cyrilzakka/clinical-trials huggingface dataset:
Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

To determine the effects of policosanol on the cholesterol profile.

The primary objectives of this study are to determine the changes in the lipid profile \[LDL-C, HDL-C, triglycerides, total cholesterol\] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.

Eligibility Criteria:
Inclusion Criteria:

* LDL \> 100
* Male or Non-Pregnant Female. Women must be surgically sterile or postmenopausal and not using hormone replacement therapy (HRT) or using a stable, consistent HRT dose with intentions to continue therapy throughout the course of the study
* Mentally competent to understand study rationale and protocol
* Speak and read English
* Currently receiving low to moderate dose statin therapy with plans to continue to the same dose for at least 8 weeks. Low to moderate dose statins include the following daily doses: atorvastatin ≤20 mg, fluvastatin ≤40 mg, lovastatin ≤40 mg, pravastatin ≤40 mg, rosuvastatin ≤10 mg, simvastatin ≤ 40 mg

Exclusion Criteria:

* LDL \< 100
* Sensitivity to policosanol
* Currently taking a high-dose statin or other lipid-lowering agents (i.e. high-dose niacin formulations \[\>500mg/day\], bile-acid sequestrants, ezetimibe, fibrates and high-dose Omega-3 fish oils \[\>900mg of combined EPA/DHA daily\])
* Currently taking medications which have the potential to interact with policosanol (i.e. warfarin, high-dose aspirin)
* Active liver disease or ALT level 2.5 times the upper limit of normal
* Chronic disease involving hepatic, renal or coronary artery disease
* Currently experiencing "flu-like" symptoms
* Currently experiencing any form of acute physical injury
* Acute psychiatric disorders
* Immuno-compromised state
* Currently taking systemic steroidal drugs
* Currently pregnant or lactating
* Females of childbearing potential
* Dependence on alcohol or illicit drugs
* Participation in any other clinical trial within the last 30 days
* Displays s/s of acute systemic infection (oral temperature \>100°F, WBC\>12x10³/µL)
Investigation of Cervix Tumor Oxygenation and Microvasculature Using Magnetic Resonance Techniques

In cervix cancer tumor oxygen levels and fluid pressure in the tumor have been shown to be related to patient outcome. Analysis of the way tumors enhance after intravenous contrast injection using MRI and CT can be used to determine parameters that relate to tumor blood vessels. In this study we hope to determine if there is a relationship between the enhancement of cervix cancer on MRI and CT and tumor oxygen levels and interstitial fluid pressure. If such a relationship exists then it could help improve the care of patients wiht cervix cancer by allowing for more aggressive therapy of patients with cancer that have more ominous imaging characteristics

MRI is already used routinely in the radiation planning and staging of carcinoma of the cervix. Prognostic factors such as T-stage (local extent), tumor size and lymphadenopathy are routinely obtained from MRI, however some prognostic parameters can only be obtained invasively. Tumor oxygenation correlates with prognosis and response to treatment in patients undergoing radiotherapy for carcinoma of the cervix. Interstitial fluid pressure (IFP) has been shown to correlate with tumor oxygenation as well. Currently the only way to measure these parameters is by using an invasive technique which involves the placement of probes into the tumor and obtaining multiple measurements.

Recent studies have shown that a specific MRI pulse sequences may be able to measure the oxygenation in the microcirculation. A second way of assessing the tumor microvasculature and perfusion is based on the behavior of intravenous contrast agents routinely used in the MRI examination. Estimates of blood volume, and capillary permeability can be made by mathematically modeling the kinetics of an MRI contrast agent. Similar measurements can be performed with CT.

A total of 60 patients will be investigated. Additional images will be obtained from these patients after their routine MRI examination. One set of images is designed to measure a parameter that correlates with tumor oxygen levels. The second set of images will be obtained after the injection of intravenous contrast agent. Using mathematical models a number of parameters will be extracted and correlated with IFP and tumor oxygen measurements.

Eligibility Criteria:
Inclusion Criteria:

* Cervix cancer intended for radiation therapy

Exclusion Criteria:

* Contraindication to contrast enhanced MRI and CT
* Prior therapy for cervix cancer
* Prior pelvic radiation
Quantification of Side Effects During Hepatitis C Therapy

This study aims to assess the frequency and severity of adverse events during Hepatitis C therapy with or without first generation protease inhibitors.

Hepatitis C Virus infection is one of the main causes of chronic liver disease worldwide with current estimates of approximately 130 - 210 million individuals (according to 3% of the world population) chronically infected with the hepatitis C virus. However, hepatitis C virus infections are among the most common causes leading to chronic hepatitis, liver cirrhosis and liver related death worldwide.

The current standard of care is a combination of pegylated Interferon and Ribavirin (dual-therapy). Since 2011, direct-acting antiviral drugs inhibiting viral protease are approved as an addition to the standard therapy (triple-therapy).

The occurrence of adverse events as well as their severity generally depends on the therapy regimen and is influenced by type and dosage of medications.

Most common adverse events (affects up to 95% of patients) are fever, fatigue, headache, nausea, arthralgia, depression, skin reactions, neutropenia, and anemia.

A more frequent occurrence of adverse events with triple-therapy compared to dual- therapy has become clear since it's introduction, particularly with regard to anemia, neutropenia, gastrointestinal discomfort, fatigue, dysgeusia, and skin reactions. How- ever, there is accumulating evidence for a more often appearance of infections and/or infestations in patients receiving triple-therapy.

The medical consequence from adverse events is a reduction of quality of life and consecutively the loss of antiviral therapy adherence. Thus, early recognition and immediate treatment of adverse events are crucial aspects in the success of antiviral treatment.

Aim of this study is to quantify reported adverse events with respect to therapy reg- imen (dual-therapy vs. triple-therapy) in patients who are treated at the Department of Internal Medicine, Division of Gastroenterology and Hepatology at the Medical University Graz. Furthermore, a detailed review of international treatment recommendations, as well as an analysis of possible predictor parameters for the appearance of adverse events and treatment success is done.

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis C
* Indication for a hepatitis C therapy

Exclusion Criteria:

* none
Alcohol-ROC-Training

The goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.The two active conditions of ROC-T are based on cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT).

This is a Stage 1B Randomized-Controlled Trial (RCT). 177 heavy drinking young adult participants will be randomized to 4 x 45-minute web-based sessions of (1) CBT-ROC-T training, (2) MBT-ROC-T, or (3) CONTROL (no strategy) delivered over three weeks. Participants will be enrolled for 16 weeks (three weeks pre-, three weeks during, and ten weeks post-intervention).

Eligibility Criteria:
Inclusion Criteria:

(1) Young adults ages 18-26 years, who (2) report ≥ 3 heavy drinking days (i.e., heavy drinking defined by \>3 drinks for women, \>4 drinks for men) in the prior month; (3) are motivated to quit or reduce drinking; (4) are fluent in English and have a 6th grade or higher reading level; (5) have access to a computer with working internet; (6) use a working smartphone; (7) can commit to the full length of the protocol; and (8) are willing to be randomized to intervention condition.

Exclusion Criteria:

(1) Current (past 12 months) clinically-severe alcohol use disorder (AUD; e.g., history of seizures, delirium, or hallucinations during withdrawal) or current severe alcohol withdrawal; (2) Current (past 12 months) clinically-severe substance use disorder (except tobacco) or current severe drug withdrawal; (3) serious other psychiatric illness by history or examination; (4) severe or unstable physical disease within the past 6 months; (5) psychoactive medications (e.g., mood stabilizers) that have not been at a stable dose unless determined to be on a stable dose of medication by the study psychiatrist; (6) current use of any investigational medication; (7) color blindness; (8) biological females who are pregnant; and (9) notable dislike to any particular type of alcoholic beverage depicted in study stimuli; (10) Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized; (11) Participants who cannot understand or follow study-related instructions (e.g., unable to correctly use the intervention strategies, indicate lack of understanding of study instructions despite multiple attempts).
Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)

To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 21 and 65 years
* Patient is able to read and understand and complete study questionnaires
* Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period

Exclusion Criteria:

* Patient has a history of significant psychiatric disorder (such as major depression, bipolar disorder, bulimia, or anorexia nervosa
* Patient is HIV positive as determined by medical history
* Patient has undergone surgical treatment for obesity
* Patient plans to consume more than two 8 ounce glasses of grapefruit juice per day during the study
* Patient participated in another clinical study involving an investigational drug) within 3 months prior to Visit 1
* Patient is currently a heavy consumer of alcohol (\>2 drinks per day or \>14 drinks per week \[1 drink is defined as 2 oz hard alcohol, 5 oz wine, 12 oz beer\], or uses (including recreational use) any illicit drugs, or has a history of drug or alcohol abuse
The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

This is a prospective single center pilot randomized controlled study to assess the efficacy and safety of YiQiFuMai injection (YQFM), a widely used Chinese medicine, as an adjunctive treatment for sepsis.

