cyrilzakka/clinical-trials huggingface dataset:
Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up

The aim of the Study is to monitor the performance of the Signature Orthopaedics Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.

The Objective of this Post market Clinical Follow up (PMCF) study is to collect data confirming safety, performance and clinical benefits of the Everglade Stem, World Acetabular Cup and World Liner when used for a primary total hip arthroplasty at 2 years follow-up.

This prospective follow-up series is necessary to gather data for the Everglade Stem, World Acetabular Cup and World Liner as they are recently launched to the market.

The data concerning the performance and safety of the devices are gathered in various time frames starting with pre-operative status and then includes operative, at discharge, i year post-operative and 2 year post-operative evaluations.

The revision rate of the components will be monitored as the primary objective, along with pre- and post-operative measurement of the Oxford Hip Score(OHS) patient-reported outcome measure(PROM) to quantify patient satisfaction and radiographic analysis to monitor the bony response to the implants and quantify the effectiveness of the cementless fixation.

Eligibility Criteria:
Inclusion Criteria:

* patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
* patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient
* male and non-pregnant female patients aged 18-75
* patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

* patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
* patient is a female of child-bearing age and not taking and not taking contraceptive pills
* patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
* patient has a known or suspected metal sensitivity
* patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
* patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
* patient is severely overweight with a BMI\>40.
Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)

This prospective study is to characterize the genomic landscape and genetic heterogeneity of multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical, histopathological and medical imaging information, in order to improve disease diagnosis and tailored treatment for MSLC patients.

* To initiate a prospective registry of MSLC patients with high-quality clinical samples and detailed medical data.
* To define the clonal relationship, genomic landscape and potential driver alterations of MSLC using whole-genome sequencing.
* To determine the intrapatient and intratumor genetic heterogeneity of MSLC.
* To correlate molecular features with clinical parameters and patient outcome.
* To serve as a continuous infrastructure for a large variety of research purposes including: A. Diagnostic research B. Prognostic research C. Biological research D. Interventional trial design testing new therapies in MSLC.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Confirmed diagnosis of multiple synchronous lung cancers (MSLCs) without metastatic disease
* Signed informed consent

Exclusion Criteria:

* Medical or psychiatric condition that would preclude informed consent
* History of known high-risk infections
* With metastatic tumors except lung
The CT-based Deep Learning Model Predicts Complications in Partial Nephrectomy

The investigators combine radiomics and deep learning to analyze the lesions more thoroughly, aiming for a more accurate prediction of complications in partial nephrectomy, and compare this approach with traditional models.

In this study, patients diagnosed with renal cell carcinoma or renal cyst who underwent partial nephrectomy across multiple centers was included. And the participants were excluded if they had (a) missing or unavailable imaging data or (b) no available enhanced CT images. The cohort was divided into training and test sets at a 7:3 ratio. After that, the radiomics features were extracted from the images, and lasso regression was used to select features. Then a deep learning model was developed to predict complications and risk grades and compared with traditional classification models (RENAL and PADUA), demonstrating superior applicability.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of renal cell carcinoma or renal cyst
* Underwent partial nephrectomy between June 2014 and July 2024

Exclusion Criteria:

* Missing or unavailable imaging data
* No available enhanced CT images
Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

This study is looking at whether the addition of Aprepitant (Emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting.

This study is looking at whether the addition of a fairly new drug for the treatment of post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) will provide added efficacy if added to 2 drugs that are already used as a standard of care for PONV and PDNV.

The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on the procedure they are having done and/or on patient risk factors.

