cyrilzakka/clinical-trials huggingface dataset:
Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil

Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern anesthesia. The purpose of this study is to compare two methods of administering desflurane, an volatile anesthetic during balanced anesthesia. The investigators hypothesized that administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth than administering desflurane according to the patient's BIS (bispectral index) value.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for operation under balanced anesthesia using desflurane and remifentanil

Exclusion Criteria:

* Refusal of consent
* General anesthesia with agents other than desflurane and remifentanil
* Patients with allergy to neuromuscular blocker, volatile anesthetics, opioids
* History of malignant hyperthermia
* Patients taking CNS stimulants
* Chronic alcohol abuser
* Patients with severe depressed left ventricular function, EF \< 30%
* Patients with convulsive disorders
* ASA class IV, V, VI
* Patients with systolic arterial blood pressure lower than 90mmHg before surgery
* Patients needing inotropic infusion during surgery
* Anesthesia time less than 30 minutes
Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones

Normal testicular hormonal and spermatogenic function depends not only on the testis itself, but also on the integrity of the hypothalamus and anterior pituitary. Systemic diseases has been shown to influence male gonadal function in variety of ways, leading to reduced libido, erectile impotence, infertility, osteoporosis, and decreased physical stamina and muscle mass. The effect of systemic diseases may occur directly at the testicular level: reduced Leydig cell function will lead to androgen deficiency, while diseases affecting Spermatogenesis may lead to infertility. Alternatively, acute and chronic illness may interfere with the hypothalamic-pituitary axis and lead to reduced testicular function.

Liver is thoroughly involved in proteins, cytokines and interleukins synthesis and destruction. Therefore, abnormal function of endocrine organs is expected in patients with liver cirrhosis.

Hypogonadism is a frequent clinical feature in patients with liver cirrhosis. These patients have gynecomastia, decreased libido, signs of feminization, testicular atrophy and low testosterone level, as well as reduced Spermatogenesis. These features are more severe in patients with higher Child Pugh score.

Several hormonal abnormalities are responsible for these clinical alterations. Estrogen/androgen ratio has been increased in cirrhosis while there is reduction in serum testosterone and dehydroepiandrosterone level.

Hyperprolactinemia is present in patients with cirrhosis and may involve in Hypogonadism by an inhibitory effect on gonadotropins.

Eligibility Criteria:
Inclusion Criteria:

* male patient with liver cirrhosis of any etiology and severity.

Exclusion Criteria:

1. Systemic conditions like:chronic renal failure, diabetes mellitus, thyrotoxicosis, hypothyroidism, Cushing's disease and cancer.
2. Local conditions like :Varicocele, urogenital infections, history of cryptorchidism, functional and obstructive azoospermia.
Physiological Parameters and Crying Time in the Newborn Bath

Bathing is essential for maintaining and improving the health of the newborn. It has numerous beneficial effects, such as cleaning and protecting the skin, preventing infections, cleaning unwanted substances, regulating blood circulation and the respiratory system, regulating body temperature, relieving pain, providing comfort, and supporting the parent-infant bond. Although bathing has many benefits, it is a stressful experience for newborn babies. Research on the effects of bathing on babies has shown that babies experience behavioral difficulties during bathing, such as crying, restlessness, hiccups, yawning, tremors, body looseness, looseness of the extremities, facial looseness, opening of fingers, and grimacing. Bathing may also lead to some physiological responses, such as hypothermia, hypoxia, dyspnea, cyanosis, desaturation, and tachycardia.Therefore, this study aimed to determine the effect of palmar grasp reflex stimulation during neonatal bath on the physiological parameters and crying time of the newborn.


Eligibility Criteria:
Inclusion Criteria:

* At least 24 hours after birth
* have a gestational age over 36
* not be asphyxiated
* Feeding at least 1-3 hours before bathing
* Not receiving analgesic sedation before bathing
* Stable vital signs

Exclusion Criteria:

• Ineligible for immersion tub bathing
Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots)

Specific Aims:

1. The primary aims of this study are to conduct formative interviews with teen mothers to inform a targeted adaptation of empirically based weight management and parent training programs for teen mothers for their preschoolers.
2. To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods \& the intervention.

Study Hypotheses:

Given the small sample size and fact that this is a pilot study, focus will be on estimating effect sizes rather than statistical hypothesis testing. However, the investigators exploratory hypotheses are as follows:

1. (a) The adapted intervention will be more feasible compared to the wellness control condition, with a participant retention rate of ≥80% and an average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%; (b) The adapted intervention will be more acceptable compared to the wellness control condition, based on the Consumer Satisfaction Scale and Therapy Assessment Inventory with ≥90% of the participants responding to the item, "In general how satisfied were you with the intervention?" by choosing "unsatisfied" to "very satisfied."
2. (a) The adapted intervention will result in greater improvements in child behavior and parent-child connectedness compared to the control condition; (b) the adapted intervention versus wellness control condition will result in greater increases in child and teen mother individual as well as joint physical activity and physically active play and greater reductions in individual and joint teen mother and child sedentary behavior (television viewing) from baseline to post-intervention; (c) the greater teen mother and child fruit and vegetable consumption; and reduced child juice and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the adapted intervention versus wellness control condition will result in smaller increases in child BMI percentile and teen mother BMI from baseline to post-intervention; (e) participants who attend higher numbers of intervention sessions will show greater improvements in target outcomes (child behavior, parent-child connectedness, and teen mother and child physical activity, sedentary behavior and BMI); with participants receiving the adapted intervention versus wellness control showing the greatest dose-based improvements.


Eligibility Criteria:
Inclusion Criteria:

* Must be teen moms
* Be between 16 and 20 years of age

Exclusion Criteria:

* Does not have a child between the ages of 6 months and 5 years
A Study of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients

The purpose of this study is to assess the effect of pre-transplant mRNA-1647 on post-transplant cytomegalovirus (CMV) virologic outcomes, anti-CMV antiviral use, and clinical outcomes in CMV-seropositive and CMV-seronegative liver transplant candidates who receive transplants and to assess the safety, reactogenicity, and immunogenicity of mRNA-1647 in all participants.


Eligibility Criteria:
Inclusion Criteria:

* Having a negative (that is, CMV-seronegative) or a positive (that is, CMV-seropositive) result using a blood IgG assay performed at the central laboratory or a previously documented seropositive result.
* Listed and anticipated to receive their first deceased donor or living donor liver transplant within 2 months to 12 months of enrollment.
* A person of nonchildbearing potential, as defined in the protocol.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 3 months following last study injection.

Exclusion Criteria:

* Listed as "status 1A" for liver transplant.
* Hypersensitivity to acyclovir, ganciclovir, or valganciclovir.
* Previous receipt of a solid organ or hematopoietic transplant.
* Listed for or anticipated to receive an organ transplant other than liver, either simultaneously or sequentially.
* Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic study that may interfere with study outcome measures as determined by the Investigator.
* Suspected or known allergic reaction to any component of any mRNA vaccine, including mRNA-1647, or its excipients.
* Human immunodeficiency virus (HIV) infection (based on documented testing performed during the transplant evaluation process and no clinical suspicion of HIV infection).
* Prior (ever) receipt of a stem cell transplant (peripheral blood stem cell, marrow, cord blood).
* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.

Note: Other inclusion and exclusion criteria may apply.
Regional Partnership for Pregnant Women at Risk of Substance Misuse and Their Newborns

This study recruits pregnant women and new mothers who are at risk of substance use concerns during pregnancy or delivery. These women are followed for 6 months and randomized into two groups; they may receive services as usual, or enhanced services. Enhanced services include evidence based interventions and case management to support referrals to substance abuse treatment, and to teach strategies specifically targeted to parenting newborns.

The dual goals of this project are to (i) improve communication and collaboration between substance abuse treatment providers, obstetricians, and child welfare providers, and (ii) to enhance child welfare outcomes for pregnant women who are at risk of substance misuse and their babies. There is a particular need for a partnership in this area as New York State implements the 2016 Comprehensive Addiction and Recovery Act (CARA) legislation, which focuses on a multi-agency approach to the problem of substance abuse for families at risk of child welfare involvement.

Services are delivered through Montefiore's Department of Obstetrics \& Gynecology and Women's Health (Obstetrics). Mothers-to-be who have screened at risk or tested positive for substances will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced prenatal services as part of the program group. Program services include 3 empirically supported interventions: Motivational Enhancement to enhance intrinsic motivation to change unhealthy behaviors and support their referral to substance abuse treatment; Incredible Years to improve parenting skills, especially related to infancy and early childhood; and Contingency Management to reinforce healthy behaviors, including attendance at treatment and abstinence.

Women enrolled into the study are randomly assigned into a program or comparison group. Parent, child, and family outcomes are evaluated using self-report and administrative data.

Eligibility Criteria:
Inclusion Criteria:

-The potential subject: (i) is a woman who receives prenatal care at Montefiore Medical Center, (ii) is at least 16 weeks pregnant and at most 12 weeks post-partum, and (iii) is identified as at-risk for substance use, and/or has tested positive for at least one substance.

Exclusion Criteria:

* Minors
* Those who are less than 16 weeks pregnant or more than 12 weeks post-partum
Choroidal Change on OCTA in Eyes With High Myopia

Myopia is a global healthy concern, especially the high myopia and pathological myopia among Asian populations. However, its mechanism still remains largely unclear. Recent findings suggested choroidal changes might be related to the development of myopia. This study is to useOCT angiography (OCT-A) to investigate parapapillary choroidal microvasculature change in myopic eyes, and try to find the cause-and-effect relationship between choroidal change and the development of myopia.


Eligibility Criteria:
Inclusion Criteria:

1. Spherical equivalent measurement can be included in above 4 groups
2. Willing to be followed up in the future 10 years

Exclusion Criteria:

1. Deny to sign the patient consent, or deny to be followed
2. Evidence of cardiac, or diabetic, or CNS disease.
3. Clinically diagnosed with retinal or choroidal disease
4. Glucoma
5. Cataract or corneal disease that influence the quality of fundus OCTA image
The Influence of Radiotherapy on Cognitive Function

The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.

The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up visit. The assessment tools that will be used are Neurotrax standard cognitive computerized tests and 2 short questionnaires.Patients that will receive a one-day treatment will be tested on 2 time points only- before the treatment and on FU.The research will reveal the positive and the negative influences of the Radiotherapy, along with the assessment of norms for the cognitive function and quality of life of oncologic patients being treated by RT.Eligibility criteria:oncologic patients of both genders, with primary brain tumors, metastases or with increased risk of brain metastases, that are referred to conformal/palliative or preventive Radiotherapy treatment or to Stereotactic Radiosurgery, who are able to follow instructions in Hebrew.The participants will be 20-80 years old.Main comparisons will be performed between the cognitive tests results on 3 time points mentioned. The study will continue until the needed number of participants will be achieved.

Eligibility Criteria:
Inclusion Criteria:

* 20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases.
* Are able to follow instructions in Hebrew.

Exclusion Criteria:

* Non-Hebrew speakers can not participate.
HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis

Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.

* Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
* Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
* ECOG (Eastern Cooperative Oncology Group) : 0\~2
* Age: 18\~75 years old
* Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl
* Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
* Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
* Not participating in other study projects before and during the treatment
* Signed the Informed Consent Form

Exclusion Criteria:

* Not conforming to above inclusion criteria
* Distal metastasis to lung, liver, or para aortic lymph node metastasis
* Ever operation on the stomach
* Operation intolerance due to other systemic basic diseases
* Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
* Allergy to the drugs in this protocol
* Pregnant or lactating women
* Women at childbearing age and of pregnancy desire during the study
Observational Study Comparing the Efficacy of Ganciclovir as a Function of Blood Exposure to the Drug During a Curative or Preemptive Treatment

This study aims to better define the target range of ganciclovir trough concentrations by investigating the relationship between ganciclovir concentration and the time to undetectable CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.

