cyrilzakka/clinical-trials huggingface dataset:
Stopping Heavy Periods Project

This study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for improving quality of life among women who report heavy menstrual bleeding.

This study is designed to be conducted within the context of a patient's standard/usual/typical care from their primary gynecologic care provider. We hypothesize that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related quality of life at 6 months and one year. To test this hypothesis, we plan to enroll 59 women from several sites who present for gynecologic care and self-report heavy menstrual bleeding into a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported heavy menstrual bleeding
* Age 18-51 years
* Etiology of heavy menstrual bleeding from either ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E)

Exclusion Criteria:

* Plan pregnancy in the next year
* Menopausal
* Currently has a copper IUD in place
* History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS
Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort

The SCOLTA project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.Aim of the proposed study is:

1. to evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project Tipranavir cohort and to identify possible risk factors
2. the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.


Eligibility Criteria:
Inclusion Criteria:

* All patients \> 18 years old HIV infected treated with tipranavir

Exclusion Criteria:
Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

The primary aim of this randomized controlled trial is to determine the efficacy of Virtual Reality in pediatric otolaryngology clinics as distraction analgesia and anxiolysis for patients undergoing otologic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients, ages 7-17 years old, undergoing an in-office microscope ear examination with possible debridement/instrumentation by a single fellowship trained neurotologist .

Exclusion Criteria:

* 1) patients with a history of chronic pain disorders 2) developmental delay including autism spectrum disorders 3) neurologic or seizure disorders 4) visual impairment 5) claustrophobia
Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain

A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain

Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the procedures of this trial and provide written informed consent voluntarily;
2. Age ≥ 18 years, male or female;
3. Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
4. Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
5. HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.

Exclusion Criteria:

1. With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
2. Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
3. Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
4. Known treatment failure on pregabalin or gabapentin;
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)

This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.

The main purpose of the study is to evaluate if stevia (as with other sweeteners and consistent with prior research in children and adults) has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.

The proposed study will be an 8 to14-week three-arm randomized controlled blinded trial in children ages 8 to12 years from the Central, Arkansas region. Children with normal weight (BMI percentile \<85th, n = 90) and excessive weight (BMI percentile ≥85th and \<140% of the 95th, n =120) will consume either:

1. Sucrose-sweetened beverage
2. Stevia-sweetened beverage
3. Calorie free flavored water beverage Participants with excessive weight will complete a 14-week intervention to assess both primary and secondary hypotheses. In parallel, normal weight participants will be enrolled with the objective of monitoring indicators of safety for steviol consumption through assessment of changes in metabolic function (glucoregulation and cardiometabolic) markers as well as assessment of shifts in gut microbial communities and steviol metabolism over 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Age 8-12 years
* Normal weight: BMI percentile ≥5th to \<85th
* Excessive weight: BMI percentile ≥ 85th and \<140% of the 95th percentile or BMI ≥35 to \<40 kg/m2
* Current consumption of sugar sweetened beverages (≥3 times /wk)
* Low consumption of non-nutritive sweeteners (≤ 3 time/wk)
* Willingness to consume experimental products

Exclusion Criteria:

* Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0 kg/m2)
* Dislike of experimental beverage taste (assessed at initial screening)
* Severe persistent asthma (determined by daily use of inhaler(s) to keep asthma symptoms under control).
* Exercise induced asthma.
* Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).
* Attention deficit hyperactivity disorder (ADHD).
* Oppositional defiant disorder (ODD).
* Epilepsy.
* Chronic kidney disease.
* Hormonal disease (e.g., hypothyroidism and growth hormone deficiency).
* Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)
* Bleeding disorders (e.g., hemophilia)
* Chronic infections (e.g., HIV, hepatitis B, hepatitis C).
* Mental health disorders (e.g., depression and anxiety).
* Type 2 and type 1 diabetes mellitus.
* Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
* Parent/child refusal to have blood drawn.
* Fasting glucose ≥126 mg/dl at enrollment.
* Fasting A1C ≥6.5% at enrollment or follow up visits.
* Less than 2 months since completion of antibiotics
Contamination Free Bacterial Swap

A test of a newly designed device (Contamination free bacterial swab). This device can be used to introduce a standard bacterial swab into the nose without direct or indirect contact with the nasal vestibule.

Aim:

The investigators want to improved the current method for bacterial culture test in patients with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The investigators will examine whether significantly fewer Staphylococcus Aureus are detected in the middle meatus when applying a new device for bacterial swab introduction. This device is designed to prevent bacterial pollution from the nasal vestibule.

More precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in nasal swabs from 10-15 % to 0-5 %.

The overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients with sino-nasal disease.

Design:

A comparative study in which patients serve as their own control. A bacterial swab will be introduced to both sides of the nose; on the right side using the new device, on the left side using the present day technique (visual guidance). 70 participants will be included.

Statistics:

A chi-square test will be used for comparison of frequencies.

Eligibility Criteria:
Inclusion Criteria:

* symptoms of upper airway disease

Exclusion Criteria:

* mental illness
* Need for interpreter
An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have different pharmacological effects of neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among mehtamphetamine addicts.

Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility Criteria:
Inclusion Criteria:

1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine dependence.
2. Must sign a Information consent form.
3. Required to provide detailed address and phone number

Exclusion Criteria:

1. Serious organic disease.
2. Suicide ideation or hurt others.
3. Taking antipsychotic within two weeks before.
4. drug allergy to Risperidone or Aripiprazole.
5. pregnancy and breastfeeding women.
Clinical Investigation of the Clareon® Intraocular Lens (IOL)

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.

Eligibility Criteria:
Key Inclusion Criteria:

* Planned routine cataract surgery in at least one eye;
* Calculated lens power within the available range;
* Willing and able to sign an informed consent statement;
* Clear intraocular media other than cataract.

Key Exclusion Criteria:

* Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
* Previous corneal surgery;
* Rubella or traumatic cataract;
* Ocular trauma, previous refractive surgery;
* Current or recent use of certain medications as specified in the protocol;
* Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.
Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma

Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted-images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native DWI images and low ADC. Several studies indicate the value of DWI for differentiation of benign and malignant lymph nodes, detection of tumor recurrence and for ADC-based prediction of treatment outcome in various solid tumours (Koh DM et al, Am J Roentgenol 2007).

Patients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study. These patients will receive a WB-DWI scan before treatment, once or twice during treatment (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan will be performed on a 3 Tesla-MRI system without contrast administration and without exposing the patient to radiation.

Whole body diffusion-weighted images will be prospectively interpreted by two experienced radiologists, blinded to all clinical and imaging data. Findings will be correlated to FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.

The purpose of this study is:

* to evaluate Whole body diffusion-weighted imaging for staging of lymphoma
* to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for treatment outcome
* to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor from post therapy changes


Eligibility Criteria:
Inclusion Criteria:

* every patient with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cel lymphoma, mantle cell lymphoma, follicular lymphoma and PTLD)

Exclusion Criteria:

* patient with general contraindications for MRI (pacemaker, claustrophobia, etc.)
* patients with a type of lymphoma other than those described in the inclusion criteria
Septic Management and Outcome of Open Fracture

The aim is the study of the management and outcome of the open fractures.

Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not.

The management and evolution of all the open fractures will be described in order to identify the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non septic).


Eligibility Criteria:
Inclusion Criteria:

* all patients with open fractures

Exclusion Criteria:

-
Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer

This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. first detected and endoscopically confirmed esophageal cancer;
2. preoperative evaluation showed no distant metastases and suitable for RAME;
3. preoperative clinical stage of I to III;

Exclusion Criteria:

1. patients had a history of thoracic or abdominal surgery;
2. patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system;
3. patients had other malignancies;
4. patients had missing clinical data
Registry for Hirschsprung Disease of the BELAPS

Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym

/ Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with Hirschsprung's disease in Belgium. Primary objective The primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. Secondary objective (s) Evaluating the long-term results and evaluate risk factors for constipation / incontinence. Study Design Prospective registry Endpoints Krickenbeck score, urinary, sexual and QoL evaluation


Eligibility Criteria:
Inclusion Criteria:

Hirschsprung Disease, surgery

Exclusion Criteria:

-
Acute Kidney Injury in Patients With Liver Cirrhosis

In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital.

Acute kidney injury (AKI) is a common condition in patients with cirrhosis. It occurs in up to 50% of hospitalized patients with cirrhosis and in 58% of such patients in the intensive care unit. AKI is one of the key predictors for short-term mortality in patients with liver cirrhosis with mortality rates as high as 90%. There is a remarkable increase in length of hospital stay with high financial burden on patients with AKI.

In general, the three main causes of AKI are renal hypoperfusion (also referred to as prerenal AKI), which in most cases is due to hypovolemia; intrinsic, structural kidney injury; and postrenal injury due to urinary obstruction. A unique cause of AKI due to renal hypoperfusion in patients with cirrhosis is the hepatorenal syndrome (HRS), which is the result of renal vasoconstriction. Early identification and management of AKI may improve outcomes.

In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients ( age more than 18 years old ) in Sohag University Hospital

Exclusion Criteria:

* patients with known preexisting chronic kidney disease
* patients who had undergone renal transplantation
* malignancy
* pregnancy
Predictive Value of Venous Excess Ultrasound Score in Management of Cardiorenal Patients

To assess predictive value of venous excess ultrasound score in cardiorenal patient management

Cardiorenal syndrome encompasses a spectrum of disorders involving both the heart and kidneys in which acute or chronic dysfunction in 1 organ may induce acute or chronic dysfunction in the other organ.

Fluid overload is deleterious in critically ill patients; apart from increased mortality, it can cause end-organ damage, thereby increasing the incidence of acute kidney injury (AKI), length of stay in ICU, and duration of mechanical ventilation.

Elevation of central venous pressure is directly transmitted to the renal veins because venous vascular resistance is negligible. As the encapsulated kidney has little room to expand, venous congestion causes renal interstitial hydrostatic pressure to increase. Furthermore, as the post-glomerular vascular and tubular network is a low-pressure system , the increase in the renal interstitial pressure causes compression or even occlusion of renal tubules. That in turn results in reduction or even shut down of tubular flow and shut down in the glomerular filtration .

The venous excess ultrasound (VExUS) score incorporates hepatic venous, intrarenal venous Doppler, inferior vena cava (IVC) assessment, and portal vein Doppler. By utilizing multiple parameters, the negative aspects of individual parameters might get negated and could be considered as a reliable tool to assess congestion of kidneys.

The investigators hypothesise that VExUS score could be valuable in predicting cardiorenal patients who need ultrafiltration in ICU. In this study the investigators will use VEXSUS score to predict response to diuretic therapy, to evaluate patients' volume status, and to predict mortality in cardiorenal patient

Every patient will be subjected to

1. Medical history taking.
2. Complete physical examination.
3. Routine laboratory investigations including baseline urea, creatinine, electrolytes, urine analysis, complete blood count, coagulation profile, liver functions test, arterial blood gas, serum lactate and daily follow up urea, creatinine, and electrolytes.
4. ECG, echocardiography, and lung ultrasound.
5. Volume status will be assessed by urine output, CVP, mean arterial pressure.
6. The following work up.

   * VExUS score (IVC assessment, hepatic venous, intrarenal venous Doppler and portal vein Doppler)
   * Cardiorenal patient will receive diuretic therapy as a standard treatment in patients with VEXSUS score 1-3
   * Daily VExUS score will be done
   * Diuretic resistance will be defined as failure to produce 0.5 ml/kg/h of urine after administration of at least double the dose of the patient's home diuretic therapy or after administration of 250 mg of Lasix and 10 mg of Metolazone in diuretic naïve patient).

Eligibility Criteria:
Inclusion Criteria:

* Patients with congestive heart failure and GFR less than 100 ml/minute

Exclusion Criteria:

* Patients below 18 years old. Patients with liver cirrhosis and portal hypertension. Patients with IVC thrombus. Patients with inadequate ultrasonography window.
Comparative Efficacy of 4 Oral Analgesics

The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.

To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:

1. Oxycodone/acetaminophen (5/325)
2. Hydrocodone/acetaminophen (5/325)
3. Codeine/acetaminophen (30/300)
4. Ibuprofen/acetaminophen (400/1000)

Eligibility Criteria:
Inclusion Criteria:

* Complaint of acute pain of \< 7 days duration
* Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
* Radiologic evaluation is planned

Exclusion Criteria:

* Inability to confirm reliable means of phone followup.
* Past use of methadone
* Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
* History of an adverse reaction to any of the study medications
* Opioids taken in the past 24 hours
* Ibuprofen or acetaminophen taken in past 8 hours
* Pregnancy by either urine or serum HCG testing
* Breastfeeding per patient report
* History of peptic ulcer disease
* Report of any prior use of recreational narcotics
* Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
* Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.