cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver

Non-alcoholic fatty liver disease (NAFLD) is rising in prevalence, and will likely become the predominant cause of chronic liver disease in HIV-infected individuals.

Metabolic factors and obesity are important risk factors for NAFLD in HIV-infected individuals. There is currently no approved effective pharmacological treatment for fatty liver disease. Therefore, lifestyle modification directing at weight loss is currently the cornerstone of treatment for fatty liver disease in the general population. Hypocaloric diets can improve fatty liver in the general population, but the most effective specific dietary interventions are yet to be elucidated.

The study aims to 1. determine the efficacy of a lifestyle modification programme in inducing resolution of NAFLD in HIV-infected individuals 2. to determine the efficacy of a lifestyle modification programme in improving insulin resistance, pro-inflammatory markers, and liver fibrosis in HIV-infected individuals with fatty liver disease 3. to determine changes in intestinal microbiome secondary to the lifestyle modification programme, and the association with resolution of NAFLD in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or above
* positive HIV antibody, on anti-retroviral therapy
* HIV viral load ≤50 copies/mL for ≥6 months
* intrahepatic triglyceride content ≥5% on magnetic resonance spectroscopy

Exclusion Criteria:

* current AIDS-defining illness
* active malignancy, or history of malignancy within the last 5 years
* hepatitis B and/or hepatitis C co-infection, as determined by positive HBsAg and anti--HCV antibody
* alcohol consumption \>30g per week in men or 20g per week in women
* alanine aminotransferase (ALT) above 10 times the upper limit of normal
* liver decompensation (as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices).
Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices

The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs.

Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.

Gastric varices (GVs) is a common complication of portal hypertension, with an incidence of 20%. Though the bleeding rate of GVs (25%) is lower than that of Esophageal varices (EVs), the mortality rate is higher due to greater GVs rupture and less space for endoscopic intervention. In addition, in 30% of patients with GVs, the possibility of treatment failure exists.

Guidelines differ on endoscopic treatment for secondary prevention of GVs.Current studies suggest that EVL, due to its low incidence of complications, is suitable for GOV1, while it is still controversial for the treatment of gastric varices. Compared with glue, the advantage of ligation is that it can avoid serious complications caused by glue injection, such as ectopic embolization, large ulcer and sepsis. As there are few studies comparing GVL and GVO in secondary prevention of gastric varices, the treatment methods are different, and the treatment effect is controversial. In addition, the choice of treatment for different types of GVs needs further study.

The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs.

Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age；Past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination

Exclusion Criteria:

* Patients who are not suitable for endoscopic treatment judged by the clinician; Patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; Patients with acute hemorrhage
Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

This study aims to determine the inter- and intra-variability of Transcranial Doppler (TCD) ultrasound in neuro-critical care patients who are planned for consecutive daily TCD evaluations.

Patients enrolled in the study are recruited from the pool of neuro-critical care patients admitted to the surgical intensive care unit (SICU). When the patients are admitted in the surgical ICU, the study staff will determine eligibility based on the protocol inclusion criteria. Due to the nature of the disease, there is a high likelihood that patients are either unconscious, of limited mental capacity and/or have been intubated therefore when appropriate the legally authorized representative will be utilized to obtain research consent.

To meet study inclusion, transcranial Doppler (TCD) testing will be ordered as part of the standard of care for these patients. The test will not be ordered solely for research purposes. There are no known side effects from the non-invasive measurement of cerebral blood flow using ultrasound

Three different TCD technicians will do triplicate readings on 3 consecutive days on up to 12 patients already undergoing TCD as ordered by their treating team. Standard of care on specific neuro critical care patients (such as cerebral aneurysms) is to undergo daily TCD monitoring to assess for possible vasospasm. Patients will be in the supine position while measurements are obtained. The probe will be placed in the preauricular region of the temporal window

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years of age or older
2. Current hospitalization for a neurologic issue and admitted to the surgical intensive care unit.
3. Undergoing daily transcranial Doppler imaging No
4. English speaking patients and/or legally authorized representative (LAR)

Exclusion Criteria:

1. Less than 18 years of age
2. Patient is unable to obtain consent and no LAR is identified to provide consent
3. Non-English speaking patient or LAR
4. Unable to perform the study due to lack of availability of TCD technologists
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology

Needle-free jet injector provides an alternative for patients with diabetes treated by insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD) profiles of lispro administered by jet injector and conventional pen.

This is a randomized, double-blind, double-dummy, crossover study. Eighteen healthy volunteers will be recruited. Lispro (0.2 units/kg) will be administered by jet injector or by conventional pen and a seven-hour euglycemic clamp test will be performed. PK-PD profiles of lispro will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. The range of height should be 170±10cm.
2. The range of weight should be ±10%kg.
3. Liver and renal function should be normal.
4. Health subjects with no chronic diseases or medications.

Exclusion Criteria:

1. Drug allergy, history of allergic disorders or allergies.
2. A history of liver or kidney disease.
3. Smoker, drinkers.
4. Subjects who participated in other drug trials within a month.
5. Subjects who used medication which is known to organ damage.
Investigation of Preoperative Frailty in Elderly Patients With Colorectal Cancer and Correlation Between Preoperative Frailty and Early Postoperative Prognosis

To investigate and analyze the status of preoperative frailty and its influencing factors in elderly patients with colorectal cancer using FRALL scale and other related scales, and to explore the correlation between preoperative frailty and early prognosis in elderly patients with colorectal cancer, so as to attract the attention of medical staff to preoperative frailty in this population and provide a preliminary research basis for the study of frailty intervention in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥60 years old;
2. Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer;
3. able to complete physical assessment without communication barriers;
4. voluntarily participated in this study after informed consent.

Exclusion Criteria:

1. taking antidepressants, levodopa, donepezil hydrochloride and other drugs;
2. patients with preoperative colorectal cancer surgery or neoadjuvant therapy;
3. patients with TNM stage Ⅳ;
4. complicated with other malignant tumors except primary skin cancer or melanoma.
The Comparison Of Nerve Blocks In Cesarean Delivery

The purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.

Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* weight from 50 to 70 kilogrammes
* a normal singleton pregnancy
* ≥37 weeks gestation

Exclusion Criteria:

* congenital coagulopathy
* anatomic abnormalities
* localized skin infection
* allergy to any of the drugs used
Graded Exposure Therapy in Chronic Pelvic Pain

Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. The objective of this study was to evaluate the effects of graded exposure therapy in women with chronic pelvic pain.

Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. This condition lasts at least 6 months, and many times is associated with negative cognitive, emotional, sexual and behavioral consequences.In addition to the high economic cost, CPP is also costly in emotional and psychological suffering. This clinical trial aims to evaluate the effects of a program based on graded exposure therapy in women with chronic pelvic pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic pelvic pain
* Moderate fear of movement

Exclusion Criteria:

* Other clinical diagnosis.
* Men
* Other pathology such as neurological disease.
* Cognitive impairment.
Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.


Eligibility Criteria:
Inclusion Criteria:

* age at least 6 months,
* weight at least 5 kg,
* residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
* able to receive oral treatment,
* having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
* suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.

Exclusion Criteria:

* presence of severe or complicated malaria (WHO 2000),
* severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
* allergic to one of the drugs involved in this study,
* pregnant (reported pregnancy, detected clinically or with the β HCG test),
* use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.
Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 70 years old
2. Histological proven unresectable recurrent or advanced breast cancer, including de novo stage IV disease.
3. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER \<1%, PR \<1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
4. No prior chemotherapy for metastatic breast cancer is permitted. Prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
6. Performance status no more than 1
7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
8. Life expectancy longer than 12 weeks
9. No serious medical history of heart, lung, liver and kidney
10. Be able to understand the study procedures and sign informed consent.
11. Patients with good compliance.

Exclusion Criteria:

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
4. Treatment with an investigational product within 4 weeks before the first treatment
5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
7. Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
8. Uncontrolled serious infection
Companion Dog Walking for ICU Survivor Health

The goal of this clinical trial is to determine the feasibility and acceptability of a randomized controlled trial comparing a pet dog walking intervention to an attention control education intervention in adult intensive care unit survivors.

The main question\[s\] it aims to answer are:

* What is the feasibility of a pet dog-walking intervention compared to an attention control education intervention on depression, anxiety, cortisol, and quality of life for adult ICU survivors.
* What is the acceptability of a pet dog-walking intervention compared to an attention control education intervention on depression, anxiety, cortisol, and quality of life for adult ICU survivors.

The secondary question\[s\] it aims to answer are:

- What are the differences in depression, anxiety, serum cortisol, and quality of life between and within a companion dog walking intervention compared to an attention control education intervention for ICU survivors?

Participants in the intervention group will be asked to:

* Participate in dog walking with their pet dog at least three times per week, for at least 10 minutes each walk, for 8-weeks.
* Wear an activity monitor and record their dog walks in a diary.
* Complete surveys to measure depression, anxiety, and quality of life at the start of the study, after week 4, and after week 8.
* Have blood drawn to measure cortisol levels at the start of the study, after week 4, and after week 8.

Participants in the control group will be asked to:

* Read educational materials about their pet dog's health once every week (education materials are provided by the researchers).
* Wear an activity monitor and record when they read their education materials in a diary.
* Complete surveys to measure depression, anxiety, and quality of life at the start of the study, after week 4, and after week 8.
* Have blood drawn to measure cortisol levels at the start of the study, after week 4, and after week 8.

Participants will be assigned to an intervention group or a control group to see if there are differences in depression, anxiety, serum cortisol, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years)
* ICU survivors (spent ≥24 hours in the ICU)
* Will be discharged directly home from hospital.
* Able to speak, read, and understand English
* Physically capable of dog walking
* Individuals who have symptoms of depression and/or anxiety
* Individuals who own a companion dog and walk their dog \<10 minutes/week
* Participants scoring ≤ 20 seconds on the TUG Test

Exclusion Criteria:

* Individuals at high risk for suicide
* Individuals with severe depression or anxiety
* Individuals who recently started treatment for depression and/or anxiety
* Individuals with cognitive impairment
* Dog walking is deemed unsafe with and for the dog
* Medical Provider authorization is indicated but not provided
* Individuals who live outside a 45-mile radius of Colorado Springs.
Effect of Protein Restriction Plus EAA/KA Supplementation on GFR Decline in CKD

This study aims to investigate the effect of protein restriction plus KA/EAA supplementation on GFR decline in CKD patients.

In chronic kidney disease (CKD) patients, ketoacid analogues of essential amino acids (KA/EAA) are administered to reduce the production of harmful metabolic products and enhance nutritional status. Protein restriction combined with AA supplement may have beneficial effects on CKD in several ways, by reducing nitrogen waste, oxidative stress, and inflammation, and by protecting against hemodynamic changes in glomerular hyperfiltration.

several clinical trials have documented that very low protein diets (VLPD) supplemented with KA/EAA preserve the rate of progression of advanced CKD. However, in long-term follow-up of the MDRD study, VLPD plus KA/EAA treatment did not delay progression to dialysis or transplantation.

As a result, no firm conclusions have been drawn on the effectiveness of protein-restricted diets combined with KA/EAA supplements in retarding CKD progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD stages (G2 to G4), aged ≥ 18 years old

Exclusion Criteria:

1. Active malignancy
2. Protein energy wasting
3. Advanced organ disease
4. pregnancy
Micafungin Lock Therapy

The study proposes to investigate, in children admitted at Children's Medical Center at Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (CVC) and at the same time to investigate the effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a pediatric population.

The antimicrobial lock therapy (ALT) consists of filling a catheter lumen with a supraphysiologic concentration (100- to 1000- fold higher) of an antimicrobial agent and allowing it to dwell (lock) for several hours in an attempt to sterilize the lumen. Advantages of the ALT are: the ability to administer high local concentrations; the ease of administration; the cost-savings and vein access-savings by decreasing the number of surgical procedures in an operating room for catheter replacement; the decrease in possible surgical complications and risks. The Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America and others recommend the ALT for the treatment of uncomplicated bacteremias. This technique however is not currently recommended for the treatment of catheter-related fungal infections, primarily due to lack of adequate data. This study plans to enroll approximately 20 children admitted to the Children's Medical Center at Dallas in high need of central venous catheters or with evidence of fungemia in this study to investigate the effectiveness of ALT with Micafungin against fungal infections.

Eligibility Criteria:
Inclusion Criteria:

* Children, 6 months-18 yrs, with a central line fungal infection, presumed Candida, admitted at Children's Medical Center.
* Signed informed consent by parents and assent by minor if applicable.
* Subjects with likely survival beyond 1 week.

Exclusion Criteria:

* Pocket, tunnel or exit-site infection
* Known allergic reactions to the Micafungin or echinocandins.
* Severe systemic symptoms (disseminated candidemia, fungal balls, endocarditis)
* Mixed infections
* Inability to lock the catheter lumen for minimum 8h because of other medications administration
* Subjects requiring ECMO or CVVH.
* Patients with HIV, congenital immunodeficiencies.
* Positive pregnancy test or breastfeeding.
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.


Eligibility Criteria:
Inclusion Criteria

Participants must meet all of the following criteria to be included in this study:

* Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.
* Body Mass Index ≥18.5 and \<25.0 kilograms per meters squared at Screening

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from this study:

* Females who are breastfeeding or pregnant at Screening or Baseline
* Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing
* Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing
* Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening
* Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
* A prolonged QT/QT corrected interval (QT interval, Fridericia correction \>450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline