cyrilzakka/clinical-trials huggingface dataset:
Effects of Enteral Nutrition Content on Disease Progression in Sepsis Patients

The aim of this study was to investigate the effects of enteral nutrition content on disease progression in sepsis patients.

Sepsis is a serious health problem with high mortality and morbidity rates worldwide. Over-activation of the inflammatory response and related organ dysfunctions are the main characteristics of sepsis. Rapid diagnosis and effective management are of vital importance in the treatment of sepsis. In this context, the role of enteral nutrition in the progression of the disease is increasingly being investigated.

Enteral nutrition is the practice of providing nutrients through the gastrointestinal tract and is a preferred method compared to parenteral nutrition in critical illnesses, especially in sepsis. The enteral route may reduce the risk of microbial translocation and modulate the immune system by maintaining intestinal integrity. Therefore, the content of enteral nutrition in sepsis patients may significantly affect the course of the disease.

Existing literature examines the effects of different enteral nutrient contents on patients with sepsis, with a particular focus on how macro- and micronutrient compositions can modulate inflammatory and immune responses. This study aims to examine the effects of enteral nutritional content on disease progression in patients with sepsis.

This prospective cross-sectional study will be conducted with patients diagnosed with sepsis being treated in the intensive care unit of Mehmet Akif Inan Training and Research Hospital. The study was planned to evaluate the effect of energy and nutrient intake on disease outcomes. Within the scope of the study, 60 patients diagnosed with sepsis will be followed up according to treatment in intensive care unit.

The inclusion criteria of the study include being diagnosed with sepsis and being 24 hours after the start of treatment in the intensive care unit and being able to receive enteral nutrition. Exclusion criteria included having chronic liver disease, chronic renal failure, active cancer disease and being on parenteral nutrition.

Data Collection General and health information of the participants will be obtained from the patient file. Nutritional information of the participants will be calculated by the researcher by noting the amount of food and formula taken with enteral nutrition for 7 days and 7-day food consumption will be calculated.

Biochemical and inflammatory data including glucose, albumin, CRP, haemoglobin, urea, creatinine, lymphocytes, leukocytes, monocytes, neutrophils, eosinophils, basophils will be obtained from the patient records at the beginning of the study and after 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with sepsis and being able to receive enteral nutrition 24 hours after starting treatment in the intensive care unit

Exclusion Criteria:

* chronic liver disease, chronic renal failure, active cancer or parenteral nutrition
Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study

The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.

PRIMARY OBJECTIVE(S):

The primary objective of this pilot study is to assess PAI-performance in a clinical setting to understand limitations of our current PAI instrumentation and to help improve the next-generation design.

SECONDARY OBJECTIVE(S):

To do preliminary evaluations of oxygen saturation in lesions based on PAI-measurements in order to distinguish malignant from benign prostatic tissue as a basis for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Consent signed
* Male \>= 18 and \<= 80 years of age
* Patients must have an elevated PSA And/ Or Abnormal digital rectal exam Or Other indication for prostate biopsy Or Patients with biopsy proven prostate cancer who are scheduled for prostatectomy.

Exclusion Criteria:

* History of prostatectomy or other surgical history that would preclude transrectal imaging (i.e. abdominal perineal resection), anal stenosis/stricture disease
* Men with anatomic abnormalities or previous surgical history that make transrectal imaging impossible (for example, men with previous abdominal-perineal bowel resections or anal atresia/stenosis)
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).

This is a two-part (1 year double-blind inclisiran versus placebo / 1 year open-label inclisiran) multicenter study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C) on stable standard of care background lipid-lowering therapy. The primary objective is to demonstrate superiority of inclisiran compared to placebo in reducing LDL-C (percent change) at Day 330.

Eligibility Criteria:
Inclusion Criteria:

* Heterozygous Familial Hypercholesterolemia (HeFH) diagnosed either by genetic testing or on phenotypic criteria
* Fasting LDL-C \>130 mg/dL (3.4 mmol/L) at screening
* Fasting triglycerides \<400 mg/dL (4.5 mmol/L) at screening
* On maximally tolerated dose of statin (investigator's discretion) with or without other lipid-lowering therapy; stable for ≥ 30 days before screening
* Estimated glomerular filtration rate (eGFR) \>30 mL/min/1.73 m2 at screening

Exclusion Criteria:

* Homozygous familial hypercholesterolemia (HoFH)
* Active liver disease
* Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
* Major adverse cardiovascular events within 3 months prior to randomization
* Previous treatment with monoclonal antibodies directed towards PCSK9 (within 90 days of screening)
* Recent and/or planned use of other investigational medicinal products or devices

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Eligibility Criteria:
Inclusion Criteria:

* Normal eyes (other than correction for visual acuity);
* Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
* Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
* Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
* Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
* History of intolerance or hypersensitivity to any component of the investigational products;
* Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
* Moderate, severe, abnormal, or other ocular findings;
* Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
* Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
* Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
* Ocular surgery within the last 12 months;
* Other protocol-defined exclusion criteria may apply.
Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.

This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.

Eligibility Criteria:
Inclusion Criteria:

* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments

Exclusion Criteria:

* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery

The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic surgery. All subjects received conventional multimodal analgesia. On this basis, the experimental group received whole-process transcutaneous electrical acupoint stimulation, while the control group received corresponding false stimulation.

Conventional multimodal analgesia protocols as follows：

1. Before the end of the operation, the surgical incision was infiltrated with 0.5% ropivacaine 10 mL locally.
2. Patients were transferred to the PACU and provided with patient-controlled intravenous analgesia with sufentanil for postoperative analgesia. The analgesia devices were set to a concentration of 1ug/mL, with a lockout interval of 15 minutes, and a 3 mL bolus，without an infusion dose. The pump was withdrawn 72h after surgery.
3. Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older;
* scheduled for elective laparoscopic gastrointestinal surgery；
* informed consent；
* American Society of Anesthesiologists Physical Status Grades I-III；
* body mass index (BMI) between 18.5 kg/m2 and 28 kg/m2

Exclusion Criteria:

* local skin infection, incision or scar near the study acupoints;
* nerve damage in upper or lower limbs;
* participation in other clinical trials that influence the evaluation of the results of this study;
* inability to understand the Visual Analog Scale (VAS) score or disagreeing with the use of patient controlled analgesia;
* presence of a pacemaker;
* patients with severe CNS diseases or severe mental disorders;
* operations requiring enterostomy or converts to laparotomy;
* patients who need to be transferred to the intensive care unit (ICU) for treatment after surgery.
Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study

1. This pilot randomized controlled trial aims at investigating the effects of different intensities of aerobic walking exercise to alleviate depression in older adults with major depressive disorder. Both baseline and post-intervention measurements will be conducted at the Exercise Physiology Laboratory, Division of Kinesiology, School of Public Health, The University of Hong Kong, while the exercise intervention will be conducted outdoors in a small group setting (3-5 participants).
2. Three-time-per-week moderate-intensity (\~3.5 METs) or vigorous-intensity (\~7 METs) walking exercise will be prescribed to participants in two exercise groups, while the participants in the waitlist group will receive no intervention. The intervention duration is 12 weeks.
3. We will recruit participants from the community in HK. Interested participants will be invited for a semi-structured interview including an assessment on the Beck Depression Inventory and medical history record to confirm eligibility.


Eligibility Criteria:
Inclusion Criteria:

1. Older adults aged equal or over 50 years;
2. Ethnic Chinese;
3. Beck Depression Inventory score over 9 points;
4. Diagnosed with MDD and currently on pharmacological treatment for MDD.

Exclusion Criteria:

1. Incapable of participating in physical exercise with major confounding conditions which are known to affect mobility;
2. Cannot walk without assistive device;
3. Regular exercise habit (defined as exercise \> 3 times per week and each time \> 50 minutes)
4. Any serious somatic condition that prevents walking exercise participation (such as limb loss)
5. History of major diseases e.g. cancer, cardio-/cerebrovascular, neurodegenerative and renal diseases;
6. Diagnosis of dementia/Alzheimer's disease, or currently using antidementia medication;
The Culture of Ovarian Cancer Organoids and Drug Screening

The tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.This is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(OC) patients.

Tissue will be received from operative specimens( primary ovarian carcinoma) at time of primary cytoreductive surgery.Ovarian cancer(OC) organoids will be then cultured. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and immunohistochemistry (TP53, PAX8 etc). After then, the patient-derived organoids cultured from OC will be compared the sensitivity to standard regimens (chemotherapies and targeted agents) recommendated by NCCN guidlines versus patients treated in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma.
2. ECOG score 0\~1,age 18\~70 years old
3. Expected survival over 6 months
4. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
5. CBC：Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
6. Serum ALT≤2×UL, AST≤2×ULN；Serum creatinine≤1.5×ULN；

Exclusion Criteria:

1. Activity or uncontrol severe infection
2. Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
4. Chronic renal insufficiency or renal failure
5. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis
1540nm Non Ablative Fractional Laser Treatment of Scars

Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect can play a key role in patient satisfaction and self-image.

Non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound healing response. There are different reports on the positive effect of these type of laser treatment in the treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars.

The low morbidity of the treatment and the lack of satisfying treatment regimes for different types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with the 1540nm non ablative fractional laser in the treatment of scars.

Objectives:

* To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser treatment for 3 different "scar" patient groups :

  1. Patients with hypopigmented scars
  2. Patients with hypertrophic scars
  3. Patients with scars due to grafts and reconstructions in the head and neck region.
* To evaluate the treatment related pain. on a categorical scale from 0-10
* To evaluate the adverse effect of 1540nm fractional laser versus untreated control in the 3 patient groups.

The study design is a prospective single blinded randomised within-patient controlled study The study involves 6 visits.


Eligibility Criteria:
The patients needs to have a scar fulfilling the inclusion and exclusion criteria of one of the 3 patient groups:

Patient group 1: patients with hypopigmented scars :

Inclusion criteria:

* Patients with a hypopigmented scar allowing 2 side by side test areas of similar sizes and appearance within the same anatomical region.
* Skin type 1-4
* Age at least 18 years old
* Willingness and ability to give written informed consent and to comply with the requirements of the protocol

Exclusion criteria:

* Pregnancy and lactation
* Oral retinoid drugs within the past 6 months

Patientgroup 2: patients with hypertrophic scars :

Inclusion criteria:

* Patients with a hypertrophic scar allowing 2 side by site test areas of similar sizes and appearance within the same anatomical region.
* Skin type 1-4
* Male / Female
* Age at least 18 years old
* Willingness and ability to give written informed consent and to comply with the requirements of the protocol

Exclusion criteria:

* Pregnancy and lactation
* Oral retinoid drugs within the past 6 months

Patient group 3: Patients with scars due to grafts and reconstructions in the head and neck region.

Inclusion criteria:

* Patients with a graft or reconstruction with 2 site by site test areas of similar sizes and appearance within the same anatomical region (head and neck region).
* Skin type 1-4
* Age at least 18 years old
* Willingness and ability to give written informed consent and to comply with the requirements of the protocol

Exclusion criteria:

* Pregnancy and lactation
* Oral retinoid drugs within the past 6 months
Clinical Study on Oral Nemonoxacin Malate Capsules

The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

Single dose study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg.

Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, aged between 18 and 45 during screening
* Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study
* No use of tobacco or nicotine product within 3 months prior to this study
* BMI 19-25
* Willing to abstain from coffee and any caffeine drink during the study
* Voluntarily sign the informed consent

Exclusion Criteria:

* History of diabetes, or cardiovascular, hepatic or renal disease
* Active digestive disease (e.g. diarrhea)
* Central nervous disease or psychiatric disorders
* Had surgery or trauma within 6 months prior to this study
* Alcohol or drug abuse
* HIV, HBV or HCV positive
* Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study
* Donated 400ml of blood or plasma within 3 months prior to this study
* Have an abnormal laboratory examination value that exceeds the normal range by 10%
* Drug allergies
* Have cardiac disorders or have a family history of cardiac disorders
* Have abnormal 12-lead ECG during screening
* Pregnant or lactating
* Participated in any study within 3 months prior to this study
Optimizing the Tobacco Cessation Clinical Decision Support Tool.

The existing tobacco cessation best practice advisory (BPA) fires for providers (physicians, residents, fellows, midwives, nurse practitioners, physician assistants) during outpatient encounters when a patient is identified as a current tobacco user in the Social History section of their chart. The BPA was designed to help facilitate tobacco cessation interventions; it is part of the The Centers for Medicare \& Medicaid Services (CMS) Quality Payment Program (QPP). The purpose of the project is to optimize this BPA utilization and improve patient outcomes by comparing multiple versions of the tobacco cessation BPA.


Eligibility Criteria:
Inclusion Criteria:

* All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation.

Exclusion Criteria:

* non smokers