cyrilzakka/clinical-trials huggingface dataset:
Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region

The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score).

A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years of age or older;
2. Patient has a histologically documented diagnosis of cancer of the head and neck region;
3. Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;

This criterion was amended (Amendment 01 dated August 28, 2000) to read as follows:

3. Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:

1. patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
2. with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;

   4. Patient has a Karnofsky Performance Scale (KPS) score of 60% or more;

   5. Patient is willing and able to cooperate with the protocol including rinsing of the oral cavity with the investigational or vehicle oral rinse 6 times per day.

   6. The patient or guardian is capable of providing informed consent.

   7. If female, the subject has undergone a urine pregnancy test with negative results, and has agreed to practice effective methods of contraception for the duration of the study.

   Exclusion criteria
   1. Patient has had previous radiation therapy to the oral mucosa;
   2. Patient is about to receive hyperfractionated radiation therapy;
   3. Patient has active oral H. simplex lesions, oral candidiasis, or oral mucositis due to other disease processes;
   4. Patient has uncontrolled infection;
   5. Patient has HIV, Hepatitis B (HBV) (as measured by HBs-Ag) or Hepatitis C (HCV) infection;
   6. Patient has not recovered from oral toxicity attributable to prior treatment;
   7. Patient has abnormal laboratory values that meet the following criteria:

      * Serum creatinine greater than 2 x upper limit of normal
      * Total bilirubin greater than 3 x upper limit of normal;
      * SGOT greater than 3 x upper limit of normal;
      * LDH greater than 3 x upper limit of normal;
   8. Patient has known sensitivities to any of the study preparation ingredients;
   9. Patient has participated in a clinical research study within the last 30 days prior to enrollment;
   10. Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or other reasons.
Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies

This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician
* DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT);
* Vision impairment associated with DME
* Prior treatment with available therapies for DME; and
* Patients considered by the physician insufficiently responsive to available therapies

Exclusion Criteria:

* Patients with contraindications according to the current Summary of Product Characteristics (SPC)
* The presence of pre-existing glaucoma
* Active or suspected ocular or periocular infection
* The patient is hypersensitive to the active agent or to one of the excipients
* Elevated IOP
* Pregnancy or breastfeeding
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)

The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are:

* What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)?
* What is the PK profile of single ascending doses of the FENM in human?
* What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor (BDNF) plasmatic levels of single ascending doses of the FENM? Participants will receive one single oral dose of FENM.


Eligibility Criteria:
Inclusion Criteria:

* willing and able to sign written informed consent,
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, a total body weight \>65 kg,
* efficient contraceptive mean,
* no major psychiatric disorder per the Mini-International Neuropsychiatric Interview (MINI) questionnaire,
* normal laboratory tests results, arterial Blood Pressure/pulse rate, 12-lead Electrocardiogram recording.

Exclusion Criteria:

* evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease including drug allergies, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality,
* history of febrile illness within 5 days prior to administration,
* any condition possibly affecting drug absorption,
* using of prescription drugs, vaccine, routine or as needed consumption of medications or herbal supplements,
* having positive serology, positive urine test for drugs of abuse, a general medical or psychological condition or behavior, including current substance dependence or abuse,
* history of drug or alcohol abuse within 1 year before screening,
* consuming currently of nicotine containing products, any food or any beverage containing grapefruit or grapefruit juice within 48 h prior to administration,
* having blood donation or loss of significant amount of blood within 2 months prior to study.
Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia

The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we will study the safe use of this therapy and its effects on making new blood vessels will be evaluated.

Coronary ischemia is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.

CI needs a comprehensive treatment since the condition will not improve on its own. The overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina.

The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart.

Patients eligible to participate in this study are those suffering from severe blockages to the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.

Once the final mixture of stem cells is prepared, the cells will be intracoronary infused through a catheter into the blocked vessel of the heart.

Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe, feasible and works.

Patients will be evaluated for 6 months after cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 18-20
* Angina Pectoris: CCS Class II or IV or angina symptom equivalent
* 70% blockage in at least one epicardial vessel documented within 6 months
* Stable medical therapy
* Reversible perfusion defects by SPECT
* Not a candidate for percutaneous intervention or coronary by-pass surgery

Exclusion Criteria:

* Previous angiogenic therapy or myocardial laser therapy
* Severe valvular heart disease
* Recent malignancy or radiation therapy within 6 months
* Renal insufficiency with creatinine greater that 2.7
* White blood count greater than 13,000 or lower than 3,000
* Platelet count lower than 60,000 or higher that 500,000
* Pregnant or planning to become pregnant
* History of skeletal muscle disease
* AST or ALT greater than two times upper limit of normal
Implementing Shared Decision Making in Interprofessional Home Care Teams

This study will train health providers in home care teams across Quebec in shared decision making about the decision to stay at home or move to another location. This decision is one of the toughest for older Canadians. Decisions that are informed, shared and supported produce better results. An interprofessional approach to shared decision making is when older persons and their caregivers are supported by not just one but by all the professionals involved in their care.The impact of the training program in interprofessional shared decision making (IPSDM) above that of the passive dissemination of a decision guide will be assessed by measuring to what extent older persons caregivers say they took active part in the decision-making process.

Other outcome measures will be:

i) what option they chose, whether they feel conflict or regret about their decision, and the burden of care they feel; ii) the quality of life of clients;


Eligibility Criteria:
Inclusion Criteria:

Clients or caregivers of clients :

* Aged ≥65 years;
* Receiving care from the IP home care team of the enrolled CISSS/CIUSSS
* Have made a decision about whether to stay at home or move to another location during the recruitment periods
* Are able to read, understand and write French or English
* Can give informed consent

In the case clients are not able to provide informed consent, their caregiver will be eligible.

Exclusion Criteria:

* Clients who are not able to provide informed consent and who don't have a caregiver
Breastfeeding, Antiretroviral, and Nutrition Study

This is a comparative clinical trial among HIV-infected women and their infants to determine:

1. the benefit of nutritional supplementation given to women during breastfeeding
2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation

This study addresses the complex issues of HIV related maternal morbidity, mortality, and postnatal HIV transmission during breastfeeding and weaning in resource-poor countries. Objectives include assessment of mortality and morbidity among HIV-infected women; evaluation of interventions to reduce HIV transmission to infants exposed by breast milk; and assessment of early weaning as a risk-reduction strategy for infants of HIV-infected mothers.

The study will evaluate the following:

1. The efficacy of a high-density caloric/micronutrient nutritional supplement given to HIV-infected women who breastfeed in preventing maternal depletion (weight loss and micronutrient status).
2. The safety and efficacy of maternal or infant antiretroviral regimens, taken for up to 6 months during breastfeeding, in reducing infant HIV infection rates at 48 weeks.
3. The feasibility of exclusive breastfeeding for 6 months followed by rapid weaning.

Additional study objectives are to evaluate the feasibility of delivering these interventions in resource poor settings and to identify maternal, infant, and virologic factors associated with HIV transmission during breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

Recruitment and primary eligibility criteria:

* Age \> 14 years.
* Ability to give informed assent or consent.
* Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
* Currently pregnant (with a single or multiple fetuses).
* Gestation \< 30 weeks at referral from 'Call to Action' Program
* No serious current complications of pregnancy.
* Intention to breastfeed.
* Intention to deliver at the institution at which the study is based.
* Not previously enrolled in this study for an earlier pregnancy.
* Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses.
* No previous use of antiretrovirals including the HIVNET 012 regimen.
* Mother's CD4 count \> 250 cells/uL determined in the antenatal clinic.
* Mother's ALT \< 2.5 x ULN (upper limit of normal) determined in the antenatal clinic

Secondary eligibility criteria and treatment assignment:

* Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery.
* Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant.
* Infant birth weight \> 2000 g.
* No severe congenital malformations or other condition(s) not compatible with life.
* Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.
Targeting Social Determinants to Improve Chronic Kidney Disease Care

The primary research goals of this application are to characterize social factors including health literacy and numeracy skills of CKD patients and examine associations with knowledge, self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an efficient interactive educational intervention to facilitate patient-provider communication. The investigators will accomplish these goals by executing a cluster-randomized controlled trial and performing detailed analysis of baseline measures. The specific aims of this study are:

Specific Aim 1: Determine the association of social factors with patient kidney knowledge, self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to advanced CKD.

Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated with older age, non-white race, fewer years of education, lower socioeconomic (income) status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with medication and diet self-care recommendations. Low literacy/numeracy is also associated with higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance.

Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used cooperatively by physicians and patients to improve self-care and outcomes in CKD.

Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool will be feasible and associated with higher patient kidney knowledge, self-efficacy of self-care and greater adherence to medication and nutrition recommendations compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Receiving care in the Vanderbilt General Nephrology Clinic for at least 1 prior visit past 12 months;
* Serum creatinine available in the medical record in the last 12 months demonstrating Chronic Kidney Disease (eGFR\<60mls/min);
* Age 18-80 years;
* English-speaking.

Exclusion Criteria:

* Pre-existing diagnosis of significant dementia or psychosis as determined by primary provider and documented in the medical record;
* Corrected visual Acuity \>60/20 using a Rosenbaum Pocket Vision Screen;
* Patient receives dialysis or has a functional kidney transplant.
Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)

This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or female, histologically or cytologically diagnosed locally advanced or metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2. Patients must have completed 4 cycles of platinum based first line doublet chemotherapy without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the following: gemcitabine, paclitaxel, docetaxel, vinorelbine.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic (stage=IIIB/IV) non-small cell lung cancer (NSCLC) before the front line chemotherapy. Note: sputum cytology alone is not acceptable
* Patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity.
* Patients with PR or SD on study entry need to have one or more measurable lesions according to RECIST criteria.
* The study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment.

Exclusion Criteria:

* Prior exposure to monoclonal antibodies or small molecule inhibitors against EGFR receptors. (e.g. gefitinib, erlotinib, C225)
* Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication.
* Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
* Known biomarker status of one or more of the following: Tumour EGFR gene copy number, tumour EGFR gene mutation status, tumour EGFR protein expression.
Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy

This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.

Once eligibility is confirmed, participants will undergo a specialized baseline periodontal examination, gingival sulcus microbiota sampling and saliva sample at baseline before starting chemotherapy.

Patients will be separated into 2 cohorts, with periodontitis (Arm A) and without periodontitis (Arm B). All patients will receive standard oncologic supportive care including antibiotic prophylaxis. Serum samples will be obtained at baseline, at the onset of neutropenic fever, and weekly until day 28 or discharge (whichever sooner).

Study participation will continue during the duration of standard of care chemotherapy for 28 days or until discharge from hospital, whichever later.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of AML, new diagnosis or relapsed/refractory disease
* Planned intensive inpatient chemotherapy, defined as expected hospitalization for 4 weeks or longer
* Sufficient time to perform periodontal examination and treatment by the end of day 1 of chemotherapy without delaying chemotherapy
* Written informed consent prior to performance of any research related activities

Exclusion Criteria:

* Unstable for transfer to the School of Dentistry
* Fever at the time of enrollment
* Documented blood stream infection at the time of enrollment
* Inherited bleeding diathesis
* Periodontitis requiring treatment before starting chemotherapy
* ANC \<0.5 x 10\^9/L at the time of enrollment
* Unstable for transfer to the School of Dentistry
* Fever at the time of enrollment
* Documented blood stream infection at the time of enrollment
* Inherited bleeding diathesis
* Periodontitis requiring treatment before starting chemotherapy
Targeted Intervention for Melanoma Prevention

In this study, the researchers will conduct interviews with melanoma patients to describe the sun exposure and sun protection practices of patients and their children. The researchers will use the findings of this interview study to develop a salient intervention targeted to the needs of melanoma patients and their children. The researchers will evaluate the intervention in a randomized, controlled trial.

The specific aims of this study are:

* To interview 210 melanoma patients with children 12 years of age or younger to describe patients' socio-cognitive and psychological factors, describe patients' and children's sun exposure and sun protection practices, and identify determinants of patients' and children's sun exposure and protective practices.
* To develop a targeted behavioral intervention that is designed to increase patients' protective practices to reduce their children's sun exposure, increase patients' self-protective practices, decrease the sun exposure levels of patients and their children, and positively influence socio-cognitive and psychological determinants of child-centered and self-protective practices.
* To conduct a randomized, controlled trial in a sample of 360 melanoma patients with children 12 years of age or younger to evaluate the targeted behavioral intervention consisting of print and video materials. The intervention will be assessed for its effects on: 1) child sun exposure and sun protection; 2) patients' protective practices to reduce their children's sun exposure; 3) patients' sun exposure and self-protective practices; and 4) patients' socio-cognitive and psychological factors that facilitate behavior change.

Research is to learn about awareness, attitudes, and behaviors related to sun exposure, sun protection, skin examination, and other risk-reducing behaviors. The results of this study will be used to design an educational program on sun protection for persons who have had melanoma and their children.

The study will involve a telephone interview that will last about 45 minutes and will be scheduled at your convenience. Your participation in this study is completely voluntary and you may refuse to participate. Your decision about participating will not affect the care or services you or your family may receive at The University of Texas M. D. Anderson Cancer Center.

Eligibility Criteria:
Inclusion Criteria:

1. Melanoma patients are eligible if they were diagnosed with in situ, localized, or microscopic stage III melanoma after January 1, 1988.
2. Melanoma patients are eligible if they are the parent of a child 12 years of age or younger and reside with the child.
3. Melanoma patients are eligible if they provide informed consent.
4. Melanoma patients are eligible if they are 18 years of age or older.
5. Melanoma patients are eligible if they are able to speak, read, and write English.
6. Melanoma patients are eligible if they meet all inclusion criteria.

Exclusion Criteria:

1) Melanoma patients are not eligible if they cannot provide informed consent.