cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions

The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.


Eligibility Criteria:
INCLUSION

1. Male or female subjects \>=18 years of age with HIV-1 infection and chronic liver disease as reflected by a documented biopsy with hepatic fibrosis present.
2. a. Participants must be receiving nevirapine 200 mg twice daily as part of a stable ARV regimen for a minimum of 6 weeks prior to trough level sample collection.

   b. Participants receiving nevirapine 400 mg once daily as part of a stable ARV regimen for a minimum of 6 weeks, who are willing to switch to nevirapi0 mg twice daily for a minimum of 14 days prior to trough collection.
3. Participants must have uoxylin and Eosin (H and E) stained slide and one trichrome stained pathology slide available at the time of enrollment. There is no time restriction on liver biopsy slides that pathologically confirm the presence of cirrhosis. The presence of cirrhosis must be documented on the liver biopsy report.

EXCLUSION

1. Current (within the past 4 weeks) HIV antiviral therapy with other NNRTI's.
2. Concurrent use (within the past 7 days) of any of the following:

   1. Systemic azole antifungal agents (fluconazole, itraconazole, ketoconazole, etc.)
   2. Clarithromycin
   3. Rifampin
   4. St John's Wort
3. Inability to provide a blood sample.
4. Patients who have evidence for hepatic or other encephalopathy above Grade 1
5. Patients with renal failure who require dialysis.
6. Pregnant and/or breast feeding women..
Impact of SCFA Supplementation on Metabolic Profiles in Serum and Urine of Kidney Transplant Recipients.

This is a randomized, double-blind, placebo-controlled clinical trial evaluating the impact of short-chain fatty acid (SCFA) supplementation on the serum and urinary metabolome in stable kidney transplant recipients. A total of eligible patients will be randomized 1:1 to receive either SCFA or placebo for a period of 12 weeks. Metabolomic profiling of serum and urine will be performed at three time points: at baseline, after 12 weeks of intervention, and after a 12-week washout period without supplementation. The primary objective of the study is to investigate whether SCFA supplementation leads to measurable changes in systemic and renal metabolomic profiles. Secondary outcomes include assessment of tolerability, safety, and potential immunometabolic correlations and also impact on the serum level of immunossupresants (tacrolimus). This study aims to explore the potential of microbiota-targeted therapies in modulating post-transplant metabolic homeostasis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

Stable kidney transplant recipients (≥ 6 months post-transplantation)

Stable graft function defined as eGFR ≥ 30 mL/min/1.73 m² with no significant change (\>15%) in the last 3 months

No episodes of acute rejection within the last 6 months

On stable immunosuppressive therapy for at least 3 months

Ability to provide written informed consent

Willingness and ability to comply with study procedures and sample collection

Exclusion Criteria:

* Use of antibiotics or probiotics within 4 weeks prior to enrollment

Known gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, short bowel syndrome)

Uncontrolled diabetes mellitus (HbA1c \> 9%)

Current infection or active malignancy

Pregnancy or breastfeeding

Participation in another interventional clinical trial within the past 30 days

Known allergy or intolerance to SCFA formulations or study components (lactose intolerance)

Severe hepatic impairment (Child-Pugh class C)

Any condition that, in the opinion of the investigator, may interfere with the participant's ability to complete the study or affect the interpretation of results
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

The incidence of efficacy failure at 12 months between two regimens.


Eligibility Criteria:
Inclusion Criteria

* Age: 13 years or older, 40 kgs or more
* End-stage renal disease
* African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft

Exclusion Criteria

* Evidence of active infection
* Evidence abnormal chest x-ray
* Patients with HIV.
Enteral Nutrition and Vasoactive Drugs

Enteral nutrition in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial. Hypothesis: enteral nutrition delivered in such patients can be feasible and safe.

Nutrition support in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial and challenging. However, if it is delivered according to an enteral nutrition protocol and under proper medical supervision, it can be feasible and safe. The present multicenter prospective study was designed to examine the feasibility and safety of enteral nutrition support in such patients.

Eligibility Criteria:
Inclusion Criteria:

* Authorization to participate in the study by informed consent.
* Dependence of vasoactive drugs and/or mechanical circulatory support to at least 48 hours from Intensive Care Unit admission.
* Invasive mechanical ventilation time of at least 48 hours.
* Expected survival greater than 72 hours.
* ICU Stay greater than or equal to 72 hours.

