cyrilzakka/clinical-trials huggingface dataset:
Measurement of Cardiopulmonary Variables After Acute Exposure to High Altitude

As altitude increases, the availability of oxygen in the air decreases, and just to compensate for this lack, the body increases cardiac and respiratory work and changes blood pressure. But that is not all: at altitude the body's ability to use oxygen is also limited. Thus, there is on one hand less oxygen available, and on the other a lower capacity to use it. All this generates significant alterations at the cardiovascular level, to the point of running possible risks of heart attack, stroke and acute pulmonary edema, particularly for individuals already suffering from cardiovascular disease.

The availability of modern cable cars allows an increasingly large number of individuals, including sedentary people, elderly subjects, and cardiorespiratory patients, to easily and rapidly reach high-altitude locations. Data on what happens on the cardiovascular system at high altitude are relatively scarce, and most experiments in the literature are limited by low sample sizes.

The primary purpose of this study is to assess the characteristics of a large population that acutely reached high altitude at Punta Helbronner (3,466 m above sea level), a location on Mont Blanc that is readily accessible by a 20-minute cableway ride from Courmayeur (Entreves station, 1,300 m, Skyway Monte Bianco). We aim to create a unique database and study correlations between altitude and cardiorespiratory parameters (heart rate, blood pressure, and Hb saturation) by collecting medical history data and biometric measurements in a very large population and to identify subjects most at risk of developing hypoxia at altitude. In a subset of subjects, differences in biometric variables after acute exposure at high altitude (in the transition between the downstream and the upstream measuring station) will be evaluated.

Two biometric multiparametric recording systems (Keito K9; Keito, Barcelona, Spain) were installed at Entreves station as well as at Punta Helbronner. Keito K9 is an automatic multiparametric recoding system for measuring peripheral oxygen saturation SpO2, heart rate HR (pulse oximeter), blood pressure (BP; wrist pressure cuff, automatic), height (laser height meter), weight (scale platform), and body mass index (BMI). Once initiated by the subject with the completion of a cardiology history questionnaire (self-reported), the automated Keito K9 system provides a sequence of vocal and animated directions to guide subjects through the measurements (the subject may elect to abstain from some of the measurements). Upon completion, the system prints a summary receipt for the subject, and the measurements are transmitted through a Wi-Fi network and collected in an Excel sheet.

It should be noted that all data collected will be anonymized or not traceable to the subject, through the use of a disposable identification card (for subjects who will perform both downstream and upstream measurement).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Age \< 18 years
Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry

Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. Moreover, the Chinese vancomycin TDM guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(PPK) and Bayesian methods. However, there is a gap between clinical practice and the guideline. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods. Pharmacists could provide the vancomycin individualized dosing service by joining the ICU multidisciplinary team. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

This is a single-center, ambispective cohort study. Patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. The exposure is whether patients received pharmacists' consultation. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care unit(ICU), Peking University Third Hospital since JAN 2010.
* Receiving vancomycin therapy for 72 hours or more.
* Aged ≥ 18 years.

Exclusion Criteria:

* Administration of vancomycin in non-intravenous access.
* Life expectancy of less than 24 hours.
* Pregnancy women.
* Presence of immunodeficiency.
* Presence of hematological disorder.
* