cyrilzakka/clinical-trials huggingface dataset:
ACTHAR Therapy for Central Nervous System Sarcoidosis

There is a need for a more reliable, expeditious therapy that can be used as an alternative to glucocorticoids in severe Central Nervous System (CNS) sarcoidosis. This study aims to provide evidence for effectiveness of ACTHAR gel in CNS sarcoidosis, and provide information about its safety and tolerability

Central nervous system (CNS) involvement is one of the most severe manifestations of sarcoidosis. Sarcoidosis affecting the leptomeninges, spinal cord, or brain parenchyma portends a difficult course and frequently results in severe disability or death (1). Treatment of moderate and severe CNS sarcoidosis typically involves a combination of corticosteroids and cytotoxic agents such as methotrexate (2). Unfortunately, most response rates are reportedly only in the 29-38% range for corticosteroids alone, and the effects of cytotoxic agents in sarcoidosis require up to 6 months to occur. A typical scenario is that patients are treated for prolonged periods with high dose glucocorticoids with suboptimal effectiveness despite development of substantial toxicities. Some series report that cyclophosphamide or infliximab may be beneficial (3), but these approaches are limited by potentially severe toxicities, loss of effectiveness, or payor constraints.

. ACTHAR is a 39-amino acid peptide natural form of adrenocorticotropin hormone (ACTH) that was initially approved in 1952 by the FDA. It has since been approved for 19 indications including respiratory sarcoidosis, multiple sclerosis, and infantile spasms.

Eligibility Criteria:
Inclusion Criteria:

* Patient with sarcoidosis as defined by ATS/ERS/WASOG (American Thoracic Society/European Thoracic Society/World Association for Sarcoidosis and Other Granulomatous Disorders)
* Stable baseline immunosuppressive medications
* Moderate to severe disease as defined by at least one of the following criteria:

  * Cranial nerve palsy
  * Neurologic deficits related to intraparenchymal brain, spinal cord and/or cauda equina involvement
  * Dural or leptomeningeal involvement of brain and/or spinal cord
  * Hydrocephalus
  * Seizures

Exclusion Criteria:

* Diagnosis of any underlying neurologic disorder that would potentially confound interpretation of the study results
* Significant change in corticosteroid dose within the past 4 weeks, or other immunosuppressive medication within the past 6 months
* Evidence of current serious infection, or a history of chronic or recurring infections.
* Contraindication to high-dose corticosteroids (e.g. uncontrolled blood sugar).
* Allergies to pig-derived proteins
* Have a history of any opportunistic infection within 6 months prior to screening
* History of malignancy.
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients

The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
* Written informed consent has been obtained

Exclusion Criteria:

* Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
* Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
* Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
* Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
* Patients who are pregnant, lactating or intend to become pregnant during the study period
* Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
* Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
* Participation in any clinical trial within 1 month prior to randomization
Myocardial Protection and Anesthetic Agents

The aim of this study was to investigate the myocardial protective effects of remifentanil and dexmedetomidine in cardiac surgery.

Fifty patients is included in this study. Routine monitorization included a 5-lead electrocardiogram (ECG), invasive arterial monitoring, pulse oximetry, capnography, temperature monitoring. Invasive arterial catheter were inserted under local anesthesia. Central venous catheter (jugular or subclavian) and esophageal heat probe were inserted after tracheal intubation.

Anesthesia induction was standardized in all patients and included 1 mg/kg propofol, 1 μg/kg fentanyl and 0.1 mg/kg vecuronium bromus to facilitate endotracheal intubation. The patients were divided into two groups by computer randomization method. Group R (n=25), remifentanil group and Group D (n=25) dexmedetomidine group. In the remifentanil group, anesthesia was maintained with 0.5-1.5% sevoflurane and 0.125-0.25 μg/kg/min remifentanil infusion. In the dexmedetomidine group anesthesia was maintained with 0.5-1.5% sevoflurane and 0.5 μg/kg dexmedetomidine loading dose during 10 minute and 0.3-0.9 μg/kg/min infusion.

Cardiopulmonary bypass (CPB) period was started after aort and venous cannulae were inserted. Mean arterial pressure, central venous pressure, venous oxygen saturation (SVO2) and arterial blood gase analysis were recorded. All blood samples include laktat, pyruvate, CKMB and Troponin-T were taken via the coronary sinus catheter at specific time intervals (precardiopulmonary bypass, 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass).

Cardiopulmonary bypass time, aortic cross clamping time, the need of defibrillation/intraaortic balloon pumping (IABP)/extracorporeal membrane oxygenator (ECMO), urine output, positive inotropic agents requirement were recorded. At the end of surgery, the patients were transferred intensive care unit intubated and full monitorized.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to open heart surgery
* American Society of Anesthesiologists (ASA) physical status of II-III

Exclusion Criteria:

* Emergency surgery, prior cardiac surgery, ejection fraction \< 50%, restrictive or obstructive pulmonary disease, preoperative mechanical ventilation, intra-aortic balloon pump, chronic liver and renal failure.
Variation of Genes Controlling Carbohydrate and Lipid Metabolism

Aim of the study is to investigate genes regulating glucose and lipid metabolism in subjects whose glucose metabolism, lipid metabolism, blood flow, or body fat distribution has been measured using positron emission tomography (PET), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS) or computed tomography (CT) as part of their previous participation in clinical trials conducted at Turku PET Centre.

By combining information from PET, MRI, CT, proteomics, metabolomics and genetics analyses we aim to find connection between genetic variation and metabolic and cardiovascular disease.

The data is collected as a separate part of the clinical imaging study protocols using a separate inform consent approved by the local ethics committee. The participation for this study consists of drawing whole blood, serum and plasma samples for genetics, proteomics and metabolomics analyses. The results from these studies are combined with baseline data from the original clinical imaging studies to find connections between genetic variation, metabolism, blood flow and body fat distribution in a cross-sectional setting.

Eligibility Criteria:
Inclusion Criteria:

* Previous participation of studies measuring glucose metabolism, lipid metabolism, bloow flow and adiposity at Turku PET Centre

Exclusion Criteria:

-
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial

The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population).

Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of Public Policies in Brazil.

The aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.

This study, in the form of a blind randomized clinical trial, was approved by CAPPesq under protocol number: 0163/10.

49 adults with tinnitus and sensorineural hearing loss were randomly assigned into 2 groups. Both groups received counseling about tinnitus. One group received hearing aids with only amplification and the other group received hearing aids with an integrated sound generator. After the fitting process, both groups were told to use the hearing devices 8 hours per day. The outcome measures as the tinnitus handicap inventory and psychoacoustics measurements were conducted by a blind audiologist that didn't know each group each patient belonged to.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate sensorineural hearing loss
* tinnitus (THI \> 20)
* first user

Exclusion Criteria:

* profound hearing loss
* conductive hearing loss
* THI \< 20
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)

The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.

Tumor specimens of consenting patients will be tested by immunohistochemistry (IHC) for the presence of IE-1 and/or pp65. Subjects whose tumors test positive for either or both CMV antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of CTL infusion.

This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before termination.

Eligibility Criteria:
Inclusion Criteria:

FOR SCREENING

* Patients must have a histopathologic diagnosis of GBM.
* Patients from 5 to 65 years of age with GBM.

FOR TREATMENT

* GBM has progressed following primary therapy.
* Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC).
* Subjects must have pulse oximetry \> or = 94 % on no supplemental oxygen.
* Creatinine clearance must be \> 50 cc/min as estimated by patient's serum creatinine, weight, and age.
* Bilirubin must be \< 2.0 mg/dl and SGOT/SGPT \< 2.5 X normal.
* ECOG performance status must be \< or = 2, and for patients \<16 years of age, Lansky performance status must be \> or = 70%.

Exclusion Criteria:

* Pregnant females
* Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion
Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer

RATIONALE: Tamoxifen may be able to increase bone density and decrease cholesterol in women who are undergoing chemotherapy for breast cancer.