Exclusion Criteria:

* Refusal to participate in the study.
* Refractory shock, defined as the progressive elevation of the dose of vasoactive drugs and / or markers of tissue hypoperfusion, or mean arterial pressure ≤ 60 mm Hg despite the therapeutic maneuvers.
* History of significant abdominal vascular disease (ischemic colitis, chronic mesenteric ischemia, aortic aneurysm abdominal, aortic dissection with involvement of mesenteric vessels, etc).
* Absolute contraindication for the onset of enteral nutrition (active gastrointestinal hemorrhage, intestinal obstruction, etc.) or patients with a non-functional gastrointestinal tract.
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers, able to give written informed consent for participation in the trial;
* Men or women 50% each , aged 18-45 years old;
* Subjects must have physical examination required and prove medical fitness in 7 days before the clinical starts. BMI should be between 19-24, similar BMI among subjects enrolled at the same time;

Exclusion Criteria:

* Acute or chronic infection, or history of active tuberculosis;
* History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
* Subjects who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
* Subjects with a history of mental problems;
* Pregnant and lactating women or women who plan to be pregnant in 3 months;
* Occurence of clinical significant abnormal laboratory examination value during the screening;
* Subjects that lack of understanding ,communication or collaboration, and can't comply with the protocols;
* Subjects that the researchers considered to be not appropriate to participate the trial due to other reasons;
A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)

18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic pain following surgical lumbar discectomy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the subjects primary area of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery
A Double Blind Clinical Trial of DCS for Food Anxiety

This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.

This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified

Exclusion Criteria:

* Pregnant or planning on becoming pregnant
* Psychotic or Manic
Single-center, Prospective Study on the Identification and Delineation of Brain and Lung Tumors and At-Risk Organs, and Functional Testing of Surrounding Tissues Based on Dual-Energy CT

This study explored the feasibility of dual-energy CT in head and lung tumors. Dual-energy CT can achieve quantitative CT imaging based on traditional imaging by dual-energy spectral imaging, and enhance the clarity of head and lung tumors. In this study, we will prospectively explore the image accuracy and delineation accuracy of dual energy CT in radiotherapy to verify whether dual energy CT performs better with conventional CT.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in and sign the informed consent in person. 2. Over 18 years old, gender unlimited; 3. After imaging diagnosis of primary lung cancer or space-occupying lung lesions with oligometastases, MDT decided to treat SBRT 4. Clinical stage IA-IV (cT1-4N1-3M0-1); 5. No serious abnormality of blood system, heart, lung, liver, kidney function and immune deficiency; 6. Coagulation function: activated partial thromboplastin time (APTT) \< the upper limit of normal 10 seconds, prothrombin time (PT) \< the upper limit of normal 3 seconds, plasma fibrinogen 2-4g/L; 7. Hemoglobin ≥100g/L, WBC≥4×109/L, neutrophils ≥1.5×109/L, platelets ≥100×109/L 8. Bilirubin \< 1.5 times the upper limit of normal value; Glutamic oxalic aminotransferase (ALT) \& Glutamic pyruvic aminotransferase (AST) ≤1.5 times the upper limit of normal value; 9. Serum creatinine ≤1.5 times the upper limit of normal value; 10. The willingness of men or women of childbearing age to use contraception in the trial; 11. Physical condition score ECOG level 0 \~ 2; 12. Expected survival \>3 months;13, Can acquire MRI scanning

Exclusion Criteria:

1. Patients could not tolerate or were unwilling to undergo CT examination; 2. The primary lesion has undergone surgery or radiotherapy or chemotherapy or targeted or immunotherapy; 3. Subjects who have received other drug trials within the last 1 month; 4. People with severe allergic history or idiosyncrasies; 5. Patients with a history of severe lung or heart disease; 6. Severe comorbidities, such as uncontrolled hypertension, heart failure, etc.; 7. Pregnant or lactating women; 8. Previous history of malignant tumor; 9. Refusal or inability to sign informed consent to participate in the trial; 10. Currently or planning to participate in other clinical trials; 11,Can not acquire MRI scanning
Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve

Women delay maternity and, as a consequence, available oocyte number and their quality decrease (9-18% of all IVF patients). Different treatment protocols have been developed nevertheless none of them optimal: the number of oocytes retrieved depends on the present ones. New generation of oocytes and follicles has been defended by some authors and bone marrow seems to be involved. What seems crucial is the niche that produces paracrine signals able to activate dormant cells and to attract undifferentiated cells from other tissues (homing). This phenomenon has been described by our group in other human reproductive tissues like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women with poor ovarian reserve by means of bone marrow protective capacity.

Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to colonize ovarian niche.

The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve differentiating themselves into germ cells or, more likely, stimulating the niche to activate dormant follicles.


Eligibility Criteria:
Inclusion Criteria:

* \< or= 40 years old
* FSH\<15UI/L
* poor ovarian response after controlled ovarian stimulation with conventional doses (\<3 oocytes) or two episodes of poor ovarian response after ovarian stimulation with maximal doses even if young or normal ovarian reserve study.
* Antral follicle count\>2
* \>1 antral follicle in the perfused ovary
* AMH between 0,5 and 3pmol/L
* regular menstrual bleeding each 21-35 days
* To be candidate to autologous hematopoietic progenitors transplantation

Exclusion Criteria:

-
sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis

The aim is to investigate macrophage activation markers and correlations to liver fibrosis in patients with Wilsons Disease. Researchers wish to investigate associations to neurologic and metabolic liver function. Researchers will assess this by comparing blood samples with fibrosis and liver function analyses. This study provides new insight into macrophages and their involvement in Wilsons Disease.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Wilsons disease

Exclusion Criteria:

-
Validation of Betalactam ML Prediction Models - TDMAide

The goal of this study is to learn about the real wold behavior of developed machine learning models that predict the plasma concentration of piperacillin-tazobactam and meropenem in critically ill patients admitted to the intensive care unit (ICU).

