cyrilzakka/clinical-trials huggingface dataset:
Kinematics Analysis of SIGMA® Partial Knee System

The proposed study is a prospective collection of health related personal data (observational study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich. The UKA subjects are recruited based on the inclusion and exclusion criteria.

The primary objective is to quantify and describe the three-dimensional kinematics for patients with a traditional medial SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) during these daily activities.

The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee.

The knee arthroplasty for each patient was implanted more than one year ago as per inclusion criteria of this study with the sole purpose of standard clinical practice of the recruiting surgeons.

Eligibility Criteria:
Inclusion criteria (group 1):

* medial SIGMA® High Performance Partial Knee System due to medial OA
* Intact/functional ACL
* BMI ≤ 32
* good clinical outcome, KOOS \>70
* no or very low pain VAS \< 2
* Follow-up at least one year post-op
* Standardized general health survey score (SF-12) within the normal range for people in their age group
* Age ≥ 18 years

Exclusion criteria (group 1):

* Actual significant problem on lower extremities
* Misaligned UKA
* Deficient / non-functional ACL (Lachman Test)
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing the motion tasks
* Pregnancy

Inclusion criteria (group 2):

* medial SIGMA® High Performance Partial Knee System due to medial OA
* Deficient / non-functional ACL
* Central to posterior wear of medial tibial plateau (pre-op MRI)
* 50% reduced tibial posterior slope after UKA (post-op radiograph)
* BMI ≤ 32
* good clinical outcome, KOOS \>70
* no or very low pain VAS \< 2
* Follow-up at least one year post-op
* Standardized general health survey score (SF-12) within the normal range for people in their age group
* Age ≥ 18 years

Exclusion criteria (group 2):

* Actual significant problem on lower extremities
* Misaligned UKA / non-reduced posterior tibial slope (post-op radiograph)
* Intact / functional ACL
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing the motion tasks
* Pregnancy
Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism

Prospective, multicenter observational study, of the effectiveness of a standard of care protocol implemented to enhance home treatment of VTE. Study population will be selected as part of usual care as eligible for home treatment. Study personnel will travel to participating institutions to qualify the sites, deliver a Powerpoint® lecture to introduce the protocol, meet and train site principal investigators, emergency physicians and research personnel on the implementation of the protocol as part of usual clinical care, and data collection methods for a quality assurance registry with plans to use the data collected in this registry in future publications. Follow-up will be 30 days using medical records and/or telephone interview to assess for primary outcomes of bleeding or VTE recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be low risk, as defined by either A or B below:

   A. The modified Hestia criteria:
   * Systolic blood pressure \> 100 mm Hg
   * No thrombolysis needed
   * No active bleeding
   * SaO2 \>94% while breathing room air
   * Not already anticoagulated
   * No more than two doses of IV narcotics in the emergency department
   * Other medical or social reasons to admit
   * Creatinine clearance \>30mL/min
   * Not pregnant, severe liver disease or heparin induced thrombocytopenia OR

   B. The physician opinion that a patients' overall social and medical situation is favorable for home treatment and the patient has a zero score on the simplified pulmonary embolism severity index (sPESI).

   All of the following must true:
   * Age \< 81 years
   * No history of cancer
   * No history of heart failure or chronic lung disease
   * Pulse \< 110 beats/min
   * SBP \> 99 mm Hg
   * O2 sat \>89%%

   We have chosen either criteria because both have been found equal in terms of safety for outpatient treatment of PE.6,22 Hestia includes implicit questions that most emergency physicians would use as criteria for discharge (e.g., overall medical status and social situation), whereas sPESI does not. For that reason, we have added the additional gestalt assessment question about physician discretion.
2. Patients must be discharged in \<24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.

Exclusion Criteria:

* VTE diagnosis while taking anticoagulants with evidence of compliance (e.g., physician opinion that patient is taking a Eliquis®, Xarelto® or Pradaxa®, low molecular weight heparin injections or warfarin as prescribed for any condition)
* Sensitivity or contraindication to use of apixaban
* Troponin assay value, drawn as part of usual care and found to be positive, using local standards
* High risk for hemorrhage defined by a score\>1.5 using the method of Ruiz Gimenez.3 (Note that several criteria are already excluded by Hestia):

Recent major bleeding, 2 points Creatinine levels \>1.2 mg/dl, 1.5 points Anemia, 1.5 points Cancer, 1 point Clinically overt PE, 1 point Age \>75 years, 1 point
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.

SECONDARY OBJECTIVES:

I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.

II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

EXPERIMENTAL OBJECTIVE:

To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Eligibility Criteria:
Inclusion Criteria:

* Patients with the following cancer types:

  * Brain cancer
  * Bladder cancer
  * Urothelial cancer
  * Testicular cancer
  * Skin cancer
  * Thyroid cancer
  * Hepatocellular carcinoma
  * Cholangiocarcinoma
  * Thymus cancer
  * Pleural cancer
  * Cervical cancer
  * Adrenal cancer
  * Neuroendocrine tumors
  * Hematologic cancer
  * Cancer of Unkown Primary
* Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
* Patients are ≥ 18 years old at the time of the radiotracer administration.
* Patient can provide written informed consent
* Patient is able to remain still for duration of imaging procedure (up to one hour)

Exclusion Criteria:

* Patient is pregnant or nursing
* Patients with any new cancer therapy between the baseline PET/CT and the investigational FAPI PET/CT
* Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

The aim of the study is to compare self-reported gastrointestinal symptoms and intestinal fermentation rates of the study products as measured by breath hydrogen and methane in adult population with self-reported mild abdominal sensitivity to pulses. The study products are a pulse products with two different cereals.

The study is a randomized, controlled, double-blind, cross-over intervention trial. The aim is to recruit 25 subjects to the trial. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and breath gas measurement two times (two different test products) in a randomized order. The study meals are identical in appearance but differ in fiber content. After study breakfast the breath gases are analyzed every 15 minutes during 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with subjective experience of gut symptoms after consumption of pulses
* Celiac disease and wheat allergy excluded by antigen test
* Age 18-65
* BMI 18,5 - 30
* Normal liver, thyroid and kidney functions

Exclusion Criteria:

* Celiac disease, Crohn's disease, ulcerative colitis or acute diverticulitis
* Any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs)
* Antibiotic treatment within previous 3 months
* Blood donation or participation to another clinical trial within one month prior to study entry
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

* Approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking GLPG0974 or matching placebo (2:1 ratio) for 28 days.
* During the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of GLPG0974 present in the blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the blood, colon biopsies and faeces will be explored.


Eligibility Criteria:
Key Inclusion Criteria:

* Men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent with a documented history of UC.
* Presence of mild-to-moderately active ulcerative colitis as evidenced by clinical signs and endoscopy.
* Medication: 5-ASA.
* Absence of infectious colitis.

Key Exclusion Criteria:

* History of sensitivity to any component of the study drug
* Any concurrent illness, condition, disability or clinically significant abnormality (including lab tests) that represents a safety risk , may affect the interpretation of data, or may prevent the subject to safely complete the assessments
* Positive serology for HIV 1 or 2 or hepatitis B or C, or any history of HIV or hepatitis.
* History of active infections requiring intravenous antibiotics within the past four weeks prior to randomization.
* History of bowel surgery, or presence or history of intestinal malignancy.
* Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis.
* History of lower GI bleeding disorder, other than UC.
* A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (other than UC), pulmonary or metabolic disease.
* History of tuberculosis (TB) infection.
* Treatment with systemic corticosteroids within 1 week prior to randomization.
* Treatment with TNF-α inhibitors or other biologics within 2 months prior to randomization.
* Treatment with immunosuppressants, initiated or changed within 3 months prior to randomization .
* Current use of probiotic or prebiotic preparations
* Regular daily use of NSAIDs, within 7 days prior to randomization.
* Administration of any experimental therapy within 90 days or 5x the half-life.
* History of drug or alcohol abuse.
* Pregnant or lactating women.
* Medical, psychiatric, cognitive, or other conditions that compromise the subject's ability to complete the study.
SmartTouch Catheter for Left Anterior Line - SmarT Line Study

This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.

Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF).

The three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.

The ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter
* Patients with persistent atrial fibrillation
* Patients with perimitral flutter
* Patients with recurrence after a circumferential PV isolation procedure
* Patients with paroxysmal atrial fibrillation and AF episodes lasting \> 7 days
* Patients (\>18 und \<80 Jahre)

Exclusion Criteria:

* moderate to severe valvular heart disease,
* congenital heart disease
* reduced left ventricular function (ejection fraction \<35%)
* any reversible cause for atrial fibrillation (e.g. hyperthyroidism)
* intracardiac thrombi documented by transesophageal echocardiography
* myocardial infarction within 3 months, cardiac surgery in the previous three months
Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures

To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.

Exclusion Criteria:

* Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.
Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry

The purpose of this study is to provide a registry of participants in order to assess the acute adverse event rates following ablative radiotherapy for metastatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Radiographic evidence of metastatic disease (may include oligoprogression, oligorecurrence or oligometastasis) at the time of study enrollment
* Planned to receive, currently receiving, or have completed hypofractionated image guided radiotherapy (ablative radiotherapy) to an extracranial site(s)
* Patient must sign study-specific informed consent

Exclusion Criteria:

• None
Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)

The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.

The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.

Glucocorticoids have become standard of care for critical COVID-19 patients, with a mortality benefit shown in several recent randomized control trials. Critical COVID-19 can lead to ARDS, in which the use of glucocorticoids has uncertain benefit beyond 10 days. Studies have shown increased harm in the use of these agents in persistent ARDS (≥14 days). Additionally, studies supporting the use of steroids in COVID-19 only used steroids for a limited time (up to 10 days). Given that these agents can possibly lead to increased patient morbidity and mortality, prolonged use of glucocorticoids is not without risk. To date, there have been no studies evaluating the clinical impact of glucocorticoid use beyond 10 days for treatment of critical COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* ICU admission at any time during first hospital admission for COVID-19
* COVID-19 diagnosis
* Dexamethasone, hydrocortisone, or methylprednisolone therapy for SARS-CoV-2 infection

Exclusion Criteria:

* Prior ICU admission before study start date
* Death or hospice before day 11 of hospital admission
* Still admitted at time of data analysis from index admission
Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients

Peripheral intravenous catheterization (PIVC) is the most frequent invasive clinical procedure in a hospital setting, associated with significant complication rates for the patient, compromising their well-being, as well as the quality, safety, and efficacy of the care provided. The traditional approach to PIVC is considered reactive and ineffective, resulting in the exhaustion of the patients' peripheral venous access prior to consideration of other access methods and options (Moureau et al., 2012).

Evidence suggests that the safety and effectiveness of patients with a peripheral catheter are also intrinsically associated with the adequacy of materials and technologies used in clinical contexts for vein selection, as well as for catheter insertion and maintenance care (Marsh, Webster, Mihala \& Rickard, 2017). Several studies point to the inadequacy of the technologies and medical devices used in this area, enhancing the occurrence of complications such as infection, phlebitis, occlusion and accidental catheter removal (Braga, 2017; Costa, 2017; Nobre \& Martins, 2018).

The project investigators aim to determine whether the use of a PIVC pack will significantly reduce associated complications when compared with the usual care. Additionally, the research team aims to determine if the use of a PIVC pack will reduce the number of insertion attempts and overall procedure time, as well as improving patient and provider satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Participants who require peripheral intravenous catheterization as part of their therapeutic plan (caliber 20G or 22G);
* Participants whose primary nurse agrees to participate in the study;
* Participants who are able to give written assent or oral assent.

Exclusion Criteria:

* Confused and/or disoriented participants;
* Participants who are unable to communicate orally and/or in writing.
Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People

This study evaluates the effect of balanced and sustainable diet application on fat composition, insulin resistance and inflammation marker in obese people.

Intervention: Obese subject will receive intervention on balanced and sustainable diet application Control: Obese subject will receive a balanced diet application only

Maintaining the adherence of weight loss programme while selecting healthy and sustainable foods will become a worldwide future challenge in nutrition. Therefore, we investigated the suitable content, graphic, and flow in developing a mobile application as an alternative solution for enhancing the compliance of weight control and selecting healthy food with the least environmental impact.

The treatment for obesity consists of dieting, physical exercise, pharmacology, and surgery. Restricted balanced diet is a well known diet recommendation for people with obesity. Sustainable diet is an alternative form of diet which contributes to healthy life and is protective of biodiversity.

The main challenge in obesity management is the sustainability of weight loss programme. Mobile apps are an alternative solution for enhancing compliance.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 25 kg/m2
* using Android-based smartphone
* willing to join this research by signing informed consent

Exclusion Criteria:

* pale in physical examination
* in weight loss program
* have obesity with comorbidities
* have hormonal diseases
* consumed hormonal drug, PTU, anti diabetes drug
* smoking or stop smoking under 2 years
* pregnant and breastfeeding women