cyrilzakka/clinical-trials huggingface dataset:
Conservative Treatment of Postprostatectomy Incontinence

The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

The primary purpose of this project is to test the effectiveness, impact on quality of life, and durability of conservative therapies for persistent post-prostatectomy urinary incontinence in a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

The second purpose of the study is to examine and compare the cost-effectiveness of the 8-week, multi-component behavioral training program to the same program with the addition of biofeedback and pelvic floor electrical stimulation.

Prostate cancer is the most common internal cancer in men in the United States. The most common treatment for early disease is radical prostatectomy, the removal of the prostate gland. The two most common sequelae of prostatectomy are incontinence and erectile dysfunction. The incontinence improves and often resolves in the first year after prostatectomy, but surveys of patients show that 40% of men have incontinence severe enough to require pads 1 and 2 years after their surgery. There are currently no randomized, controlled studies of non-surgical treatments for persistent post-prostatectomy incontinence.

Eligibility Criteria:
Inclusion Criteria:

1. Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year.
2. One-week bladder diary with interpretable data and at least two incontinence episodes

Exclusion Criteria:

1. Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
2. Cardiac pacemaker or implanted cardiac defibrillator
3. Current use of anticholinergic agents for detrusor instability
4. Folstein's Mini-Mental State Exam score below 24 (impaired mental status)
5. One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents.
6. Poorly controlled diabetes, defined as (glycosylated hemoglobin \> 9 within last 3 months).
7. Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation.
8. Urodynamic evaluation: Post-void residual volume greater than 200 mL
Body Image and Physical Activity of Women with Breast Cancer

The goal of this self-initiated questionnaire-based follow-up clinical trial is to map the body image and physical activity of Hungarian women treated for breast cancer.

The main questions it aims to answer are:

1. How body image changes during different treatments among women treated for breast cancer?
2. How is physical activity among Hungarian women treated for breast cancer?

The aim of our research is to assess the changes in physical activity and body image of women with breast cancer and the impact of these changes on their quality of life using subjective measures, through cross-sectional research and validation of the Body Image After Breast Cancer questionnaire in Hungarian.

Eligibility Criteria:
Inclusion Criteria:

* Adult women diagnosis of breast carcinoma

Exclusion Criteria:

* neuromuscular diseases
* severe congenital musculoskeletal and other disorders
* other surgical procedures within 1 year
Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru

This protocol aims to implement, using a stepped wedge trial design, a population-level intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban area of Tumbes.

We hypothesize that participants aged 18 years and over from villages receiving a salt substitute will have lower blood pressure compared to control villages.

Several randomized clinical trials and meta-analysis have reported that reduction of sodium intake decreases blood pressure. Also, the increase of potassium ingestion in minimal doses has been found in systematic reviews to produce a small reduction in blood pressure levels.

The proposed intervention is a community-wide mass-strategy in which direct delivery of a salt substitute to households is accompanied by wide social marketing campaigns, both before and during the intervention period. With this experimental stepped wedge trial design, we will estimate the impact of a reduced-sodium salt substitution program on blood pressure at the population level.

We propose the following specific aims:

Specific Aim 1: To implement and assess the impact of an intervention using a salt substitute on blood pressure at the population level using a stepped wedge trial design.

Specific Aim 2: To determine costs and efficacy of this implementation strategy using cost-effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years and over from the randomly selected villages.
* Capable of understanding study procedures and providing informed consent.
* Full-time resident in the area.

Exclusion Criteria:

* Self-reported history of chronic kidney disease or heart disease.
* Refusal to participate.
Low Dose Statins, Ezetimibe and Nutraceuticals

It remains unknown if the association between moderate to low intensity statin therapy and ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin intolerant patients

The aim of this study will be to evaluate whether the association between statin and exetimibe vs statin + ezetimibe + nutraceuticals can lead to higher percentage of LDL target achievement

Eligibility Criteria:
Inclusion Criteria:

Patients with angiographically assessed diagnosis of coronary artery disease

Exclusion Criteria:

None
Study of Cellular Impairments Involved in Diabetic Complications

The purpose of this study is to examine if an early detectable dysfunction in a cellular component (mitochondria) may predict complications in diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus

Exclusion Criteria:

* Age below 18 yrs
* Psychiatric disease
* Other metabolic disease
Enhanced SexHealth Intervention to Improve Adolescent Outcomes

This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT.

