cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)

The purpose of this study is to evaluate the efficacy of topical tacrolimus in different subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T lymphocytes play a key role in the pathogenesis of lupus erythematosus. Tacrolimus targets T lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes, such as IL-2. Therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus might result in an improvement of skin lesions in such patients.

In patients with cutaneous lupus erythematosus (CLE), topical corticosteroids are the mainstay of treatment; however, a long-term use can lead to numerous side effects including skin atrophy. Recently, topical tacrolimus has been suggested to be effective in patients with different manifestations of CLE as single or additive therapy. Its anti-inflammatory effect can be explained by inhibition of calcineurin and suppression of proinflammatory cytokines such as interleukins-2, -3, -4, granulocyte colony-stimulating factor, and tumour necrosis factor alpha. In this study, we evaluate the efficacy of tacrolimus in 30 patients with different forms of CLE (ACLE, SCLE, DLE, LET). During a period of 3 months tacrolimus ointment and its placebo are applied on two separate skin lesions. Clinical follow-up examinations including photo documentation are performed every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Cutaneous lupus erythematosus confirmed by histological analysis
* Topical use of glucocorticosteroids stopped at least two weeks before the start of the study
* Presence of two primary skin lesions with a clinical score ≥ 1
* Written informed consent available prior to any screening procedures

Exclusion Criteria:

* Systemic medication if taken for lupus erythematosus (e.g. chloroquine or hydroxychloroquine) started at least 6 months prior to the beginning of the study
* Women of childbearing potential using inadequate birth control measures
* Pregnancy and lactation
* Known hypersensitivity to tacrolimus or any of the excipients
* Patients receiving systemic immunosuppressive drugs and cytotoxic agents other than antimalarial agents
Photodynamic Therapy in Treating Patients With Skin Cancer

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

OBJECTIVES:

* Determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions.

OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma \[BCC\] vs nodular BCC vs superficial squamous cell carcinoma vs actinic keratoses). Individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).

ALA is topically applied in a cream mixture and an occlusive dressing is placed over the lesion. After the randomized duration of ALA application has expired, the dressing is removed and a dye laser is used to treat the lesion.

Patients are followed for 2-5 years after treatment.

PROJECTED ACCRUAL: Up to 200 patients could be accrued, assuming 1 lesion per patient. 50 lesions are required for each stratified group.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Actinic keratoses
  * Histologically proven superficial or nodular basal cell carcinoma (BCC), squamous cell carcinoma in situ (Bowen's disease), or microinvasive squamous cell carcinoma
* No nodular BCC greater than 4 mm thick that will not be surgically removed
* No carcinoma with uncertain margins requiring Moh's surgery

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No known photosensitivity disease
* No porphyria or hypersensitivity to porphyrins

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No prior treatment with systemic photosensitizer that would cause residual cutaneous photosensitivity during study participation
Resistance Training to Improve Physical Function in the Elderly

The primary purpose of this study is to examine the effectiveness of the current resistance training guidelines for older adults proposed by ACSM/AHA to improve physical function in individuals with reduced physical abilities. A randomized controlled intervention trial will be used to compare change in physical function pre- and post-intervention between a treatment group receiving the minimum recommendations of the guidelines and a control group asked not to change their physical activity participation. To better understand the clinical significance of such an occurrence, a secondary purpose was to determine if older adults with reduced physical abilities who adhere to the recommended intervention dosage will experience a change such that they can be reclassified to a more favorable level of functioning. It is hypothesized that the minimum recommended dosage of the guidelines would be sufficient to both improve physical function and improve functional classification in older adults with reduced physical abilities.


Eligibility Criteria:
Inclusion Criteria:

* Older Adults aged \>65yrs; reduced physical function

Exclusion Criteria:

* Those with a history of resistance training
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk

The purpose of this study is to learn more about how the body stores fat in and around organs (for example in the liver) and why this affects some people's health more than others. Understanding this may lead to better treatments for diseases such as diabetes and cardiovascular disease.

