cyrilzakka/clinical-trials huggingface dataset:
Comparison of Screening Tests in Detecting Cervical Neoplasia

RATIONALE: Screening tests may help doctors detect abnormal cells in the cervix early and plan effective treatment.

PURPOSE: Screening trial to compare different types of screening tests used to detect cervical neoplasia.

OBJECTIVES:

* Compare the sensitivity and specificity of primary screening strategies for the detection of cervical intraepithelial or invasive neoplasia.
* Compare the positive and negative predictive values of these strategies.

OUTLINE: This is a multicenter study. Patients are stratified according to the reason for the visit (general gynecological screening vs colposcopy referral).

* Stratum 1 (general gynecological screening): Patients undergo Pap smear, visual inspection aided by acetic acid (VIA), a colposcopy, and finally a visual inspection aided by toluidine blue (VIT) followed by an acetic acid wash. A biopsy may be performed at this initial visit. Within 2-3 weeks, patients are notified of results.
* Stratum 2 (colposcopy referral): Patients undergo Pap smear, VIA, colposcopy, VIT, and possible biopsy as in stratum 1. During the same visit, patients receive histologic evaluation and treatment with See-and-Treat loop electrosurgical excision procedure and/or endocervical curettage.

PROJECTED ACCRUAL: A total of 600-1,000 patients (300-500 per stratum) will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria::

* History of cervical neoplasia
* Presenting for a well-woman visit, annual Pap smear, or family planning

  * Other gynecological or non-gynecological complaints allowed OR
* Referred for colposcopy secondary to an abnormal Pap smear
* Planned screening for cervical cancer
* Over 18 years of age
* Prior laser surgery, cryotherapy, or conization or loop electrosurgical excision procedure for cervical neoplasia allowed

Exclusion Criteria:

* bleeding diathesis
* pregnant
* prior hysterectomy
* concurrent anticoagulants
Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm

The aim of this study is to evaluate the tolerance of intravenous milrinone combined to the current standard treatment for cerebral vasospasm following subarachnoid hemorrhage. Assessment of IV milrinone safety in this setting is mandatory before the conduction of a large study assessing its effectiveness.

The aim of this prospective observational study is to evaluate the hemodynamic tolerance of intravenous milrinone for the treatment of arterial vasospasm following subarachnoid hemorrhage. Intravenous milrinone is part of our standard care protocol for the management of cerebral vasospasm in association with nimodipine (intravenous or enteral route) and high arterial blood pressure (mean arterial pressure of 100-120 mmHg, spontaneously or induced by volume expansion and norepinephrine). All patients of our ICU who were diagnosed with cerebral arterial vasospasm during the few days following a subarachnoid hemorrhage will be included.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years
* Hospitalized in our intensive care unit
* Subarachnoid hemorrhage proven on CT angiogram
* Cerebral vasospasm proven on CT angiogram

Exclusion Criteria:

* Pregnant women
* Minor
* Major under guardianship
Imunomodulation in Acute Pancreatitis

Acute pancreatitis is an acute inflammatory pathology of the pancreas with activation of both innate and adaptive immune system, including T and B lymphocytes and release of inflammatory cytokines. We aim to characterize the circulating profile of T and B cells, its regulatory populations and B cell maturation, as well as inflammatory cytokines, in a prospective way of 50 patients with acute pancreatitis admitted to Hospital da Luz Lisboa. Blood samples will be collected at hospital admission, 48h, one month and 6 months after hospitalization of patients, relating these values to the severity of acute pancreatitis. Patients with acute pancreatitis in the previous 6 months, diabetes mellitus, pregnant women, uncontrolled comorbidity and terminal neoplasms will be excluded. A control group of 30 ambulatory individuals observed at the Hospital da Luz Lisboa will be recruited. Laboratory evaluation will be performed at the Immunology Laboratory of NOVA Medical School.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients with acute pancreatitis

Exclusion Criteria:

* acute pancreatitis in the last 6 months diabetes mellitus, pregnant women, uncontrolled comorbidity such as organ disease (cardiac, renal, hepatic) and terminal neoplasms
Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus

Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of type 2 diabetes mellitus.
* Age between 20 and 64 years.
* BMI \< 40 kg/m2.
* On fixed oral hypoglycemic dosage for at least 3 months.
* Normal serum creatinine (0.5 to 1.3 mg/dL) with no clinical evidence suggestive kidney disease.
* Normal liver function tests (ALT 7 to 55 U/L, and albumin ˃ 3.5 g/dL).

Exclusion Criteria:

* Those diagnosed of osteomalacia, chronic alcoholics. Patients with type 1 Diabetes Mellitus.
* Those who were taking multivitamin containing zinc or magnesium or any sort of mineral supplements in the previous three months or hormone replacement therapy (estrogen, progesterone) or chelating therapy such as penicillamine, or anticonvulsant (phenytoin, valproate).
* Those with a history of recent surgery or with concurrent acute illness including infectious disease, trauma, inflammatory bowel disease, malignancy, and active immunological diseases, using corticosteroids.
* Pregnant or intend to be pregnant for t least 3 months or lactating women.
* Those who were receiving insulin preparations as a part of diabetes management.
Vitamin D to Prevent Autism in Newborn Siblings

The purpose of this study is to determine whether by administering vitamin D to mothers who already have at least one child with autism and who are pregnant, that the vitamin D will prevent the recurrence of autism in the newborn sibling.

The incidence of autism is increasing. Also, women of childbearing age are increasingly found to be insufficient/deficient in vitamin D. Vitamin D is a neurohormone which is important for development of the child, especially of the child's brain. The primary source of vitamin D is from the sun through one's skin. People have been avoiding the sun because of skin cancer, because of increasing Television watching, computer viewing and wearing clothes that cover most of the body. This approach will study whether making the pregnant mother, whose child is at risk for autism because of a previous child with autism, replete with vitamin D will prevent that recurrence of autism in the newborn sibling.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant mothers who have had at least one child with autism spectrum disorder

Exclusion Criteria:

* Child with autism must not be from a syndrome such as Fragile X syndrome, Retts Syndrome
* Mother must be before the third trimester
Cost-Effectiveness of Lung Volume Reduction Surgery

Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Background:

Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Objectives:

Evaluate cost-effectiveness of LVRS compared to current therapy for COPD.

Methods:

This is a case control study in which veterans undergoing LVRS at VA Puget Sound Health Care System (VAPSHCS) are compared to patients with a similar severity of disease at Boise VAMC who are not undergoing LVRS. Changes in health related quality of life are being evaluated using three instruments: the SF-36, the St. George�s Respiratory Questionnaire, and the Quality of Well-Being Scale, the latter to calculate utility associated with different health states. Costs will be determined using utilization data on outpatient visits, medications, oxygen use, inpatient days, radiology tests, laboratory tests, and emergency room visits are being collected for the twelve months before and after surgery. Costs will be calculated according to VA and community standards.

Status:

Complete.

Eligibility Criteria:
Inclusion Criteria:

Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of \>165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease

Exclusion Criteria:
Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens

This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Hemodialysis patients utilizing an arteriovenous fistula (AVF) for hemodialysis access are 10 times less likely to develop bacteremia than those patients utilizing a hemodialysis catheter. Because of this, a great focus has been on placing AVF in all patients undergoing hemodialysis. While AVF are relatively simple to place from a surgical standpoint, 30-60% of AVF will not mature adequately to be used for hemodialysis. In order to be utilized for hemodialysis, the blood flow in the vein used to create the AVF will need to increase by over 100 fold. In order to do so, the vein will need to dilate by more than 150%. AVF which fail to mature do not dilate, and the major histologic finding in these AVF has been neointimal hyperplasia. The factors (both circulating and tissue) which contribute to AVF maturation or failure are poorly understood, and investigations in this area are limited. Current studies in the literature have either described pre-AVF vein characteristics, or have looked at serum or tissue specimens following AVF failure. To date, no studies have looked at specimens from patients both before and after fistula placement, or described factors associated with fistula maturation. This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years of age or greater
* Arteriovenous fistula placement for hemodialysis access scheduled within 30 days

Exclusion Criteria:

* Incompetent to provide informed consent
Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

This is a global randomized double-blind placebo-controlled study in patients with Stage IV untreated non-small cell lung cancer (NSCLC) with or without bone metastasis. Eligible participants are to receive 4 to 6 cycles of a standard of care platinum-doublet chemotherapy regimen. Participants will be randomized in a 2:1 ratio to receive denosumab or matching placebo with the first investigational product dose coinciding with participant's first cycle of chemotherapy and continuing until the primary analysis, unacceptable toxicity, withdrawal of consent, death, or lost to follow-up. Participants who discontinued the investigational product early (ie, before primary analysis) were followed for disease status and survival. The primary analysis took place when 149 events of death had been reported. All participants were followed for 2 years after the last dose of blinded investigational product.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IV non-small cell lung carcinoma (NSCLC), according to 7th Tumor/Node/Metastasis (TNM) classification (cytological specimens obtained by bronchial washing or brushing, or fine-needle aspiration are acceptable)
* Subject has available and has provided consent to release to the sponsor (or designee) a tumor block with confirmed tumor content (or approximately 20 unstained charged slides \[a minimum of 7 slides is mandatory\]) and the corresponding pathology report
* Planned to receive 4 to 6 cycles of pemetrexed or gemcitabine in combination with cisplatin or carboplatin

  • For subjects to receive pemetrexed, planned to receive vitamin B12 and folate per pemetrexed approved labeling
* Radiographically evaluable (measurable or non-measurable) disease (according to modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
* Other inclusion criteria may apply

Exclusion Criteria:

* Known presence of documented sensitizing epidermal growth factor receptor (EGFR) activating mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation (screening following local standards, but strongly encouraged in non-squamous histology)
* Known brain metastases (systematic screening of patients not mandatory)
* Any prior systemic therapy (before randomization) for the treatment of NSCLC (including chemoradiation), except if for non-metastatic disease and was completed at least 6 months prior to randomization
* Planned to receive bevacizumab
* Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, or with the following:

  * Active dental or jaw condition which requires oral surgery
  * Non-healed dental/oral surgery
  * Planned invasive dental procedures for the course of the study.
The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical VCIND) represents a relatively homogeneous disease process and is a suitable target for therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of Butylphthalide Soft Capsules in patients with VCIND.


