cyrilzakka/clinical-trials huggingface dataset:
Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery

Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The effectiveness of fondaparinux compared with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery has been evaluated in database studies; however, the effectiveness of injectable anticoagulant medications following cancer-related surgeries in the practice setting has not been as well documented.

The objective of this study is to analyze patient records from a national hospital database and compare the outcomes and costs between four types of injectable anticoagulant medications that were prescribed for the prevention of VTE following cancer-related surgery. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).

The source of data for this study is the Premier Perspective Database™. This hospital claims database links de-identified inpatient medical, pharmacy, and billing data from more than 500 hospitals.

This study is a retrospective cohort study that uses propensity score matching to adjust for the differences between the numbers of patients treated with each medication.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* at least one record of a primary inpatient discharge diagnosis of cancer (index hospitalization)
* a procedure code for a cancer-related surgery during the index hospitalization
* a code for an anticoagulant treatment (dalteparin, enoxaparin, fondaparinux or unfractionated heparin (UFH)) as thromboprophylaxis therapy during the day prior to or two days after cancer-related surgery during the index hospitalization (this is the INDEX EVENT)

Exclusion Criteria:

* a record that the patient received more than one injectable anticoagulant on Day 1 of anticoagulant therapy
* a record that the patient received anticoagulant therapy prior to index anticoagulant
* a primary diagnosis code of DVT, PE, or major bleed
* evidence of an outpatient emergency department or hospital outpatient clinic visit that included a diagnosis code for DVT or PE during the 6 months prior to the index hospitalization
* patient records for patients transferred from another facility outside Premier system on index hospitalization
Clinical Evaluation of a Restorative Glass Ionomer and a Composite Resin for the Restoration

The clinical performances of a restorative glass ionomer and a composite resin will be compared in the restoration of non-carious cervical lesions (NCCLs) at patients with systemic diseases.

After recruiting participants with at least 2 NCCLs and at least one systemic disease, all restorations will be placed by a single clinician. All lesions will be cleaned before restoring.

NCCLs will be divided into two groups: a conventional restorative glass ionomer cement \[Fuji Bulk (GC, Tokyo Japan) (FB)\] and a posterior composite resin \[G-ænial Posterior (GC, Tokyo Japan) (GP)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility Criteria:
Inclusion Criteria:

Patients with at least one systemic disease such as hypertension, cancer in remission after chemotherapy or radiotherapy, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus.

Patients using medications for hypertension, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus.

Patients who are able to attend recall appointments.

Age greater than 18 years who had at least one systemic disease At least two NCCLs needed to be restored.

At least 20 teeth in occlusion.

Exclusion Criteria:

Non-vital teeth

Mobility of teeth

Severe periodontal disease

Heavy bruxism habit
To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.

Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.

OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.

Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.

OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.

PATIENTS \& METHODS All women who arrived to the delivery room at Lis hospital and which the newborn is about to undergo glucose levels follow-up after birth regardless the study, because his affiliation to the at-risk population including: delivery below 37th week, maternal diabetes during pregnancy and newborns in weight under percentile 10 or above percentile 90 by Dolberg graphs.

Eligibility Criteria:
Inclusion Criteria:

1. Single pregnancy
2. Vaginal or cesarean birth.
3. Births where there is an indication of neonatal hypoglycemia follow-up - one or more of the following:

   * Delivery week below 37 full weeks.
   * Maternal diabetes during pregnancy (gestational diabetes or pre-gestational).
   * Newborn under percentile 10 by Dolberg graph.
   * Newborn above percentile 90 by Dolberg graph.

Exclusion Criteria:

1. Multiple Pregnancy
2. pregnancies in which there is no indication for routine monitoring of glucose levels after birth
Effects of Telerehabilitation Exercise Program on Maternal Glycemic Control

Gestational diabetes is in which high blood glucose concentration results from body's inability to create enough insulin to fulfil the needs of pregnancy. It appears in week between 24 to 28 and and raises the mothers and Childs risk of problems. It is thought to affect about 1 in 7 pregnancies worldwide. Through these remote exercise sessions the study evaluates the effectiveness of tele rehabilitation in improving glycemic management during pregnancy.The results will help clarify how telehealth intervention can best support GDM patient's maternal health outcomes.

Literature suggests that hormonal changes during pregnancy can interfere with insulin, the hormone that regulates blood glucose.This excess glucose can cross the placenta, affecting the developing fetus and increasing risks for both mother and child. The rising trends in obesity and advanced maternal age suggest that the prevalence of GDM will continue to increase.Approximately 7-10% of pregnancies worldwide are affected by gestational diabetes.Managing glucose levels is critical for women with gestational diabetes to ensure a healthy pregnancy and reduce the risk of complications for both mother and baby. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve blood glucose levels in participants with GDM.

The control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving maternal blood glucose level.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 20 to 35 years
* Gestational age between 20-28weeks
* diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
* Primigravida and multigravida
* able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
* Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone)
* Who signed informed consent

Exclusion Criteria:

* Previously diagnosed T1DM or T2DM
* High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
* Patients taking insulin regularly.
* Patients with fetal anomalies diagnosed at 20 th week.
* Multiple gestation (twin or triplets)
Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization

The primary purpose of this project is to compare the accuracy of transcutaneous oxygen monitoring and near infrared spectroscopy in assessing cutaneous oxygen levels in chronic wounds of patients following revascularization procedures as well as those with conservatively managed chronic wounds. This study will also compare the efficiency and practicality of both methods in guiding treatment decisions and management of these wounds.


Eligibility Criteria:
Inclusion Criteria:

* Are between the ages of 18-85
* Presented with a non-healing lower extremity wound and have a Wagner classification for wound healing of grade 1 or 2

Exclusion Criteria:

* Wagner grade 3-5
* Congestive heart failure (CHF) with a left ventrical ejection fraction (LVEF) \< 30%
* Have had a below the knee drug eluting stent placed (paclitaxel is chemo, can make wounds worse)
The Effect of Horticultural Activities on Physical and Cognitive Status, Mental Well-Being, Social Participation and Quality of Life in Individuals Diagnosed with Dementia

This study aims to examine the effects of horticultural activities on the physical and cognitive status, mental well-being, social participation, and quality of life of individuals diagnosed with dementia living in nursing homes. Forty individuals participated in the study. The intervention group received a 10-week horticultural activity program, conducted two days a week (one activity day and one visit day), while the control group underwent evaluations without participating in the horticultural activities. Various standardized assessment tools were used to evaluate mental status, functional mobility, cognitive performance, mental well-being, social participation, and quality of life.

The objective of this study is to investigate the impact of a structured horticultural activity program on individuals diagnosed with dementia who reside in nursing homes. The study was conducted with a total of 40 participants. The intervention group participated in a 10-week horticultural activity program, held twice weekly, which included one activity session and one visit session per week. The control group did not participate in the activity program but underwent the same evaluation procedures.

The assessment tools used in this study included:

Mini Mental State Examination to evaluate mental status, Timed Up and Go Test to assess functional mobility, balance, and performance, Rapid Mild Cognitive Impairment Test for cognitive assessment, Warwick-Edinburgh Mental Well-Being Scale to measure mental well-being, Social and Emotional Loneliness Scale for Adults to assess social and emotional loneliness, World Health Organization Quality of Life Scale Elderly Module to evaluate quality of life.

The study is designed to explore whether horticultural activities can be beneficial as part of occupational therapy interventions for individuals with dementia living in nursing homes.

Eligibility Criteria:
Inclusion Criteria:

Residents of a nursing home Age 65 years or older Diagnosed with dementia Mini Mental State Examination (MMSE) score of 18 or higher

Exclusion Criteria:

Orthopedic dependency requiring the use of a wheelchair Diagnosed with any neurological or psychological disorder other than dementia
A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy

Cystoscopy is a commonly performed procedure after gynecologic surgery, however, its use may increase patients' risk for acquiring urinary tract infections due to urinary tract instrumentation entry and reentry of the lower urinary tract with the cystoscope and foley catheter. Use of a novel multi-channel transurethral bladder catheter that allows for cystoscopy through a specialized port will permit cystoscopy to be performed without catheter removal. This may allow for intraoperative detection of urinary tract injuries with a reduction in both urethral manipulation and hospital-associated urinary tract infections. Other potential benefits may include a shorter procedure time and ease of use for providers.

A cystoscopy is a procedure that inserts a thin tube with a light and camera through the urethra, so that the inside of the bladder can be checked for injuries. Current guidelines recommend that this is done after a hysterectomy. Normally, doing a cystoscopy requires that a patient's foley catheter (a tube inserted through the urethra and into the bladder to drain urine) gets removed and then replaced. This can potentially lead to a urinary tract infection (UTI).

CystoSureTM is a silicone device that was developed by surgeons to enable easy and standardized cystoscopy. The design of the CystoSureTM catheter has separate channels for draining the bladder and performing cystoscopy, so doctors can perform a cystoscopy without removing the catheter (which can, as described above, potentially lead to a UTI). In this study, investigators want to examine whether using a CystoSureTM catheter instead of a standard foley catheter could therefore lead to a reduced number of UTIs in hysterectomy patients. CystoSureTM is cleared by the FDA.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18-90
* Undergoing hysterectomy with or without concomitant procedures

Exclusion Criteria:

* Known history of urinary tract anomaly (i.e. urethral diverticulum, ureteral duplication, ectopic ureter)
* ≥3 UTIs in past 6 months
* Immunosuppressed patients
* Premeditated urologic procedure during hysterectomy surgery
A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA

TEMA elbow system is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within five years after the surgery, and thus to assess the short-term performance and safety of this implant.


Eligibility Criteria:
Inclusion Criteria:

1. Patient's age ≥ 18 years old.
2. Patient has given written informed consent to participate to the trial and to his/her personal data processing
3. According to the device indications for use, patient suffers from disability due to one or more of the following:

   * Elbow joint destruction which significantly compromises the activities of daily living
   * Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis with hemophilia.
   * Rheumatoid arthritis or degenerative arthritis with incapacitating pain
   * Correction of severe functional deformity.
   * Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
   * Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
   * Any other medical reason that the investigator determine that subject is a good candidate for a total elbow arthroplasty
4. Patient has undergone a total elbow arthroplasty, receiving TEMA prosthesis.
5. Patient is able to comply with the study protocol.

Exclusion Criteria:

A patient will be excluded from the study participation if he/she meets any of the following criteria:

1. Patient is affected by one or more of the conditions that are stated as TEMA contraindications for use, which are:

   * Local or systemic infection;
   * Septicemia;
   * Persistent acute or chronic osteomyelitis.
   * Uncooperative patient or patient with neurologic disorders who are incapable of following directions;
   * Osteoporosis;
   * Metabolic disorders which may impair bone formation;
   * Rapid joint destruction, marked bone loss or bone resorption.
2. Patient suffers from a diaphyseal fracture
3. For female patients, current pregnancy and/or lactation or planning a pregnancy.
4. Only for patients implanted with the unlinked configuration of TEMA prosthesis, the intraoperative testing showed a bad quality of medial and lateral elbow ligaments.
5. Patient is enrolled in another investigational drug/device study that in the opinion of the Investigator could interfere with this clinical trial
Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain

This study is being done in healthy volunteers to help researchers understand how ABT-614 works in the human body, specifically in the brain. The PET imaging technique can be thought of as a way to take pictures of chemical changes in the brain. To take a PET scan (picture), a substance with low levels of radioactivity (radiotracer) has to be injected when you are in the PET camera. The radiotracer is only radioactive for a short period of time. In this study, PET is being used to measure how the study drug attaches to specific receptors in the brain. The radiotracer used in this study, \[11C\]-(+)-PHNO, is currently being used for studies in people at the CAMH PET Centre.


Eligibility Criteria:
Inclusion Criteria:

1. Body Mass Index (BMI) is 18 to 26 kg/m2, inclusive
2. A condition of general good physical health based upon the results of a medical history, physical examination, vital signs, laboratory profile, 12-lead electrocardiogram (ECG)

Exclusion Criteria:

1. Presence of a metal implant (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker) that would preclude a MRI scan
2. During the last year, a radiation exposure that on its own or in addition to the expected radiation from this study exceeds the allowed annual radiation exposition level (20 mV)
3. Use of tobacco or other nicotine-containing products within 6 months prior to Screening
4. Diagnosis of substance or alcohol disorder within 12 months prior to Screening
5. History of claustrophobia or feeling of inability to lie still on his back in the PET camera
6. History or presence of any neurological or psychiatric conditions
Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection

This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.

During liver resection the control of bleeding is a major concern. The liver is predisposed to diffuse bleeding because of its extreme vascularity. Locally applicable agents (haemostats) are in use in order to achieve control over parenchymatic diffuse bleeding from the resection surface and to prevent intraperitoneal complications attributed to bleeding. These haemostats include bone wax, gelatine, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues. A composite product with well documented efficacy is Tachosil®. It consists of a collagen fleece carrying the fibrin glue components human fibrinogen and human thrombin. It was shown in a RCT to be superior in obtaining intraoperative haemostasis over argon beamer in liver resection. A new haemostat product is Sangustop®. It is indicated for local haemostasis of capillary bleeding and bleeding of parenchymal organs. Sangustop® is composed of native absorbable collagen fibrils without any blood serum products or any pharmaceutical activity. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus provides an additional impetus to clotting. The aim of this study is to show that the new microfibrillar collagen hemostat Sangustop® is not inferior to the carrier-bound fibrin sealant Tachosil® with regards to haemostatic efficacy.

Eligibility Criteria:
Inclusion:

* Age: \> 18 years
* Gender: male / female
* Patients with an indication for liver resection (segmental or non-segmental)
* Willing and able to complete the clinical trial procedures, as described in the protocol
* Signed written informed consent to participate in this clinical trial

Exclusion:

* Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor
* Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints
* Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamix acid, activated factor VII, and aprotinine
* Known allergy or hypersensitivity to a component of the investigational treatments Sangustop® or TachoSil®, to riboflavin or to proteins of bovine origin
* Pregnancy or breast feeding
* Inability to understand the nature and the extent of the trial and the procedures required
* Missing signed written informed consent to participate in the study

Exclusion criteria to be checked during surgery (liver resection):

* Resection area estimated by operating surgeon \< 16cm2
* Infected wound area
* Persistant major bleeding after primary haemostasis
* No bleeding after resection
A Randomized Study of Gas Bubble Technique in Cataract Surgery

To investigate the efficiency and safety of using "Gas Bubble Technique" to reduce corneal endothelial damage in hard nucleus cataract patients.

The study is designed to: Test the hypothesis that the "Gas Bubble Technique" is an effective method for reducing corneal endothelial damage. Describe and evaluate the effects of "Gas Bubble Technique" on a well-defined group of patients over a 1-month period following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent approved by the Ethics Committee
* Over 18 years of age
* Catract patients with hard nucleus (LOSIII N Score ≥4) who are scheduled for phacoemulsification
* Feasible for all visits and willing to follow instructions from the study investigator

Exclusion Criteria:

* Any ocular surgery history
* Currently diagnosis of severe ocular disease and under medication
* Uncontrolled systemic diseases