cyrilzakka/clinical-trials huggingface dataset:
ERAS Anesthetic Care for Metastatic Spine Cancer Resection

Spinal metastases account for 60% of all malignant bone metastases and represent a medically important treatment goal. For patients with malignant tumors diagnosed at this stage, performing En bloc spondylectomy with wide margin of resection facilitate the improvement in quality of life including ambulatory ability, daily activities independence and attenuation of bone pain. However, En bloc spondylectomy is a major operation with long operation time and frequent hemodynamic instability during the operation. Therefore, the anesthetic care plays an important role and an enhanced recovery after surgery (ERAS) is the goal.

For the ERAS anesthesia protocol for En bloc spondylectomy, we propose two major components to achieve this goal: (1) an encephalographic spectrum guided multimodal anesthesia combined with ultrasound-guided nerve block and (2) the advanced machine-learning algorithm index, namely the hypotension predictive index (HPI) guided hemodynamic protocol.

The anesthetic protocol comprises of two major proposed components to enhanced recovery after spine cancer total en bloc resection. First, a multimodal general anesthesia consisting of GABAnergic hypnotic agent (propofol or sevoflurane), ketamine and dexmedetomidine was conducted by using the encephalographic density spectrum array. In addition, ultrasound-guided erector spinae plane block is applied. These techniques potentially prevent anesthesia induced delirium and may profoundly improve postoperative analgesic quality. Second, advanced hemodynamic monitoring device, namely the hypotensio predictive index, will be used for prevention of intraoperative hypotension and facilitate precise transfusion protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing metastatic spine cancer resection surgery

Exclusion Criteria:

* Expected survival less than 6 months
* Previous surgery or radiotherapy for the spine metastasis
The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars

The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A randomized, split-mouth design including 40 children aged 4-8 years was implemented. The study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair, one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is carried out to evaluate the teeth clinically and radiographically.

A double blinded, randomized, controlled clinical trial was performed in a split-mouth design. Eighty primary molars in forty subjects were randomly allocated that each subject had one tooth treated with 2% chlorhexidine gluconate and MTA (experimental group), and the other tooth treated with only MTA (control group).

The study was held at King Abdulaziz University Dental Hospital (KAUDH), Jeddah. Forty healthy children with the age range 4- to 8-year-old were included. Each patient had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.

Preoperative periapical radiographs of the teeth considered for treatment in the study were made using extension cone paralleling technique in the x ray machine.

The procedure was performed in two visits by one operator to allow for the setting of MTA. Stainless steel crowns were used as final restorations.

Eligibility Criteria:
Inclusion Criteria:

Patient inclusion criteria:

* 4-8 years old.
* Healthy.
* Cooperative.
* Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.

Teeth inclusion criteria:

* No spontaneous pain.
* No pain on palpation or percussion.
* No signs of fistula or abscess.
* No abnormal mobility.
* No radiolucency at the periapical or interradicular areas.
* No loss of lamina dura.
* No radiographic signs of internal resorption.
* Sufficient tooth structure allowing placement of rubber dam.
* Not expected to exfoliate within 1 year.

Exclusion Criteria:

* Spontaneous pain.
* Pain on palpation or percussion.
* Signs of fistula or abscess.
* Presence of abnormal mobility.
* Radiolucency at the periapical or interradicular areas.
* Loss of lamina dura.
* Radiographic signs of internal resorption.
* No sufficient tooth structure allowing placement of rubber dam.
* Expected to exfoliate within 1 year.
Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%

The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.

Pain after hemorrhoidectomy remains a major postsurgical complication.Therefore pain management in patients is an important goal.Many studies have focused on surgical techniques,preoperative and postoperative regimes.We assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with grade 3 or 4 hemorrhoid who underwent Milligan-Morgan surgery.

Exclusion Criteria:

* Patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoidal surgery,or those who had previous adverse effect from calcium channel blocker drugs and also those who were pregnant.
Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a fNIRS

Investigators investigate the patterns of cortical activation using the NIRST in patients with peripheral neurological injury caused by lower extremity burns.

Understanding the mechanisms associated with locomotor networks may be of benefit for rehabilitation of burn victims with neurological locomotor deficits. However, the effects of peripheral neurological injury on locomotor network remains unknown. A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury.

Investigators assessed 15 patients with lower extremity burns and 11 healthy controls.

Investigators measured walking-related cortical activity using an fNIRS device at baseline and during usual walking.

Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment.

Eligibility Criteria:
Inclusion Criteria:

* burn patients with lower extremity or upper extremity thermal injury
* patients who could walk unassisted for at least 5min.

Exclusion Criteria:

* patients with critical systemic conditions
* severe cognitive impairment
* had severe pain
* unable to walk.
Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis

The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* GERD and a history of Erosive Esophagitis documented by endoscopy
* H. pylori negative

Exclusion Criteria:

* Gastrointestinal conditions such as esophageal stricture, esophageal varices, previous vagotomy
* Achlorhydria
SNORE (Smartphone Analyses of Nocturnal Obstruction by Respiratory Evaluation) SOUNDS

This is a prospective multipart clinical performance study to compare the ability of the SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST) device to identify patients with obstructive sleep apnea (OSA).

Consecutive patients referred to a sleep lab for possible OSA (obstructive sleep apnea) will be offered participation in this study. Study subjects will participate in either Part A, Part B or Part C of the study. Subjects will not participate in more than one part of the study. Study sites can participate in multiple parts of the study.

Part A: Sleep Lab

Consecutive patients referred to a sleep lab for possible OSA will be offered participation. Participants who provide informed consent will fill out a questionnaire and then have PSG, as it would normally be performed. During PSG additional sound recordings will be made in three ways:

1. Microphone placed 50-100 cm (20-40 inches) from the patient's mouth.
2. Android type Smart Phone with a recording application (app). The phone will be placed on a table 50-100 cm (20-40 inches)) from patient's mouth.
3. iPhone type Smart Phone with a recording app. Phone will be placed on a table 50-100 cm (20-40 inches) from patient's mouth.

The sound recordings obtained via the microphone and Smart Phones will be analyzed electronically for OSA by the sponsor's proprietary algorithm. A blinded comparison will be made between the PSG results and SnoreSounds algorithm results.

PSG will be performed and scored in a manner consistent with current (2012) American Academy of Sleep Medicine (AASM) standards. PSGs will be scored twice - with each scoring performed independently. If the Apnea Hypopnea Index (AHI) for each score places the patient in the same OSA severity range \[0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, \>30 severe\] the average of the two scores will be utilized. If however the scores put the patent in different OSA severity ranges, then the study will be scored by an independent sleep medicine physician-sleep technician team and assigned an AHI.

The results of the SnoreSounds testing will not be known to the sleep lab and the results obtained from Snore Sounds analysis will not be utilized in the clinical management of study participants.

Part B: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) (currently not enrolling in Part B)

Part C: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) and to Polysomnography (PSG) (currently not enrolling in Part C)

Eligibility Criteria:
Inclusion Criteria:

* Patients \>or= 18 years old who are referred for polysomnography (PSG) or Home Sleep Test (HST) because of possible obstructive sleep apnea (OSA)

Exclusion Criteria:

* Previous PSG or HST confirming OSA
* Prior surgery for snoring or OSA
* Medical contraindication for PSG
* Cognitive impairment that might interfere with obtaining informed consent or completing Clinical Questionnaire
Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients

Title of study: An observational, multicenter study on the safety and efficacy of Femara® (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed adjuvant Tamoxifen or Toremifen treatment

Objectives:

The major objective of the study is to assess safety and efficacy of Femara® in women who had undergone resection of a primary breast cancer and subsequently received prior adjuvant tamoxifen or toremifen therapy for 5 years in real-life condition.

The study aims at the following objectives:

1. To identify unknown adverse reactions, especially serious adverse reactions
2. To evaluate incidence and descriptions of adverse reactions under the routine drug use
3. To identify factors that may affect the safety of Femara®
4. To identify factors that may affect the efficacy of Femara®

Methodology: This will be an open-label, multi-center, single-arm, observational phase IV study.

Number of centers \& patients: Approximately 610 (planned No. of patients for total study period) patients from 4 centers will be enrolled in this study.

Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling.

Investigational drug: Femara® will be administered orally as described in "dose \& administration" of local product labeling up to 3 years.

Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3 years with renewal of contract on yearly basis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent form
* Postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
* Age ≥50 years with cessation of menses and Age \<50 years Postmenopausal status defined by one of the following:

  * FSH level \> 30-40 IU/L
  * cessation of menses over the past 1 year
  * are/become amenorrheic due to either chemotherapy or LHRH, are/become amenorrheic due to surgical ovarian ablation
* The tumor was to be ER and/or PgR-positive or the receptor status could have been unknown
* No evidence of recurrence of the disease at entry
* Patient must be accessible for follow-up

Exclusion Criteria:

* Those patients known to have had receptor-negative primary tumors
* Any concurrent malignancy
* Patients who previously received hormone replacement therapy (HRT) during 5 years of adjuvant therapy with tamoxifen or toremifen
* Patients who are currently receiving other aromatase inhibitors, or chemotherapy
* Patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
* Life expectancy \< 12 months
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis

The purpose of this study is to determine whether Urinary Kallikrein has an additional effect on enhancing collateral circulation in symptomatic intracranial atherosclerotic patients under clopidogrel and aspirin dual antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke or TIA within 72 hours;
2. Intracranial ICA, MCA M1 segment stenosis (\>70%)

Exclusion Criteria:

1. \>70% Stenosis in an intracranial artery other than the culprit artery.
2. \>50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.
3. Perforator strokes based on MRI.
4. Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.
5. Potential cardiac embolism as cause.
6. Intracranial haemorrhage within 6 weeks.
7. Concomitant intracranial tumour, aneurysm or arteriovenous malformation.
8. Known contraindications for heparin, aspirin, clopidogrel or contrast.
9. Haemoglobin \<10 g/dL, blood platelet count \<100 000, international normalisation ratio \>1.5, or other uncorrectable coagulopathies.Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
10. A baseline modified Rankin Score of ≥3.
11. Life expectancy of \<1 year due to the concomitant illness.
12. Pregnant or lactating women.
13. long-term statins users.
14. History of mental instability or dementia.
Safety and Efficacy of "Standardized" CHIP

In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients.

The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft

Exclusion Criteria:

* Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.)
* History of recent (within 1 month) stroke or TIA
* Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors
HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction

Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition. Previous reports have reported that HLA-B\*5801 is an important genetic risk factor significantly associated with the development of allopurinol-induced SCAR. However, there has been no prospective study to prove the clinical efficacy of a HLA-B\*5801 screening before administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this prospective study is to test our hypothesis that a pre-screening of HLA-B\*5801 will significantly reduce the risk of allopurinol-induced SCAR development compared to the historical control.


Eligibility Criteria:
Inclusion Criteria:

* a subject who needs an allopurinol treatment based on the physician's assessement
* a subject with chronic kidney disease (CKD)

  * CKD is diagnosed on at least 2 occasions for a period of at least 3 months, irrespective of the underlying cause and on the basis

    1. an estimated or measured glomerular filtration rate \<60 mL/min/1.73 m2 and/or
    2. evidence of kidney damage (albuminuria, proteinuria, haematuria after exclusion of urological causes, or structural abnormalities on kidney imaging tests)

Exclusion Criteria:

* a subject who refuses to participate in this study
Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM

Purpose and significance: To explore the clinical efficacy and safety of Chiglitazar sodium in polycystic ovary syndrome with type 2 diabetes

Methods: From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.

Type of study: randomized controlled, prospective, intervention study.

From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Type 2 diabetes mellitus Clinical diagnosis of Polycystic ovarian syndrome Must be able to swallow tablets

Exclusion Criteria:

Mental diseases, autoimmune diseases, hematological diseases, malignant tumors, other ovarian diseases (such as ovarian cysts), sexually transmitted diseases Infertility caused by gynecological diseases such as uterine cat's eye disease and other reasons Abnormal function of important organs Congenital adrenocorticosis, hypothyroidism, Cushing's syndrome and other endocrine diseases Patients who have recently prepared or become pregnant
Pre-discharge vs. Early Post-discharge Stress Testing and GRACE Score for Safe Discharge of ACS-patients With a Negative Hs-troponin T Result

New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score \>140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.


Eligibility Criteria:
Inclusion Criteria:

* patients presenting to the emergency department ("chest pain unit")
* typical angina pectoris
* absence of symptoms since presentation
* at least 18 years
* low GRACE risk score (\<140 points)
* informed consent, signed agreement

Exclusion Criteria:

* conditions with need for immediate workup
* mental disorders
* dementia
* pregnancy, breast feeding
Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions

This study aims to understand why some people who have had COVID-19 develop scarring of the lungs and why some people recover more quickly than others.

A large number of people diagnosed with COVID-19 suffer from long term symptoms, predominantly breathlessness and fatigue whether or not they were admitted to hospital. While there are a number of causes of long-term breathlessness following COVID-19 one of the most common, and potentially concerning with regards to long term prognosis is Interstitial Lung Disease.

The fibrogenic potential of SARS-CoV-2 is currently unknown but is predicted to be substantial based on the experience of previous coronavirus outbreaks and emerging data from this pandemic.

The investigators do not yet understand how scarring occurs following SARS-CoV-2, nor why there is resolution in some individuals and persistent or progressive disease in others. The investigators therefore plan to undertake bronchoscopy (camera test into the lungs) to examine for changes in the way the cells lining the lung behave, using genetics, and differences in the bacteria living in the airways in patients whom have developed scarring following COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of SARS-CoV-2 PCR/Seropositive
* Presence of interstitial lung disease on CT
* Participant is willing and able to give informed consent for participation in the study
* Aged 18 years or above

Exclusion Criteria:

* Confirmed ILD diagnosis prior to March 2020
* Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.
* Use of steroids at baseline visit
TATE and KN046 in MCRC

A single-arm, multicenter, Phase IIA study of Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (TATE) and KN046 (recombinant humanized anti-PD-L1/CTLA-4 bispecific single-domain antibody Fc fusion protein injection) in patients with liver metastases from colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Liver metastatic MSS/pMMR-mCRC;
* mCRC progressed on at least two lines of standard chemotherapy;
* Measurable disease;
* ECOG 0-1;
* Adequate organ function

Exclusion Criteria:

* Prior organ transplantation;
* Oxygen saturation less than 92% in room air;
* Prior autoimmune disorder;
* Major GI bleeding in the last 2 months;
* Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways.