cyrilzakka/clinical-trials huggingface dataset:
Comparison of General Anesthesia Hemodynamics Between R and P in Patients Undergoing Laparoscopic Hepatectomy

This study is a randomized controlled trial designed to investigate the effects of two anesthetics, remimazolam and propofol, on intraoperative hemodynamics in patients undergoing laparoscopic liver resection. The experimental group receives remimazolam, while the control group receives propofol. The primary objective is to compare the hemodynamic responses of patients in both groups during the surgical procedure, aiming to provide insights into the potential differences in cardiovascular stability and anesthetic management associated with these two drugs


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for LMH;
* Age 18-80 years, BMI 18-28 kg/m2;
* American Association of Anesthesiologists（ASA）I-III;
* Child-Pugh grade A or B;
* No serious heart, brain and other important organ lesions;
* Informed and consent, and signed informed consent.

Exclusion Criteria:

* ASA IV-V or Child-Pugh C;
* Left ventricular ejection fraction (EF) \<30%;
* Implanted with temporary or permanent pacemakers;
* Organic heart disease;
* Uncontrolled hypertension, diabetes and other chronic diseases;
* Prolonged use of sedative and analgesic drugs (such as opioid analgesics, benzodiazepines, antianxiety, antidepressants, antipsychotics, etc.);
* Alcohol addiction;
* Allergic to benzodiazepines or propofol, or to any ingredient in the studied drug;
* Known history of allergy to other anesthetics; difficulty in airway and intubation during induction.
Natural Frozen Embryo Transfer (FET) vs Substituted Frozen Embryo Transfer (FET)

In frozen embryo transfer substituted cycles, patients are treated with progesterone and estrogen in an attempt to mimic the natural cycle and a transfer is planned whenever the endometrium is ready. In contrast, in frozen embryo transfer natural cycle patients are not taking any hormones, only triggered with hCG (human chorionic gonadotropin) when a dominant follicle is ready or they wait for the disappearance of the dominant follicle to plan the transfer date. Some doctors and centres shift towards using the substituted protocol in an attempt to make scheduling easier with less frequent ultrasounds.

This study will aim to compare clinical and biochemical pregnancy rates in patients who underwent frozen embryo transfers in natural cycles vs substituted cycles at the centre.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 40 years old
* Women having undergone either a frozen embryo transfer in natural cycle or substituted cycle
* IVF and FET cycles done at Clinique OVO

Exclusion Criteria:

* egg or embryo recipient
* History of recurrent miscarriages, defined as ≥ 3 consecutive losses
* Patients that needed Viagra, Plasma-Rich Platelet (PRP) or other modalities to improve their endometrial thickness
* Uterine abnormalities
* Abnormal hormonal profiles
* FET Stimulated cycles
* History of recurrent implantation failure defined as failed ≥ 2 euploid embryos transfer or ≥ 3 blastocysts
Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

A randomized controlled trial comparing the efficacy and safety of Paul glaucoma implant and Ahmed glaucoma valve in refractory childhood glaucoma patients

A prospective randomized controlled trial was conducted at Al Watany Eye Hospital in Egypt. Patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either Paul or Ahmed glaucoma drainage devices.

Patients will be followed up for at least one year during which the following data are collected.

Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded

Eligibility Criteria:
Inclusion Criteria:

* Childhood glaucoma patients (whether primary or secondary) including Juvenile open angle glaucoma if the age at the time of surgery was ≤18 years.
* The included patients are those with refractory glaucoma who require a tube to control their intraocular pressure.

Exclusion Criteria:

* Any patient with incomplete data or has a follow-up less than 1 year will be excluded from the study.
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea

The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.

This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:

• Participants with UC or CD

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Eligibility Criteria:
Inclusion Criteria:

1. With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
2. With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions

Exclusion Criteria:

1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
3. For whom vedolizumab SC is contraindicated as per product label
Comparison of Time Taken for Intubation and Cormack Lehane View Between C-Mac With Glidescope Video Laryngoscopy in Paediatric Patients

This study compares the time taken to intubate between Cmac video laryngoscopy with Glidescope video laryngoscopy in paediatric patients aged 3-12 years old.

This study aims to determine whether are both devices comparable to each other in terms of intubation time and Cormack Lehane view in paediatric patients with normal airway undergoing elective surgery.

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients 3-12 years old undergoing elective surgery
* American Society of Anesthesiology (ASA) 1-2
* No difficult airway features/history of difficult intubation
* Not obese

Exclusion Criteria:

* Any difficult intubation features/history of difficult intubation
* Obese child
Telomeres Parameters in Cirrhosis

There are several factors that influence telomere length in patients with cirrhosis, such as metabolic derangements and infectious etiologies, The aim of the study is to compare telomere length and other parameters related to genetic instability in telomere/ telomerase system, in peripheral blood lymphocytes in cirrhosis from different etiologies.


Eligibility Criteria:
Inclusion Criteria:

* cirrhotic patients from different etiologies

Exclusion Criteria:

* decompensated cirrhosis (Child C)
* age under 18 years
* any known malignancy, including hepatocellular carcinoma
* patient that are unable to sign for informed consent
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer

The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of head and neck squamous cell carcinoma
* Cisplatin-based chemoradiotherapy (monotherapy or combination-therapy, adjuvant or neo-adjuvant) or only radiotherapy (control group)
* Age 18 to 85 years
* Signed agreement and willingness to participate in the study and adhere to the study protocol

Exclusion Criteria:

* Severe hearing impairment (WHO grade 3 or 4, corresponding to an audiometric ISO value of ≥61 dB in the better ear at frequencies of 500, 1000, 2000 and 4000 Hz)
* Self-reported tinnitus or vestibular dysfunction in the last 3 months (only lead to exclusion of the corresponding secondary objectives, not to complete exclusion from the study)
* Current cochlear implant
* Concurrent treatment with loop diuretics (e.g. furosemide), aminoglycoside antibiotics or other known ototoxic substances in the last three months
* Acute psychosis or serious psychiatric illness
* Addiction disorder
Evaluation of a Middle School Comprehensive Sexual Health Media Literacy Education Program

The purpose of this study is to conduct a randomized controlled trial of a media literacy education program for middle school students with the goal of enhancing decision-making skills to prevent early and risky sexual behavior and teen pregnancy, and encourage healthy relationships.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to read and write in English

Exclusion Criteria:

* None
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-B )

To compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) treated in a standard stroke unit adherent to guidelines versus treated in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

Mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. Faster door-to-puncture time (DPT) is associated with significantly better clinical outcomes. With the development of low-field magnetic resonance imaging, it is poised to play an increasingly significant role in the early diagnosis and management of acute ischemic stroke. This prospective, multicenter, week-wise randomized controlled trial will compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Can be treated between 4.5-6 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle);
3. Presenting with ischemic stroke symptoms;
4. Pre-stroke mRS score 0-1;
5. Baseline NIHSS score ≥ 5;
6. Eligible for endovascular thrombectomy;
7. Informed consent signed.

Exclusion Criteria:

1. Baseline NIHSS score \< 5;
2. Unable to undergo MRI because of claustrophobia;
3. Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
4. Definite contraindication for endovascular thrombectomy;
5. Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
6. Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
7. Participation in other interventional randomized clinical trials within 3 months before enrollment;
8. Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis

The upper extremity in people with Multiple Sclerosis (pwMS) has become a more popular research topic in recent years, with the increase in studies reporting widespread involvement. The aim of our study was to evaluate the upper extremity from multiple perspectives in early stage pwMS, to identify problems by comparing them with healthy individuals, and to examine the relationship of problems with activity and participation.


Eligibility Criteria:
Inclusion Criteria:

* MS diagnosis according to McDonald criteria
* Relapsing Remitting MS clinical course type
* 18-65 age range
* Being able to understand and read Turkish

Exclusion Criteria:

* Having an MS attack in the last 3 months
* To have done regular exercise for the upper extremity in the 6 months before starting the study
* Having different neurological, orthopedic or cardiac problems other than MS
* Being addicted to alcohol or drugs
* Getting a score below 24 on the Mini Mental Test Scale
* Having a spasticity of 3 or more according to the Modified Ashworth Scale
Dilapan-S/Dilasoft E-Registry in Induction of Labor

International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.

International Observational E-Registry to monitor current common clinical practice of use of Dilapan-S / Dilasoft for cervical ripening and following procedures of labour induction with the main focus on the duration of induced labor procedure .

Eligibility Criteria:
Inclusion Criteria:

* Indication for induction of labor
* Unfavourable cervix

Exclusion Criteria:

* Presence of overt genital tract infection
Proton Beam Re-Irradiation in Thoracic Cancers

This pilot clinical trial studies proton beam radiation therapy in treating patients with thoracic cancer that has come back and have received prior radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits.

SECONDARY OBJECTIVES:

I. To assess the efficacy of thoracic re-irradiation with proton therapy.

OUTLINE:

Patients undergo proton beam radiation therapy per standard of care.

After completion of study treatment, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Women of child-bearing age must have a negative pregnancy test
* Patients must have received prior radiation treatment to the chest; records of prior radiation treatment must be available
* Patients must have received prior chest radiation at least 3 months prior to enrollment in this trial; radiation treatment to other body sites not overlapping with current radiation fields are allowed within the 3 months period (example, brain radiation is allowed)
* Patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography \[CT\] scans at least 6 weeks apart, with either a \> 25% or \> 5 mm increase in longest dimension)
* Patients must have a life expectancy of \> 6 months
* Patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on CT imaging)
* Patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least BED2Gy 60 Gy
* Patients must be able to receive proton radiation treatment
* All stages of cancer are eligible
* There are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment
* Patients are allowed to be on another study concurrent with this protocol
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have never received radiation to the chest
* Patients who received radiation to the chest within the past 3 months (in a region that overlaps with current radiation fields)
* Patients with life expectancy \< 6 months
* Pregnant women
* Patients unable to provide informed consent
* Prisoners
The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn

Inhalation burn injury and lung complications caused by large surface burns occurring during a fire remains a serious problem. Pulmonary rehabilitation has been used successfully to improve pulmonary function(PF) in patients with chronic obstructive pulmonary disease. But there were no studies that pulmonary rehabilitation induce improvements in PF in patient with large surface burn and inhalation injury.

The investigators will performe pulmonary function and respiratory muscles strength evaluation in 40 patients with thermal injury in order to evaluate the effects of pulmonary rehabilitation in patients with thermally injury.

The investigators will performe pulmonary function and respiratory muscles strength evaluation in 40 patients with thermal injury in order to evaluate the effects of pulmonary rehabilitation in patients with thermally injury.

The investigators will study 40 patients who had burn injury. Burned patients will be randomized into two groups. The experimental group(EG) will participate in a 12-week pulmonary rehabilitation program daily for 60 minutes. The control group(CG) will participate in a 12-week conventional exercise program daily for 60 minutes. Spirometer will be done to evaluate pulmonary function. Pulmonary function tests include forced vital capacity(FVC), 1 second forced expiratory volume(FEV1), forced expiratory flow rate between 25 and 75% of the FVC(FEF 25-75) FEV1/FVC ratio expressed as a percentage(FEV1/FVC %) and peak expiratory flow(PEF). Maximum voluntary ventilation(MVV) and respiratory muscles strength(MEP\[maximal expiratory pressure\], MIP\[maximal inspiratory pressure\]) will be measured by mouth pressure-meter in sitting position. Pulmonary function tests will be performed for all groups at baseline and after 12 weeks programs. A 6-minute walk test and health-related quality of life will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* inhalation injury
* The burn surface area of chest and neck are more than 50% of the anterior or posterior trunk areas.

Exclusion Criteria:

* vocal cord palsy
* who were intubated
* had a tracheostomy
* anoxic brain injury
* psychologicical disorders
* quadriplegia
* severe cognitive disorders
* who took medications that affect pulmonary function.
To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.


Eligibility Criteria:
Main inclusion criteria:

* Written informed consent
* Asthma diagnosis for at least 6 months
* Prebronchodilator FEV1 45-90% of the predicted value
* Demonstration of reversible airway obstruction
* Stable asthma on the same regular treatment for at least 4 weeks before the study
* Non-smoker for at least 6 months before the study

Main exclusion criteria

* Respiratory infection within 4 weeks before the study
* Smoking history of more than 10 pack-years
* Other severe chronic respiratory disease than asthma
* Concurrent illness that would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study
* Corrected QT interval \> 450 ms in males or \> 470 ms in females
* Abnormal serum potassium value or other clinically significant laboratory finding
* Systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 100 mmHg
* Treatment with a long-acting β2-agonist, a xanthine-derivative, a β-blocker or with a corticosteroid (other than inhaled) within 4 weeks before the study
* Use of drugs that prolong QT-interval
* Women who are pregnant, breast-feeding or without reliable contraception
* Participation in another clinical drug study
Efficacy Study of Atorvastatin to Treat Variant Angina

The objective of this study is to evaluate effect of statin treatment for vasospastic angina.

Vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. The precise mechanisms have not been established, but a reduction in NO (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested.

Impaired FMD(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies.

So, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Vasospastic angina or spontaneous spasm during coronary angiography (Vasospastic angina is defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or EKG change; Spontaneous spasm is defined as TIMI flow grade 0-2 of coronary artery without ergonovine injection)
* Normal or insignificant lesion (diameter stenosis \<50%) on coronary angiography

Exclusion Criteria:

* Elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
* Significant lesion( diameter stenosis ≥50%) documented in coronary angiography
* Pregnancy
* Prior percutaneous coronary intervention or coronary artery bypass surgery
* Previous statin use
* Impaired renal function with serum creatinine ≥ 2.0 mg/dl
* Severe left ventricular dysfunction ( LVEF ≤ 30% on echocardiography)
* Myopathy