cyrilzakka/clinical-trials huggingface dataset:
Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis

To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 18 to 80 years old;
2. abdominal pain consistent with AP;
3. serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
4. abdominal imaging consistent with AP imaging changes.
5. severe hyperlipidemia "fasting serum TG\> 1,000 mg/dL (11.2mmol/L)";
6. except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.

Exclusion Criteria:

1. other etiologies other than hyperlipidemia leading to AP;
2. fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
3. acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
4. the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia.
5. without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
Cough Assessment in Patients With Severe Acquired Brain Injury

The cough assessment is fundamental in the weaning process as it gives information on the possibility to expel food and secretion out from the airways. The majority of persons suffering from severe acquired brain injury are not able to cough voluntary due to severe cognitive deficit. In the present study, it would be evaluated the intensity of the reflex cough (RC) and the results would be correlated with weaning outcome.

All the participants will undergo firstly to the RC assessment. RC would be trigged by the inhalation of 0.4M of citric acid solution using the ultrasonic nebulizer (MO-03 Norditalia Elettromedicali). The face mask would be connected with the spirometer and the nebulizer via a bidirectional valve in order to measure Peak of Cough Expiratory Flow (PCEF) of the RC. Secondly, it would be assessed parameters of the weaning protocol in order to verify the feasible of removing the tracheostomy cannula. Hence, if the previous assessments are positive, the cannula 's patients would be removed. The follow-up would be taken after 96 hours from the decannulation in order to verify the outcome of weaning.

In this study, it would be recruited a number of 30 consecutive patients admitted to IRCCS Ospedale San Camillo. The data would be firstly analyzed using Kolmogorov-Smirnov test in order to verify the distribution. Secondly it would be chosen to t-test for parametric outcomes or Wilcoxon non parametric outcomes. Thirdly, the correlation between the Peak of Cough Expiratory Flow of the RC and the weaning outcome would be completed using Pearson Test (parametric) or Spearman test (non parametric).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Acquired Brain Injury
* presence of tracheostomy cannula and positive cupping trial
* provide informed consent independently

Exclusion Criteria:

* presence of allergy to citrus;
* presence of asthma
* presence of mechanical ventilation;
* presence of trachomalacia
* presence of laryngeal stenosis
Video-Assisted Intervention in Improving Recovery in Patients With Cancer Undergoing Lung Surgery and Caregivers

This pilot clinical trial studies a video-assisted intervention in improving recovery of patients undergoing surgery to remove lung cancer or cancer that has spread to the lung and their caregivers. The intervention uses educational videos to prepare patients and families for surgery and teach them how to manage the symptoms after surgery. Teaching patients and their families what to expect before and after surgery may help improve patient and caregiver quality of life, help patients recover better from surgery, and support families in their role as caregivers after surgery.

PRIMARY OBJECTIVES:

I. To pilot test a video-assisted intervention designed to enhance post-operative recovery by preparing patients and informal caregivers for lung surgery.

SECONDARY OBJECTIVES:

I. To describe preliminary effect of the video-assisted intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes.

OUTLINE: Patients and their caregivers are assigned to 1 of 2 arms.

ARM I: Patients and caregivers receive standard care during routine clinic visits.

ARM II: Patients view Parts 1 and 2 of the video program, which focus on what to expect before surgery and after surgery in the hospital, on a tablet over approximately 8 minutes at a scheduled pre-operative visit. Patients then receive an educational handbook and discuss the video with a nurse. After surgery and before hospital discharge, patients view Part 3 of the video over approximately 6 minutes, which focuses on what to expect after going home.

After completion of study, patients and caregivers are followed up at approximately 2-4 weeks and 2 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS: Scheduled to undergo surgery with lung resection for treatment of primary or secondary neoplasms of the lung
* PATIENTS: Able to read and understand English
* INFORMAL CAREGIVERS: The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery
* INFORMAL CAREGIVERS: Able to read and understand English
* This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects

This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794 (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper Period of SP790 or SP794 are allowed to enroll in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed the Maintenance Period and Taper Period of SP790 or SP794

Exclusion Criteria:

* Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
* Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial
Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life

Outpatient treatment of Primary Spontaneous Pneumothorax (PSP) compared to usual inpatient management could improve quality of care and represent a more efficient, generalizable and sustainable strategy.

This multicenter, cluster-controlled, randomized interventional study with stepped wedge implementation will evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 50 years presenting to the emergency department with a 1st episode of right or left primary spontaneous pneumothorax (PSP) of large abundance diagnosed by chest X-ray or CT scan defined according to British Thoracic Society (BTS) recommendations as a detachment greater than 2 cm over the entire height of the axillary line.
* Patient living less than an hour from hospital and able to be accompanied for the first 48 hours
* Patient able to understand the aims and risks of the research and to give informed, dated and signed consent
* Patient with Internet access and able to complete online questionnaires
* Patient affiliated to or benefiting from a social health insurance

Exclusion Criteria:

* Small pneumothorax (≤ 2cm)
* Suffocating pneumothorax defined by the presence of signs of respiratory distress or hemodynamic failure with indication for emergency exsufflation
* Patient on emergency oxygen or long-term oxygen therapy
* Traumatic pneumothorax
* Secondary spontaneous pneumothorax
* Bilateral pneumothorax
* Associated fluid effusion
* Risk-benefit balance unfavorable to outpatient treatment (comorbidities, isolated patient, difficulty understanding monitoring instructions)
* Patient living more than one hour from hospital
* Patients living alone or unable to be accompanied on discharge for the first 48 hours
* Patients under legal protection
* Pregnant or breast-feeding women
* Patient participating in a therapeutic interventional clinical trial or in a period of exclusion linked to previous participation in a clinical trial
Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions

At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.

The main questions it aims to answer are:

* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.

Participants will:

* Induction of anesthesia with the experimental drug or placebo；
* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age 40\~60 years old；
* ASA Class I to II；
* The operation time was 1h\~2h；
* BMI 18\~25；
* Sign informed consent.

Exclusion Criteria:

* Known allergy to narcotic drugs used in this study;
* Severe pulmonary insufficiency;
* Abnormal liver and kidney function；
* History of severe anemia and hematoporphyrin；
* History of asthma;
* Uncontrolled high blood pressure or diabetes;
* Pregnant and lactating women；
* Accompanied by cognitive impairment or inability to communicate.
Prevalence and Environmental Factors for Myopia Among Chinese School-aged Children and Adolescent in Tianjin

The high prevalence of myopia has become a global public health problem. The study amied to investigate the prevalence and progression of myopia associated with social environmental factors in Tianjin, a Chinese megacity in north China.

The high prevalence of myopia has become a global public health problem, especially in East and South Asian countries. It's still not clear for the prevalence and progression of myopia associated with social environmental factors. Thus, the investigators will conducted a long-term observational study to the effect of the socioeconomics, medical resources and school-related environmental parameters and others on the prevalence and progression of myopia among Chinese school-aged children and adolescent.

Eligibility Criteria:
Inclusion Criteria:

* aged 6 to 18 years
* no ocular diseases and systemic diseases
* consent to undergo an eye examination

Exclusion Criteria:

* schoolchildren unwilling to participate
Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars

This is a study about the dynamics and effects of different types of blocks (intraoral conduction anesthesia of the alveolar nerve and extraoral US block of the mandibular nerve) for extraction of lower third molars.

Standard method of anesthesia for extraction of horizontally positioned lower thirdmolars is intraoral conduction anesthesia of the inferior alveolar nerve. However, the analgesiceffect of block is short and it is necessary to use analgesics. In this prospective clinical study,analgesic effect of ultrasound (US) -guided extraoral block of mandibular nerve will beinvestigated, in order to prolong pain-free time and reduce the use of analgesics associated withrisks (bleeding, hepatotoxicity).

Characteristics of alveolar nerve block and US block of the mandibular nerve will becompared, such as: pain during application of anesthesia, amount of anesthetic, duration ofanesthesia, need to use analgesics, time to and level of pain when using analgesics, andcomplications

Eligibility Criteria:
Inclusion Criteria:

* age 18-64 years
* horizontally placed lower third molars
* ASA I or II group

Exclusion Criteria:

* allergy to local anesthetics
* local infection at the site of needle puncture
* parotitis
* serious liver disease
* use of antiarrhythmics group III (eg amiodarone), anticoagulant or antithrombotic drugs
* lactation
* people who took an analgesic as a preventive measure before coming to the procedure
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).

* Participants will be randomized into one of two study groups. The first group will receive Androgen Deprivation Therapy (ADT) plus bevacizumab. The second group will receive ADT alone.
* For the Androgen Deprivation therapy either (treating physician discretion)leuprolide or goserelin acetate (given as injections) every 3 months for a total of 6 months. Bicalutamide will also be taken orally daily for a total of 6 months.
* Bevacizumab will be given intravenously every three weeks for a total of 8 infusions over 6 months.
* Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS, laboratories including PSA and testosterone.

Eligibility Criteria:
Inclusion Criteria:

* History of biopsy documented prostate cancer (any Gleason score)
* Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
* If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
* PSA recurrence with PSAdt \< 18 months. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be greater than 2.0 ng/ml
* No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR
* Prior ADT allowed if \< 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
* ECOG Performance status of 0-1
* Absolute neutrophil count of \>1,500
* Platelet count \> 100,000
* Hg \> 8g/dl
* No history of bleeding or thromboses within the last 12 months that required medical intervention

Exclusion Criteria:

* History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
* Medical condition requiring concomitant corticosteroids
* Active infection
* Prior chemotherapy allowed if was \< 6 cycles and \> 6 months prior to study entry
* Documented local recurrence or metastatic prostate cancer
* Inability to comply with study and/or follow-up procedures
* Life expectancy of less than 2 years
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
Frequency of SARS COVID-19 Infection Among Malignant Patients at South Egypt Cancer Institute

Assessment the frequency of SARS COV-2 infection among malignant patients at south Egypt Cancer institute

Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. However, some will become seriously ill and require medical attention. Older people and those with underlying medical conditions like cardiovascular disease, diabetes, chronic respiratory disease, or cancer are more likely to develop serious illness. Anyone can get sick with COVID-19 and become seriously ill or die at any age Cancer is one of the most common examples of immunocompromised states

Eligibility Criteria:
Inclusion Criteria:

* Malignant patients.
* PCR positive for covid-19

Exclusion Criteria:

* PCR negative for covid-19
Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)

The purpose of this study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.

The purpose of this randomized, open-label study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.

Patients with CD4 cell counts over or equal to 200/mm3, HIV viral load between 10,000 and 750,000 copies per milliliter, and wild-type genotype at baseline will be eligible. This multicenter study will enroll 60 patients (n=30 in each group). The planned duration of the study is 48 weeks from the enrolment of the last subject.

The primary efficacy endpoint will be virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment. The durability of this response will be evaluated and patients will be followed for 48 weeks.

The primary safety endpoint will be treatment interruptions because of adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Protease inhibitor naive patients
* Wild type genotype
* CD4 greater than 200/mm3
* Viral load between 10,000 copies/ml and 750,000 copies/ml
* Signed informed consent

Exclusion Criteria:

* Pregnancy; breast feeding
* Antiretroviral (ARV) pretreated patients
* Hyperlipidemic treatment
* Evolutive disease
Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults

Obesity is a major global health issue and a primary risk factor for metabolic-related disorders. While physical inactivity is one of the main contributors to obesity, it is a modifiable risk factor with exercise training as an established, non-pharmacological treatment to prevent the onset of metabolic-related disorders, including obesity. Exposure to low-oxygen availability (hypoxia) via normobaric hypoxia (simulated altitude via reduced inspired oxygen fraction), termed hypoxic conditioning, in combination with exercise has been increasingly shown in the last decade to enhance blood glucose regulation and decrease body mass index, providing a feasible strategy to treat obesity.

However, findings from studies investigating the potential for hypoxia to augment the exercise training response and subsequent metabolic health are equivocal. Notably, there is a lack of information regarding the optimal combination of exercise variables and hypoxic severity to enable an individualized and safe practice of exercising in a hypoxic environment.

In the present randomized, single-blind, cross-over study, the investigators will investigate the effects of single-bout of different exercise modes under moderate hypoxia (FiO2, 16.5%).

The investigators hypothesize that all exercises combined with hypoxia improve glucose homeostasis in overweight individuals.

In the present randomized, single-blind, cross-over study, participants will be exposed to moderate hypoxia (oxygen level 16.5%) during three different exercises (low-intensity cycling, sprint interval and functional exercises). Participants will be randomly assigned to each exercise condition (computer-generated randomization plan), separated by a washout period (5-7 days). To accomplish this, participants will exercise in an environmental chamber in which oxygen concentration of the ambient air and, as such, oxygen levels can be closely controlled and monitored.

Participants are required to attend the laboratory 8 times. These visits are including pre-exercise screening, baseline blood sampling, body composition screening and exercise in altitude conditions.

Eligibility Criteria:
Inclusion Criteria:

* BMI is between 25-29 kg/m²
* Physical inactive (physical activity \<150 min/week)
* No known heart or metabolic diseases (such as Type 2 diabetes)
* Not currently taking any prescribed medication
* No reported musculoskeletal injuries recently
* Not exposed to hypoxia \>1000 m prior to the study

Exclusion Criteria:

* Impaired glucose tolerance (2 hour glucose: \>7.8 - 11.1 mmol/L)
* Type 2 diabetes mellitus
* Obstructive sleep apnea
* Chronic obstructive pulmonary disease
Study on the Difference of Axilo-rectal Temperature in Appendicitis

The investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute appendicitis
* Patients with acute gastroenteritis
* Patients older than 15 years of age

Exclusion Criteria:

* Other acute abdominal diseases