The purpose of this study is to determine the specific cellular and organ system metabolic and immunologic alterations that are associated with insulin resistance and inflammation in order to identify putative mechanisms and novel bio-markers involved in the pathogenesis and progression of inflammatory and cardiometabolic diseases.

Eligibility Criteria:
Inclusion Criteria:

Lean, metabolically healthy group - Body mass index (BMI) 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration \<100 mg/dl, 2-h OGTT plasma glucose concentration \<140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.

Obese, metabolically healthy group - BMI ≥30 kg/m2, HHbA1C ≤5.6%, fasting plasma glucose concentration \<100 mg/dl, 2-h OGTT plasma glucose concentration \<140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.

Obese, metabolically healthy group - BMI ≥30 kg/m2, IHTG content ≥5.6% and HbA1C ≥5.7% or fasting plasma glucose concentration ≥100 mg/dl or 2-h OGTT plasma glucose concentration ≥140 mg/dl.

Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery - BMI 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration \<100 mg/dl, 2-h OGTT plasma glucose concentration \<140 mg/dl and IHTG content ≤5%.

Obese, scheduled for bariatric and gallbladder surgery - BMI ≥35.0kg/m2

Exclusion Criteria:

* active or previous history of liver diseases other than NAFLD
* history of alcohol abuse
* currently consuming ≥20 g alcohol/day
* severe hypertriglyceridemia (\>300 mg/dL)
* smoke tobacco
* cancer diagnosis within the previous 5 years
* medications that might confound the study results
* pregnancy or lactation
* exercise \>2 h/week
Outcomes After Parastomal Hernia Repair

The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish Patients Registry. Specifically, the readmission and reoperation rates will be evaluated.

The Danish Hernia Database covers about 80% of all ventral hernia repairs performed in Denmark. Data on size of hernia, type of surgery, type of mesh and fixation method is available from the Danish Hernia Database. All healthcare services in Denmark are registered in the Danish National Patients Registry and data on 30-day readmission rate, readmission diagnosis and reoperation is found here. Each Danish citizen has a unique personal identification number and by merging data from the Danish Hernia Database and National Patients Registry, nationwide data on parastomal hernia repairs is available. The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 focusing on readmission and reoperation rates.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing parastomal hernia repair in Denmark from 2007-2017

Exclusion Criteria:

* If data is not fully registered in the Danish Hernia Database
Safety and Feasibility Study of Targeted Temperature Management After ICH

Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited experience with the use of TTM after intracerebral hemorrhage (ICH), the most devastating type of stroke. TTM may be a an intervention to improve patient outcomes. This trial addresses the safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may be the basis for future larger clinical trials.

Morbidity and mortality from intra-cerebral/intra-parenchymal hemorrhage (ICH/IPH) are important public health problems. As the most common etiology of ICH/IPH is hypertension, this places a large proportion of the population at risk. In 2011 The American Heart Association (AHA) estimated that in the US, there were 610,000 new stroke cases of which 10% were ICHs, and many required long-term health care. ICH/IPH is associated with the highest morbidity and mortality and only 20% of patients regain functional independence. Temperature modulation to hypothermia (T, 32-34°C) has been associated with modulation of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. Currently, there are no therapies to specifically target ICH/IPH. To this end, novel strategies that go beyond control of glucose, blood pressure, and intra-cranial pressure, aimed at reducing the enlargement of the hematoma and "swelling" surrounding it, could be "the new frontier in the management of ICH/IPH". Since the early resuscitation phase in the Neuro-ICU represents the greatest opportunity for impact on clinical outcome after ICH/IPH, it also appears to be the most promising window of opportunity to demonstrate a benefit when investigating novel therapies.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous supratentorial ICH documented by CT scan within 18 hours after the onset of symptoms
* Admission to the Neuro-ICU
* Baseline hematoma \>15cc with or without IVH
* Need for mechanical ventilation.

Exclusion Criteria:

* GCS \<6
* Age \<18 years
* Pregnancy
* Pre-morbid modified Rankin Scale (mRS) \>2
* Do Not Resuscitate (DNR) order "prior" to enrollment
* Uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding \[UGIB/LGIB\])
* Planned surgical decompression within 24 hours
* Secondary causes of ICH (ischemic stroke, coagulopathy \[INR\>1.4, aPTT\> 1.5 times baseline, thrombocytopenia platelets \<100,000/uL\], trauma, AVM, aneurysm, cerebral sinus thrombosis, or other causes)
* Evidence of sepsis
* Spontaneous hypothermia (core Temperature \<36C)
* Inability to obtain written informed consent
* Participation in another trial.
Advanced Approach to Arterial Stiffness

The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the "classic" carotid-femoral Pulse Wave Velocity (PWV).

Hypothesis The aim of thie 3A study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the "classic" carotid-femoral Pulse Wave Velocity (PWV).

STUDY OBJECTIVES

1. Objectives Primary Objective: Assess the influence of MetS on CAVI values (primary study endpoint) in 3 different age groups (40-54, 55-69, 70-85 years) of a European population.
2. Secondary Objectives

   * Establish the CAVI values in a European population according to the clusters of (MetS) components i.e. cardiovascular risk factors: abdominal obesity, high triglycerides, low HDL cholesterol, elevated blood pressure (BP), systolic or diastolic, and elevated fasting glucose (and diabetes), as well as tobacco smoking.
   * Assess the correlation between CAVI and the carotid-femoral PWV in the full population and in each age group; and compare the impact of MetS and its components on both the CAVI and PWV
   * To establish, the relationship between cardiovascular risk factors and the evolution of arterial stiffness as evaluated by CAVI and carotid-femoral PWV over a 2-year follow-up period.
   * To assess changes and predictive value of CAVI on organ damages and CV events during the follow-up period.
   * To assess 24h ABPM and its correlations and variations with the CAVI and PWV in patients with MetS and/or its different components.

This is a multinational European prospective longitudinal study.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 40-85 with life expectancy over 2 years will be included. Patients will be stratified according to their age (3 groups: 40-54, 55-69, 70-85 years)) and the presence or not of MetS.

Exclusion Criteria:

* Factors that may impair the quality of the CAVI and /or the PWV measurement or make PWV recording unreliable: known significant peripheral vascular disease with proximal artery stenosis, ankle brachial index \< 0.9, or limb amputation; history of vascular surgery at the level of the carotid artery, femoral artery or aorta; body mass index \> 40 kg/m²; atrial fibrillation and/or other major arrhythmia.
Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer

Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment for breast cancer.

The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane (125mg/m2) Combined With Q3week Xeloda (1250mg/m2) in early operable (stage of T2-4N0-3M0) breast cancer. This study will be an open label non randomized, single arm, single center study.

The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is feasible and achieves high response rates.

It is proposed that 50 patients will be enrolled in this study. The target population is women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic therapy.

The primary objective of the trial is to determine the overall response rate. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Women and men at least 18 years of age or older.
3. Pathological confirmation of breast cancer
4. Tumor stage(TNM):T2-4N0-3M0
5. No evidence of distant metastasis
6. Adequate bone marrow, hepatic, and renal function
7. Measurable disease as per RECIST criteria
8. Karnofsky≥70
9. Laboratory criteria:

PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN

Exclusion Criteria:

1. Presence of metastatic disease.
2. Inflammatory breast cancer.
3. Bilateral breast cancer.
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
5. other malignant tumors (concurrent or previous).
6. Pregnant woman.
7. Hypersensitive to any drug in Abraxane or Xeloda regimen or any ingredient of Abraxane or Xeloda.
8. Any severe systemic disease contraindicating chemotherapy
Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM

Julius Schachter, PhD, from the Department of Laboratory Medicine at UCSF, and Jeffrey Klausner, MD, from the Department of Public Health, are conducting a study to evaluate a type of test (nucleic acid amplification test) for the detection of two sexually transmitted diseases, Chlamydia trachomatis and Neisseria gonorrhoeae, in men who have sex with men (MSM), using urine samples and swabs taken from the throat (pharynx), tip of penis (glans), and rectum. The use of nucleic acid amplification tests on these swabs is experimental, which means that the use of the tests for this purpose have not been approved by the Food \& Drug Administration.

