cyrilzakka/clinical-trials huggingface dataset:
The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy

Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute \[L/min\], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.

It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.

Eligibility Criteria:
Inclusion Criteria:

* (1) undergoing sedated bronchoscopy
* (2) 18 to 70 years of age;
* (3) American Society of Anaesthesiologists (ASA) class: I-III

Exclusion Criteria:

* (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
* (2) severe hypoxemia (SpO2 \< 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
* (3) upper respiratory tract infection or lung infection;
* (4) refusal to participate in this study.
Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

The goal of this clinical trial is to evaluate the effectiveness and safety of autologous costal osteochondral transplantation in the treatment of Hepple Stage V talar osteochondral lesions, compared with autologous osteoperiosteal transplantation. The main question it aims to answer is:

• Whether autologous costal osteochondral transplantation can achieve better clinical outcomes and cartilage repair quality with lower donor site morbidity than autologous osteoperiosteal transplantation in the treatment of Hepple Stage V talar osteochondral lesions.

Participants will be randomly assigned to the intervention group (undergoing autologous costal osteochondral transplantation) or the control group (undergoing autologous osteoperiosteal transplantation). Both groups of participants will receive the same postoperative rehabilitation process and follow-up evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Hepple stage V talar osteochondral lesions with a lesion depth ≥5 mm and an AOFAS score ≤80 points;
* Failed conservative treatment for at least 6 months;
* Unilateral talar osteochondral lesions without corresponding lesions on the tibial side;
* Willingness to participate in this clinical trial and signing an informed consent form.

Exclusion Criteria:

* Combined with lower limb deformity.
* Combined with hip or knee joint diseases.
* Combined with ipsilateral ankle arthritis with joint space narrowing .
* Diagnosis of gouty arthritis of the ankle joint.
* Combined with osteoporosis (T score \<-2.5).
* Other conditions considered inappropriate for participation in this clinical trial by the researchers.
Using Retinal Photograph Based AI to Predict Incident Coronary Heart Disease

To determine whether an integrated retinal AI decision support can improve predictive accuracy of coronary heart disease (CHD), the investigators are conducting a randomized controlled study of AI guided prediction of CHD compared to clinical prediction by physicians (e.g., usingPCEs), both using clinical intuition as baseline.

This is a randomized controlled trial (RCT) evaluating the effectiveness of an AI-based decision support tool in CHD risk prediction and decision making by physicians. Prospective cohort study participant cases will be randomly assigned to either guideline group (e.g., PCEs) or AI group after baseline assessment (clinical intuition):

There are three settings: (1) Clinical Intuition (baseline assessment) Physicians' make decision about prevention strategy initiation (e.g., statin initiation) without any external assistance. Assessment relies solely on the physician's clinical judgment and experience. (2) Guideline-Based Group (Guideline Group) Physicians use a PCE table to calculate the 10 year ASCVD risk. This approach aligns with current clinical guidelines to assist in decision-making. (3) AI-Assisted Group (AI Group) Physicians receive CHD probability estimates from an AI model based on retinal photographs. The AI tool provides individualized obstructive CHD probabilities, leveraging retinal biomarkers associated with cardiovascular risk.

Primary Objective To evaluate whether AI-guided decision support could improves diagnostic accuracy of CHD to a greater extent than standard clinical assessments, both compared to clinical intuition. The accuracy could be assessed by the extent of prevention initiation (e.g., prescribing statins) corresponding with actual CHD outcomes observed.

Secondary Objective To assess whether AI-guided decision support reduces the time required to complete CHD assessments and decision making.

Participants, Readers and Randomization:

Participants: Participants in prospective cohort studies, with 10-year follow up.

Readers: Physicians performing evaluations of CHD probability and make primary prevention recommendations.

Randomization: Participants will be randomized into one of the groups (PCEs or AI) after clinical assessment at baseline using block randomization to ensure balanced group sizes.

Eligibility Criteria:
Inclusion criteria:

* Individuals without uncontrolled vascular risk factors
* Age range: 40-75 years old
* Can accept and cooperate with the examination and potential follow-up work after being selected for clinical trials

Exclusion criteria:

* Severe lung disease and cancer or surgery patients
* Statin user or pre-existing cardiovascular disease
* Individuals with severe liver and kidney dysfunction and electrolyte imbalance
mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy

A multicenter,open,prospective randomized controlled trial;11 study center in China; Plan to enroll 328 patients（ Power Analysis and Sample Size ）.Comparing FOLFIRI with mFOLFOX6,Superiority design.Investigate difference PFS,ORR,R0 resection rate,OS ,QoL and Safety from two regimens Stratification factors : Analyzing patients recurrence within 6-12months,and 12-18months .Obtain definite chemotherapy regimen shift opportunity for patients recurrence/metastasis after adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

