cyrilzakka/clinical-trials huggingface dataset:
Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, the previous studies have presented controversial results. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.

Standard Pressure Laparoscopic Cholecystectomy, SPLC；12-16mmHg，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis.

According to literature, Low Pressure Laparoscopic Cholecystectomy, LPLC；8-10mmHg is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, most of the existing study have combined population with all age scale, bringing bias to the result. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-85;
2. Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases;
3. Older patient or accompanied by cardiopulmonary diseases (age\>60 years, hypertension, Diabetes Mellitus, coronary heart disease, arrhythmia, chronic bronchitis, emphysema, history of heart surgery, history of lung surgery, history of mediastinal surgery, asthma, et al);
4. Aged older than 60, with or without the above diseases;
5. American society of Aneshesiologists (ASA) II or higher;
6. Informed consent acquired.

Exclusion Criteria:

1. Having contraindication of laparoscopic operations;
2. History at epigastric surgery. -
Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe crow's feet lines
* Female or male, 18 to 65 years of age and in good general health
* Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation at the treatment area
* Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
* Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body
A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to \<65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age, mentally competent, in good health as determined by medical history, physical examination and clinical judgment by the Investigator; able to comply with all study procedures, to be contacted, and to be available for study visits according to the protocol.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered.
* Females of childbearing potential who refuse to use an acceptable method of birth control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination, and, if sexually active, who have not used a reliable birth control method for at least two months prior to study entry.
* Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
* Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7 days prior to enrolment in this study or who are planning to receive any type of influenza vaccine within 7 days (before or after) from the study vaccines.
* Individuals who received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any (non-influenza) vaccine within 28 days (before or after) from the study vaccines.
* Individuals with known or suspected impairment of the immune system.
Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling

Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.

Mitral Doppler will be performed before vascular filling. Patients will be classified in two groups (normal or high cardiac filling pressure).

The evolution of the respiratory data (SpO2/FiO2) of the two groups of the patients before and after vascular filling will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation
* And hemodynamic failure
* And decision of the attending physician to perform a vascular filling

Exclusion Criteria:

* Pregnancy and breast-feeding women
* Patients deprived of their administrative or judicial freedom
Metoprolol XR in Heart Failure With Normal Ejection Fraction

In contrast to the treatment of HF with reduced EF, information to guide the pharmacological therapy of patients with HFNEF are lacking and there is no evidence based treatment for patients with HFNEF. Thus, present treatment strategies for HFNEF are largely based on assumptions regarding its pathophysiological mechanisms and on extrapolations from proven strategies used in systolic HF. Till now, no study enlightens the efficacy and safety of beta blockers in HFNEF in a randomised controlled manner although the role of beta blockers in HF with impaired systolic function has been sufficiently time tested leading to their therapeutic approval in that condition. Keeping in view the small reported benefit of beta blockers in HFNEF as mentioned above, there is a need to provide a conclusive proof of their role in this condition as well. Hence, investigators planned to test the efficacy and safety of metoprolol CR in patients with HFNEF in a randomised double blind placebo controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above of either sex
* Presence of New York Heart Association functional class II-IV of at least 4 weeks' duration
* LVEF ≥ 50% in a nondilated LV (LV end-diastolic volume \< 97 ml/m2 measured by echocardiography)
* Echocardiographic evidence of LV diastolic dysfunction
* Willing to give written informed consent

Exclusion Criteria:

* Clinically unstable as defined by any change in diuretic dose in the month prior to enrolment.
* Significant valvular heart disease, pericardial disease, hypertrophic or restrictive cardiomyopathy
* Unstable angina or MI within the past 4 weeks.
* Alternative probable cause of the patient's symptoms (e.g.significant pulmonary disease);
* Any previous left ventricular ejection fraction below 40%
* Other systemic disease limiting life expectancy to less than 3 years
* Any contraindication to metoprolol use (heart rate less than 45 beats per minute, heart block greater than first-degree i.e. PR interval ≥ 0.24 second, systolic blood pressure \<100 mm Hg, asthma)
* Conditions associated with alteration in serum levels of procollagen type I e.g. alcoholic liver disease, metabolic bone disease, hyperthyroidism
* Current participation (including prior 30 days) in any other therapeutic trial
* Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
Aurolab Hydrophobic Foldable Intraocular Lens Study

The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.

Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 65 years
* Senile Cataract
* Posterior Subcapsular Cataract (PSCC)

Exclusion Criteria:

* Obviously debilitated patients
* Cardiac and other serious illness
* Diabetic Patients
* Traumatic cataract
* Complicated cataract
* Congenital cataract
* Drug induced cataract
* Shallow anterior chamber
* Poor mydriasis
* Amblyopia
* Pseudo exfoliation (PXF)
* Dense posterior polar cataract (PPC)
* One eyed patients
* Glaucoma
* Uveitis
* Corneal Pathology
* Retinal Pathology
* Intra operative complications like PC rupture, Zonular dialysis
Copenhagen Prospective Personalized Oncology (CoPPO)

Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA for identification of pts who could benefit from a personalized treatment.

Two ultrasound-guided biopsies obtained to be stored in RNAlater® for DNA and RNA purification. A 3rd biopsy for histology is paraffin embedded. SNP-array (Affymetrix Cytoscan HD) from DNA (tumor) is performed to identify copy number changes. Whole exome sequencing (WES) from DNA (tumor and blood) will be performed using sequence capture, SureSelect v5 (Agilent) and Illumina HiSeq2500 to call tumor specific mutations. Expression levels of therapeutic targets are revealed by expression Array from tumor RNA. In addition to the expression array, RNA-seq (Nugens Ovation RNA-seq system v2) is performed to investigate whether chromosomal translocations were the reason for tumor specific expression of an oncogene. Results will be reviewed by a tumor board. Patients with specific genetic profiles that can be targeted with marketed drugs or drugs under development are offered such treatment. PFS from the treatment is compared to PFS of the most recent standard treatment (PFS ratio).

Eligibility Criteria:
Inclusion Criteria:

* Solid tumor
* No standard treatment option
* PS 0-1
* Lesion assessable for biopsy
* Measurable disease
* Informed consent

Exclusion Criteria:

* Life expectancy \< 3 months
* Bone marrow suppression
* Abnormal renal or hepatic function
* Serious concurrent medical conditions
Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.

The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is:

• Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments?

Participants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise.

Researchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.


Eligibility Criteria:
Inclusion Criteria:

* Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis
* Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting.

Exclusion Criteria:

* Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.
Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis

Inflammatory responses in response to alcohol have been identified as contributing to the development of alcoholic hepatitis. The inflammatory response including that to LippoPolySaccharide is known to lead to progression of alcoholic liver disease. In addition to the inflammatory response mitochondrial perturbations exist and redox homeostasis is altered in patients with alcoholic hepatitis. Though this is known there have been very few studies targeting mitochondrial function in Peripheral Blood Mononuclear Cells (PBMCs). We plan to collect 50 milliliters of blood from healthy control patients so that we can compare the data to that of patients with alcoholic hepatitis and those who are heavy drinkers without liver disease. In addition to studying mitochondrial function we will investigate cytokine response, as well as fatty acid metabolism, glucose, and insulin measurements


Eligibility Criteria:
Inclusion of Subjects with Alcoholic Hepatitis (AH):

\*diagnosis of AH either by imaging, biochemical values or liver biopsy as well as drinking history

Inclusion Heavy Drinking Controls:

\*heavy alcohol drinking will be defined as \>40 g/day or \>280g/week on average for women and \>60 g/day or \>420 g/week on average for men for a minimum of 6 months \[6\] and within the 4 weeks prior to study enrollment.

Exclusion Criteria for all groups

* inability or unwillingness to sign informed consent
* cancer
* autoimmune disease that in the opinion of the PI will confound study data

Control subjects (drinking and non drinking) must meet the following criteria:

* INR \< 1.4
* total bilirubin levels must \<3
* no prior history of known alcoholic liver disease
* absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.

To evaluate the efficacy of replacement of ETT with LMA and administration of Magnesium sulphate at the end of the surgery in attenuating systemic stress response during emergence of patients undergoing supratentorial tumours

Rapid recovery from neuroanesthesia and early neurological examination are desirable in most cases.(1)Although, Systemic and cerebral hemodynamic changes caused by extubation and emergence from anesthesia may endanger neurosurgical patients and increase the risk of postoperative intracranial hemorrhage and cerebral edema and may even result in the requirement of reoperation.(2) During this phase, heart rate and arterial blood pressure increase leading to increases in cerebral blood flow and intracranial pressure.(3) Some studies have reported such hemodynamic effects in up to 50% of patients after supratentorial craniotomy.(4,5) Replacing the endotracheal tube (ETT) with laryngeal mask airway (LMA) prior to emergence from anesthesia is safe and effectively reduces the cardiovascular response.(6) The potential protective benefit of this approach has not yet been demonstrated for awakening neurosurgery patients, however.

Magnesium is the forth most abundant cation in the body and the second most abundant intracellular cation. It activates many of the enzyme systems.(7) Magnesium sulphate inhibits catecholamines release from adrenergic nerve terminals and from adrenal medulla, through blocking N-type of Ca-channel at peripheral sympathetic nerve ending so it is used to decrease the adverse cardiovascular effects during larygeoscopy and endotracheal intubation.(8) But its role in attenuating stress response during extubation is not well studied and need more research.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I, II.
2. Ages between 18 and 60 years.
3. Body mass index (BMI) \< 30.
4. Elective surgery

Exclusion Criteria:

1. Patients have cardiovascular, pulmonary, renal, hepatic and endocrine diseases.
2. Patients have any degree of disturbed conscious level.
3. Ages \<18 or \>60 years.
4. BMI \>30.
5. Patients have history of allergy to Magnesium sulphate.
6. Patients have uncontrolled hypertension during preoperative assessment.
7. Patients have risk of aspiration (eg. hiatus hernia)
8. Patients have difficult airway management during intubation with direct laryngoscope or time of intubation \>30 seconds.
9. Failed ventilation with LMA.
10. Emergency surgery.
Calcium Electroporation for Early Colorectal Cancer

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer.

In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.

Patients will be followed for one month after the elective surgery.

Eligibility Criteria:
Inclusion Criteria:

* • Patients must be mentally capable of understanding the information given.

  * Patients must give written informed consent.
  * Histologically verified adenocarcinoma of the rectum or sigmoid colon.
  * Tumor described as passable at index endoscopy.
  * Men or women aged at least 18 years.
  * Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
  * ASA class I-II (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

* • Uncorrectable coagulation disorder.

  * Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
  * Patients with ICD or pacemaker units.
  * Ongoing immunosuppressive treatment.
  * Patients with concomitant use of phenytoin.
  * Concurrent treatment with an investigational medicinal product.
  * Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
  * Advanced tumor stages, clinical UICC stage IV.
  * Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
  * Acute surgical resection.
  * Pregnancy
A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment

The motivation-enhancing intervention is designed for participants in the ILIT.NU trial. The participants are patients with hay fever who are treated with a vaccination in an inguinal lymph node. The motivation-enhancing intervention is a web-based app developed in collaboration with patient partners and is intended to increase retention and reporting in the ILIT.NU trial.

The ILIT.NU trial (EudraCT 2020-001060-28) investigates whether patient reported outcome measures compound symptom-medication score (cSMS) are relieved by intralymphatic immunotherapy (ILIT). The participants are asked for a three-year period to attend annual consultations and to daily fill in an online questionnaire about their allergy symptoms and medication use during the grass pollen season (100 days).

High attrition rates have been a problem in previous ILIT trials. High attrition affects generalizability, validity and reliability of a trial. To increase retention and reporting in the ILIT.NU trial, a motivation-enhancing web-based app has been developed. The web app is based on the Self-Determination Theory and is developed in collaboration with patient partners and clinicians. Participants are randomized across treatment group to either the motivation-enhancing web app or the standard reporting method. The project is conducted as a Study Within a Trial (SWAT).

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in the ILIT.NU trial

Exclusion Criteria:

* Participants not enrolled in the ILIT.NU trial, Denmark
The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer

This is a 6-visit, single-center, non-dispensing, randomized, single-masked, 5×5 crossover study. Subjects will participate in 6 scheduled over the duration of approximately 10.5 months.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read and sign the Informed Consent form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Healthy adult males or females age ≥18 and ≤30 years of age.
  4. Normal color vision as measured using the Ishihara 38-plate test.
  5. Normal stereopsis as measured by a suitable test.
  6. Auto-refraction must show a spherical component of -2.00 through +2.00 D, and a cylindrical component of 0.00 through 1.50 D.
  7. The subject's distance refractive sphere must be between -2.00 and +2.00 D in each eye.
  8. The subject's distance refractive cylinder must be ≤ 1.50 D in each eye.
  9. The subject must have unaided distance Snellen visual acuity of 20/200 or better for each eye.
  10. The subject must have best corrected distance Snellen visual acuity of 20/25 or better for each eye.

      Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. History of refractive surgery or other ocular surgery.
  3. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  4. Subjects that participated in the pilot study CR-6318.
  5. Systemic conditions or the use of medications that the investigator believes will contraindicate participation in this study.
  6. Abnormal Level 3 neuro-ophthalmology exam including crystalline lens clarity Grade 3 or worse (Lens Opacities Classification System).
  7. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.