cyrilzakka/clinical-trials huggingface dataset:
Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children

Maternal depression is a pervasive problem that disproportionately affects low-income mothers. The effects of depression on mothers and their parenting result in many negative outcomes for children, particularly in terms of school readiness. The proposed research will build on a successful partnership between the University of Southern California School of Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start mothers with depression or dysphoric mood with the goal of reducing their depression and promoting positive changes for both mothers and children. The objectives of the study are: (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G via a randomized controlled trial in Head Start centers in Los Angeles County operated by CII; (3) evaluate the effects of the intervention on maternal depression, parenting behaviors, goal-directed behavior, interpersonal relationships, physical health, and child behavior and school readiness; and (4) develop a manual for use of the intervention in Head Start and disseminate findings nationally. The study will feature 2 groups of 60 mothers each, randomized by Head Start site; one will receive the intervention and the other services as usual. Outcomes for both mothers and children will be tracked for 2 years after the intervention, allowing for the evaluation of short- and long-term effects. The intervention will be delivered by Head Start mental health workers under the supervision of Scott Stuart, a national trainer of the intervention. This intervention has the potential to be a low-cost, high-impact intervention that can be replicated to other Head Start sites across the country to improve the lives of Head Start children and families.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of children in Head Start with scores on screening measure that are in depressed or possibly depressed range to be assigned to intervention or TAU. Also will have additional control group of non depressed mothers

Exclusion Criteria:

* Not able to function in group environment
Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict whether cancer will come back after treatment.

PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.

OBJECTIVES:

* Assess the prognostic utility of the Oncotype DX™ 21 gene profile for risk of relapse in women with node positive or high-risk node negative breast cancer.
* Identify individual genes whose RNA expression is associated with an increased risk of relapse in these patients.
* Perform an exploratory analysis of individual genes whose RNA expression is associated with an increased risk of relapse differentially in patients previously treated with docetaxel.

OUTLINE: This is a multicenter study.

Tissue samples are examined for association of RNA expression and clinical factors (e.g., tumor size, nodal status, hormone receptor status, age, menopause status), as well as estrogen receptor, progesterone receptor, and HER-2/neu expression by immunohistochemistry and other studies.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Node positive OR high-risk node negative disease
  * Tumor \> 1.0 cm in diameter
* No locally advanced, inflammatory, or metastatic breast cancer
* Previously treated with 4 courses of anthracycline-containing chemotherapy (i.e., doxorubicin and docetaxel OR doxorubicin and cyclophosphamide)
* Enrolled on clinical trial ECOG-E2197
* Adequate tumor material available in ECOG Pathology Coordination Center
* Previously consented to future cancer-related research
* Hormone receptor status known

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Comparison of IV PCA and Wound Infusion After Repair of Pectus Excavatum

Postoperative pain management is a major problem after repair of pectus excavatum.Various methods of pain management have been introduced. However, the effects of continuous wound infusion of local anesthetics through ON-Q catheters were not well evaluated in pectus surgery. Therefore, we conducted prospective randomized controlled study to compare the effects of IV PCA and continuous wound infusion after repair of pectus excavatum.

Pain control is an important issue after correction of pectus excavatum. Insufficient pain control leads to develop postoperative pulmonary complications, such as hypoxia, atelectasis and pneumonia. Additionally, hospital length of stay could be prolonged. Therefore, successful pain management is mandatory to improve clinical outcome, to decrease postoperative morbidity and to shorten the duration of hospital stay. Various methods of pain management have been introduced. Current typical methods for pain management include thoracic epidural analgesia and intravenous patient-controlled analgesia (IV PCA). Epidural analgesia has shown superior pain control effects. However, there may be rare but serious complications, such as spinal cord and nerve root lesions, epidural hematoma, or infections. IV PCA is a well-established method of postoperative pain management. However, the systemic side effects of opioid, such as nausea, vomiting, sedation, or respiratory depression may occur. Continuous wound infusion of local anesthetics through ON-Q catheters is another method for pain management. It has been used for various surgical procedures. However, the effect is not well evaluated in pectus surgery. The purpose of this study is to compare the effects of opioid-based IV PCA and continuous wound infusion using a catheter.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing the repair of pectus excavatum

Exclusion Criteria:

* allergy to opioid or local anesthetics
* reoperation
Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.

Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups:

* Arm 1 : Patients with aortic clamping with pre-conditioning
* Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during 60 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patient \> 18 and \<85 years old
2. Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,
3. Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,
4. Aortic aneurysmal patient with or without distal femoral circulatory assistance,
5. Patient with aortic aneurysm of atheromatous or dissecting etiology,
6. Woman of childbearing potential with effective contraception (estrogen-progestin or intrauterine device or tubal ligation), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
7. Patient who read and understood the newsletter and signed the consent form
8. Patient affiliated with a social security scheme

Exclusion Criteria:

1. Patient with aortic aneurysms requiring supra-visceral aortic clamping but not requiring visceral artery reconstruction (supra-visceral aortic clamping for renal aortic juxtaposition aorta),
2. Patient with thoraco abdominal aortic aneurysms requiring a circulatory arrest (aortic aneurysms affecting the descending thoracic aorta or the aortic arch)
3. Patient requiring emergency aortic surgery
4. Patient under treatment known as interfering with PCI (Nicorandil or oral antidiabetic agents),
5. Pregnant or lactating woman (negative result of baseline blood test)
6. Participation in another interventional study within 28 days before randomization or during this study
7. Person deprived of liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults,
8. Patient under the protection of justice, patient under guardianship or curatorship.
The Evaluation of the Safety and Effectiveness of ANIMERS Chiara LA and JUVÉDERM VOLUMA® for Aging Mid-Face

This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the active control group.


Eligibility Criteria:
Inclusion Criteria:

1. Age 30 to 60 years of male or female
2. MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator.

Exclusion Criteria:

1. Injection site with infection or other skin diseases present which may affect the evaluation
2. With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at midface
3. With permanent implants or planning to receive permanent implants during the study period at the injection sites
4. Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 6 months
5. With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period
6. With Major surgery 3 months before the start of the trial
7. With under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period
8. With systemic immunosuppressive therapy or systemic corticosteroids within the past 2 months or planning to receive these therapies during the study period (subjects who have received inhaled/intranasal corticosteroids could be considered to include.)
9. With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis movement medications
10. With epilepsy or porphyria
11. With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
12. With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period
13. With history of hypersensitivity or allergy to lidocaine, amide anesthetics, hyaluronic acid or any component of the device; Gram-positive bacterial or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study
14. Planning to undergo any surgery which may cause significant body weight change (such as bariatric surgery) or take any medication which may cause significant body weight change
15. Pregnant, planning pregnancy or in breastfeeding females
16. Participated in clinical study of other device or drug and have not terminated within the past 30 days -Other circumstances which judged to be unsuitable for participating in the study by the investigator
OHQoL With Removable Partial Dentures; a Pilot Study

Removable false teeth (called removable partial dentures (RPDs)) are commonly made for people with missing teeth.

RPDs are made out of a framework and the replacement teeth/gum. The framework sits on the teeth and the gums and can be made out of different materials, metal or non-metal, with different properties. The plastic teeth and gum sit on the framework.

A common framework material is cobalt chromium, a rigid, non-precious metal alloy. Other framework materials include titanium and non-metal materials such as medical grade polyetheretherketone (PEEK).

A review of the literature shows that no research has been reported investigating how different RPD framework materials impact on a person's oral health related quality of life (OHQoL). The sensation that different frameworks have in the mouth can be quite varied between people, and it would be relevant to be able to tell patients which type of framework is better tolerated based on research evidence.

We hope to conduct an un-blinded randomised crossover pilot trial investigating the difference in patient preference and oral health related quality of life measured by patient centred outcomes in a group of patients due to receive tooth supported removable partial dentures at the Charles Clifford Dental Hospital.


Eligibility Criteria:
Inclusion Criteria:

Adults from age 18 upwards:

* with the absence of 3 or more teeth, excluding third molars, per jaw arch,
* with or without previous denture wearing experience, and
* with a stable oral health in terms of absence of disease activity affecting the periodontium, dental hard tissues (caries), pulp and the structural/aesthetic integrity of restored teeth.

Exclusion Criteria:

* Patients requiring extensive treatment prior to the provision of a removable partial denture.
* Patients with active primary disease; caries, periodontal disease or symptoms of pulpal or apical pathology to the remaining teeth.
* Patients with irreversibly compromised structural/aesthetic integrity of restored teeth that cannot be restored as part of the provision of treatment.
Knowledge Regarding Diagnosis of MIH Among Dental Interns in Faculty of Dentistry Cairo University

assessment of knowledge of dental interns regarding diagnosis of MIH among Group of interns in faculty of dentistry Cairo university

The study will be done in faculty of dentistry Cairo university in form of survey with data being gathered via a questionnaire. The survey was conducted among the dental interns

Eligibility Criteria:
Inclusion Criteria:

* any nationality both gender

Exclusion Criteria:

* interns who refuse to participate
A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS

To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.

Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* AZT, d4T, ddI, or ddC.
* Antipneumocystis prophylaxis.

Allowed:

* Short course (\< 14 days) of ciprofloxacin for acute infections.

Patients must have:

* AIDS.
* CD4 count \<= 100 cells/mm3.
* NO prior or current MAC infection.

Prior Medication:

Required:

* Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.

Allowed:

* Prior rifabutin.
* Prior ethambutol.
* Prior clarithromycin.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Positive tuberculin skin test (PPD \> 5 mm).
* Active M. tuberculosis.
* Perceived as unreliable or unavailable for frequent monitoring.

Concurrent Medication:

Excluded:

* Other antiretrovirals not specifically allowed.
* All investigational drugs.
* Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (\>= 14 days).

Patients with the following prior conditions are excluded:

Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.

Prior Medication:

Excluded within 4 weeks prior to study entry:

* Rifampin.
* Isoniazid.
* Clofazimine.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.
A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine

This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female, 18-55 years of age (inclusive) at enrollment;
2. Subjects who voluntarily provide signed written ICF;
3. Subjects who are able to well communicate with investigator as well as understand and adhere to the requirements of this study;

Exclusion Criteria:

1. Previous history of gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncologic, respiratory, immunological, cardiovascular and cerebrovascular diseases, which, as judged by the investigator, may affect the safety of the patient or may affect the PK, PD or immunogenicity assessment of this study;
2. Exposure to tetanus vaccines or vaccines containing antigenic components of tetanus toxoid within the past 10 years;
3. Exposure to tetanus immunoglobulin, receipt of blood transfusion or use of blood products within the past 6 months prior to screening;
4. History or family history of neurologic symptoms such as convulsions, epilepsy, encephalopathy and psychosis;
5. Subjects with thrombopenia or other coagulation disorders, or bleeding constitution or bleeding time prolongation, which may cause contraindications to IM injection;
6. Subjects with any acute illness requiring systemic antibiotics or antiviral therapy within 7 days prior to screening. Subjects with fever within 3 days prior to screening;
7. Receipt of immunosuppressants or immunopotentiators, other than inhaled or topical immunosuppressants within 3 months prior to dosing;
8. Allergy to the investigational product or its excipients, or have a history of allergy to vaccines or human immunoglobulin products or other therapeutic monoclonal antibodies (mAbs);
9. History of surgery within 3 months prior to screening, or planned surgery during the study;
10. Known or suspected history of drug abuse within 5 years prior to screening, or with positive urine drug abuse screening result; or a previous history of drug addiction;
11. Participation in other clinical studies with the investigational drugs or devices within 3 months or within 5 times the half-life of the specific drugs/biological products prior to dosing, except for observational, non-interventional clinical studies;
12. Use of any other drug, including over-the-counter medications and Chinese herbal medicines within 14 days prior to dosing ;
13. Exposure to other vaccines within 1 month prior to dosing, or plan to receive live vaccines within 3 months after dosing;
14. Pregnant or lactating women;

Other protocol defined Inclusion/Exclusion criteria may apply.
Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation

The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is 4 to 22% failure. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. Some risk factors are well defined in the literature as the duration of intubation, ENT and neurological history, the persistence of a respiratory disease, a high level of sedation. Other factors are more controversial as age, ventilatory parameters just before extubation before extubation blood gases, the interest of a leak test.

Also pediatric populations are extremely heterogeneous, so the investigators would like to highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support these high-risk children.


Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.
* Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes.

Exclusion Criteria:

* Refusal to participate in the study
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Established Type 2 diabetic not treated with insulin
* Stage 1 hypertensives blood pressure \> 130/80 mmHg and \< 160/100 mmHg
* BMI \< 35
* Hemoglobin A1C \< 8.5
* Must be postmenopausal or taking some form of birth control of surgically sterile

Exclusion Criteria:

* Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
* Active angina in the last three months
* Diabetes requiring treatment with insulin
* Severe asthma
* Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
* Recent history of substance or alcohol abuse .
* Uncontrolled hypertension systolic blood pressure \>160mmHg or diastolic blood pressure \> 100 mmHg
Antenatal Micronutrient Supplementation and Infant Survival

The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.

Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a \~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and consents to participate

Exclusion Criteria:

* Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing