cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.


Eligibility Criteria:
Inclusion Criteria:

* Aged 53 to 70 days inclusive on the day of inclusion

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the past.
* Mother known as seropositive to HIV or hepatitis B
* Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin \[BCG\])
* History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients

The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.

At every stage of chronic kidney disease (CKD), the leading cause of mortality is cardiovascular disease. This is due, in part, to vascular calcification (VC) of the coronary arteries. The extent of VC in the coronary arteries of patients with CKD is commonly determined by high resolution CT scan. The total coronary artery calcium (CAC) score, measured in Agatston units (AUs), reflects the calcium burden in the three major coronary arteries and is the current standard for determining extent of vascular calcification in hemodialysis patients. Matrix Gla protein (MGP), a vitamin K dependent protein, is a key inhibitor of vascular calcification and is present in the arterial wall. It is established that MGP becomes up-regulated adjacent to sites of calcification and that vitamin K is critical to its function. Therefore vitamin K status may be critical to the extent of vascular calcification in this patient group. However, to date, no trial has examined whether vitamin K supplementation prevents the progression of coronary artery calcification in patients with kidney failure, a group in which high risk has been established. Therefore, our primary research question is: Does vitamin K supplementation with 10 mg of phylloquinone thrice weekly reduce the progression of coronary artery calcification (as measured by CAC score) over 12 months in prevalent hemodialysis patients with a baseline CAC score of ≥ 30 Agatston Units compared to placebo?

Eligibility Criteria:
Inclusion Criteria:

* Able to provide signed informed consent
* ≥18 years of age
* Expected to survive one year
* Have end-stage kidney disease and require hemodialysis
* Have a baseline coronary artery calcification score ≥30 Agatston units (AUs)

Exclusion Criteria:

* Have a medical condition that requires warfarin
* Require hemodialysis for acute kidney injury
* Are Pregnant
* Have other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than one year
* Have undergone coronary artery bypass grafting or have stents placed in their coronary arteries
* Are currently enrolled in another interventional trial
Contingency Management for Hoarding Disorder

Aim 1: To test the efficacy of contingency management for patients with hoarding disorder (HD).

Hypothesis 1. Participants completing CM will show significant pre- to post-treatment decreases in severity of hoarding symptoms and clinician-rated impairment, and significant increases in quality of life.

Exploratory analyses will examine whether effect sizes compare with those of prior trials of cognitive-behavioral therapy (CBT) for HD conducted within our clinic, whether problem severity at follow-up is predicted by hoarding severity measured immediately after treatment completion, and whether readiness for change improves with treatment.

The primary aim of the current study is a preliminary investigation of the efficacy of contingency management (CM) in the treatment of hoarding disorder (HD). CM is a highly efficacious treatment that has been used to treat issues such as substance use disorders, medication/ medical regimen nonadherence, and schizophrenia. While the current best-practice treatment for HD (cognitive behavioral therapy; CBT) is efficacious in that it results in significant symptom reduction, many patients continue to have high levels of functional impairment and distressing symptoms after treatment completion. We strongly feel that CM is able to address many of the issues that arise in the context of CBT for hoarding and we feel that the addition of CM to as CBT will result in significant pre- to post-treatment decreases in severity of hoarding symptoms and impairment, and significant increases in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Primary Hoarding Disorder,
* currently participating in the Hoarding Disorder treatment group at the HH Anxiety Disorders Center

Exclusion Criteria:

* Not clinically appropriate for a group treatment format (i.e., active suicidality or aggressive behavior, psychosis, current physiological substance dependence, or personality issues that would be expected to substantially interfere with the group milieu; cognitively intact).
* Participants will also be excluded if they have previously completed CBT for HD.
* In addition, participants in the CM portion of the treatment will be required to live within one hour travel time of the treatment facility to allow for home visits with the independent rater.
Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals with an Ultra High Risk for Psychosis

The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, quality of life.


Eligibility Criteria:
Inclusion Criteria:

* People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score)

Exclusion Criteria:

* Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder
* Previous antipsychotic treatment for more than 12 months
* Organic mental disorder or intellectual disability
* Serious suicidal/homicidal risk (but admissible if this risk has been resolved)
* Insufficient French language skills
* Adult incapable of giving consent and not under legal protection
* Protection measure (guardianship/curatorship/court supervision) or under court supervision
* Person deprived of liberty by judicial or administrative decision (including forced hospitalisation)
* Persons in a life-threatening emergency
* Not affiliated to a social security regime
Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy

The purpose of the study is the identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy

This is a single arm prospective, monocentric, open, experimental pilot study. The response to NAC in breast cancer is extremely heterogeneous. The study and the identification of factors that can predict the response to treatment is therefore a priority, constituting a relevant "clinical unmet need".Modern molecular biology techniques as well as imaging diagnostics could be valuable tools for characterizing the response to NAC toward the definition of more personalized therapies.The prediction of therapy response after two cycle of chemotherapy rather than at the end of six cycles using non-invasive procedures will spare unwanted toxicity to the patients and resources to the Regional and National Health system. This study will also provide the patients, their familiar and all the stakeholders involved in the cure of Breast Cancer new important information regarding the management of breast cancer patients.This is a non-interventional study; therefore, the treatment will be as per physician choice according to the most appropriate therapeutic opportunities available for each patients' based on the type and stage of disease and the patients' performance status.Currently, the NAC regimens commonly used at CRO-Aviano for NAC are Epirubicine 90 mg/mq + Ciclophosphamide 600 mg/mq d1 q21 or q14 (EC)(dose dense) followed by weekly Paclitaxel 80 mg/mq for a total of 12 administrations. Occasionally, due to patients and tumor features only weekly Paclitaxel is used, and usually in this case up to 24 administrations may be given. Only in the case of HER2 positive BC trastuzumab 2 mg/kg is added to weekly Paclitaxel. Given the low response rate of hormone-based neoadjuvant therapy, only in rare cases (e.g. patients not amenable of surgery due to comorbidities), this approach is used.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histological Diagnosis of Infiltrating Breast Cancer.
3. The presence of measurable mammary lesions;
4. The presence of metabolically active mammary lesions;
5. Performance Status (Eastern Cooperative Oncology Group scale, ECOG) ≤ 1;
6. Compliance with periodic blood withdrawal;
7. Compliance with periodic PET/CT and RMN imaging;
8. Adequate clinical and laboratory test results for undertaking neoadjuvant chemotherapy and surgery;
9. Written informed consent.

Exclusion Criteria:

1. The presence of contraindications for the execution of RMN and PET-TC;
2. Presence of metastatic disease;
3. Pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma of the skin;
4. Uncontrolled active infections;
5. Insufficient patient compliance;
6. Absence of signed informed consent
Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy

This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.


Eligibility Criteria:
Inclusion criteria:

* ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib
* Adequate bone marrow function, liver function, renal function
* Adequate birth control

Exclusion criteria:

* Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone ≤ 20 mg/day for adrenal insufficiency OK
* Topical or inhaled steroids OK)
* Active bleeding
* Uncontrolled angina, CHF, heart attack ≤ 6 months, uncontrolled diabetes

Other protocol-defined inclusion/exclusion criteria may apply
Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, men or women ≥ 40 years
* A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
* Post-bronchodilator FEV1 \< 80% of predicted normal value and FEV1/FVC \< 70%, post-bronchodilator

Exclusion Criteria:

* A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis
* Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start.
* Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
Nanovectors to Prevent Placental Passage of Tocolytic Agents

The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.

This is a prospective observational study.

Subjects will undergo a biopsy from the middle of the upper margin of the uterine incision measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean section after delivery of the baby. Once the tissue is obtained, the site will be closed using sutures similar to the usual closure of the uterus at cesarean section. This biopsy will be taken to the laboratory to test whether the nanovector will increase or decrease contractions in the uterus. Once this test is finished, the tissue will be frozen and test for the absence or presence of the nanovector within the tissue.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing elective cesarean section who are greater than 37 weeks

Exclusion Criteria:

* Known infection
Music Therapy in Acute Leukemia Patients With Fatigue

The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia.

The researchers will explain the study objectives and methods, obtain informed consent, and have participants sign the consent form before commencing the study. Participants are randomly assigned to Group A and Group B. Participants in Group A undergo 30 minutes of self-selected music playback every day in addition to receiving standard therapy, while participants in Group B only receive standard therapy. The entire study duration spans 21 days.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with acute myeloid leukemia by a clinical specialist.
2. Patients undergoing chemotherapy for the first time.
3. Aged 18 years or older, capable of communicating in Mandarin or Taiwanese.
4. Normal hearing ability.
5. No history of psychiatric disorders and clear consciousness.
6. Participants with no prior involvement in any intervention studies related to fatigue management.
7. Demonstrates understanding of the research objectives, willingly participates in the study, and completes the informed consent form.
8. Willing to cooperate with study procedures throughout the research period.

Exclusion Criteria:

1. Severe hearing impairment.
2. Individuals with unstable vital signs or altered consciousness.
A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer

This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors or non-Hodgkin's lymphomas for which YM155 has the potential, based on preclinical and/or clinical data, to show efficacy, namely:

  * castrate resistant prostate cancer
  * non-small cell lung cancer
  * metastatic melanoma
  * muscle invasive bladder cancer
  * follicular lymphoma
  * diffuse large B-cell lymphoma
* Life expectancy ≥ 3 months; and Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline

Exclusion Criteria:

* Radiotherapy, major surgery, hormonal therapy, and chemotherapy within 4 weeks prior to the first dose of study medication and 6 weeks in the case of mitomycin-C or nitrosourea
* Previous therapy with YM155
* Patients with renal, hepatic or colorectal cancers
* Inadequate bone marrow, renal and/or hepatic function
* History of being treated for other malignancy within 5 years except for treated basal or squamous cell carcinoma of the skin
* Participation in any clinical study within 4 weeks prior to start of the first dose of study medication
* Known brain or leptomeningeal metastases
* Active uncontrolled systemic infection at baseline
Sleep Quantity and Quality in the ICU: a Prospective Observational Stud

Several evidences in the literature suggest sleep interruption in critical care patients. Nowadays, the amount and the quality of sleep phases during the length of stay in the intensive care unit are largely unknown.

In this study, the amount of time spent by the patients in N1, N2 N3 and REM phases during sleep is quantified.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years

Exclusion Criteria:

* Pregnancy
* Previous enrollment in the same study (sleep recording during previous night)
* Previous use of hypnotic drugs
Genetic Testing for the Prevention of Cancer in Indigenous American Communities (JUNIPER Trial)

This clinical trial is studying the genetic changes in cells associated with different types of cancer in Indigenous American (IA) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. IA tribes have much lower rates of cancer screening, have more limited access to healthcare, are more often diagnosed at later stages of disease, and have the poorest outcomes in all types of cancer when compared to any other racial and ethnic group in the United States. Due to these significant cancer health disparities, IAs have been understudied and little is known about the molecular characterization of tumors arising in IAs. Undergoing genetic testing of tumors may improve cancer outcomes in IA participants and communities.

PRIMARY OBJECTIVES:

I. To develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit Indigenous Americans (IAs) affected by cancer (newly diagnosed cancer participants, participants undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.

Ia. Conduct direct participant engagement with cancer participants/survivors, community advisors, and partners to refine and optimize methods/processes.

Ib. Identify, recruit, and consent eligible IA cancer participants/survivors. Ic. Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks.

Id. Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.

SECONDARY OBJECTIVE:

I. Translate any discoveries to improved cancer screening, precision prevention, and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in Indigenous American participants and communities.

OUTLINE:

Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from standard of care (SOC) surgical procedure or biopsy, or stored tissue samples for genetic testing on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.

After completion of study intervention, patients are followed up once a year up to 5 years from study registration.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults \>= 18 years of age
* Cancer patient undergoing active treatment or a cancer survivor
* Self-identify as Indigenous American

Exclusion Criteria:

* Unable to provide informed consent
* Individuals who are under 18 years of age
* Prisoners
Prophylactic Antibiotics in Cystectomy With Diversion

Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.


Eligibility Criteria:
Inclusion Criteria:

* Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
* 18 years of age or older

Exclusion Criteria:

* Currently receiving antimicrobials for active infection
* Poor renal function with GFR \< 30 ml/min
* Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
* Pregnancy
* Unable to provide Informed consent