cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV

Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.

This is an open label, randomized study with 4 arms: 1.) Standard dose and 2.) high dose nevirapine; and 3.) standard dose and 4.) high dose efavirenz. Subjects in all 4 arms will also receive 2 nucleoside analog drugs. Patients will have routine monitoring for the treatment of TB and HIV, as well as some additional blood samples to follow the virus in the blood and to determine the effect of the TB therapy on the amounts of anti-HIV drugs that are in the body.

Eligibility Criteria:
Inclusion Criteria:

* ARV naïve subjects
* Documented HIV infection
* Documented TB infection
* Platelet count 40,000/mm3
* Hemoglobin ≥8.0 g/dL
* Absolute neutrophil count (ANC) \>500/mm3
* AST (SGOT), ALT (SGPT), and alkaline phosphatase \<3 X ULN
* Total bilirubin \<2.5 x ULN
* Calculated creatinine clearance ≥60 mL/min
* For women of reproductive potential, negative urine pregnancy test

Exclusion Criteria:

* Unable to provide informed consent.
* History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.
* Patients on hemodialysis.
* Tuberculosis meningitis.
* Women with CD4 \> 250 and men with CD4 \> 400 due to higher risk of hepatotoxicity related to use of NVP.
* Positive serology for hepatitis C.
* Evidence for active hepatitis B including positive serologies for HBsAg, HBeAg, or HBV-DNA. Note: If anti-HBs is positive, patient is eligible for study if liver enzymes are within the parameters indicated in the inclusion criteria
* Women who are breast-feeding
* Known allergy/sensitivity to study drug(s) or their formulations
* Patients with other OIs or intercurrent illness that could affect their ability to take study drugs
Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen

The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question\[s\] it aims to answer are:

* The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography.
* The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster.

Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score.


Eligibility Criteria:
Inclusion Criteria:

1. 16 to 80 years of age;
2. symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks;
3. LDH at a corresponding level and side on imaging;
4. surgical candidates for epidural steroid injection (ESI) or percutaneous endoscopic lumbar discectomy (PELD). If the patient underwent ESI and PELD surgery on the same day, we only selected the data for the first one.

Exclusion Criteria:

1. other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures);
2. body mass index (BMI) greater than 32 kg/m2;
3. pregnancy;
4. refusal to participate;
5. severe mental illnesses in the trial.
Biotherapy for MRSA Enterocolitis

Methicillin-resistant Staphylococcus aureus (MRSA) is one of the major sources of nosocomial infection. Along with the widely application of antibiotics around perioperative period, MRSA infection is increasing by years.Fecal microbial transplantation (FMT),infusion of fecal preparation from a healthy donor into the GI tract of a patient is being proposed as a novel therapeutic approach to modulate diseases associated with pathological imbalances within the resident microbiota, termed dysbiosis.It has been used to treat intestinal disease such as inflammatory bowel diseases and Clostridium difficile infection, but no reports are available on its role in treating MRSA enteritis yet. vancomycin is the first choice to treat MRSA but can also lead to an increase in antibiotic resistant organisms such as vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus and transfer of antibiotic resistance genes among the microbial community. So FMT seems a more harmless and reasonable measure to treat similar diseases.

Five cases from July, 2013 to February, 2014 were collected in Jinling hospital.They developed unexplained high fever, bloating, nausea, vomit, a high stoma output or diarrhea in the color of yellow-green with copious amounts of mucus leading to dehydration and tachycardia after short time of operation (2-4d).We got the etiology diagnosis from all the patients' gastric juice cultures which revealed MRSA.Vancocin cp had a dissatisfied effect,so FMT was supplied for treating MRSA.All the patients had a decreased intestinal flora species before FMT and the content of staphylococcus aureus almost reached half of total intestinal flora . Patients' gut bacteria after FMT gradually agree with the donors' reflected the alleviative symptoms.

Eligibility Criteria:
Inclusion Criteria:

1.18-70 years old 2.patients diagnosed as MRSA enterocolitis

Exclusion Criteria:

1.infectious diarrhea caused by other pathogenic bacteria
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion criteria:

* Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria, that has been present for at least 1 year prior to the Screening Visit
* Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit and ≥ 16 at the Baseline Visit
* Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the 0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening and Baseline visits

Exclusion Criteria:

* Presence of skin comorbidities that would interfere with study assessments of the underlying disease.
Moderate Bleeding in Cardiac Surgery Post Operative

Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

Secondary objectives:

To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative transfusion.

To evaluate the prognostic impact of the SPO moderate in terms of post-operative complications.

Determine predictors of moderate SPO.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the postoperative intensive care in cardiac surgery

Exclusion Criteria:

* Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.
Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.

The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.

Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.

Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.

The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* age \>=20 years
* spot urine albumin/creatinine ratio \> 30mg/g in two consecutive measurements
* patients on ACE-inhibitor or ARB as an anti-hypertensive drug
* blood pressure \<= 150/100 mmHg
* HbA1c \<10%

Exclusion Criteria:

* taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months
* ischemic heart disease, stroke, malignant disease, severe infection in 6 months
* serum creatinine \> 2.0mg/dl
* severe liver disease or AST, ALT \> 3\* ULM
* taking systemic steroid in 1 month
* pregnant or plan to become pregnant during the clinical trial
* lactation
Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation

The purpose of this research study is to investigate any changes seen in mood or behavior following deep brain stimulation for movement disorders.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD diagnosed by a movement disorders neurologist
* Approved by a movement disorders neurologist as clinically needing a DBS device
* Absence of significant cognitive dysfunction (Mattis Dementia Rating Scale Score of greater than or equal to 116)
* MRI without evidence of structural abnormality (stroke, tumor, malformation, etc)
* No prior neurosurgical intervention

Exclusion Criteria:

* None
Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients

This ancillary study will determine if early administration of a single high-dose (540,000 IU) oral vitamin D3 (cholecalciferol) treatment improves 12-month global cognition and executive function as determined by comprehensive neuropsychological testing in 140 critically ill patients with Vitamin D deficiency at enrollment.

VIOLET-BUD is an ancillary study to a parent double-blinded, placebo-controlled randomized control trial (RCT) evaluating how a single, high-dose (540,000 IU) oral Vitamin D3 treatment affects 90-day mortality in patients who are at high risk for ARDS and have Vitamin D deficiency (plasma 25-hydroxyvitamin D \< 20 ng/ml) at enrollment. The parent RCT (Vitamin D to Improve Outcomes by Leveraging Early Treatment \[VIOLET\], NCT03096314) is part of the Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL) sponsored by the NHLBI. The VIOLET trial completed enrollment in July 2018 with 1,360 randomized to either high dose, enteral Vitamin D3 or placebo.

This ancillary study will provide additional funding to perform comprehensive neuropsychological (cognitive) evaluations, which were not part of the parent trial. These neuropsychological evaluations will be conducted 12 (+/- 4) months after randomization among a subset of 140 survivors enrolled in VIOLET. This ancillary study will conducted in 7 (out of 42) sites.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the VIOLET parent study

Exclusion Criteria:

* Deaf or blind
* Non-English speaking
Associations Between Diabetes, Arterial Stiffness and Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?

Diabetes Mellitus (DM) is frequently appearing in patients with cardiovascular disease and these patients, as a consequence herby, has a lesser prognosis. DM is often related to increased arterial stiffness and hypertension. The investigators thesis is that DM and pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is under-diagnosed. At the same time the investigators imagine that DM is closely related to the degree of arterial stiffness, and that these parameters are closely related to a new biochemical marker, fibulin-1.

The investigators aim to describe the prevalence of type 2 DM and dysmetabolism in patients admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if there is a connection between the degree of the dysmetabolism and arterial disease, by studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the investigators newly have identified. The results of this project will give us a measure for the quantity of unknown DM in patients undergoing cardiovascular surgery and furthermore tell us more in terms of the connections between a newly identified plasma arterial marker, arterial stiffness and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* undergoing heart- or vascular surgery

Exclusion Criteria:

* Physical or mental disability not enabling participation in the study
Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome

Middle and inner ear malformations on two boys with velocardiofacial syndrome are discussed.Special attention should be given to the presence of hearing loss due to middle and inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid and middle ear inflammatory processes.

Two boys with clinical signs of velocardiofacial syndrome, at ages of 4.7 and 6,7 years old are the subjects of this study.Audiological evaluation, including pure tone audiometry, tympanometry, acoustical reflex, and Computerized Tomography of temporal bones, and analyses of DNA sample with markers of 22q11 region were performed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with velocardiofacial syndrome
Exercise-induced Ischemia and the Influence of Pain Modulation in a Nerve Growth Factor (NGF) Model

The purpose of this study is to investigate responses of pain and the maintenance of mechanical muscle hypersensitivity following an acute exercise-induced ischemic condition repeated over time in a prolonged NGF-sensitized muscle. Additionally, the influence of the pain modulating system on prolonged NGF muscle hypersensitivity caused by peripheral mechanisms and central mechanisms will also be investigated.

The hypothesis is that an ischemic conditioning in a NGF-sensitized muscle is able to facilitate pain responses and that over time the pain modulation system is responsible for a subsequent reduction in muscle sensitivity towards mechanical pressure and a decrease in pain intensity following a period of NGF-induced muscle hypersensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and pain free volunteers

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, mental illnesses, or psychiatric diseases.
* Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
* Participation in other pain trials throughout the study period
* Lack of ability to cooperate
* Taking any analgesic 24 hours before the injections
* Performing any strenuous leg exercise through out the study period causing sore muscles
Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars

Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona.


Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years old or older, from both genders that wished to voluntarily participate in the study and that required the extraction of third molars.

Exclusion Criteria:

* Systemic diseases (ASA III or IV) that contraindicate the performance of the surgical procedure
* Pregnant women
* Individuals that did not understand and/or could not respond the given questionnaire.
* Patients that required the extraction of a different tooth than a third molar or that required the extraction of more than two third molars in the same surgical time.
* Patients who had undergone extraction of a third molar in the twelve months prior to the current visit.
* Patients taking antidepressant medication or anxiolytic medication
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

CKJX839D12304 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo or ezetimibe can effectively reduce LDL-C as measured by percentage change from baseline to Day 150. This study is being conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.

This study is a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 300 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study will evaluate the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo.

The study consists of:

* a screening period of up to 14 days;
* a double-blind treatment period of 150+/- 5 days during which participants will be randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and
* a safety follow-up / End of Study visit conducted 30+5 days after the Day 150 visit.

The overall study duration is approximately 190 days.

Eligibility Criteria:
Inclusion Criteria to be met at screening:

* informed consent must be signed prior to participation in study
* fasting LDL-C of \>= 100mg/dL but \< 190mg/dL
* fasting triglycerides \<= 400 mg/dL
* 10-year ASCVD risk score \< 7.5%
* not on any lipid-lowering therapy within 90 days

Key Exclusion Criteria:

* history of ASCVD
* diabetes mellitus or fasting plasma glucose of \>= 7.0 mmol/L or HbA1c \>= 6.5%
* secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)

Other protocol-defined inclusion/exclusion criteria may apply.
The Histological Analysis in Renal Transplantation Patients With Deterioration of Graft Function

Identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplant recipients, then to identify the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor \[CNI\]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered one of the major causes of CAD, however, recently there has been found most death-censored graft losses to be the result of alloimmune or autoimmune injury, with only a minority of cases attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in CAD in China is not well analyzed. To improve perception of Neo safety with more local evidence, we want to do a retrospective study to identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplantation recipients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Kidney transplant recipients, only including recipients of living-donor grafts
* Underwent an allograft biopsy between January 2005 and December 2011 because of developing deterioration of graft function\*.

  * Deterioration of function was defined as (1) an unexplained and persistent greater than or equal to 25% increase of CR over baseline (in the absence of potential confounding factors) or (2) new onset proteinuria (defined as albumin/CR ratio ≥0.2 or a protein/CR ratio \>0.5).

Exclusion Criteria:

* Multiple organ transplants, prior transplant with any other organ or tissue
* Patients who did not have the information regarding the pathological diagnosis
* Patients who did not have the histological sections of the allograft biopsy
A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants

This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has been specially prepared to contain radiolabeled carbon \[\^14C\]. \[\^14C\] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered.

In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected.

This study will last about 3 weeks for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or female participants as determined by medical history and physical examination
* Male participants will be sterile
* Female participants will be surgically sterile or postmenopausal
* Have a body mass index (BMI) of 18 to 29 kilograms per square meter (kg/m\^2)
* Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study-specific procedures.
* Self-reported active symptoms of OIC at screening (\<3 SBMs/week and experiencing ≥1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (\<3 SBMs/week on average over the 2-week OIC confirmation period.
* Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
* Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a BM has not occurred within at least 72 hours of the last recorded BM.

Exclusion Criteria:

* Patients receiving Opioid regimen for treatment of pain related to cancer.
* History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
* Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
* Other issues to the gastrointestinal tract that could impose a risk to the patient.
* Pregnancy or lactation.