cyrilzakka/clinical-trials huggingface dataset:
Self Management in Urinary Catheter Users

Learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters.

Urinary catheter users commonly experience adverse health effects, such as urinary tract infection (UTI), blockage, dislodgement, and leakage, leading to poor quality of life indicators. Catheter-related problems often require health care utilization resulting in increased health care costs. Self-management of urine flow is an essential part of self-care for people with long-term urinary catheters and may lead to prevention or reduction of catheter-related problems and improved quality of life.This study tests the effectiveness of a urinary catheter self-management intervention in a randomized trial of 220 patients, with 12 months of follow-up. The experimental intervention is designed to enhance self-management of urine flow in individuals with long-term urinary catheters, with the goal of decreasing catheter related complications and enhancing quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year.
* Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City.
* Able to complete study measurements alone or with the help of a family member or caregiver.
* Able to communicate with the study personnel in English.
* Have access to a telephone for data collection.

Exclusion Criteria:

* Terminally ill
* Cognitively impaired
* No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)
Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis

This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or non-pregnant female 18 years of age or older.
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months.
4. Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 2/Baseline.
5. Males (or their female partner) must agree to use an effective method of birth control throughout the study.
6. Subject has two similar contralateral Target Plaques.
7. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
8. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis.
4. Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study.
5. Subject is currently enrolled in an investigational drug or device study.
6. Subject has been previously enrolled in this study and treated with test article.

Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.
Genome Scan for Obesity in a Multi-Ethnic Sample

To scan the genome for obesity in a multi-ethnic sample.

BACKGROUND:

Despite intensive efforts the genetic basis of obesity has been difficult to establish. Linkage analysis using a genome-wide scan can potentially identify genomic regions not previously thought to be associated with susceptibility to obesity and provides a comprehensive test of the consistency of previous studies. The study used the considerable resources generated by the four cooperating networks in the NHLBI-supported "Family Blood Pressure Program" (FBPP) to conduct a genome-wide scan data for obesity.

DESIGN NARRATIVE:

In the Family Blood Pressure Program, microsatellite markers were typed at a density of -10cM by the Mammalian Genotyping Service (MGS) in Marshfield, WI. The complete data set was to include 9,940 individuals representing 4 ethnic groups (white, black, Hispanic and Asian). Obesity was characterized as a weight/height ratio (body mass index) and waist/hip ratio. This data set was larger than any prior genome scan for obesity, and the inclusion of multiple ethnic groups made it possible to examine genetic heterogeneity. The specific aims of the study were to conduct linkage and association analyses to localize regions influencing obesity. Investigators worked closely with the FBPP Coordinating Center (Washington University, St. Louis) and investigators from each of the four FBPP networks. Evidence was sought for consistency between results obtained from analyses of the genome scan performed by each of the individuals, and results summarized from the literature, with those found in meta-analysis.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Impact and Burden of Rugby Injuries in Argentina. A Complete Season Retrospective Multicentric Study.

The aim of this study was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019.

Introduction:

Currently, Rugby is a sport that is giving priority to the well-being of the player. Players are subjected to high training and match loads exposing them to constant stress that can lead to overload injuries in addition to frequent contact injuries. Despite knowing what the situation is like at the international and national level, the "Unión Argentina de Rugby" lacks conclusive epidemiological data.

Our main purpose was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019.

Design:

Observational, descriptive, retrospective and multicenter study.

Participants:

250 male amateur rugby players belonging to three clubs from three rugby unions (Buenos Aires, Córdoba and Rosario) of Argentina.

Methods:

Registration methods were applied according to the consensus of the World Rugby by a single observer per center. Injuries occurred in players from top rosters of 3 amateur rugby clubs (data collection centers) as well as the number of matches and hours of training were recorded. Medical diagnoses were classified under the rules of the OSIICS classification system. The incidence (injuries / 1000 hours-game-player), prevalences (point and period), the severity (days of absence) and the injury load will be calculated as well as the location, type, nature. This study followed the guidelines of the STROBE-SIIS Initiative Declaration.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Participation in more than 80% during training and matches of the competitive season.
* First, intermediate, Pre-intermediate A and Pre-intermediate B categories of the University teams of Córdoba, Old Resian and Los Matreros, belonging to UAR member unions.

Exclusion Criteria:

- Lost patient data
Intrapartum Ultrasound for Assessment of Fetal Progression

The use of ultrasound has been suggested to support the management of labour. According to several studies, ultrasound examination is more accurate and reproducible than clinical examination in diagnosing fetal head position, fetal station, and the prediction of labour arrest. Furthermore, there is growing evidence that ultrasound in labour may predict the outcome of instrumental vaginal delivery: a support to assess when an operative delivery is necessary. Ultrasound in labour can be performed using a transabdominal approach, mainly to determine head and spine position, or a transperineal approach, to assess head station and the situation at low stations. Several sonographic parameters have been proposed to evaluate the head station.

Furthermore, all ultrasound parameters studied so far, have always been measured with the woman in a supine position. While the biomechanics of childbirth with its mechanisms (known as nutation, counter-nutation of the pelvis, and the coccyx retropulsion) together with maternal movement, promote fetal rotation and the adaptation of its diameters with those of the maternal pelvis, allowing to gain more room for the fetal descent. Moreover, in most of the studies on intrapartum ultrasound, the mobility of the pelvis has not been mentioned. The contracted pelvis is the absence of mobility that leads to fetal-pelvic disproportion, arrest of labour, and operative delivery. Maternal pelvis biomechanics studies by high technological techniques have shown that maternal shifting positions during pregnancy and childbirth can create more room in the pelvis for safe delivery. The external and internal pelvic diameters are closely related.

For this reason, the evaluation of the mobility of the pelvis appears to be a necessary element to understand the ability of that pelvis to widen its diameters for fetal descent.

The aim of the study is to measure the variation of AoP, HSD, HPD, PAA in the supine position and in kneeling-squat position in the same woman and the cut-offs of the new ultrasound parameters and predictive capacity for vaginal birth.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women with singleton pregnancies
* at term gestation (37 weeks)
* fetus in cephalic presentation
* absence of factors hindering vaginal delivery

Exclusion Criteria:

* complicated pregnancies
* vaginal birth after Cesarean
* twin pregnancies
* early pregnancy
* women condition that exclude vaginal birth
Platelets Indices and Its Role to Predict Liver Fibrosis in Patients With Chronic Hepatitis B Infection

Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection

Patients with chronic Hepatitis B infection will be collected and will do liver fibroscan to predict the degree of liver Fibrosis and correlate between the role of platelets count and degree of liver Fibrosis in patients with Chronic hepatitis B virus

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70 years
* without a history of clinical illness

Exclusion Criteria:

* with other hepatitis virus infection; (b) with alcoholic liver disease; (c) with any disease related to fibrosis (such as connective tissue diseases, chronic obstructive pulmonary disease, kidney failure, tumors, and so on); (d) have received any anti-fibrosis therapy; and (e) pregnancy
Implementing a Nurse-Driven Aromatherapy Protocol to Decrease the Effect of Postoperative Nausea and Vomiting

This is a quality improvement project that aims to assess the effect of nurse-driven administration of essential oil aromatherapy on postoperative nausea and vomiting (PONV) in patients while in the post-anesthesia care unit (PACU) after general anesthesia.

In this three-month quality improvement project, nurse-driven aromatherapy will be offered to all patients in the main PACU setting at the Hospital Corporation of America (HCA) Houston Healthcare Southeast Hospital after they have undergone surgical procedures with general anesthesia, with the exception of patients who report allergies or sensitivity to ginger or lavender essential oils (EO) and patients who wish to be excluded from the project.

Eligibility Criteria:
Inclusion Criteria:

* PACU patients who are in the main PACU setting at HCA Houston Healthcare Southeast Hospital after having undergone general anesthesia for a surgical procedure

Exclusion Criteria:

* patients with allergies or sensitivity to ginger or lavender essential oils
* patients who wish to be excluded from the project
Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease

The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).

The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of \> 10% fibrosis on computed tomography imaging.
* Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score \>1.

Exclusion Criteria:

* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
* Cognitive impairment or inability to understand and follow instructions.
* Traditional PR completed within 3 months of study recruitment.
* Hospice or end-of-life care at the time of screening.
* Acute exacerbation at the time of screening.
Fluid Restriction and Quality of Life on Dialysis

Almost 30,000 people in the UK receive dialysis due to end stage renal disease (ESRD). Although dialysis prolongs life, people receiving dialysis are still typically bothered by a range of physical symptoms and need to make substantial adjustments in order to accommodate ESRD and its treatment. One adjustment that is often required is a dramatic reduction in fluid intake. Although sticking to fluid intake restrictions improves the efficiency of dialysis, monitoring fluid intake is complicated. The restrictions also leave people feeling very thirsty so restrictions can be hard to stick to. This project will develop and test a brief psychological intervention for people who struggle to adhere to fluid intake restrictions and will aim to increase quality of life whilst on dialysis. The intervention will be developed with input from people with lived experience of ESRD. It will then be offered to 12 people, recruited from clinics, who will complete questionnaires to monitor experiences and symptoms before, during and after the intervention. Participants' data will be analysed to find out whether the intervention has been helpful in reducing fluid intake and improving quality of life. If the findings are promising, this would suggest that the intervention could be tested in a larger clinical study in the future.

Please note: this study adopts a between-subjects concurrent multiple baseline single case ABC experimental design. Participant change within and across phases A (baseline, variable with participants randomised to a 6, 8, or 10 week baseline), B (4 week intervention phase) and C (4 week follow-up) will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Currently receiving haemodialysis for end-stage kidney disease
* Aged 18+
* Adequate fluency in written and spoken English to undertake the intervention and complete measures (assessed by research psychologist during discussion of study commitment)
* Willing and able to participate in face-to-face and/or digital delivery of a psychological intervention (e.g. if digital delivery is requested or/or necessitated by Covid 19 restrictions patient has access to a computer, tablet or phone).
* Identified by clinical staff as having difficulty with adherence to fluid intake recommendations.
* Consents to participation, including recording of video sessions for fidelity/adherence rating and supervision.

Exclusion Criteria:

* • Lack of capacity to consent

  * Poorly controlled diabetes resulting in recent hospital admissions for hypo/hyperglycaemic episode(s)
  * Intellectual disability that prevents self-management of fluid intake
Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)

The main purposes of this study are:

* to determine the effects of chondroitin sulphate on brain response to pain assessed through fMRI in patients with knee osteoarthritis.
* to investigate the relationship between treatment response detected by fMRI and the results of the different parameters of clinical assessment.


Eligibility Criteria:
Inclusion Criteria:

* Primary knee OA according to ACR criteria
* OA of radiological stages 2 to 3 according to Kellgren-Lawrence
* Estable knee pain during the last months before to start the clinical trial
* Patients with pain as the VAS≥50mm at baseline

Exclusion Criteria:

* Patients with skin conditions that could interfere in the clinical trial evaluation
* Pregnant or breastfeeding woman
* Patients with a history of alcoholism or other drug abuse
* Patients with an uncontrolled active psychiatric disorder
* Patients with other inflammatory or systemic conditions affecting other joints
* Patients who suffer more intense pain in the joint in another location
* Patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite
* OA of radiological stages 1 or 4 according to Kellgren-Lawrence
* Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis
* Patients with contraindications to perform an MRI such as: certain tattoos, pacemakers, intracranial clips incompatible with MRI, in the heart valves, hearing aids and other types of implants are incompatible with MRI
* Known allergy to chondroitin sulphate
* Washout period for OA treatments before beginning the study
Guided Cartilage Regeneration Membrane

Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury

MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old and ≤50 years old, regardless of gender
2. 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
3. Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up

Exclusion Criteria:

1. Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
2. Those with stage III or above degeneration of bone and joint
3. Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
4. Those who are sensitive to collagen, foreign protein or pig-derived materials
5. Repair the damaged area\> 8 cm2 or \<2 cm2, lack of normal cartilage tissue around the injury
6. Severe heart, liver and kidney insufficiency are defined as:

   Heart function: NYHA grade III or above; ALT, AST\> 2.5 times the upper limit of normal value; Serum creatinine\> 1.5 times the upper limit of normal value;
7. People with systemic immune diseases or systemic or local infections
8. Joint fibrosis, joint stiffness, and obviously restricted movement
9. Those with moderate or severe osteoarthritis
10. People with contraindications for MRI examination
11. Patients with hemophilia
12. Those who cannot tolerate surgery
13. Women who are pregnant or plan to become pregnant and breastfeeding women
14. Persons with mental abnormalities and incapacity to act autonomously
15. Other conditions that the doctor judges cannot participate in the trial
A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors

This is a single-arm, open-label, multi-center phase 1 clinical study designed to evaluate the safety and preliminary efficacy of NK042 cell injection in patients with advanced solid tumors.

This study is divided into two phases: Phase Ia and Phase Ib.

Dose-Escalation and Expansion:

* Phase Ia: This dose-escalation phase involves both single-dose and multiple-dose administrations of NK042 in patients with advanced solid tumors.
* Phase Ib: This multiple-dose cohort-expansion phase will focus on solid tumor indications that demonstrated preliminary efficacy in Phase Ia.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary signing of a written informed consent form.
2. Age between 18 and 70 years.
3. Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients who are not amenable to surgical resection, with no standard treatment options, or who have relapsed or progressed after standard treatment, or are resistant or intolerant to standard treatment.
4. At least one assessable tumor lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
6. Expected survival ≥12 weeks.
7. Must have adequate bone marrow, liver, and renal function.

Exclusion Criteria:

1. Insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy.
2. Participation in another clinical trial and use of investigational drugs within 28 days before the first dose.
3. Requirement for anticoagulation therapy.
4. Symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment.
5. Active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis.
6. Uncontrolled active infections.
7. Uncontrollable massive pleural effusion, ascites, or pericardial effusion.
8. Previous receipt of other cellular therapies.
9. Planned concurrent participation in other anti-tumor treatments during the study.
10. Pregnant or breastfeeding women.