cyrilzakka/clinical-trials huggingface dataset:
The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)

The TRI-MOM program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV mother-to-child transmission (MTCT) in nine maternal and child health services, 5 in Burkina Faso and 5 in The Gambia.

The TRI-MOM program has two components:

1. an "intervention" component consisting of a pilot study to reinforce the antenatal screening and prevention of MTCT (PMTCT) capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT.
2. an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.

The TRI-MOM (TRIple elimination Model Of Mother-to-child transmission of HIV/Syphilis and HBV in Burkina Faso and The Gambia) program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV MTCT in nine maternal and child health services, 5 in Burkina Faso and 5 in The Gambia. In The Gambia, the program will be conducted in collaboration with the national HIV, sexually transmitted infections (STI) and hepatitis programmes.

The TRI-MOM program has two components:

1. an "intervention" component consisting of a pilot study to reinforce the antenatal screening and PMTCT capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT. This pilot study will be conducted in 9 selected maternities.
2. an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.

Intervention component :

The TRI-MOM strategy includes 4 main activities:

1. Training of healthcare professionals in charge of maternal health (nurses, midwives and doctors in charge of maternal health services)
2. Triple screening of HIV, Syphilis and HBV by rapid diagnostic tests
3. Assessment and treatment of women positive for any of the 3 targeted infections
4. Raising awareness on MTCT among pregnant women visiting antenatal services and empowering women infected with at least one of the three infections

Evaluation component :

The TRI-MOM program will include three studies :

1. A quantitative and qualitative cross-sectional study before and after the implementation of the strategy.
2. A cohort study of pregnant women positive for any of the three infections.
3. Cost and cost-effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

* Women attending a postnatal visit in one of the selected maternities (no maternal age limit)

Exclusion Criteria:

* Refusal to participate in the study
* Unable to provide consent
Cortisol Levels in Infants Born by C-section - Electric Unipolar Needle Versus Electric Bipolar Needle

The purpose of this study is to determine whether there is a difference between cortisol levels in fetal blood of babies who were born while using a unipolar needle opposite to using a bipolar needle, and compared to the control group (infants who were born in a vaginal birth).

Today, on Caesarean section, there's a widely usage of electric unipolar needle for cutting tissue and / or bipolar needle to burn blood vessels. These Needles use an electric current flow for cutting the tissue. When using unipolar needle there's a transfer of the electric current through the mother's body and through the amniotic fluid , while when using bipolar needle the current goes back through the needle directly the generator so that the flow does not transfer to the amniotic fluid and fetus.

Despite the growing usage of electric needles, there is no literature information about the extent of electrical current that is transferred to the fetus during cutting, hence, no information about stress level felt by the baby as a result of electrical current exposure.

The purpose of this experiment is testing the possibility that there is a difference between cortisol levels in fetal blood of babies who were born while using a unipolar needle opposite to using a bipolar needle, and compared to the control group (infants who were born in a vaginal birth).

Also, we want to check whether there is correlation between maternal cortisol levels and newborn cortisol levels (whether motherly cortisol levels affects newborn cortisol levels).

To assess cortisol at birth, blood will be taken from the umbilical vein following clamping of the cord after birth. Saliva-based cortisol will be collected from mothers.

Other measures which will be taken are: week of birth, newborns weight, Apgar score 5 minutes after birth, mother's age and the indication for cesarean section.

Then we will compare the two experimental groups, as well as compare the two groups, to the control group, and see whether there is a statistically significant difference between the groups.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy women, without significant background and/or chronic diseases.
2. Women who did not experienced illnesses that may pass to the fetus during pregnancy, or any other medical complication related to pregnancy.
3. All indications for C-section are medical indications.
4. Male newborn, week 37-42 of pregnant.
5. Without any evidence of stress event suffered by the mother or fetus during pregnancy or at birth.

Exclusion Criteria:

1. Women over 45 years of age, or under the age of 20.
2. Women with significant background and/or chronic diseases.
3. Women who experienced medical complications during pregnancy.
4. C-section indication are urgent due to mother/fetus distress.
5. Female newborn, or a male newborn who wasn't born during week37-42 of pregnancy.
6. Evidence of a stress event suffered by the mother and/or fetus during pregnancy or at birth.
Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry (CAIR)

Following acute cardiovascular injury, inflammation is vital to activate reparative mechanisms. However, there is compelling evidence implicating excessive inflammation and dysregulated resolution in fibrosis, ventricular remodelling, and heart failure (HF). Recently, the anti-inflammatory agent colchicine reduced cardiovascular events after myocardial infarction (MI) compared to placebo, indicating that targeting inflammation in acute cardiovascular conditions is feasible. Several acute cardiovascular conditions are characterised by inflammation, including myocarditis, MI, and acute heart failure. However, there is large variability in definition, epidemiology, clinical presentation, pathophysiology, and natural history of acute inflammatory cardiovascular diseases. This relates, in part, to the difficulty in performing adequately powered studies. Clinical studies that include sufficient patients and extended observation periods are necessary to address some of these knowledge gaps. This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases characterised by inflammation in an observational-based registry. By doing so, the investigators hope to understand the contribution of inflammation to the pathophysiology of acute cardiovascular disease, improve risk stratification, and identify potential novel therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Any patient 13 years of age or older with an acute cardiovascular condition requiring hospital admission is eligible.

Exclusion Criteria:

* \<13 years of age
CAR-T Re-treatment for Refractory/Relapsed Multiple Myeloma

This is a single arm, open-label, single-center, phase 1 study, to determine the safety and efficacy of autologous reinfusion of CAR-T cells targeting BCMA in the treatment of refractory/relapsed multiple myeloma (r/r MM) who get recurrence and progression after previous CAR-T cell therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria.
2. Patients with refractory multiple myeloma. Clear BCMA expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry.
3. Refractory disease：1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors.
4. Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2).

Exclusion Criteria:

1. Women of child-bearing potential or who are pregnant or breastfeeding.
2. Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection.
3. Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.
4. Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder.
5. Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression).
6. History of allogeneic stem cell transplantation. Have active acute or chronic graft-versus-host-disease (GVHD), or require immunosuppressant medications for GVHD, within 6 months of enrollment.
7. Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.
8. other conditions that excluded by clinicians.
Effects of Receptive Music Therapy Combined With Virtual Reality on Prevalent Symptoms in Patients With Advanced Cancer

The present research seeks to determine whether a single responsive music therapy intervention combined with virtual reality (RMT+VR) reduces prevalent symptoms and improves their overall well-being in hospitalized adult patients with advanced oncologic disease receiving palliative care. This is a prospective study of a randomized clinical trial with a control group. The main variables are pain, exhaustion, drowsiness, nausea, loss of appetite, dyspnea, depression, anxiety, sleep and well-being as well as heart rate.

Music therapy has been shown to be effective in hospitalized patients, reducing the level of stress and anxiety, lowering tension, regulating breathing and relieving pain. However, despite the fact that there are many precedents of this type in palliative care, the quality of the evidence is low. The present research seeks to determine whether a single responsive music therapy intervention combined with virtual reality (RMT+VR) reduces prevalent symptoms and improves their overall well-being in hospitalized adult patients with advanced oncologic disease receiving palliative care. This is a prospective study of a randomized clinical trial with a control group. The main variables are pain, exhaustion, drowsiness, nausea, loss of appetite, dyspnea, depression, anxiety, sleep and well-being as well as heart rate. The duration of the study will be 48 hours. After signing the informed consent, patients will be randomized on the first day receiving RMT+VR, or no intervention at all. The variables will be measured on three occasions, before and after each condition, and 24 hours later.

Eligibility Criteria:
Inclusion Criteria:

* All of them are treated by the Palliative Care Unit of the Austral University Hospital.
* Individuals ≥ 18 years of age with advanced cancer defined from the use of the NECPAL-CCOMS Instrument
* They can be hospitalized in the medical clinic service (AUH) or in the Integral Care Unit (ICUA) within the hospital, and must sign the informed consent after being duly explained by the principal investigator.
* Likewise, they must have a minimum previous ESAS-r of at least 7 points in a symptom,
* they must be able to adopt a posture of at least 45º in bed and a state of alertness and adequate response.

Exclusion Criteria:

* they should not present cognitive impairment (measured by Pfeiffer scale \[21\] \> 2 errors)
* have functional hearing (with or without hearing aids or other devices).
The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

The dopamine agonist cabergoline inhibits phosphorylation of the vascular endothelial growth factor receptor-2(VEGFR-2), which prevent vascular endothelial growth factor (VEGF) overexpression and reduce the severity of Ovarian hyperstimulation syndrome. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis.This study was designed to analyze whether the timing cabergoline administration on the day of human chorionic gonadotropin (hCG) injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

BACKGROUND:Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation induction. It results from increased vascular permeability caused by ovarian hypersecretion of VEGF), which activates its receptor-2. The dopamine agonist cabergoline inhibits phosphorylation of the receptor VEGFR-2, which prevent VEGF overexpression and reduce the severity of OHSS. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis. In human, cabergoline averts OHSS, but a possible detrimental effect on oocyte maturation has not been explored. This study was designed to analyze whether the timing cabergoline administration on the day of hCG injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

PURPOSE: To assess whether the timing cabergoline administration affects metaphase II oocytes numbers, embryo quality, pregnancy outcome and the incidence of OHSS.

METHODS: A prospective randomized study was designed to evaluate the possible of cabergoline affect on oocyte maturation. Women (n=120) under controlled ovarian hyperstimulation with the risk of OHSS (Estradiol(E2)\>4000 pg/ml, or \>18 follicle, \>11 mm development) randomized into two groups. Group I (n=60) received 0.5 mg oral cabergoline per day for 8 days on the day of hCG. Group II (n=60) received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval immediately.

ANTICIPATED RESULTS: No significant differences were seen in the number of metaphase II oocytes, the embryo quality, the pregnancy rate and the incidence of OHSS.

Eligibility Criteria:
Inclusion Criteria:

* the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria:

* allergic to cabergoline
Gestational Diabetes: the Prevention

To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.

A clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. Finally, 257 were studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A physical exercise program three times per week during pregnancy was developed. The duration of session was 60 minutes and 50 minutes in land and water, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women
* At week 8-14
* Adherence 80% (minimum) until the end of pregnancy

Exclusion Criteria:

* Contraindications appointed by American College of Obstetricians \& Gynecologists (ACOG)
* No adherence
Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer

The purpose of this research study is to look at the effectiveness of a combination of doxil, carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types.This study is being conducted for the following research purposes:· To find out what effects, if any, the study drug has on metastatic breast cancer. For instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the safety of the study drugs and to see what affects it has. For instance, are there any side effects? If so, what kind of side effects does the study drug cause? How severe are the side effects, and how often do they occur?· To see if the study drugs have any effect on keeping the disease from getting worse.


Eligibility Criteria:
Inclusion Criteria:

1. Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.
2. Age \>= 18
3. ECOG performance status \<= 2
4. Normal organ and marrow function
5. Normal cardiac function as evidenced by LVEF within institutional normal limits

Exclusion Criteria:

1. History of hypersensitivity reactions to doxil or bevacizumab
2. Myocardial infarct or unstable angina within 6 months before enrollment
3. Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
4. Proteinuria
Intensive Discharge Intervention in Diabetes

The goal of this study is to design and implement an intensive discharge intervention for inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the intervention on post-discharge insulin adherence, glycemic control, cardiac medication adherence, hypoglycemic events, and emergency department visits and hospital readmissions.


Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients at BWH on the medicine or cardiology services with a primary care physician who belongs to a participating practice or has not explicitly opted out of the study
* Type 2 diabetes
* Active cardiovascular disease
* Likely to be discharged home, and one of the following:

  1. prescribed insulin prior to admission
  2. prescribed two oral agents and with an A1c \> 8.0 within 30 days of admission. - Practices that have already agreed to participate in this study for all their eligible patients.

Exclusion Criteria:

1. Discharge to a location other than home or rehabilitation (or to a caregiver's home)
2. Patient does not administer own medications and absence of a caregiver who lives with patient and administers all medications
3. Police custody, no telephone or homeless
4. Previous enrolment in the study within 90 days of discharge
5. Patient unable to communicate in either English or Spanish
6. Participation in the Integrated Care Management Program (iCMP)
A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children

An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.

The trial will be conducted in 6000 children in Burkina Faso and Mali in 2008 and 2009. Each site will enroll 3,000 children. All children will be allocated a long lasting insecticide-treated net and randomized to receive to treatment (amodiaquine + sulfadoxine-pyrimethamine (AQ+SP)) or placebo (AQ-placebo + SP-placebo. Treatment will be administered over 3 rounds during the high malaria transmission season, with one month interval between rounds. Full course treatment of AQ and SP will be administered on each occasion. Treatment will not be given in the second year. Passive surveillance of malaria will be implemented for the monitoring of malaria morbidity and to assess whether children who received intermittent preventive treatment (IPT) are at increased risk of malaria. Adverse events will be monitored during each round of IPT administration. To assess the effect of IPTc on the prevalence of malaria infection, a random sample of 150 children will be visited every week during the high malaria transmission period. This number will be increased to 300 during the low transmission season, but the survey will be reduced to monthly visits. Baseline prevalence of genetic markers of resistance to SP and AQ will be estimated. A second cross-sectional survey will be conducted at the end of the malaria transmission season to assess the effect of IPT on the prevalence of genetic markers of resistance to SP and AQ, on the prevalence of anaemia and on nutritional indicators.

Eligibility Criteria:
Inclusion Criteria:

* Permanent residence in the study area with no intention of leaving during the surveillance period.
* Obtention of informed consent.

Exclusion Criteria:

* Temporary residence in the study area.
* Absence of informed consent.
* Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
* A history of a previous, significant adverse reaction to either of the study drugs.
NM32-2668 in Adult Patients with Selected Advanced Solid Tumors

This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed, advanced-stage protocol-specified solid tumors.
* Confirmed ROR1 tumor expression.
* Patients who have undergone at least one prior systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable or have medical contraindications to standard therapy.

Exclusion Criteria:

* Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cell engaging therapy.
* Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 days prior to first dose of NM32-2668.
* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of NM32-2668.
* Wide-field radiotherapy (\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of NM32-2668, or no recovery from side effects of such prior interventions.