cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body temperature) will be recorded.

In the study period, a single dose of 2 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 100 cm2 skin area covered by an occlusive dressing will be administered. Sampling Time Schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 20, 24, 36 hours after dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female is 20 years of age or above.
2. Patient has AK lesions located within a 100 cm2 contiguous or non-contiguous treatment area.
3. Patient has at least one clinical confirmed AK lesion within the selected treatment area before.

Exclusion Criteria:

1. Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon, cytotoxic drugs.
2. Patient had treated with topical 5-FU, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
3. Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
4. Patient had received any of the following treatments on the treatment area in the 6 months before study treatment initiation: psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, chemical peel.
5. Patient had used any topical preparations, such as sunscreens, moisturizers, body oils, or alpha or beta hydroxyl acids, in the treatment area within 24 hours before and during the study course.
6. Use of any medication, including over the counter products, herb medicine and dietary supplements such as vitamins, which would interfere with study results, within one week before and during the study course.
7. Patient is known to be hypersensitive to the study medication.
8. Female who is pregnant, breast-feeding or considering becoming pregnant while on the study.
9. Donation of 500 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
10. Patient had used of any investigational drug within the past 30 days before enrollment.
11. Patient has any dermatological disease and/or condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area (5 cm distances from treatment area).
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma

Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma

This is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large B-cell lymphoma at high risk of central nervous system recurrence. The main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. Patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. Growth factor support and Pneumocystis jirovecii prophylaxis is required. The primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens
* No central nervous system involvement on initial staging
* Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale)
* Renal function: creatinine clearance \>45 ml/min
* Not pregnant; agreeable to contraception
* Written informed consent
* High risk for central nervous system recurrence as determined by one of the following high-risk features:

  1. high central nervous system International Prognostic Index,
  2. testicular, breast, or uterine involvement,
  3. dual expresser or double/triple-hit status,
  4. HIV positive status, or
  5. Molecularly defined high-risk subtype.

Exclusion Criteria:

* pregancy
* unable to provide informed consent
* significant comorbidity in the investigator's judgement
The Impact of Smoking on the Prognosis of Elderly Surgical Patients

Postoperative delirium is a common complication that frequently occurs in elderly patients after surgery. It not only increases the length of hospital stays and healthcare costs but also raises the incidence of postoperative cognitive dysfunction and even mortality. However, the underlying mechanisms of its onset are not yet fully understood. Evidence suggests that smoking can lead to gut microbiota dysbiosis and metabolic dysfunction, and the gut microbiota and its metabolites play a crucial role in cognitive function through the gut-brain axis. Yet, no studies have reported whether smoking could affect the occurrence of postoperative delirium and the quality of postoperative recovery through the gut microbiota. This study aims to observe the incidence of postoperative delirium and the postoperative recovery quality scores between smokers and non-smokers.

After obtaining approval from the ethics committee, patients are recruited, informed of the trial process and potential risks, and their informed consent is obtained and signed. According to the WHO definition, patients are classified into smokers (defined as those who smoke more than one cigarette per day continuously or cumulatively for six months; more than four times a week but averaging less than one cigarette per day) and non-smokers (never smoked). Fecal and blood samples are collected from both groups of patients preoperatively, and perioperative data is gathered. Postoperatively, an uninformed observer assesses the patients for delirium and recovery quality.

Eligibility Criteria:
Inclusion Criteria:

* Age \>60 years;
* American Society of Anesthesiologists (ASA) preoperative anesthesia classification ASA Grades I and II;
* Undergoing elective surgery;
* Patients and their families are able to understand and complete various scoring scales and voluntarily sign informed consent.

Exclusion Criteria:

* Mini-Mental State Examination (MMSE) score \<23;
* Preoperative biochemical tests indicate renal dysfunction or active liver disease;
* History of definite neurological or psychiatric disorders or history of taking corresponding medications before surgery;
* History of alcohol abuse or drug dependency;
* Taking antidepressant medications;
* American Society of Anesthesiologists (ASA) preoperative anesthesia classification \> Grade II.
Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese Subjects

This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of PAZ-417 after administration of ascending single oral doses to healthy young Japanese male and healthy elderly Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria

1. Men aged 20 to 45 years inclusive (healthy young male subjects) and ≥65 years inclusive (healthy elderly male subjects)
2. Nonsmoker or smoker of fewer than 10 cigarettes per day.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. Subjects who are identified as being at risk for hypercoagulability
3. Use of any investigational or prescription drug within 30 days before test article administration
Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews

Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings autograft may contribute to failure of the graft and/or present technical challenges secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing the biomechanical properties of the graft construct. The purpose of this investigation is to examine the tibial tunnel widening relationship between bioabsorbable interference screws composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as tibial fixation devices.

Specifically the study has the following objectives: 1) To quantify the extent of tibial tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To hypothesize mechanisms for any observed differences between tibial fixation devices; and 4) To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial tunnel widening around the implant but rather between the implant and articular surface, compared to the PLLA alone screw. It is also hypothesized that there will be no effect of observed tunnel widening on clinical outcomes or graft failure rates.


Eligibility Criteria:
Inclusion Criteria:

* Must have a unilateral ACL rupture
* Patients must be between 18 and 45 years old

Exclusion Criteria:

* Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears
* Severe chondromalacia or severe meniscal tear
* Previous history of ipsilateral knee joint pathology, surgery, or trauma to that knee
* Unwillingness to be followed for 12 months post-operatively
* History of arthritis (osteoarthritis or rheumatoid)
* Pregnancy
* Psychiatric illness that precludes informed consent
* Unable to speak or read English/French
* Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
lncRNA-based Nomogram to Assist Childhood Asthma Diagnosis

Asthma is the most common chronic disease in children, however, underdiagnosis of childhood asthma is an important issue in asthma management. The lack of reliable and objective diagnostic indicators requires the development of rapid and accurate strategies for the early diagnosis of childhood asthma. Recent studies have found a correlation between long-chain non-coding RNA (lncRNA) expression and childhood asthma, suggesting that lncRNA may be a potential biomarker for asthma diagnosis.

The investigators envision exploring the early diagnosis of asthma by combining lncRNA with electronic medical records. In this project, the investigators will combine high-throughput sequencing, asthma case database, electronic medical record and informatics to investigate the feasibility of combining lncRNA with electronic medical record for asthma diagnostic model. The expected results will establish the foundation for the diagnosis and treatment of childhood asthma and open up new ideas.

Eligibility Criteria:
Inclusion Criteria:

children with recurrent wheezing

Exclusion Criteria:

1. diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
2. immunodeficiency- acquired or congenital
3. neuromuscular disease
4. congenital heart disease
A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors

Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment, while the majority of patients will eventually develop evasive resistance. It is proposed that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute to VEGF inhibitor resistance, such that combining a c-MET inhibitor with a VEGF inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with the VEGF inhibitor, axitinib.Since this will be the first study of axitinib given in combination with crizotinib, the study will primarily assess the safety and tolerability of the combination regimen.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis - Dose Escalation Phase: Histologically or cytologically confirmed diagnosis of advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available.
* Diagnosis - Dose Expansion Phase: Histologically or cytologically confirmed advanced RCC with a component of clear cell subtype
* Dose Expansion Phase: at least one measureable lesion as defined by RECIST \[Response Evaluation Criterion in Solid Tumors\] version 1.1.
* ECOG \[Eastern Cooperative Oncology Group\] Performance Status 0 or 1.

Exclusion Criteria:

* Major surgery \<4 weeks or radiation therapy \<2 weeks of patient registration.
* History of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
* Dose Expansion Phase only: diagnosis of any other malignancy within 2 years prior to registration.
MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury

The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and that the impaired cortical activation can be detected with magnetoencephalography (MEG), and that the results of these imaging examinations will correlate with neurocognitive status and functional recovery after TBI.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* single episode of blunt traumatic brain injury
* symptoms of persistent post-concussive syndrome present an average of 4 months to 4 years since date of injury
* fluency in English (cognitive battery not available in other languages)
* capable of self-consent

Exclusion Criteria:

* \< 18 years or \> 50 years of age
* pregnancy
* history of previous TBI with loss of consciousness
* alcoholism as evidenced by Audit questionnaire
* regular use of illicit drugs
* non-English fluency
* significant psychiatric history excluding mild depression or anxiety disorder any contraindication to MRI, including claustrophobia, pregnancy, any trauma or surgery which may have left ferromagnetic material in the body, ferromagnetic implants or pacemakers; and inability to lie still for 1 hour or more
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Study has been completed and is in the data analysis and manuscript writing phase of the project.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.

Exclusion Criteria:

* Age less than 18 or greater than 90 years; emergency surgery
* Circulatory arrest
* Combined non-cardiac procedures such as carotid endarterectomy
* Congenital heart repair
* Off-CPB coronary artery bypass grafting (CABG)
* Clotting disorder
* Fibrinolytic agents (e.g. streptokinase), severe hepatic disease
* Aprotinin use
* Cooling \< 28 degrees C during CPB
* Dialysis dependent renal failure; and
* Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.


Eligibility Criteria:
Inclusion Criteria:

* History of erection problems
* Never taken treatments known as PDE5 inhibitors for erection issues
* Abstain from using any other erection treatments during the study
* Anticipate a monogamous female sexual relationship
* Must be able to make required sexual intercourse attempts

Exclusion Criteria:

* History of other primary sexual disorder
* Treatment with nitrates
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Do not meet certain lab value reference ranges
Clinical Profile in Patients With Essential Tremors

Essential tremors are no longer a single motor disorder but disorder of movement associated with non-motor symptoms and the aim of this study is to explore the clinical profile of patients with essential tremors including motor and non-motor features and their relationship.

and to identify clinical predictors of these features.

Essential tremors (ET) was defined as mono-symptomatic tremor syndrome involving both upper limbs during action for at least 3 years, with or without tremor in other body parts . ET is considered the most prevalent adult movement disorder, The crude prevalence of ET varies widely from 0.08 to 220 cases per 1000 persons. Many pathological post-Mortem studies are providing evidence that ET is mostly can be recognizes as neurodegenerative disease of the cerebellum and brain stem .

In the last decade there is an emerging studies that discuss the presence of associated motor, non- motor, sensory and psychological symptoms besides the tremors . Motor features of ET are not confined to tremors. Another feature of ET is gait ataxia , Eye movement abnormalities of subclinical degree, difficulties in learning motor skills, Bradykinesia and slowness of finger tapping .

Studies of the last two decades reported mild cognitive deficits in patients with ET in comparison to healthy controls. These deficits affect number of cognitive domains, especially verbal memory, naming, verbal fluency, attention- concentration, working memory and concept formation . In addition ET was found to be associated with hearing impairment with abnormal threshold at higher tone frequencies which refer to sensorineural hearing loss, and olfactory deficits which both may points to cochlear pathology. Moreover, patients with ET thought to have higher incidence of depression and anxiety symptoms than age-matched healthy individuals correlated with tremors severity .

Eligibility Criteria:
Inclusion Criteria:

1. All adults Patients are fulfilling cases definition of essential tremors will be included.
2. Gender: both sexes are included.
3. Any patient is, able to provide informed consent including permission to obtain information from patients' clinical medical history of at least three years' duration

Exclusion Criteria:

1. Patients are diagnosed with other neurological disorders unrelated to essential tremors.
2. Patients had any other condition presented with other cognitive or psychiatric disorders or known as drug abusers.
3. Patient had any systemic disease presented with tremors rather than essential tremors or compliant on medication had tremors side effect.
Clinical Performance Evaluation of DxN CMV Assay

The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.

same as brief summary

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Must have had a kidney transplant and be evaluated for post-transplantation care
* Must have demonstrated post-transplant CMV DNAemia
* Must be eligible for and treated with anti-CMV drugs

Exclusion Criteria:

* HIV positive
* Proven ganciclovir or valganciclovir resistance
A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes

To test the hypothesis that there is no difference in change in HbA1C among men with type 2-diabetes after an exercise intervention with strength versus endurance training.

Exercise training is well documented as part of effective treatment for type 2-diabetes patients. Endurance training has been suggested as the most suitable form of exercise. There are reasons to believe that strength training also has a positive effect. However, comparisons of endurance training and strength training regimes are limited.

Therefore we randomized 26 men with type 2-diabetes to either an endurance training group or a strength training group. Both groups exercised three sessions per week for three months. The training was supervised.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2-diabetes
* Male, 35-71 years
* Managing their diabetes through a lifestyle and/or the drug metformin only
* Able to participate in either of the exercise groups

Exclusion Criteria:

* Symptomatic cardiovascular disease
* Uncontrolled hypertension
* Physical or cognitive disabilities that will interfere with participating in the exercise regimes.
* Trained consistently during the last six months.
Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco

This study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of Vycavert are comparable to those following oral dosing of Norco.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant disease
* History of obstructive sleep apnea
* Life time history and/or recent evidence of alcohol and/or drug abuse