cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

Background:

Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. But abdominal CTs use a contrast agent (CECT). Therefore, the Agatston score cannot be used. Researchers want to find a way to measure plaque in CECTs. This will help them use abdominal CTs to measure plaque without extra radiation.

Objective:

To measure atherosclerotic plaques on CECT in a group of males.

Eligibility:

Men ages 30-90 with prostate cancer (proven with biopsies) who have abdomen CT studies in the PACS (picture archiving system) in the Clinical Center. Also, men or women of all ages who have multiphase abdomen and pelvic CT studies that are in the PACS.

Design:

This study will use data gathered since 1/1/2013. Data will also be taken from protocol 03-CC-0128 and clinical trials 15-C-0124, 16-C-0048, 14-C-0112, and 04-C-0274. Participants from these studies have allowed their samples to be used in the future.

Participants will be found via keyword searches on NIH databases. Their CT and MRI scans will be used. Data such as age, race, disease, and treatment will be used. Results of other tests may be used.

The plaque in participants abdomen and iliac arteries will be measured. It will be compared with biomarkers related to CVD and prostate cancer, such as weight, age, and race.

This study will take place at one site. Data will be stored on secure computers. Printouts will be kept in locked rooms.

Evaluation of Atherosclerotic Plaques in Prostate Cancer Patients.

Study Description:

This study measures atherosclerotic plaques in the vessels of prostate cancer patients in contrast-enhanced computed tomography (CECT), then finds correlation between the plaque and clinical biomarkers. These biomarkers include laboratory tests, pathologic findings, underlying risk factors, demographic information, and outcomes of the patient.

Objectives:

Primary objective: Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT).

Secondary objective: Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.

Study Population:

Up to 1,000 NIH Clinical Center patients.

Description of Sites/Facilities conducting research:

NIH Clinical Center

Study Duration:

10 years

Eligibility Criteria:
* INCLUSION CRITERIA:

The study will use existing radiologic data.

EXCLUSION CRITERIA:

NONE
Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain

This study investigated the effects of navigated repetitive Transcranial Magnetic Stimulation on nociception and quality of life in patients suffering from chronic pain conditions. Two cortical targets (dorsolateral prefrontal cortex/DLPFC and M1 area) were stimulated and compared to Sham stimulation.

From 34 patients, 24 completed the study. The M1-area was stimulated with 10 Hz rTMS while the DLPFC received a 5Hz stimulation. In total, 13 session were administered over a period of 36 weeks with most frequent stimulation in the first 4 weeks of the trial. Results were compared to Sham-TMS over the M1 area at the same schedule than the actual therapy. Outcome parameters included the German Pain Questionnaire (GPQ), the Depression, Anxiety and Stress Scale" (DASS) and quality of life (QoL) with the SF-12 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* clinical diagnosis of chronic LBP (low back pain) and or neck pain
* average resting pain-level \> than 3 in the Numeric Rating Scale (0-10)
* no changes in pain medication 4 weeks at baseline
* no surgical procedures in the last 2 years

Exclusion Criteria:

* metallic and electronic implants in the head, neck and chest
* medication e.g. tetracyclic antidepressants, antiviral, antipsychotic, opioid doses \> 100mg orally/d
* history of frequent headache or tinnitus
* alcohol or drug abuse
* pregnant patients
* breastfeeding patients
Reiki/Energy Healing in Prostate Cancer

The purpose of this study is to determine whether Reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer who are candidates for radical prostatectomy.

120 newly diagnosed prostate cancer patients will be randomized to one of 3 groups: Reiki, another touch therapy, or guided imagery. Subjects in the Reiki and touch therapy groups have 8 sessions in the 4 weeks prior to their medical intervention. Those in the imagery group have one session prior to their medical intervention.

Eligibility Criteria:
Inclusion criteria:

* Newly diagnosed with prostate cancer
* Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these

Exclusion criteria:

* Already involved in energy healing treatments
* Any patient whose medical intervention could not wait the 4-weeks for intervention for medical reasons
* Any patient who gets neo-adjuvant therapy or any herbal product that could affect PSA
Delayed Cord Clamping in Infants Born by Cesarean Section

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean section, especially elective one, reduces the placental transfusion, mainly because of uterine atony. Therefore, during an elective cesarean section umbilical cord management may play a relevant role on blood passage to the neonate and, as consequence, it may affect neonatal hematological values and cardiovascular parameters. The most effective way to manage umbilical cord in in elective cesarean section remains to be established.

Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the hematocrit on the second day of life; in addition, we will assess the effect on perinatal and postnatal cardiovascular parameters.

Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by cesarean sections. After obtaining parental consent, all mothers \> 38 weeks' gestation will be assigned to eithr ECC or DCC group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome will be the hematocrit on day 2 of life. Secondary outcomes will be pre-ductal oxygen saturation (SaO2) and the heart rate (HR) during the first ten minutes after the birth, arterial blood pressures during the first 3 postnatal days and transcutaneous bilirubin (BT) at day 3 after birth.


Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section
* Gestational age \> or = 39 weeks
* No labor
* Single pregnancy
* Parental consent; a written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian

Exclusion Criteria:

* Emergent or urgent cesarean sections
* Twin pregnancies
* Parental refusal to participate to the study
* Major congenital malformations (such as cardiopathies)
* Chromosomic abnormalities
* Fetal hydrops
* Severe maternal diseases (such as hypertension)
* Cord abnormalities (length \< 20 cm, funicular prolapse, funicular knots)
* Intrauterine growth restriction (IUGR)
TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial

To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.

This is a single center, open-labeled , single arm, phase-II pilot study which aims to evaluate the efficacy and safety of thalidomide, cyclophosphamide and prednisone (TCP regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.There would be two phases of the study. The treatment and the response evaluation phase will last from the time of enrollment up to 24 months (evaluation will be carried out every 3 months). The follow-up phase to assess for progression of disease will last from 24 months (2 years) to 4 years after enrollment (evaluation will be carried out every 12 months).The total study duration will be 4 years after the last patient starts study medication.

Eligibility Criteria:
* Inclusion Criteria:

  * ≥18 years, all race/ethnic groups in China；
  * Newly diagnosed and previously untreated (patients are allowed to have received oral prednisone for up to 1 week before enrollment) symptomatic MCD patients (symptomatic disease is defined by the presence of clinical symptoms with the NCI-CTCAE grading ≥1 that are attributable to the disease, and for which treatment is indicated);
  * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
  * Clinical laboratory values meeting these criteria at screening: absolute neutrophil count ≥ 1•0 x 109/L, Platelets ≥ 50 x 109/L, Alanine aminotransferase (ALT) within 2•5 x upper limit of normal (ULN); total bilirubin within 2•5 x ULN; estimated glomerular filtration rate (according to MDRD formula) \<15ml/min;
  * Women of childbearing potential must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening period. Men must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent;
  * Informed consent must be signed.
* Exclusion Criteria:

  * age under 18 years;
  * ECOG (eastern cooperative oncology group) status above 2;
  * Immunosuppressive or anti-neoplastic drugs within the last 3 months;
  * serious diseases including malignancy;
  * Plan to have babies within 1 year after enrollment (for women and men), or pregnancy / breast-feeding (for women);
  * Known hypersensitivity to study agents;
  * Active infection requiring systemic treatment;
  * Other severe concurrent disease (eg. uncontrolled diabetes, symptomatic coronary heart disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study;
  * Unwilling or unable to provide informed consent;
  * Unwilling to return for follow-up at PUMCH.
STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing

The STYLE-LBBP study aims to compare the efficacy and safety of left-bundle branch pacing between the two types of available pacing leads: lumenless vs stylet-driven.

STYLE-LBBP is a randomized, non-blinded, multicenter clinical trial that compares the efficacy and safety of two types of available pacing leads in conduction system pacing (CSP). Patients referred to CSP who meet the inclusion and exclusion criteria will be enrolled and randomized into two groups: i)Left bundle branch pacing (LBBP) using leads without internal light (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA) or ii) LBBP with stylet-driven leads (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA).

Efficacy in terms of achieving LBBP (selective and non-selective left bundle capture criteria) will be measured at implantation and after 24 hours. Complications of the procedure will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients referred for conduction system pacing

Exclusion Criteria:

* Patients with a prosthetic (metal or biologic) tricuspid valve.
High-Intensity Exercise in Older Adults

The goal of this interventional study was to test the high-intensity interval training called Aphasia Physical Exercise (APEX) in healthy older adults. The main questions it aimed to answer were:

1. what is the safety and feasibility of APEX?
2. what are APEX's acute physiological effects?
3. what is APEX's effects on functional fitness?
4. what is APEX's effects on cognition?

Participants underwent:

* Baseline testing session (#1) with cognitive measures only (a week before the Pre-exercise session);
* Pre-exercise session (#2) with maximum oxygen consumption and heart rate assessment, functional fitness and cognitive measures (3-7 days before the start of the exercise program);
* APEX program, two APEX classes per week for four weeks (eight classes in total);
* Post-exercise session (#3), functional fitness and cognitive measures, (0-2 days after the end of the exercise program).


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 50 and 80
* Ambulatory and community-dwelling
* Able to travel to University of San Francisco for weekly exercise classes
* No serious underlying health or neurological conditions

Exclusion Criteria:

* Inability to complete physical function assessment or inability to do a chair stand without using hands
* Use of antidiabetic medications
* Use of testosterone supplement or replacement
* Clinical disorder precluding/interfering with participation or assessments (identified by Physical Activity Readiness Questionnaire (PAR-Q+)), including: unstable angina, arrhythmia, uncontrolled hypertension, end stage renal disease on hemodialysis, lower extremity amputation or paralysis, neurological conditions causing functional or pronounced cognitive impairments, active malignancy except for non-melanomatous skin cancers
* Previous neurological history such as stroke, traumatic brain injury, multiple sclerosis, long-term pre-stroke seizures, Parkinson's, Alzheimer's, etc.
* Unable to provide consent
The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients.

the risk of bleeding may be greater than the benefit of antithrombotic protection when prophylactically anticoagulating a patient with a lower limb fracture and advanced CKD.

The primary objective was to evaluate the risk major bleeding in patients with lower limb fractures and advance CKD. The secondary objectives were to assess major bleeding in patients with lower limb fractures in CKD stage 4 and 5, thrombosis, death.


Eligibility Criteria:
Inclusion Criteria:

* lower limb fracture before surgery
* CKD (chonic kidney disease)

Exclusion Criteria:

* \<18 years old
* kidney transplant
* hospital stay \<48 hours
* had received any anticoagulant before random assignment to a patient group
* had missing data that would render analysis incomplete
Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

gemigliptin,SGLT-2i DDI study

LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin \& dapagliflozin and gemigliptin \& empagliflozin.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adults at age between 19 to 55 at the time of the screening
2. Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
3. Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
4. subjects who is consented in writing to be sure to comply with the requirements of the clinical trial

Exclusion Criteria:

1. Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
2. Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
3. Subject who had infection disease or serious injury within 21 days before the randomization
4. Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
5. Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
6. Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
7. Those who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the clinical trial drug within 30 days of randomization
8. Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
9. subject who drinks the average amount per week exceeding 140 g of alcohol
10. Subject whose daily average smoking amount exceeds 20 pieces per day
11. Average daily grapefruit juice intake exceeding 2 cups
12. Subject who had a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 70 mmHg, or greater than 100 mmHg at the time of screening test
13. Subject with a glomerular filtration rate of less than 60 mL / min / 1.73m\^2 calculated from serum creatinine values at the time of screening
14. Subject whose blood creatinine, AST, ALT or γ-GT levels exceeded the upper limit of the reference range by 1.5 times the screening test
15. Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test
16. Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history
17. Subject who have clinically significant abnormalities in other clinical tests
18. Subject with clinically significant abnormal ECG findings
19. Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment
Impact of Music Therapy on Speech Intelligibility in Noise with Cochlear Implants

The aim of this clinical study is to investigate whether six months of music therapy immediately after CI implantation helps to improve speech intelligibility in noise. To investigate the effect of music therapy, a randomized study will be conducted with a "start group A" and a "delayed group" B (control group 1). Group A will start six months of music therapy immediately after cochlear implantation, group B six months later. A further control group 2 will not receive any music therapy. The speech intelligibility values resulting from the OLSA sentence test will be compared between the three groups after six and twelve months.

Improved speech perception is a main objective for any hearing rehabilitation using hearing devices. Even more challenging is speech comprehension in noisy environments.

Music therapy is one of the approaches that can assist users with achieving better performance in situations of difficult listening comprehension such as speech perception in noisy environments. One such music therapy concept developed in Heidelberg is based on the parallelism of language and music, whereby targeted training using musical parameters such as rhythm, pitch and timbre can have an impact on the ability to perceive speech. At present, the fact that music therapy can help improve speech intelligibility is primarily based on research with normal hearing listeners.

Nowadays, cochlear implant technology has the primary goal to restore functional hearing and speech perception in people with bilateral severe-to-profound sensorineural hearing loss. Good results will be achieved by post lingually deafened CI users regarding the understanding of open-set sentences presented in quiet. But our surroundings are rarely quiet. Therefore, the goal of good rehabilitation must be to ensure that CI users also can cope well in our noisy environment. Music therapy is thus intended to be the crucial piece in the puzzle that enables such understanding in noisy situations.

This study aims to investigate the benefits of music therapy for cochlear implant users in terms of their speech intelligibility performance in noise. This is an explorative study to determine suitable parameters such as the time point of starting the music.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged between 18-85 years
2. Patients who undergo a new CI Implantation
3. Patients who speak German as their main language

Exclusion Criteria:

1. Patients with congenital deafness
One-or Two Person Technique and Quality Performance of Colonoscopy

Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Uncontrolled data report that 1 operator technique is associated with a higher adenoma detection rate, although it is also characterized by a lowwer cecal intubation rate and longer intubation time. The aim of present randomized controlled study was to assess whether one technique is better than the other one in terms of colonoscopy quality performances.


Eligibility Criteria:
Inclusion Criteria:

* adult outpatients colonoscopy for screening or surveillance indications

Exclusion Criteria:

* previous colonic surgery
* poor bowel prep
* inability to provide consent
Emergence From Anesthesia in Anterior Temporal Lobectomy and Amygdalohippocampectomy Patients

Smooth emergence (wake up) from anesthesia is an important consideration in patients undergoing neurosurgical procedures as blood pressure changes associated with violent emergence can cause intracranial hemorrhage and brain swelling. At the same time, emergence should also be quick so that patients' neurological function can be assessed at a timely manner. Pattern of emergence from anesthesia is poorly investigated and understood.

Epilepsy surgery involves resecting epileptogenic tissues including limbic structures which may be functionally normal. Hence the emergence process can be complicated in patients having diseased limbic structures or those having therapeutic removal of limbic structures as in epilepsy surgery. Limbic structures are responsible for memory, language and executive function and hence loss of some of these higher functions is to be expected in the postoperative period. Preoperative neuropsychological assessments are often used to predict their risk for postoperative loss of higher functions and behavior changes. In our experience the investigators have seen that there is a spectrum of emergence characteristics in patients undergoing temporal lobectomy that can vary from dangerously agitated patient to much sedated, unarousable patient. Delirium and agitation can be dangerous and have serious consequences for the patient such as injury, increased pain, hemorrhage, self-extubation and removal of catheters requiring physical or chemical restraint. On the other hand the unarousable patient may pose dangerous airway complications and limit neurological assessment in the immediate postoperative period. Hence it is essential to have a clue about post anesthesia emergence behavior in patients having epilepsy surgeries. The aim of this study is to look at the pattern of emergence from anesthesia after epilepsy surgery and to determine if preoperative neuropsychological assessment help predict the pattern of emergence in patients undergoing anterior temporal lobectomy and amygdalohippocampectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients above the age of 18 who are scheduled for elective anterior temporal lobectomy and amygdalohippocampectomy under General Anesthesia

Exclusion Criteria:

* Lack of informed consent Patients needing intensive care unit postoperatively