cyrilzakka/clinical-trials huggingface dataset:
Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED

Hepatic steatosis is a common radiographic "incidental finding" that is overlooked and underreported to patients. The investigators developed a clinical decision support system using machine learning and natural language processing that will prompt reporting to patients and provide ED clinicians risk stratified follow-up care recommendations. Data on both the implementation and effectiveness of our intervention resulting from this trial will inform future use with a goal of ultimately improving diagnostic safety and outcomes for patients with hepatic steatosis.

Metabolic associated steatotic liver disease is a public health crisis affecting one third of the US adult population. Steatotic liver disease is an obesity related disease with serious health and quality of life consequences. Hepatic steatosis is reported on \~10% of written radiology reports. Unfortunately, lack of awareness often leads to hepatic steatosis being overlooked by providers and unreported to patients leading to delays in diagnosis and referral to specialty care.

This project, Improving Diagnostic Safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED), proposes to improve diagnostic safety by ensuring that patients receive timely notification of the new finding and referral to follow up care. The STIRRED CDSS intervention employs natural language processing and machine learning to identify hepatic steatosis in written emergency department (ED) radiology reports and combine it with common clinical data and co-morbidities in the electronic health record to create an individualized risk profile and follow up recommendations for patients with suspected metabolic associated steatotic liver disease. This recommendation is communicated to the ED clinician during the ED discharge process via an OurPractice Advisory (OPA) and triggering outpatient referral for follow-up care stratified by risk level.

This trial will evaluate STIRRED across a large health system using a type 2 implementation-effectiveness stepped wedge cluster randomized trial across 11 Emergency Departments in a single health system. Effectiveness of providing risk-based care linkage and implementation outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* imaging finding of hepatic steatosis on ED imaging study
* discharged from the ED to home
* first Northwestern Medicine ED visit in the study period with a hepatic steatosis finding

Exclusion Criteria:

* admitted to the hospital
* age \< 18
* pre-existing Liver Disease diagnosis (Liver Cancer, HCV, HBV, Cirrhosis, NAFLD/MASLD/NASH/MASH, Alcohol Liver Disease, PSC, PBC and autoimmune hepatitis)
* multiple incidental findings on ED imaging study
Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis

The current study sought to determine the reliability of the rehabilitation protocol using the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic success. The investigators hypothesized that this measurement would provide objective data regarding the efficacy of rehabilitation for these challenging patients.

CONTEXT AND OBJECTIVE: In cases of peripheral facial paralysis (PFP), diminished facial movements and their resultant cosmetic sequelae may have significant emotional repercussions, in addition to producing pronounced functional deficits. Abnormal muscle proprioception and deviation of the nasal-labial filter may also interfere with articulation of the labiodental and bilabial phonemes, thus diminishing speech intelligibility. In relation to stomatognathic functions, weakened labial occlusion decreases intraoral pressure, thereby hindering liquid retention in the buccal cavity and giving rise to vestibular stasis on the paralyzed side. The aim of this study was to evaluate the reliability of the labial commissure angle (LCA) as an anthropometric marker for objectively assessing changes in facial muscle tonus.

Eligibility Criteria:
Inclusion Criteria:

* age range between 20 and 70 years
* incomplete PFP (Degree IV)
* integral facial nerve (FN)

Exclusion Criteria:

* systemic disease
* potentially aggravating the PFP (neurological, degenerative, endocrinological)
Study of the Prognostic Role of Gene Polymorphism in the Development of B-cell Leukemias and Lymphomas in Children of Kazakh Nationality

To search for a genetic marker of B-cell leukemias and lymphomas in children of Kazakh nationality, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with B-cell leukemias and lymphomas in children of Kazakh nationality and normal control will be performed.


Eligibility Criteria:
Inclusion Criteria:

* ethnicity - Kazakhs in at least three generations
* active disease or a history of B-line ALL or B-NHL, established on the basis of morphological, cytochemical, immunophenotypic or immunohistochemical research methods with confirmation of the fact of the disease in medical documentation
* Signed voluntary informed consent of the legal representative to participate in the project

Exclusion Criteria:

* Children suffering from other types of malignant neoplasms
* Children with B-linear leukemia and lymphomas with concomitant specified genetic and chromosomal diseases
* Children of non-Kazakh nationality
* Absence of signed informed consent or informed refusal of the legal representative to participate in the study before starting therapy
A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China

This is a Phase III Study that includes a single arm, open-label, multi-dose PK study cohort and a randomized, evaluator-masked, active drug-control multicenter study.

Subjects diagnosed with POAG (Primary Open Angle Glaucoma) or OHT (Ocular Hypertension) who meet eligibility criteria will washout of their current IOP lowering medication(s), if any.

The study will investigate plasma pharmacokinetics of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension.

It will investigate the safety of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension.

There will be a bridging cohort and extension follow-up phase


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary open angle glaucoma or ocular hypertension in both eyes.
* Corrected visual acuity ≥0.2 in both eyes.
* Anterior chamber angle grade ≥2 (Shaffer scale) in both eyes.
* Central corneal thickness ≥480 μm to ≤600 μm in both eyes.
* At completion of the washout phase, IOP ≥22 mmHg in at least one eye and ≤34 mmHg in both eyes at all measurement time points.

Exclusion Criteria:

* Consider visual field disorder at risk for progression during the study based on the current clinical examination result.
* Severe visual field disorder (e.g., mean deviation lower than -12 dB, as assessed by Humphrey field analyzer).
* Any corneal abnormality or other condition potentially interfering with reliable applanation tonometry.
* History of iritis or uveitis.
* Presence of any active external ocular disease, inflammation, or infection of the eye or eyelids.
* History of macular oedema, retinal detachment, or diabetic retinopathy, or current retinal disease at risk for progression during the study.
* History of refractive keratotomy.
* History of invasive surgery for glaucoma (including laser therapy).
* Anterior segment or intraocular surgery (other than glaucoma) within 90 days prior to start of washout phase.
* History of severe eye injury.
* History of allergy to agents that were to be used during the study (e.g., benzalkonium chloride, instillation anesthetics, fluorescein, latanoprost eye drops).
* Intended use of prohibited concomitant medications or therapies during the study.
* Required use of contact lenses from 1 week before treatment phase initiation and during the study.
* Pseudophakic eye, aphakic eye.
* Current participation in another clinical study, or participation and treatment with study medication within 90 days before the start of the washout phase.
* Females who are pregnant, nursing, or potentially pregnant (e.g., positive pregnancy test), planning a pregnancy during the study, or unable to use appropriate contraception during the study.
Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Older Adults in Primary Care

The purpose of this study is to assess the impact of a combined exercise-nutrition intervention in primary clinics on sarcopenia indices, physical function, and quality of life in community-dwelling older adults with possible sarcopenia.

This study will investigate the effects of a 12-week combined exercise-nutrition intervention by comparing it with a control group receiving standard care (usual care) by assessing the sarcopenia indicators, functional recovery, and individual satisfaction. This is an interventional clinical study designed to recruit subjects, analyze data, identify problems, find improvement areas, and explore potential solutions.

Eligibility Criteria:
Inclusion Criteria:

* 65 to 85 years of age
* Men and women with possible sarcopenia

  * If included in the possible sarcopenia criteria in the 2019 Asian Working Group for Sarcopenia(AWGS) criteria A Simple Questionnaire to Rapidly Diagnose Sarcopenia(The Korean SARC-F questionnaire) score is 4 or higher; or Calf circumference (Men's: \<34 cm, Women's: \<33 cm) + Decreased muscle strength (male: \<28kg, female: \<18kg) or Decreased physical function (if it takes more than 12 seconds from the 5-chair stand test)
  * \[(1) and {(2) or (3)}\]

Exclusion Criteria:

* Renal failure: Serum creatine exceeding 2.0 mg/dl
* Uncontrolled hypertension: systolic/diastolic blood pressure greater than 150/90 millimeter of mercury(mmHg)
* Uncontrolled diabetes: glycated hemoglobin (HbA1C) over 7.5%
* Subject who are receiving treatment (steroids, anticancer drugs, etc.) that can affect muscle mass
* Subjects with myocardial infarction or angina pectoris, stroke disease
* Malignant tumor: Subject who has a history of cancer within 5 years or is currently receiving treatment
* Subjects who have liver cirrhosis and uncontrolled hepatitis (Aspartate aminotransferase or Alanine aminotransferase is more than three times the upper limit of the reference range)
* Subjects who have chronic diseases such as musculoskeletal disorders that are impossible to exercise
* Subjects who are allergic to soybeans, coix, and brown rice
The Role of Laparoscopy in Upper Abdominal Surgical Emergencies in Adults: A Retrospective Observational Study.

Introduction Laparoscopy can be used to diagnose and treat the etiologies of acute abdominal pain. This study aimed to assess laparoscopy's effectiveness in upper gastrointestinal (G.I.T) emergencies regarding intra-and postoperative outcomes.

Method: A retrospective observational study was conducted in the emergency departments of Zagazig University on 215 patients who had upper abdominal emergency surgeries between June 2017 and June 2020.

When surgical procedures are standardized, laparoscopy's benefits in a range of emergency scenarios are without question acknowledged. When only a basic strategy is set for the surgery, and the surgical approach entirely depends on intra-abdominal findings, the benefits are diminished or unknown. The evidence unequivocally supports the superiority of a laparoscopic approach in numerous emergency cases, such as acute cholecystitis, gastroduodenal perforated ulcers, infected pancreatic necrosis, and splenic injuries Laparoscopy gives the primary advantages of a shorter hospital stay, a quicker procedure, and faster recovery without complications. Rapid recovery is connected with early enteral feeding. Adequate nutritional support aids in maintaining homeostasis and, as a result, enhances immunity, thereby decreasing the incidence of wound infection. Laparoscopy should be considered with caution whenever abdominal access is considered difficult, as in cases of organ enlargement, adhesion, and bowel distension. In actuality, creating the pneumoperitoneum is an essential step in the procedure. Increased intraperitoneal pressure produces cardio-respiratory and neurological effects.

In this study, the investigators designed a retrospective observational study to present our experience in assessing the outcomes of a laparoscopic approach in emergent upper abdominal surgery in terms of intraoperative and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnoses of upper G.I.T. emergencies, namely acute cholecystitis, perforated P.U., acute necrotizing pancreatitis, and splenic trauma.

Exclusion Criteria:

* \< 18 years of age and
* open surgeries for upper G.I.T.
Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis

This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver.

Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1.

Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 - 65 years of age
* Chronic liver disease of any etiology
* Stage 1-3 fibrosis by Metavir score on a liver biopsy.
* Body mass index \<36 kg/m2

Exclusion Criteria:

* Any evidence of hepatic decompensation past or present
* Subjects currently abusing amphetamines, cocaine, opiates, or alcohol
* Clinically significant cardiac disease
* History of cancer, other than non-melanomatous skin cancer, within 5 years prior to Screening
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Use of systemic immunosuppressants within 28 days of the Pre-treatment Phase
* Use of approved therapy for hepatitis C or hepatitis B virus within 28 days of the Pre-treatment Phase
* Pregnant or lactating
* History of bleeding diathesis within the last 6 months of study Day 1
Management of Mandibular ORN: PENTO as Medical Treatment

Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.

Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.

Mandibular osteoradionecrosis which occurs after the use of radiation therapy for the treatment of head and neck cancer remains being the most problematic and irreversible complication despite its low incidence with no medical treatment to limit or reduce symptoms.

Clinical trials conducted to date have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis that have been irradiated based on the properties of this drugs in increased tissue oxygenation and their antioxidant effect.

The aim of this study is to determine if there is a clinical improvement of mandibular osteoradionecrosis using Pentoxifylline in combination with Tocopherol as treatment because, currently, there is no effective treatment to achieve bone healing and/or a symptomatic improvement.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years and under 90 years old.
* Patients who have received radiotherapy after being diagnosed with head and neck cancer and currently are diagnosticated of mandibular osteoradionecrosis (any clinical stage)
* Follow-up for at least a year after the radiation treatment is completed.
* Absence of tumor at the time of recruitment.
* Patients with the capacity to give informed consent

Exclusion Criteria:

* Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
* Patients taking oral anticoagulants (acenocoumarol, warfarin).
* Known hemorrhagic/coagulation disorder.
* Vitamin K deficiency due to any cause.
* Use of estrogens oral contraceptives.
* Serious bleeding or extensive retinal hemorrhage.
* Ischaemic heart diseases, including recent Myocardial Infarction.
* Serious cardiac arrhythmia.
* Severe LIVER DISEASE.
* Severe renal failure (creatinine clearance \<30 mL/min).
* Hypotension.
* Female patients who are pregnant or lactating
* Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study.
IMSI in Couples With Previous Implantation Failures

There is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with previous implantation failure with ICSI.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ICSI indication, who have previously underwent \>= 1 ICSI attempt in which at least 2 blastocysts were transferred, with no implantation.
* Regular menstrual cycles every 25-35 days.
* Body Mass Index less than 35 as calculated according to the following formula: body weight (kg) / height x height (m2)
* Presence of both ovaries.
* No pelvic and / or clinically significant uterine anomalies.
* Normal cervical cytology.
* Serum follicle stimulating hormone (FSH) within normal limits.

Exclusion Criteria:

* Clinically significant systemic disease.
* Infection by the human immunodeficiency virus (HIV).
* Infection by the by the hepatitis C virus
* Positive test for surface antigens of hepatitis B.
* Endometriosis stages III - IV (classification of the American Society for Reproductive Medicine).
* Hydrosalpinx, unilateral or bilateral.
* Abnormal gynecological bleeding, undiagnosed.
* Allergy or hypersensitivity to human gonadotropin preparations or any other related to the study medication.

-Simultaneous participation in another clinical trial. -
RCT of the Naturopathic Anti-Inflammatory Diet

The purpose of this study is to determine if the naturopathic Anti-Inflammatory Diet results in reduced inflammation and a better response by the immune system when compared to a standard diabetic diet based on the current American Diabetes Association guidelines.

This study will test the effects of two different diets on the immune system and inflammation in diabetes and pre-diabetes. These diets are the "Anti-Inflammatory Diet" (AI Diet) used by many naturopathic doctors and a standard diabetic diet based on the American Diabetes Association recommendations (ADA Diet). The AI diet excludes wheat, dairy products, eggs, red meat, caffeine, alcohol, peanuts and certain fruits and vegetables. The ADA diet includes most foods but controls the amount of each of the food groups.

Naturopathic physicians often use healthful diets to treat diseases but many of these diets have not been compared to usual medical diet treatments. We will be looking at blood markers that show how the immune system responds to the different diets. We are expecting that the AI diet will result in less inflammation and a better response by the immune system than the ADA diet. We will also be looking at levels of blood lipids and glucose to see any effects on these risk factors.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 25-45 kg/m2
* Age 18-75 yrs
* Diagnosed with type 2 diabetes or pre-diabetes
* At risk for type 2 diabetes. Must meet 2 of the following 3 criteria: BMI 30-45 kg/m2, age 50 or older, and/or family history of type 2 diabetes
* Fasting blood glucose of 100-200 mg/dl
* Provide informed consent

Exclusion Criteria:

* Current major debilitating mental or physical illness that would interfere with participation (as determined by the participant's medical history)
* Taking diabetic medication other than sulfonylurea
* Taking Gymnema silvestra (a naturopathic diabetes treatment)
* Taking medications that have anti-inflammatory affects (lipid lowering agents, NSAIDS, COX 2 inhibitors, aspirin, HRT, oral contraceptives, testosterone, seizure medications)
* Taking weight loss medications
* Severe renal, hepatic, or heart disease
* Triglycerides \>500 mg/dL
* Bulimia
* Pregnancy or lactation
* Current excessive use of alcohol
* Current/recent chronic use of recreational drugs
* Smoker
* More than 4 hours/week of aerobic exercise
* Have gained or lost more than 15 pounds during previous 6 months
* Planning on moving out of the area in the next 4 months
* Is a participant in another medical research study
* Is following a weight loss diet
* Is unwilling to accept random assignment of the experimental diets
* Food preferences and/or allergies that will interfere with consumption of experimental diet