cyrilzakka/clinical-trials huggingface dataset:
Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

RATIONALE: A stress-management program may improve quality of life and reduce anxiety and depression in patients receiving chemotherapy for cancer.

PURPOSE: This randomized clinical trial is studying how well stress management therapy works in patients receiving chemotherapy for cancer.

OBJECTIVES:

Primary

* Determine if a self-administered stress management intervention is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in Hispanic and non-Hispanic patients receiving cancer chemotherapy.

Secondary

* Determine if the degree of acculturation in Hispanics influences the observed helpfulness of the intervention.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, use of psychotropic drugs (yes vs no), and ethnicity (Hispanic vs non-Hispanic). Patients are randomized to 1 of 2 arms.

* Arm I (self-administered stress management training plus usual psychosocial care): Patients receive a video DVD, audio CD, and brochure that provides information and instruction in 3 stress management training techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills training) to use during chemotherapy. Patients also receive usual psychosocial care.
* Arm II (usual psychosocial care only): Patients receive usual psychosocial care.

Patients complete questionnaires to assess mood, quality of life, and other factors at baseline and before chemotherapy courses 2, 3, and 4.

PROJECTED ACCRUAL: A total of 442 patients will be accrued for this study.

Eligibility Criteria:
INCLUSION CRITERIA:

* At least 18 years of age
* Newly diagnosed with cancer
* Scheduled to receive a minimum of 4 cycles of intravenous chemotherapy
* Able and willing to give informed consent to participate

EXCLUSION CRITERIA:

* Had intravenous chemotherapy prior to study entry
* Are scheduled to receive radiotherapy prior to the end of the fourth cycle
* Have severe depression or other severe psychiatric disorders
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.


Eligibility Criteria:
Main Inclusion Criteria:

* Subject must provide written informed consent
* The target reference vessel diameter (RVD) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online QCA.
* Target lesion length is ≤ 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent
* Single de novo lesion with ≥ 50% and \< 100% stenosis in up to 2 coronary arteries

Main Exclusion Criteria:

* Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
* Planned intervention of non-target vessel(s) within 30 days after the index procedure
* Planned intervention of target vessel(s) after the index procedure
* Target lesion is located in the left main
* Target lesion is located in or supplied by an arterial or venous bypass graft
* Target lesion involves a side branch \> 2.0 mm in diameter by visual estimate or by online QCA
* Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off
Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.

The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients over 16 years of age with complicated urinary infection produced by bacteria that are suspected to be susceptible to treatment with Piperacillin-tazobactam.

Exclusion Criteria:

* Patients known, or thought to be hypersensitivity to beta-lactams
* Patients with an uncomplicated urinary tract infection
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers

This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):

The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an adult male or female subject aged 18 years or older. Females of childbearing potential must have a negative pregnancy test before beginning the study.
* Subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in Group A) as determined by medical history, physical examination, 12-lead ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis \[if able to pass urine\]), and serology results (hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with positive results for hepatitis C virus but who have normal liver enzymes will not be excluded. Any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded.
* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

* Subject is on maintenance hemodialysis.
* Subject has a BMI of \>37 kg/m2.
COgnitioN With VERiciGuat Evaluation in Heart Failure

CONVERGE-HF is a 4-center pilot phase IIb randomized control trial in ambulatory patients with chronic heart failure (≥ 6 months) and mild-to-moderate cognitive impairment.

CONVERGE-HF is a randomized, open label, phase IIb trial evaluating the effect of sGC stimulator, Vericiguat versus standard of care on imaging markers and blood markers of cerebral and coronary small vessel diseases, function status, cognitive status, quality of life and clinical events in patients with heart failure and mild-to-moderate cognitive impairment. Patients will be randomized and allocated to either vericiguat or standard of care, for 26 weeks including the greater than 4 weeks timeframe for the uptitrations to the target dose.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. Established chronic heart failure (≥ 6 months)
3. Mild-to-moderate cognitive impairment (as per the diagnosis of cognitive impairment or a Montreal Cognitive Assessment (MoCA) score 10-25).

Exclusion Criteria:

1. Patients who have contraindications for sGC stimulator and vericiguat therapy (i.e. use of long-acting nitrates, other soluble guanylate cyclase stimulators (e.g., riociguat), or phosphodiesterase type 5 (PDE-5), pregnancy or breast-feeding)
2. Unable to undergo CMR imaging or brain MRI.
3. CMR exclusions: renal failure \[a glomerular filtration rate \&lt;30 mL/min)\], incompatible implantable cardiac device (ICD or CRT), uncontrolled atrial fibrillation or recurrent ventricular arrhythmias).
4. General medical conditions: uncontrolled thyroid disorders, hepatic failure, or myocardial revascularization procedures \[coronary angioplasty and/or surgical revascularization in the previous 3 months\], cancer/malignancy, or with severe dementia).
5. Patients with allergies to the study products.
6. Patients currently hospitalized.
Use of a Selected Mixture of Probiotic Strains for Degrading Gluten During Digestion

Gluten intake spreads worldwide, being the major food protein consumed in the Western diets (up to 20 g gluten/d). But gluten has unique and unusual features. It resists the complete luminal digestion by gastric, pancreatic and intestinal brush border enzymes, and is susceptible to post-translational modification (deamidation) by mucosal transglutaminases. Apart from partial digestion, gluten per se has a negative impact on a consistent part of the worldwide population, which mainly results in the manifestations of celiac disease (CD) or other gluten-related disorders. This study will enable to test in vivo a novel multi-species probiotic that in vitro has proven to degrade gluten to non-immunotoxic peptides.

Hypothesis and Significance:

The project intends to confirm whether the novel multi-species probiotic preparation has the ability to degrade gluten upon digestion at increasing dosages (from 50mg/d up to 10g/d). Further we aim to evaluate the efficiency of the probiotic to persist and colonize the human gut as well as its ability to modulate the human gut microbiome.

Since this is a phase 1 trial, healthy participants will be recruited to avoid any triggers of CD symptoms. Participants will undergo gluten free diet for 10 days to eliminate any traces of gluten from their feces and will be provided probiotic/placebo capsules as long as specific amounts of gluten to be ingested with their meal. Faecal samples will be collected at the end of each period that increasing gluten amounts were ingested. Residual gluten amounts in feces will be evaluated and the fecal microbiome will be studied by 16S metabarcoding analysis. Fecal metabolome will be also assessed as long as the persistence and colonisation ability of the probiotic preparation by qPCR.

Specific Aim 1:

Evaluate the gluten depredating efficiency of the probiotic by ELISA

Specific Aim 2:

Investigate the gut microbiome alterations between the intervention groups and possible modulation

Specific Aim 2:

Investigate the fecal metabolome (Volatiles and short chain fatty acids) between intervention groups

Specific Aim 2:

Monitor the persistence and colonization ability of the probiotic preparation by qPCR

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals;
* adherent to Mediterranean diet

Exclusion Criteria:

* known medical disease;
* known digestive disease symptoms;
* known family history of celiac disease (CD);
* wheat allergy;
* and use of prescription medications (including antibiotics or probiotics in the previous 2 months)
Cervical Changes by 4h of Hyper-buoyancy Flotation and Followed by 15 Mins 1g Re-loading

Study with the aim to see the effect on a space ground anaologue, Hyperbuoyancy Floatation (HBF) on cervical column.

the aim of the study is to determine the effect of 4h HBF and subsequent passive 1g axial loading upon stature, cervical IVD height) cervical muscle (Longus Collis and Semispinalis Cervicis) thickness and CSA assessed with ultrasound, cervical vertebral compliance, their relationships to induced stature increments and neck pain.

Eligibility Criteria:
Inclusion Criteria:

* physical requirements (1.57-1.90m, 50-95kg)

Exclusion Criteria:

* current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant
Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

The aim of this study is to provide conclusive clinical evidence as to whether or not the preoperative administration of oral carbohydrate-rich solutions is effective on the outcomes of patients undergoing colorectal surgery.

Preoperative oral carbohydrate loading is an issue that has been investigated extensively in terms of its fundamental and biochemically apparent effects and potential benefits. Most commonly, proponents of the application advocate that it may be beneficial for improving patient outcomes and for decreasing complication rate by attenuating postoperative insulin resistance. To date, however, no study with a sufficient sample size has been able to demonstrate that it has a marked value in clinical practice. Almost all of the clinical benefits ascribed to the application have been based on subjective well-being, which can also be provided with non specific simple beverages. A study conducted to show whether or not the application has direct influence on patient outcome, therefore, could significantly contribute insights on this topic. The present study was planned to consist of three study arms, namely: 1.Study group, which will be given high-carbohydrate beverage (Nutricia preOp®, Numico, Zoetermeer, The Netherlands) 2. Placebo group, which will be given flavored water, and 3. Control group (surgery after overnight fast). The revised power analysis shows that an accrual of 74 patients in each group would allow detecting a 15% difference in the rate of complications with 80% power at the 5% level of significance (two tailed). We hope we will have recruited at least 220 subjects at the end of a two-year course. Once the data recording is complete, this study will be the largest one ever conducted to investigate this topic.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing colorectal surgery for malignant or benign diseases

Exclusion Criteria:

* diabetes
* disorders that prolongs gastric emptying
* existence of an increased risk for aspiration of gastric content
* anal surgery (haemorrhoidectomy, fistulotomy...etc)
* emergency operations
Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing In Vitro Fertilization Cycles

Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules is higher than in serum and it was increasing during the movement through the epididymis and the deferent duct. In the present study, the role of myo-inositol has been investigated as a possible antioxidant agent for the systemic treatment of male infertility and the improvement of the sperm's quality.

Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle: healthy subjects and subjects with oligoasthenospermia (OA, \< 15 mil/ml). The collected samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's number and motility, during the initial semen analysis and after density gradient separation method; these parameters were evaluated before and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid for three months.

These values were compared with samples of seminal fluid of healthy patients undergoing to a IVF cycle for a female cause of infertility (control group).


Eligibility Criteria:
Inclusion Criteria:

* 3-5 days of sexual abstinence

Exclusion Criteria:

* systemic and endocrine diseases
* genital infections
* history of cryptorchidism or varicocele
* microorchidism
* hormonal treatment in the last six months
* alcohol intake, cigarette smoke and/or drug abuse
Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients

Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 35 kg/m\^2

Exclusion Criteria:

* Heart function abnormalities (arrhythmia, AV block, using pacemaker, severe aorta stenosis)
* Morbid obesity
* Bradycardia (\< 50 bpm)
* Tachycardia (\> 110 bpm)
* refuse to participate
Topical Lidocaine Patch in Low Back Pain

Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.


Eligibility Criteria:
Inclusion Criteria:

* Non-radicular LBP pain for

  ≤12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg)
* Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms
* Had an average daily pain intensity score of \>4 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) within 24 hours prior to the screening visit.
* Had a normal neurological examination, including:

  * Motor strength
  * Sensory testing (light touch, pinprick, and vibration)
  * Deep tendon reflexes

Patients were eligible for participation in the long-term chronic (\>12 months) group of the study if they also:

* Had LBP for greater than one year. Patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy

Exclusion Criteria:

* Had a history of greater than one back surgery or one back surgery within 3 months of study entry
* Had severe spinal stenosis and radicular symptoms
* Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief
* Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
* Had received trigger point injections within 2 weeks prior to study entry
* Had received Botox Injections within 3 months prior to study entry
* Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
* Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Patients were excluded from participation in the long-term chronic (\>12 months) group if they also:

* Had an undefined spinal diagnosis
* Had a history of lumbar spine surgery within 6 months prior to study entry
Liquid Biopsy of Head and Neck Cancer Patients in Blood and Saliva

Prospective study for therapy monitoring of locally advanced and metastatic head and neck cancer patients by detection of circulating tumor nucleic acids in peripheral blood and saliva

Clinical examination including imaging and - if necessary - tissue biopsy sampling - is the current clinical standard in therapy monitoring of metastatic head and neck tumors. This includes both the initial diagnosis, the assessment of the therapeutic response during ongoing chemotherapy / radiochemotherapy and follow-up care with the aim of detecting recurrences at an early stage. The detection of circulating nucleic acids as well as proteins in the peripheral blood and saliva could represent a minimally invasive and exact method for the assessment of the tumor burden, for the early detection of recurrences and for the individual assessment of the therapy response in patients with head and neck cancer. The present study aims to evaluate the value of tumor-specific nucleic acids and proteins in peripheral blood and saliva as possible biomarkers for minimally invasive therapy monitoring of head and neck tumors. For this purpose, Next Generation Sequencing (NGS), ELISA and quantitative polymerase chain reaction (PCR) methods are used as diagnostic methods. NGS initially enables the creation of a genetic profile of the primary tumor with targeted massive parallel sequencing of frequently mutated genes in head and neck tumors. The amount of nucleic acids in the peripheral blood and saliva is then quantified by means of digital PCR with the aid of specifically designed digital PCR assays. In addition, tumor-associated nucleic acids and proteins in the primary tumor, blood and saliva are examined. The aim is to examine if the amount of tumor specific circulating nucleic acids and the concentration of protein biomarkers found in the blood and saliva are associated with the response to treatment, early detection of recurrence, and the overall prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck squamous cell carcinoma (HNSCC)
* Written informed consent

Exclusion Criteria:

* Neoplasms other than HNSCC
Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

A phase III, prospective, within patient controlled, multi-center study to compare Blue light cystoscopy with Hexvix and standard White light cystoscopy in the detection of bladder cancer, to evaluate the efficacy and safety of Hexvix Blue light cystoscopy in Chinese population.

Patients with suspicious or confirmed bladder cancer will participate in the trial and undergo Blue light cystoscopy with Hexvix in addition to the standard White light cystoscopy. Specific clinical questions will be asked:

* What is the proportion of patients who have at least one specific kind of tumor found by Blue light cystoscopy with Hexvix but not by White light cystoscopy?
* What is the proportion of patients who have at least one specific kind of lesion found by Blue light cystoscopy with Hexvix but not by White light cystoscopy?
* What is the proportion of false positive lesions detected with Hexvix Blue light cystoscopy and White light cystoscopy?
* What is the proportion of patients with Adverse Events (AE) during the study?

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in clinical study; thoroughly informed, signed and dated the informed consent form; willing to follow and have the ability to complete all trial procedures.
2. Suspicious or confirmed patients with bladder cancer.
3. Age 18 or older.

Exclusion Criteria:

1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the possible interference with cystoscopy).
2. Patients who have received BCG immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure.
3. Porphyria.
4. Known allergy to hexaminolevulinate hydrochloride or a similar compound.
5. Pregnancy or breast-feeding or women who plan to become pregnant during the trial, and men or women who are unwilling to take barrier contraceptives from 2 weeks before application of investigational medication to 28 days after application of investigational medication (Note: All women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study.
6. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
7. Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
8. Patients that the investigator assessed unsuitable to the study.
9. Subjects with contraindications to white light cystoscopy.
Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry)

The objective of this study is to evaluate effectiveness and safety of drug-eluting stent implantation in the "real world" daily practice.


Eligibility Criteria:
Inclusion Criteria:

* coronary disease amenable to percutaneous coronary intervention (PCI)
* no clinical and lesion limitations

Exclusion Criteria:

* patients with a mixture of several drug eluting stents
* terminal illness with life expectancy less than 1 year
* patients with cardiogenic shock