18-75 years，male or female Colorectal adenocarcinoma Accepting more than 4 cycles oxaplatin based adjuvant chemotherapy after radical operation Reccurrence in 6-18 months after adjuvant chemotherapy At least one assessable lesions No intestinal obstruction ECOG 0-1 Estimated survival≥ 3 months CBC：WBC\>4×109/L，PLT\>80×109/L，Hb\>90g/L， Liver function：ALT or AST \< 2× normal maximum value， T-bile\<1.5× normal maximum value without hepatic metastatic， ALT or AST \< 5× normal maximum value， T-bile\<1.5× normal maximum value with hepatic metastatic Cr\<1.8mg/dl Signed informed consent

Exclusion Criteria:

Locally resectable lesions Grade 2-4 oxaliplatin induced neurotoxicity Arrhythmias，coronary heart disease，or congestive heart failure（NYHA≥grade 2） requiring treatment Poorly controlled hypertension HIV infected or active HBV or HCV infected Active serious infection Cachexia or organ function decompensation Multiple primary carcinoma except carcinoma in situ of skin and cervix Participate in other clinical studies at the same time Serious heart or brain disease Drug abuse or other serious psychosocial diseases Suspected trial drug allergy Other factors affecting patient safety and compliance Pregnant or lactating women，or fertility without adequate contraceptive measures
Impact of Dietary Advice on the Progression of Tooth Wear

The aim of this research is to investigate the impact of dietary advice on the progression of tooth wear over 6 months using a randomised clinical trial design. Participants with severe tooth wear will be recruited. Half of those patients will receive a detailed dietary advice and the other half will be receive standard of care dietary advice. Moulds will be made of their mouths at the original appointment and 6 months later. These moulds will be scanned and superimposed to see if there is any difference in their level of tooth wear

A sample size of 60 patients will be recruited separately from an epidemiology study and written informed consent will be obtained. Patients presenting with moderate to severe tooth wear will be recruited. Those with a Basic Erosive Wear Examination (BEWE) cumulative score greater than or equal to 8 but with at least one score of 3 on the occlusal surfaces of the lower molars or the incisal edge of the upper central incisor. After randomisation, an impression will be taken of the upper and lower teeth using a silicone material. One group will receive one-to-one dietary advice (with dietary information sheets) as the intervention and the other group will not receive any intervention. The silicone impressions will be repeated 6 months later. Impressions will be cast in stone and the occlusal surfaces of the upper or lower molars and the buccal surface of the upper central and lateral incisors will be scanned to monitor tooth wear progression. The two scans of the involved teeth will be superimposed and the level of tooth wear over that time will be calculated.

The investigators aim to see if giving detailed dietary advice will result in less erosive tooth wear.

Eligibility Criteria:
Inclusion Criteria:

1. Severe tooth wear with a BEWE score of 3 on the occlusal surface of the first lower molars or incisal/buccal surface of the upper central incisor.
2. This wear will be as a result of a high acid diet i.e. as at least two dietary acidic challenges a day.
3. Adult 25-70 years old.
4. Minimum of at least 10 occluding tooth pairs (i.e. at least 10 upper teeth which bite against 10 lower teeth) - including the opposing upper molars and lower incisors
5. No anterior crowns/ bridges or implants opposing the lower molars or upper incisors
6. Written consent to the study

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Medical history likely to impact on attendance or mobility
3. Presence of periodontal disease or caries on more than one tooth. BPE score of 2 or above.
4. Unable to speak or understand English
5. Saliva diagnoses (xerostomia- dry mouth)
6. Orthodontic appliances
7. Severe dentine hypersensitivity
8. Restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars.
9. Have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning or previous use of the weight loss medications.
Aerosol Inhalation Treatment for Dyspnea

The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

This is study of aerosol treatment in a laboratory model of dyspnea in healthy subjects. This study is the first in a series of studies that will include investigation of a second dose in the laboratory and investigation of the treatment effect in hospitalized patients with refractory dyspnea. The outcome of this first study will determine the details of protocol for the succeeding studies.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Unstable heart or circulation disease
* Stroke
* Seizure disorder
* Severe migraine headaches
* Liver or kidney disease
* Adrenal gland problem (Pheochromocytoma)
* Nerve problems that may affect your breathing sensation
* Brain cancer
* Drug or alcohol problem
* Systemic lupus erythematosis (SLE)
* High levels of depression, panic disorder, or other significant mental health problems
* Serious ongoing pain
* Pregnant
* Under 18 years old
* Not Fluent in English
Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal Syndrome

This project is to understand the LTBP4 expression in human renal fibrotic tissues. The investigators will exam major location of LTBP4 expression and check any similar or discrepancy in renal fibrosis with different etiologies.

The investigators will obtain the residual renal tissues with different etiologies and check the expression of LTBP4. The location and quantitation of LTBP4 in renal tissues will be checked. It will be great to understand the association between the severity of fibrosis and the expression of LTBP4 and other matrix proteins.

Eligibility Criteria:
Inclusion Criteria:

* Abnormal kidney function, proteinuria, hematuria

Exclusion Criteria:

* N/A
Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery

The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.

About 80% of patients develop high glucose after cardiac surgery. High glucose is linked to an increased risk of hospital complications. High glucose increases the risk of wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. This study will determine if sitagliptin can prevent the development of high glucose after heart surgery. Sitagliptin is a diabetes pill approved by the Food and Drug Administration (FDA) to treat patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
* No previous history of diabetes
* No previous history of hyperglycemia

Exclusion Criteria:

* Patients with hyperglycemia (blood glucose \> 125 mg/dL); or glycated hemoglobin (HbA1c) \> 6.5%; or previous treatment with oral antidiabetic agents or insulin
* Severely impaired renal function (serum creatinine ≥3.0 mg/dL or GFR \< 30 mL/min) or clinically significant hepatic failure
* Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
* Subjects with gastrointestinal (GI) obstruction or adynamic ileus or those expected to require GI suction
* Patients with clinically relevant pancreatic or gallbladder disease
* Treatment with oral or injectable corticosteroid
* Mental condition rendering the subject unable to understand the scope, and consequences of the study
* Female subjects who are pregnant or breast feeding at time of enrollment into the study
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)

The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

The key Inclusion Criteria include but are not limited to the following:

* Have a histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit
* Must submit a baseline tumor sample for analysis
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.

Exclusion Criteria:

The key Exclusion Criteria include but are not limited to the following:

* Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention or has not recovered to CTCAE Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
* Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active infection requiring therapy
* History of an allogenic stem cell transplant or a solid organ transplant
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study
* Has not fully recovered from any effects of major surgery without significant detectable infection
* Has received radiation therapy to the lung that is \>30 gray (Gy) within 6 months of the first dose of study treatment
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Is currently participating and receiving study intervention in a study of an investigational agent or has participated and received study intervention in a study of an investigational agent or has used an investigational device within 28 days
Activity and Participation in Vestibular Disorders

This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation.

Adults aged 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction will be recruited at the time of their entry into vestibular rehabilitation. The investigators will analyze what factors (impairments and personal factors) are related to activity and participation in people with vestibular disorders and see if change in activity and participation is related to recovery from vestibulopathy.

Eligibility Criteria:
Inclusion Criteria:

- 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction

Exclusion Criteria:

* 1. Cognition \<18 on Montreal Cognitive Assessment (MoCA)
* 2. Visual acuity worse than 20/40 with corrected lenses
* 3. Loss of protective distal sensation (defined as the inability to feel a 4.31 size monofilament on the plantar surface of the foot)
* 4. Inability to engage in community mobility
Evaluation of a LAM FLISA for the Diagnosis of Tuberculosis

Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. The development of rapid point of care diagnostics is required.

Lipoarabinomannan (LAM) is part of the bacterial cell wall in M. tuberculosis. It is released when bacteria are multiplying or dying. LAM can be detected in the urine since it is filtered from the blood in the kidneys. The detection of LAM in the urine by conventional enzyme linked immuno-sorbent assay (ELISA) techniques was hampered in the past by a low sensitivity and multiple processing steps. Recently, fluorescence linked immuno-sorbent assay (FLISA) has been shown to detect LAM in concentrations that are several magnitudes lower that with ELISA based methods. Furthermore the procedure requires less separate steps for processing the sample.

This study aims to validate the new diagnostic test by comparing patients with (a) confirmed tuberculosis (n=25), (b) infection with non-tuberculous mycobacteria (n=25), (c) bronchial carcinoma (n=25), (d) suspected tuberculosis but confirmed alternative diagnosis (estimated n=20). Single blood and urine samples of these groups will be used to evaluate the sensitivity and specificity of the test.

In patients with confirmed tuberculosis the LAM FLISA will also be assessed as a biomarker for the monitoring of tuberculosis treatment success. Initially, 2-5 samples blood and urine are required during the first week, followed by twice weekly and weekly sampling intervals over a period of 12 weeks maximum. The study participation ends when the patient is discharged from hospital.

As a substudy, the blood samples will be used to evaluate an enzyme linked immuno-sorbent assay (ELISA) for the detection of lipid antigens that are specific for Mycobacterium tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

1. Suspected or confirmed infection with M. tuberculosis (MTB) or confirmed infection with non-tuberculous mycobacteria (NTM) or confirmed bronchial carcinoma
2. Oral and written consent to study participation (children: parent's consent)

Exclusion Criteria:

1. Inability to follow the study requirements
2. Patient in custodianship or guardianship