cyrilzakka/clinical-trials huggingface dataset:
Effect PEEP on Diaphragm

This study evaluates the effect of positive end-expiratory pressure on the position, length and function of the diaphragm. During the first part of the study, physiological measurements of the diaphragm will be performed while participants receive non-invasive ventilation at different PEEP levels. During the second part of the study, MRI measurements of the diaphragm will be performed during a change in PEEP level.

In almost all mechanically ventilated patients, positive end-expiratory pressure (PEEP) is used. Its function is to prevent alveolar collapse and to maintain oxygenation. However, it has recently been found that PEEP may contribute to diaphragm weakness, which is an important problem in the intensive care unit (ICU). This study showed that mechanical ventilation with PEEP resulted in a caudal displacement of the diaphragm, since PEEP increases the end-expiratory volume. Furthermore, their study in rats showed that this displacement resulted in a reduced fiber length and sarcomere length on the short term.

After rats were ventilated with PEEP for 18 hours, it was found that adaptation of the diaphragm occurred; i.e. the number of sarcomeres were decreased. It is hypothesized that this adaptation may also occur in mechanically ventilated patients. This could lead to problems in weaning a patient off the ventilator, as PEEP is abruptly removed during a spontaneous breathing trial (SBT). This leads to a reduction in end-expiratory volume which would mean that the newly-adapted diaphragm fibers are being stretched. These stretched muscle fibers are not working at their optimal length of the force-length relation, thereby contributing to diaphragm weakness.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Symptoms relating to respiratory or cardiovascular disease
* History of pneumothorax or family history of primary pneumothorax
* Obesity (defined as BMI \> 30kg/m²)
* Known pregnancy
* Contraindications for the placement of a nasogastric tube (upper airway/esophageal/gastric/mouth or face pathology (e.g. recent surgery, esophageal varices, diaphragmatic hernia), nasal bleeding within the last 2 weeks or use of anticoagulants)
* Contraindications for MRI (electrical/metallic implants, claustrophobia or history in metalworking)
* Subjects who are employed at the department of intensive care adults, directly involved in the study and/or family from staff of the ICU.
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.


Eligibility Criteria:
Key inclusion criteria

* Male with both parents of Japanese descent
* Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive). Body weight equal to or greater than 65.0 kg
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Key exclusion criteria

* Any disorder that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator
Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis

Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi


Eligibility Criteria:
Inclusion Criteria:

* Liver Cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.)
* CTP ≥ 7-15 (Child's B/C)
* Small esophageal varices with RCS and large esophageal varices (\>5 mm)
* No history of previous bleed

Exclusion Criteria:

* Malignancy-HCC, PVT
* Child A
* MELD \>35
* Contraindications to β blockers.
* Platelet count \< 30,000/mm3
* Previous endoscopic variceal treatment. (Beyond 21 days)
* Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month
* Post TIPS, Shunt surgery
* Acute kidney injury (Sr.Cr\>1.5mg/dl)
* Non cirrhotic portal hypertension
* Acute on chronic liver failure
Nuts and Extra Virgin Olive Oil Pilot Study

This study is designed to test the feasibility of asking older adults with high blood pressure to supplement their daily diets with walnuts and extra-virgin olive oil.

Even though cardiovascular disease (CVD) continues to be the leading cause of death in the United States, Americans have yet to widely adopt evidence-based dietary modifications necessary to reduce CVD risk factors. Encouraging evidence from the Prevención con Dieta Mediterránea (PREDIMED) trial indicates that adding olive oil and nuts to the diets of older adults in Spain substantially impacted CVD risk factors and events.

A large trial testing EVOO and nuts in a U.S. population is needed to determine if supplementing with EVOO and nuts can reduce risk of cardiovascular events and mortality in adults living in the U.S. Prior to launching a large trial, it is important to assess whether adults 55 and older would be interested in participating in a supplementation trial such as PREDIMED. Additionally, it is important to assess if they are willing to consume the nuts and EVOO and attend study related-data collection visits.

Eligibility Criteria:
Inclusion Criteria:

* Being treated for hypertension-defined by being prescribed at least one hypertension medication; willing to comply with study visits, as outlined in the protocol; able to read and speak English; no allergies or hypersensitivities to olive oil or nuts; ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Plans to move from the study area in the next 8 weeks; dementia that is medically documented or suspected; homebound for medical reasons; cancer diagnosis and/or treatment in the last 3 years.
Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-derived Mononuclear Cells on Mortality in Patients With Chronic Post-infarction Heart Failure

Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure

Improve mortality and morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy, by single versus repeated intracoronary infusion of autologous bone marrow-derived mononuclear cells.

