cyrilzakka/clinical-trials huggingface dataset:
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients

This is a single arm study of the use of a personalized sterile humidification device for 12 weeks for head and neck cancer patients undergoing radiation therapy to determine if the usage of this humidification system will result in a decrease in severity in head and neck related quality of life as measured by the MDASI HN subscale following radiation therapy as compared with historical experience. In addition, we are exploring correlative measures using CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to mucositis and presumably related to quality of life as indicated by the patient.

The patients complete MDASI at baseline, 6 weeks, and 12 weeks. The MDASI is a validated instrument that measures symptom burden and we measure a subscale (HN) as our primary endpoint. The patients are asked to use a personal humidifier daily and complete a weekly diary showing compliance with the humidifier use.

Eligibility Criteria:
Inclusion Criteria:

* Receiving a dose of radiation therapy greater than or equal to 6000 cGy to one third of the oral cavity.
* Receiving definitive or post-operative adjuvant radiotherapy.
* Receiving radiotherapy or chemoradiation.
* Of age greater than 18 years.
* Life expectancy greater than 6 months.
* Able to provide informed consent.
* Participation of patients on other clinical trial protocols permitted, if not prohibited by trial guidelines.

Exclusion Criteria:

* Undergoing induction or neoadjuvant chemotherapy prior to radiotherapy.
* Treatment with amifostine or palifermin (keratinocyte growth factor) during radiotherapy.
* High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator.
Effects of Motivational Interviewing on Risky Injecting Practices Among Injecting Drug Users (IDUs)

The purpose of this study is to evaluate the effects of a brief motivational intervention in reducing risky injection practices among injecting drug users (IDUs). The investigators hypothesis is that motivational intervention will be more effective than educational intervention in reducing risky injection practices among IDUs.

Injecting drug users (IDUs) are among the most vulnerable populations at risk to contract human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Among Canadian cities, Montreal holds one of the higher HIV and HCV contraction rates in the IDU population. Results from SurvUDI, a population survey among IDUs conducted in the province of Quebec (Canada), show that in Montreal 18% of IDUs are infected with HIV and 67% are infected with HCV. The cornerstone of HIV and HCV prevention strategies is to give information on safe injection practices and to make available sterile syringes and other injection equipment. However, the SurvUDI survey reveals that a large proportion of IDUs recruited in community programs offering sterile injection equipment and information on safe injection practices are still sharing needles with other IDUs. Indeed, it seems that information dissemination and distribution of sterile injection equipment are not sufficient in order to control the HIV and HCV epidemic among IDUs. As a matter of fact, it is obvious that complementary interventions such as behavioural interventions are required. Motivational interviewing is an intervention technique centered on the individual. It aims to enhance intrinsic motivation to change behavior by helping the individual to resolve ambivalence. The scientific literature indicates that brief motivational intervention is a significantly effective intervention in order to reduce drug use problems and other related health problems. Furthermore, motivational intervention is well adapted for IDUs' resistance to change and their difficulties related with involvement in long-term therapeutic process. The present study's hypothesis is that IDUs assigned to the experimental group (brief motivational intervention) will present a greater diminution of their risky injection practices in comparison with IDUs assigned to the control group (educational intervention).

Eligibility Criteria:
Inclusion Criteria:

* In the last month, at least one cocaine injection
* In the last month, at least one injection with a syringe or another piece of injection equipment that has been used by someone else
* 16 years old or more
* French speaking
* Being able to give informed consent
Natural Course for Renal Function After Heart Transplantation

The outcome of heart transplantation has improved by years. The renal dysfunction is a major complication after heart transplantation.The natural course of renal function following orthotopic heart transplant is not clear in Taiwan. A retrospective study was conducted on patients who received a heart transplant at National Taiwan University Hospital between 1987 and 2015.

The investigators conducted a retrospective cohort study of patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015 . Clinical data were obtained and a retrospective chart review, and were collected up to 10 years .

Data was collected from medical records and the heart transplant electronic database including: demographic parameters such as age and gender; etiology of heart failure; the presence of any of the following comorbidities: history of smoking, diabetes, hypertension, peripheral vascular disease and previous sternotomy; pre-transplant cholesterol levels; the use of any of the following pretransplant hemodynamic support measures:intravenous inotropes, intra-aortic balloon pump and ventricular assist device;creatinine levels; listing status according to the UNOS classification; waiting time; heart ischemic time;immunosuppression drug levels(cyclosporine,prograft or certican) and development of end stage renal disease requiring onset of dialysis therapy.

Creatinine levels and GFRwere collected before transplantation and then the closest level to every month after heart transplant.

The clinical outcomes of interest analyzed in this study included the development of post-transplant end stage renal disease and death.

Eligibility Criteria:
This study included patients with a first HTx performed at NTUH between1987 and 2015.

Patients were excluded if their first HTx was a combined transplant involving a KTx, they had renal replacement therapy prior to their HTx.
Impact of a Tolerability Switch to Dorzolamide/Timolol Preservative-free Fixed Combination on Ocular Surface Symptoms

This study aims at validating in real-life clinical practice and using the self-reported Glaucoma Symptom Scale (GSS) questionnaire, the impact of a switch to preservative-free dorzolamide/timolol fixed combination (DTFC) in patients using preserved topical therapy for glaucoma.

The study is an 8-week multi-center, prospective, observational and non-interventional, open-label study aiming at assessing a change in visual-related quality of life of glaucoma patients that switch therapy to preservative-free DTFC. As a non-interventional study, the decision for the to switch was at the discretion of the physician. Patients scheduled to switch therapy to preservative free DTFC will be asked to fill in the 10 item, linkert-type GSS questionnaire at baseline, at week 4 and at week 8 of therapy switch.

The study data will be collected at a baseline and at 2 follow-up visits occurring 4 weeks +/- 1 week and 8 weeks +/- 1 week. If no visit was scheduled, the patient was asked to send the completed documents to the physician.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients aged over 18 years old at inclusion visit
* Diagnosed as having OAG in one or both eyes
* Who have used the previous preserved eye drops treatment for at least 4 weeks in one eye or both eyes
* Experiencing pre-established ocular surface disease symptoms, as defined in the 2007 report of the International Dry Eye Workshop
* Being scheduled by their ophthalmologist for a switch to preservative-free DTFC eye drops (as monotherapy or replacement of one preserved product of a combined therapy) at inclusion visit due to tolerability issues
* Accepting to participate in the study and who has provided a written informed consent

Exclusion Criteria:

* Patients who had filtering or other ocular surgery within the 6 months preceding the inclusion visit
* Who have already been treated with preservative-free DTFC
* Whose visual acuity is importantly impaired by a severe ocular disease other than OAG, as assessed by the physician
* Currently involved in a clinical trial or study cohort or pharmaco-epidemiology study or interventional study
* With serious mental or physical disability which could interfere with a patient-reported assessment
* Pregnant women.
Advancing Water Security: a Community Participatory School-Based Hydration Intervention

The goal of this study is to determine the effectiveness and sustainability of a community-participatory hydration intervention over 3 years within a district that has newly installed hydration stations and is operating under a policy designed to enhance heathy hydration practices and promote equitable access to drinking water.

The goal of this study is to determine the effectiveness of a hydration intervention on hydration station usage (primary outcome), Body Mass Index z-scores (zBMI) and dental caries (primary biomedical outcomes), and water bottle usage, beverage selection and intake, and academic outcomes (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Lunchroom observations: All students (K-5th \[Pre-Kindergarten if applicable\]) who eat lunch in the cafeteria on assessment days are eligible
* BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g)
* Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district.
* Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.

Exclusion Criteria:

* Lunchroom observations: None.
* BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration
* Student surveys: None.
* Staff surveys: None.
DynamX Bioadaptor Hong Kong Registry

Prospective, non-randomized, multicenter registry

Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and\<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic

Eligibility Criteria:
Inclusion Criteria:

1. Subject age ≥ 18 and ≤ 80 years
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction)
4. Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion
5. All lesions requiring PCI should be amendable for implantation with the study stent
6. Successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being \< 35%

Exclusion Criteria:

1. Target lesion / vessel specific

   1. Lesions in the left main
   2. Venous or arterial bypass grafts
   3. In-stent restenosis
   4. Chronic total occlusion
   5. Ostial lesions (\< 3 mm from the ostium of the RCA, LAD or Cx)
   6. Stent implanted \< 10 mm from the target lesion in the previous 30 days.
   7. Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification
   8. Bifurcation lesions requiring a planned 2 or more stent technique
2. Patient specific:

   1. STEMI
   2. Acute myocardial infarction with Killip Class III and IV
   3. Known LVEF \< 30%
   4. Life expectancy \< 1 year
   5. Patients on renal dialysis or known GFR \< 30 ml/min
3. Planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months
4. Known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy)
5. Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin)
6. Subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint
7. Known pregnancy or breastfeeding
8. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy

This project will study the effect of oxytocin on hemodynamics in patients undergoing laparoscopic myomectomy, and how to prevent and manage such hemodynamic changes effectively.It provides a reference for the rational use of oxytocin in clinical practice, which can not only effectively contract the uterus and reduce bleeding, but also reduce the influence on hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* General anesthesia for gynecological laparoscopic surgery,ASA I\~III

Exclusion Criteria:

* Oxytocin use contraindications
At-Home Genital Nerve Stimulation for SCI Bowel

The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management.

Researchers will:

* Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label
* Compare a target stimulation level to a placebo stimulation level

Participants will:

* Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home
* Visit the research center 3 times to participate in exams and answer questions
* Keep a daily diary of their bowel symptoms and stimulation times

The objective of this proposal is to determine how genital nerve stimulation (GNS) acutely modulates neurogenic bowel dysfunction (NBD) in individuals with different severities of spinal cord injury (SCI) and to determine the key study design and methodology parameters of daily at-home administration of GNS. This study will determine the feasibility of daily application of GNS as an intervention for NBD. Key feasibility measures related to dosage and adherence will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Traumatic SCI.
2. Minimum of 6 months' post-injury.
3. Aged 18 years and older.
4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
5. Score of 14 or higher on the ISCI BF BDS v2.1.
6. Response to genital nerve stimulation able to be elicited upon screening.
7. Able to understand and provide informed consent.

Exclusion Criteria:

1. Currently enrolled in another functional electrical stimulation (FES) research trial.
2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
3. Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS.
4. In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Eligibility Criteria:
Inclusion Criteria:

* Female or male aged 25 or over
* Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
* Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
* At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
* Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification

Exclusion Criteria:

* Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
* Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given \> 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
* With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade \>1 at the time of starting study treatment.
* Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
* Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.
Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma

Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.

Treatment scheme

* Screening period: D-21 to D1 (treatment day)
* Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.
* Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)
* Tumor response is assessed every 2 cycles (6 weeks)
* Treatment is repeated until,.

  * 4 cycles
  * progressive disease
  * unacceptable toxicity
  * patient's withdrawal
* Gastric surgery should be performed within 4\~6 weeks of the last dose of chemotherapy
* Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
* Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.
* Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.
* Follow up for survival is repeated every 3 months for 2 years

Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months

Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed gastric adenocarcinoma
* Age 18 to 70 years old
* ECOG performance Status 0\~1
* Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA\~IV), M0, P0, H0, CY0
* No pretreatment (radiotherapy or chemotherapy) for gastric cancer
* Adequate organ function

  * Hb ≥ 9.0 g/dL
  * WBC ≥ 4,000/µL
  * ANC ≥ 2,000/µL (\*ANC = Neutrophil segs ＋ Neutrophil bands)
  * Platelet ≥ 100 × 103/ µL
  * Total bilirubin: ≤ 1.5 × UNL
  * CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)
  * AST/ALT, ALP: ≤ 2.5 × UNL
* Written informed consent

Exclusion Criteria:

* Distant metastasis on diagnosis
* cT1-2
* Cancer of gastroesophageal junction (GEJ)
* Poor oral intake or absorption deficiency syndrome
* Gastric outlet obstruction, perforation or bleeding
* Medically uncontrollable chronic illness or infection
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* History of clinically significant cardiac disease
* Past or concurrent history of neoplasm last \< 5 year other than gastric cancer
* Prior gastrectomized patients
* Concomitant administration of any other experimental drug under investigation
* Peripheral neuropathy ≥ NCI-CTC grade 2
Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence

Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence (SUI) and urgency urinary incontinence (UUI).

Methods: 51 women were prospectively divided into two groups, according to the symptoms as SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min Pad Test. Subjective \[urine stream interruption test (UST), visual survey of perineal contraction and transvaginal digital palpation\] and objective (vaginal manometry) evaluations of PFM were performed in all patients.


Eligibility Criteria:
Inclusion Criteria:

* presence of stress urinary or urgency incontinence

Exclusion Criteria:

* neurological diseases
* previous pelvic surgeries
* diabetes
* cognitive difficulties
* vaginal and urinary infection