cyrilzakka/clinical-trials huggingface dataset:
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines

OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell pertussis vaccine vs. placebo in infants living in Italy.

II. Compare the relative protection of each of the acellular vaccines vs. the whole-cell vaccine vs. laboratory-confirmed pertussis.

III. Assess the relative efficacy of the acellular vaccines with respect to one another.

IV. Assess the immunogenicity of acellular vs. whole-cell vaccines in the study population.

V. Compare the frequency of adverse events with each vaccine. VI. Compare the frequency of adverse events attributable to the pertussis component in each of the 3 vaccines.

VII. Assess alternative laboratory diagnostic techniques for pertussis in estimating vaccine efficacy, i.e., mucosal immune response, DNA probes, or antibody response to other components of the organism.

VIII. Assess the relative efficacy estimates of each vaccine, using clinical criteria to compare the relative incidence rates in each vaccine group.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and randomly assigned to 1 of 3 vaccines and a placebo vaccine in a 3:3:3:1 ratio.

One group receives diphtheria-tetanus-pertussis (DPT) vaccine containing filamentous hemagglutinin (FHA), Pt-9K/129G, and 69 kDA outer membrane protein (OMP).

A second group receives DPT containing FHA and OMP. The third group receives DPT containing whole-cell pertussis. The control group receives diphtheria-tetanus (DT) vaccine. All vaccines are administered as an intramuscular or deep subcutaneous injection at 6-12, 13-20, and 21-28 weeks of age. The first vaccine is given at week 12 if hepatitis B or other immune globulin was given at birth.

All patients receive a DT booster at 11 months, and are followed every 4 weeks for approximately 20 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Population Characteristics-- Newborns enrolled at first vaccine clinic visit Weight at first vaccination at least third percentile, i.e.: Girls: 3.2 to 3.8 kg Boys: 3.4 to 4.0 kg No previous illness compatible with pertussis --Prior/Concurrent Therapy-- No prior pertussis vaccination --Patient Characteristics-- Age: Over 6 weeks to under 12 weeks Renal: No renal failure Other: No prior prolonged immunosuppressive therapy No prior systemic corticosteroids, unless duration less than 14 days and at least 48 hours since last dose No major congenital abnormality No failure to thrive No known or possible immune system deficit, e.g.: HIV-infected mother Autoimmune anemia Lymphoma Other erythropoietic disease No perinatal central nervous system disease or damage No history of convulsions Mother Italian-speaking and accessible by telephone Planned residence in clinic district for at least 1 year
Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players

This study is being conducted for a master's dissertation. Our goal is to determine if there are physical performance benefits to performing the FIFA11+ soccer warm-up program in adult female soccer players over an eight week period. This topic has been studied primarily using male soccer players. The performance effects in adult female soccer players is currently unknown.

This warm-up has been shown to reduce non-contact injury rates in soccer players aged \>13. If performance benefits are demonstrated in this study, in addition to the reported injury reduction benefits of the FIFA11+ warm-up, program adherence and player performance could improve.


Eligibility Criteria:
Inclusion Criteria:

* Must be a female amateur soccer players on a North Shore Girls Soccer Club Selects A Team
* Must be between the ages of 18 and 45
* Must play a forward, midfield or defender position

Exclusion Criteria:

* Mustn't play a goal keeper position. The physical demands of this position is drastically different than all other soccer positions. The training effects from practices and games are unique and may therefore influence the effects the FIFA11+ has on players of this particular positions.
* Mustn't have an illness or injury preventing them from participating in soccer practice, games, and testing procedures. Injury or illness would likely result in poorer physical performance outcomes relative to healthy participants.
* Mustn't miss a physical performance testing session. Pre- and posttest data is required to determine if there are changes in performance metrics in relation to both the intervention and control groups.
* Mustn't be pregnant or of childbearing potential for the duration of the study (10 weeks). The PI and Co-Investigators are not familiar with each participant's reproductive health and history or how pregnancy may affect each participant's response to either the intervention or control group. It is therefore decided that participants that are pregnant or of childbearing potential will be removed from the study.
Oxytocin Infusion and Abdominal Myomectomy

Objective:To compare oxytocin infusion with control, in patients undergoing abdominal myomectomy in terms of mean blood loss.

Design: Single blinded randomized control trial Setting: Obstetrics and Gynecology Department, Military Hospital, Rawalpindi Population: 60 women of ASA class I-II, with intramural fibroids, candidate for elective abdominal myomectomy.

Methods: Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given.

Main outcome measure: Intra-operative blood loss


Eligibility Criteria:
Inclusion Criteria:

1. women of ASA class I-II with intramural fibroids,
2. women planned to undergo elective abdominal myomectomy

Exclusion Criteria:

1. Women with hemoglobin (Hb) \< 10g/dl
2. Women with any respiratory or cardiovascular disease.
Post-fracture Medication and Mortality

Osteoporotic fracture is a common public-health problem in the whole world. Although postfracture usage of anti-osteoporosis medications, may reduce mortality, recent results have been inconsistent. The investigators aim to examine associations between osteoporosis medication and mortality in older adults and any type of fracture patients. The investigators also aim to discuss the pleiotropic effects of different types of anti-osteoporosis medications.

Osteoporotic fracture has become a serious health and economic burden as life expectancy increases. In a WHO report, the burden of osteoporotic fractures in 2002 was 2.8 million disability-adjusted life years, which is more than that for hypertension and slightly less than that for diabetes mellitus or chronic obstructive pulmonary diseases. Many patients who have had a diagnosed fracture have never been diagnosed with osteoporosis, therefore, closing the gap in osteoporosis treatment is important. This situation is primarily due to the fact that osteoporosis symptoms are often not recognized until a fracture occurs. Osteoporotic fractures, especially those of the hip and vertebral, are associated with an increased risk of death. Early detection of high risk for osteoporotic fractures is important; however, post-fracture management, especially interventions intended to lower mortality, is an emerging public health issue in rapidly aging societies. The burden of osteoporotic fracture is higher than that of hypertension, however, osteoporosis is always given less attention than other chronic diseases by health professionals and the general population.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed osteoporosis and hip fracture are defined as a claim record from the NHIRD between 2009 and 2017.

Exclusion Criteria:

* Patients with a diagnosis of osteoporosis or osteoporotic fractures in 2008 or before were excluded.
Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model

The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).

This is a prospective observational multicentre study. The study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients) by using therapeutic drug monitoring(TDM). A population-pharmacokinetic(PPK) model of CAZ-AV in these patients will be established in this study. The main question it aims to answer is the clinical success rate and microbiological success rate of CAZ-AVI based regimen in the treatment of critically ill patients with CRO infections. According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of CAZ-AVI, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

1. 18-85 years old.
2. Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
3. Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
4. at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.
5. sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.
6. intravenous injection of Ceftazidime Avibactam for more than 72 hours.
7. understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing.

Exclusion Criteria:

1. Participants are less than 18.
2. Death within 72 hours after the start of treatment.
3. Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.
4. No indication for treatment with ceftazidime avibactam.
5. Pregnant and lactating women.
Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136

The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.

The chronicity of the disease which will require treatment over decades, long-term adverse events associated with standard combined antiretroviral therapy, emphasize the need for simpler, alternative treatment strategies for HIV infection. The goal of antiretroviral therapy in 2006 is the durability of treatment with less toxicity and reduced exposure to drugs. Previous studies have shown that single boosted PI maintenance therapy such as lopinavir (LPV/r), were effective in maintaining virological efficacy. Furthermore, in case of virological failure, limited resistance has been described. darunavir/r, a new PI, has been shown to be highly potent, exhibits a high genetic barrier to resistance and appears to be well tolerated. This study aimed to evaluate whether darunavir/r can represent a potential strategy therapeutic as single therapy in patients who have full virologic suppression At entry, subjects with HIV RNA below 50 cp/ml switch from their current therapy which can be 2 NRTI and IP, 2 NRTI and NNRTI, 3 NRTI to darunavir/r with their 2 NRTIs for 8 weeks (Phase I). If patients remain below 50 cp/ml and has no intolerance to darunavir at week -4, they are included in the phase II and will be randomized either to receive darunavir/r alone or to continue 2 NRTI and darunavir/r for until W48 (Phase II). Patients will be monitored at W4, W8 and then every 8 weeks until W48 for the primary endpoint. To evaluate the durability and safety of this strategy, patients will be followed up to W96

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1 infection.
* Documented level of HIV-1 RNA at initiation of antiretroviral treatments
* Prior antiretroviral regimen, including at least 2 NRTIs combined to 1 PI or NNRTI or a third NRTI for at least 18 months prior to study entry.
* CD4 count of 200 cells per mm3 or greater.
* Viral load below 400 copies per ml within 18 months prior to entry and below 50 copies per mL at entry.
* Willing to use acceptable methods of contraception

Exclusion Criteria:

* Previous virological failure under prior PI-based regimen.
* Prior therapy in the darunavir.
* HIV-2 infected patients.
* Absence of documented level of HIV-1 RNA at initiation of antiretroviral treatments
* Hepatitis B or C infection within 90 days prior to study entry.
* Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
* Serious acute illness requiring systemic treatment or hospitalization in the 14 days prior to study entry.
* Treatment for an active AIDS defining opportunistic infection within 30 days prior to screening
* Drug or alcohol use or any dependence that would interfere with compliance.
* Pregnancy or breastfeeding
CAREMM-2306: Advanced Immunotherapy vs. Classical Immunotherapy

The goal of this retrospective study is to compare between the case cohort and control cohort.

The case cohort consists of lymphoma patients treated with novel immunotherapy regimen including Chimeric antigen receptor T cell therapy, bispecfic antibody, and/or antibody-drug conjugate.

The control cohort consists of lymphoma patients who received conventional chemotherapy as standard-of-care

The main question\[s\] it aims to answer are:

* Survival times
* Response outcomes

1. Primary endpoints Comparison of survival time by treatment between two groups
2. Secondary endpoints 2.1 Comparison of progression-free survival between two groups 2.2 Comparison of response rates between two groups 2.3 Comparison of input medical costs between two groups.

2. Study subjects: Patients treated for lymphoma at Yeouido St. Mary's Hospital and Seoul St. Mary's Hospital (Both are located on Seoul, Korea) between May 2009 and June 2023.

3. Selection criteria: 3.1 Patients diagnosed with malignant lymphoma at Catholic Yeouido St. Mary's Hospital and Seoul St. Mary's Hospital between May 2009 and June 2023.

3.2 Age 19 or older. 3.3 Patients who treated with salvage chemotherapy for the relapsed/refractory lymphoma.

4. Exclusion criteria: 4.1 Patients suffering from acute leukemia. 4.2 Patients additionally diagnosed with solid cancer (colon cancer, lung cancer, stomach cancer, etc.) during treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with malignant lymphoma at Catholic Yeouido St. Mary's Hospital and Seoul St. Mary's Hospital between May 2009 and June 2023.
2. Age 19 or older.
3. Anti-cancer salvage chemotherpay for the treatment of relapsed/refractory lymphoma.

Exclusion Criteria:

1. Patients suffering from acute leukemia.
2. Patients additionally diagnosed with solid cancer (colon cancer, lung cancer, stomach cancer, etc.) during treatment.
Change In Diaphragmatic Thickness Predicts Extubation Success

We will investigate whether measurement of the change in thickness of the diaphragm during the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We will also asses whether this is only possible on low levels of pressure support as has been shown previously, or if this technique retains its predictive power at higher levels of pressure support.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18, ventilated for \>24 hours

Exclusion Criteria:

* already chronically on mechanical ventilatory support, already has tracheostomy, has pathology that obscures visualization of the right hemidiaphragm, has acute stroke either hemorrhagic or ischemic, cannot identify appropriate decision maker to get informed consent.
Clinical Study of AK159 in Healthy Postmenopausal Women

The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.

This study consists of Part 1 and Part 2. \<Part 1\> Part 1 will be conducted according to a single-centre, randomized, single-dose, 3-period, 5-treatment alternating crossover design in two groups of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of a single dose of AK159 (4 levels) will be investigated versus teriparatide acetate for injection as a control.

\<Part 2\> Part 2 will be conducted according to a multiple-centre, randomized, double-blind, placebo-controlled, repeated dose parallel design of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of AK159 (4 levels) for 8 weeks will be investigated versus teriparatide acetate for injection and placebo as controls. Pharmacokinetics, safety, and tolerability following long-term application will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal ethnic Japanese women; At least 45 years of age at the time consent is obtained; and Give voluntary consent in writing with a sufficient understanding of the study.

Exclusion Criteria:

* Clinical abnormality identified in the laboratory tests
* Weight \< 40.0 kg
* Body mass index \< 17.5 or \>=30.5
* History of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects
* Previously received radiation treatment potentially affecting bone
* Systolic blood pressure \< 90 mmHg
* QTc exceeds 470 msec in a 12-lead electrocardiography
* Serum calcium level exceeding 10.4 mg/dL
* History of contact dermatitis or skin disease potentially compromising study evaluation
* Used drugs which impact bone metabolism in the 8-week period preceding investigational product administration
* Used a bisphosphonate;
* Used a teriparatide product;
Changes in Out-patient Visits in Taiwan During the Time of Global COVID-19 Pandemic

The COVID-19 pandemic becomes a global challenge. This study aims to analyze the possible changes in out-patient visits during the time of COVID-19 pandemic between January and June, 2020, compared with the same period in 2019, and the impact of the related healthy policies.

Using the statistical data of the Health Insurance Bureau, this study aims to analyze the possible changes in out-patient visits during the time of COVID-19 pandemic between January and June, 2020, compared with the same period in 2019, and the impact of the related healthy policies.

Eligibility Criteria:
Inclusion Criteria:

* patients visited the out-patient clinic using the health insurance cards.

Exclusion Criteria:

* patients visited the out-patient clinic without using the health insurance cards.
The Effect of Continuous Midwifery-led Care in Birth Management

Caesarean section is an emergency procedure necessary to prevent harm or death to the mother or newborn. Worldwide, caesarean section rates are steadily increasing. This increase not only has negative consequences on maternal and child health, but also leads to a reduction in essential resources and impedes access to health services worldwide. The International Federation of Gynaecology and Obstetrics (FIGO) has called for help from government bodies, professional organisations, women's groups and other stakeholders to reduce unnecessary caesarean sections. According to a review of antenatal and intrapartum interventions to reduce caesarean section, promote vaginal birth and reduce fear of childbirth; the importance of support in the intrapartum period is prominent. The National Institute for Health and Care Excellence (NICE) states that this support with a midwife who provides care and one-to-one support to the woman in labour reduces women's anxiety and increases their sense of trust.

Vaginal delivery of low-risk pregnancies is best provided and guided by a midwife. It is seen that receiving support from a midwife in the birth of low-risk pregnancies does not increase the risks for the mother or newborn and has many economic and emotional advantages. The World Health Organisation recommends respectful care based on woman-centred care in the intapartum period for a positive birth experience. Respectful Maternity Care has been recognised as a key strategy to improve the quality of maternity care. Although there is no clear consensus on the definition of respectful maternity care, it is generally considered synonymous with intimate and woman-centred care. It is a care approach that emphasises the fundamental rights of women, newborns and families and increases adequate access to evidence-based care while recognising their needs and preferences. In this direction, midwives are expected to add respectful maternity care to their clinical skills in the management of the birth process. In the literature, it is seen that respectful and helpful interaction between women and health professionals during labour creates positive perceptions in women. In the study of Liu et al. (2021), it is stated that midwife-led management of labour leads to the formation of positive perceptions in women. Fear of labour, labour pain and duration of labour in midwife-led care on the behaviour of the students in the study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with spontaneous pregnancy between 38-42 weeks of gestation
* single fetus head presentation
* first pregnancy
* without any pregnancy-related risk status (such as preeclampsia, gestational diabetes)
* who were admitted to the delivery room for normal labour will be included in the study.

Exclusion Criteria:

* WOMEN WHO CANNOT GIVE BIRTH NORMALLY
* WANT TO LEAVE THE LABOUR FORCE
Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer

Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
* ECOG Performance Status of 0 to 1.
* Adequate organ function as defined by study-specified laboratory tests.
* Signed informed consent form.
* Willing and able to comply with study procedures.

Exclusion Criteria:

* Previous chemotherapy or target therapy.
* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
* Systemically active steroids.
* Another investigational product within 28 days prior to receiving study drug.
* Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
* Infection with HIV, hepatitis B or C at screening.
* Pregnant or lactating.
* Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.