cyrilzakka/clinical-trials huggingface dataset:
Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease

This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.

This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.

Eligibility Criteria:
Inclusion Criteria:

Clinical indication:

* Patients with angina or patients with documented silent ischemia
* Patients who are eligible for intracoronary stenting
* Age \> 18 years old, \< 75 years old

Angiographic indication:

* Intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation
* Reference vessel diameter ≥ 3.0mm by visual estimation

Exclusion Criteria:

* Acute or old myocardial infarction
* Previous coronary artery bypass graft
* Left main disease (≥ 50% stenosis)
* In-stent restenosis lesion
* Chronic total occlusion
* Low ejection fraction (\< 40 %)
* Graft vessel lesion
* History of bleeding diathesis or coagulopathy
* Limited life-expectancy (less than 1 year) due to combined serious disease
* Contra-indication to heparin, everolimus
* Contraindication to aspirin, clopidogrel or cilostazol
* Pregnant
Ultrasonographic Fetal Soft Markers and Aneuploidy

The purpose of this study is to investigate the prevalence of soft markers which will be identified during a second trimester ultrasound. Secondary aims were to estimate the association between the soft markers and trisomies 13, 18 and 21 as well as the effect on the number of invasive tests will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. pregnant woman between (16-24) weeks of gestation.
2. singelton pregnancy.

Exclusion Criteria:

1. Multiple pregnancies.
2. Mental condition rendering the patients unable to understand the nature and scope of the study.
Project QueST 2023: Queer Survivors of Trauma

This study aims to test the initial efficacy of tailored online writing interventions specifically designed for sexual minority women, transgender individuals, and/or nonbinary people to target the primary outcomes: posttraumatic stress disorder (PTSD) symptom severity and hazardous drinking.

This study aims to provide a novel method for adapting and testing evidence-based expressive writing (EW) treatments for trauma-exposed sexual minority women (SMW) and gender diverse individuals. The investigators will (1) describe the development and components of the proposed EW treatments, (2) discuss our plan for evaluating acceptability and feasibility of the proposed study, (3) identify steps for characterizing preliminary efficacy of EW treatments in reducing PTSD symptom severity and hazardous drinking levels compared to control, and (4) highlight our strategy for preliminarily evaluating mediators and moderators of treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* being at least 18 years of age
* reporting English fluency
* identifying as sexual minority women, inclusive of gender-diverse people
* living in the United States (US)
* reporting one or more Criterion A traumatic events
* having internet and email access
* not having received inpatient psychiatric support in the past six months

Exclusion Criteria:

* failing an inclusion criterion
The Effects of Pumpkin Seed Oil Supplementation on Cardiovascular Function in Postmenopausal Women.

Postmenopausal women have a higher prevalence of cardiovascular (CV) disease than age-match men. Growing evidence from rat studies have demonstrated CV-protective effects of pumpkin seed oil (PSO).

The investigators hypothesis is that PSO would improve CV health in postmenopausal women.

The purpose of the study is to examine the effects of 6 weeks of PSO on arterial and autonomic function in postmenopausal women. Specific aims of the study are to:

To investigate the extent to which PSO will improve cardiovascular disease risk factors by assessing arterial stiffness, aortic BP and wave reflection, and autonomic function (heart rate variability).

Eligibility Criteria:
Inclusion Criteria:

* Female
* 45 to 65 years of age
* At least 1 year after menopause
* BMI \<39.9
* Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

* known heart disease
* peripheral vascular disease
* diabetes, body mass index
* BMI\> 40 kg/m2
* other chronic diseases
* taking medications (e.g., hormone replacement therapy, beta blockers, calcium channel blockers, antidepressants and stimulants) that could affect the outcome variables
* smokers
* history of steady exercise or received exercise training and dietary changes in the last year
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

This is a multinational, double-blind, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of TAS-102 plus BSC versus placebo plus BSC in participants with metastatic gastric cancer who have previously received at least 2 prior regimens for advanced disease. Eligible participants will be centrally randomized (2:1) to TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).

Eligibility Criteria:
Inclusion Criteria:

1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
2. Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
3. Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
4. Is able to take medications orally (ie, no feeding tube).
5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Has adequate organ function as defined by protocol defined labs.
7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has certain serious illnesses or medical conditions
2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent within the specified time frames prior to study drug administration.
3. Has previously received TAS-102.
4. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
5. Is a pregnant or lactating female.
Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients

2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.

The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.

Eligibility Criteria:
Inclusion Criteria:

* SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI \> 4

Exclusion Criteria:

* Inadequate response to therapeutic dose of indomethacin or etoricoxib, taken for at least 2 weeks continuously
* Abnormal serum creatinine : serum creatinine \>1.3 mg/dl
* Abnormal SGPT: SGPT \> 40 U/L
* Hypertension: Systolic blood pressure \> 140 mm Hg and/ or diastolic blood pressure \>90 mm Hg or on anti-hypertensive drug
* Dyspepsia or active peptic ulcer disease : upper abdominal discomfort or upper abdominal pain related with food or peptic ulcer disease diagnosed by upper gastrointestinal endoscopy
* Diabetes mellitus: abnormal random plasma glucose or diagnosed case of diabetes mellitus
* Ischemic heart disease: history of angina or ECG changes suggestive of ischemic heart disease
* Active congestive heart failure: pedal edema with tender hepatomegaly with raised JVP or diastolic dysfunction on echocardiography
* Asthma: diagnosed case of asthma or rhonchi on chest auscultation
* Bleeding problems: having a history of prolonged bleeding
* Pregnancy: missed period followed by positive pregnancy test
* Simultaneous use with certain medications such as warfarin, phenytoin, cyclosporine, probenecid, lithium, digoxin, ACE inhibitor, thiazide
Pharmacokinetics and Pharmacodynamics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade

The purpose of this study is to illustrate pharmacokinetics and pharmacodynamics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in anesthesia obese patients undergoing bariatric surgery.

16 obese patients undergoing bariatric surgery were divided into 2 groups according to body mass index (BMI), including obese group (O group, n=8, 25≤BMI≤39.9kg/m²) and morbidly obese group (M group, n=8, BMI≥40kg/m²).

Vecuronium was continuous infusing to maintain moderate neuromuscular blockade during the laparoscopic surgery and stopped infusing after the laparoscopic procedure. A single dose administration of sugammadex (Sug) 2.0mg/kg according to ideal body weight (IBW) was given at the reappearance of the second twitch of the train-of-four (TOF) response.

On one hand, venous blood samples were obtained before administration of Sug and at 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours after administration of Sug to determine plasma concentration of Sug using HPLC-MS. On the other hand, time from start of administration of Sug to recovery of TOF ratio to 0.9 and other clinical indicators were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA: Ⅰ\~Ⅲ
* BMI≥25kg/m²
* Patients receiving bariatric surgery.

Exclusion Criteria:

* Pregnant or lactating women
* Neuromuscular diseases
* Malignant hyperthermia or allergic history during general anesthesia
* Drugs that react with rocuronium and vecuronium were taken
Prospective Cohort Study of Breast Cancer Patients Treated With Radiotherapy

breast cancer occurred 19,219cases in 2015 and is the second most common cancer among female cancers in the country. despite there's been a disease understanding and treatment developing through study, the prevalence and mortality of breast cancer have increased steadily over the last 15 years. In the last 20 years, through random clinical studies of breast cancer, radiation therapy is well-established standard therapy as postoperative supplement of invasive breast cancer and intraepithelial carcinoma but, the need for further study with new questions about radiation therapy has been raised through these studies. according to the prospective study outcome, the radiation treatment of the regional lymph node in breast cancer patients with lymph node positive increases the free-disease survival rate, radiation therapy for regional lymph node is being actively treated than in the past. on the contrary, the results of another study are being reported that treating regional lymph node may increase the risk of arm edema, radiation pneumonia and heart toxicity. In the recently, due to advancement in radiation therapy technique, the implement of new radiation therapy such as IMRT that reducing radiation dose to normal tissues of the axillary, lungs, heart and others has been actively attempted.

additional research is needed on dose-fractionation schedule, regional lymph node treatment, post-treatment toxicity of radiation therapy in breast cancer. this study establishes a prospective cohort at breast cancer patients with radiation treatment and analyze the local and regional lymph node control, recurrence, toxicity, radiation planning, clinical data, discover the factors that predict local control, regional control, overall survival, recurrence-free survival, toxicity for treatment, so we intend to construct basic data that establishes a radiation treatment strategy based on comprehensive outcomes and predictors.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to be a radiotherapy at National cancer center
* agreed to participate in the study

Exclusion Criteria:

- disagreed to participate in the study
Evaluation of SureCore Plus Biopsy System

This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.

Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.

Eligibility Criteria:
Inclusion Criteria:

* Patient has BPH requiring a prostate biopsy
* Able and willing to provide consent

Exclusion Criteria:

* Active infection
* Subject participating in an other device study of the prostate
Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods

Comparison of four methods for measuring temperature perioperatively in patients scheduled for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme; Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner. The study is a single-center, observational study carried out by the Central Surgical and Intensive Section at Vestfold Hospital Trust.

Issues

* Perioperative hypothermia is associated with several serious complications and therefore most likely to be avoided. Monitoring of body temperature is therefore required perioperatively .
* There are in the literature concerns that some methods of measuring temperature perioperatively is accurate enough and whether they reflect core temperature adequate.
* Some authors have questioned whether temporal scanner (TS ) - and nasopharynx ( NP) - measurements are accurate enough to measure the actual core temperature. Much of the research on TS measurements have been done on children and newborns in an intensive setting, but little perioperatively .

A total of 120 patients will be included ; 60 at Central Operations and 60 at Intensive Section at the Vestfold Hospital Trust. Duration of inclusion will be approximately one year . Starting around January 2014. The study emanates from Vestfold Hospital Trust and was designed by Espen Lindholm who is responsible for the project , Camilla B Norén who is principal investigator and project manager. Kjetil G Ringdal , Karl - André Wian and Knut Arvid Kirkebøen (University Hospital of Oslo ) are supervisors. The study is supported by research, Vestfold Hospital Trust and 3M Company Norway (study material ) and it is applied Regional Ethics Committee. Patients will not get different treatment than standard treatment in hospital and it causes no follow-up calls or hospital visits. All patients (if possible) give written consent for participation.

Eligibility Criteria:
Inclusion Criteria:

Surgical Patient group:

* \> 18 years
* ASA 1-3
* Laparoscopic surgery
* Elective surgery

Intensive Patient group:

* \> 18 years
* Defined as intensive patient
* ASA 1-5

Exclusion Criteria:

Surgical Patient group:

* BMI\> 30 kg/m2
* No bladder (ileum-bladder)
* Known malignant hyperthermia
* Malformations of the face that prevents nasopharynx and temporal scanner measurements
* Patient is participating in another study that may influence the results of the Tempstudy
* The patient is not competent to give consent, eg severe dementia
* The patient INR\> 2.0 and / or Trc \<50

Intensive Patient group:

* BMI\> 30 kg/m2
* No bladder (ileum-bladder)
* Malformations of the face that prevents nasopharynx and temporal scanner measurements
* Hypothermic patient below 32 ° C (bladder temperature)
* Hyperterm patient over 40 ° C (bladder temperature)
* Active cooling of the bladder
* The patient is under ongoing cooling or heating
* Patient is participating in another study that may influence the results of the Tempstudy
Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction

A clinical trial to study the effects of dosage, infusion methods and complications of unfractionated heparin (UFH) treating acute progressive cerebral infraction was conducted. In this study, we observed the effects of four UFH treatments on 480 acute progressive cerebral infraction patients during from the 6th and the 72nd hour after the attack. It was concluded that the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction, increase the cure rate, decrease the recurrence rate, and improve long-term quality of daily life. It is more effective than the treatment of intravenous infusion of low- molecular- weight UFH at once a day, and the risk of bleeding may not necessarily be increased.

Treatment' effectiveness rates of the four groups were 95.80%, 85.22%, 85.47%, and 87.72% respectively. The result of Group A was significantly different from those of Group B, C, and D (p \<0.05). The adverse complication occurrence rates of the four groups were 5.88%, 3.48%, 4.27% and 3.51%.

Eligibility Criteria:
Inclusion Criteria:

* Time after breakout: 6- 72 hours
* Blood pressure: below 180/100 mm Hg (1 mm Hg= 0.133 kPa)
* Paralyzed limb muscle strength: Level 0
* Being conscious or in mild or moderate coma, and hernia- free
* The nerve function continued to aggravate from several hours to a week after the breakout.
* No abnormal blood coagulation Platelet count Plt \>10×109/L
* Brain CT or MRI confirming and ruling out the occurrence of bleeding
* Match the diagnostic standards of acute cerebral infraction established by the 4th Chinese China Neurology Association
* Informed consent Agreement Signed

Exclusion Criteria:

* History of intracranial hemorrhage bleeding risk or Plt \<10 × 109/ L
* Record of severe heart, liver, or renal insufficiency or severe diabetes mellitus
* Infarct area larger than 1/3 of hemispheric area
* Pregnant
SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP

This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level).

Eligibility Criteria:
Inclusion Criteria:

* skeletally mature adults
* completed 6 month non-operative or conservative therapy
* signed informed consent
* back pain with radicular symptoms as evidenced by leg pain
* Degenerative Disc Disease involving a single level between L2 and S1
* subject willing to participate in study and follow protocol
* subject willing to comply with Post-op management program

Exclusion Criteria:

* systemic infection such as AIDS, HIV or Active hepatitis
* autoimmune disease
* significant metabolic disease that might compromise bone growth
* history of malignancy
* previous surgery for primary tumor, trauma or infection
* subject requires 2 or more levels of fusion
* previous spinal instrumentation or previous interbody fusion at involved level
* spondylolisthesis of grade greater than/equal to 2
Role of Activin A (ActA) in the Human Cancer Cachexia

The goal of the investigators study is to investigate the role of a hormone named Activin A (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy gene program. To answer this question, the investigators plan first to compare circulating levels of ActA in cancer patients with and without cachexia. In a second step, the investigators would like to assess whether ActA circulating levels are predictive for the development of cachexia and short survival.


Eligibility Criteria:
Inclusion Criteria:

* 18-year-old or older
* Colorectal or lung cancer demonstrated by histology or cytology
* New diagnosis or new recurrence
* Expected survival more than 3 months
* No previous history of other cancer in the last 5 years
* No pregnancy or lactation
* Signed informed consent

Exclusion Criteria:

* Non-caucasian
* Major digestive malabsorption
* Major depression
* Artificial nutrition
* Height doses of steroids (\>1 mg/kg hydrocortisone equivalent)
* Hyperthyroidism
* Other causes of malnutrition
* Expected survival less than 3 months
* Severely impaired walking
* Anticoagulants or antiplatelet therapy
* Disability or medical condition which might prevent the compliance to the protocol
* Any conditions which may prevent the compliance to the protocol
* Performance status ECOG \> ou = 4
* Participation to other clinical studies
Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria:

* Patients who are contraindicated based on the product label