cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for Renal Cell Carcinoma

This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide comparable local control, with similar or improved toxicity rates compared to Radio Frequency Ablation (RFA) when treating small renal cell carcinomas.


Eligibility Criteria:
Inclusion Criteria for SBRT vs. RFA Randomization:

* Patients with renal cell carcinoma less than 4 cm in maximum diameter, who are poor surgical candidates are eligible for randomization between SBRT and RFA (Renal cell carcinoma must be pathologically proven).
* The primary tumor must be in a location amendable to RFA within the kidney.
* Patients must be appropriate candidates for RFA, with platelets ≥50,000/mm3 and an international normalized ratio of 1.5.
* Patients must have an ECOG (a measurement of general well being and activities of daily living; scores range from 0 to 5 where 0 represents perfect health) score ≤ 3.
* There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
* Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
* Ability to understand and the willingness to sign a written informed consent.
* If a patient is randomized to the RFA arm, but is deemed not to be an anesthesia candidate, he/she will be placed in the non-randomized SBRT cohort.

Inclusion Criteria for non-randomized SBRT arm:

* Patients with renal cell carcinoma less than 8 cm in maximum diameter, patients with metastatic RCC who require local palliation or are progressing through systemic disease, patients who are poor surgical candidates and have tumor location not amenable to RFA, or patients who would prefer a noninvasive means of treatment are eligible for the non-randomized SBRT cohort (Renal cell carcinoma must be pathologically proven).
* There are no limitations based on location of the primary tumor within the kidney.
* Patients must have an ECOG score ≤ 3.
* There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
* Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients younger than 18 or pregnant women.
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification

This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.


Eligibility Criteria:
Inclusion Criteria:

* Stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal)
* New TASC (2007) A, B, or C lesions
* Vessel diameter between 4.5 and 6.5 cm
* Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
* At least 1 outflow vessel down to the ankle
* Signed informed consent
* \> Age 50, life expectancy \> 1 year
* Capable of concluding the necessary follow-up visits

Exclusion Criteria:

* Refusal to participate in the study
* Acute ischemia
* Inflow lesions \> 50%, not successfully corrected before the procedure
* Combination with other treatment with the exception of treatment to improve the inflow
Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip

Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.

Patients and methods:

For this prospective single center clinical trial study, we recruited 14 proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.

Exclusion Criteria:

* Patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.
A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs

The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN).

The real-world study is not a research study. It involves real patients who receive medicines prescribed by their doctors in the real world. Metastatic breast cancer is the type which has spread from breast to other organs.

HR positive stands for Hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help cancer cells grow.

HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to come back or spread to other parts of the body.

This study will mainly measure:

- duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (Ibrance) in combination with hormone therapy as first line treatment for HR+ HER2- metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Received at least one cycle of palbociclib as first line therapy for metastatic breast cancer between 01 January 2016 and 31 December 2022
* Histologically confirmed HR+/HER2- metastatic breast cancer
* Minimum of 3 months available follow-up on palbociclib

Exclusion Criteria:

* Received a different CDK4/6 inhibitor before palbociclib in the first line
* Received other systemic therapy, including hormone therapy, 15-60 days prior to initiation of palbociclib
* Invalid or incomplete records (more specifically, complete duration of treatment on palbociclib, endocrine therapy or LHRH)
* Death date recorded on or before the date of index date
Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn

The primary hypothesis of the present study is that supplementation with the Upset Stomach Relief test product will reduce the severity of the symptoms of occasional indigestion and heartburn.

The purpose of the present study is to evaluate 1) the impact of the test product on symptoms of occasional indigestion and heartburn in 200 adult participants who suffer from occasional indigestion and heartburn and 2) the subjective experience of these participants related to general health, indigestion and heartburn symptoms, and personal experience with the test product.

While dietary and lifestyle changes can ease the symptoms of indigestion and heartburn, HLNatural, Inc. created the test product to reduce occasional indigestion and heartburn. The test product is a plant-based remedy formulated with ingredients that have demonstrated efficacy reducing symptoms associated with occasional indigestion and heartburn.

Eligibility Criteria:
Inclusion Criteria:

* Adult candidates who are in overall good health but who suffer from the symptoms of indigestion.
* Participants will be deemed to be in good health if they do not report any of the existing medical conditions asked about in the screening questionnaire.

