cyrilzakka/clinical-trials huggingface dataset:
Assessment of Ventilation Parameters for Extubation Prediction in ICU

The study aims to research the values of mechanical power, driving pressure, and elastic power in predicting the duration of mechanical ventilation in critically ill patients undergoing invasive mechanical ventilation. This will help determine which patients may be considered for early extubation, which patients should wait for extubation, and the patients where extubation is anticipated to be prolonged, attention should be paid to initiating preparations for alternative treatment methods like tracheostomy early.

Due to acute respiratory failure, mechanical ventilation support is provided to over 20 million patients worldwide. Therefore, various studies are being conducted to prevent ventilation-associated lung injury in patients receiving invasive mechanical ventilation, especially in conditions such as acute respiratory distress syndrome (ARDS).

Initially, protective mechanical ventilation studies have shown that keeping plateau pressure (Pplat), reflecting static compliance, below 30 cmH2O along with low tidal volume reduces all-cause mortality. Subsequent studies have defined driving pressure as Pplato-PEEP, suggesting that keeping driving pressure below 15 cmH2O may reduce excessive strain on healthy lung tissue and the development of ventilator-associated lung injury.

In 2016, Gattinoni and colleagues defined mechanical power as the power applied by the ventilator to the entire respiratory system per minute during mechanical ventilation, prompting research into the relationship between mechanical power and mortality, particularly in ARDS.

Mechanical power consists of three components: energy delivered with each breath when PEEP is applied, energy applied to overcome airway resistance, and elastic energy delivered with each tidal breath.

Finally, Yongpeng Xie and colleagues hypothesized that elastic power, normalized by compliance, has a more significant relationship with mortality in ARDS patients. Studies on mechanical power, driving pressure, and elastic power typically focus on values measured on the first day of intubation and are predominantly conducted in ARDS patients.

By including all patients under invasive mechanical ventilation in the study, the importance of measuring and monitoring mechanical ventilator parameters (mechanical power, driving pressure, and elastic power) at 0th, 24th, and 48th hours to predict extubation within the first week is being determined. This aims to identify when early extubation should be considered, when extubation should be delayed, and to prepare for alternative treatment options like tracheostomy in cases where extubation might be prolonged.

Eligibility Criteria:
Inclusion Criteria:

* consenting patients who have recently been intubated for acute respiratory failure

Exclusion Criteria:

* patients with lung cancer/ lung metastasis
* ECMO
* death within 24 hours
Trial of Simplified Pneumococcal Vaccination in Vietnam II

This is a single-blind, open-label, randomised controlled trial with five groups. There are four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.

This is a single-blind, open-label, randomised controlled trial with five groups. There are four different PCV schedules to be evaluated: a 0+1 schedule of PCV10 at 12 months of age (Group V), a 0+1 schedule of PCV13 at 12 months of age (Group W), a 1+1 schedule of PCV10 at 2 and 12 months of age (Group X), and a 1+1 schedule of PCV13 at 2 and 12 months of age (Group Y); along with a control group that receives a dose of PCV10 at 24 months of age (Group Z). Additionally, all participants will receive four doses of Infanrix-hexa at 2, 3, 4 and 18 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 2 months and 2 months plus 2 weeks;
* No significant maternal or perinatal history;
* Born at or after 36 weeks gestation;
* Written and signed informed consent from parent/legal guardian;
* Lives within approximately 30 minutes of the commune health centre;
* Family anticipates living in the study area for the next 22 months

Exclusion Criteria:

* Known allergy to any component of the vaccine;
* Allergic reaction or anaphylactic reaction to any previous vaccine;
* Known immunodeficiency disorder;
* Known HIV-infected mother;
* Known thrombocytopenia or coagulation disorder;
* Administration or planned administration of any immunoglobulin or blood product since birth;
* Severe birth defect requiring ongoing medical care;
* Chronic or progressive disease;
* Seizure disorder;
* History of severe illness;
* Receipt of any 2 month vaccines through the Expanded Programme of Immunization (EPI) program;
* Family plans on giving the infant Quinvaxem (DTP-Hib-HBV).

Additionally, enrolment will be deferred and infants asked to return to the health centre one week later for reassessment if they have at least one of the following deferral criteria:

* Axillary temperature ≥37.5°C or ≤35.5°C;
* Acute infection, especially bacterial;
* Oral administration of corticoid therapy in past 14 days; or
* Any of the following symptoms that interfere with normal activities: crying more than usual, sleeping more than usual, or loss of appetite.
Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration (IMMUNOSEPSIS)

Septic syndromes (systemic inflammatory response associated with infection) remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units. While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immunologic response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and deactivated monocyte functions). New promising therapeutic avenues are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (IFNg, GM-CSF, IL-7) however relies on the investigators capacity in identifying the patients who could benefit from it, as there is no clinical sign of immune dysfunctions. The main objectives are:

1. to identify the best biomarkers for sepsis-induced immunosuppression and
2. to evaluate ex vivo whether drugs could rejuvenate immune functions.


Eligibility Criteria:
Inclusion Criteria:

* septic shock is defined by an identifiable site of infection, persisting hypotension despite fluid resuscitation requiring vasopressor therapy, and evidence of a systemic inflammatory response

Exclusion Criteria:

* age \< 18
* immunosuppressive disease (HIV, cancer, primary immune deficiency)
* immunosuppressive treatment or corticoid treatment (dosage \> 10mg/day or cumulative dose \>700 mg equivalent prednisolone)
* aplasia as defined by number of circulating neutrophils \< 500 cells / mm3
* extracorporeal circulation during the month prior ICU admission
Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)

Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports have demonstrated severe infectious complications including psoas abscess and necrotizing fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques increase in popularity, infectious complications will undoubtedly become more common.

The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of antiseptic solutions with an alcohol base for skin disinfection before peripheral regional techniques due to their penetration of the stratum corneum and their rapid and prolonged effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution for skin preparation before epidural catheter and intravascular device insertion (Kinirons et al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora associated with short term ( 48 hours) postoperative continuous femoral nerve catheter placement. The investigators will also compare the ability of chloraprep and betadine disinfection at the time of catheter placement to prevent bacterial contamination of the continuous femoral catheter.

After antisepsis four different cultures will be analyzed:

1. The femoral nerve catheter will be removed after 48 hours and a culture of the distal tip of the femoral nerve catheter will be performed between the 2 arms.
2. immediately before skin antisepsis, a culture of the the skin will be performed to identify baseline skin flora.
3. immediately after antisepsis with both betadine and chlorhexidine, a culture of the skin will be performed to assess antiseptic efficacy.
4. just prior to removal of the femoral nerve catheter, a culture of the skin/catheter interface will be performed between the 2 arms.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3,
* Undergoing primary total knee arthroplasty.

Exclusion Criteria:

* Hypersensitivity/allergy to antiseptics,
* Recent opioid/alcohol abuse,
* Presence of contraindications to regional anesthesia,
* Coagulation disorder,
* Diabetic/femoral neuropathy,
* Prior surgery to inguinal area,
* Patient refusal.
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)

The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.

The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Eligibility Criteria:
Inclusion Criteria:

* women with a uterus
* presence of a mullerian variation
* Maximum age 45y

Exclusion Criteria:

* women without a uterus
* aged \>45y
Intervention for Abused Chinese Immigrant Women

The purpose of this study is to evaluate the efficacy of a purpose-built intervention in improving the mental health of abused Mainland Chinese immigrant women in a community in Hong Kong.

Depression is one of the most common mental health sequelae of Intimate partner violence. Not only does depression have an adverse effect on abused women's health and well-being, it also reduces their capacity to cope with the abuse by limiting their ability to perform self-care, meet work requirement, maintain independence, establish relationships, and access social support. Previously, the ability of abused women to take care of themselves was found to be a protective factor for depression. In order to enhance abused women's self-care, advocacy interventions have been developed to help them make sense of the abusive situation, identify potential solutions, and achieve their goals. Also, immigration status was shown to be significantly associated with a higher level of depressive symptoms among the abused women. The findings are important as they point to the need for further research to develop and evaluate culturally congruent interventions to meet the needs of abused Mainland Chinese immigrant women in Hong Kong. Therefore, the purpose of this study is to develop a purpose-built intervention to address the unmet needs of Mainland Chinese immigrant women survivors of Intimate partner violence and to assess its effect on the mental health of the women.

Eligibility Criteria:
Inclusion Criteria:

* Mainland Chinese immigrant women,
* 18 years of age or older,
* holding a one-way or two-way permit,
* have settled in Hong Kong with their intimate partners for less than seven years,
* have at least one child under 18 years of age,
* residing in the Kwai Chung, Tsuen Wan or Tsing Yi districts, and
* assessed to be abused by an intimate partner, based on the Abuse Assessment Screen.

Exclusion Criteria:

* participated in our positive parenting program or advocacy intervention previously, or
* will not be in Hong Kong during the intervention/standard health education program or the follow-up telephone interview, or
* is abused by someone who is not her intimate partner, or
* is unable to communicate in Cantonese or Putonghua.
Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews

The tools to measure safety culture (CS) have recently become available. No study has focused on the measure in France, apart from pilot studies. intensive services are particularly at risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or therapeutic strategies have report "risk-benefit" narrow. They may well be complicated by EIG.Safety of care is a priority in the field of health in general, and especially in intensive care. CS measure in this context seems particularly relevant.

The main objective is to describe the CS intensive care units in France. The study will explore the development of the CS level for the units investigated.

This study will also describe the main features of RMM practiced in intensive care units in France.


Eligibility Criteria:
Inclusion Criteria:

* practicing resuscitation activity (this practice is medical or surgical, pediatric or adult, in public or private sector)
* volunteer to participate in the study (agreement of the head of the unit)
* for which at least 2 matching / references for the study were identified:

  * a medical officer,
  * caregiver responsible (Health Framework).

Exclusion Criteria:

* measurement safety culture done in a period of significant change during a period where the staff and activities of the respondent unit of work is relatively stable.
* the responses of professionals to the questionnaire can be influenced by internal factors in their work unit (recent accident occurred, change of close supervision, personnel changes ...) and by factors external to their unit work (establishment certification period, arrival of a new director, recent media coverage of medical accidents ...).
Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

Objectives: To compare the stability of implant surface treated by dual acid etching (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after installation.

Methods: it will be a clinical study with individuals with missing teeth requiring rehabilitation with dental implants in the maxilla and that fulfill the study inclusion criteria. The research sites will be randomized into two groups: the control group patient's sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive statistics and comparative.


Eligibility Criteria:
Inclusion Criteria:

* patients who have missing teeth in the maxilla,
* over 30 years old and under 60 years old,
* the implant sites with at least 3 months of healing after extraction,
* the implant sites with width and length to installation of an implant of 4 mm x 10 mm.

Exclusion Criteria:

* patients who experience any of the following conditions:
* general contraindications for surgical procedures,
* uncontrolled diabetes,
* severe bruxism or clenching,
* pregnant and lactating women,
* active periodontal disease,
* smoker and user of alcohol or drugs.
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Eligibility Criteria:
Inclusion Criteria:

* Total serum testosterone concentrations \< 300 ng/dL at baseline

Exclusion Criteria:

* Presence or history of prostate cancer
* Elevated PSA \> 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.
A Decision Aid for Women With Early Stage Breast Cancer

To enhance information transfer and decision making for women with breast cancer.

Our specific objectives are: (i) to develop computer and paper based versions of the Decision Boards for (a) chemotherapy for early stage breast cancer (chemotherapy versus no treatment), (b) mastectomy versus lumpectomy plus radiation and (ii) to compare the relative effectiveness of the computer and paper based versions with the standard Decision Board for patients with early breast cancer.

Eligibility Criteria:
Inclusion Criteria:

Chemotherapy Group:

* Female
* Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy
* Axillary node dissection
* Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option

Surgery Group:

* Female
* Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy
* Clinical stage I or II disease
* Candidate for breast conserving surgery

Exclusion Criteria:

Chemotherapy Group:

* Candidate for CEF chemotherapy
* Clinical evidence of metastatic disease
* Serious comorbidity that would preclude receiving chemotherapy treatment
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making

Surgery Group:

* Previous surgery for breast cancer
* Previous breast irradiation
* Pregnant
* Clinical suspicion of bilateral breast cancer
* Serious comorbidity that would preclude definitive surgery
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making
A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Patients with treatment-requiring chronic lymphocytic leukemia (CLL)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Life expectancy \>6 months

Exclusion Criteria:

* Transformation to aggressive B-cell malignancy
* History of other malignancy unless the patient was treated with curative intent and has been in remission for more than 5 years prior to enrolment
* HIV or Hepatitis B positive unless clearly due to vaccination
* Inadequate liver or renal function
* Any coexisting medical or psychological condition that would preclude participation in the required study procedures

Additional exclusion criterion for Part 1:

* Any previous treatment for CLL except for up to 4 cycles of rituximab IV in combination with FC chemotherapy as first-line treatment for CLL

Additional exclusion criterion for Part 2:

* Any previous treatment for CLL
Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period

H0: Preconceptional preparatory training period between pregnancies with and without women is no difference in terms of changes in health behavior.

H1: Preconceptional preparatory training period between pregnancies with and without women there is a difference in terms of changes in health behavior.

In order to reach for the second follow-up of women both her and her partner/mother phone number were registered.

Eligibility Criteria:
Inclusion Criteria:

* Accept to participate in the research and have signed the informed consent form,
* Being over 18 years old,
* To be literate,
* Lack of a psychological diagnosis,
* To be married,
* Having no pregnancy,
* Pregnancy is thought.

Exclusion Criteria:

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