will also be excluded
Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity

One purpose of the present study was to evaluate the effect of elevating serum bicarbonate concentration more than had been achieved in previous studies without inducing potentially ergolytic GI distress. In order to do so, a modified SB ingestion protocol (ModSB) of 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) was administered. It was hypothesized that ModSB would significantly elevate serum bicarbonate concentration to a greater extent than would an acute SB ingestion protocol (AcuteSB).

This study was also designed to corroborate the results of previous studies regarding the ergogenic effects of sodium bicarbonate ingestion. Most studies have administered sodium bicarbonate in solutions, which would make the participants aware of the substance ingested due to the distinctive flavor of SB, possibly inducing a placebo effect. All doses in the present study were administered in gelatin capsules to mask the flavor of the ingested substances, maintaining participant blindness to the procedure.

Blood samples were collected at baseline and following placebo (CaCO3), acute sodium bicarbonate ingestion, and modified sodium bicarbonate ingestion to determine the effects of the ingestion protocols on serum bicarbonate, sodium and lactate concentrations, as well as on serum pH and blood hematocrit. The study design was a randomized double-blind crossover.


Eligibility Criteria:
Inclusion Criteria:

* Peak oxygen consumption greater than 60 ml·kg-1·min-1 (men) or 50 ml·kg-1·min-1 (women)
* Currently training; defined as at least 5 days·week-1 of running
* Elite-level performance (750 or more points on the International Associations of Athletics Federations Scoring Table) for an 800m-5000m race during the preceding 6 months.

Exclusion Criteria:

-
Live Enterovirus Vaccine and Type 1 Diabetes

Enterovirus infections may either increase or decrease the risk of type 1 diabetes depending on the age of infection and the type of enterovirus in question. This study evaluated whether early serial exposures to three replication-competent enterovirus strains (live poliovirus vaccine, OPV) can influence the immunity to other enteroviruses and the possible initiation of autoantibodies e.g. islet autoimmunity in young genetically predisposed children.

Enteroviruses have been associated with type 1 diabetes in several studies. Enterovirus infections may either increase or decrease the risk of type 1 diabetes depending on the age of infection and the type of enterovirus in question. There is remarkable homology between the structure of poliovirus and other enteroviruses. It has been shown in previous studies that the T-lymphocytes recognize these structures and cross-react with different enterovirus serotypes. Our hypothesis is that polio vaccination induces a cross-reacting T-cell response which strengthens enterovirus immunity and thus accelerate the elimination of the enterovirus infections. We evaluated whether early serial live enterovirus vaccine (oral polio vaccine, OPV) can influence the enterovirus immunity and initiation of islet autoimmunity in young genetically predisposed children.

This study was carried out in the birth cohort of the ongoing Diabetes Prediction and Prevention (DIPP) study in Finland. All the children carried HLA-DQ genes conferring moderately increased risk for type 1 diabetes (HLA DQB1\*0302/x, x≠ DQB1\*0201, \*0301, \*0602). Sixty-four children (34 males) were given doses of OPV (Polio Sabin®, SB Biologicals, Rixensart, Belgium) at the age of 2, 3, 6 and 12 months during the years 1999-2000 (two drops per os in each dose). This vaccine includes attenuated replication competent strains of the three poliovirus types (polioviruses 1, 2, 3) leading to infection in vaccinated children. The control group comprising 251 children received inactivated poliovirus vaccine (IPV) at the age of 6 and 12 months according to the national immunization protocol in Finland at that time. After the age of 12 months both groups were recommended to continue the national immunization program with IPV vaccine.

All children were followed regularly from birth with blood samples taken at 3-12 months interval for detection of type 1 diabetes-associated autoantibodies in serum including insulin autoantibodies (IAA), islet cell cytoplasmic antibody (ICA), insulinoma-associated protein 2 antibodies (IA-2A) and GAD antibodies (GADA) (5-7). Stool samples were collected monthly at the age of 2-24 months and systematically screened for the presence of enterovirus and using RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

* The infants parents give signed consent to participate and their HLA genotype is eligible

Exclusion Criteria:

* The newborn has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation
Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter

This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique regarding the acute and long term efficacy and safety.

This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique. The RF ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence. However, ablation with RF is painful since the underlying cardiac tissue heats up (up to 70-80°C inside the tissue) and especially the target of ablation in typical atrial flutter, the so-called cavo-tricuspid isthmus, is a very pain-receptive area. Cryo-ablation, which destroys tissue by freezing it down to -80 to -90°C, is thought to be less painful or even painless with the same efficacy than RF ablation.

The acute and long term (6 months follow-up, non-invasive) efficacy and safety is the combined endpoint.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* documented atrial flutter which is most probably typical isthmus dependent atrial flutter
* informed written consent

Exclusion Criteria:

* prior ablation for atrial flutter
* concomitant arrhythmia which is treated during the same ablation procedure
* prior MAZE operation
* contra indication for catheterization
* physical or psychiatric disorder making participation in the study impossible
* pregnancy
* prior participation in the study
* participation in another study
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

* Any adult with a history of previous hepatitis B infection
* A history of vaccination with any hepatitis B vaccine
* Recent (\<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
* Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
* Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
* Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
* Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
* Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
* Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
* Pregnant women, nursing mothers, and women planning to become pregnant within the study period
* Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study

Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
* 30 years or older
* Recorded sex
* Free of symptomatic CVD at inclusion.

Exclusion Criteria:

* Pregnant women in the 6 months before the eligibility date
Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and emotional well-being in people with amyotrophic lateral sclerosis (ALS).

The study will employ a RCT to test the two hypotheses. The study will incorporate a 2 x 3 two-way factorial design with repeated measures at three time points. The two between-subject factor conditions will be participation in a yogic breathing exercise program (YBEP) versus a waitlist control condition that will be evaluated at baseline, immediately post-program, and at 3-month follow-up. Thirty adults with ALS will be recruited for this study.

Hypothesis #1: Adults with ALS who participate in a YBEP will demonstrate improvement in breathing, speech function, and emotional well-being compared to waitlist controls at the conclusion of a 6-week YBEP.

Hypothesis #2: The positive impact of the YBEP on the participants' improved breathing, speech function, and emotional well-being will be maintained at 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. confirmed ALS or myasthenia gravis diagnosis
2. age \>18 yrs old;
3. ability to follow multistep commands,
4. on a stable dose of medications for \>60 days,
5. FVC ≥20% predicted,
6. Score of either 2 or 3 on the ALSFRS-R "Speech" subscale, and
7. access to internet and a computer or smartphone that can perform videoconferencing.

Exclusion Criteria:

1. life expectancy is less than 6 months,
2. severe hearing or visual impairments that prevent online learning (breathing exercise), or
3. current participation in another clinical trial during the study period that can affect the outcomes of the study.