cyrilzakka/clinical-trials huggingface dataset:
VISUPRIME® Eye Drops

The study purpose is to assess the efficacy of VISUPRIME® eye drops in preventing the conjunctival bacterial load in patients undergoing to anti-VEGF injection.

Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18)
* Naïve and pre-treated patients scheduled for IVI
* Diagnosis of one of the following:

  * ARMD
  * mCNV
  * Proliferative diabetic retinopathy
  * Diabetic macular oedema
  * Macular oedema secondary to retinal vein occlusion
* The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the local Ethics Committee (EC).

Exclusion Criteria:

* Use of systemic antibiotics, corticosteroids within 3 months
* Use of topical antibiotics and or corticosteroids within 15 days from study enrolment
* Use of topical Artificial Tears within 15 days from the enrolment
* Use of topical antiseptic agents within 1 month from study enrolments
* Presence of topical ocular therapies that cannot be suspended for the entire duration of the study
* Ongoing ocular or systemic inflammatory or infectious processes
* Known hypersensitivity to the constituents of the study product
* Diagnosis of Open-Angle Glaucoma
* Uveitis
* Acute and Chronic Conjunctival Disease
* Any intraocular surgery within 6 months from study enrolment, excluded IVI
* Severe and Moderate Dry Eye
* Pregnancy or breast-feeding
* Participation in other clinical studies
* Patients with cognitive impairment and unable to manage home-assigned treatment.
Vaccine for Recurrent Urinary Tract Infections in Women

The purpose of this study is determine whether a vaginal mucosal vaccine given to women with a history of recurrent urinary tract infections can reduce the number of infections occurring in a six-month study period, as compared to placebo treatment.

Recurrent urinary tract infections (UTIs) affect approximately 10% of women in the United States. Since antibiotic prophylaxis is not always effective, alternate treatments need to be developed. One such treatment would be immunization with a vaccine containing bacteria known to cause these infections. The objective of the study is to immunize susceptible women with inactivated bacteria contained in a vaginal suppository and to monitor the rates of reinfection compared to a group of women treated with placebo suppositories. Each group of patients will receive a total of six suppositories in the first four-months of the six-month study during which all UTIs and side effects will be recorded. The infection rates between vaccine- and placebo-treated women will be statistically analyzed to determine vaccine efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Three or more urinary tract infections in the previous year

Exclusion Criteria:

* Neurogenic bladder
* Interstitial cystitis
* Urinary diversion
* Kidney stones
* Indwelling catheter
Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

In this study, the investigators show that by upskilling of primary care physicians (PCPs) in SDM and leveraging on a novel pictorial Visual Analogue Uroflowmetry Score (VAUS), they can enhance older men's recognition of LUTS and stimulated discussion with their PCPs.

Lower urinary tract symptoms (LUTS), often related to prostatomegaly, is common but seldom sought medical attention amongst older men. Visual-aid and shared decision-making (SDM) are potential solutions to address LUTS. The study aimed to determine the effect of a novel pictorial Visual Analogue Uroflowmetry Score (VAUS) and primary care physicians (PCP) SDM training on the decisional quality amongst men selecting their treatment options for LUTS.

This study recruited 60 multi-ethnic Asian men aged ≥50 years with moderate-to-severe LUTS (International Prostate Symptoms Score≥8 and/or QOL≥3) in a Singapore public primary care clinic. Men used the VAUS to report their symptoms. 60 men were randomly assigned to PCPs trained in SDM in the intervention group (n=30) and the other 30 to the control group (PCPs without SDM-training). Patient-physician dyad decision quality was measured using the validated SDMQ-9 (patient) and SDMQ-Doc (physician) questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* men aged 50 years old and older attending the polyclinic for routine follow up of a chronic disease (non-communicable disease)
* have moderate-to-severe LUTS and/or poor quality of life (QOL) as assessed by the validated International Prostate Symptom Score (IPSS) of eight or more and/or its individual QOL score of three or more
* men of any local Asian ethnicity and were willing to provide written consent
* can communicate with their allocated PCP in either of the three main local languages; English, Mandarin or Malay.

Exclusion Criteria:

* have indwelling catheters
* urinary incontinence requiring diapers
* anuria due to any renal pathology
* gross hematuria
* acute urinary retention
* symptoms consistent with an acute urinary tract infection
* existing treatment of LUTS or other prostate pathology
* visual or hearing impairment which render men incapable of understanding the study procedure and providing informed consent
* men unwilling to discuss their LUTS treatment options with their PCP
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years of age and able to give their own consent
* Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
* Study ulcer has a Wagner grade of 1 or 2
* Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
* A full thickness diabetic foot ulcer located on the foot or ankle
* An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.

