cyrilzakka/clinical-trials huggingface dataset:
Anesthesia Counseling, Consent, & Professionalism

The anesthesia consent form has become a standard before surgery. However, verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion has not been addressed. This study will use preoperative discussions and postoperative patient questionnaires to examine the degree of awareness that the patients and the patients families have regarding what general anesthesia is, the responsibilities of the anesthesiologist, and the specifics of what the participants are agreeing to by signing the consent form.

There is a substantial body of work regarding the written anesthesia consent form. As a result, the written anesthesia consent form has become a standard requirement throughout the United States of America. However, there has been little examination of verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion that should take place prior to surgery. Non-anesthesia medical studies have indicated that inadequate patient-physician communication and an inadequate patient-physician relationship will result in misunderstanding and an increased malpractice risk. Lack of understanding of the duties and responsibilities of anesthesiologists is also damaging to the professional status of the field of anesthesiology. This study will utilize patient interviews and questionnaires to examine the degree of awareness that the patients and the patients families possess regarding what general anesthesia is, the duties and responsibilities of the anesthesiologist, the role of the anesthesiologist within the operating room and the specifics of what the participants are agreeing to by signing the consent form. If it is determined that a more structured and thorough pre-anesthesia discussion will help patients and the patients families understand what general anesthesia is, understand the specific responsibilities of anesthesiology providers, understand the professional status of anesthesiologists, give the participants a better feeling of autonomy and better understand what the participants are agreeing to by signing the consent form, then there will be substantial ramifications to the priority and importance given to pre-anesthesia discussions nationwide. Secondary benefits include influences on anesthesia residency training and improved patient satisfaction with the anesthesia experience.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and up
* Elective Procedures
* English-speaking
* Consenting for general anesthesia

Exclusion Criteria:

* Obstetric patients
* Prisoners
* Emergency cases
* Patients under age 18
* Patients don't speak English
* Not consented for general anesthesia
Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients

The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.

The GERODIAB study is the first prospective, longitudinal follow-up cohort study, the main aim of which is to assess the link between glycaemic balance (evaluated on the basis of HbA1c levels) and total mortality at 5 years in diabetic patients aged 70 and over, and suffering from type 2 diabetes. An extension to 10 years is considered given the innovative features of this cohort follow-up procedure.

The secondary endpoints are as follows:

* To assess the link between glycaemic balance and the mortality rate with specific causes.
* To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications.
* To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy.
* To specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.

Eligibility Criteria:
Inclusion Criteria:

* Patient with type 2 diabetes, aged 70 and over,
* Patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years),
* Diabetes diagnosed for at least one year,
* Patient with autonomy defined by a score greater than or equal to 3/6 on the ADL scale,
* Patient who can be monitored during hospital or private consultations over the next 10 years,
* Patient who did not refuse to take part in the study after receiving information on the study (Patient Information Leaflet), Patients are monitored in the hospital or private sector throughout France.

Exclusion Criteria:

* Patient with type 1 diabetes,
* Patient with secondary diabetes (mainly corticosteroid-induced),
* Patient with a loss of autonomy defined by a score of less than 3/6 on the ADL scale,
* Patient who cannot be monitored in the months or years to come,
* Patient in an acute situation (transient exclusion criterion),
* Patient expressing their refusal to participate in the study.
Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention

This study evaluates whether the utilization of integrated health services such as help with medications, muscle strengthening, balance training, pain management and home modification interventions can help improve older adults' ability to sleep, balance, walk, and take care of themselves after hospitalization.

Currently, there is no evidence-based approach to improve post-hospitalization functional decline. CAPABLE uses a novel inter-professional team involving an occupational therapist, nurse, and handyman to improve ADLs in older adults post-hospitalization.

In a Center for Medicare \& Medicaid Innovation (CMMI) demonstration project, CAPABLE demonstrated a 45% reduction of ADL difficulties in older adults from baseline to five months.The significance of this improvement could make the difference between aging at home independently and relocating to institutional care. While these results are encouraging, CAPABLE needs evaluation in real world health delivery contexts with more ethnic diversity.The purpose of this study is to test the effectiveness of CAPABLE in older adults in an active community health care program.

Interventions: CAPABLE Intervention: Participants in the treatment group will receive up to 10 in-home sessions (≤6 visits with an occupational therapist and ≤4 visits from a nurse)-and up to $1500 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component (education, assessment, and identification of functional goals, specific strategies tailored to goals and based on protocols). Usual Care Group: Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare. After baseline, all study participants will be reassessed at 20 weeks and possibly a third interview at 52 weeks. Assessments will be completed by a research assistant masked to treatment condition.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 65 years old;
* Are 60 days post-hospitalization in an acute care setting and have had a Visiting Nurse Service of New York (VNSNY) visit;
* Have difficulty with at least one activity of daily living (ADL);
* Are a member of the VNSNY CHOICE Medicare Advantage Health Plan;
* Are able to stand with or without assistance; and
* Are available during the intervention period

Exclusion Criteria:

* Have significant cognitive impairment identified by the Callahan screening tool;
* Do not speak English or Spanish;
* Have had more than 3 hospitalizations within the past 12 months;
* Are actively receiving radiation or chemotherapy;
* Have plans to relocate in less than one year;
* Have diagnoses of the following: Dementia, Alzheimer's, Other Cerebral Degeneration, and serious cognitive impairment or OASIS assessment level 3 response on M1034 "serious progressive conditions that could lead to death within a year"
Effect of Acupuncture on Human Brain Activity

The purpose of this study is to use brain imaging technology to examine the way acupuncture affects brain function.

Acupuncture is emerging as an important procedure in complementary medicine. Its mechanism of action remains unclear, but research suggests that its effects are mediated through a widely connected network that is involved in the regulation of mood, behavior, and function of physiological systems. This study will use functional magnetic resonance imaging (fMRI) to monitor the effects of manual acupuncture on the brain function of study participants.

Participants in this study will undergo acupuncture one needle at a time. Researchers will then ask participants questions about how they feel and will compare the sensations reported by participants to their images of brain response.

Eligibility Criteria:
Inclusion Criteria:

* In good physical health
Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy

The major research objective is to assess the potential of Proton Magnetic Resonance Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single meal. Furthermore we aim to investigate whether the addition of protein to a high fat breakfast results in a reduced postprandial accumulation of lipids when compared to a high fat breakfast alone.

Fat accumulation in non-adipose tissue, such as liver and muscle, is associated with reduced insulin sensitivity and cardiovascular disease. Little is known about the dietary determinants and the time course of this ectopic fat accumulation. Therefore the general aim of this project is to develop and validate methodology to follow postprandial hepatic and muscular lipid retention. Proton Magnetic Resonance Spectroscopy (1H-MRS) is a well-established tool for noninvasive quantification of intrahepatic lipids (IHL) and intramyocellular lipids (IMCL). Previous studies have suggested a relatively rapid regulation of IHL and IMCL levels, indicated by changes in these total lipid pools after high fat diets of 3 or 4 days. Although IHL and IMCL levels seem to change rapidly, data on IHL and IMCL levels after a single meal are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Healthy
* Stable dietary habits
* No use of medication
* Lean subjects: BMI 18-25 kg/m2
* Obese subjects: BMI 30-35 kg/m2

Exclusion Criteria:

* Any medical condition requiring treatment and/or medication use
* Alcohol consumption of more than 20 g per day (± 2 units)
* Smoking
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Participation in another biomedical study within 1 month prior to the screening visit
* Contraindications for MRI scan:

  * Central nervous system aneurysm clips
  * Implanted neural stimulator
  * Implanted cardiac pacemaker of defibrillator
  * Cochlear implant
  * Iron- containing corpora aliena in the eye or brain
  * Hearing aids and artificial (heart) valves which is contraindicated for MRS
  * Claustrophobia
"Treatment Use of ECMO In Pregnancy or Peripartum Patient."

The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 18 years or greater at the time of ECMO treatment.
3. Pregnant or within 6 months post-partum at the time of ECMO cannulation

Exclusion Criteria:

1. No history of pregnancy.
2. No treatment with ECMO.
Fluid Overload and Pulmonary Function

Esophageal atresia is a rare but severe malformation, and it requires early surgery. Coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft. In the postoperative period after coloesophagoplasty children require careful monitoring of fluid balance, because clinically significant fluid overload can lead to dysfunction of various organs and systems.

Esophageal atresia (EA) is a defect of the embryogenesis of the laryngotracheal tube. There are isolated forms of EA and combinations with a tracheoesophageal fistula (TPF). Esophageal plastic surgery with an isoperistaltic transplant from the transverse colon was performed in children with EA. After this surgical intervention children require observation in the intensive care unit (ICU). During this period, infusion therapy satisfies physiological needs and compensates for physiological and pathological losses. However, it is not always possible to compensate for the body's fluid needs and maintain a normovolemic state. Thus, fluid overload develops. It is based on a pathophysiological process when severe operational stress leads to the damage of glycocalyx in the vascular wall. As a result, albumin freely passes into the interstitium, and oncotic pressure rises in tissues. Fluid overload in the intra- and postoperative period can be a factor in an unfavorable outcome, leading to organ damage, as well as death.

Eligibility Criteria:
Inclusion Criteria:

* Аge from 1 month to 3 years
* EA with / without
* Tracheoesophageal fistula (TPF)
* Сoloesophagoplasty.

Exclusion Criteria:

* Аesophageal burn,
* Oesophageal peptic stenosis,
* Congenital heart disease
* Cardiotonic support in the postoperative period
* Renal malformations
* Bacterial pneumonia in the postoperative period,
* Bronchopulmonary malformations.
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)

This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.

The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin.

The study is looking at several other research questions, including:

* What side effects may happen from taking mibavademab
* How much mibavademab is in the blood at different times
* Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines
2. Treatment with metreleptin for ≥6 months at time of screening at a stable dose, defined as no change in dose within the last 3 months prior to screening
3. Generally stable diet (based on participant's recall) and stable medication regimen for diabetes and/or dyslipidemia (in addition to metreleptin), for the last 3 months prior to screening
4. Willing and able to comply with clinic visits and study-related procedures. Participants who are unable/unwilling to self-inject, but are willing to have a capable caregiver inject, are considered eligible
5. Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting triglycerides from at least 6 months prior to screening, as defined in the protocol

Key Exclusion Criteria:

1. Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
2. Current chronic treatment with high-dose corticosteroids, as defined in the protocol
3. Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit except for fully treated basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus
4. Estimated glomerular filtration rate (GFR) of \<30 mL/min/1.73 m\^2 based on chronic kidney disease epidemiology collaboration (CKD-EPI)/Schwartz equation at screening. Assessment can be repeated once
5. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure, or intracardiac device placement within 3 months before the screening visit, as defined in the protocol
6. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study, as defined in the protocol

NOTE: Other protocol-defined inclusion / exclusion criteria apply
Dietary Intervention and Assessment of Obesity-related Gene Methylation Levels in Overweight Women

The clinical study aimed to study the effect of an intervention with foods containing folate and hazelnut oil to assess whether this diet could modulate the methylation levels of two obesity-related genes, LEP and POMC, in addition to impacting body weight and values of lipid profile of overweight women. The hypothesis of the clinical study is that the intervention diet could reduce the methylation levels of the genes mentioned and this would impact on the reduction of body weight and improvement of the lipid profile of the women studied.

The intervention study was carried out with a sample selected by randomization, and n = 40 adult women classified as overweight were considered for the study. After assessing the eligibility criteria, women were instructed to have stable weight, eating habits and levels of physical activity constant to those found during the baseline, as well as receiving an individual diet plan one week before starting the dietary intervention. Before the start of the intervention, the 40 women were allocated to four groups of 10 each, and three groups started the individual diet plan for weight maintenance with a focus on vegetables and legumes with antioxidant and folate-rich action, and were also invited to consume foods fortified with folic acid and foods naturally rich in folate to achieve a usual folate intake close to the RAS (≥400 µg), this amount was for intervention group 1 and 2, group 3 received a lower amount (approximately half of the consumption of groups 1 and 2) and group 4 was the control group.

Still referring to the intervention, the participants of the three groups received advice from a nutritionist, responsible for this research and all the printed material free of charge, including pre-packaged foods, and also delivered hazelnut oil capsules, used as a source of monounsaturated fat. Counseling sessions with the nutritionist were offered daily at the homes during the entire period of the intervention, except for group 4, where the monitoring was weekly, to maintain eating habits.

After the end of the 8 weeks of the intervention, the third stage of the study began, which consisted of anthropometric assessment, analysis of the dietary intake of the 24-hour food record and blood collection for biochemical tests and DNA methylation.

Eligibility Criteria:
Inclusion Criteria:

* Adult women, aged between 20 and 59 years;
* Women with classification of overweight and obesity;
* Women who signed the informed consent form.

Exclusion Criteria:

* Women who changed their lifestyle 3 months before the study started;
* Alcoholic women or smokers;
* Taking medications known to interfere with folic acid metabolism (in the past 3 months), such as antacids and anticonvulsants;
* Individuals who use supplements in general, such as fish oil or other fatty acids;
* Pregnant or planning to become pregnant during the study period.
The Effect of Laughter Yoga on the Stress Levels of Infertility Women

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. At the beginning of the study, the Infertility Stress Scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks. No application was made to the control group. After 4 weeks, the Infertility Stress Scale was administered to the women in both groups to re-determine their stress levels.

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. At the beginning of the study, necessary ethics committee permission and institutional permissions were obtained. Both of the researchers have a certificate of leadership in laughter yoga. As a result of the power analysis, it was determined that 80 women should be included in the study. Considering that there may be losses, it was decided to include 90 women in the study. By providing randomization, 90 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 45 experimental and 45 control. At the beginning of the study, the Infertility stress scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks, two sessions a week. No application was made to the control group. After 4 weeks, the Infertility stress scale was administered to the women in both groups to re-determine their stress levels.

Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 19-45
* have been diagnosed with infertility
* At least primary school graduate
* Not having a diagnosed psychiatric disease
* Will not have an ovulation pick up process, Intrauterine insemination and Embryo transfer procedure in the next 1 month

Exclusion Criteria:

* Have ovulation pick up process in the last 1 month
* undergoing Intrauterine insemination in the last 1 month
* undergoing an Embryo transfer in the last 1 month
* Not regularly attending laughter yoga sessions (for the experimental group)
* Applying another alternative method to reduce stress during the research process