Eligibility Criteria:
Inclusion Criteria:

* patients with at least 2 of the common risk factors for PONV/PDNV; patients having a procedure deemed at high risk for PONV/PDNV

Exclusion Criteria:

* patients under 19 years of age; pregnant and breast-feeding patients
ER Stress in NAFLD

The investigators overall hypothesis is that exacerbation of endoplasmic reticulum (ER) stress in the liver is associated with significant alterations in phosphatidylcholines that drive the NASH phenotype in obese humans. The investigators plan to examine this hypothesis in a well-characterized cohort of obese subjects that are scheduled for bariatric surgery. Methyl-D9-choline chloride will be infused before and after a 2-week high fructose or glucose feeding to determine the biosynthesis and kinetics of secretory lipoprotein phospholipids. It is proposed that phospholipid metabolism play an important role in the pathogenesis or etiology of fatty liver in non-alcoholic conditions through mechanisms that invoke ER and oxidative stress responses.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory females age 30-60 years old
* Women of all ethnic groups
* BMI≥35 kg/m2
* Approval for Roux-en-Y gastric bypass or sleeve gastrectomy.

Exclusion Criteria:

* Smoking \>7 cigarettes per day
* Previous malabsorptive or restrictive intestinal surgery
* Pregnant or breastfeeding
* Recent history of neoplasia (\<5 years ago)
* Malabsorptive syndromes
* Inflammatory intestinal disease
* Patients with established organ dysfunction
* Diagnosis of type 1 or type 2 diabetes mellitus or current use of anti-diabetic medication (last 30 days; last 60days for thiazolidinediones)
* Diagnosed hyperbetalipoproteinemia or hypobetalipoproteinemia
* Patients on cholesterol lowering medicines
* Vegan diet
* Hepatic fat content \<10% by MRI
* Inability to comply with study protocol such as unable to make study visits or be available daily for phone contact
* Any condition which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, chronic back pain limiting ability to lay flat, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body which may interfere with MRI scanning.
Controlling Hyperglycemia Among Minority Population

The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care. The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.

The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes. Patients from a safety-net hospital will be randomized into three groups: 1) a control group, 2) an intervention providing diabetes self-care text messages, or 3) an intervention using community health workers to provide diabetes education and linkage to care. Secondary objectives include increasing diabetes knowledge, improving diabetes self-management, and increasing use of primary care (i.e., make one visit to the physician in 6 months) among the intervention participants. A cost-effectiveness analysis will determine the most appropriate way to reduce the burden of uncontrolled diabetes.

Eligibility Criteria:
Inclusion Criteria:

\*Hyperglycemia with A1C ≥9%

Exclusion Criteria:

* Lives greater than 20 miles driving distance from Mount Sinai Hospital
* Pregnant women with gestational diabetes
* Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes
* Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
* Unable to understand and give informed consent in either English or Spanish
* Currently or previously participated in a diabetes research study
* Family member currently enrolled in a diabetes research study
* Previously received diabetes care related cell phone text messages
* Unable to receive text messages 3-4 times per week
* Living in a homeless shelter or temporary housing
* Plans to travel outside of the United States for more than 3 months in next year
Robotic Rehabilitation for Stroke Survivors

Pilot study on the physiological response of robotic rehabilitation therapy for improving the performance of activities of daily living of stroke patients

The purpose of this research is to study the feasibility of the robotic therapy that can train activities of daily living tasks for chronic stroke patients. The participant will be involved in a feasibility study (one-time visit) to prove the efficacy of the robotic device with different force feedback (assistive and resistive force) and other feedback such as VR (virtual reality). We will collect movement data from a motion capture system and sEMG sensors that measure muscle activity to monitor the effect of a robotic rehabilitation device, named Spherical Parallel Instrument for Daily Living Emulation (SPINDLE). We will use a robotic therapy device to practice activities during daily living. This pilot study will be used to understand the effect of SPINDLE to translate the device as a home-based training for chronic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic stroke, which affected their upper limb motor functions
* Adults could able to understand the verbal cues during the training

Exclusion Criteria:

* Adults with chronic stroke, who did not lose their upper limb motor functions
Alternative to Two-Stage Hepatectomy

Two-stage hepatectomy with or without portal vein embolization allows to treat multiple bilobar metastases expanding surgical indications for these patients. However, it has some related drawbacks: two operations are needed, and some patients do not complete the treatment strategy for disease progression. Using experience gained from our ultrasound guided resection policy we explored the safety and effectiveness of one-stage surgical procedures in patients otherwise recommended for the two-stage approach.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with resectable colorectal cancer liver metastases (CLM)
2. 4 or more lesions
3. Bilobar involvement of the liver
4. Contact or close adjacency (less than 0.5 cm) of at least one CLM with major intrahepatic vascular structures (1st or 2nd order portal branches and/or hepatic vein at caval confluence).

Exclusion Criteria:

1. Patients with 3 or less resectable CLM
2. Patients with 4 or more resectable CLM but nor bilobar
3. Patients with 4 or more bilobar resectable CLM without any lesion presenting condition of point 4 of the inclusion criteria
Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours

The purpose of the protocol is to determine safety, tolerability, recommended dose (RD), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090 as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part C) in patients with advanced solid tumours and to evaluate food effect (Part D).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years of age
* Patients with solid tumours who have received at least one line of therapy for advanced disease
* Measurable or non-measurable evaluable disease per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1
* Standard of care and/or any investigational therapies must have been completed at least 3 weeks prior to treatment

Exclusion Criteria:

* Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder
* Known primary central malignancy or symptomatic central nervous system metastasis
* Major surgical intervention within 28 days before study drug administration
* Significant acute or chronic infections
The Use of Angiotensin Receptor Blockers and the Risk of Cancer

The primary objective of this study was to assess whether angiotensin blockers (ARBs) and telmisartan in particular, are associated with an increased overall risk of the four most common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective was to explore these effects separately for each of the four cancers and in combination with angiotensin-converting-enzyme-inhibitors (ACEIs).


Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed an antihypertensive agent between 01-JAN-1995 and 31-DEC-2008 with at least two years of up-to-standard medical history in United Kingdom's General Practice Research Database (GPRD)

Exclusion Criteria:

* History of cancer at any time prior to cohort entry
Chronic Pain Attitudes Medical and Physiotherapy Students

This is an analysis of data collected from 2009-2014 from medical students at GCU and physiotherapy students at UoG measuring attitudes towards patients with chronic low back pain and their functionality.

This is longitudinal study with the data collected from 2009-2014 from medical students and physiotherapy students at two different Scottish universities measuring attitudes towards patients with chronic low back pain and their functionality. The outcome measure used was HC-PAIRS the original 15 point Likert Scale. Data was analysed using SPSS (version 25). All data was found to be normally distributed. Descriptive statistics were presented as mean (Standard Deviation). Inferential statistics were carried out using a two-way ANOVA with year of study and discipline of degree as independent variables with post hoc analysis. A p-value of \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

-Engaged in the 2009 physiotherapy degree at Two Scottish universities

Exclusion Criteria:

-Anyone who is not on the above degree courses.
King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial

The goal of this study is to compare the first pass success rate of intubation between video assisted intubation and traditional direct visualization intubation in the field by Emergency Medical Service (EMS) professionals

We will equip several local advanced life support ambulances with a low cost video laryngoscope for a total of 12 months. We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods including first pass intubation success, total success rate for intubation, and complications (need for surgical airway, rescue device, need to revert from KVL to DL, etc.). Please see the attached protocol page for additional details.

Eligibility Criteria:
Inclusion Criteria:

* all patients \>= age 18 year of age undergoing ETI in the prehospital setting

Exclusion Criteria:

* age \< 18 years of age
Topical Therapy With Cooling Effect in Dry Itchy Skin

Dry skin is a physiological condition and is characterized in contrast to greasy skin by roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of tension, burning and itching can occur. The skin reacts more intensive on external and physical noxae. Dry skin is caused by a lack of moisture. This is most common during the winter months, when heating systems dry the air. Bathing with hot water, spending extended periods of time in the hot sun, and the skin's natural aging process also remove moisture and oils from the skin. It is diagnosed through clinical observation. People suffering from dry skin often desire to improve this condition for optical cosmetic reasons and due to the occasional feeling of tension. The aim of this investigation is to observe the improvement (or not) of dry itchy skin by a lotion containing a cooling compound

