cyrilzakka/clinical-trials huggingface dataset:
Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock

Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Patients over than 18 years old
* Septic shock
* Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min
* Written informed consent

Exclusion Criteria:

* Corticotherapy
* Known allergy to Fludrocortisone
* Esophageal or gastric disease
* Pregnant woman
* Inclusion in another clinical trial
Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.

The Multiple Patient Expanded Access Program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) following platinum-based chemotherapy. The dose of olaparib tablets is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg. The 100 mg tablet is available for dose reduction. Treatment may continue until disease progression, unacceptable toxicity or withdrawal of patient consent. The program will collect observational data only.

Eligibility Criteria:
Inclusion criteria

For inclusion in the program patients must fulfill the following criteria:

* Provision of informed consent prior to any program specific procedures
* Female patients ≥ 18 years of age and has platinum-sensitive relapsed high grade epithelial ovarian, primary peritoneal or fallopian tube cancer
* Patient is in response (complete response or partial response) following platinum-based chemotherapy.
* Patients must have normal organ and bone marrow function measured within 28 days prior to administration of program treatment.
* Postmenopausal or evidence of non-childbearing status for women of childbearing potential.

Exclusion criteria:

Patients should not enter the program if any of the following exclusion criteria are fulfilled:

* Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
* Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors.
* Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
* Patient with moderate or severe hepatic impairment.
* Breast feeding women.
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder

To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).


Eligibility Criteria:
Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

* Primary diagnosis of recurrent MDD or persistent MDD.
* Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s).
* Participants must be willing and able to comply with all study procedures and restrictions.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

* Participant is pregnant or breastfeeding or plan to become pregnant during the study.
* Participant has an unstable medical condition or unstable chronic disease.
* Participant has a history of neurological abnormalities.
* Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
* Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
* Participant has an alcohol or substance use disorder.

Note: Other inclusion/exclusion criteria may apply
Red Cell Lysis Buffer Application Versus Conventional Sample Processing in EUS-FNB

The goal of this clinical trial is to evaluate the application of red cell lysis buffer (RCLB) versus conventional sample processing in endoscopic ultrasonography (EUS)-guided biopsy for solid pancreatic lesions. The main questions it aims to answer are:

whether the application of red cell lysis buffer improves histological tissue quality by decreasing blood contamination.

Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-guided biopsy. The obtained specimens will be processed by RCLB and conventional formalin solution.

Researchers will compare the blood contamination score of specimens in RCLB group with the conventional group see if the blood contamination can be improved.


Eligibility Criteria:
Inclusion Criteria:

18 to 80 years old; Solid pancreatic lesions confirmed by clinical and CT/MRI/ PET imaging. Signed written informed consent

Exclusion Criteria:

Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant Patient is enrolled in any other clinical protocol or investigational trial
Evaluation of the Effects of Eccentric Muscle Training Versus Conventional Concentric Training in Chronic Heart Failure

This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation.

In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. This group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.


Eligibility Criteria:
Inclusion Criteria:

Patients :

* Patients who have provided written informed consent
* Patients with national health insurance cover
* Men or women aged between 45 and 85 years with stabilized chronic heart failure (ischemic or dilated cardiopathy) for at least one month, New York Heart Association stage\> 2.
* Echocardiographic left ventricular ejection fraction (Simpson method) \< 45% OR N-terminal-ProBNP \> 3 x upper limit of normal\* (\*= 125pg/ml for the CHU laboratory).
* First period of rehabilitation for chronic heart failure.

Healthy volunteers:

* Subjects who have provided written informed consent
* Subjects with national health insurance cover
* Men or women aged between 18 and 85 years.

Exclusion Criteria:

Patients:

* persons without national health insurance cover
* Severe obstructive cardiopathy,
* severe aortic valve stenosis,
* severe progressive heart rhythm or conduction disorders not corrected with a pacemaker, discovered at the initial effort test
* intra-cavitary thrombus,
* severe pulmonary artery hypertension (systolic pulmonary arterial hypertension \>70mmHg),
* recent history of venous trombo-embolism (last 3 months),
* impaired executive function making it impossible to understand and follow reconditioning programme (Mini Mental Test \< 24),
* heart transplant,
* associated medical disorders that could predominately impair functional capacity compared with the chronic heart failure (examples: respiratory insufficiency, non-stabilized metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilized disorder such as neoplasia, systemic disease...).

associated chronic motor deficit of a neurological origin (example: sequelae of a cerebrovascular accident), an osteo-articular origin (example: impairment due to Rheumatoid arthritis), of a peripheral vascular disease (example: peripheral artery disease, venous disease, lymphedema) will not be included in the exclusion criteria provided thay are compatible with the level of physical ability defined in the inclusion criteria. The presence of an implantable pacemaker and/or defibrillator will not be an exclusion criterion

Healthy volunteers:

* persons without national health insurance cover
* Any organic disorder whatever its nature (cardiac, respiratory, neurological, orthopedic, ...) that could affect adaptation to effort or is a contra-indication for physical activity.
Interaction of MTNR1B Genotype and Type of Breakfast (protein-enriched V Carbohydrate-rich) on Postprandial Glucose Response.

The risk version of the MTNR1B gene (which codes for a melatonin receptor) has been associated with type II diabetes (T2D) and associated physiological markers. People with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose tolerance when they eat late. Previous research suggests eating a protein enriched breakfast can improve glucose response. Therefore, the present study will investigate if the version of the MTNR1B gene that people have is associated with their glucose response after breakfast. Also, whether a protein enriched breakfast improves glucose response in participants with the risk version of the gene. Measures of glucose response collected over the two-week duration of the study will be compared between groups with the different versions of the gene. These findings can be used to provide personalised nutrition advice which may reduce the risk of T2D.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-48 years\*, not diabetic, not sleep disorder, not relevant medication (weight loss, sleeping, melatonin), not restricted diet, not allergic to oats, milk, wheat, barley or soya, not implanted medical device, such as pacemakers.

Exclusion Criteria:

* aged \< 18 or \> 48 years, diabetic, sleep disorder, eating disorder, taking relevant medication (weight loss, sleeping, melatonin), following a restricted diet, implanted medical device, such as pacemakers.
Virtual Therapeutic Garden for Depressive Symptoms

This study evaluates the addition of virtual therapy intervention in the treatment of depression in the elderly. Half of the participants will receive virtual reality treatment as an addition to physical exercises and psychoeducation, while the other half will receive physical exercises and psychoeducation alone.

Depressive disorders are frequent and can either first be manifested at a younger age and recurrent during later life or have an onset beyond 60 years (late-life depression). The multifactorial genesis of depression in old age includes psychosocial, vascular and metabolic factors and requires multimodal and multi-professional therapy including physical activity and psychosocial interventions. However, there is still a percentage of older people who do not show improvement in depressive symptoms.

In recent years, various types of virtual reality are gaining in popularity, primarily because of the availability and ease of use. A systematic review from 2018 concluded that VR treatment had moderate to large effects in anxiety and depression, compared to controls and it could be another effective choice available to clinicians and patients.

Therefore, the aim of this project was to evaluate the effectiveness of virtual therapy in the elderly, in whom the previous multimodal therapeutic program has not brought the expected results.

Eligibility Criteria:
Inclusion Criteria:

* GDS≥10 or HADS-A≥8 or HADS-D≥8

Exclusion Criteria:

* cognitive impairment (MMSE\<24);
* aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE;
* contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
* substance abuse;
* participation in another therapeutic project or individual psychotherapy;
* antidepressant treatment;
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.

This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored \>10 years) and adjuvant (ie, stored \>5 years).

Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female
* Provide written informed consent prior to study-related procedures
* Stable health status
* Access to consistent and reliable means of telephone contact
* Able to understand and comply with planned study procedures
* Agree to stay in contact with site, and no plans to move from study area for study duration

Exclusion Criteria:

* Allergic to eggs, other vaccine components, or squalene-based adjuvants
* Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
* Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
* Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
* Have an active neoplastic disease or history of hematologic malignancy
* Have long term use (≥14 consecutive days) of glucocorticoids (\>20 mg/day) or high-dose inhaled steroids (\>800 mcg/day) within preceding 6 months
* Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
* Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years
Improving Patient Access to Stroke Therapy Study

Limited access is a major hurdle in the treatment of AIS; many hospitals, especially rural hospitals, do not have the infrastructure or medical support to effectively treat AIS patients.5 Failure to recognize the signs and symptoms of stroke by the patient and/or emergency medical services (EMS) is another barrier to the timely treatment of AIS. Several studies, including the Paul Coverdell National Acute Stroke Registry (PCNASR), have reported low rates of adherence to stroke care guidelines, suggesting that many AIS patients do not receive proper treatment according to established guidelines. Thus, there remains an increasing need to assess and address the barriers that prevent patient access to proper AIS treatment.

Annually, approximately 20,000 patients are discharged from Wisconsin hospitals with the diagnosis of stroke and an estimated 4,000 patients die from stroke each year in WI. To date, there have been no statewide studies initiated in Wisconsin to assess the regional barriers to the treatment of AIS patients with thrombolytic or endovascular therapy, and many hospitals do not routinely collect and analyze AIS patient data.

The goal of the Improving Patient Access to Stroke Therapy (IMPACT) pilot study is to engage community hospitals statewide to identify the regional barriers to AIS therapy in WI.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)
* ICD-9-CM code indicative of stroke or TIA

Exclusion Criteria:

* Clinical diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage
* Stroke or TIA occurred while patient was hospitalized
Effects of Yoga on Heart Rate and Heart Rate Variability Responses to Stress

Introduction: Yoga has been shown to reduce stress and have benefits for a number of stress-related disorders. However, the effects of an acute bout of yoga practice on cardiac autonomic response to and recovery from stress remain unclear. This study aimed to examine the effect of a single bout of yoga on heart rate (HR) and heart rate variability (HRV) response to and recovery from mental stress.

Materials and Methods: This study was conducted with a randomized, counterbalanced, crossover design. A total of 44 participants completed two sessions (yoga and video watching (VW)) in randomly assigned order. After each condition, participants underwent a Stroop task and mental arithmetic task. Electrocardiogram was measured and HR and HRV for resting, each condition, and the stress and recovery periods were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 40 years old
* a body mass index (BMI) between 18.5 and 30
* being sedentary

Exclusion Criteria:

* Electrocardiogram (ECG) abnormalities (e.g., arrhythmia, atrioventricular blocks)
* history of cardiovascular disease, diabetes, or renal disease
* contraindications for exercise (e.g., orthopedic problems)
* involvement in any yoga practice
* being pregnant or nursing
* use of tobacco products or medications that may affect cardiovascular function
Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)

The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.

This is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. The duration of treatment is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A 6-month history of asthma with periodic episodes requiring treatment.

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Body Mass Index (BMI) of 30.0 kg/m\^2 or above
* Body Mass Index (BMI) of 27 kg/m\^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
* Stable body weight
* Preceding failed dietary effort

Exclusion Criteria:

* Known type 1 or type 2 diabetes
* Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
* Screening calcitonin of 50 ng/L or above
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
* Personal history of non-familial medullary thyroid carcinoma
* History of acute or chronic pancreatitis
* Obesity induced by drug treatment
* Use of approved weight lowering pharmacotherapy
* Previous surgical treatment of obesity
* History of major depressive disorder or suicide attempt
* Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
Comparison of Two Treatment Strategies in Hypertensive Patients

The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.


Eligibility Criteria:
Inclusion Criteria:

* • Male or female patients \>18 years of age

  * Hypertension defined by MSDBP ≥ 90 and /or MSSBP ≥ 140 mmHg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects,

Exclusion Criteria:

* • Severe hypertension, secondary hypertension, type 1 diabetes mellitus

  * History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
  * Other protocol-defined exclusion criteria may apply.