Exclusion Criteria:

* Suspected or confirmed signs/symptoms of wound infection
* Wounds with exposed bone or tendon
* Hypersensitivity to bovine collagen
A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) and nivolumab on pancreatic tumors in patients who are treated with gemcitabine and abraxane. The study will also look at the safety of including paricalcitol and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, apparently resectable adenocarcinoma of the pancreas at registration.
* Age greater than or equal to 18 years
* ECOG performance status of 0-2.
* Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the subject on the trial.

  a. Note: subjects must have: Creatinine \< 2xULN, Neutrophils \>1.5x109/L, total bilirubin \< 3xULN, AST \<5xULN, ALT \<5xULN, and Platelets \>100,000/mm3
* Ability to provide written informed consent

Exclusion Criteria:

* Subjects with hypercalcemia (blood levels greater than 11.5 mg/dL). In subjects creatinine clearance \<60mL/min, blood calcium levels must be 9.5 mg/dL or lower.
* Subjects who are currently pregnant, planning to become pregnant, or breast-feeding

  1. Females participants of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose
  2. Males participants with partners of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose 3. Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation 4. Subjects with contraindications to immune checkpoint therapy, as follows:

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  1. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
  2. Prior organ allograft or allogeneic bone marrow transplantation
  3. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  4. Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator
  5. Condition requiring systemic treatment with either corticosteroids

     * Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy are strongly discouraged (see section 5.1.3)
     * Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted
Lingzhi for Cancer Children

Ganoderma lucidum (Lingzhi) is a Traditional Chinese Medicine which is widely used as a means to 'strengthen immunity' among patients with cancers. However, there is no published randomized controlled clinical trial on its efficacy and safety despite the many in vitro studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective and immunomodulatory effects. This study was a randomized, double-blind, placebo-controlled, parallel clinical trial that investigated the benefits and safety of Ganoderma lucidum (Lingzhi) in treating children with cancers. Patients were randomized to receive identical capsules of either Lingzhi or placebo for six months. The primary outcome was the general Paediatric Quality of Life score. Secondary outcomes included immune functions, infection-related morbidities, complete blood counts and serum biochemistry, and overall and event-free survival.

Alternative and complementary medicine are widely used in treating children with cancers. A population-based survey in British Columbia revealed that they were used by 42% of the respondents. Among Chinese in Hong Kong, Traditional Chinese Medicine (TCM) is also widely practiced. Some 60% of the population had consulted TCM practitioners at one time or another. TCM use could be dated back to more than five thousand years ago, and written records were available for over two thousand years. TCM is considered to be an integral part of the Chinese culture. In our experience, TCM is believed to be commonly used to 'strengthen immunity and promote health' among local children with cancers, despite the lack of well-designed study to prove its usefulness. Ganoderma lucidum (Ling Zhi) is a mushroom long-used in China for a broad range of disorders. Its use is common in the general population and among both adults and children with a wide range of malignancies. However, there is no randomized controlled trial to support its clinical efficacy and safety. Therefore, we conducted this clinical trial of Ganoderma lucidum (Ling Zhi) among Hong Kong children with cancers.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 2-18 years
* Acute lymphoblastic leukaemia who completed induction chemotherapy and pending maintenance chemotherapy treatment
* Solid tumours completed chemotherapy
* Aute myeloid leukaemia who completed induction and consolidation chemotherapy treatment
* All patients and their parents signed informed written consent

Exclusion Criteria:

* Relapsed cancer patients
* Received Traditional Chinese Medicine (TCM) treatment within preceding one month
* Could not swallow capsules
* Syndromal disorders (e.g. Down syndrome)
* History of hypersensitivity reaction to Lingzhi or any TCM
* Significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular or allergic diseases
* In the judgement of investigators were unable to comply with study protocol requirements
Feasibility and Utilization of an Application-based Question Prompt List

This trial studies how well an application-based question prompt list works in improving treatment cost discussion between patients with breast, prostate, lung, or colorectal cancer and their oncologists. An application-based question prompt list, called Discussion of Cost Application (DISCO App), may help to improve how patients and oncologists discuss cancer treatment costs.

The overall goal of this research is to reduce financial toxicity related to the cost of cancer treatment in a diverse patient population. The research tests the feasibility of an application-based ("app") communication intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions during clinical interactions, which, in turn, should improve other short- and longer-term patient outcomes, including referrals to economic support (e.g., social work); efficacy in managing treatment cost; treatment cost distress; financial toxicity; and treatment adherence. If successful, this study will result in an evidence-based tool that can reduce financial toxicity and improve medical outcomes for a diverse patient population.

Eligibility Criteria:
Inclusion Criteria:

* Medical oncologists or radiation oncologists at KCI McLaren Detroit, McLaren Flint, McLaren Macomb and McLaren Port Huron oncology centers
* Oncologists will be eligible if they treat patients with prostate, breast, lung or colorectal cancers.
* Oncologists will be consented
* Patients must be 18 yrs. old or older
* Patients will be consented
* Patients must be able to read and write in English
* Patients must have a confirmed diagnosis of breast, prostate, lung or colorectal cancer and are scheduled to see an oncologist for an initial treatment discussion.

Exclusion Criteria:

* N/A
Data Analysis to Evaluate Which Specific Gait Measures Are Associated with Risk of Injurious Falls Evaluating Gait Measures Associated with the Risk of Injurious Falls Through Data Analysis

The goal of this study is to understand if specific gait and activity measures can help predict injurious falls in older women. The main questions it aims to answer are:

Can combining daily gait (DLG) and daily physical activity (DLPA) measures more accurately predict the risk of injurious falls? How effective is wearable technology and machine learning in analyzing these activity measures for fall prediction? Researchers will analyze data from the Women's Health Study (WHS), using wearable technology to track daily walking patterns and physical activity, and apply machine learning to assess the likelihood of harmful falls.


Eligibility Criteria:
Inclusion Criteria:

* after menopause or without intention of pregnancy

Exclusion Criteria:

* history of CHD, cerebrovascular disease, cancer (except non-melanoma skin cancer), or other serious illness;
* history of serious side effects to study treatments;
* taking aspirin, drugs containing aspirin, or non-steroidal anti-inflammatory drugs \&gt; once a week, or ready to give up the use of these drugs;
* taking anticoagulants or corticosteroids;
* Taking vitamin A, E or ß-carotene supplements \&gt; once a week.
The Relationship Between Maternal Perinatal Depression and Feeding Behavior Among Primiparas

The goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Participants will be asked to finish questionnaires four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum).

Background: Perinatal depression and infant feeding (breastfeeding and complementary feeding) are important global health issues. The prevalence of perinatal depression is high around the world, and breastfeeding rates in middle- and high-income countries are on a downward trend. Past research has pointed out that perinatal depression is related to infant feeding. However, there is a lack of research on the impact of maternal depression on infant feeding in Asian Chinese pregnant women, and "whether there is a bidirectional causal relationship between postpartum depression and infant feeding" remains unclear.

Purpose: To explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding.

Method: This is a longitudinal cohort study. It's estimated to recruit 500 pregnant women. It is planned to recruit participants at the Obstetrics and Gynecology Clinic of National Taiwan University Hospital. At the same time, research recruitment advertisements will also be posted online. This study will collect data by questionnaires distributed a total four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum). Variables include: sociodemographics, maternal variables (parity, number of births, planned pregnancy, maternal complications, mode of delivery, height and weight during pregnancy and postpartum, blood pressure), infant variables (gender, health status , height, weight), anticipatory feeding schedule, health-risk behaviors (smoking and alcohol use), social support, situation of breastfeeding and complementary feeding, reactive feeding, sleep, fatigue, exercise habits, and tendency to depression.

Eligibility Criteria:
Inclusion Criteria:

* Primipara
* Adult women over 18 years old
* Those with no recurrent pregnancy loss and stable signs of pregnancy
* Those who agree to participate in this study

Exclusion Criteria:

* No exclusion conditions
A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria

* Histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit); patients with basal cell carcinoma will be excluded from this study unless they do not qualify for another open GDC-0449 clinical trial
* For patients with disease that is evaluable by physical examination only, diagnosis must also include biomarker confirmation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Documented negative pregnancy test for women of childbearing potential and agreement to use an effective form of contraception for the duration of the study
* Adequate hematopoietic capacity
* Adequate hepatic function
* Adequate renal function
* At least 3 weeks since last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities

Exclusion Criteria

* Known, untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
* Active infection requiring intravenous (IV) antibiotics
* Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis
* Any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis)
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
* Pregnant or lactating
* Treatment with excluded medications, including strong CYP450 inhibitors and inducers
Pro-2-Cool Pivotal Trial II

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling, using the Pro-2-Cool device, when applied after mTBI injury sustained by adolescents aged 12-21 years, participating in sporting activities.

This is a multi-center, prospective, randomized, non-blinded, dual-arm comparator study enrolling up to a total of 72 patients (approximately 36 patients in the treatment arm and 36 patients in the control arm) following sports-related, mTBI.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ages 12 - 21 years
2. Initial provider visit is within 8 days of mTBI injury
3. Confirmed mTBI diagnosis from sporting activities
4. In generally good health as confirmed by medical history and as determined by site investigator
5. Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
6. Has informed consent obtained per protocol and as required per IRB

Exclusion Criteria:

1. Cleared to return to play during initial visit
2. Suffers a serious TBI as evidenced by worsening symptoms, specifically:

   2.1. GCS \<14 2.2. Seizure 2.3. Hospitalization 2.4. Existing positive diagnostic testing which include radiology scans that indicate brain bleed 2.5. Slurred speech, which has not resolved within 72 hours of mTBI injury
3. Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
4. History of a serious medical or psychiatric disorder that include:

   4.1. Suicide attempt in the last 6 months 4.2. Unmanaged depression or anxiety 4.3. Hospitalization in the last 6 months for psychiatric treatment
5. History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
6. Previously diagnosed with a cerebrovascular disorder
7. Is unable to understand the study requirements or the informed consent
8. Currently enrolled in another investigational research study that may confound the results of this study
9. Non-English speaking subjects and parents/legal guardians
Bariatric Surgery and Pharmacokinetics of Venlafaxine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on venlafaxine are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract