cyrilzakka/clinical-trials huggingface dataset:
Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285

This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other antiretrovirals (selected by the investigator to be optimal for the specific subject) containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.

This is a randomized, placebo-controlled, multi-site, parallel-group, double-blind study of vicriviroc (SCH 417690) in 500 adult HIV-infected subjects with R5/X4 mixed viral tropism who have at least 5000 copies/mL HIV RNA despite standard antiretroviral therapy (ART) that the subject has been receiving continuously for at least 3 months. Eligible subjects will be randomized to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to an individually optimized PI-containing ART regimen containing at least 3 drugs, including a PI, boosted by at least 100 mg ritonavir QD prescribed by the investigator. The vicriviroc dose and placebo will be double-blind, and the optimized background therapy will be open-label. Treatment visits after Day 1 are scheduled for Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. A planned interim analysis will be conducted when 100 subjects have completed 12 weeks of dosing. After completion of the primary analysis (24-week virologic response of all subjects), subjects will be given the optimal dose of vicriviroc and follow-up will be continued to at least 48 weeks. Safety will be monitored by standard laboratory tests, assessment of adverse events, and emergence of complicating medical conditions. Cardiac safety will be monitored periodically by ECG, and plasma samples will be collected from all subjects through the study for population pharmacokinetic analyses.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with documented R5/X4 mixed-tropic HIV infection
* Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
* HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen of at least 3 months of duration
* Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI
* Acceptable hematologic, renal, and hepatic laboratory parameters.

Exclusion Criteria:

* No history of recurrent seizure or CNS condition predisposing to seizure
* No active AIDS-defining opportunistic infection
* Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit
* Use of any drugs that predispose to seizures.
Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism

Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population

In this study, we conduct a cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected MSM group will be used as comparison group. We will also determine the risk factors associated with male hypogonadism (age, duration of HIV infection, comorbidities, BMI, ART use). Correlation will be made between serum testosterone levels and sexual function, vitality, exercise capacity, mood, and bone mineral density.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected men who have sex with men
* HIV non-infected men

Exclusion Criteria:

* Use of testosterone supplement, anabolic steroid in the past one year.
* History of pituitary , adrenal or gonad diseases
* History of pituitary surgery or radiation therapy
* History of systemic chemotherapy
* Active opportunistic infection under treatment
* Cancer
* Severe hepatic, renal or cardiac impairment
Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes

This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.

In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written informed consent
* Age \> 18 years
* Patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months
* Doses of insulin \> 0.7 U / Kg / d
* HbA1c ≥ 7.5 %
* Without OAD for at least 4 weeks (sulfamides, Incretines, glinides, acarbose) except Metformin
* BMI ≥ 28.5 kg / m2
* Diabetes diagnosed for at least 10 years
* Patients able to monitor themselves and manage an insulin pump.

Exclusion Criteria:

* Patients treated with glitazones during the 3 months preceding inclusion
* Patients with proliferative ischemic retinopathy not treated by laser
* BMI \< 28.5 kg / m2
* Presence of implantable material ( CI MRI )
* Pacemaker ( CI MRI )
* Pregnancy, breast feeding
* Medically significant physical or psychiatric inability, patients under guardianship or wards of court
* The practice of violent sports
* Poor conditions of hygiene
* Professional environment of extreme cold or heat.
Predictive Character Analysis of Ganglionic Echography for the Diagnostic of Benin or Malignant Superficial Adenopathy

Investigators need to establish a formal diagnostic of superficial adenopathy through complementary investigations to find etiologic diagnostic ( Echography, adenogram).

Echography examination should be a guide to take in charge the adenopathy and to predict presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of this study is to codify the management of adenopathic patient with a diagnostic in 48 hours after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting time in case of a serious pathology.


Eligibility Criteria:
Inclusion Criteria:

- superficial adenopathy

Exclusion Criteria:

- obvious adenopathy
Hyperbaric Oxygen Therapy in Diabetic Foot

This study seeks to assess changes in genes that are related to inflammation and oxidative stress in patients with type 2 Diabetes with diabetic foot treated with hyperbaric chamber

Aims: Patients with an uncontrolled glycemic index develop a wide variety of pathologies associated with diabetes, such as diabetic foot ulcers (DFUs). Hyperbaric oxygen therapy (HBOT) is an adjunctive therapy used to help wound healing and prevent lower extremity amputations in this population. The aim of this study was to analyze the effect of HBOT on the gene expression of Super Oxide Dismutase 1 (SOD1), Super Oxide Dismutase 2 (SOD2), Glutathione Peroxidase (GPX2), and pro-inflammatory cytokines (TNFα, IL-1β, IL-12, IL-4, NLRP3) in patients with Wagner stage II-IV DFUs.

Methods: The effect of HBOT was evaluated in 15 patients that underwent 12 and 30 sessions in the hyperbaric chamber. Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). In the analysis, qualitative variables are presented in frequencies and percentages, compared with the Chi-square test; quantitative variables according to the Shapiro-Wilk normality test, normally distributed variables are presented in means and standard deviation, compared with Student;s t-test, those related with ANOVA test; quantitative variables of free distribution are presented in medians and interquartile ranges, compared with Mann Whitney U-test, those related with Kruskall-Wallis test. Data analysis was carried out with SPSS version 23, Graph Pad Prisma. A value p \< 0.05 was taken as statistical significance, 95%.

Eligibility Criteria:
Inclusion Criteria:

Men and women with diabetic foot and hyperbaric treatment. Ages 30-60 years. Signed informed consent form.

Exclusion Criteria:

* Patients with diabetic foot without presence of dermatologic lesions.
The Effect of Multi-target Magnetic Stimulation on Freezing Gait in PD

This study is a double-blinded randomized study examining the effectiveness of the multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord will improve FOG and gait symptoms in patients with Parkinson's disease.

Patients in the Experimental group underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one month post intervention.

Eligibility Criteria:
Inclusion Criteria:

* 1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
* 2.Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
* 3.Age between 40 and 80 years old.
* 4.Mini-Mental State Examination score \>24.
* 5.Ability to walk 30 meters independently.
* 6.Stable medication.
* 7.Patients experienced FOG in both medication "on" and "off" states.

Exclusion Criteria:

* 1.Other neurological or psychiatric disorders.
* 2.Severe personality disorder.History of epilepsy, seizures, or convulsions.
* 3.History of head injury or stroke.
* 4.Metal remains of the skull or inside the brain (outside the oral cavity).
* 5.Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
* 6.Severe dyskinesia, termor, cognitive, visual or auditory impairment.
* 7.Patients who could not complete the follow-up.
Novel Prediction Score for Postoperative Acute Renal Failure (ARF) Following Liver Resection

ARF is a frequent event after hepatic resection and therefore clinically highly relevant.

There is limited evidence on the incidence of postoperative ARF and its clinical relevance in patients undergoing liver resection.

This study will evaluate the incidence of acute renal failure (ARF) after liver resection and its impact on postoperative mortality.

ARF is a frequent event after hepatic resection and therefore clinically highly relevant.

There is limited evidence on the incidence of postoperative ARF and its clinical relevance in patients undergoing liver resection.

This study will evaluate the incidence of acute renal failure (ARF) after liver resection and its impact on postoperative mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \>/= 18 years
* Benign and malign liver diseases

Exclusion Criteria:

* Trauma cases
Dynamic Changes of Torquetenovirus (TTV) Load in Chinese Renal Transplant Recipients

The goal of this observational study is to learn about dynamic changes of Torquetenovirus (TTV) load in Chinese renal transplant recipients. The main questions it aims to answer are:

* Is there correlation between TTV load and rejection?
* Is there correlation between TTV load and infection?
* Can changes in the TTV load of kidney transplant recipients predict rejection or infection?

Participants will:

* receive 13 follow-up visits within 1 year after kidney transplantation
* provide 2 ml of whole blood for TTV load testing and other related testing at each follow-up
* provide 10 ml of whole blood for dd-cfDNA testing at four follow-ups (1, 3, 6 and 12 months after transplantation)
* provide 1 ml of serum for donor-specific antibody testing at three follow-ups (1, 6 and 12 months after transplantation)


Eligibility Criteria:
Inclusion Criteria:

* Receiving ABO compatible renal allotransplantation from the initiation of the study to December 31, 2023
* Receiving tacrolimus /mycophenolate mofetil(or mycophenolic acid)/prednisone as maintenance immunosuppression after renal transplantation
* Receiving universal prophylaxis for CMV infection and PJP infection

Exclusion Criteria:

* Receiving combined liver-kidney, pancreas-kidney or heart-kidney transplantation
* Recipients with active hepatitis B or hepatitis C infection
* Recipients with anticipated irregular follow-up
An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® \[bortezomib\] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of symptomatic multiple myeloma as defined by International Myeloma Working Group (IMWGURC).
* Phase 1: Relapsed or relapsed/refractory myeloma after at least 1 previous treatments and with a life expectancy of more than 3 months.
* Phase 2: Measurable (as defined by IMWGURC) disease after at least 1 previous treatment.

Exclusion Criteria:

* History of allogeneic stem cell transplant.
* Phase 2 only: Prior bortezomib therapy will only be allowed if there was a demonstrated positive response, and disease progression occurred off therapy.
* Must have not experienced significant blood level changes, e.g. very low platelets, while on previous bortezomib therapy
* Prior radiation therapy to \> 25% of the bone marrow (whole pelvis is 25%).
The Reliability of the Box and Block Test in People After Stroke

The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got in Box and Block Test administered according to the new Czech extended version of its manual.

New Czech manual for the Box and Block Test was made by back-translation method. It was updated and extended by new rules for unification of it´s performing. The manual include instructions for performing three trials.

At least 20 adult people after stroke will be tested by this test according to this new Czech manual. Video of patients' performance will be obtained.

The inter-rater reliability, internal variability and variability of results will be established.

Eligibility Criteria:
Inclusion Criteria:

* Czech language as a mother tongue
* Adult (age 18 and more)
* Patient after Stroke attending the Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
* Able to move 25mm X 25mm block at least by 10 cm
* Able to complete testing with full 3 attempts
* Able to sit for 20 minutes

Exclusion Criteria:

* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas

This phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.

CX-4945 is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. This drug was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.This Phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed solid tumors or lymphomas.
* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.
* One or more tumors measurable on radiograph or CT scan, or evaluable disease. (e.g., malignant ascites)
* Karnofsky performance status of greater than or equal to 70.
* Life expectancy of at least 3 months.
* Age at least 18 years.
* Patients must have central IV access, or agree to the insertion of a central IV line.
* A negative urine pregnancy test (if female.)
* Acceptable liver function as evaluated by laboratory results
* Acceptable hematologic status as evaluated by laboratory results
* No clinically significant urinalysis abnormalities
* Acceptable coagulation status as evaluated by laboratory results
* Fertile men and women must use effective contraceptive methods during the study.

Exclusion Criteria:

* Seizure disorders not controlled by anticonvulsant therapy.
* Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months.)
* Severe chronic obstructive pulmonary disease with hypoxemia or a pulmonary compromise not correctable with therapy.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Pregnant or nursing women.
* Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C.)
* Unwillingness or inability to comply with procedures required in this protocol.
* Known infection with HIV, hepatitis B, or hepatitis C.
* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
* Patients who are currently receiving any other investigational therapy.
* Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones), biological agent, or formulation.
The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms

Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. However, there is no effective treatment method for BPD. So,the investigator would like to investigate the effect of Intratracheal PS and mononuclaer cells in pretems

This is a Phase 1 clinical trial that constitues one time points cohor and three group,each group with 80 participants,which receive intratracheal PS and mononuclaer cells,receive intratracheal PS,receive intratracheal mononuclaer cells.

1. Eligibility Criteria:Preterm(gestational age more than 28weeks and less than 37weeks)
2. Exlusion criteria: Preterm infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
3. Demographic Data and Baseline characteristics of the study groups were collected:

Gestational age(weeks) birth weight(g) gender Cesarean section delivery antenatal steroids prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes Thrombocytopenia before intervention CRP befor intervention(mg/l) TNF-αbefore intervention（pg/ml） 4.Autologous cord blood mononuclear cells doses is 25million cells/kg 5.the following are monitored at 3、7、14、21 days after birth: mortality, incidence of bronchopulmonary dysplasia 5.Long-term follow up:in 1m，3m，6m,1y:neurodevelopment,asthma，anemia and physic growth

Eligibility Criteria:
Inclusion Criteria:

twenty-eight weeks to thirty-seven weeks

Exclusion Criteria:

Pretem infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Clinical Study Spartan COVID-19 V2 System

This multicentre prospective study will enroll a sufficient number of patients to afford approximately 60 positives and \> 40 negatives (as determined by the SOC - Comparator method) in the United States and/or Canada. One to three sites in the United States and/or Canada will participate over an approximate 12-week enrolment period. The actual enrolment period will be dependent upon prevalence of Covid-19. Once positives sample size is achieved, expected SARC-CoV-2 negative subjects will be permitted.

This study is observational and will not impact the medical management of the patient. The results of the Spartan Test will be blinded to the clinical staff during the study and will not impact the medical management of the subject.

Once informed consent is obtained and eligibility is confirmed, subject demographics, and patient reported COVID-19 symptoms will be recorded. For the purposes of this study, enrolment will be defined as the collection of the two study-specific nasopharyngeal (NP) samples for Spartan's Test. Each patient's active involvement in the study will last for approximately 30 minutes.

To support the EUA, a minimum of 30 individual natural positive clinical specimens will be collected from patients suspected of SARS-CoV-2 infection by a healthcare provider in COVID-19 disease endemic regions in the United States. Additionally, a minimum of 30 individual negative samples will also be used to support the EUA from patients in the United States.

Once subjects are consented and recruited for the study, three nasopharyngeal samples for each patient will be collected by trained operators at the clinical site. The first sample will be tested at the clinical site according to standard of care protocols currently in place for the sites' nasopharyngeal swab-based SARS-CoV-2 RT-PCR testing. The second nasopharyngeal sample will be tested at the site using the Spartan COVID-19 v2 System. The third nasopharyngeal sample will be tested using the Spartan COVID-19 v2 System only when the test conducted with the second nasopharyngeal swab does not produce a positive or negative result.

The sample for the SOC test will be collected prior to the samples for the Spartan COVID-19 v2 System as per clinical regulations.


Eligibility Criteria:
Inclusion Criteria:

* Individuals suspected of SARS-CoV-2 infection by a healthcare provider
* Individuals whose first symptom onset occurred less than or equal to 7 days of presentation
* Individual (or authorized representative) able or willing to provide written informed consent for study participation

Exclusion Criteria:

* Vulnerable populations (e.g., women with pregnancy, institutionalized individual) as deemed inappropriate for study by the site investigator
* Individuals with self-reported nosebleed within 24 hours of presentation