cyrilzakka/clinical-trials huggingface dataset:
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

This a prospective single arm study enrolling patients with bone metastases from breast cancer who have been on opioid therapy for bone pain for at least 4 weeks. All patients start on Syndros at 4.2 mg po BID for 3 days, if tolerated without side effects the dose is increased to 8.4 mg QAM and 4.2 mg QPM for an additional 3 days. If the patient continues to tolerate the medication, the dose will be increased to 8.4 mg BID for the rest of the study period (total of 8wks). For patients who have side effects secondary to Sydnros, the dose will be decreased. Side effect assessment will be done by the research team 2 days after making the dose adjustment. If subject continues to have side effects, dose will be held until resolution of symptoms. If the study medicine is held for more than a week continuously, they will be taken off the study. In addition, they will have baseline blood and urine collected for biomarkers and also complete study related questionnaires (for secondary end points). They are also provided an opioid drug diary which they will take home during visit 1 to record their opioid pain medication use. Research staff will be calling patients on a weekly basis to reinforce opioid drug diary, assess for Syndros side effect, and adjust dose of Syndros. At the end of 8 weeks blood and urine is collected again and they will complete the study questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines
3. Have metastatic breast cancer with bone metastases
4. Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
5. Age ≥ 21 years
6. Must be on opioid therapy for bone pain for at least 4 weeks

Exclusion Criteria:

1. Have a known sensitivity to dronabinol or alcohol
2. Have a history of hypersensitivity reaction to alcohol
3. Using medical marijuana currently
4. Using Syndros for nausea or appetite stimulant
5. Receiving or have received disulfiram- or metronidazole- containing products within past 14 days
6. Are currently pregnant or are of child-bearing age and refuse to use adequate contraception
7. Have a history of psychiatric illness
8. Have a history of seizure disorders
Nitrous Oxide Analgesia Vaso-occlusive Crisis

Patients who have sickle cell VOC are usually treated with opioids, such as morphine. However, this current way of treating them has not improved the health, medical outcomes, or rates of hospitalizations. In addition, since VOC can happen very frequently over a long period of time, giving opioids over and over again can cause both short-term and long-term problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better alternative to repeatedly giving opioids over long periods of time. N2O has been shown to provide up to 3 hours of pain relief in inpatient patients with VOC whose pain did not improve with morphine infusions, and is used extensively in France, where almost half of 85 pediatric emergency departments use nitrous oxide to treat children with VOC whose pain did not get better with standard treatment with morphine. However, pain relief which N2O provides in the acute setting has not been well described. Therefore, the purpose of our study is to describe how well N2O can relieve the pain in patients with SCD who present to the emergency department and are experiencing a VOC.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sickle cell disease
* Ages 8 to 18, inclusive
* Present to the pediatric emergency department with VOC and whose pain scores remain greater than or equal to 7/10 on the NRS after initial standard treatment (i.e. IV fluids, morphine and NSAIDs).

Exclusion Criteria:

* life-threatening illness as determined by attending clinician
* developmental delay
* altered level of consciousness
* any contraindications to receiving N2O
* foster children and wards of the state
Interpretable Machine Learning Models for Prognosis in Gastric Cancer Patients

This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer.

This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer. The study included patients who underwent radical gastrectomy for primary gastric or gastroesophageal junction cancer across multiple institutions in China.

The primary objective was to create a machine learning-based model to predict postoperative outcomes following gastrectomy, using readily available clinical and pathological parameters. The main outcome of interest was early recurrence within 2 years after surgery, which significantly impacts overall prognosis.

The study employed various machine learning algorithms to develop prediction models, which were then compared and validated. Model performance was assessed through measures such as area under the receiver operating characteristic curve (AUC), calibration, and Brier score. The SHapley Additive exPlanations (SHAP) method was used to interpret the model and rank feature importance.

This research aims to provide clinicians with a tool for identifying patients at higher risk of poor postoperative outcomes who may benefit from more intensive post-operative monitoring and early intervention strategies, potentially improving prognosis for gastric cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary gastric or gastroesophageal junction cancer
* Underwent radical gastrectomy
* Complete clinical and pathological data available

Exclusion Criteria:

* Presence of distant metastases before surgery
* Non-adenocarcinoma histology
* Incomplete follow-up data
Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients

The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.

Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of wet age-related macular degeneration.
* No prior therapy for wet age-related macular degeneration.
* Patients for whom the decision to initiate treatment with IVT-AFL in a T\&E regimen was made as per routine clinical practice.
* Patient age \>55 years of age

Exclusion Criteria:

* Participation in an investigational program with therapeutical interventions outside of clinical routine practice.
* Patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
* Concomitant ocular or systemic administration of drugs up to 3 months before commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye
Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers

Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Clinically significant disease
* Recent history of serious infection
Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)

The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (NMIBC) who have at least 6 months of disease-free survival from last recurrence.
* Able to provide urine for testing and comply with study protocol.
* Have an email address and be willing to complete surveys online.

Exclusion Criteria:

* History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma)
* Patients with predominant (\>50%) variant histology
* Patients with a history of upper tract and/or urethral cancer
* Women who are pregnant
The Effect of the Use of Sterile Transparent Film Dressing in Newborns

It is important that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. The aim of this study was to determine the effect of sterile transparent film dressing and tape methods used in pe- ripheral intravenous catheter application in newborns on the duration of catheter stay and the development of catheter-related complications.

It has been reported that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. Intravenous cannulas are usually fixed with a thin board, a bandage, and tape. There is no standard way of using PIVC dressings in Turkey. After the catheter is inserted into the vein, gauze and a blaster, sterile transparent dressing materials, or just a blaster, are used to prevent contact of the fixed part and the area of intervention with the external environment. Transparent dressing used for catheter fixation contribute to a more comfortable evaluation of the catheter entry site. It has been suggested that the use of transparent film dressing may be effective in preventing and early detection of catheter-related complications. Moreover, it was concluded that due to the short duration of the procedure, it reduced the cost of manpower, and nurses could devote more time to other patients.

Eligibility Criteria:
Inclusion Criteria:

* less than 4 kg (due to the infiltration scale criteria)
* PICV was inserted for the first time

Exclusion Criteria:

* existing catheter,
* who has a catheter other than PICV (PICC, umbilical catheter, etc.),
* sterile transparent film dressing, tape, babies with allergies to antiseptic solution and catheter,
* with immunodeficiency, and with skin problems that prevent catheter opening
Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence

To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years old
* Signed informed consent form
* Women with urinary stress incontinence defined as follow
* Involuntary loss of urine during increased abdominal pressure. In case of mix urinary incontinence (i.e., stress urinary incontinence associated to urge urinary incontinence) the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogic scale is higher for stress incontinence than for urge incontinence symptoms.
* closure pressure between 10 and 60 cm H2O
* the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogical scale is higher than 40/100
* Patients never treated with transvaginal electrical stimulation
* Vaginal muscle strength less than 3/5 on the muscular testing
* Positive Pad test (\>2 g of leakage measure by pad test with standardised bladder volume)

Exclusion Criteria:

* Patient refusing to sign the consent form
* patient unable to understand or follow the protocol
* inadequate cognitive ability
* patient participating in another research protocol within the 3 previous months
* pregnancy
* women with no contraception
* pacemaker
* history of recent (\< 1 year) transvaginal electrical stimulation treatment at home
* urinary incontinence other than stress incontinence
* neurological disease
* permanent metrorrhagia
* ongoing urinary tract infections
* vaginal prolapse \> 2
* untreated atrophic vaginitis
* history of surgical treatment for urinary stress incontinence or genital prolapse
* recent pelvic surgery (\<6 months)
* anatomic defect that preclude the use of the device
* genitourinary cancer or colic cancer
* patient already treated for urinary stress incontinence
* Recent oestrogen treatment (less than 3 weeks)
Wasting in Chronic Kidney Disease

Protein energy wasting is an independent factor associated with morbi-mortality in chronic kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients diagnosed with chronic kidney disease according to the degree of evolution of the disease and the diagnostic method.

Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney disease. Nutritional treatment differs depending on the stage of the kidney disease acute or chronic treated whether or not by dialysis. Nutritional monitoring should be regular, individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding techniques should allow all the nutritional needs. Their indications depend on the clinic, biochemical assessment and nutrient intake.


Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney disease
* Patients hospitalized in a university hospital renal ward

Exclusion Criteria:

- Hospitalization less than two weeks
Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact in children with cystic fibrosis (CF) on endocrine growth factors and height, gastrointestinal function and gut microbiome, lung function and respiratory microbiome, liver and pancreatic function, sweat chloride, inflammatory markers, and bone health.

Total duration of the study is expected to be 10 years. Part A will be a prospective cross-sequential study to describe the natural history of hormonal growth factors in early childhood and assess the feasibility of additional measurements. In Part A, subjects will have up to 8 visits over a period of up to 5 years.

Part B will be a prospective longitudinal study to observe the effects of administration of either ivacaftor or elexacaftor/tezacaftor/ivacaftor (elex/tez/iva) on growth. In Part B, subjects will have 1 "before ivacaftor or elex/tez/iva" visit within 30 days before initiation of the therapy and 8 "after ivacaftor or elex/tez/iva" visits over a 60-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Part A:

  * Less than 10 years of age at the first study visit.
  * Documentation of a CF diagnosis.

Part B:

* Participated in Part A OR less than 7 years of age at the first study visit.
* Documentation of a CF diagnosis.
* CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor).
* Physician intent to prescribe ivacaftor or elexacaftor/tezacaftor/ivacaftor.

Exclusion Criteria:

* Part A and Part B:
* Use of an investigational drug within 28 days prior to and including the first study visit.
* Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 28 days prior to and including the first study visit.
* Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
Service Development: Assessing Non-attendance Rates in Outpatient Clinics

Many studies have shown a high non-attendance rate in hospital outpatient clinics. The investigators have found a non-attendance rate of 25% in their asthma clinics and would like to investigate whether a reminder phone call will improve attendance rates. Patients will be randomised into two groups; one group will receive a reminder phone call one week prior to their hospital consultation and the other group will be managed in the standard manner (i.e. no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a respiratory nurse specialist and a research officer for two asthma clinics based on a Wednesday morning and a Thursday afternoon.

Many studies have shown a high non-attendance rate in hospital outpatient clinics. The investigators have found a non-attendance rate of 25% in their asthma clinics and would like to investigate whether a reminder phone call will improve attendance rates. Patients will be randomised into two groups; one group will receive a reminder phone call one week prior to their hospital consultation and the other group will be managed in the standard manner (i.e. no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a respiratory nurse specialist and a research officer for two asthma clinics based on a Wednesday morning and a Thursday afternoon.

To have an 80% chance of detecting a 10% reduction in non-attendance rates (at 5%) 500 patients are required for this study. The rate of non-attendance will be monitored for all the patients in both groups and some demographic information will be recorded for each patient(age, sex, diagnosis and home postcode).

Eligibility Criteria:
Inclusion Criteria:

* Patients with appointments booked for 2 respiratory outpatient clinics

Exclusion criteria

Patients likely to only need one appointment
Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis Pigmentosa

The purpose of the study is to evaluate the safety and tolerability of a single intravitreal injection of virally-carried Multi-Characteristic Opsin I (vMCO-I)

This open label dose-escalation study evaluated 2 dose levels in up to 11 subjects of retinitis pigmentosa (3 in low dose and 8 in high dose per dose) with active vMCO-010. Subjects with confirmed diagnosis of Advanced Retinitis Pigmentosa (RP) based on clinical examination and dilated fundus examination, were considered for participation in this study. The primary endpoint for this study is safety and tolerability of vMCO-I at 16 weeks. All subjects were assessed for 52 weeks following treatment with vMCO-I

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Diagnosis of advanced RP using Fundus Photographs
3. Clinical diagnosis of advanced retinal dystrophy
4. Prior documented (if any) retinal electrophysiological evidence of rod-cone photoreceptor degeneration
5. Snellen's visual acuity equivalent LP/NLP in worse (study) eye
6. Visual acuity in the non-study eye of no-better-than finger counting
7. Presence of retinal bipolar cells and retinal nerve fiber layer on OCT testing

Exclusion Criteria:

1. Prior participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy or any gene or stem cell therapy in the past six months.
2. Concurrent participation in another interventional clinical ocular study.
3. Pre-existing eye conditions such as glaucoma, diseases affecting the optic nerve causing significant visual field loss, active uveitis, corneal or lenticular opacities).
4. Presence of any complicating systemic diseases such as malignancies whose treatment could affect central nervous system function.
5. Subjects who are positive for hepatitis B, C, and HIV will be excluded.
6. Subjects who have undergone ocular surgery in the study eye within three months prior to Day 0.
7. Presence of narrow iridocorneal angles contraindicating pupillary dilation in the study eye.
8. Known sensitivity to any component of the study agent or medications planned for use in the peri-operative period.
9. Subjects will be excluded if immunological studies show presence of neutralizing antibodies to AAV2 above 1:1000.
10. Presence of narrow iridocorneal angles contraindicating pupillary dilation.
11. Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including OCT, during the study period.
12. Presence of vitreo-macular adhesion or traction, epiretinal membrane, macular pucker and macular hole, evident by ophthalmoscopy and/or by OCT examinations and assessed by the investigator to significantly affect central vision.
13. Current evidence of retinal detachment assessed by the investigator to significantly affect central vision.
14. Active ocular inflammation or recurrent history of idiopathic or autoimmune associated uveitis.