cyrilzakka/clinical-trials huggingface dataset:
Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.

The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery

* However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair.
* The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation.

Methods

* Institutional database retrospective review for surgical mitral repair and MitraClip implantation.
* Time frame: January 2012-December 2019
* 2793 patients identified; Euroscore II 1.3% \[0.6%-2%\]
* Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure.

Statistical analysis

* Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test.
* The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point.
* ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.


Eligibility Criteria:
Inclusion Criteria:

* Patients undewent mitral valve repair with an open surgical approach, also in association with concomitant procedures (for example, but not limited to, aortic valve replacement, tricuspid repair, etc.)
* Patients undergoing transcatheter mitral valve repair with MitraClip implantation
* Patients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019

Exclusion Criteria:

* Patients underwent mitral valve replacement with prosthesis
* Cardiac surgery patients not eligible for mitral valve surgery
* Patients undergoing mitral implantation, both open and transcatheter, of devices in experimental clinical study (e.g., but not limited to, adjustable rings and neocords, etc.)
A Prospective Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location

A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.

A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.

The management of asymptomatic patients with pregnancies of unknown location (PUL) remains a challenge. Determining the location of the pregnancy is the first priority in the evaluation of these women. Some of these asymptomatic women present with inappropriate raising beta-human chorionic gonadotropin (βHCG), while others have assurance of pregnancy duration (e.g. IVF pregnancies) with no sonographic evidence of intra or extra uterine pregnancy. Most of the PULs are failed intra-uterine pregnancies.

The main concern regarding PUL is the late diagnosis of an ectopic pregnancy (EP). Some studies report that between 5 and 42% of women seen for US assessment with a positive pregnancy test have a PUL and only 6-20% will subsequently diagnosed with EP (1). Other studies report that 94% of PUL will resolve spontaneously, and out of the 6% that did not spontaneously resolve 68.9 % were finally diagnosed with failed IUP and only 5.6% were diagnosed with EP (2).

Women with PUL should be evaluated in minimum time, but also with minimal invasiveness. Management that will resolve such pregnancies in a rapid manner will save time and money and possibly avoid unnecessary administration of MTX or surgical intervention.

Several protocols have been investigated in order to fasten the diagnosis of PUL. For example, obtaining serial β-HCG, the first one in the initial presentation, two days later and seven days later (3). Another protocol suggested endometrial sampling by D\&C or aspiration of uterine continents with Karman cannula and checking the β-HCG after 24 hours (2).

Purpose: The aim of our study will be to prospectively assess the use of misoprostol in asymptomatic patients with pregnancies of unknown location(PUL).

The study group will contain hemodynamically stable women \>18 years old with a PUL with abnormal plateauing serum β-HCG trend (increase\<53%or decrease \<15% in 2 days) \< 1000 IU/l and a pelvic ultrasound unremarkable for an intrauterine pregnancy (IUP) or an ectopic pregnancy (EP).

Each participant will get Vaginal misoprostol 800 mcg or placebo. Main Outcome Measure(s): The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (\<2 IU/l) by the initial intervention strategy. Secondary outcome measures will include additional treatment (e.g. methotrexate (MTX) administration or laparoscopy), side effects and serum β-HCG clearance time, features of the optimal candidates for treatment by cytotec.

Eligibility Criteria:
Inclusion Criteria:

* hemodynamically stable women \>18 years old with a PUL with abnormal plateauing serum βHCG trend

Exclusion Criteria:

* Hemoglobin\<10
Peri-operative Expression Analysis of Pancreatic Stone Protein in a Surgical Study Population

The purpose of this study is to analyze the peri-operative expression of pancreatic stone protein and pancreatitis-associated protein in surgical patients following major abdominal surgery by blood samples.


Eligibility Criteria:
Inclusion criteria: - \>= 18 years

* abdominal major surgery
* need for post-operative ICU care

Exclusion criteria: - \<18 years

- patients who do not agree the written informed consent
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have at least one of the following characteristics:

  * Documented evidence of a VTE prior to this study
  * At least 60 years of age
  * A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
  * Age 50 to less than 60 years and BMI 25 to less than 30 kg/m².
* Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).

Exclusion Criteria:

* Participant should have no reason to not take a TNF inhibitor.
* Participants must not be pregnant or breastfeeding.
* Participants must not have had more than one VTE.
* Participants must not have cancer.
* Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.
* Participants must not have had a live vaccine within four weeks of study start.
* Participants must not have participated in any other clinical trial within four weeks of study start.
* Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.
Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect.

This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain.

This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.


Eligibility Criteria:
Inclusion Criteria:

* non-specific low back pain \> 30 days previous year
* non-specific low back pain with previous episodes
* age 18-65
* access to a mobile phone
* knowledge of how to text message
* proficiency in the Swedish language
* must rate themselves as "definitely improved" by the 4th visit

Exclusion Criteria:

* pregnancy
* contraindication to spinal manipulative therapy
* liability issues
Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ

This study aims to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG) from healthy subjects.

The aim of the study is to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG).

The study will enroll 20 healthy subjects who will wear the UNEEG™ SubQ device for 365 consecutive nights. All subjects are prescreened and invited to an interview to confirm eligibility. Subjects who provide informed consent are enrolled and will complete a detailed demographic, medical, health, sleep, and lifestyle survey. The enrolled subjects will have the UNEEG™ SubQ implanted and after approximately 10 days of healing the study subjects will start wearing the external part of the 24/7 EEG™ SubQ. Throughout the study the subjects will wear an ActiGraph, fill out a sleep diary and conduct cognitive tests. The duration of the study from screening to removal of sutures will be approximately 58 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Subjects must be of general good health

Exclusion Criteria:

* Has cochlear implants.
* Involved in therapies with medical devices that deliver electrical energy into the area around the implant
* Is at high risk of surgical complications, such as active systemic infection and hemorrhagic disease.
* Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
* Has an infection at the site of device implantation.
* Operates MRI scanners.
* Has a profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). N.B.: diving/snorkeling is allowed to 5 meters depth.
* Has a profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).
* Previous stroke or cerebral hemorrhage and any other structural cerebral disease.
* Ongoing or history of sleep disorders.
* Known neurological diseases.
* Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the Danish Health Authority or any other neuro-active substances.
* Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
* Medication judged by investigator to influence sleep to such a degree that data quality will be compromised.
* Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
* Pregnancy or intention to become pregnant within the next 12 months.
Liquid Biopsy MonitORing of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)

This study explores the potential value of a new blood test approach to detect measurable residual disease or early recurrence/progression in patients with cholangiocarcinoma.

PRIMARY OBJECTIVES:

I. To estimate the association of PUMA levels from peripheral blood with disease progression (radiographically or clinically) in patients that are candidates for curative surgical intervention of cholangiocarcinoma.

Ia. Pre- and post-neoadjuvant-treatment PUMA levels will be associated with treatment response to neoadjuvant therapy (short term progression).

Ib. Pre-surgical and post-surgical PUMA levels will be associated with progression free survival.

II. To estimate the association of PUMA levels from peripheral blood with postoperative survival in patients treated for cholangiocarcinoma.

OUTLINE: This is an observational study.

Patients undergo collection of blood samples and have their medical records reviewed on study. Patients also undergo collection of archived tissue samples on study.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a suspected or clinical diagnosis cholangiocarcinoma and under evaluation for surgical intervention with intent to cure
* Age ≥ 18 years

Exclusion Criteria:

* Patient has metastatic disease involving other organs (excluding lymph node)
* Patent has known primary cancer outside of the bile ducts within the last 3 years prior to blood collection (not including basal cell or squamous cell skin cancers, indolent cancer not requiring treatment within 3 years i.e. kidney, prostate or thyroid being observed)
* Patient has had surgery to remove current target pathology completely or partially
* Patient has undergone any prior radiation therapy to target lesion prior to blood collection
* Patient has received chemotherapy class drugs in the 3 years prior to blood collection
* Patient has had any transplants prior to blood collection
* Current target pathology is a recurrence
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients

Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.

This project will study the impact of scheduled administration of IV acetaminophen on the incidence, duration, and severity of postoperative delirium and other important hospital outcomes. Additionally, this trial will evaluate the effects of IV acetaminophen on longer-term postoperative cognitive dysfunction and functional status and develop a biorepository of perioperative samples as a future resource to probe the mechanisms of postoperative delirium.

The investigators propose three specific aims by conducting a randomized, triple-blind clinical trial that enrolls 900 patients 60 years of age or older undergoing cardiac surgery. Through this trial, the investigators will determine the effect of IV acetaminophen on;

1. the incidence, duration, and severity of postoperative delirium,
2. the use of opioids and other rescue analgesics in the first 48 postoperative hours, daily pain scores at rest and exertion, and length of stay in the Intensive Care Unit and overall hospital length of stay
3. longer-term (one, six, 12 months) cognitive, physical, and self-care functional recovery after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 60 years of age
2. Patients undergoing cardiac surgery \[coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery\] requiring cardiopulmonary bypass

Exclusion Criteria:

1. Pre-operative left ventricular ejection fraction (LVEF) \< than 30%
2. Emergent procedures
3. Isolated aortic surgery
4. Liver dysfunction (liver enzymes \> 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice
5. Hypersensitivity to the study drugs
6. Active (in the past year) history of alcohol abuse (≥5 drinks per day for men or ≥ 4 drinks per day for women)
7. Any history of alcohol withdrawal or delirium tremens
8. Delirium at baseline
9. Non-English speaking
10. Prisoners
11. Physician Refusal
12. COVID-19 Positive, symptomatic
13. Co-enrollment with non-approved interventional trial
Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation

In patients with missed lower posterior teeth and resorbed lower jaw, the study aimed at restoring the jaw's height and width to accommodate placing dental implants. The study was designed as a clinical trial with two arms; control group and study group. In the control group, titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane was used to secure the grafted bone mixture in the recipient site. While in the study group, bone-plate technique (Khoury technique) for bone restoration was used to secure the grafted bone mixture as well. The donor bone was the lower jaw (for bone particles and bone-plate harvesting) and bovine bone particles mixed together to form the graft mixture. Patients were monitored for six months and assessed by X-rays. The outcome variables were volume and height of gained bone in cubic millimeters and millimeters, respectively.

This study targeted bone augmentation in atrophic posterior mandible. Two groups were assigned. The first group included titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane as a rigid modality to achieve guided-bone regeneration (GBR): A mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the mentioned membrane. The second group utilized rigid bone-plates (a bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and the same bone mixture was prepared and introduced as in the first group. All procedures were operated under local anesthesia in a minor oral surgical setting.

Follow-up time intervals were the first postoperative day, and the sixth postoperative month. Two outcome variables were assessed; gained bone volume and gained bone height.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years old.
2. Good oral hygiene.
3. Missing mandibular posterior teeth.
4. No history of bruxism or para-functional habits.
5. Residual alveolar ridge height cannot accommodate dental implant placement.
6. Patients prepared to comply with the follow-up and maintenance program.
7. Agreement and signing the informed consent.

Exclusion Criteria:

1. Systemic diseases that may contraindicate the surgery or affect soft tissue or bone healing.
2. Heavy smoking (more than 20 cigarettes/day).
3. Intraosseous pathological lesion at the intended grafting site.
4. Gingival inflammation at the intended implant site.
5. Periodontal diseases affecting teeth adjacent to the edentulous space.
6. Inadequate inter-arch space after the indented vertical augmentation.
A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation

The purpose of this study is to determine whether or not a low calorie, low glycemic index diet with omega-3 fatty acid supplements can prevent some of the negative consequences of sleep deprivation.

This pilot study included 18 medical residents at two academic medical centers in New York City. All residents who participated in the study were assigned to work a night shift schedule for two weeks, and began the study on the morning prior to their first evening shift. The study subjects were randomly assigned to one of two groups:

* Intervention diet -- consisting of 40% carbohydrates, 30% protein, and 30% fat with 2.4g of long chain fatty acid supplements (n=9) Total calories for males was 1600/day, and 1200/day for females
* Control group -- ad lib diet.

Main outcome measures included:

* weight
* resting metabolic rate
* percent body fat
* lipid profile
* CRP
* fasting glucose and insulin levels
* urinary neurotransmitter levels
* salivary cortisol
* six cognitive tests of memory, attention, and executive function.

Subjects were tested on day 1, 7, and 14 of the study.

Eligibility Criteria:
Inclusion Criteria:

* Medical resident in good standing at Cabrini Medical Center or Saint Vincent's Hospital, NY.
* Must be scheduled for two consecutive weeks of night shift work.

Exclusion Criteria:

* Febrile illness
* Smoker
* Food allergies of any kind
* Taking any prescription medication
* History of diabetes or thyroid dysfunction
* Body mass index (BMI)\>30
* Pregnancy
PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer

This is a single-center randomized, placebo-controlled, double-blind feasibility study comparing the intervention of perioperative nutritional supplements (immunomodulation, carbohydrate loading, and protein isolate) with an identical placebo for each solution in patients with gastrointestinal cancer undergoing surgery. Eligible and consenting patients will be randomly allocated to receive the intervention or placebo in a 1:1 ratio.

This study will assess the feasibility of a large, multi-centre trial by establishing the feasibility of randomization to intervention or placebo. This study will be conducted at the Juravinski Hospital and will enroll 100 patients over 18 months.

The study intervention includes three perioperative nutritional supplements: (1) a protein supplement administered 3 times a day for 30 days before surgery, (2) a sugar-based supplement administered the day prior to and the day of surgery, and (3) a formulated liquid diet containing arginine, RNA, proteins and omega-6 fatty acids (referred to as immunonutrition for the purposes of this study) administered for 5 days prior to and 5 days after surgery.

The primary outcome for each eligible patient is defined as being randomized to intervention or placebo. The criteria for success of this study is defined as the proportion of eligible patients randomized as ≥ 60%. If the estimated proportion is \<40%, the trial will be considered not feasible. If the proportion is between 40%-59%, the trial will be considered feasible with modifications to improve enrolment. Other secondary objectives include compliance with study intervention, estimating differences in postoperative complications, length of hospital stay, and quality of life between groups.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age or older
* Diagnosed with a resectable type of gastrointestinal cancer (e.g. cancers of the gallbladder, liver, pancreas, stomach, small intestine, colon and rectum) for which an elective operation is planned (resection vs. palliative procedure).
* Patients with distant metastasis are eligible for the study.
* Patients who are lactose intolerant are also eligible for the study because the amount of lactose in ISOlution and PreCovery is minimal (trace).

Exclusion Criteria:

* Malabsorption syndrome (e.g. chronic pancreatitis)
* Cannot tolerate oral intake (e.g. gastric outlet obstruction or delayed gastric emptying)
* Organ failure (liver, kidney); end stage liver disease with a Child Pugh Score ≥ B or end stage renal disease defined as stages 3 and 4 with a glomerular filtration rate between 30-59 for stage 3 and 15-29 for stage 4.
* Inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematous, Crohn's disease and ulcerative colitis
* Patients currently on steroids
* Poorly controlled type 1 or 2 diabetes mellitus
* Female patients who are pregnant and/or lactating
* Galactosemia
* Ongoing infection.