cyrilzakka/clinical-trials huggingface dataset:
Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.

PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.

OBJECTIVES:

* Determine the ability of Sonablate to focus ultrasonic waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with organ-confined prostate cancer.

OUTLINE: This is a multicenter study.

A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2-3 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken at least 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU.

Patients are followed at 2, 14, 30, 90, and 180 days.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed organ-confined prostate cancer (clinical stage T1 or T2 only)
* Pretreatment prostate weight less than 40 g
* Gleason score no greater than 7
* PSA no greater than 10 ng/mL
* No significant intravesical median lobe (greater than 2 cm) on ultrasound
* Able to visualize prostate gland adequately on transrectal ultrasound imaging
* No prostate calcification greater than 5 mm
* No metastases by bone scan

PATIENT CHARACTERISTICS:

Age:

* 40 to 80

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* No bleeding disorder as determined by abnormal PT and PTT

Renal:

* No active urinary tract infection
* No history of urinary bladder neck contracture

Other:

* No prior allergy to latex
* No Anesthesia Surgical Assignment category IV or greater
* No interest in future fertility
* No history of inflammatory bowel disease
* No other concurrent major debilitating illness
* No other prior or concurrent malignancy except skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior biologic therapy for prostate cancer

Chemotherapy:

* No prior chemotherapy for prostate cancer

Endocrine therapy:

* At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer

Radiotherapy:

* No prior radiotherapy for prostate cancer

Surgery:

* No prior transurethral resection of prostate
* No prior urethral stent
* No prior major rectal surgery

Other:

* No prior cryotherapy for prostate cancer
* No prior thermotherapy
* No other prior therapy for prostate cancer
* No concurrent warfarin or other anticoagulant
Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

This study will assess the efficacy and safety of different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 70 years.
* Clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last two years.
* Adequate exposure to mountain cedar pollen.
* Positive skin prick test to mountain cedar allergen within 12 months of screening.
* Sufficient nasal symptom score during a run-in period.

Exclusion Criteria:

* Non-allergic rhinitis.
* Bacterial or viral respiratory tract infection.
* Chronic respiratory disorders.
* Asthma requiring treatment other than inhaled short-acting Beta2-agonists.
* Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus surgery or perforation.
* Smoking within the last year.
* Ongoing or recent treatment for seasonal allergic rhinitis.
* Initiation of allergen immunotherapy within 6 months of screening.
Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets

Open-vent jet nebulizers are frequently used to promote drug lung deposition but their clinical efficacy and indications are not clear.

Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a 110 ml corrugated piece of tubing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers between 18 and 60 years old

Exclusion Criteria:

* Smokers
* Pathological spirometry
* History of treatment with aminoglygosides 1 month prior the study
* Known allergy to aminoglycosydes
* Any lung pathology or history of lung surgery
Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2

The FreeStyle Libre 2 system is a Flash glucose monitoring system that, after a scan, provides information on interstitial glucose for the last 8 hours in the form of a reading every 15 min. The system is approved for non-adjuvant use for therapeutic decision-making. The acceptability and effectiveness of the FSL is well documented in patients with type 1 and 2 diabetes mellitus (DM2). Most of the studies in patients with DM2 have been developed in patients with insulin treatment, either basal or with multiple doses.

For all these reasons, we proposed an exploratory study to evaluate satisfaction with treatment (main variable) in people with DM2 who start glucose monitoring in the Endocrinology Day Hospital context compared to patients who use capillary blood glucose monitoring. These are patients treated in a context of debut/acute decompensation/intercurrent pathology, who will not necessarily be using insulin treatment. The aim is to know if the use of FSL2 provides benefits of user satisfaction with the treatment, assessed with the Diabetes Treatment Satisfaction Questionnaire at the end of follow-up (mean score of all items); in this context.

When the doctor determines that the patient who has attended the Endocrinology and Nutrition Day Hospital needs to start glucose monitoring and goes to the nursing office, if he meets the inclusion criteria, he will be asked to participate in the study. After signing the informed consent, the control group (MGC) or intervention group (FSL2) will be randomised. The necessary therapeutic education for glucose monitoring will be carried out in parallel with the other necessary aspects of Diabetes Therapeutic Education.

Follow-up visits in both groups will take place 24-48 hours after the first visit, a week, 2 weeks, and 1, 2, and 3 months after the first visit. During visits, frequently according to usual clinical practice, by the nurse and/or doctor, therapeutic decisions will be made based on the monitoring system assigned to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with DM2.

  . Who have reached 18 years of age.
* Who are candidates to start glucose monitoring according to the usual clinical practice of the Endocrine Day Hospital of the Hospital de Sant Pau.
* That they are not using any glucose monitoring tool. These may be patients with debut diabetes, worsening control with high HbA1c levels, or starting treatment with glucocorticoids. Patients may have any of these conditions, or similar ones, as long as they meet the other inclusion criteria and none of the exclusion criteria. Similarly, no specifications are made for drug treatment prior to or initiated at the recruitment visit.

Exclusion Criteria:

* Pregnant or expecting to be during the duration of the study.
* Assessed by the healthcare professional responsible for proposing the study to them as more harmful than beneficial their inclusion in it.
Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis in Pediatric Patients

The use of ultrasound is becoming widespread to guide the placement of arterial lines for both vascular access and regional anesthesia in the field of anesthesia. Arterial line placement can be challenging, especially in the pediatric population. Frequently multiple attempts are required with relatively high failure rates. This can result in excessive needle punctures and extended OR times. A few studies have looked at the use of ultrasound to decrease OR time and increase success rates both in adult and pediatric populations. These studies compared the traditional palpation method with either short axis or long axis views of the vessel using ultrasound guidance. No study to date has compared short axis and long axis views for arterial line placement in either the pediatric or adult population. Our study compares success rates and OR times when long and short axis methods of arterial line insertion are employed in the pediatric population.

An Arterial line is an intraoperative monitor that is frequently placed in the pediatric population. Due to their smaller anatomy and more compliant skin, arterial lines can be more difficult to insert in the pediatric population than in adults. Additionally, lower perfusion pressure and larger subcutaneous adipose tissue can make pulse palpation more difficult. Ultrasound is a modality that can directly image the radial, ulnar, or brachial artery. Along with 2D ultrasound, doppler ultrasound can be utilized to confirm that an artery is not a vein. Once the vessel is identified, the vessel can be viewed in either the long or short access. The ultrasound beam is only 1 millimeter thick so a practitioner must stabilize the probe to view the vessel, especially in the long axis view. Once the artery is viewed in long axis, the needle can be directly visualized all the way into the vessel. Visualization of a guidewire or catheter in the vessel can confirm proper arterial access. In a short access ultrasound view, it is possible to see tissue movement and sometimes a hyperechoic (bright) dot which represents the needle. Tissue movement can help confirm the needle is immediately above the artery at all times. The advantage of the short axis view is that less precision is needed to hold and position the transducer than with the long axis view. The disadvantage of the short axis view is that the operator cannot see the tip of the angiocatheter as it enters the vessel. As a result, the proximal portion of the angiocatheter can be above the artery but the distal tip could be to the side of the artery.

Eligibility Criteria:
Inclusion Criteria:

* The investigators will identify patients 0 to 14 years of age who are classified as ASA physical status ≤4 and scheduled to have surgery under general anesthesia

Exclusion Criteria:

* History of vasculitis, autoimmune disease, Reynauds phenomenon or disease
* History of no collateral perfusion
* The absence of an upper extremity artery to cannulate such as a bilateral amputee
* A child in DHS custody
* Infection at the site of insertion
* Patient refusal.
Interprofessional Education and Collaborative Practice Model for Dementia in Acute Care

The purpose of this study is to develop an interprofessional education and practice model for acute care related to dementia and evaluate its effectiveness of implementation.

The researchers will recruit participants from a medical center (experimental group) and two regional hospitals (control group) in southern Taiwan. Both the experimental group and the control group will contain 150 healthcare professionals and 64 patients with dementia. Both of the groups will receive a six-hour dementia care course. Then, only the experimental group will receive a half-day interprofessional education workshop, maintain a six-month interprofessional practice model, and join interprofessional practice experience-sharing conferences. The evaluation of outcomes will include the analyses of healthcare professionals' knowledge, attitudes, and self-efficacy of dementia care. The evaluation times are to be before and after the dementia care course and after the six months of interprofessional practice. The other evaluation of outcome is comparison of the outcomes of hospitalized patients with dementia between the two groups before the interprofessional education workshop and after the interprofessional practice.

Eligibility Criteria:
Inclusion Criteria:

* healthcare professionals having worked for 3 months or more
* emergency/hospitalized patients with dementia
* patients diagnosed dementia
* scoring 1 or more in Clinical Dementia Rating (CDR).

Exclusion Criteria:

* healthcare professionals working in obstetrics, pediatrics, outpatient, or hemodialysis.
Group Treatment for Insomnia in Primary Health Care

The aim of this study is to analyze if group treatment is effective to treat insomnia in primary healthcare.

Insomnia is a common health problem. Untreated insomnia may lead to decreased physical and mental health. The patients turns to Primary Health Care when daytime symptoms decrease social and occupational function. Previous studies have shown that cognitive and behavioral therapy have effects on insomnia and recommends as first line treatment but is not widely available in primary health care.

The purpose is to test the effect of group intervention in Primary Health Care for patients with insomnia. The outcomes is insomnia severity, sleep habits, use of hypnotics, Fatigue, general health and health related quality of life. Characters with insomnia visiting in Primary Health Care.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia symptoms regarding DSM-V
* Motivated to group treatment.

Exclusion Criteria:

* Insomnia Severity Index less than 7 points
* Presence of acute life crises, acute psychiatric illness, bipolar disorder
* Shift work
* Linguistic or cognitive difficulties causing inability participate in group or fill in forms
* Insomnia directly caused by medical illness. Other sleep disorder.
Comparison of Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated.There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB , as in the multimodal analgesia method. This study seeks to evaluate the effect of ESPB and combined DSAPB-SSAPB pain after VATS.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-30 kg/m2
* Patients undergoing elective video assiste thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* History of chronic analgesic or opioid therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Emergency surgery
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials

This study will follow men with metastatic castration resistant prostate cancer throughout their standard of care treatment for their disease to determine if the presence of different genes or proteins can predict which patients respond to the cancer treatment they receive. As tumors grow and begin to spread, they may release cells into patients' bloodstream. These cells are called "circulating tumor cells", or CTCs. CTCs can be used to look for differences in "biomarkers" (genes or proteins that may change based on how a person is or is not responding to treatment). The purpose of this research study is to learn whether scientists can use biomarkers from CTCs to predict which tumors will respond to certain hormonal therapies. Participants will have blood collected and provide an archival sample from a previous tumor biopsy. The researchers will compare biomarkers from participants who responded well to treatment to those who responded poorly in order to answer the research question.


Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for inclusion in this study only if all of the following criteria apply:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell/neuroendocrine tumors of the prostate are not permitted.
2. Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.
3. Prior documented disease progression on one potent AR inhibitor (darolutamide, abiraterone, enzalutamide, or apalutamide or combinations of these) in any disease setting (mHSPC, nmCRPC, mCRPC) based on sequential PSA rises or radiographic progression.
4. Planned therapy with either standard of care enzalutamide and/or abiraterone acetate or another potent AR inhibitor (darolutamide, apalutamide if available) within the coming 6 weeks
5. Castrate levels of testosterone (\<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy.
6. Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:

   1. Consecutive PSA rises at least 2 weeks apart
   2. Minimum PSA of 1.0 ng/dl prior to entry
7. Age \> 18 years.
8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. History of intercurrent or past medical or psychiatric illness including active stage IV malignancy that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
2. Unwillingness to be followed longitudinally for serial CTC biomarker studies.
3. Life expectancy \< 6 months
4. Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.
Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

Acute graft versus host disease is a frequent and often life threatening complication of allogeneic blood and marrow transplantation. The bacteria that normally reside in the intestine play a critical role in its development. Injury to the lining of the bowel that results from the high dose chemotherapy or radiation that transplant patients receive during the week preceding the transplant allows the bacteria to invade the intestines and spread to nearby lymph nodes. This, in turn, causes inflammation which has been shown to promote GVHD. Both pre-clinical and clinical research has demonstrated that oral antibiotics can prevent graft versus host disease by inhibiting these gut bacteria. Rifaximin has several features that suggest it could be effective in preventing GVHD. Rifaximin prophylaxis might also provide an added benefit by protecting highly immunocompromised transplant patients from severe bacterial infections. This pilot trial will allow the investigators to determine the feasibility of using Rifaximin for prevention of GVHD and infection in patients undergoing allogeneic blood and marrow transplantation. The preliminary results will be used to plan a more definitive trial.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be at least 12 years old.
2. Patients will be eligible regardless of their type of disease (malignant or non-malignant), type of donor (HLA matched related, mismatched related or unrelated donors), type of hematopoietic cell source (unstimulated marrow, cytokine stimulated marrow, cytokine stimulated peripheral blood or umbilical cord blood), or GVHD prophylaxis.
3. Patients must receive a myeloablative or moderately intensive reduced intensity (at least 8 mg/kg oral busulfan (or the equivalent IV dose), or at least 100 mg/m2 of Melphalan , or at least 100 mg/kg of cyclophosphamide, or at least 500 cGy of TBI) conditioning regimen.

Exclusion Criteria:

1. Age under 12 years.
2. Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.
3. Minimally toxic conditioning regimen (e.g. low dose TBI based). Since these regimens induce minimal myelosuppression and gut injury, patients receiving them probably stand little to gain from antibiotic prophylaxis.
4. Patients with documented severe active infection (viral, bacterial, fungal, protozoal) will not be eligible.
5. Patients with treatment unresponsive hematologic malignant diseases (based on an assessment done within two weeks of the start of conditioning therapy).
A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers

This study will evaluate the potential for a drug-drug interaction of Dimebon with ketoconazole and omeprazole, potent inhibitors of the drug metabolizing enzymes CYP3A4 and CYP2C19, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects must have either a CYP2D6 EM (n=12) or PM (n=12) status based on genotyping at screening.
* Subjects must have a CYP2C19 EM status based on status at screening.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Subjects with any history of a previous seizure or convulsion or significant head trauma.
* Subjects specifically allergic to imidazole antifungal agents.
* Subjects specifically allergic to omeprazole or other proton pump inhibitors.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Subjects with hypersensitivity reactions to Dimebon or other antihistamines.
* Consumption of grapefruit or grapefruit containing products within 7 days prior to the first dose of study medication.
* Subjects currently taking omeprazole, other proton pump inhibitors, antacids, H2-blockers or CYP2C19 inhibitors.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.