Exclusion Criteria:

* Age \<18 years old.
* Unwilling to take test product for their symptoms.
* Are not able to swallow pills.
* Allergy to any of the following: Licorice, Artichoke Leaf, Marshmallow Root, Ginger, Chamomile, Cellulose Capsule, Rice Hull Concentrate, Carrageenan.
* Has any of the following medical conditions:

  * Has had an ulcer
  * Has been diagnosed with a digestive disorder
  * Diagnosed with gastroesophageal reflux disorder
  * Participants with diagnosed with irritable bowel syndrome
  * Participants with active HP infection or with gastric or duodenal ulcer
* Participants who have been prescribed any medication by their physician for any GI disorder or medication that can affect the GI system.
* Participants with previous diagnosis of cancer or with previous surgery of the upper gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy)
* Pregnant women or breastfeeding.
* Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion
* Participant who scores a 0, 3, or 4 on the Dyspepsia Symptom Severity Index
* Participants who are currently using anticoagulation medications daily. (Aspirin, Coumadin, Heparin etc.)
MRE Scan for the Assessment of Differences in Tissue Stiffness Between Radiation Necrosis and Recurrent Glioma in Patients With Previously Treated Gliomas

This trial uses magnetic resonance elastography (MRE) to estimate tissue stiffness (hardness or softness of the tissue) in tissue that is affected by radiation treatment (radiation necrosis) and tumor tissue that has come back (recurrent) after treatment in patients with gliomas. Diagnostic procedures, such as MRE, may estimate the differences in tissue stiffness between radiation necrosis and recurrent glioma post treatment and ultimately lead to a more accurate diagnosis and/or surgery, and/or a better assessment of the disease's response to treatment.

PRIMARY OBJECTIVES:

I. To estimate the mean lesion stiffness in patients with radiation necrosis using magnetic resonance elastography (MRE).

II. To estimate the mean lesion stiffness in patients with glioma recurrence using magnetic resonance elastography (MRE).

SECONDARY OBJECTIVE:

I. To investigate the mean lesion stiffness between radiation necrosis and glioma recurrence.

OUTLINE:

Patients undergo MRE over 10 minutes and then undergo standard of care magnetic resonance imaging (MRI) of the brain with and without contrast at baseline. Within 4 weeks after the initial MRI and MRE scans, patients may undergo standard of care biopsy to check the status of the disease. Within 48 hours after biopsy, patients undergo standard of care MRI to check the status of the disease. Patients who do not undergo biopsy undergo standard of care MRI 4-8 weeks after MRE scan to check the status of the disease.

Eligibility Criteria:
Inclusion Criteria

* \>/=18 years old.
* History of a pathology proven intracranial glioma (including IDH mutant, IDH wildtype or 1p19q co-deleted tumors) treated with chemotherapy and radiation.
* The lesion of concern (T2 Flair Hyperintense or contrast enhancing lesion) is \> 2 cm
* Patient is able to understand and give consent to participation in the study.

Exclusion Criteria

* Patients less than 18 years of age.
* Pregnant.
* Known allergy to gadolinium-based contrast agents.
* Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m2.
* Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:

  * electronically, magnetically, and mechanically activated implants
  * ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
  * metallic splinters in the eye
  * ferromagnetic hemostatic clips in the central nervous system (CNS) or body
  * cochlear implants
  * other pacemakers, e.g., for the carotid sinus
  * insulin pumps and nerve stimulators
  * non-MR safe lead wires
  * prosthetic heart valves (if dehiscence is suspected)
  * non-ferromagnetic stapedial implants
  * claustrophobia that does not readily respond to oral medication
PCI vs. CABG in UPLM-ISR

Left main (LM) coronary artery disease is associated with high morbidity and mortality owing to the large myocardial territory at risk for ischemia. Evidence from randomized controlled trials supports that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for LM disease is an acceptable treatment strategy compared with coronary artery bypass graft surgery in patients with low or intermediate anatomic complexity. However in-stent restenosis (ISR) after DES in LM disease is still occurring with an incidence of 9,7%. Studies comparing the percutaneous coronary intervention with coronary artery bypass grafting (CABG) in the treatment of in-stent restenosis in unprotected left main have been scarce. While surgical revascularization is considered to be the standard treatment for this kind of stent failure, owing to a high risk of perioperative morbidity and mortality, the restoration of flow with PCI may be a reliable alternative. Additionally, it is not clear whether re-PCI is safe in these patients. Therefore, the purpose of the present study was to compare long-term outcomes following PCI or CABG for UPLM-ISR disease.


Eligibility Criteria:
Patients were divided into two separate cohorts for the analyses. The data included consecutive patients with ≥50% diameter UPLM-ISR, with or without multivessel coronary artery disease. Patients with an equivalent of UPLM-ISR: left main distal bifurcation disease, within the proximal 5 mm of the left anterior descending artery (LAD) or left circumflex artery (LCx) ostium (in the absence of significant angiographic stenosis in the left main coronary artery), were eligible. Patients who had protected LM-ISR, defined as the occurrence of at least one patent arterial or venous graft to the left coronary artery, other concomitant non-CABG procedure during surgery, were excluded.
Prognostic Value of CT-guided Sarcopenia for Surgical Outcomes in Esophagetomy and Total Gastrectomy Due to Neoplasia

The purpose of this study is to assess the degree of sarcopenia by CT and to analyze its association with morbidity and mortality after esophagectomy and / or total gastrectomy. It is also intended to analyze the association between the degree of the CT-guided sarcopenia and the nutritional status of the patients evaluated by clinical parameters, both preoperative and postoperative. Besides that, to verify the association between the degree of sarcopenia and body fat rate.

Background: Malnutrition is highly prevalent in patients with esophageal and / or stomach cancer, and is often followed by sarcopenia (loss of muscle mass and strength). Both syndromes influence negatively on prognosis of oncological patients, by increasing hospitalization time, number of complications and hospital expenses. Therefore, it is extremely important to identify patients at nutritional risk. This nutritional assessment can be done through clinical and laboratory tests, as well as can be inferred through computed tomography (CT) imaging.

Hypothesis: To evaluate the relationship between the rate of CT-guided sarcopenia and the surgery outcomes of patients undergoing esophagectomy and / or total gastrectomy due to neoplasia.

Methods: Prospective non-randomized study evaluating the nutritional status and morbidity and mortality of patients. The cases will be conducted according to a pre-established protocol and the sample, for convenience, will be 80 patients. Demographic data and information on diagnosis, treatment and post-surgical data will be collected, as well as anthropometric evaluation. In addition, biochemical data such as hemoglobin, transferrin and serum albumin values will be assessed to classify the patient's nutritional status. The CT images will be analyzed in order to evaluate the degree of sarcopenia and body fat rate, using the distal sections of the third lumbar vertebra. In order to evaluate skeletal muscle mass, the areas of interest will be ones between -30 and +110 hounsfield units (HU) and for the analysis of visceral fat area analysis, pixels with densities between -190 to -30 HU will be used. Both results will be converted to cm2 and analyzed through pre-set cutoff values.

Statistical analysis: Descriptive analyzes will be performed using Fisher's exact tests, for proportions; Wilkcoxon rank-sum test for analyzes of continuous and non-parametric variables. Univariate analyzes will be performed to compare the variables of interest of the study, with the other variables. All tests will have a 5% significance level.

Eligibility Criteria:
Inclusion Criteria:

* elective esophagectomy and / or total gastrectomy due to neoplasia,
* received oral or enteral diet in less than 48 hours postoperatively. For those who started with an enteral catheter, will be included in the study those with oral feedback up to 7 days.

Exclusion Criteria:

* Need for colonic transposition instead of gastric tube for reconstruction;
* Presence of any adverse events related to the anesthetic act or not related to the surgical act.
Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD.

Treatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild Alzheimer's disease with a MMS between 21-30
* Without anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
* No antidepressant or anxiolytic treatment or stopped for at least 15 days
* The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
* Signed informed consent
* Able to carry out all visits and follow study procedures
* Affiliation to the French social security system

Exclusion Criteria:

* Genetic form of alzheimer's disease
* Insufficient clinical and paraclinical information for the diagnosis of AD
* Patient living in a nursing home
* Illiteracy or inability to perform psycho-behavioural tests
* Major physical or neurosensory problems that may interfere with the tests
* Patient deprived of liberty, by judicial or administrative decision;
* Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Major protected by law;
* Short-term life-threatening conditions
A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Exclusion Criteria:

* History of acute angle closure or closed/barely open anterior chamber angle.
* Current use of contact lenses.
* Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
* Ocular inflammation/infection occurring within three months prior to pre-study visit.
* Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
* Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
* Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
* Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
* Pregnancy
* Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
* Inability to adhere to treatment/visit plan.
* Have participated in any other clinical study within one month prior to pre-study visit.
Oral Quality of Life

The restorative and surgical odontological department at the Nantes University Hospital frequently hosts patients with a severely degraded oral condition who has never benefited from a removable prosthetic rehabilitation. The chosen treatment plan consists most of the time in extracting all the residual teeth at one or both arches with the immediate insertion of a complete removable prosthesis performed prior to the extractions. This prosthesis is adapted by regular relining during the osteomucosal healing and is replaced by a usage removable prosthesis on average 6 months after the extractions.

The transition from dentate state (even dilapidated) to toothless state can be a source of discomfort and impairment and lead to a decrease of life's quality for patients. The purpose of this study is to evaluate oral health of the patients at the different stages of prosthetic rehabilitation by using GOHAI (Geriatric Oral Health Assessment Index).

Patients are selected at the beginning of their prosthetic rehabilitation and selected patients give their consent for the participation at the clinical trial. The filling of the GOHAI questionnaire is performed in 3 steps:1- before treatment, 2- after teeth extractions and the delivering of immediate complete denture or without immediate prosthetic rehabilitation and 3-during inspection visits after the delivery of the definitive denture.

Eligibility Criteria:
Inclusion Criteria:

* An adult man or a woman, speaking and understanding French, benefiting from social security cover.
* Patient presenting one or more teeth to be extracted, these extractions resulting in a complete uni or bimaxillary edentulism rehabilitated or not by an immediate complete removable prosthesis.

Exclusion Criteria:

* Patients under the age of majority, patients under protection, protected persons, patients refusing to participate in the study, patients whose follow-up can't be performed, patients who don't speak French and patients who don't benefit from social coverage.
* Patients rehabilitated by immediate partial removable prosthesis (persistence of teeth on the rehabilitated arch).