cyrilzakka/clinical-trials huggingface dataset:
Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention (POUR)

A prospective randomized control trial will be conducted at Good Samaritan Hospital and TriHealth Evendale Hospital. Subjects will receive total hip or knee surgery and follow-up via standard care at the discretion of the treating physician or the experimental study arm in which all patients will undergo the integrated care pathway.

Patients will be randomized to the control group or the experimental group. Patients in the control group will receive the treating physician's standard of care, and undergo bladder scans in the post anesthesia care unit (PACU), upon admission to the unit, and prior to discharge from the hospital. Patients in the experimental group will undergo a multimodal pain control care pathway that minimizes opioid consumption.

The primary endpoint will be the presence of or absence of post-operative urinary retention (POUR) between discharge from the PACU and prior to discharge from the hospital. POUR will be defined as bladder volume of greater than 500cc and the inability to void for at least 2 hours within the first 24 hours. POUR, once identified will be treated with intermittent straight catheterization (ISC). Secondary endpoints will include opioid consumption (in morphine milligram equivalents; MME), genito-urinary consultation, type (knee or hip) and duration of surgery, type of anesthesia, duration of anesthesia, total amount of IV fluids, blood loss, length of hospital stay (LOS), discharge status (home with early outpatient physical therapy, etc.), time of first spontaneous voiding, and the number of ISCs and any necessary indwelling catheterization and adverse events of interest including POUR, post-operative nausea and vomiting (PONV), severe pain of 7 or greater on the numeric rating scale(NRS), blood loss requiring transfusion, and lower urinary tract symptoms (LUTS).

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I- III
* BMI under 36 kg/m\^2
* Scheduled surgery for primary total hip or knee replacement
* Age 18+ years

Exclusion Criteria:

* Contraindications or failure of neuraxial anesthesia
* Patients must not be outpatient total hip or knee procedure
* Known intercurrent UTI, incontinence, or urinary retention not addressed by pre-operative urologic consultation and correction
* Pregnancy
* Current nicotine, alcohol or drug abusers
* Pre-operative narcotic use (any narcotic consumption within 3 days prior to surgery)
* Post- operative parenteral narcotic administration
* Allergy or intolerance to liposomal bupivacaine, bupivacaine, celecoxib, dexamethasone and/or pregabalin
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)

This study will collect safety information on the use of GARDASIL™ in the Philippines.


Eligibility Criteria:
Inclusion Criteria:

* Received GARDASIL™
A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension
* No use of Lumigan® in the past 3 months

Exclusion Criteria:

* Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

Gastric banding has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. We have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40
* ASA Class I or II

Exclusion Criteria:

* Comorbid cardiac, pulmonary, renal, hepatic disease
* Bleeding disorder
* Previous gastric/esophageal surgery
Sensory Approach of Food Modifications Led by Chemotherapy

The aim of the present study was to evaluate the impact of chemotherapy on sensorial perception in lung cancer patients in comparison to a control group (individuals without lung cancer and chemotherapy treatment). We will use a longitudinal approach whereby 44 patients and 44 controls will be tested for olfactory and gustatory abilities before and after treatment (for patients) and for two sessions separated by the same duration for controls. Primary measure outcome will be to examine the impact of treatment on the perception of hedonic valence of odors. Secondary measure outcome will include odor and taste perceptual changes and questionnaires on eating habits and behaviors, in order to examine the impact of treatment on odor, taste and food perception.


Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Age ≥ 18 years old
* People capable of giving their consent and of understanding the study
* 18 ≤ BMI \< 30 kg/m²

Control group:

* controlled blood pressure
* absence of pathology which can interfere with the criteria of the study (ENT, neurological, digestive,...)
* absence of treatment which can interfere with the criteria of the study
* absence of digestive disorders
* women with contraception

Patients:

* Patients affected by a bronchial cancer (post-operative or metastatic) with small cells or not, that must be handled by a chemotherapy with salts of platinum (at least 3 cycles)
* patients without previous chemotherapy
* Absence of ENT or neurological pathologies

Exclusion Criteria:

- Subjects having lost more than 10 % of their weight in the previous 2 months

Patients:

* Symptomatic intellectual and/or meningeal metastases
* Mycosis of oral or superior digestive tract
* Cancer of ENT or esophageal or gastric ways
* Patients with digestive disorders (≥ rank 1)
* Patients presenting a pathology which can interfere with the study
CT Mar Technology and MR Mavric, Semac Sequence in Removing Artifacts of Orthopedic Metal Internal Fixation

1. Objective to compare the effect of single energy imaging and mar technology in reducing artifacts of knee and hip replacement, and to explore the appropriate keV range of Mar technology in removing metal artifacts.,2. Objective to compare the effects of different MRI sequences (mavric / semac, stir, ideal, FSE) in removing artifacts of spinal internal fixation, knee and hip replacement.

Conventional spiral CT \[4\] examination will form black-and-white stripe artifacts around the metal implant, making the display of adjacent important structures unclear. In routine MRI examination \[5\], metal will interfere with the uniformity of local magnetic field, resulting in signal loss, and the artifacts will seriously affect the observation of bone and its surrounding structures.

The purpose of this study was to comprehensively evaluate the effect of Mar technology on reducing metal artifacts after internal fixation and joint replacement, and then to explore the appropriate keV range of Mar technology to reduce metal artifacts. We also aim to compare the reduction effect of different sequences of MRI on internal fixation artifacts after internal fixation and joint replacement, and to explore the sequence suitable for clinical diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients after spinal internal fixation or knee or hip replacement

Exclusion Criteria:

* Patients with poor image quality caused by their own factors such as patients' movement can not meet the diagnostic requirements
The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Patients With Insomnia

This plan will be implemented on the staff of the Qazvin University of Medical Sciences. The Insomnia Severity Index questionnaire will be used to screen for insomnia and low sleep health. This questionnaire is provided online to the staff through communication channels such as telegrams to help people who are interested in participating in this research. Individuals who scored more than 8 were randomly assigned to intervention and control groups and completed the Insomnia Index Index. The intervention group will then receive an app-based educational intervention designed to improve sleep hygiene. Control group: Participants in the control group perform routine activities. The intervention and control group will fill out the relevant questionnaire one and three and six months after the completion of the training to assess the impact of the intervention online.


Eligibility Criteria:
Inclusion Criteria:

* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-IV-TR
* Enough language skills
* Have access to an Android smartphone or a desktop computer with Internet access
* Participants will be required to sign an informed consent form

Exclusion Criteria:

* Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study
* Alcohol/drugs abuse
* Participation in other trials concurrently
* pregnancy
* having children under 2 years old
* Not having an internet-connected computer, cellular phone or tablet
* Working night shifts
* Somatic or psychiatric conditions requiring acute care
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.

This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male patients ≥18 years old；
2. Biopsy-confirmed primary IgA nephropathy；
3. Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
4. Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
5. Willing and able to take adequate contraception during the trial;
6. Willing and able to give informed consent and follow the protocols during the trial.

Exclusion Criteria:

1. Systemic diseases which could lead to secondary IgA nephropathy；
2. Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
3. Patients with severe cardiovascular diseases；
4. Patients diagnosed with malignancy within the past 5 years；
5. Patients with liver cirrhosis；
6. Patients received organ transplantation；
7. Patients with uncontrolled Type 1 or 2 diabetes；
8. Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；
9. Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening；
10. Patients treated with any systemic corticosteroids within the past 3 months before screening.
A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is \<3 months, and the target sample size is 100-500 individual s.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-60 years of age;
* diagnosis of schizophrenia (based on screening tests);
* outpatients, with no hospitalization for worsening of schizophrenia within 3 months;
* medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months;
* currently taking no more than 2 antipsychotic drugs.

Exclusion Criteria:

* began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months;
* on \>1 antidepressant, or a change in dose of antidepressant within 3 months;
* alcohol or substance abuse or dependence within 3 months;
* has previously received RO4917838.
Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer

The introduction of PSMA diagnostics and therapy has fundamentally changed the treatment management of prostate cancer and has significantly replaced other clinical and radiological diagnostic methods. As a result, 18F-PSMA-1007 (Radelumin®) was approved in Germany and several EU countries, most recently in Germany in 01/2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This could be seen as a milestone in the management of prostate cancer and will significantly promote the widespread use of PSMA-PET diagnostics in the coming years.

The investigators now intend to prospectively generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will enable us to analyze the diagnostic accuracy of Radelumin® in more detail under everyday conditions, whereby dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for the future use of artificial intelligence (AI) will be made possible.

Depending on the study design and definition of the patient population, the detection rate of pelvic lymph nodes in particular using PSMA imaging is reported to be \>80%. The results of the studies thus demonstrate a superior diagnostic accuracy compared to previous methods as well as a significant influence of PSMA imaging on the clinical course. Radelumin® was approved on the basis of these promising results from numerous retrospective studies and the prospective, randomized approval study.

Nevertheless, it should be noted that the results derived from such data generally deviate from the data in everyday clinical practice for various reasons. Furthermore, the retrospectively planned studies show multiple general weaknesses, whereby the prospective randomized approval studies also show a priori weaknesses. These result from a very limited observation phase and the lack of long-term data, despite good planning with a high power, a small number of patients and the targeted homogeneity of the patient population. In the context of a real-world evidence study, which focuses on routine clinical care, the above-mentioned disadvantages are compensated for by long-term observation, a considerably larger patient population and a realistic patient mix.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Planned \[18F\]PSMA-1007 PET/CT examination in patients with a first diagnosis of prostate cancer
* Informed consent

Exclusion Criteria:

- Examinations with limited assessability due to technical errors, such as imaging artifacts.
Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty

TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (TKA). The investigators want to determine if TXA or EACA compared with placebo are effective and safe for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled to receive primary unilateral total knee arthroplasty

Exclusion Criteria:

* Subject requires bilateral staged total knee arthroplasty
* Religious beliefs that would limit blood transfusion
* History of acquired defective color vision (inhibits monitoring for adverse events)
* Patients with a known history of upper urinary tract bleeding
* History of abnormal coagulation
* Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery
* Active intravascular clotting
* Known allergy to either TXA or eACA
* Myocardial Infarct within 6 months
* History of stroke
* Patient is a prisoner
Light Emitting Diode in the Treatment of Vulvodynia

Vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. The main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. Photobiomodulation has been described in the literature as an alternative to treat pain. Our group has studied blue LED for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. A pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. Participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. The following questionnaires will be used: Female Sexual Function Index (FSFI), Sexual Quotient - Female Version, Vulvar Pain Assessment Questionnaire. After answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. Pain assessments will be quantified by the visual analogue pain scale (VAS), which ranges from 0 (no pain) to 10 (maximum pain). At the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked "What is your perception of improvement" and "What is your level of satisfaction with the treatment?". The answers will be giving according to a Likert Scale of five points. The LED application protocol will be carried out with external use equipment model Antares, from the company IBRAMED (Amparo, São Paulo, Brazil), with a cluster G2 applicator. The power will be 450mW/cm2 and dose 5J/cm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). The treatment consists of eight sessions, carried out daily, except on weekends.


Eligibility Criteria:
Inclusion Criteria:

* vulvodynia diagnosis

Exclusion Criteria:

* patients diagnosed with vaginal infection
* difficulty in understanding the proposed instruments
* patients with chronic degenerative neurological diseases
* pregnant women
Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Type 2 Diabetes

This study evaluates the nutritional meal replacement and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus. Half of participants will receive nutritional meal replacement and individualized exercise prescription on the basis of conventional glucose-lowering treatment, while the other half will only receive conventional glucose-lowering treatment.

Diabetes mellitus is a chronic metabolic disease which seriously threatens people's health at present. Although new drugs for the treatment of diabetes continue to emerge, but the effect of diabetes treatment is still not satisfactory. Medical nutrition therapy (nutrition therapy medical, MNT) and exercise therapy are essential measures for prevention and control of diabetes at any stage of the natural course of the disease, especially for the overweight and obese patients with type 2 diabetes. However, at present, the majority of patients could not get the guide from nutrition specialist and sports specialist. In addition, the existing diet programs are often more complex, difficult to implement and adhere to in daily life, and exercise programs are often lack of targeted. In view of this, the Shanghai peak Sports Management Co., Ltd. developed a kind of nutritional meal replacement for weight loss. The nutritional powder has the characteristics of high nutrition, low calorie, low glycemic and strong satiety, and the heat is only 126kcal, and have a good sense of satiety. Studies have shown that 1 times a day with bags of nutritional meal replacement instead of 1 meals for obese people have a role in weight loss. In theory, the meal is also suitable for diabetes patients, especially overweight and obese type 2 diabetes, such as the combination of individual exercise prescription may be better, but there is still a lack of relevant research. In view of this, we proposed a joint sports workers, explore nutritional and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus, to explore suitable for China's diabetes lifestyle intervention measures, improve the level of prevention and treatment of diabetes in China.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of overweight and obesity type 2 diabetes
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease
Evaluating the Impact of CHOICE-AYA on Contraceptive Use, Continuation and Satisfaction

This is a prospective study involving two phases: 1) adaptation and 2) intervention, in adolescents aged 14-21 experiencing homelessness. The overarching goal is to develop and evaluate the effectiveness and feasibility of a counselling intervention to improve access to contraception among AYA experiencing homelessness. During the first phase, referred to as the adaption phase, we will rely on collective input from formative groups of AYA experiencing homelessness to adapt the CHOICE counselling intervention for this underserved and under-resourced population. In the second phase, referred to as the intervention phase, we will evaluate the effectiveness and feasibility of the adapted intervention (CHOICE-AYA).

This study will adapt an evidence-based contraceptive counseling intervention (CHOICE) using input from the formative groups of AYA experiencing homelessness and study the impact of the adapted counseling (CHOICE-AYA) on contraceptive use, continuation, and satisfaction in a specialized community care setting. After informed consent is obtained, participants will receive the CHOICE-AYA counseling intervention by trained clinic staff. Provision of contraception based on participant choice will occur through the clinic provider same day.

Participants will be sent links to complete the follow-up surveys at 1, 3, 6, and 12 months. In addition, Clinic staff (e.g., prescribers and nurses) will be sent electronic surveys following randomly selected study visits.

Findings will inform best practices for this vulnerable population and provide foundational evidence for future studies focused on expanding care to other sites that serve this group.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults experiencing homelessness and housing instability (defined as those seeking care at our community-based clinic on the campus of a youth shelter) aged 14-21 who have female reproductive organs (In Missouri, youth aged ≤13 are not legally able to consent to sex)
* English speaking
* Prior sexual activity or anticipated future sexual activity that creates the risk of pregnancy
* Either not currently on hormonal contraception OR interested in switching methods

Exclusion Criteria:

* AYA currently seeking pregnancy in the next 3 months
* AYA with a severe developmental or cognitive delay that interferes with the ability to engage in consensual reproductive sex (determined by the investigator)