PURPOSE: Clinical trial to study the effectiveness of tamoxifen in preventing bone loss and heart disease caused by chemotherapy treatment in premenopausal women who have stage I or stage II breast cancer.

OBJECTIVES:

* Compare the bone density in the femoral neck and lumbar spine and cholesterol levels in premenopausal women with stage I or II breast cancer treated with adjuvant chemotherapy with or without tamoxifen.
* Collect information regarding breast cancer risk factors, treatment, pathology, diet, activity levels, weight, and smoking in these patients.

OUTLINE: Patients are stratified according to type of treatment (adjuvant chemotherapy plus tamoxifen vs adjuvant chemotherapy alone).

Patients receive adjuvant chemotherapy with or without oral tamoxifen at the discretion of the treating physician.

Prior to starting chemotherapy, patients undergo blood draw to measure baseline levels of follicle-stimulating hormone, estradiol, total cholesterol, high-density lipoproteins, and low-density lipoproteins. Patients undergo baseline bone densitometry of the femoral neck and lumbar spine to assess bone density prior to starting chemotherapy or within 30 days of the first drug treatment. Laboratory studies and bone densitometry are repeated at years 1 and 2. A comparison is made between the study findings at baseline and at years 1 and 2.

PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven stage I or II breast cancer
* Must be scheduled to receive adjuvant chemotherapy with or without tamoxifen
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 35 to 50

Sex:

* Female

Menopausal status:

* Premenopausal by follicle-stimulating hormone and estradiol levels

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* See Disease characteristics

Radiotherapy:

* Not specified

Surgery:

* Not specified
Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.

A total of 75 patients with CP/CPPS were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. The patients were treated for 4 weeks and were subsequently followed for 12 weeks. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of category IIIa of IIIb chronic prostatitis
* NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15

Exclusion Criteria:

* Urinary tract infection or uropathogen within the past 12 months
* Serious medical problems
* NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.)
* Drug therapy that might affect lower urinary tract functions within the past 3 months
Register for New Oral Anticoagulants

Patients, who are adjusted to a new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in routine treatment will recorded in this register. Within this register a characterization of patients (with regard to demography and indication) and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* indication for treatment with long term anticoagulation
* initial adjustment or change to nex oral anticoagulant within routine treatment
* indication for treatment with long term anticoagulation within the register:
* permanent anticoagulation in arterial fibrillation
* intended anticoagulation in acute venous thromboembolism for min. 3 months
* other anticoagulation for min. 3 months within the approved indication

Exclusion Criteria:

* missing Informed Consent Form
* missing phone number for telephone follow up
* contraindication for therapy with new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) according to Summary of Product Characteristics
Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations

The single-center, randomized, open-label, five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Study will be conducted with single dose CoQ10 to assess bioavailability.

Eligibility Criteria:
Inclusion Criteria:

* Subject Informed consent form (ICF) is singed
* Aged between 18 and 65 years at the time of the signature of ICF
* A body mass index between 18.5-29.9 kg/m2
* Total blood cholesterol range 3,11 - 6,50 mmol/L (not treated with medications)
* Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study
* Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study
* Consumption of dairy and cereal products (standardised breakfast will include low lactose dairy and bread)
* Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling)

Exclusion criteria:

* Intake of any prescribed medication within 2 weeks of the beginning of the study
* Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium
* Pregnancy or planned pregnancy
* Breast-feeding mother
* Hypotension
* Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or haematological disease, diabetes
* Gastrointestinal disorders or other serious acute or chronic diseases
* Known lactose/gluten intolerances/ food allergies (limitation for standardisation of meals)
* Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
* Known drug and/or alcohol abuse
* Using any form of nicotine or tobacco
* Mental incapacity that precludes adequate understanding or cooperation
* Participation in another investigational study or blood donation within 3 months prior to or during this study
Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance

The purpose of this study is to determine whether a noninvasive method of measuring certain aspects of blood circulation (e.g., blood pressure, cardiac output) is an accurate and reliable method to detect changes in pregnant patients. Specifically,the investigators are interested in patients diagnosed with high blood pressure during their pregnancy, as compared with normal pregnant patients. A noninvasive, accurate method of taking these measurements in pregnant patients is not currently available.

During pregnancy, many aspects of blood circulation, such as blood pressure, heart rate, cardiac output, and stroke volume, adapt to accommodate the increasing needs of a pregnant body. The circulatory system works harder to provide blood flow to the placenta and the growing fetus.

Currently, the devices that can give physicians detailed information on the status of the blood circulation of normal patients and those with high blood pressure during pregnancy are invasive to varying degrees. However, recently, a new noninvasive hemodynamic monitor (NonInvasive Cardiac Output Monitoring: NICOM) was introduced to the market. In studies with non-pregnant patients, the NICOM has been found to be accurate, precise and reliable. However, it has yet to be studied in the field of Obstetrics.

The purpose of this study is to find out if the NICOM is an effective tool for monitoring hemodynamic changes in pregnant women, both with normal and high blood pressure. We are planning to compare the hemodynamic profiles of normal pregnant patients, hypertensive pregnant patients, and non pregnant patients as a control group. If this monitor proves to be reliable in assessing these changes in the pregnant patients, this could have a great impact in optimizing the care of the patients with different medical conditions in pregnancy, such as increased blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* PIH diagnosed in 3rd trimester, not yet treated
* healthy pregnant patients in 3rd trimester
* healthy non-pregnant women

Exclusion Criteria:

* under age 18 or above age 40
* refusal to participate
Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

Investigators will compared the clinical outcomes between superior capulotomy and inferior capsulotomy in bipolar hemiarthropalsty using posterior approach.

primary clinical outcome will be dislocation within 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* more than 50 years old
* displaced femoral neck fractgure

Exclusion Criteria:

* less than 50 years old
Study of Low-grade Systemic Inflammation in Adult Patients With Phenylketonuria

Patient suffering from phenylketonuria have chronic hyperphenylalaninemia. Hyperphenylalaninemia is known to be toxic to central nervous system and cardiovascular system in particular through oxydative stress.

In this context, research of low grade systemic inflammation through cytokine assay appears legitimate.

The primary outcome of this study is to describe inflammation profile of patients with phenylketonuria.

Phenylketonuria (PKU) is a metabolic hereditary disease due to lack of activity of phenylalanine hydroxylase. This lack of activity whom origin is genetic, results in chronic hyperphenylalaninemia, toxic to central nervous system and cardiovascular system. Without treatment, PKU is responsible for mental retardation in children.

PKU is subject to systematic screening at birth and if diagnosis is confirmed a specific diet controlled in phenylalanine is prescribed for infant. This diet allows a neurodevelopment as closed as healthy infant. Despite this diet, neurological and systemic complications are more often reported at adult age. It is therefore recommended to follow patient regularly in order to search for those complications.

In a PKU murine model, it has been shown (cf references) that a low grade systematic inflammation exists and was reversible after dietetic treatment using glycomacropeptide (through a probiotic effect of this protein naturally phenylalanine free). Existence of this low grade systematic inflammation, evaluated by plasmatic cytokine screening (TNF alpha IL2, IL6, IL10, IFNgamma, IL1Alpha, IL1Beta and protein C reactive) has not been proven in humans to date.

Primary outcome of this study is to characterize this low grade systemic inflammation profile in patient with PKU.

Eligibility Criteria:
Inclusion Criteria (patient with PKU)

* Age \>/= 18 years old
* Phenylketonuria diagnosis
* Fasting condition
* Registered with a social security system
* Patient consent

Inclusion Criteria (healthy volunteer)

* Age \>/= 18 years old
* No metabolic condition
* Fasting condition
* Paired to patient with phenylketonuria already included according to age, sex and BMI class
* Registered with a social security system
* Volunteer consent

Exclusion Criteria, common to healthy volunteer and patient with phenylketonuria

* Pregnant and lactating women
* Subject to legal protection measures.
* Chronic or acute inflammatory disease
* Fever on inclusion
* Undergoing anti inflammatory treatment
* Surgery in the previous months
* Diabetes
* Included in other therapeutic trial