Eligibility Criteria:
Inclusion Criteria:

* Literate Han Chinese aged from 40 to 65 years
* MMSE ≥24
* Normal or slightly impaired activities of daily living
* The MRI entry criteria are as follows:

  * Subcortical small infarcts (3-20 mm in diameter),or one or more strategically located subcortical small infarcts in the caudate nucleus globus pallidus, or thalamus
  * Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis); and
  * No hippocampal or entorhinal cortex atrophy (scored 0 according to medial temporal lobe atrophy scale of Scheltens)

Exclusion Criteria:

* Patients with Diabetes mellitus
* Disorders other than subcortical VCIND that may affect cognition; the score of Hamilton depression scale more than 17 or schizophrenia
* Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction; use of medications that may affect cognitive functioning
* Known hypersensitivity to celery
* Inability to undergo a brain MRI
Fast Track Concept for Transfemoral TAVI

Transcatheter aortic valve implantation (TAVI) in high-risk patients with severe aortic valve stenosis has developed itself until today as an established minimally invasive alternative procedure worldwide, with a focus on the transfemoral access (TF-TAVI). Meanwhile a number of studies have shown that analgosedation for patients undergoing TF-TAVI is a safe and feasible alternative to general anaesthesia (1). The median length of stay in hospital in Europe is currently 8 days independent to the anesthesia management (2). In the University Hospital Schleswig-Holstein, Campus Kiel, a new TF-TAVI fast-track-concept has been implemented in June 2018. The main intraprocedural aspects of the concept are the preprocedural fluid optimization using transthoracic echocardiography, the idea to decrease or omit the central venous line and the urinary catheter, if reasonable, and finally the individualized low-dose, bolus-based AS.

The investigators are going to monitor 200 patients in 2019 treated with the newly established fast-track concept. During the premedication visit, the investigators informed the patients that the intention is to perform the TF-TAVI, if acceptable, solely in local anaesthesia, in order to minimize potentially adverse pharmacological central effects by analgosedation. After insertion of two peripheral venous lines and an arterial line, monitoring of cerebral oxygenation using near-infrared spectroscopy was established. Transthoracic echocardiography has been performed to evaluate volume status, using the inferior vena cava collapsibility index. Additionally, cardiac output and ejection fraction was calculated.

Based on the data of the investigators and current data from the literature, the investigators assume a postoperative hospital stay of 8 days after TF-TAVI. With a possible reduction of the hospital stay by about 25%, the investigators calculated a case number of 100 patients per group. The study is designed with a control group under standard therapy. Data are recorded and analyzed descriptively. Qualitative comparisons will be made in the discussion of previously published data.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for transfemoral TAVI
* informed written consent

Exclusion Criteria:

* rejection by the patient
* switching to another procedure
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder

This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of overactive bladder
* Capable of independent toileting and completing a micturition diary
* Able to comprehend English and follow study procedures and instructions

Exclusion Criteria:

* Post void residual \> 100ml/sec
* Urine flow rate (Qmax) \<10ml/sec for males only

Other protocol-defined inclusion/exclusion criteria may apply
Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

The aim of this study was to evaluate the effect of intraoperative methadone on postoperative analgesic requirements, pain scores and patient satisfaction in comparison to standard intraoperative pain control with fentanyl.

Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia. Patients were randomized to receive either a single shot of methadone (0.2mg/kg) or fentanyl (0.003mg/kg) for induction of anesthesia. In cases of insufficient intraoperative analgesia repeated fentanyl administration was possible. Postoperative analgesia was provided with patient controlled morphine in both groups (PCA = Patient Controlled Analgesia). Pain was assessed using the numerical rating scale (NRS) at rest and after coughing, at 15 minutes post extubation, and repeated every 6 hours up to 72 hours postoperatively. The levels of sedation and nausea/vomiting were also evaluated in parallel.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia.
* german speaking patients

Exclusion Criteria:

* patients including other studies
* pregnant
* breast feeding
* patients in methadone substitution therapy
* dependent drug user
* patients with BMI greater than 36kg/m2
* patients with chronic or acute renal failure with serum creatinine greater than 400µmol/L
* patients with liver insufficiency or failure
* alcoholics
* patients with acute heard attack
Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery

In children undergoing pulmonary resection, the diaphragm function is evaluated using ultrasound before and after surgery to evaluate the incidence of diaphragm dysfunction after pulmonary resection. In addition, we examine if there is a relationship between diaphragmatic dysfunction and pulmonary complications, including postoperative lung atelectasis.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients under 7 years undergoing lung resection

Exclusion Criteria:

* Asthma
* Myopathy or neuropathy
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parents or guardians of the subject.
* Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
* Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
* Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
* History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
* Major congenital defects
* Serious chronic illness
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Acute disease at the time of enrollment.