cyrilzakka/clinical-trials huggingface dataset:
Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial

An estimated 76 million adults in the United States over the age of 20 have hypertension (HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25% for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the population together with increases in obesity and sedentary behavior, it is not surprising that HTN is projected to increase significantly over the next several decades; with over 1.5 billion adults having HTN by the year 2025. Thus the public health implications to preventing and/or reducing elevations in blood pressure are substantial.

This study compares the efficacy of two different non-pharmacologic interventions (device guided breathing and isometric hand grip exercises) used alone and in combination for lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension. The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the interventions by participants. The knowledge gained from this study can provide information on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge may be especially useful for patients for whom access to medications and health care is limited and among patients unwilling to take or intolerant to pharmacologic therapies.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 21 years old, and
* Have Stage 1 high blood pressure. (Defined as a systolic blood pressure between 140 mm Hg and 159 mm Hg (the top blood pressure number) and/or a diastolic blood pressure between 90 mm Hg and 99 mm Hg (the bottom blood pressure number) in the prior 6 months.)

Exclusion Criteria:

* Take drugs to control blood pressure.
* Have a history of left ventricular hypertrophy.
* Have a history of cardiovascular disease such as stroke, mini-strokes, heart attack, unstable angina, bypass surgery, stents, angioplasty, abnormal heart rhythms, heart failure, or peripheral artery disease.
* Have diabetes.
* Have a history of poor kidney function.
* Have an upper arm circumference greater than 17 inches.
* Are currently participating in a formal exercise or weight loss program.
* Plan to participate in a formal exercise or weight loss program in the next 6 months.
* Are pregnant or plan to become pregnant in the next 6 months.
Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines

This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437).

The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 107005 and will not be further randomized in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 36 and 40 months of age at the time of Visit 1; between, and including, 48 and 52 months of age at the time of Visit 2; and between, and including, 72 and 76 months of age at the time of Visit 3.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects who previously participated in the primary and booster studies, who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part, in the booster study, of the blood sampling subset.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of any additional meningococcal serogroup C, Hib, hepatitis B and pneumococcal vaccine since the end of the booster study
* History of meningococcal serogroup C, Haemophilus influenzae type b, hepatitis B and invasive pneumococcal diseases since the end of booster study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of booster study, based on medical history and physical examination (no laboratory testing required).
* Administration of immunoglobulins and/or any blood products within the three months preceding the first blood sampling.
Relationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer

The purpose of this study is to determine whether evolution of resting energetic expenditure is a predictive marker of tumoral response for patients suffering from metastatic pancreatic cancer and treated with 1st line of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic metastatic cancer
* Patient older than 18 years
* Initiation of a first line of chemotherapy by Folfirinox, or Gemcitabine or in combination with Nab-Paclitaxel.
* At least one measurable target lesion
* Patient signed consent for Energie-Pancreas study participation

Exclusion Criteria:

* Other concomitant cancer
* Major general status alteration ( Performance status = 3 or 4 at inclusion)
* Concomitant diseases explaining an altered general status or having an impact on energetic expenditure (i.e.chronic or severe infection, severe cardiac insufficiency, severe respiratory insufficiency, chronic inflammatory disease, recent surgery (\< 1 month), ongoing Healing, hyperthyroidism.
* Smoker
* Patient deprived of his liberty, under guardianship, curator.
* Pregnant patient or breastfeeding
* Claustrophobic patient
Nicotine Gum Recovery After Colorectal Surgery

The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.

The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.

Eligibility Criteria:
Inclusion Criteria:

* Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
* Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy;

Exclusion Criteria:

* Prior intestinal surgery
* Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
* American Society of Anesthesiologists (ASA) Class IV or V;
* History of abdominal carcinomatosis;
* History of radiation enteritis;
* Children \< 18 or adults \> 85 years of age
* Pregnant women
* Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than 3 months ago.
* Patients requiring postoperative ventilation, pressor requirement or ICU stay
* Patients with prior cardiovascular disorders
Improving Breaking Bad News in Pediatrics by Simulated Communication

Breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. Being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved.

This prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. The simulation patient has prior unexpectedly died during a simulated resuscitation. The intervention group broke the bad news after receiving a short communication

Conversations about death and dying present discomfort for both healthcare professionals, patients and their families. These conversations, emotionally laden, pose lasting challenges and impact decision-making. Despite extensive medical training, physicians often lack adequate communication skills for such conversations, leading to frustration and distress. Delivering bad news, particularly in pediatrics, requires managing not only medical intricacies but also emotional impact. Communication skills, crucial for such scenarios, are typically developed over time through observation and practice, yet are often inadequately emphasized in medical training. Our study aimed to assess the impact of communication training on medical students delivering death notifications to simulation parents in pediatric simulation scenarios.

Eligibility Criteria:
Inclusion Criteria:

* Medical students, enrolled at the Medical University of Vienna.
* Successful completion the mandatory basic life support training "Block 16" in the third year of medical training and
* Successful completion of the mandatory communication seminar "Ärztliche Gesprächsführung B" also in the third year of medical training.
* Obtained written informed consent.

Exclusion Criteria:

* quality of the obtained video recordings were unsatisfactory and not usable for analysis
* unmet inclusion criteria
Acceptable Range of Inspiratory Effort During Mechanical Ventilation

Partially assisted mechanical ventilation is ideally titrated to maintain adequate inspiratory muscle activity (i.e. preventing disuse atrophy) while avoiding excessive (i.e. fatiguing) inspiratory loads. The advent of ventilator modes enabling flow and pressure assistance in proportion to patient inspiratory effort (i.e. Proportional Assist Ventilation (PAV), Neurally-Adjusted Ventilator Assist (NAVA)) permit careful titration of ventilatory support to achieve desired levels of patient inspiratory effort. However, data on the acceptable range of values for inspiratory effort and respiratory muscle load-capacity balance during mechanical ventilation are currently very limited. Such data are critical to inform a physiologically sound evidence-based approach to titrating partially-assisted ventilatory support. This study is designed to ascertain a physiologically acceptable range of inspiratory effort in mechanically ventilated patients. The study protocol includes measurements of the respiratory system during spontaneous breathing as well as evaluating the diaphragm in real-time with the use of ultrasonography. The experimental design outlined in the present study is predicated on the assumption that the range of values for inspiratory effort and load-capacity balance observed in patients who are successfully weaned from mechanical ventilation represent the safe and appropriate range of target values.


Eligibility Criteria:
Inclusion Criteria:

- Adult patients (\>17) receiving invasive mechanical ventilation following elective cardiac surgery who will undergo a trial of spontaneous breathing

Exclusion Criteria:

* Pregnant women
* Decompensated cardiac insufficiency or acute coronary syndrome
* Severe COPD
* Contraindications to esophageal catheter placement, namely known esophageal varices
Emotion Regulation Dysfunctions in NSSI Adolescents in Naturalistic Contexts

Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention. Recent studies indicate that prevalence rates are increasing worldwide, in particular under adolescents, indicating a growing public health issue. An impaired ability to regulate negative emotion has been suggested to play a potential role in NSSI behavior. Some recent interventions aim at improving dysfunctional emotion regulation via 'acceptance'. Acceptance represents an objective, nonreactive, nonjudgmental, and calming emotion regulation strategy, partly based on the philosophy of dialectical behavior therapy (DBT) that has been widely used in the clinical treatment of NSSI behaviors. The aim of the present functional magnetic resonance imaging (fMRI) study is to examine whether adolescents with NSSI can implement the acceptance strategy in naturalistic emotional contexts (immersive video clips) and whether they differ from healthy controls in terms of behavioral and neural effects. To this end, the investigators recruit one group of NSSI adolescents (n=40) and one healthy control group (n=40), to compare the subjective emotional experience as well as underlying neural activity as measured by blood oxygenation level-dependent (BOLD) fMRI. The investigators hypothesize that compared to HC, NSSI adolescents will experience stronger negative emotions and show dysregulated neural recruitment of brain systems engaged in emotional reactivity and regulations (e.g. limbic regions, default mode network, and frontal regions).


Eligibility Criteria:
Inclusion Criteria:

* 15-18 years
* right-handed
* normal or corrected normal visual acuity
* meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)

Exclusion Criteria:

* diagnosis of borderline personality disorder, major depressive disorder, other psychiatric disorders, etc.
* high suicidal risk
* recent use of medications that can affect neural activity
* have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
* have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives

The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.

Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25

Exclusion Criteria:

* Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
* Regularly consumed dried plum or prune juice
Shockwave Lithotripsy (SWL) Under Selective, General Anesthesia.

SWL is widely used in the treatment of patients with renal and ureteral calculi. Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. Moreover, in some cases it is very difficult to focus on the stone because of its movement as a results of breathing. In order to prevent stone movement we want to use a bronchial blocker, processing a selective ventilation of the opposite side of stone location.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Not pregnant
* All patients who failed in SWL process, taken under sedation (standard protocol)

Exclusion Criteria:

* Age \< 18
* Pregnancy
Feasibility of Estimating the Prevalence and Management of Stage 4 CKD the Gard, France

The main objective of this study is to evaluate the feasibility of estimating the prevalence of stage 4 and 5 chronic kidney disease in the Gard department of France from data obtained via laboratory databases. To verifiy if the demand for care thus authenticated by laboratory tests is adapted to nephrology care delivery, as recommended by the French High Authority of Health (HAS), laboratory data will be compared with those of patients seen by nephrologists in the department.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease (stage \>= 4)

Exclusion Criteria:

-
Oxidative Stress in Hypobaric Hypoxia

The trial investigates changes in metabolism during high altitude expedition up to 6865m. A mass-spectrometry based platform is used to detect different oxidative stress related metabolites. Symptoms of acute mountain sickness are evaluated and correlated with laboratory parameters.

Background

Altitude related illness, which include acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE), is common in subjects exposed to high altitude during professional or leisure time activities. There are independent risk factors such as: individual susceptibility and rate of ascent. HAPE is a potentially life-threatening complication of high altitude stay, mostly occuring within the first 2-5 days of exposure. Although there is a controversial discussion, excessive hypoxic pulmonary vasoconstriction is thought to be the main trigger for developing HAPE. Beside the controversial discussion if hypobaric hypoxia leads to oxidative stress it is not known whether oxidative stress contributes to AMS or HAPE.

Objective

The investigators hypothesize that reactive oxygen species are generated during high altitude stay and contribute to the development of acute mountain sickness. Furthermore they would like to describe other changes in metabolic pathways possibly contributing to vessel tone dysregulation.

Methods

36 healthy volunteers will examined during an high altitude medical research expedition to Mount Muztagh ata (7549m) in Western China. Acute mountain sickness scores and clinical parameters will be assessed. Metabolomics analysis of more than 390 parameters, using a mass spectrometry-based targeted metabolomic platform, is used to detect systemic oxidative stress and functional impairment of enzymes that require oxidation-sensitive co-factors. Furthermore routine laboratory test will be done, for example CRP, creatinine and interleukines

Eligibility Criteria:
Inclusion Criteria:

* healthy
* physical fit
* mountaineering experience
* 18-70 years

Exclusion Criteria

* any type of disease
* regular intake of medicaments
* history of high altitude pulmonary edema
* severe acute mountain sickness below an altitude of 3500m
* any history of high altitude cerebral edema
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening
* Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination
* Body mass index (BMI) 19 to 28 kg/m2 inclusive

Exclusion Criteria:

* Pregnant or currently lactating females
* History of any clinically relevant disorder
* Any history of depressive episodes or treatment with antidepressants
* History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1
* Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1
* Positive for HIV, hepatitis B or hepatitis C infection
* Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco
* Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing
* Medical history of significant drug allergies
Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy

Cardiovascular disease (CVD) is the leading cause of Taiwan. American Heart Association (AHA) indicated that CVD patients with Statin therapy would decrease the recurrence of CVD. The goal for lipid lowering in CVD patients was set at the level of low-density lipoprotein cholesterol (LDL-C) below 100 mg/dL. Coenzyme Q10 is recognized as a lipid soluble antioxidant, Statin treatment might affect the level of coenzyme Q10. Therefore, the purposes of this study are going to investigate the relation of coenzyme Q10 with other antioxidant vitamins (Vitamin A and E), the markers of lipid peroxidation, antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD) patients during Statin therapy. The study is going to design a placebo-controlled study. The investigators will recruit coronary artery disease (CAD) patients who are identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery, and healthy subjects. CAD subjects are randomly assign to placebo and coenzyme Q10 supplements (150 mg/bid = 300 mg/d) groups. Intervention is going to administration for three months. Fasting blood will be obtained in each month and determine the concentration of antioxidant vitamins, lipid peroxidation markers, antioxidant enzymes activities after intervention. Meanwhile, the investigators will measure the level of inflammatory markers in all subjects of this study. Hopefully, the results of this study could provide information of coenzyme Q10 supplementation for clinical dietitian in advising CAD patients who are under Statin therapy.


Eligibility Criteria:
Inclusion Criteria:

CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery and under statin therapy.

Exclusion Criteria:

* age \< 18 years old
* pregnancy women
* taking antioxidant vitamins supplements
Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)

This study is being done to assess the clinical course and treatment options for Crohn's Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East, and North Africa.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Crohn's disease or ulcerative colitis.
The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy

This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* esophageal cancer (squamous and adenocarcinoma subtypes)
* eligble for Ivor-Lowis esophagectomy
* expected survival time longer than 12 months

Exclusion Criteria:

* palliative resection(non-R0)
* anastomosis leak
* jejunum or colon transversum interponate