Sepsis is a major clinical challenge with high mortality and morbidity worldwide. Sepsis is characterized by the dysregulated host response to an infection followed by organ dysfunction. Early sepsis mortality has diminished with advances in intensive care management and goal-directed interventions, only to surge after "recovery" from acute events, which prompts a search for sepsis-induced alterations in immune function. When suffered from sepsis, patients may have evidence of hyper-inflammation and immunosuppression. There are no high-quality evidence examining the effect of intravenous (IV) immunoglobulins or other immune modulators on the outcomes of patients with sepsis or septic shock. YiQiFuMai Injection (YQFM) is a redeveloped preparation based on the traditional Chinese medicine formula Sheng-Mai-San, which is widely used in clinical practice in China, mainly for the microcirculatory disturbance-related diseases. YQFM is proved to be effective for treating sepsis (unpublished data). And several researches reveal that YQFM attenuates acute respiratory distress syndrome and lipopolysaccharide-induced microvascular disturbance in vitro.

The purpose of this study is to explore the adjunctive treatment effect of YQFM to prognosis, immune dysfunction and organ dysfunction of sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis defined by Sepsis-3 definition
* Adult patients between the ages of 18 and 90.
* Informed consent is provided by patients or obtained by family member if patient is incapacitated.

Exclusion Criteria:

* Known severe allergic reaction to drugs including but not limited to YQFM.
* Pregnant patients or those who may be pregnant
* Patients with severe intracranial diseases (intracranial artery stenosis, intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, subjects after intracranial surgery)
* Patients with extremely severe brain injury, after cardiopulmonary resuscitation, advanced malignant tumor, combined with serious primary diseases such as liver, lung, kidney and hematopoietic system, and poor prognosis;
* Autoimmune diseases, immune deficiency diseases, continuous use of immunosuppressants within the last 6 months, or organ transplants;
* Major surgery or trauma within the last 2 weeks;
* Participated in other clinical trials or took similar drugs within 1 month;
* The investigator considered that the subjects had poor compliance or other clinical, social, or family factors that were inappropriate for inclusion in the study.
Observational Study of ALNA® (Tamsulosin) in Patients With Benign Prostatic Hyperplasia (BPH)

The objectives of this post marketing surveillance study were to document the comorbidity and comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign Prostatic Hyperplasia).


Eligibility Criteria:
Inclusion Criteria:

* Indication for the treatment with ALNA according to its summary of product characteristics (SPC)

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency cannot be included in the study
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (OS) has been observed.

Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility.

The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
* Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
* Prior therapy defined as 1 prior systemic therapy for advanced disease
* Documented disease progression during or following most first line therapy for advanced disease
* Adequate hematologic, hepatic, renal function

Exclusion Criteria:

* Epidermal growth factor receptor (EGFR) mutations
* Anaplastic lymphoma kinase (ALK) translocations
* Predominantly squamous, adenosquamous or unclear histologic type
* Active or untreated central nervous system (CNS) metastases
* Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
* Serious cardiac illness or medical conditions
* Pregnant or lactating women
* Uncontrolled intercurrent illness
RISCA : Prospective Study of Individuals at Risk for SCA1, SCA2, SCA3, SCA6, SCA7

The spinocerebellar ataxias (SCAs) are a clinically and genetically heterogeneous group of autosomal dominantly inherited progressive ataxia disorders. It is estimated that there are 30,000 individuals in the European Community that directly descend from individuals affected by a SCA disorder and thus carry a 50% risk of having inherited an SCA mutation. These at risk individuals provide a unique research opportunity to prospectively study the presymptomatic phase of SCA disorders and to identify the earliest and most sensitive clinical signs and biological markers that herald the onset of the illness. This information is of critical importance for the development of future therapeutic interventions aimed at postponing the clinical onset of ataxia.

We therefore propose to perform a prospective observational study of individuals at risk for the most common SCA disorders, SCA1, SCA2, SCA3 and SCA6 (RISCA). It is our aim to answer the following questions: (1) What is the incidence of disease manifestation in mutation carriers? (2) Which clinical signs precede the onset of manifest ataxia in SCA1, SCA2, SCA3 and SCA6? (3) What are the prevalence and incidence of preceding signs? (4) Are the prevalence and incidence of preceding signs affected by genotype, gender, age, estimated time until disease manifestation and repeat length? (5) Does the presence of certain preceding signs predict the manifestation of ataxia ? (6) Are there MRI alterations that precede the onset of ataxia? It is planned to enroll 480 study participants and to follow them at regular intervals over six years. At each visit, study participants are asked in a structured interview for a number of predefined clinical signs that potentially precede the onset of ataxia. In addition, the following self-assessment scales will be applied: Pittsburgh Sleep Quality Index (PSQI), Diagnostic Criteria for Restless Legs Syndrome, Patient´s Health Questionnaire (PHQ-9). All study participants will undergo a physical examination including the Scale for the Assessment and Rating of Ataxia (SARA). Study participants will further perform the SCA Functional Composite (SCA-FC) which is a comprehensive measure of functional capacity based on results in quantitative tests related to gait (8m timed walk), speech (PATA rate) and hand function (9 hole pegboard). In a subset of study participants, we will record eye movements and obtain volumetric MRIs. The study will also be used to collect and store blood and urine samples for proteomic and gene expression studies.

RISCA is conducted by the Ataxia Study Group (ASG). It relies on the network structure created by the EUROSCA project.


Eligibility Criteria:
Inclusion Criteria:

* individuals at risk for spinocerebellar ataxia type 1, type 2, type 3, type 6 and type 7 (SCA1, SCA2, SCA3, SCA6 and SCA7)
* age between 18 and 50 years old for SCA1, SCA2, SCA3 or SCA7
* age between 35 and 70 years old for SCA6
* no clinical sign of ataxia (SARA \< 3)

Exclusion Criteria:

* no writing consent
* no family members affected
* presence of clinical sign of ataxia (SARA \> 3)
The Role of Pentraxin 3 and Cathepsin B Levels in Preeclamptic Pregnancy

In this study, the investigator aim was to compare Cathepsin B and Pentraxin 3 levels measured from maternal serum of pregnant women diagnosed with preeclampsia in the second trimester, the effects of these levels on maternal/ fetal outcomes and the composite results of Cathepsin B and Pentraxin 3 levels alone or together and contribute to the literature in this area.

This prospective case-control study was conducted between 1 January 2022 and 31 December 2022 at Bursa Yuksek Ihtisas Training and Research Hospital. The study was conducted with pregnant women between ages of 18-45 who were diagnosed with preeclampsia in the second trimester. This study was conducted with total 156 pregnant women. participants were grouped according to the presence of preeclampsia; Group1: Patients diagnosed with preeclampsia between 20-28 weeks (study group) (n:78) , Group 2: Healthy pregnant women between 20-28 weeks without a diagnosis of preeclampsia ( control group) (n:78) . As soon as preeclampsia is diagnosed and before any treatment was started, maternal serum samples were collected in the Cathepsin B and Pentraxin 3 kit in amounts suitable for the study. The samples obtained were kept in biochemistry laboratory at -80 degrees until the study was conducted. After all samples were collected, Cathepsin B and Pentraxin 3 values were measured by ELISA method.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Pregnant women diagnosed with preeclampsia between 20-28 weeks of gestation
* Healthy pregnant women between 20-28 weeks of gestation who want to be involved in the study.

Exclusion Criteria:

* Multiple pregnancies
* Pregnant women who gave birth below 24 weeks of gestation
* Pregnant women diagnosed with other hypertensive diseases of pregnancy other than preeclampsia ( gestational hypertension, chronic hypertension, superimposed hypertension)
* Pregnant women with chromosomal or congenital anomalies in the fetus
* Women with a known infective or autoimmune disease before pregnancy
Effect of Vagus Nerve Stimulation on Chronic Stroke Patients

Stroke is still one of the top causes of death and adult-onset disability in the world.

Despite physiotherapy and rehabilitation, a sizable percentage of chronic stroke patients are permanently disabled. These neurological deficiencies include cognitive impairment, sensory impairment, loss of coordination, spasticity, dysphasia, dysphagia, visual field dysfunction, and weakness.

Exercises, neurophysiological and electrical stimulations, compensatory strategies, strengthening facilitation approaches programs, and programs are all used as general approach methods in the rehabilitation of stroke patients.

Transcutaneous stimulation of the vagus nerve offers non-invasive stimulation of the vagus nerve and is commonly carried out by stimulating the auricular vagus nerve in the ear or transcutaneous cervical branch vagus in the neck.

Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-80.
* Having been diagnosed with a stroke by a neurologist.
* Speech disorder after a cerebrovascular accident to be.
* To volunteer to participate in the study.

Exclusion Criteria:

* Being mentally affected (Mini-Mental Test Score \<24).
* Having other neurological diseases other than stroke.
* Concomitant symptoms that prevent individuals from participating in the study (Having undergone amputation surgery, having cardiac arrhythmias be etc.)