For all subjects enrolled in the study, the following clinical data information will be obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment.

For each subject enrolled in the study, three clinician-collected pharyngeal, four rectal swabs (three clinician-collected, 1 self-collected) specimens, one glans swab (self-collected) and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician collected swabs will be randomized.

Three pharyngeal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG (TMA, SDA) and CT culture at UCSF. Four rectal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG on Clinician- and self-collected rectal swab (TMA, SDA) and CT culture at UCSF. Self-collected glans swab and the FCU will be tested by NAATs for CT/NG (TMA, SDA) at UCSF. All NAAT specimens collected in a universal NAAT transport medium. After specimen processing, samples will be frozen at -70 C for discrepant analysis.

Eligibility Criteria:
Inclusion Criteria:

* A subject must be a man who has sex with men (MSM). Subjects must provide verbal consent, must be able to submit all required specimens and must not have urinated within 1 hr prior to providing a study urine specimen.

Exclusion Criteria:

* Subjects are excluded if they do not have sex with men, refuse to give verbal consent, are unable to provide all required specimens and minimum specimen volume, have been on antibiotic therapy within the last 21 days, have urinated within 1 hr prior to submitting study specimens, and have already been evaluated as part of this trial. Subjects will be excluded if specimens are mishandled or inappropriately stored.
Data Collection During CT for Axial Flow VADs

At present, there is not accurate way to determine specific flow rates for axial flow ventricular assist devices (VADS). If a right heart cath is needed for these patients for clinical purposes, they will also undergo a cardiac CT scan while the pulmonary artery catheter is in place. It is possible to visualize the flow rates of axial flow VAD's and determine a more accurate rate per specific patient.

Data Analyzed with following results:

Article in Press for Cardiopulmonary Support and Physiology, results state "Pairwise comparison of calculated output from left ventricular assist devices is feasible using first pass dynamic computed tomography test bolus technique versus thermodilution output measurements yielded good agreement (P=.03). The output calculated using dynamic CT underestimated the thermodilution output measurement by 0.54+ 0.37 L/min (95% confidence interval 0.66-0.94).

Description as listed in Summary. The hemodynamic data collected along with pump parameters may help determine more accurate flow rates specific to each patient.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed consent
Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients

This study is phase 3 study for prevention of VTE in patients with abdominal surgery.


Eligibility Criteria:
Inclusion criteria:

* Patients aged \>=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
* General or urologic surgery
* Cancer surgery
* Gynecologic surgery
* Radical surgery for pelvic malignancy

Exclusion criteria:

* Active, clinically significant bleeding Thrombocytopenia Body weight \<40kg
Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy

Several methods have been demonstrated to improve intubating conditions during sevoflurane induction in children. These include opioids, propofol, and addition of neuromuscular blocking agents in pediatric patients. But the study about the comparison of these agents has been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short procedure performed under general anesthesia. The investigators aimed to compare intubating conditions among children with propofol, alfentanil or rocuronium after sevoflurane induction.


Eligibility Criteria:
Inclusion Criteria:

* Children, 1-9 years old scheduled elective frenectomy under general anesthesia

Exclusion Criteria:

* Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction

The purpose of the study is to test two different doses of ketamine sub-lingual (under the tongue) wafer against placebo to see how effective the medication is to treat moderate to severe pain after wisdom tooth extraction.

This is a Phase 2, randomized, double-blind, parallel group, dose-ranging placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post-operative pain after undergoing third molar extraction.

The study will enroll approximately 80 subjects at a single site. Subjects will be at least 18 years to 38 years of age. Subjects will receive a single dose of 70 mg or 100 mg sublingual ketamine wafer or placebo.

Efficacy assessment will include pain intensity, use of rescue medication, and Patient Global Assessment (PGA) of pain control. Safety assessments will include monitoring of AEs and SAEs, clinical laboratory tests, vital sign measurements, oral assessments, and ECGs.

A maximum of eight 4ml blood samples will be taken from each participant up to 8 hours after study drug administration for plasma analysis.

Eligibility Criteria:
Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.