cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery

Adequate equipment for lifelong health is essential to ensure healthy health for fetal development. In France, pregnant women with normal weight have increased protein intake to 0.78-0.95g / kg / day (ANC 2001). And more recently, AFSSA from 2007 proposed a recommended nutritional intake of 0.82-1g / kg / d. An increased requirements in the second and third trimester of 0.25 g / kg / day and 0.46 g / kg / day, respectively, compared with non-pregnancy values. However, the prevalence of the incompatibility remains unknown.

In addition, maternal protein intake is inadequate or excessively associated with both intra-uterine growth retardation and small gestational age weights. Neonatal hypotrophy is also associated with a risk of chronic diseases in adulthood, including cardiovascular disease, type 2 diabetes, insulin resistance, high blood pressure and coronary heart disease.

In obese women or patients undergoing surgery for bariatric surgery, there is currently no recommendation on the recommended protein intake. Or, maternal obesity plays a role in the metabolic development of children and bariatric surgery is associated with a major risk of maternal micronutrient deficiencies and intra-uterine growth retardation.

Prevalence of obesity in France is currently estimated at 17%. Moreover, bariatric surgery is also fast-growing in France with a number of interventions having tripled since 2006.

Thus, a better understanding of maternal food needs and applications throughout pregnancy is needed to improve dietary guidelines and promote fetal, neonatal and long-term health.

The main objective is to evaluate the protein intake of the pregnant woman in the 3rd trimester of pregnancy in 3 populations:

* Women with BMI ≥ 18.5 and \<30 kg / m² (group 1)
* Obese women (BMI ≥ 30 kg / m²) (group 2)
* Women operated on a bariatric surgery (group 3)

Eligibility Criteria:
Inclusion Criteria:

* - Pregnant women from 20 amenorrhea weeks.
* Women aged at least 18 years old.
* Women with BMI ≥ 18.5 and \<30 kg / m² = Group 1
* Obese women (BMI ≥ 30 kg / m²) = Group 2
* Women operated on a bariatric surgery (by-pass, sleeve-gastrectomy, gastric band) = Group 3

Exclusion Criteria:

* - Women with BMI \<18.5 kg / m²
* Troubles of eating behavior
* Women with gestational diabetes
* Medical history of type 1 or type 2 diabetes
* Multiple pregnancy
Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Eligibility Criteria:
Inclusion Criteria:

* Using oral contraceptive pills (OCPs) for less than 1 month, or plan to initiate OCP use at their current visit
* Be willing to use OCPs that are on formulary for the duration of the study
* Having a personal mobile phone with text messaging capabilities
* Proficiency in English or Spanish
* Agreeing to surveys regarding demographics, pill adherence behavior and its influences
* If younger than 18, must be accompanied by a parent or legal guardian who can provide informed consent for research participation

Exclusion Criteria:

* Electing OCPs solely for non-contraceptive benefits only
* Interest in pregnancy within the next 12 months
* Inability to give informed consent
* Planning to move from the local area before study completion, and is unable to return for follow-up and return the electronic pill bottle
* Planning travel outside the cell phone networks of United States or Canada
* Being in a situation where receiving text messages to take a birth control pill may endanger the safety of the subject
AMS Study: Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy

The purpose of this study is to examine the relationship between muscle activation and heart rate on joint generalized inflammation and arthritis development.

This study will test the hypothesis that knee trauma (as exemplified by the arthroscopy procedure) causes inflammation that alters muscle activation patterns locally and also disrupts the balance between parasympathetic-sympathetic reflexes. It is hypothesized that these factors contribute to development and progression of knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 or older
* Potential candidate for knee arthroscopy for medial
* Meniscal tear confirmed on MRI
* Prior meniscal resection at least 1 year prior with a persistent knee effusion
* Body mass index between 25-35 kg/m2

Exclusion Criteria:

* Knee injury in the 1 month before the initial study evaluation
* Knee surgery within 1 year before the initial study evaluation
* Pace-maker or defibrillator, 2nd or 3rd degree heart block, or other abnormal rhythms
* Current diagnosis of diabetes mellitus, a fasting glucose\>100mg/dl or \>140 mg/dl 2 hour after a glucose challenge
* Current diagnosis of an inflammatory condition (e.g. rheumatoid arthritis, gout, etc)
* Untreated thyroid disease
* Morbid obesity (body mass index \>35)
* Neuropathy or nerve damage
* Stroke or transient-ischemic attacks (mini-stroke)
* Recent diagnosis of congestive heart failure or heart attack
* Use of prednisone or chemotherapy, steroid or other joint or ant-inflammatory agents in the past 3 months
* Current use of medications that influence heart rate
* Cognitive impairment that limits your ability to provide informed consent
* Pregnancy
Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure

We compared the effects of 8 weeks of aerobic exercise only, resistance exercise only, or a combination of both on blood pressure in overweight or obese middle-aged adults with elevated blood pressure. Participants engaged in supervised exercise sessions 3 times per week for 60 minutes each session. Outcomes were assessed at baseline and after the 8-week intervention. Extra-intervention physical activity and diet were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Systolic/diastolic blood pressure of 120-159/80-99 mm Hg
* Non-smoking
* Overweight or obese, with a body mass index of 25-40 kg/m2
* Inactive--not meeting the aerobic or resistance physical activity guidelines, which means engaging in less than 150 minutes/wk of moderate intensity aerobic exercise and less than 2 days per week of resistance training over the past 3 months.

Exclusion Criteria:

* Unstable coronary heart disease or decompensated heart failure
* Severe pulmonary hypertension or aortic stenosis
* Acute myocarditis, endocarditis, pericarditis, or aortic dissection
* Other medical condition that is life-threatening or that can interfere or be aggravated by the exercise training such as cancer, uncontrolled diabetes, severe pain or mobility limitations.
* Premenopausal women or postmenopausal women taking hormonal replacement therapy
* Pregnant women or anticipated pregnancy via IVF or other medical procedures during the course of the intervention
Validation of an Allergic Rhinitis Control Test in Children

Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 5 to 11 years old, consulting a practitioner for an allergic rhinitis
* Parents formulated their study participation agreement by signing the consent form.

Exclusion Criteria:

* Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatment.
Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles

This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient units.

Hospital physiologic monitors can alert clinicians to early signs of physiologic deterioration, and thus have great potential to be life-saving. However, monitors generate frequent alarms, most of which are non-actionable.

When clinicians become overburdened with alarms, they begin to exhibit alarm fatigue: responding more slowly to alarms or ignoring alarms entirely. In this protocol the investigators outline the methods they will use to evaluate the impact of a safety huddle-based intervention on physiologic monitor alarm rates using a pragmatic, paired, cluster-randomized controlled trial with the intervention delivered at the unit level. This work is considered quality improvement research, and some of the approaches described in this protocol are from the field of quality improvement.

Currently, at most hospitals data like this on the numbers of alarms that patients generate are only available to researchers with the software tools needed to interrogate and record data from the monitor network. The goal of this proposal is to bring this data to the safety huddles occurring daily on inpatient units in an accessible format to help teams make informed decisions about monitoring and minimize the potential of harm from alarm fatigue.

Eligibility Criteria:
Inclusion criteria: Any nurse, physician, nurse practitioner, or physician assistant caring for a patient whose alarms are discussed in a safety huddle on an intervention unit.

Exclusion criteria: none
Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation

Each year, 110,000 English/Welsh patients are admitted to Intensive Care Units (ICU). Many face prolonged disability as a result. Over two thirds have moderate-extreme limitation in their usual activity a year later, and one-third are severely affected, being unable to continue "most activities," or to live independently. Quite why known- but severe muscle wasting isn't may play an important role. We hope to find out, measuring the degree of wasting in patients, and seeking potential causes. We shall also address the mechanism of wasting, which may reflect an altered balance of activity in muscle growth pathways and those that break muscle down. We'll do this by collecting data, taking regular blood tests, scanning the leg muscles with an ultrasound machine, and analysing small muscle samples. In addition, we'll accurately and objectively measure how impaired these patients become, using specialist questionnaires, special monitoring equipment, simple walking tests and occasional special ('Cardio-Pulmonary') exercise tests. We'll try to see how badly activity is limited, and tease out whether muscle weakness plays a significant role in this. Finally, keeping muscles working (hard to do when unconscious/drowsy/bed-bound) may maintain muscle mass, so we'll see whether maintaining muscle activity using painless electrical stimulation will help.


Eligibility Criteria:
Inclusion Criteria:

* Ventilated patients aged \> 18 years likely to survive and remain ventilated for 48 hours and on ICU for 7 days will be recruited.

Exclusion Criteria:

* Those who are pregnant,
* Have active malignancy,
* Have primary muscle/bilateral lower limb disorders or
* Are unlikely to survive 48 hrs.
Associations of Vitamin D Receptor ApaI and Tru9I Polymorphisms With the Risk of Primary Open-angle Glaucoma

This study investigated whether vitamin D receptor gene polymorphism is altered in primary open-angle glaucoma subjects carrying the risk allele.Primary open-angle glaucoma patients and age-matched people in the Han population were enrolled. Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique.


Eligibility Criteria:
Inclusion Criteria:

* intraocular pressure greater than 22 mmHg with two or more medications wide anterior chamber angle glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect) visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry

Exclusion Criteria:

* the presence of any secondary glaucoma including exfoliation syndrome or a history of ocular trauma high myopia macular degeneration other ocular diseases a known history of systemic diseases and administration of vitamin D3 or other analog
G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective randomized controlled study, the safety and efficacy of G-CSF+ Decitabine + BUCY and BUCY myeloablative conditioning regimens in patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT are evaluated.

Allo-HSCT appears to be an efficient tool to cure patients with MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. BUCY conditioning regimen is the standard myeloablative regimen for MDS and AML secondary to MDS undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of G-CSF + Decitabine + BUCY and BUCY myeloablative conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma

Previous rather poor results in liver transplantation (LT) of patients with advanced hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment for HCC patients after LT. We reported here the improved outcome of LT with combined treatment of ADV-TK gene therapy in patients with intermediate or advanced HCC.

The overall survival in the LT with ADV-TK gene therapy group was 54.8 % at three years, and the recurrence-free survival in the same group was 56.5 %, both being higher than those in the transplantation only group (P=0.0001 for overall survival and P=0.0000 for recurrence-free survival). In no-vascular invasion subgroup treated with LT with ADV-TK therapy, both overall survival and recurrence-free survival were 100 %, significantly higher than those with vascular invasion subgroup treated with the combined LT and ADV-TK therapy (P=0 for each group). Vascular invasion was an important factor affected survival and recurrence, hazard ratio=3.687; P=0.014 and hazard ratio=12.961; P=0.000, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of advanced hepatocellular carcinoma with no metastasis in lungs and bones
* Accept Liver Transplantation

Exclusion Criteria:

* Small hepatocellular carcinoma
* Advanced hepatocellular with metastasis in lungs and bones
Effectiveness and Safety Study of Filgrastine® in Patientes With Breast Cancer Treated With Myelotoxic Chemotherapy

Randomized Study of the Clinical Efficacy and Safety of Filgrastine® in Patients with Breast Cancer Treated with Myelotoxic Chemotherapy.

Primary Objective: to evaluate the activity and safety of Filgrastine® in Brazilian patients undergoing adjuvant treatment for breast cancer, with the frequency of grade 4 neutropenia in the first cycle of chemotherapy as the primary endpoint.

Secondary Objectives:

* Frequency of febrile neutropenia during treatment;
* Frequency of neutropenia of any degree in the first cycle;
* Frequency of hospitalization during treatment;
* Duration of grade 4 neutropenia in the first treatment cycle;
* Toxicity during treatment;
* Immunogenicity throughout treatment.

All endpoints will be descriptively analyzed in both groups of patients.

Study design Randomized (2:1), open-label, multicenter study.

Chemotherapy will be given on the first day of each cycle of treatment, for a maximum of four to eight cycles, depending on the regimen, patients whose chemotherapy treatment is prolonged beyond this period being withdrawn from the study.

Patients will be evaluated through laboratory tests, including complete blood count, biochemistry and anti-filgrastim antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Provision of the Free and Informed Consent Form by written;
* Female sex;
* Age between 18 and 75 years old;
* Diagnosis of breast cancer confirmed by cytology or histopathology;
* Disease in stages II or III, according to the classification tumor-node-metastasis (TNM);
* Indication of chemotherapy with full dose of one of the regimens eligible;
* Performance status of 0 or 1;
* Appropriate body functions (absolute neutrophil count \[CAN\] ≥1,500/mm³; platelet count ≥150,000/mm³; serum creatinine ≤1.2 mg/dL; bilirubin and transaminases ≤1.5 times the upper limit of normal).

Exclusion Criteria:

* Previous use of chemotherapy;
* Previous use of filgrastim;
* Prediction of prophylactic or therapeutic use of antibiotics, antifungals or antivirals in the first cycle of chemotherapy;
* Previous radiotherapy involving the pelvis or radiotherapy from any site within the last 6 weeks prior to randomization;
* History of bone marrow transplantation (as a recipient);
* Presence of other neoplasms;
* Presence of severe co-morbidities;
* Recent (\<6 months) or planned participation in other studies clinical trials involving drugs of any nature or in studies of any form of intervention;
* Known intolerance or allergy to any of the components the filgrastim formulations evaluated in the study;
* Pregnancy or lactation (patients of childbearing potential must have a negative serological pregnancy test dated within 7 days prior to randomization).
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer

This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* metastatic pancreatic cancer (adenocarcinoma);
* good liver, kidney, and bone marrow function.

Exclusion Criteria:

* previous systemic treatment for metastatic pancreatic cancer;
* pregnant or lactating females;
* fertile men, or women of childbearing potential, not using adequate contraception;
* major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
* current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study.
Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation

Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not

Investigators will make milking for 100 preterm babies and placed them on warmer and assess heart rate,blood pressure,oxygen saturation,fio2,maximum pip,PEEP and 100 babies other without milking to see the difference between two groups.

Eligibility Criteria:
Inclusion Criteria:

* babies who need resuscitation
* Preterm babies with 28-34 weeks gestatinal age

Exclusion Criteria:

* preterm babies above 34 weeks gestational age, -- -
* refusal by mother or obestatracain, -- -babies with congenital anomalies
Neural Indices Associated With Relapse in Cannabis Dependence

The aim of this fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. Therefore, neural markers of brain processes underlying the beforementioned components will be studied. Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.


Eligibility Criteria:
Inclusion Criteria:

* Cannabis Dependence
* 24 hours abstinence

Exclusion Criteria:

* other DSM-4 diagnosis
* neurological disorder