cyrilzakka/clinical-trials huggingface dataset:
Discrete Hypothermia in the Management of Traumatic Brain Injury

The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.


Eligibility Criteria:
Inclusion Criteria:

* Patient is treated for severe traumatic brain injury at Grady Health System, GCS \< 8
* Patient is \>18 years of age
* Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment)
* Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission
* Patient and/or guardian must speak English (in order to ensure proper Informed Consent)
* Patient and/or guardian/family must sign an Informed Consent

Exclusion Criteria:

* Unwillingness or inability of patient and/or guardian/ family to sign an informed consent
* Physical placement of cooling cap impedes routine treatment
* Patient has a core body temperature of 36 degrees C or less at time of assessment
National Survey of People With Haemophilia in Portugal

The purpose of this study is to implement a national survey to collect information regarding Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial factors.

This is a cross-sectional design investigation focused on the socio-demographic, clinical and psychosocial characterization of Portuguese people with haemophilia (PWH). All PWH, registered in the Portuguese Hemophilia Association (APH) will be identified in APH registries and contacted through mail, in order to be invited to participate in the first Portuguese survey on haemophilia. In case of acceptance, patients must sign the Informed Consent, fill in the questionnaires and send both back to the investigation team through a pre-paid envelope in the national mail system.

PWH of all ages are invited to participate in this survey. Adults (aged 18 and over) and children/youth from 10 to 17 will answer the questionnaires by self report. Parents of small children (0 to 9) will fill in the proxy versions. All questionnaires are adapted for the specific age groups.

This study will comply with ethic guidelines and was approved by the Life Sciences and Health Ethics Subcommittee (University of Minho) and is registered on the Portuguese authority for data collection (CNPD).

Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A or B
* Portuguese nationality

Exclusion Criteria:

* Acquired Haemophilia
* Psychiatric or neurological deficit
A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide

This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent for the trial
* ≥ 18 years of age
* Histologically- or cytologically- confirmed locally advanced or metastatic WDNET
* SSA therapy is recommended by physician for disease management, and has not yet begun
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Currently participating in a study of an investigational agent
* Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

  \*Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study
* No concurrent chemotherapy or targeted small molecule therapy
* If received major surgery, not recovered adequately from the toxicity and/or complications from the intervention prior to starting the study
* Known additional malignancy that is progressing or requires active treatment
* Active infection requiring systemic therapy
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy is 10-22 weeks gestation
* Between 18-34 years of age inclusive at estimated date of delivery
* No prenatal screening indicators for high risk including serum biochemical and ultrasound screening
* No personal or family history of Down syndrome
* Willing to provide written informed consent
* Willing to provide a whole blood sample
* Willing to provide access to medical records supporting fetal outcome

Exclusion Criteria:

* Fetal demise at the time of the blood draw
* Previous specimen donation under this protocol
The Physiology of Human Brown Adipose Tissue

Brown fat is a type of fat, found in both children and adults, which can produce heat and regulate the body's metabolism and energy use. White fat is the more common type of fat which is used to store extra calories. Understanding more about differences between brown and white fat may allow us to develop new approaches to improve the body's metabolism.

The overarching goal of this study, is to map fat (adipose) tissue differences in humans. The investigators will probe multiple aspects of fat cell (adipocyte) identity by integrating quantitative chemical imaging, single-cell and single-nucleus RNA sequencing (sc and snRNAseq), and site-specific collection of adipocytes and adipocyte precursors.

Deidentified data from these studies will be submitted to the Human Cell Atlas. The investigators anticipate that these studies will ultimately increase understanding of mechanisms by which fat (adipose) tissue regulates systemic metabolism (energy transformation in the body), and promotes risk for metabolic disease. Knowledge gained from this research may be used to set the stage for disease-specific analyses, and aid in the development of personalized medicine for metabolic diseases such as type 2 diabetes.

Eligibility Criteria:
Inclusion criteria:

1. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC.

Exclusion Criteria:

1. Body mass index (BMI) greater than or equal to 40 kg/m2
2. History of any local or systemic infectious disease with fever or requiring antibiotic within four weeks of drug administration;
3. Diabetes, either previously diagnosed or hemoglobin A1c greater than or equal to 6.5%
4. Use of oral or parenteral corticosteroids (epidural permitted) or other medication known to cause insulin resistance in the previous 6 weeks.
5. Willingness to provide informed consent and follow study procedures, including attending scheduled visits.
6. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
7. Hepatic disease, including serum alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
8. Active malignancy (except squamous or basal cell carcinoma of skin)
9. Bleeding disorder, treatment with anticoagulants (if not discontinued prior to surgery), or platelet count \<50,000;
10. Current addiction to alcohol or substances of abuse;
11. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation;
12. Use of an investigational drug within 30 days prior to screening.
13. There will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
14. Because the goal is to study adult human brown adipose tissue, children are not eligible to participate.
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.

This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for \>=1 week prior to dosing with GK Activator (2);
* normal renal function, or moderate or severe impairment.

Exclusion Criteria:

* type 1 diabetes;
* treatment with insulin or PPAR gamma agonist within 6 months of screening.
A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database

The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL) 2024 care pathway


Eligibility Criteria:
Inclusion Criteria:

For All and Study population:

1. Male or female, age above or equal to 18 years on health-check-up visit day
2. No missing value on sex

For EASL at risk population

1. Must be part of study population.
2. People with T2D or \[obesity＋above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes

For EASL not at-risk population

1. Must be part of study population.

For EASL-SAFE

1. Must be part of EASL at risk population

For AGA at risk population

1. Must be part of study population.
2. People with 2 or more metabolic risk factors (EASL-MASLD criteria) or T2D or steatosis on any imaging modality or with elevated aminotransferases

For CSH MAFLD population

1. Must be part of study population.
2. Liver steatosis on abdominal ultrasound
3. With at least one component of Metabolic syndrome (MetS \[CSH\])

Exclusion Criteria:

1. Individuals originating from centers with fewer than 100 participants
2. Missing value of liver stiffness measurement (LSM)
3. Had an interquartile range/median ratio above or equal to 30% of the measurement of LSM
4. Missing value on either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or platelet count (PLT)
5. Missing value on FPG, TG, HDLc or BP (to define the presence of metabolic risk factors)
6. Missing value on abdominal ultrasound

For EASL not at-risk population 1. People with T2D or \[obesity＋above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes

For EASL-SAFE/NFS

1. Missing value on globulin
Analysis of the Microbiota in Goldmann Applanation Tonometers at a Reference Service in Goiânia

This study aims to evaluate the microbiota of goldmann tonometers and its possible change over the visits


Eligibility Criteria:
Inclusion Criteria:

* collection of material in the period

Exclusion Criteria:

* collection of material out of the period
Robotic-Assisted Percutaneous Coronary Intervention

Percutaneous coronary intervention is a safe procedure. However, its execution is manual, fully operator-dependent. The procedure is also associated with radiation exposure to patients and physicians. This study will evaluate the robotic assisted percutaneous coronary intervention as an alternative to manual operation.


Eligibility Criteria:
Inclusion Criteria:

1. Age\> = 18 years;
2. Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions;
3. Elective for percutaneous procedure (i.e. performed in a non-urgent context)
4. The target lesion (s) must be obstructive, with stenosis diameter \> 50% (visual analysis);
5. The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator;
6. Acceptable candidate for myocardial revascularization surgery.

Exclusion Criteria:

1. ST-segment elevation myocardial infarction in the last 48 hours before the index procedure;
2. Ejection fraction \<30%;
3. Impaired renal function (creatinine\> 2.0 mg / dL) or calculated creatinine clearance \<30 ml / min;
4. Platelet count \<100,000 cells / mm 3 or\> 700,000 cells / mm 3;
5. Total Leucocytes count \<3,000 cells / mm 3;
6. Suspected or documented active liver disease (including laboratory evidence of hepatitis);
7. Heart transplant recipient;
8. Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel;
9. Patient with a life expectancy of less than 1 month;
10. Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study;
11. Participation in other research in the last 12 months, unless there may be direct benefit to the research subject;
12. Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure.

Angiographic exclusion criteria

1. Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month;
2. Target lesion not accessible by robotic treatment, according to the judgment of the operator;
3. Unprotected coronary artery trunk lesion (stenosis\> 50%);
4. Angiographic thrombus;
5. Target lesion in surgical graft;
6. Total occlusion (TIMI 0 or 1 anterograde flow)
Lung Cancer Screening in High-risk Black Women

The goal of this research study is to study U.S. Black women with a history of smoking to examine the feasibility, acceptability, and performance of low-dose computed tomography (LDCT) screening among this population.

The name of the intervention used in this research study is:

Low-dose computed tomography (radiologic scan) chest scan

The goal of this single-arm pilot research study is to evaluate the feasibility and acceptability of low-dose computed tomography (LDCT) screening for lung cancer among U.S. Black women with a history of smoking.

LDCT screening is currently the only recommended way to screen for lung cancer among high-risk individuals. However, the majority of Black women at high-risk for lunch cancer are currently ineligible for lung cancer screening.

Study procedures include screening for eligibility, completion of questionnaires, and a LDCT screening test.

Participation in this study is expected to last up to 3 months.

It is expected about 900 people will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified Black women.
* Have a self-reported history of smoking. No restriction will be placed on the number of smoking pack years participants must have nor the number of years former smokers must have quit smoking.
* Aged \>= 50 years.

Exclusion Criteria:

* Individuals with a history of lung cancer.
* Individuals with symptoms suggestive of lung cancer. We will evaluate whether women have symptoms suggestive of lung cancer by administering an online screening questionnaire, which will ask whether they have experienced shortness of breath, whether they become easily winded, and whether they have had a chronic cough within the last 12 weeks that has not improved. Women who select that they have any one of these symptoms will be advised to follow up with their primary doctor and will not be eligible to participate in the study.
* Individuals with pneumonia or acute respiratory infection within 12 weeks prior to enrollment that was treated with antibiotics.
Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

Abnormal cervical cytology was the most common reason for women being referred to the colposcopy unit. We prospectively included the women with negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV 16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+ of other high risk HPV genotypes


Eligibility Criteria:
Inclusion Criteria:

* negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive HrHPV test other than HPV 16 or HPV 18

Exclusion Criteria:

* Previous diagnosis for cervical cancer Previous diagnosis for vaginal cancer Previous diagnosis for cervical dysplasia Previous diagnosis for ASCUS previous history of cervical conisation or hysterectomy previous history ofhysterectomy
Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic Ulcers

The aim of this study is to study the natural history of the ulcer healing while on proton pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer patients.

Non-steroidal Anti-inflammatory Drugs (NSAID), Non-Helicobacter pylori (HP) bleeding peptic ulcers are relatively common in the West (11%-44%). It is uncommon in Hong Kong (4%). Significant number of these patients with non-NSAID, non-Hp bleeding ulcers had co-morbid illness and many had life-threatening conditions. Our recent study showed that there is an increasing incidence of non-steroidal anti-inflammatory drugs (NSAID), non-Helicobacter pylori (Hp) bleeding peptic ulcers. There is no datum on the natural course of these patients and this is our aim to have this observational study.

Eligibility Criteria:
Inclusion Criteria:

* Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer
* Age \> 18 years old
* Informed consent

Exclusion Criteria:

* Concommitant use of high dose steroid or warfarin
* New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors
* Renal failure (serum creatinine \> 200umol/l)
* Previous gastric surgery
* Oesophagitis, esophageal varices
* Terminal illness or malignancy
Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients

Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in our center.

Oral lactulose is a treatment for constipation. Several studies have compared the effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk patients. However, the data in low-risk patients is vacant. The objective of current study was to compared the effectiveness of bowel preparation and patient tolerance using lactulose and 2L PEG regimen in low-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old and with low-risk were eligible. Patients were considered as low risk if they did not meet any of the following risk factors: age\>70 years old, body mass index (BMI)\>25Kg/m2, constipation, Parkinson's disease, diabetes, history of stroke or spinal cord injury, use of tricyclic antidepressant or narcotics.

Exclusion Criteria:

* (1) history of colorectal resection; (2) Known or suspected colonic stricture or obstructing tumor; (3) Known or suspected colonic perforation; (4) toxic colitis or megacolon; (5) use of prokinetic agents or purgatives within 7 days; (6) hemodynamic instability; (7) pregnancy or lactation; (8) inability to provide informed consent.
Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial

Few studies have compared different methods for optimalizing intubation conditions in general anesthesia. This randomized controlled trial will compare two different methods for intubation in general anesthesia in gastro- or gynecological procedures.

In general anesthesia, it is neccessary to secure the airways with an endotracheal tube. There is no international consensus on how intubation is most efficiently conducted. A cochrane review compared using muscular relaxing medication versus not using blocks for intubation. Primary outcomes were intubation conditions and discomfort in upper airways. The authors concluded that research is limited, and that further research is needed. No studies have compared local anesthetic spray on the glottis and muscular relaxing medication in intubation, focusing on discomfort in upper airways. The null-hypothesis of this study is that there is no difference in upper airway discomfort when using local anesthetic spray or muscular relaxing medication. The study will have a randomized controlled design, randomizing patients undergoing gastro- or gynecological procedures in general anesthesia to receiving either rocuronium (muscle relaxing medication) intravenous, or lidocain spray on the glottis before intubation. The primary outcome is postoperativ hoarseness one hour after intubation.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Association of Anesthesiologists Classification system for physical status) I-III
* Understand and can express themselves in Norwegian
* Able to give informed consent to participate

Exclusion Criteria:

* Cave lidocain and/or muscle relaxing medication
* BMI above 40
* Anticipated difficult intubation
* Need for ventricular tube
* Pathology or malformations in upper airways
The Effect of Beta-blockers in Substance P Levels and the Swallowing Function

A non-randomised, prospective study to assess the effects of beta-blockers on substance P levels and the swallowing function. The study is going to be carry out in the Gastrointestinal Physiology Laboratory of the Hospital de Mataró (Spain). All participants will be actively recruited from a Linked hospital and primary care database. We include two groups: the first group (group 1) are participants taking beta-blockers and the second group (group 2) are participants not-taking beta-blockers.


Eligibility Criteria:
Inclusion Criteria:

- Patients taking and not taking beta-blockers

Exclusion Criteria:

* Participants with heat and neck or esophageal cancer
* Participants with stroke or neurological disease
* Participants with central nervous system disease
* Participants with concomitant treatment with Angiotensin converting enzyme inhibitors (ACEI), Angiotensin II receptor antagonists (ARA-II), Antipsychotics, Dopamine agonists, Capsaicine.
* Participants with severe clinical signs of aspiration, including oxygen desaturation ≥3%.