cyrilzakka/clinical-trials huggingface dataset:
Adaptive Coordination in Anaesthesia Teams and Its Relationship to Clinical Performance.

The impact of different coordination patterns on team performance during anesthesia inductions are analyzed using videotapes. These records are examined using various categorization systems (ETHZ), focussing on changes of coordinative behaviour with shifting situational requirements. A rating system comprising multiple categories is used to evaluate team performance. An integrated simulator study facilitates validation of the rating system.

Video tapes and vital parameter readings are recorded with a setup allowing synchronized recordings. Thus, exact timing between events on different data channels can be determined. Data are analyzed for unforeseen events, technical performance, and team coordination / non-technical performance.

Eligibility Criteria:
Inclusion criteria:

* Anesthesia personnel with at least 3 months practical anesthesia experience
* Patients undergoing surgical procedures

Exclusion criteria:

* Not meeting inclusion criteria
* Lack of consent
The Effect of Individualized Exercise Guidance on Pregnancy Outcome

A single center, randomized controlled trial was conducted to investigate whether individualized exercise guidance was more effective in improving pregnancy outcomes in normal pregnant women. What's more, the trial was also conducted to find out whether there is a mediating effect between prenatal exercise and pregnancy outcomes.

Fetal macrosomia refers to newborns with a birth weight more than 4000 grams, which poses varying degrees of risks to the health of both mother and infant and also affects the health outcomes of future generations. Research has found that exercise can effectively reduce the incidence of macrosomia and prevent gestational diabetes mellitus, pregnancy-induced hypertension, and excessive weight gain during pregnancy. However, every pregnant woman's individual situation and exercise habits are different, and personalized guidance based on their own circumstances is necessary during pregnancy exercise. The use of intelligent devices for supervision and management is also essential. To explore the impact of personalized exercise guidance during pregnancy on macrosomia, as well as the mediating effect of weight gain during pregnancy on exercise and macrosomia, we conducted a prospective randomized controlled clinical trial. The study included pregnant women who were over 20 years old, married, singleton, in the mid-term of pregnancy, and had no contraindications for exercise during pregnancy. They were randomly divided into an individualized exercise guidance group and standard clinic prenatal care group. Both groups received routine prenatal care and did not have any special dietary recommendations. The pregnant women in the individualized exercise guidance group received regular exercise guidance from a professional teacher and were supervised and managed through a WeChat group. The main outcome indicators were the incidence of macrosomia and the total weight gain during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 45 years.
* With singleton pregnancy.
* Second trimester.
* No contraindications to exercise during pregnancy.
* Be able to use smart phone for chatting, read and write basic Chinese.
* Volunteer for research.

Exclusion Criteria:

* Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.
A Single-Center Study of RO5508887 in Healthy Volunteers

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, \>/=18 years of age
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Use of adequate contraception methods or surgically sterile

Exclusion Criteria:

* Evidence of active or chronic disease
* Regular consumption of drugs of abuse
* Regular smoker (\>5 cigarettes per day)
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* History of significant allergic reactions
* Abnormal blood pressure
* Clinical significant abnormalities (e.g., cardiovascular, laboratory values)
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

The purpose of this study is to find out the genetic and biochemical makeup of your neuroblastic tumor, which influences its aggressiveness and the suitable therapy. These research studies include surface marker analysis, cytogenetics, cancer genes,genome sequencing, tumor growth-related genes and tumor growth in test tubes. Your blood, marrow, and hematopoietic stem cell samples will also be tested for tumors or leukemia cells, and your serum tested for anti-tumor antibodies.

To collect tumor, marrow specimens prospectively to study the molecular-genetic makeup of individual neuroblastic tumor and its metastasis by blood and marrow, and to correlate these findings with clinical outcome, and to relate the signaling circuitry of neuroblastic tumors to that of embryonic neuroectodermal cells. .

Eligibility Criteria:
Inclusion Criteria:

* Neuroblastic tumors diagnosed in accordance with the International Neuroblastoma Staging System

OR

* Clinically suspected neuroblastic tumors.

PK DRAW INCLUSION CRITERIA (FOR PK DRAWS ONLY):

PK Draw Inclusion Criteria

* Patients who receive naxitamab as part of their standard of care

Exclusion Criteria:

* None
Clinical Trials of Two Non-drug Treatments for Chronic Depression

This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression, bright light exposure or high-density negative air ion exposure. Treatments are self-administered at home by the patient under close clinical supervision.

Bright light exposure and high-density negative ion exposure have been designed to mimic outdoor environmental conditions and are effective in relieving symptoms of seasonal (winter) depression, but their effectiveness in treating chronic depression has not been explored.

Participants in this 10-week study will have an interview, a complete physical exam, and six one-hour appointments for progress evaluations. They will be randomly assigned to either light or high- or low-dose negative ions. Each treatment must be taken consistently for five weeks at the same time every day, after which treatment is temporarily suspended to determine whether symptoms return. Participants will then have the opportunity to try the alternate active treatment to determine which works best for them. On two occasions, participants will provide saliva samples, used to determine the level of melatonin, a hormone that becomes active at night and indicates whether a person's internal circadian clock is "in sync" with the day-night cycle or is early or late. This diagnostic test for melatonin, which is not yet readily available in medical practice, provides our research participants with unique information that can be used to optimize the timing of future treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depression
* Must be able to maintain a regular sleep schedule

Exclusion Criteria:

* Depression restricted to certain seasons of the year
* Presence of other psychiatric disorders
* Current use of psychotropic medication, except for selective serotonin reuptake inhibitors (SSRIs)
* Current use of recreational drugs or supplements that may affect mood
* Current medical illness or medication that may affect response to antidepressant treatment
* Long-distance travel while participating in the program
* Pregnancy
Multi-Antibiotic Resistance Carriage in Gut Flora

Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.

Emergence of MDRGN bacteria is blowing worldwide up leading to therapeutical failure in hospitalized patients with severe infections, as well as in outpatients with community-acquired infections such as UTI. Variation in prevalence exists across countries and regions. Travels outside own country of residence, like France, whatever the duration (short or long)or the reason (professional or leisure), are known risk factors for acquiring and disseminating MDRGN bacteria. Digestive carriage of multidrug-resistant Enterobacteriaceae could be a source of infection for the host as well as a source of dissemination. Qualitative and quantitative gut colonization by MDRGNB is poorly studied in non-hospitalized people who stayed for a few months out of France. The total amount of multidrug-resistant Enterobacteriaceae influences the spread of the dissemination. In our knowledge, no clinical study has been carried out to qualify and quantify gut colonization by MDRGNB in volunteers after staying 4-6 months outside country of residence such as France. A specific microbiological method will be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* Being older than 18 years
* Have given an informed consent by signing the written consent
* Being able to give a stool sample
* Being member of military forces, supported medically by the French Military Health Services (SSA), and to participate outside mission during 4- 6 months

Exclusion Criteria:

* Participating in another biomedical study during the study
* Volunteer unable to give informed consent.
Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.

Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological substrates of these symptoms are largely unknown.

The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging (DTI).

More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data obtained with DTI) in the ventral tegmental area (VTA) is different between patients with ICD and patients without ICD. Secondary objectives are to demonstrate a difference in volume of VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus accumbens, amygdala), and in number of fibers between VTA and the other structures of reward system between this two groups. Other objective is to measure and compare these same variables between Parkinson's patients and healthy controls.

We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's patients to ICD.

Type of study: Prospective, case control study.

Number of centers: 1 (Clermont-Ferrand)

Patients :

Inclusion of 25 patients with Parkinson's disease and impulse control disorders (inclusion's criteria detailed later), 25 matched Parkinson's disease patients without impulse control disorders and 25 healthy volunteers.

Study Performance :

J0 (inclusion; 3 hours) :

Each subject will perform a clinical and neurological examination (UPDRS) and a neuropsychological evaluation for diagnostic and quantification of impulse control disorders and to ensure of the absence of exclusion criteria.

J0+1week (MRI; 1hour) Each subject will then have an MRI acquisition including anatomical sequences (T1 and T2 weighted sequences) and a diffusion tensor imaging sequence (60 directions).

Analysis Analysis (Pre-processing and processing) will be realized with the Oxford Centre for Functional MRI of the Brain (FMRIB) Software (FSL).

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease (UK Parkinson's Disease Society Brain Bank Criteria)
* from 18 to 85 years old
* Impulse control disorder (one item ICD ≥2 at the scale ECMP : Evaluation Comportementale de la maladie de Parkinson)

Exclusion Criteria:

* Dementia (Mini Mental State \< 26 or MATTIS \< 130)
* Apathy (LARS (Lille Apathy Rating Scale) \> 7)
* Depression (MADRS (Montgomery and Alsberg Depression Scale) ≥16
* Contra indication to MRI (claustrophobia, deep brain stimulation, pace maker...)
Progesterone Levels and Pregnancy Results

The aim of this study is to evaluate the amniotic fluid and serum progesterone level and pregnancy outcome

Studies have investigated the relationship between maternal serum progesterone level and low birth weight baby birth, hypertensive disorders of pregnancy, and early pregnancy bleeding. In some cases, patients are supported by oral or vaginal progesterone treatments during pregnancy. We also measure the relationship between maternal serum progesterone by measuring the level of amnion progesterone; We aimed to analyze the effects on pregnancy outcomes by observing preterm birth, premature rupture of membranes, low birth weight, baby gender, maternal problems that may occur during pregnancy, fetal problems.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Women who did not receive progesterone treatment during pregnancy

Exclusion Criteria:

* Women who receive progesterone treatment during pregnancy
* multiple pregnancies
* Diagnosed hypertension, diabetes mellitus, kidney disease, heart disease, liver disease
Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma

Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.

This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.

Eligibility Criteria:
Inclusion Criteria:

* airway responsiveness to methacholine
* adequate baseline lung function
* no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks

Exclusion Criteria:

* pregnancy
* current smoker
* requirement for medications other than salbutamol that will interfere with airway response to methacholine
A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases

This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.

This is a single-center, parallel-controlled clinical study. The study plans to enroll 10 subjects, with 5 in the multi-mode ablation group (experimental group) and 5 in the conventional radiofrequency ablation group (control group). The entire study includes a screening period, treatment period and follow-up period. By comparing multi-mode ablation with conventional radiofrequency ablation, the study aims to observe the efficacy, safety of the multi-mode ablation technique in subjects and its impact on the systemic anti-tumor immunity of subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years, female gender;
2. Pathologically confirmed breast cancer liver metastases, in patients who are unable to tolerate or refuse surgical resection;
3. The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm;
4. At least an interval of 1 month since the last local treatment;
5. Child-Pugh class A or B;
6. ECOG PS score ≤2, with an expected survival of \>3 months.

Exclusion Criteria:

1. Liver function Child-Pugh class C;
2. Systemic widespread metastasis, with an expected survival of \< 3 months;
3. History of esophageal (gastric fundus) variceal bleeding within the past month;
4. Dysfunction or failure of vital organs;
5. Presence of an active infection;
6. Irreparable coagulation abnormality;
7. Refractory massive ascites, pleural effusion or cachexia;
8. Pregnancy, altered consciousness or patients unable to cooperate with treatment;
9. Previously participated in other clinical studies and still within the follow-up period;
10. Any other factors deemed inappropriate for inclusion or that may affect the patient's participation in the study, as determined by the investigator.
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* HCV RNA ≥10\^4 IU/mL at screening
* Confirmed chronic HCV genotype 1 or 3 infection
* HCV treatment naive
* Approximately 30% of individuals may have compensated cirrhosis at screening

Exclusion Criteria:

* Any other chronic liver disease
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Current or prior history of clinical hepatic de-compensation
* Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
* Chronic use of systemically administered immunosuppressive agents
* History of solid organ transplantation
Sleep Disorder and Oral Habits in Children

Sleep is a vital physiological function for the maintenance of health and quality of life. Harmful, non-nutritive and parafunctional oral habits are believed to have a negative effect on adequate rest at night. The aim of the present study was to determine associations between quality of sleep and harmful oral habits among children aged three to six years. Fifty children from a private school in São Paulo (Brazil) were evaluated using two questionnaires on sleep quality and harmful oral habits. The data were submitted to descriptive analysis. The chi-square test was employed for the categorical variables and analysis of variance (ANOVA) was carried out to compare mean values. The Student's t-test was used for all analyses, with the significance level set at 5%. The SPSS 12.0 program for Windows was used to analyze the results.

An observational cross-sectional study was carried out with the aim of determining associations between quality of sleep and harmful oral habits among children aged three to six years. This study was conducted in compliance with the Brazilian National Health Council/Ministry of Health guidelines contained in Resolution 196/96 and received approval from the Human Research Ethics Committee of the Universidade Metropolitana de Santos (Brazil) under process number 026/2010. Parents/guardians of all participants were properly informed regarding the objectives of the study and signed a statement of informed consent.

Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo were evaluated by means of two questionnaires administered to parents/guardians: The "Undesirable Habits Questionnaire", composed of 15 investigative questions on harmful oral habits as well as dietary and psychological factors, and the Sleep Habits Questionnaire.6 The data were submitted to descriptive analysis. The chi-square test was employed for the categorical variables and analysis of variance (ANOVA) was carried out to compare mean values. The Student's t-test was used for all analyses, with the significance level set at 5%. The SPSS 12.0 program for Windows was used to analyze the results.

Eligibility Criteria:
Inclusion Criteria:

* 3 to 6 years of age

Exclusion Criteria:

* over 6 years of age
Comparative Study 23G Versus 27G Vitrectomy

Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18
* No prior vitrectomy surgery in the study eye
* No prior inclusion in this trial
* Scheduled for vitrectomy for floater removal or macular surgery

Exclusion Criteria:

* Patients with serious heart, lung, liver, or kidney dysfunction
* Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)
* Patients with history of drug abuse or alcoholism
* Patients participating in other drug or medical device clinical trials before screening for this trial
* Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding
* Belief by the investigator that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression
AVAD: Asthma With Small Airways Dysfunction

The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction.

The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.


Eligibility Criteria:
General Inclusion Criteria:

* man or woman
* age ≥ 18 years
* asthma
* inform consent signed
* affiliated to health insurance

Specific inclusion criteria : asthma with proximal airways obstruction GROUP

* Maximal Voluntary Ventilation (MMV)\<80%
* MMV / Forced Vital Capacity (FVC)≤70%
* Carbon Monoxide Transfer Coefficient (KcO)\>80%

Specific inclusion criteria : asthma with small airways dysfunction GROUP

* Maximal Voluntary Ventilation (MMV)≥80%
* MMV / Vital Capacity(VC)\>70%
* Carbon Monoxide Transfer Coefficient (KcO)\>80%

General Exclusion Criteria:

* pregnant woman or breastfeeding
* patient participating to other biomedical research
* patient who have participated to other biomedical research within the past 3 months
* patient refusing to sign the inform consent

Specific exclusion criteria :

* Patient who stopped smoking since less than 12 months
* Pathological state related to obstructive distal airway damage
* Broncho-pulmonary infectious disease within the past 4 weeks
* Solid tumor curated by chemotherapy or chest radiotherapy
* Chronic respiratory disease
* Asthma exacerbation within the past 3 months
* Oral or systemic corticotherapy within the past 3 months
Prognostic Models for HCC Based on Tumor Micronecrosis

The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

1. pathologically diagnosed as HCC;
2. curative hepatectomy with R0 resection;
3. conserved liver function with Child Pugh class A or B

Exclusion Criteria:

1. with macrovascular invasion or extrahepatic metastasis;
2. receiving other anti-tumor treatments such as TACE or systemic drugs;
3. with other primary cancers;
4. incomplete follow-up data;
5. without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation
Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).

Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure.

The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Patient mechanically ventilated for more than 48 H for acute respiratory failure
* Decision to use of the APRV mode by clinicians in charge of the patient

Exclusion Criteria:

- Contraindication for the use of a nasogastric tube