The primary objective of the study is to determine whether higher concentrations of ganciclovir can reduce the time of negation of the CMV-DNA load.

Secondary objectives are to determine the concentration-toxicity relationship of ganciclovir and the relationship between concentrations of ganciclovir and apparition of CMV gene mutations responsible of drug resistance.

Each week, trough concentrations of ganciclovir are measured, associated with control of CMV-DNA load and all biological analysis currently necessary for the monitoring of the infection.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years-old
* Solid organ transplanted patients needing a treatment by oral or intravenous (val)ganciclovir
* Non-opposition to participate in the study.

Exclusion Criteria:

* pregnancy
* opposition to participate in the study
* incapable person
Baduanjin Exercise for Patients With GOLD 2-3 Stable COPD on Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for COPD patients.

To investigate the efficacy of Baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase II\~III. A prospective, randomized, controlled clinical trial was designed.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 40 to 80 years
* Diagnosed with stable chronic obstructive pulmonary disease
* Phase II\~III

Exclusion Criteria:

* The condition was serious or movement restrained by other diseases
* In the acute exacerbation of chronic obstructive pulmonary disease
* Participants who have contraindications to exercise training
* Patients who have other serious acute, chronic organic disease or mental disorders
Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients

Cancer is a frequent disease considering that one person out of three will be confronted with it in their lifetime. Cancer patients often express complaints related to cognitive impairment as an outcome of their oncological treatment. These cognitive disorders have a significant impact on the patient's and their carer's quality of life. Therefore, it appears necessary to have a reliable, quick and simple tool in order to detect cognitive impairment.

The rationale of this study relies on 3 main points :

* The cognitive complaint frequently reported by cancer patients
* The difficulty in reliably demonstrating the cause of this complaint through conventional neuropsychological tests
* The interest of cognitive processing speed as an indicator of cognitive dysfunction

The primary objective of the study is to evaluate a potential variation of cognitive processing speed at the Saint-Louis Lille Battery (SSLIB) between the beginning and during (4 months after the beginning) the oncological treatment of adults with breast cancer or colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* Beginning an oncological treatment for breast or colon cancer
* Patients of age ≥ 20 and ≤ 70 years old
* Cancer diagnosis announcement delivered since less than 3 weeks (+/- a week)
* Patient affiliated to French social security

Exclusion Criteria:

* Patient's opposition to the study
* Notion of an abnormal cerebral scan or MRI
* Drug use (alcohol, narcotics...)
* Chronic (≥ 15 days) treatment with corticosteroids \> 1mg/kg/j (prednisone or equivalent)
* Ocular pathology or cognitive disorder impairing comprehension and reading abilities
* Patients under curatorship, guardianship or under the protection of justice
Occupational Gaps After Mild Stroke: a Single-Center Observational Study

The goal of this observational study is to investigate participation restrictions and their determinants in people after a mild stroke. The main questions it aims to answer are:

Do mRS score, time since stroke onset, cognitive disorders, mood disorders and fatigue negatively impact occupations after mild stroke?

Does an increased prevalence of occupational gaps correlate with a diminished quality of life following mild stroke?


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old,
* a diagnosis of stroke confirmed by cerebral imaging,
* an mRS score \<3 at the post-stroke consultation,
* informed about the study
* not opposed to participation

Exclusion Criteria:

* cognitive dysfunction making participation in the study impossible,
* phasic disorders preventing comprehension of the questionnaires,
* neurological deficits prior to the stroke, a history of psychiatric disorders
* being under legal protection.
The Efficacy of Reminders to Complete HPV Series

The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV. Parents can chose whether they would like a phone call or text message reminder. This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).


Eligibility Criteria:
Inclusion Criteria:

* Parents of adolescents aged 10 - 17 who have had at least 1 dose of HPV
* Patients aged 18 - 21 who have had at least 1 dose of HPV

Exclusion Criteria: