cyrilzakka/clinical-trials huggingface dataset:
Lung Recruitment Improves Right Ventricle Performance

This study test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver.

Atelectasis is developed in 90% of anesthetized patients after surgery.

Protective ventilation with low tidal volumes and positive-end expiratory pressure (PEEP) promotes atelectasis with the potential right ventricle dysfunction induced by the increment in afterload (activation of the pulmonary hypoxic vasocontriction reflex).

Lung recruitment can improve the right ventricle performance caused by atelectasis because the pulmonary hypoxic vasocontriction reflex desapear in a normal aerated lungs.

Eligibility Criteria:
Inclusion Criteria:

* cardiovascular surgery with cardiopulmonary bypass.
* Patients with a New York Heart Association (NYHA) class I-II,
* Pre-operative left ventricular ejection fraction ≥ 50 %.
* Euroscore ≤ 6.

Exclusion Criteria:

* TEE contraindications.
* Hemodynamically unstable
* Needi for inotropic support
Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study

Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Patient \> 18 years
3. Follow-up in the department of clinical Nutrition of Rouen
4. BMI ≥15,0 and \<18,5 kg/m²
5. Diagnosis of anorexia nervosa according to DSM-V classification

Exclusion Criteria:

1. Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension
2. Patients with poor understanding of spoken or written French
3. Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults
4. Person subject to a safeguard of justice, guardianship or curatorship.
5. Pregnant or breastfeeding woman
Project Viva: a Longitudinal Study of Health for the Next Generation

Project Viva is a prospective cohort study of maternal and child health, following over 2,000 mother-child pairs from the mother's pregnancy into the child's adolescence.

In 1999-2002 the Project Viva team recruited 2,670 pregnant women during their first trimester of pregnancy from eight obstetric (OB) offices of a multi-site group practice in eastern Massachusetts. 2,128 of the women had a live birth and approximately 1,600 mother-child pairs are still involved in the study. Project Viva collects data annually from multiple sources, including questionnaires, interviews, medical records, examinations, and biospecimen samples. Project Viva intends to follow participants as long as there is grant funding and interest from the participants. Some of the most beneficial health findings come from long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Less than 22 weeks pregnant at the time of enrollment
* Receive prenatal care at one of the selected practices
* Plan on delivering at one of two study hospitals
* Be able to answer questionnaires in English.

Exclusion Criteria:

* Multiple gestation
* Plans to move away before delivery
* Plans to terminate the pregnancy
Topical IL-1-Ra for Treatment of Posterior Blepharitis

The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of posterior blepharitis
* A negative urine pregnancy test result for women of childbearing potential
* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
* Normal lid position and closure
* Ability to understand and provide informed consent to participate in this study
* Willingness to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

* History of Stevens-Johnson syndrome or ocular pemphigoid
* History of eyelid surgery
* Intra-ocular surgery or ocular laser surgery within 3 months
* History of microbial keratitis, including herpes
* Active ocular allergies
* Corneal epithelial defect \> 1mm2
* Use of topical steroids or Restasis within the past 2 weeks
* Use of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month
* Use of isotretinoin (Accutane) within the past 6 months
* Have had any previous treatment with Anakinra (Kineret®) or any therapeutic agent targeted at IL-1 blockade
* Pregnant or lactating women
* Signs of current infection, including fever and current treatment with antibiotics
* Liver, renal, or hematologic disease
* The use of any other investigational drug
Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure

Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (\<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (\<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-80 years; stage 1 or 2 hypertension currently receiving 0 or 1 antihypertensive medication; mean sitting systolic blood pressure \>/=140mmHg to \</=170mmHg, or mean sitting diastolic blood pressure \>/=90 to \</=105mmHg. Subjects taking one hypertensive medication had their medication withdrawn and entered a wash-out phase prior to randomization.

Exclusion Criteria:

* Subject taking two or more antihypertensive medications, known contraindication to angiotensin-converting enzyme (ACE) inhibitors or alpha- or beta-blocker therapy, subject has Type 1 or Type 2 diabetes
Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients

Opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes.

In this study the investigators selected two techniques commonly used for intubation, laryngoscopy and track light, so the investigators can verify which intubation techniques provides less hemodynamic changes in coronary patients under standard anesthesia induction.


Eligibility Criteria:
Inclusion Criteria:

* coronary disease ASA 2 e 3 using beta-blockers

Exclusion Criteria:

* emergency surgery arrythmia other antiarrythmic drugs
Prospective Cohort Study With Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma

This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma.

We dichotomize patients according to the risk of CNS involvement. Then, we perform CNS evaluation in patients at risk of CNS involvement. We prospectively monitor whether CNS relapse or metastasis occurs in patients with diffuse large B-cell lymphoma

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with diffuse large B cell lymphoma
2. \> 20 years
3. life expectancy more than 6 months
4. Written informed consent

Exclusion Criteria:

1. Refusal to informed consent
2. Lymphomas other than diffuse large B cell lymphoma
3. Primary CNS lymphoma
Ovarian Stimulation: Inositol and Melatonin

An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.

Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).

To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.

As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.


Eligibility Criteria:
Inclusion Criteria:

* Female age 18-39 years
* BMI 18-30 kg/m2,
* Fewer than 3 prior oocyte retrievals,
* No fertility Problems
On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota

The study intention is to investigate, in healthy humans, effects of 3 commonly used sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut microbiota composition.

Healthy subjects will be included in a crossover study with the purpose to investigate effects of 3 commonly used sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut microbiota composition. The subjects will consume each test product for 14 days in a random order, separated by at least a two-week washout period. On the last day in each intervention period, i.e. at day fifteen, the last test portion will be consumed together with a standardized evening meal at 9.00 pm. Thereafter the subjects are fasting until arriving to the experimental unit. Upon arrival, test variables in blood will be determined at fasting and repeatedly for 3h postprandial a standardised breakfast served approximately at 8.00 am. Cognitive performance will be determined in the postprandial period with tests evaluating working memory capacity, selective attention, psychomotor reaction time, and executive functions. After each intervention period, faecal samples will be collected for characterization of gut microflora.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* blood glucose \<6.1
* BMI \<28
* age between 40-70 years
* normal diet
* fluent in Swedish language (due to the structure of the cognitive tests).

Exclusion Criteria:

* diabetes
* cognitive decline (not able to cope with the cognitive tests)
* metabolic syndrome
* gastro-intestinal disorders
* antibiotics or probiotics during the study period
* smookers
NAFLD in HIV-infected Patients

The prevalence of NAFLD (nonalcoholic fatty liver disease) in HIV-infected patients is higher than that in general population, but the causes of morbidity and pathogenesis have not been fully explored. The investigators are planning to consecutively enroll 400 cases HIV-positive outpatients, and to detect NAFLD by ultrasound. The fecal and blood samples were also collected to explore the mechanism of NAFLD. The investigators aimed to determine the prevalence and risk factors of NAFLD in HIV infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18\~70 y;
* HIV-positive patients;
* written the informed consent

Exclusion Criteria:

* coinfected with HBV, HCV;
* secondary causes of fatty liver (eg, consumption of amiodarone and tamoxifen) and decompensated liver disease;
* significant alcohol consumption (\>20 g per day for man, \>10 g per day for woman);
* received antibiotics in preceding two months;
* autoimmune disease;
* severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
* pregnant or lactating women
Paternal Age and Fetal Aneuploidy

Trisomy 21, commonly known as down syndrome, is the most common chromosomal abnormality in humans. Advanced maternal age (AMA) is a well-recognized risk factor for trisomy 21, with the risk increasing significantly beyond the age of 35. Research on the effects of paternal age on the prenatal risk of trisomy 21 is lacking, with inconsistent findings in the literature.

The Harmony® prenatal test is an Non-Invasive Prenatal Testing (NIPT) that screens maternal blood for chromosomal abnormalities in the Cell-Free Fetal DNA (cfDNA). The harmony® prenatal test can detect conditions such as trisomy 13, 18, and 21, as well as sex chromosome abnormalities.

The Optimo test is a prenatal screening test that screens for trisomies 13, 18 and 21 in the developing fetus using extended biochemical screening in maternal. The Optimo test has shown high sensitivity and specificity in detecting trisomy 21.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 years or older (at the time of trisomy 18 and 21 screening) and who were able to complete the questionnaire in either French or English
* Pregnant women who completed the entire trisomy 21 screening process at clinique ovo were included

Exclusion Criteria:

* Patients who did not indicate the male partner/donor's age were excluded
* Patients who did not complete or sign the clinical information form
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

Radiation dermatitis is a common side-effect of radiation therapy in cancer patients who frequently can experience redness, pain, crusting, and even ulceration of the skin causing suffering and treatment interruption. A recent retrospective study by DeLand demonstrated that administering light emitting diode (LED) photomodulation after each radiation treatment for breast cancer decreased radiation dermatitis in a majority of patients. LED photomodulation is a process by which specific sequences of light are used to regulate or manipulate cell activity without causing heat or damage to the skin. Each LED treatment is painless and is completed in usually less than one minute. LED photomodulation may reduce the suffering associated with radiation treatments, improve cosmetic outcome in radiation fields, and eliminate breaks in radiation treatments which may be required because of severe ulcerating reactions.

This study will attempt to replicate the findings of Dr. DeLand's study by randomly assigning at least 40 breast cancer patients to either a treatment group or to a control group. The treatment group will receive LED photomodulation treatments before and after each radiation treatment with the Gentlewaves Select™ handheld high energy 590nm LED array using specific sequences of pulses used in other studies; the treatment group will also receive 7 additional treatments over 2 weeks after their radiation treatment course is completed. The control group will receive no LED treatment but will use the exact same skin care regimen as the treatment group. In addition to weekly evaluation and grading of skin reactions, subjects will be photographed under standardized conditions weekly and then photographs will be evaluated and graded by blinded dermatologists.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clinically diagnosed breast or head and neck cancer that will be treated with radiation therapy.
* Subjects must be at least 18 years of age

Exclusion Criteria:

* Subjects will not be eligible to participate if they are pregnant or lactating.
* Patients treated with partial breast irradiation techniques, brachytherapy, or other non-standard techniques will not be eligible.
Study of the Vaginal Microbiota in Women Under Fertile Age

Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders

The study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years;
* Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort);
* Presence of at least 3 Amsel criteria;
* Nugent score ≥ 7;
* lactobacillary grade ≥ 2 (LBG) (according to Donders classification);
* presence of blastospores and/or pseudohyphae evaluated by fresh mount microscopy

Exclusion Criteria:

* Age \< 18 years;
* Nugent score \< 7;
* presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae, or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
* Clinically apparent herpes simplex infection;
* Human papillomavirus or human immunodeficiency virus infections;
* Use of antibiotic, antifungal, probiotic, or immunosuppressive drugs during the past four weeks;
* Use of vaginal contraceptives;
* Pregnancy or breastfeeding, chronic diseases, neoplastic disease, diabetes, genital tract bleeding)
Positioning and Gastric Aspiration in Ventilated Premature Infants

Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific marker for aspiration. The objective of this study is to examine if TA pepsin will change when ventilated premature infants are positioned in two different positions; on their back vs. on their right side.


Eligibility Criteria:
Inclusion Criteria:

* Infants born between 28 and 32 weeks gestational age
* postnatal age \> 72 hours
* tracheally intubated and receiving conventional mechanical ventilation
* feeding enterally more than 20 ml per day.

Exclusion Criteria:

* neurological insult in the form of perinatal asphyxia (pH \<7, base deficit more than 12, Apgar score at \< 3 at 5 minutes of life), intracranial hemorrhage grades 3 or 4 at 72 hours of age or periventricular leucomalacia
* major congenital anomalies, or gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis ,
* receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedation
Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5

Exclusion Criteria:

* Previous reaction to memantine
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy.

This study will recruit 500 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement.

Eligibility Criteria:
Inclusion Criteria:

Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:

* Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
* Diagnosis of Type 2 diabetes

Exclusion Criteria:

* Known diabetic eye exam in the last 12 months
Primary Mesh Closure of Abdominal Midline Wounds

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.


Eligibility Criteria:
Inclusion Criteria:

* Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than 27.
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Emergency procedure
* Inclusion in other trials
* Aortic reconstruction for obstructive disease
* Life expectancy less than 24 months
* Pregnant women