In a randomized controlled trial at a pediatric emergency department, sexually active adolescents will receive the control (i.e., printed materials) or intervention (i.e., motivationally-guided facilitation) arm delivered by a health educator. The tablet-based, interactive intervention includes motivational techniques to promote risk reduction, condom skills training, and tailored service recommendations. The primary outcome is uptake of ≥1 service at the index visit (i.e., counseling, condoms, emergency contraception for immediate or future use, pregnancy/sexually transmitted infection (STI)/HIV testing, STI treatment, and clinic referral). We assess feasibility (i.e., intervention completion, recommendations discussed, and satisfaction). Participants report sexual risk and care-seeking behaviors at 2, 4, and 6 months. We compare uptake between arms using Fisher exact tests.

Eligibility Criteria:
Inclusion Criteria:

* Aged 14-19 years old
* Reside within 30 minutes travel time
* Report previous sexual activity

Exclusion Criteria:

* Subjects who are unable to provide consent (i.e., determined to be too ill by the ED team, have cognitive impairment due to chronic condition or acute medical concern)
* Subjects in police custody
* Subjects seeking care due to sexual assault or psychiatric emergency
* Subjects who do not speak English
* Subjects who are patients under the clinical care of a study investigator working in the ED
HFR Cartridge and Inflammation

A major limitation of standard hemodialysis is that it does not clear the plasma from interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular risk in end stage renal disease (ESRD). In the present study, we evaluated whether these compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge. We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240 minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session. The proinflammatory activity of UFin and UFout was determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8 healthy volunteers and cultured in vitro for 24 hr.


Eligibility Criteria:
Inclusion Criteria:

* HD patients undergoing three weekly haemodialysis \> 1 year

Exclusion Criteria:

* none
Physical Activity Promotion in the Brazilian Primary Health Care Using Community Health Workers Counseling

The aim of this study is to test a methodology of counseling on physical activity among Community Health Workers working within primary health care in Brazil.

This is an intervention study conducted with 176 people attended by two Primary Health Units in the city of São Paulo, Brazil. The intervention group received home visits of Community Health Workers trained on counseling on physical activity promotion. These workers received a course of 12 hours aimed to improve their knowledge and attitude about physical activity promotion. Evaluations will be done at the study baseline and 6 months after the beginning. The primary outcome is the population leisure-time and transport-related physical activity level.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* To be registered in the Brazilian public health system

Exclusion Criteria:

* Health problem or disease that would make the individual incapable of practice physical activity
* Cognitive problem or disease that would not allow the individual from answering the questionnaire alone
* To have plans to move house over the six-months subsequent period
* Being pregnant
Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)

Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. Medical therapy for PDA predominantly involves the administration of one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these therapies have been shown to be successful in mediating ductal closure in approximately 70% of treated infants.

However, the need for a second course of treatment for PDA closure remains quite common. The investigators hypothesize that, because of small differences between the two drugs, a greater percentage of infants who did not respond to a first course of therapy with indomethacin will respond to a second course with ibuprofen than to a repeat course of indomethacin.

As such, the investigators aim to compare secondary therapy with a repeat course of indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent after a first course of therapy with indomethacin.


Eligibility Criteria:
Inclusion Criteria:

* Inborn premature neonates (birth weight \[BW\] \<1500 grams) being treated in the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as still having a hemodynamically significant patent ductus arteriosus (hsPDA) after a first course of therapy with indomethacin, will be considered as potential candidates for study pending response to initial therapy and pending parental consent.

Exclusion Criteria:

* Any baby not considered viable
* Any baby with intraventricular hemorrhage (IVH) grade 3-4 of recent onset (within 3 days). \[If no head ultrasound has been performed within the last 3-4 days, one should be performed prior to onset of study.\]
* Any baby with dysmorphic features or congenital abnormalities
* Any baby with structural heart disease other than PDA
* Any baby with documented infection,
* Any baby with thrombocytopenia (\<50,000).
Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called \[Zr-89\]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.


Eligibility Criteria:
Inclusion Criteria:

1.18 to 65 years of age 2.Healthy volunteer OR

* Clinical diagnosis of Multiple Sclerosis (MS) OR
* Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR
* Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
5. Chronic infectious disease (e.g. HIV, HCV)
6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
7. Diagnosis of cancer, including leukemia
8. Blood or blood clotting disorder
9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
10. Positive urine pregnancy test day of procedure or a serum pregnancy test within 48 hours prior to the administration of Zirconium-89 Oxinate-4-labeled leukocytes
11. Currently enrolled in a clinical trial utilizing experimental therapies
12. Contraindication to gadolinium based contrast agents
IMPROVE Critical Care Study (Pilot)

The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management. The hypothesis is that responsiveness will improve a range of patient-based and economic outcomes, including the duration of mechanical ventilation and duration of coma in the ICU. The purpose of the pilot study is to gather information for designing a full study that might show the validity of the outcome hypothesis.


Eligibility Criteria:
Inclusion Criteria:

Patients mechanically ventilated via an endotracheal tube and receiving intravenous sedation with a hypnotic agent (midazolam or other benzodiazepine) or propofol by continuous infusion.

Exclusion Criteria:

* Primary intracerebral disorder (includes cardiac arrest with probable hypoxic brain injury; intrac-ranial haemorrhage; head injury causing reduced conscious level prior to intubation)
* Patient who is already awake at the time of enrolment defined as RASS ³ -1
* Age \<16 years
* Patient not expected to survive the next 24 hours
* Patient receiving long term ventilation prior to ICU admission
* Patient with a long term tracheostomy prior to ICU admission
* Patient transferred sedated and mechanically ventilated from another ICU unless recruitment is possible within 24 hours of first ICU admission
* Patient receiving continuous neuromuscular blocking agent at the time of screening for enrolment
* Previously enrolled in the trial during a separate ICU admission during this hospital stay
* Status epilepticus
* Confirmed meningitis or encephalitis at the time of screening for enrolment
* Chronic neurological disease interfering with normal neuromuscular function, e.g. motor neurone disease, Guillain-Barre syndrome or inherited neuromyopathies
Intravenous Ketamine and Postoperative Pain Following Cesarean Section.

The purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.

* No premedication will be given, and patients will be monitored by electrocardiogram, non-invasive arterial blood pressure, and pulse oximetry when they entered the operating room.
* 18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of lactate ringer over 20 min period.
* All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as well as the method of injection will be identical for all individuals; 10 mg (2 cc 0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting position.
* After administering bupivacaine, and prior to surgery the height of the sensory block will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion starting from T12 dermatome.
* Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will be allowed to begin. When systolic blood pressure decrease to \< 90 mmHg, or 30% of the pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.
* Patients will be asked to report any intraoperative pain using visual pain score(VPS)of 0(no pain) 10(worst pain).

Eligibility Criteria:
Inclusion Criteria:

* Eligible women ASA class 1 and 2, are at term (≥37 week gestation), Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.

Exclusion Criteria:

* • Body mass index ≥40 kg/m2,

  * Known allergy to any of the study medications,
  * Contraindication to the spinal anesthesia,
  * History of substance abuse,
  * History of hallucinations,
  * Chronic opioid therapy,
  * Chronic pain.
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema

This study is designed to investigate whether topical application of a cromolyn sodium solution is able to decrease the facial redness seen in patients with papulopustular rosacea. Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to have this effect. The study will enroll a total of 10 patients. 5 will randomly be assigned to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive the placebo solution. All participants will be instructed to apply their assigned solution twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks after the distribution of the solutions to measure the efficacy of their assigned solution.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or non-pregnant female, 18 - 80 years of age.
* Subjects willing and able to give informed consent.
* Subjects willing and able to comply with the requirements of the study.
* Subject has the clinical diagnosis of at least mild erythema.
* Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
* Subject is in general good health in the opinion of the investigator.

Exclusion Criteria:

* Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans)
* Subject has a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome or other systemic flushing causes.

Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days

* Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
* Subject has had laser or light-based treatment for rosacea within the prior 3 months.
* Subject has had systemic retinoids and retinoid derivatives over the past 6 months
* Subject has any history of renal or hepatic insufficiency.
* Subject has a known hypersensitivity or allergy to Cromolyn sodium or components of the vehicle.
* Subject is pregnant or lactating or planning a pregnancy during the duration of the study
* Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
* Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.

Subject has a known hypersensitivity or allergy to tape or other adhesive materials
Electrochemotherapy for the Inoperable Vulva Carcinoma

Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma

Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age ≥ 55 years (postmenopausal)
* histologically proved cutan accessible vulva carcinoma
* a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm
* applied electrochemotherapy with electroporation

Exclusion Criteria:

* Non compliant patients
* Patients with symptomatic or rapidly progredient metastasis outside of the vulva
Airway Evaluation by McGrath Videolaryngoscope

Difficult tracheal intubation is a cause of severe patient damage and death. There is not a good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the role of videolaryngoscope in predicting difficult intubation.

* The enrolled patients were given a bolus of sufentanil 0.3-0.5μg/kg to achieve Ramsay sedation score 2-3. The Cormack-Lehane score in sedation was evaluated by McGrath videolaryngoscope.
* Then the patients were induced with propofol. A bolus of rocuronium was given to facilitate intubation. The Cormack-Lehane score in anesthesia was recorded when intubated by McGrath videolaryngoscope.
* BMI, mouth opening, thyromental distance, intubation duration and ramsay sedation score were also recorded.
* To compare the Cormack-Lehane score in sedate and anesthesia condition

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for general surgery under general anesthesia
* ASA classification 1-3

Exclusion Criteria:

* emergent operation, aspiration risk
* a history of difficult airway
* expected difficult airway
* incooperative patients with mental diseases, hearing disorders