Eligibility Criteria:
Inclusion Criteria:

* Previous myocardial infarction at least 3 months ago, open infarct vessel or bypass
* Left ventricular ejection fraction (LVEF) ≤ 45% on echocardiography
* Stable chronic heart failure NYHA class II to III under constant (4 weeks) evidence-based optimal medical treatment
* age 18 - 80 years
* written informed consent
* women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial

Exclusion Criteria:

* Non-ischemic cardiomyopathy
* Necessity for revascularization in other vessel than the infarct vessel at the time of study therapy
* Hemodynamic relevant severe valvular disease with indication for operative / interventional revision
* Heart failure with preserved ejection fraction (diastolic heart failure), LVEF \> 45%
* Unstable Angina
* Severe peripheral artery occlusive disease (≥ Fontaine stadium III)
* Active infection (C-reactive protein \> 10 mg/dl), chronic active hepatitis; any chronic inflammatory disease, HIV infection
* Neoplastic disease without documented remission in the last 5 years
* Stroke ≤ 3 months
* Impaired renal function (Serum creatinine \> 2,5 mg/dl) at the time of study inclusion
* Relevant liver disease (GOT \> 2x upper normal limit, spontaneous INR \> 1,5).
* Diseases of hematopoetic system, anemia (Hemoglobin \< 8.5 mg/dl), thrombocytopenia \< 100.000/µl)
* Splenomegaly
* Allergy or intolerance of clopidogrel, prasugrel, ticagrelor, heparin, bivalirudin
* History of bleeding disorder
* gastrointestinal bleeding ≤ 3 months
* major surgery or trauma ≤ 3 months
* Uncontrolled hypertension
* Pregnancy, lactation period
* mental retardation
* previous cardiac cell therapy within last 12 months
* Participation in another clinical trial ≤ 30 days
Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes following cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes following cesarean section.

Eligibility Criteria:
Criteria: Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Gastric Cancer Surgery in Elderly Patients

Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in aged population because of general health condition may affect the postoperative result. Aim of the study was to identify risk factors for post-operative mortality in octogenarian patients who underwent surgery for gastric cancer.

236 patients (181: 80-85 years old and 55: \>85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The variables of the two groups of patients were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed primary gastric cancer submitted to surgical treatment;
* Age \> 80 years.

Exclusion Criteria:

* Patients with histologically confirmed primary gastric cancer submitted to surgical treatment and age \< 80 years;
* Patients with histologically diagnosis of other neoplastic and non-neoplastic diseases submitted to surgical treatment.
Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus

The purpose of this study is to compare the incidence of composite neonatal morbidity and birthweight \>4500 grams among uncomplicated large for gestational age (LGA) fetal growth at delivered 37 weeks versus expectant management.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Plan for vaginal delivery. Patients with prior cesarean section are eligible if they are planning for a trial of labor after cesarean section.
* Gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment
* Dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound \<21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization
* No known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician)
* LGA defined as estimated fetal weight (EFW) \> 90th percentile by Hadlock formula but \<4500 grams

Exclusion Criteria:

* Pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin)
* Planned cesarean delivery
* Polyhydramnios
* Known major fetal anomalies
* Multiple gestation or selective reduction of multiple gestation after 14 weeks
* Previous stillbirth at term
* Indications for delivery at \<39 weeks. Common examples include:
* Placenta previa
* Placenta accreta
* Vasa previa
* History of classical cesarean section or myomectomy
* Human immunodeficiency virus (HIV)
* Oligohydramnios (low amniotic fluid, defined as maximum vertical pocket \<2.0cm)
* High-risk pregnancy as determined by the physician. Common examples include:
* Pre-gestational diabetes or gestational diabetes on medication
* Chronic hypertension on medication
* Maternal cardiac disease
* Asthma requiring oral steroids during pregnancy
* Chronic renal disease
* Antiphospholipid syndrome
* Hyperthyroidism
* Prior stillbirth
* Systemic lupus erythematous
* Hemoglobinopathies such as sickle cell disease
Technology Assisted Programs That Promote Mental Health for Teenagers

The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

Eligibility Criteria:
Inclusion Criteria:

* Has a score of 12-39 (males) / 15-39 (females) on the Center for Epidemiologic Studies Depression Scale (CES-D) OR reported past month use of marijuana, cigarettes, alcohol or other substances on the Center for Disease Control Youth Risk Behavior Survey (YRBS).
* Is familiar with the use of computers and the Internet, as well as mobile phones
* Is able to speak and read English
* Is between 14-19 years of age

Exclusion Criteria:

* Is currently taking an antidepressant medication or has taken one in the previous 3 months
* Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone
* Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis.
* Is severely suicidal (has ideation, plan, and intent in the past 12 months) .
Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times

The objective of this study is to determine the optimal withdrawal time for colonoscopy. A 6-minute withdrawal time is currently the standard of care but has only been evaluated in an observational fashion. The investigators believe that this should be validated in a standardized fashion. If the benefits of a 6 minute withdrawal are proven in this study (ie a low polyp/adenoma miss rate and a high polyp/adenoma detection rate), then this will support widespread adoption of a 6 minute withdrawal as the standard of care. This in turn may decrease the occurence of 'interval colon cancers', which are early colon cancers arising in subjects despite their having undergone colonoscopy. Our hypothesis is that the polyp/adenoma detection rate will be unacceptably low and the polyp/adenoma miss rate will be unacceptably high in the 3-minute withdrawal group when compared to the 6-minute withdrawal group.

Eligible patients will be randomized to colonoscopy with either a 6-minute withdrawal time or a 3-minute withdrawal time. Patients will then undergo colonoscopy. All colonoscopies will be performed by a GI attending (standard of care). The colonoscopy is typically performed under conscious sedation using medications such as fentanyl and midazolam for comfort (standard of care). Occasional patients undergo colonoscopy under general anesthesia. For all patients, advancement of the colonoscope to the cecum will be followed by segmental withdrawal of the colonoscope in each of 3 segments of the examined colon (right side of colon, transverse colon and left side of colon). Following examination of each individual segment, the colonoscope will be readvanced to the proximal end of the segment and a 2 minute withdrawal will be re-performed. For those randomized to the 6-minute withdrawal each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist. For those randomized to the 3-minute withdrawal time, advancement to the cecum will also be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a "second look" over each segment over 2 minutes by the same endoscopist. All patients will therefore undergo a second look colonoscopy with a 6-minute withdrawal time ('de-facto' standard of care). Polyp/adenoma detection and miss rates will then be calculated and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Already scheduled for colonoscopy

Exclusion Criteria:

* Age \< 18
* Pregnant women
* Mentally disabled
* Decisionally challenged
* Cancer subjects
* Healthy volunteers
* Prisoners
Patient Preference With Visicol Tablet Preparation for Colonoscopy

The purpose of this study is to determine patient preference and acceptance of tablet sodium phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their prior colonoscopy. This study will provide answers related to the patient preferences and their acceptance of this new method of bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

* Prior colonoscopy with PEG solution in the past one year
* Must be able to swallow tablets

Exclusion Criteria:

* Patients below 18 years and above 100 years.
* Congestive heart failure
* Chronic renal failure
* Pre-existing electrolyte disorder
* Pre-existing mega-colon or a motility disorder.
* Patients with pre-existing seizure disorder.
* Patients scheduled for colonoscopy after 1:00 p.m. will be excluded from the study.
* Pregnant or lactating women
The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction

This study was carried out to determine the effect of controlled massage applied at birth on labor pain and duration and maternal satisfaction. The study was conducted as a randomized, controlled research. The research was conducted with 154 randomized pregnant women admitted to Erzurum Nenehatun Obstetrics and Maternity hospital between February-November 2019. The study consisted of 3 different groups: Group A included the pregnant women who received routine hospital care (control group n=53), Group B included the pregnant women who received midwife-controlled massage (n=50), and the Group C consisted of the pregnant women who received self-controlled massage (n=51). It was determined that the controlled massage intervention that was applied in this study reduced labor pain, but it did not affect the duration of labor or the satisfaction levels of the women.

This study was conducted to determine the effects of controlled massage applied during labor on pain during labor, labor duration and maternal satisfaction. This was a randomized-controlled experimental study.The study was carried out with the participation of 154 randomly selected pregnant women at an Obstetrics and Gynecology Hospital located in a province in the Eastern Anatolia Region of Turkey between February and November 2019.The study included three groups (A: control group, B: midwife-controlled massage group, C: self-controlled massage group). The data were collected using a "Personal Information Form", the "Visual Analogue Scale (VAS)", the "Verbal Category Scale (VCS)", a "Partograph", an "Individual-Controlled Massage Follow-Up Form" and the "Scale for Maternal Satisfaction in Vaginal Delivery (SMSVD)".It was determined that the controlled massage intervention that was applied in this study reduced labor pain, but it did not affect the duration of labor or the satisfaction levels of the women.

IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some nonpharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.

What the results of this study add? There is no studies using thecontrolled massage. In our study, it was found that controlled massage is effective on labor birth.

What the implications are of these findings for clinical practice and/or further research? Our study suggested that midwives and pregnant women could practice controlled massage to reduce labor pain.

Eligibility Criteria:
Inclusion Criteria:

* Having at least a primary school degree
* Not having a communication problem
* Having a primiparous term pregnancy (38-42 weeks)
* Not having an obstetric risk
* Being in the latent phase of labor (dilation 0-3cm)
* Having no contraindications for massage

Exclusion Criteria:

* Being multiparous
* Having a high-risk pregnancy
* Being in the active or transitional phase of labor
* Having a contraindication to massage