cyrilzakka/clinical-trials huggingface dataset:
Treatment of Alcohol-Related Hepatitis With Arginine

The purpose of this study is to test the effectiveness of the amino acid arginine in reducing liver injury in individuals with alcohol-related hepatitis.

Arginine is a naturally occurring amino acid that is also available in pill form. Arginine pills have been shown to aid in liver detoxification and fat breakdown in the liver. Numerous studies have examined the effects of arginine on the liver. However, few have determined the optimal concentration of arginine that would best prevent injury to the liver This study will provide participants with three concentration levels of arginine to determine which is most effective in reducing liver injury in alcoholic hepatitis patients.

This study will last 31 days. Participants will be admitted to the General Clinical Research Center for 27 days. Participants will be randomly assigned to one of four groups. Participants in Groups 1, 2, and 3 will have 1%, 2%, or 6% arginine added to their diet in the form of gel capsules. Participants in Group 4 will receive placebo capsules. Participants will be given 24 capsules of different dietary supplements, including the arginine supplements, every day during their hospital stay.

Participants who are not able to ingest at least 18 capsules per day over 3 days or who are not able to eat the majority of their solid or liquid diet while hospitalized will have a naso-gastric soft feeding tube inserted for food and supplements to be administered. A liver biopsy will be performed on Days 3 and 26. The biopsies will involve insertion of a catheter in a neck vein and a small sample of liver tissue will be removed. On Days 2 and 25, participants will undergo blood and urine collection. Participants will also be infused with nonradioactive leucine to determine the levels of albumin, a protein that is reduced in diseased livers. If participants develop fluid in the abdomen (a condition known as ascites), a small sample of fluid will be extracted from the abdomen twice a day on Days 2, 17, and 25. On Day 31, participants will return to the research center for additional blood and urine collection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of alcoholic hepatitis
* Maddrey's DF score less than 33

Exclusion Criteria:

* Hepatitis C or B virus infected
* HIV infected
* History of cancer
* Hepatic encephalopathy (a condition in which liver failure affects the central nervous system)
* Kidney failure
* A Do Not Resuscitate order (a patient-directed order not to resuscitate in the event that resuscitation is necessary to prevent death)
* Maddrey's DF score of 33 or greater after vitamin K administration during the study
* Alcohol withdrawal at study entry
* Active pneumonia at study entry
* Allergy to iodine
* Enrollment in any other clinical trials
Development of Cardio-Vascular Emergency Patients Database Using Voice and Image Technology

Video and audio data of cardio-vascular patients who visit the emergency department (ED) will be collected to build a database. Clinical information retrieved from the database using voice and image technology will be compared to that retrieved by physicians. The degree of agreement will be evaluated.

Study Objectives:

1. To develop a platform to record video and audio data of cardio-vascular patients who visited the ED.
2. To retrieve clinical information using voice and image technology.
3. To develop a tool to retrieve clinical information using voice and image technology.
4. To build a clinical database using video and audio data using voice and image technology.

Study design: Single-center observational study (tertiary hospital emergency department in Korea).

A platform to record video and audio data of physicians examining patients will be developed. The camera and microphone will be installed at an optimal location to retrieve video and audio data of cardio-vascular patients.

Voice and image technology will be used to retrieve clinical information including chief complaint, type and onset of symptoms, past medical history, and physical examination results to build a database. Clinical information including examination notes, diagnosis, patient vital signs, test results, and ED results will be retrieved from the hospital database.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Visited the emergency department of the study hospital
* Chief complaint of chest pain, dyspnea, syncope, altered mentality, side weakness, dizziness, and dysarthria

Exclusion Criteria:

* Patients who do not agree to enroll to this study
* Pregnant patient
* Without a family
* Foreign patients
Mailed Reminders Plus Fecal Immunochemical Testing

Purpose: The investigators propose to test the effectiveness, feasibility, and cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid enrollees in Mecklenburg County.

Purpose: The investigators propose to test the effectiveness, feasibility, and cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid enrollees in Mecklenburg County.

Participants: Medicaid beneficiaries who are enrolled in Community Care of North Carolina, ages 52-64, currently living in Mecklenburg County, at average risk for colorectal cancer (CRC), with no record of recent CRC screening (FOBT within 12 months, colonoscopy within 10 years).

Procedures (methods): Participants will be identified through the state Medicaid database and randomized to receive either: 1) a mailed reminder to complete CRC screening including a FIT kit, instructions for completion, and a return mailer, OR 2) a mailed reminder to complete CRC screening only.

Any recipients testing positive will be guided by care managers from Community Care of North Carolina to ensure a follow-up colonoscopy is completed.

Eligibility Criteria:
Inclusion Criteria:

1. Current Medicaid beneficiary,
2. Enrolled in Community Care Partners of Greater Mecklenburg (CCPGM),
3. 52-64 years old,
4. English or Spanish speaking,
5. No record of FOBT/FIT within 12 months or colonoscopy with 10 years, sigmoidoscopy within 5 years; barium enema within 5 years, CT colonography within 10 years,
6. No record of any CRC diagnosis or total colectomy

Exclusion Criteria:

1. \< 52 or \>64 years of age;
2. History of colorectal cancer or total colectomy (see attached table for codes),
3. Persons dually enrolled in Medicare,
4. Not enrolled in CCPGM, 5. Received FOBT or FIT within 12 months; colonoscopy within 10 years; sigmoidoscopy within 5 years; barium enema within 5 years, CT colonography within 10 years
Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure

The primary goal is to build and test a previously developed and validated risk model and clinical decision support tool embedded within the electronic health record to improve risk stratification of emergency department (ED) patients with acute heart failure (AHF).

The study team will build an electronic health record-embedded clinical decision support tool using a recently developed risk prediction model that curates patient-specific data in real-time, accurately estimates short-term patient risk, and presents tailored clinical recommendations. This will be a regional implementation study in which the tool is turned on at 21 emergency departments (ED) across Kaiser Permanente Northern California (KPNC). The study team will validate risk predictions and study key clinical outcomes as part of this trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18y) KPNC members treated in the ED for presumed acute heart failure

Exclusion Criteria:

* Children (\<18y).
* Patients who left against medical advice or eloped prior to ED physician evaluation.
Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis

This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.

Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects.

Materials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy subjects
* Sites with probing depth (PD) ≥5 mm
* Clinical attachment level (CAL) ≥4 mm
* Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

* Patients with known systemic disease
* Known or suspected allergy to the MF/ biguanide group
* Patients on systemic MF or other oral antidiabetic therapy
* Patients with aggressive periodontitis
* Patients with diabetes
* Use of tobacco in any form
* Alcoholism
* Immunocompromised patients
* Pregnant or lactating females
The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit.

Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). The causes of sleep disturbance are complicated. Poor sleep quality can lead to negative consequences for patients' physical and mental health. Non-pharmacological interventions, such as white noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality. This study is a randomized controlled trial that compared two parallel patient groups.The hypothesis of this study is that white noise can improve sleep quality in adult ICU patients compared with conventional treatment group.

Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). Statistics indicate that over 50% of ICU patients report sleep abnormalities, such as sleep fragmentation, arousals, frequent awakenings, and poor sleep quality. The causes of sleep disturbance are complicated, with evidence suggesting that environmental factors such as noise, from alarms and machines that are active around the clock in the ICU, play a significant role. Poor sleep quality can lead to negative consequences for patients' physical and mental health.

Sleep promotion interventions, including both pharmacological and non-pharmacological approaches, have been proposed. However, the side effects of pharmacological intervention may also lead to poor outcomes. Therefore, non-pharmacological interventions, such as background noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality.

This study was conducted in randomized controlled trial that compared two parallel patient groups. Patients were included by convenience sampling in a medical center in Taiwan. The Verran and Snyder-Halpern Sleep Scale (VSHSS) was used to assess subjective sleep quality. The main purpose of this study was to investigate the effect of white noise intervention in sleep quality in adult intensive care unit patients.

Eligibility Criteria:
Inclusion Criteria:

* Age must be greater than or equal to 20 years old.
* Admitted to the ICU and have been intubated for at least 24 hours.
* Aware of people, time, and place, and without hearing impairment.
* Be able to communicate in writing.
* The Glasgow Coma Scale score must be equal to or greater than 11, with a vocal response of 1 in the patient post-endotracheal tube placement.

Exclusion Criteria:

* History of insomnia, Alzheimer's disease, or depression.
* Routine use of sedative-hypnotic drugs (opioids, benzodiazepines, non-benzodiazepines, antihistamines, and melatonin) before admission.
* Post-operation in the operating room before ICU admission.
* ICDSC score of at least 4 or CAM-ICU positive.
The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory autoimmune disease that results in the destruction of joints, connective tissues, muscle, tendons and fibrous tissue. Effective therapy to manage RA still does not exit at present. Jia Wei Niu Bang Zi pill (NBZP) consists of Chinese herbals which has been widely used in the treatment of RA patients in China for hundreds of years to relieve pain and prevent the affected joints pejorative. However, there is no systematic trials to prove the effect of NBZP for management of RA.

A multicenter, randomized, double-blind, placebo-controlled clinical trials will be conducted to determine whether the NBZP could make an effect of pain relief and joints protection. 120 patients suffering from active RA will be enrolled and treated with NBZP or placebo for 3 months. The primary outcome measures are the rate of American College of Rheumatology (ACR) 50, changes of the Disease Activity Score (DAS) 28 from the baseline to 3 months and the van der Heijde modified Sharp score would be measured from the baseline to 12 months. The second outcome measures are the change rate of ACR20, ACR70, Health Assessment Questionnaire - Disability Index, change score of Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, Patient Global Assessment of Arthritis and the Athens Insomnia Scale (AIS) from the baseline to 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months' follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
* moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
* an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
* paid employment or unpaid but measurable work (e.g. caring for a family and home)

Exclusion Criteria:

* combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
* abnormal liver and my kidney function
* pregnancy or have a plan of pregnancy,breast feeding women
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse
Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer

To observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people.

This project is a non-interventional, prospective, multicenter, case follow-up registry management, aiming to observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people. Therefore, the data collected and reported in this project will reflect the actual efficacy and safety of anti-angiogenesis combined with PD-1/PD-L1 therapy in patients with advanced liver cancer. 490 patients are planned for follow-up, and enrollment is expected for this program to last for 2 years, starting in December 2021 and ending with the last patient enrollment in December 2023. The treatment period was 24 months, and the patient follow-up was 24 months after the last patient was enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 18 years old, male or female;
2. Patients diagnosed with advanced liver cancer, including barcelona stage B, C or Chinese liver cancer guidelines stage IIa, IIb, IIIa, IIIb liver cancer patients;
3. doctors evaluate patients who can benefit from anti-angiogenesis targeted therapy;
4. patients voluntarily join the program and sign informed consent.

Exclusion criteria:

The above selection criteria are not met
Normal Breathing and Swallowing in Healthy Volunteers

The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options and minimal management strategies offered to treat these individuals and improve sequelae of dysphagia. Dysphagia contributes to malnutrition, aspiration, pneumonia, reduced quality of life and increased mortality in neurodegenerative disease such as ALS. One reason for this is the lack of normative data across various measures of swallowing and respiratory function. As a result, detecting early impairments in swallowing physiology is difficult, given the variability of swallowing and unknown normative value range of swallowing physiology. Therefore, the goal of this study is to complete clinical tests of swallowing and cough function in healthy volunteers to establish normative data. This will contribute to future study in disordered populations, to determine degree and severity of impairment and efficacious treatment and management strategies based on impairment.

The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

Eligibility Criteria:
Inclusion Criteria:

* Up to 120 individuals will be included in this study.
* Subjects will include both male and females who are aged between 18-100
* Healthy and with no major medical conditions.
* No specific gender or race will be excluded or targeted for participation in this study.

Exclusion Criteria:

* Adults who are pregnant
* Those with major medical conditions (i.e., swallowing impairment, brain injury) will be excluded from this study.
* Anyone with allergy to barium will be excluded from this study.
Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence

Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.

Examine the efficacy of vaginal Erbium laser treatment for stress urinary incontinence (SUI) in compare to placebo.

Plenty of women suffer from SUI. It is a condition in which involuntary urine leakage occurs during exercise. This condition affects about 40% of all women and causes huge disturbance to daily life. There are plenty of risk factors, such as age, obesity and parity. We assume that the pathophysiology is related to hypermobility of the urethra due to damage to the surrounding tissue.

The treatment options vary from surgical interventional to conservative, each treatment has its own success rate and risk factors. An attempt to find effective treatment option has been made.

The use of laser for various gynecologic conditions are at rise. ERBIUM type laser works on the lamina propria layer and causes rejuvenation probably by strengthening collagen structures and creating new ones.

The efficacy and safety of vaginal laser therapy has been proven already, but in the field of SUI the numbers in each study were low and there was no control group.

In this study we desire to examine the effect of vaginal ERBIUM treatment on SUI in compare to placebo.

this is a randomized single blind control trial. 40 women will be included in the research group and 40 in the placebo group. Women will be assigned randomly to each group. They will be treated with vaginal laser probe, three treatments 4 weeks apart. Follow up visits will be performed 3, 6, and 12 months after the first treatment.

Effectiveness evaluation will be done by physical urodynamic examination before treatment and 6 month after finishing, by 24 hours pad test' cough test and by fulfilling questionnaires-

1. The Urogenital Distress inventory (UDI6)
2. The Female Sexual Function Index (FSFI)

Eligibility Criteria:
Inclusion Criteria:

women above 18 with SUI -

Exclusion Criteria:

1. Recurrent pelvic inflammatory disease
2. Vaginal operation in the previous year
3. Women with abnormal uterine bleeding
4. Women with diagnosed genital herpes infection
5. Any concurrent lower genital tract infection -
Factors Influencing the Results of Treatment in Patients With Hernias of Various Localizations

The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material.

For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).


Eligibility Criteria:
Inclusion Criteria:

* All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.

Exclusion Criteria:

* Patients not having a 11-digit state-assigned Personal insurance policy number.
* Parastomal hernia;
* infected hernias;
Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation

Use of amniotic membrane(AMT) and platelet rich plasma (PRP) clot for closure of central corneal perforation

Use of amniotic membrane and platelet rich plasma clot for closure of central corneal perforation either post infective or posttraumatic

Eligibility Criteria:
Inclusion Criteria:

* central corneal perforation

Exclusion Criteria:

* active infection
* posterior segment pathology
* non seeing eye
Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.

This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with intravaginal micronized progesterone.


Eligibility Criteria:
Inclusion Criteria

1. Age \<50 years old
2. Hormonal Replacement therapy cycle for embryo transfer in any of the following situations:

   1. Embryos in fresh cycle with donated oocytes.
   2. Subsequent embryo transfers of vitrified embryos in cycles of donated oocytes.
   3. Frozen embryo transfers in cycles with autologous oocytes.
3. Endometrial line: \>6.5-7mm (with trilaminar aspect) in proliferative phase, before introducing progesterone.
4. Administration of natural micronized progesterone intravaginally (400 mg/12 hours for 5 complete days (10 dosis), before the embryo transfer and maintained until pregnancy week 12.
5. Embryo transfer of blastocyst (day 5-6).
6. Signed Informed Consent

Exclusion Criteria

1. Uterine pathology (submucous o intramural fibroids (\>4 cm) or which deform the uterine cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating hydrosalpinx).
2. Simultaneous participation in another clinical study.
3. Participation in another clinical study before the inclusion in the present study, and which could affect the objectives of the present study.