The patient use the lotion twice daily for a four-week period. Additionally, the patient receives a documentation sheets to note several parameters. In a sensory assessment, product specific parameter such as spreadability, permeability, lubricating, smell of lotion and cosmetic acceptance during the treatment will be assessed (at the beginning, after 2 weeks, after 4 weeks, 2 weeks after stopping treatment). Before and after skin care measurement, the skin surface will be investigated by d-squames and corneometer. After four weeks the skin care measurement will be terminated and the patient can continue with a treatment of his choice. A monitoring of at least 70 patients is intended.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age: over 18 years
2. itch over VAS 3

Exclusion Criteria:

1. pregnancy, lactating women
2. drug abuse
3. active psychosomatic and psychiatric disease
4. active cancer.
5. topical application of tacrolimus, pimecrolimus, corticosteroids or capsaicin two weeks before study start
6. intake of antihistamines, corticosteroids, cyclosporine A and other immunosuppressants, naltrexone, UV-therapy two weeks before study start
7. participation in any other research study during the previous 4 weeks.
FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent

The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.

This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
2. Single de novo lesion requiring treatment in a major native coronary artery;
3. Target lesion is \<=18mm in length (visual estimate);
4. Target lesion is \>=3.0mm and \<=3.5mm in diameter (visual estimate);
5. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria:

1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
2. Unprotected left main coronary disease with \>=50% stenosis;
3. Have an ostial target lesion;
4. Angiographic evidence of thrombus within target lesion;
5. Calcified lesions which cannot be successfully predilated;
6. Ejection fraction \<=30%;
7. Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
8. Totally occluded vessel;
Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil

This study aims to describe in detail the patient journey from diagnosis to the beginning of treatment and patterns of care of hormone receptor- positive, HER2-negative de novo or recurrent metastatic breast cancer between January 2018 and December 2020 in Brazil.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years old
* Histologically confirmed hormone receptor-positive HER2-negative invasive breast cancer
* Hormone receptor-positive defined as 1% to 100% of tumor nuclei positive for Estrogen - - Receptor and/or Progesterone Receptor, as per ASCO/CAP Guideline 2020 - or Allred score of ≥3
* HER2-negative defined as IHC result is 0/1+ or 2+ with ISH negative as per ASCO/CAP Guideline 2018
* Diagnosed with de novo or recurrent metastatic breast cancer between January 2018 -and December 2020
* Public health system or private health system

Exclusion Criteria:

* Male Breast Cancer
* First-line treatment for mBC received through clinical trial
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months

The purpose of this study is to explore the changes in metabolic parameters in patients treated with escitalopram for six months for major depression, generalized anxiety disorder or panic disorder, with or without agoraphobia.

This is an open-label study, with 4 scheduled visits. Recruitment of 100 subjects. Assessments include demographics, diagnosis, smoking frequency, Clinical Global Scale (CGI-S), weight, height,blood pressure, waist and hip circumference and fasting blood glucose and lipd profile.

Statistical analysis will be exploratory and mainly descriptive.

Eligibility Criteria:
Inclusion Criteria:

* Give informed consent
* Requires pharmacological treatment with escitalopram for major depression, generalized anxiety disorder or panic disorder
* Aged 21 years old and above
* Able to comprehend and comply with protocol
* Not pregnant and if of child-bearing age, using adequate methods of contraception

Exclusion Criteria:

* Currently taking or has taken in previous 3 months, any other antidepressants, antipsychotics, mood stabilizers, weight loss or lipid-profile modifying drugs
* Contraindications to escitalopram
* Unstable medical illness and/or is already under treatment of diabetes, hypertension, dyslipidemia, ischemic heart disease
* History of non-response to escitalopram
* Meets IDF definition of metabolic syndrome
* Significant risk of suicide
* Primary diagnosis or comorbid diagnosis of psychotic disorder, bipolar disorder, substance dependence and/or dementia