cyrilzakka/clinical-trials huggingface dataset:
The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension

Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP)≥ 65 mmHg and a serum lactate level of \> 2 mmol/L (18 mg/dL) despite sufficient volume resuscitation

. Hypovolemia (both relative and absolute) and reduced vascular tone have a role in determining the severity of hypotension in septic shock

Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP)≥ 65 mmHg and a serum lactate level of \> 2 mmol/L (18 mg/dL) despite sufficient volume resuscitation . Hypovolemia (both relative and absolute) and reduced vascular tone have a role in determining the severity of hypotension in septic shock

. When mean arterial pressure (MAP) falls below a specific critical level organ blood flow is physiologically dependent on perfusion pressure. Fluid resuscitation and vasopressors have an influence on hypovolemia and the vascular tone in the early phase, as fluid resuscitation aims to correct hypovolemia and vasopressors-norepinephrine (NE)- as a first-line drug aiming to restore vascular tone to assure organ perfusion

. Norepinephrine is both an alpha1- and beta1-agonist so it is able to increase vascular tone and contractility

. Nevertheless, a large amount of fluids will increase the risk of fluid overload, which is a common complication during septic shock resuscitation

* After the early phase, only fifty percent of patients respond to fluid administration, meaning that fluid treatment cannot boost cardiac output (CO) The current data indicate that the time from the onset of septic shock to the initiation of norepinephrine administration is a significant survival predictor; however, a suggestion for the optimal time to provide norepinephrine support was not explicitly expressed

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged from18 to 65 years old
* had the diagnostic criteria for sepsis as the presence of infection
* systemic manifestations of infection and signs of Hypoperfusion

Exclusion Criteria:

* Acute cerebral vascular event
* Active cardiac conditions
* Valvular heart diseases
* Hypotension suspected to be due to another cause and comorbidities
* Status asthmatics
* Active hemorrhage
* Pregnancy
* Burn injury
* Requirement for immediate surgery
* Advanced-stage cancer
* Refusal to participate in the study
Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis

The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.

Psoriasis is a common, genetically predisposed, inflammatory and proliferative disease of the skin, the most characteristic lesions consisting of chronic, sharply demarcated, dull-red scaly plaques, particularly on extensor parts of limbs and in the scalp. Psoriasis can be divided into mild, moderate or severe psoriasis based on the extent of the skin changes

Psorax35, which is extracted from herring roe are shown to improve the condition of people with psoriasis.

The objective of this study is to investigate the effect, safety, and mechanism of action of Psorax35 on mild to moderate Psoriasis and comorbidities associated with psoriasis through a 32-weeks study.

The participants will be randomized into one of two arms; Psorax35 and Placebo. The study will include a total of 6 treatment visits involving Blood samples, Photo documentation, Psoriasis and Severity index (PASI), Body surface area (BSA), Physician's Static Global Assessment (PSGA), Life quality index (EQ-5D, VAS and DLQI), Blood pressure, Blood rate, Body Mass Index (BMI), Waist circumference, Waist/hip ratio, and 24 hrs dietary recall. At visit 4 Blood samples, Blood pressure, Blood rate, BMI, Waist circumference, Waist/hip ratio, and 24 hrs dietary recall are not included.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male subjects at least 18 years old understanding Norwegian oral and written information
2. Diagnosis of mild to moderate psoriasis vulgaris for at least 6 months prior to mild to moderate Psoriasis vulgaris as defined at screening by:

   * PASI scores less than 10 (mild psoriasis) and
   * Body surface area affected by chronic plaque psoriasis 1%-9.9% (mild and moderate psoriasis)
3. Women of childbearing potential must have a negative serum pregnancy test at the screening visit.

Exclusion Criteria:

1. Pregnancy
2. Initiation of a drug known to cause or exacerbate psoriasis
3. Having received an investigational medical product (IMP) or investigational device within 28 days' prior randomization
4. Alcohol and drug abuse or any condition associated with poor compliance
5. Malabsorption disorder
6. Scheduled hospitalization during the course of the study that could compromise the study
7. Major diseases or infections
8. Known or suspected sensitivity or allergic reactions to the IMP or excipients
9. Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk
10. Planned trip abroad to a sunny resort involving active sun exposure
11. Any anti psoriatic treatment
12. Immunosuppressive - immunomodulating treatment given for any other reason than psoriasis
13. UV treatment and return from a sunny resort involving active sun exposure for the last 4-6 weeks
Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures

Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* scheduled to undergo bariatric procedure

Exclusion Criteria:

* Am Soc Anesthesiology score of III or IV
* significant comorbidities
* subjects contraindicated for use of magnetic system
* clinical history of impaired coagulation
* hepatic abnormality or anatomical abnormality
Calorie Restriction, Protein Supplementation and Metabolic Health

The purpose of this study is to determine whether consuming additional protein during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Obese with body mass index (BMI) between 30 and 50 kg/m2
* Postmenopausal
* Sedentary (i.e., less than 1.5 hours of exercise per week)

Exclusion Criteria:

* Individuals with diabetes and/or uncontrolled hypertension
* Individuals with hepatitis B and/or C
* Individuals who smoke
* Individuals with an allergy to whey protein
Loaded Breathing Training in Essential Hypertension

The purpose of this study is to determine whether adding load to slow controlled breathing training could enhance blood pressure lowering in patients with essential hypertension.

Hypertension (HT) is one of the major risk of cardiovascular diseases and cost of pharmacological treatment is a very high. Lifestyle modification is the first trial in stage 1 hypertension before commencing pharmacological treatment and a co-treatment with drug in hypertensive patient. Slow paced breathing training and physical training has been shown to reduce both systolic and diastolic blood pressure in HT. Moreover loaded breathing was reported to be able to decrease blood pressure in healthy. Loaded slow breathing training may enhance the antihypertensive effect of slow paced breathing.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of essential hypertension stage I-II

Exclusion Criteria:

* Respiratory disease
* Diabetes mellitus
* Heart disease
* Renal disease
* Cerebrovascular disease
* Dyslipidemia
* Pregnancy
Electrophysiological Comparison of mAP and mADM Using EMG

The primary aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.

This is a blinded, single-center, prospective study in patients during surgery, requiring use of neuromuscular blockade. Neurostimulation will be used to monitor objective responses, as per current clinical routine. Data collection of Tetragraph EMG responses will be unavailable to the clinician for clinical decision-making, as per current clinical routine, but will be stored on the interfaced SD card.

Eligibility Criteria:
Inclusion Criteria

1. Age 18 years or older.
2. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).
3. Subject has provided verbal consent
4. BMI \<39

Exclusion Criteria

1. Presence of an underlying neuromuscular disease.
2. Presence of renal or hepatic disease.
3. Subject has open skin sores in the locations needed for electrode application (forearms).
4. Patients on oral anticholinesterase, anti-seizure medications, and magnesium sulfate.
COVID-19 and Its Effects on Chronic Pain Patients

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. Many factors can affect pain and its severity.

This study aims to explore how the COVID-19 affects chronic pain patients in terms of pain in general, intensity of pain, desire for pain treatment including follow up visits and pain medication refills as well as sleep.

Research question

What are the effects of the COVID-19 on chronic pain patients in terms of pain and pain management?

Conceptual framework

The COVID-19 is a novel emerging infectious disease which has unimaginable and unbelievable large scale distressing effects worldwide.

Up to date, there is no study which aims to evaluate the effects of the COVID-19 on chronic pain patients in terms of pain and pain management. The previous survey in patients focused on the worrisome of them for getting this infection and their confidence in their government to control the COVID-19 situation in the US.

Materials and methods

This study is an in-depth interview. The in-depth interview is the principal method to collect qualitative data by setting up open-ended questions beforehand. Patients who are interviewed, can express their attitudes freely. This method is flexible which words, sentences and questions can be adjusted to suit each interviewee (participant). The process consists of active and intentional listening as well as ask on an in-depth basis. All conversations during the in-depth interview are tape-recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pain who have been under the health care service of the pain clinic of Songklanagarind hospital.
* Chronic pain patients are patients with persistent pain for at least 3 months. Pain can be from any etiologies.
* The expected number of interviwees for this in-depth interview is 30 or until the gathered interview data are saturated.

Exclusion Criteria:

* Patients who are not willing to participate this study and have time for an in person 'in-depth interview'.
* Patients who are not influence in Thai language.
* Patients who are physically or mentally too ill to participate this study.
Mechanisms of Myocardial Infarction in Women With Non Obstructive Coronary Artery Disease

The objective of our work to determine the mechanisms of myocardial infarction in women without obstructive coronary artery disease.

Cardiovascular disease is the leading cause of death for women. Acute coronary syndrome (ACS) is usually characterized by a sudden erosion of the endothelial wall or rupture of a plaque.However, women with ACS are less likely than men to have either classic symptoms or obstructive coronary artery disease but paradoxically have a worse prognosis. Different data from the literature indicate that there may be different pathophysiological mechanisms, afflicting men and women somewhat differently.Between 5% and 30% of patients with ACS undergoing coronary angiography are found to have non visible or non obstructive coronary disease (NOCD). This is 2-3 times more common in women than in men. Several pathogenetic mechanism of myocardial infarction (MI) in the absence of obstructive coronary artery disease (OCD) have been postulated, including among others atherosclerosis with plaque disruption that does not lead to luminal occlusion ,endothelial dysfunction, vasospasm , distal microembolization and microvascular dysfunction. However the data are extremely limited.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years old, not pregnant
* with acute non ST elevation myocardial infarction (admitted within 12 hours from beginning of symptoms)
* who are candidates for coronary arteriography during the hospitalization. -

Exclusion Criteria:

\*Women with troponin elevation caused by other causes -
Follow-up of Children After Stuttering Treatment

This study aims to determine the percentage and predictors of stuttering relapse following treatment with the Lidcombe Program. It will also investigate the effectiveness of sending reminder messages to parents to assist in reducing relapse.

Stuttering treatment becomes more time-consuming and less effective as children become older. Therefore it is crucial to prevent relapse following treatment in the early years. This study will investigate predictors of relapse and assess the effectiveness of a simple two-weekly user-friendly reminder to parents, about when and how to address any re-occurring stuttering after treatment. Results from the study may help to prevent stuttering relapse in this age group in the future.

Eligibility Criteria:
Inclusion Criteria:

* Completion of stage I of Lidcombe Program
* Less than 1 percent syllables stuttered at recruitment
* Means of receiving SMS email or phone reminder
Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are:

Does 3-dimensional (3D) imaging device improve the identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve high risk adenoma identification.

Participants will:

Undertake colonoscopy examination using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years;
* Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;
* Signing the written informed consent;

Exclusion Criteria:

* Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis \[FAP\], Lynch syndrome, etc.);
* Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;
* Patients with a history of colorectal adenocarcinoma or alarming symptoms;
* Patients with a history of inflammatory bowel disease;
* Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;
* Patients with severe cardiopulmonary insufficiency;
* Patients with severe coagulation disorders or high bleeding risk (platelets \<50×10⁹/L, INR \>1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;
* Patients with severe electrolyte imbalances;
* Patients with acute peritonitis or suspected intestinal perforation;
* Patients with toxic megacolon;
* Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
* Patients with untreated severe abdominal hernia, intestinal obstruction;
* Patients with intestinal strictures of any cause;
* Pregnancy and lactation.
Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
* Tumour sample (block of slides) available for KRAS analysis

Exclusion Criteria:

* Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
* Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)
mTOR and Adipose Tissue Inflammation

The target of rapamycin complex 2 (TORC2) is an evolutionarily conserved serine/threonine protein kinase that controls growth and metabolism. In mammals (including humans), mammalian TOR complex 2(mTORC2) contains mammalian TOR (mTOR), RICTOR, mSIN1 protein, and mLST8 gene. In an animal model, the adipose-specific rictor knockout (AdRiKO) mouse, systemic insulin resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet (HFD)-induced obesity or aging. To find a molecular link between adipose mTORC2 and systemic insulin resistance, investigators have already performed transcriptomics and proteomics analysis on visceral white adipose tissue in a mouse model. The aim of the study is to confirm a molecular link between adipose mTORC2 and systemic insulin resistance in humans.


Eligibility Criteria:
Inclusion Criteria:

* Obese volunteers (BMI \> 35kg/m2) aged 18 to a maximum of 60 years, males and females; insulin-resistant, scheduled for elective bariatric surgery.
* Normal weight patients (BMI \< 27kg/m2) aged 18- max. 60 years, males and females; insulin-sensitive, scheduled for elective surgery.

Exclusion Criteria:

* Known diabetes mellitus
* Chronic inflammatory disease (inflammatory bowel disease, rheumatoid disease, cancer)
* Acute inflammatory disease
* Known renal disease: kidney failure
* Pregnancy:
* history of gastrointestinal surgery with major changes to the gastrointestinal tract (removal of stomach, any GI-bypass)
* Substance abuse, alcohol abuse
* Inability to follow procedures due to psychological disorders, dementia
* insufficient knowledge of project language (German)
A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)

This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of vaginal candidiasis
* No Trichomonas vaginalis or any other protozoa
* No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections

Exclusion Criteria:

* Known sensitivity to the formula components
* Pregnant or nursing patients
* Any gynecological condition contraindicating the use of vaginal ovule or cream.
* Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
* Presence of other sexually transmitted diseases (except from Candidal vaginitis).
* History of recurrent candidiasis (≥4 episodes per year)
* Use of intra-uterine device, spermicides, or diaphragms
* Has metabolic or immune disorder
* Has abnormal uterine bleeding
FDG PET/CT in Breast Cancer Bone Mets

This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start of new breast cancer hormone treatment and again at 12 weeks after treatment start. The baseline uptake and change in uptake after the repeat scans will be compared to clinical long term outcomes such as time to progression and overall survival. In addition the uptake will be compared to the incidence of skeletal related events that are common occurrences in patients with cancer that has spread to the bones.

This is an observational study as all patients will receive the same research diagnostic test, an FDG PET/CT study performed at 4 weeks after starting new hormone treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, at least 18 years of age, with a history of pathologically confirmed ER+ breast cancer
2. Biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone)
3. Patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
4. Willing and able to comply with scheduled visits and serial imaging procedures
5. Agrees to allow access to clinical records regarding response to treatment and long term follow up.
6. Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

1. Women who are pregnant or breast feeding
2. Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
3. Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
4. Weight exceeding capacity of imaging table
5. Previous treatment with radiation or surgery to a significant percentage of bony metastatic sites
6. Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (GCSF)) within 3 weeks of baseline scan