The main aim of the study is to validate the performance of these machine learning models. To this end, daily measured plasma concentrations of the investigated antimicrobials will be compared with the predicted concentration by the machine learning algorithms.

Additional goals of the study include:

* To describe the total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the ICU.
* To quantify the correlation between plasma concentrations of piperacillin-tazobactam and meropenem and the development of side effects.
* To evaluate the perceived necessity of therapeutic drug monitoring (TDM) of consultants and physicians in training working in the ICU.
* To evaluate the perceived added value of daily TDM.

Samples (where possible taken routinely) from participating patients will be analyzed for meropenem and piperacillin-tazobactam plasma concentration. Participating physicians will be asked to fill in a short daily questionnaire during the time a patient under their care is treated with the antimicrobial under investigation.


Eligibility Criteria:
Patients

Inclusion Criteria:

* Admission to the ICU.
* Age above 18 years old.
* Treatment with piperacillin-tazobactam or meropenem for less than 48 hours.

Exclusion Criteria:

* Pregnant or lactating patients.
* Limitation of therapy beyond "Do not resuscitate".
* Expected demise within 48 hours after inclusion.
* Haemoglobin \< 7 g/dL.
* Previous inclusion in this study for a treatment course with the same antimicrobial.

Consultants and physicians in training

Inclusion Criteria:

* Consultant or physician in training working in the ICU.

Exclusion Criteria:

* None
Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients

This study is aim to study the changes of serum creatinine levels at 72 hours after admission in patients with acute heart failure who has diuretic resistance compared to those who do not have diuretic resistance from furosemide stress test

This study is an observational prospective study to demonstrate a prognosis of acute heart failure patients who have diuretic resistance compared to those who do not have diuretic resistance from furosemide stress test. The primary outcome is changes of serum creatinine levels at 72 hours compared to baseline values at the time of admission.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of acute heart failure which is defined by 2 of the 3 following features: ≥2+ leg edema, jugular venous pressure \>10 cm from physical examination or central venous pressure \>10 mmHg, and bilateral pulmonary edema or bilateral pleural effusion from chest radiography
* Patients consent to participate into the study

Exclusion Criteria:

* Patients who receive furosemide ≥500 mg/day or hydrochlorothiazide ≥100 mg/day or spironolactone ≥100 mg/day or tolvaptan of any doses
* Patients who have systolic blood pressure \<100 mmHg or who need vasoactive drugs inotropic agents (except dobutamine)
* Patients with intravascular volume depletion from clinical evaluation
* Patients with chronic kidney disease stage 5 (estimated glomerular filtration rate \<15 ml/min/1.73 m2) or patients who receive maintenance dialysis
* Patients who require renal replacement therapy at the time of admission
* Patients whom diagnosed hypertrophic obstructive cardiomyopathy, severe valvular stenosis or complex congenital heart disease
* Patients with sepsis or systemic infection
* Pregnant women
* Patients who have history of furosemide, spironolactone or hydrochlorothiazide allergy
Evaluation of the 755nm Alexandrite Laser for Skin Toning and Epidermal Pigmented Lesions in Asian Skin Types

The purpose of this study is to assess treatment for facial skin toning and removal of epidermal pigmented lesions for Asian patients using the 755nm Alexandrite laser


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old
2. Has unwanted facial epidermal pigmented lesions or desires facial skin toning and wishes to undergo laser treatments.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has Fitzpatrick skin types III to IV.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections
4. The subject has a coagulation disorder, or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids or hypertrophic scarring.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. Allergic to topical lidocaine or topical steroids
68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients

PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including clear cell renal cell carcinoma (ccRCC). This makes it a potentially imaging target for the detection of ccRCC. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG PET/CT in the same group of ccRCC patients.

Renal cell carcinoma (RCC) is the most common solid tumor within the kidney and accounts for approximately 3% of all malignancies in the world. Clear cell RCC (ccRCC) is the most common subtype and accounts for the majority of kidney cancer-related deaths. Importantly, pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to high vascularized tumors. Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by tumor cells or neovascular endothelial cells of various solid neoplasms, such as renal cell carcinoma. Therefore, PSMA may be an ideal target for the diagnosis of ccRCC. 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in the same group of ccRCC patients, compared with 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed or suspected clear cell Renal cell carcinoma;
* 68Ga-P16-093 18F-FDG PET/CT within a week;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.