cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study of a Haptic Device Evaluation of the Acute Abdomen

The study hypothesis is a haptic sensor can aid in the evaluation of the acute abdomen. Investigators from the MSU Department of Surgery in Collaboration with MSU Engineering are assessing the ability of a non invasive, optical device that is placed on a patients abdomen (much like an ultrasound transducer) to evaluate a patient with an acute abdominal presentation. Conditions such as appendicitis, cholecystitis, diverticulitis or small bowel obstruction will be examined with the haptic device. Data will be collected by the device and later compared to the abdominal findings recorded from an examination conducted by the principle investigator who is a surgeon. The surgeon will not have acess to data collected by the haptic sensor and therefore it will have no impact on the decision making process in the care of the patient. The impact on the individual patient will require obtaining a consent to participate in the study, a few minutes to place the device gently on the abdomen and collect the sensor data. There is no direct benefit to the patient by participating in the study. The potential for such a study may be to develop the technology to have a device that non-medical staff can use to collect patient data and transmit that data to a healthcare provider at another location.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to the MSU Acute Care Surgery service for the evaluation of abdominal pain.

Exclusion Criteria:

* Under 18 years of age
Impact of Underlying Renal Disease and Immunosuppressive Regimen on Ovarian Reserve in Renal Patients

Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments, especially previous strong immunosuppression, may negatively influence the ovarian reserve in childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian reserve.

Every female with renal disease regularly menstruating that met exclusion criteria could have participated. The aim was to assess ovarian reserve in female patients with normal menstrual cycle and kidney disease, including kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Conscious written approval
* Autoimmunological disorder with kidneys affection/ kidney transplant recipient- Regular menstrual cycles
* Age above 18 years old

Exclusion Criteria:

* Irregular menstrual cycles
* Menopause
* PCOS
* Chemiotherapy or radiotherapy in the past
* Surgical interventions within ovaries
* Hypogonadotropic hypogonadism
* Folliculoma
* Age under 18 years old
Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. This would have the advantages of decreasing the false negatives and the re-biopsy rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18
* Patients with a PSA value between 3 et 20 ng/ml
* Obtained informed consent
* Patients able to comply with the study protocol
* Patients covered by a social insurance

Exclusion Criteria:

* None
Portal Vein Thrombosis Associated With Unresectable Pancreatic Cancers : a Prospective Multicentric Cohort Study

Little is known concerning the management of portal vein thrombosis (PVT) in digestive cancers other than hepato-cellular carcinoma (HCC). The use of anticoagulant treatment (ACT), screening of oesophageal varices (OV) and oesogatric varices (OGV), and primary prophylaxis of OV (treatment with beta-blocker (BB) and / or OV ligation) if necessary are not clearly defined. The autopsy series by Ogren et al. (World J Gastroenterol. 2006) found an incidence of PVT in cancer patients of 1%, with 44% of digestive cancers other than HCC as a common etiology, mostly pancreatic adenocarcinoma (42%).

We reported a retrospective French study that included 118 patients with digestive cancers other than HCC, including 50% locally advanced or metastatic pancreatic adenocarcinoma, with PVT complications. A total of 38% of patients had radiological signs of portal hypertension (PHT) and 51% had ACT. Only 1% of patients were screened for VO (n = 7). In addition, 19% (n = 22) presented gastrointestinal bleeding. Among the causes of death, 17% (n = 12) were due to gastrointestinal bleeding. Overall survival (OS) was statistically associated with a metastatic disease (HR = 2.83 \[95% CI 1.47-5.43\], p \<0.01) and gastrointestinal bleeding (HR = 1.68 \[95% CI 1.01-2.78\], p = 0.04).

Bleeding complications from PHT are not uncommon in patients with digestive cancer, especially in patients with pancreatic cancer with PVT; but above all they can be responsible for death. No data existed before our first study (Regnault et al. Dig Liv Dis 2018). However, these data must be validated in a prospective multicentric study with standardized follow-up. In order to obtain precise and homogeneous data, we have chosen to target pancreatic cancers as these tumors are the most common causes of PVT.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic adenocarcinoma proven histologically or cytologically in favor of pancreatic adenocarcinoma
* Mesurable disease according to RECIST 1.1 criteria or non measurable disease
* Metastatic disease (synchronous or metachronous) or locally advanced / borderline deemed unresectable and / or patient inoperable due to his co-morbidities and / or local recurrence after surgery
* Thrombosis of the main portal vein and/or of one of its branches (endo-luminal defect on the injected CTscan) of cruoric or tumoral origin or circumferential stenosis of the portal vein trunk, the spleno-mesaraic confluence or one of its venous branches with or without signs of portal hypertension on CTscan and / or upper GIendoscopy

Exclusion Criteria:

* - Post-surgical portal vein thrombosis and / or in patients considered in remission
* Non-adenocarcinomatous pancreatic tumor (endocrine, etc.)
Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Children with American Society of Anesthesiologist (ASA) physical status 1, 2
* Children with normal body mass index

Exclusion Criteria:

* Difficult airway management
* pulmonary disease
* upper respiratory infection
* risk of pulmonary aspiration
* intestinal obstruction or abdominal distension
* stroke history or moyamoya disease
Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections

In an effort to implement Choosing Wisely guidelines and decrease patient harm, we will implement and evaluate a clinician audit-feedback and behavioral "nudge" initiative to reduce low-value antibiotics for URIs. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will used to test the effects of behavioral "nudge" on antibiotic prescribing.

National prescription rates for low-value antibiotics for uncomplicated upper respiratory infections (URIs) remain unacceptably high, including at LAC+USC Medical Center-one of the largest safety net medical centers in the U.S. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will be compared. A three-part intervention at LAC+USC consists of (1) the urgent care medical director emailing Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, and then (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs, which will be displayed in the clinic. In contrast, the control site (Urgent Care Center at Olive View-Medical Center) will receive Centers for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics, in a broader health system effort to reduce antibiotic prescribing. Patient with URIs (e.g., acute bronchitis, bronchitis NOS, excluding guideline-based red flags such as COPD, HIV) will be identified using electronic health record clinical billable data and low-value antibiotic prescriptions rates per visit will be monitored at both sites. Differences in prescriptions rates will be determined using an interrupted time-series analysis comparing utilization between sites using a repeated measures logistic regression model.

.

Eligibility Criteria:
Inclusion Criteria:

* all patient receiving treatment for Upper Respiratory Infections (defined by ICD codes EHR billable codes) at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center

Exclusion Criteria:

* Patients not receiving treatment for Upper Respiratory Infections at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center
Predicting Poor Outcomes After Primary Knee Arthroplasty

Aim To identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis

Research Question

1. Can the investigators identify association between outcomes and patients characteristics using existing (already collected) datasets
2. What are the characteristics of patients with poor outcome after knee replacement
3. What can be done to improve the outcome of patients at risk of poor results

This is a retrospective analysis of a prospectively collected single centre database.

Eligibility Criteria:
Inclusion Criteria:

* Primary knee arthroplasty
* Osteoarthritis

Exclusion Criteria:

* No consent for joint registry data collection
Effects of Aerobic Combined With Diaphragmatic Breathing Exercise in Smokers

This study aimed to evaluate the effectiveness of aerobic exercise combined with diaphragmatic breathing exercise on pulmonary function and smoking cessation among smokers.

Twenty-four smokers aged between 20 and 45 years were allocated into 3 groups: a sedentary control group (CON, n = 8), an aerobic exercise group (EX, n = 8), and an aerobic combined with diaphragmatic breathing exercise group (EXDB, n = 8). The general physiological characteristics, pulmonary function, and respiratory muscle strength values before and after 8 weeks were meas-ured. The Quit Smoking Questionnaire and urine cotinine were measured for either 30 days after the training.

Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals included those who set the quit date within 7 days from the date of calling the TNQ. The participants have smoked more than or equal to 10 cigarettes per day for at least 1 year and had a body mass index of not more than 24.9 kg/m2. More-over, they were screened for the health risks of exercise by the Physical Activity Readiness Questionnaire (PAR-Q). They must not have exercised for 30 minutes or more at least three times a week for the past six months.

Exclusion Criteria:

* This study excluded participants with a history of respiratory system diseases such as pulmonary tuberculosis, asthma, chronic obstructive pulmonary disease, lung cancer, etc. and who were using nicotine replacement therapy.
Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore

The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>21 years, able to understand the requirements of the study and provide informed consent.
2. C2 - C5 varicose veins / CVI
3. Symptomatic primaryGSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion Criteria:

1. Current DVT or history of DVT
2. Recurrent varicose veins
3. Pregnant patients
4. Arterial disease (ABPI\<0.8)
5. Sepsis
6. Patients who are unwilling to participate
7. Inability or unwillingness to complete questionnaires
8. Adverse reaction to sclerosant or cyanoacrylate
9. GSV, SSV or AASV severely tortuous
10. Life expectancy \< 1 year
11. Active treatment for malignancy other than non-melanoma skin cancer
12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
Chinese Psoriasis Real World Evidence Research

This research is a multicenter,observational study under real world settings in patients diagnosed as psoriasis by dermatologist in the clinic. As patient's choice of medication should be fully respected, all the patients can choose the treatments they prefer, like phototherapy, traditional systemic therapy or biologics. And the study was conducted to compare the effectiveness among different choices of medication in Chinese psoriasis patients.

Psoriasis is a chronic, recurrent inflammatory disease which is caused by heredity, environment and other factors. The typical clinical manifestation are erythematosquamous lesions, and the disease can progress to involve several organs. In view of its complex pathogenesis, there exists various of treatment of psoriasis like traditional systemic drugs and biologics.

This study is an observational, multi-centre study based on real-world evidence. Inclusion criteria is the patients who visit the clinic diagnosed psoriasis by the dermatologist. There existed no exclusion criteria. Information were most collected by a phone application called "Psoriasis New World".

Primary outcome measure is the percentage of patients who achieved a PASI reduction of 100% (PASI 100). And Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition. Also, static Physician Global Assessment (sPGA), static Investigator Global Assessment (sIGA), Body surface area (BSA) and Dermatology Life Quality Index (DLQI) are measured to assess the severity of psoriasis and the change of the disease condition. It is important to monitor all the Adverse Events (AEs) over the whole study. In addition, the laboratory examinations of patients such as liver function are also collected.

Eligibility Criteria:
Inclusion Criteria:

* all the patients diagnosed as psoriasis by dermatologist in clinic.

Exclusion Criteria:

* None
Effect of Protocatechuic Acid on Biochemical Markers of Immunity Status in Healthy Adults

The purpose of this voluntary research study is to determine if a dietary supplement containing a substance called protocatechuic acid (PCA) can change markers in blood related to immunity (a body's natural ability to fight diseases and infections) over a 14-day study period. Blood tests and other assessments will be completed before and after taking either 1,000 milligrams a day of protocatechuic acid (PCA) or a placebo (i.e., a sugar pill) for 14 days.

In this pilot study, the Investigator will utilize a double-blind placebo-controlled randomized design. Fifty (50) healthy men and women will be randomized into one of two arms: either agreeing to take placebo or 1000 mg PCA oral capsules daily. Study treatment will continue for 2 weeks (14 days).

At baseline and end of 2 weeks treatment period, various clinical and laboratory measurements will be performed. Vital signs, a 2-chair test, and personal health assessment will be measured, and blood will be drawn. The following endpoints will be evaluated in blood: erythrocyte sedimentation rate (ESR), high sensitivity C-reactive protein (hsCRP), C-X-C motif chemokine ligand 9 (CXCL9), 25-hydroxy vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (i.e., no acute/new symptoms of illness) male and female volunteers
* Ability to provide informed consent and attend study visits
* Adults 50 - 65 years old
* Has not taken any of the following medications in prior 3 months and has no plan to take over the 2-week study period: corticosteroids, anticoagulants (such as aspirin, clopidogrel, heparin, and warfarin), antibiotics, or daily NSAIDs (occasional use is acceptable)
* Has no ill person currently living in household
* Current non-smoker (and has not smoked cigarettes/cigars/pipes or vaped e-cigarettes within the last 6 months)
* Ambulatory without any type of assistance

Exclusion Criteria:

* Cannot provide written informed consent
* Requires assistance ambulating
* Has had any surgery within last 3 months
* Self-report of close exposure to or infection with COVID-19 (with or without symptoms) within last 3 months
* Self-reported history or current status of cancer, uncontrolled diabetes (A1c \> 7% or fasting blood glucose of \> 140 mg/dL), or heart disease (such as coronary artery disease, arrhythmia, and heart failure)
Supraglottic Airway Needed To Achieve Ventilation

The purpose of this research is to compare if insertion of laryngeal mask airway (LMA) vs. use of face mask, will reduce the time needed to achieve adequate ventilation prior to insertion of the breathing tube.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35.
* Patients willing to participate and provide an informed consent.
* Patients scheduled to undergo an elective surgical procedure including laparoscopic or robotic that requires GETA.

Exclusion Criteria:

* Patients who require administration of succinylcholine for induction/intubation
* Patients with history of uncontrolled GERD.
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis

This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.

The primary aim is to assess the safety of ketogenic diet as compared to standard of care approach for weight loss in patients with compensated cirrhosis due to NASH. The safety endpoints captured in the study include liver decompensation events, measured through several questionnaires, fasting blood glucose, serum creatinine, fasting lipid profile and other adverse events. The tolerability of the ketogenic diet will be assessed by study compliance and by administering a questionnaire.

Secondary aims include weight loss, changes in body composition via serial use of bioelectrical impedance via an Inbody Machine, changes in liver fat and liver stiffness using MRI and proton density fat fraction (MRI-PDFF), liver biochemistries, changes in Child-Turcotte-Pugh and MELD scores measured via labs and changes in liver steatosis and stiffness via serial measures of VCTE by FibroScan®.

Eligibility Criteria:
Inclusion Criteria:

1. NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2).
2. Age 18 and greater

Exclusion Criteria:

1. Actively participation in investigational drug treatment for non-alcoholic fatty liver disease
2. Currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment
3. Have hepatocellular carcinoma and are undergoing therapy
4. Women who become pregnant or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study
5. Pacemaker or implantable cardioverter devices
6. History of hepatic surgery
7. Current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males
8. Presence of ascites or hepatic encephalopathy
9. Symptomatic gastroparesis
10. Uncontrolled diabetes, as defined by a HgbA1C \>11%
11. Uncontrolled congestive heart failure
12. Active infections
13. Child Turcotte Pugh score \> 6
14. MELD score \>12
15. Unwilling to undergo an MRI or have contraindications to an MRI
Better Evidence and Translation for Calciphylaxis

This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.

BEAT-Calci is a randomized, adaptive, multi-center, platform trial that will evaluate multiple interventions, across several domains of therapeutic care. The objective of the study is to establish high-quality evidence on the effect of a range of interventions in patients with kidney failure and newly diagnosed calciphylaxis. Calciphylaxis is a rare disease affecting 1-2 people in 10,000.

The trial will commence with a Dialysis Membrane Domain and Pharmacotherapy Domain. The Pharmacotherapy Domain of BEAT-Calci is a placebo-controlled, double blind, response adaptive, randomised controlled trial that will investigate whether any of the pharmacotherapeutic agents is superior to placebo in improving outcomes. The Dialysis Membrane Domain of BEAT-Calci is an open-label, randomised controlled two-way comparison between two different dialysis technologies.

The BEAT-Calci Wound Assessment Scale (BCWAS) is the primary endpoint for the trial. It is an 8-point ordinal categorical scale of disease outcomes and will be used to determine each participant's outcome.

The trial will utilise a Bayesian adaptive sample size re-estimation approach for sample size calculations. The trial will continue to recruit until predefined superiority or futility rules are met. As the trial progresses, in response to information accumulating during the trial, there are various adaptations that can occur, including addition or removal of an intervention arm, response adaptive randomisation and addition of new therapeutic domains.

Eligibility Criteria:
Inclusion Criteria:

1. Currently receiving haemodialysis, or peritoneal dialysis that can be converted to haemodialysis, with planned ongoing haemodialysis a minimum of three times per week for at least the duration of the protocolised calciphylaxis treatments within this trial
2. Have a new calciphylaxis ulcer present for less than 10 weeks
3. Age ≥ 18 years
4. Eligible for randomisation in at least one recruiting domain
5. The participant and treating physician are willing and able to perform trial procedures

Exclusion Criteria:

Nil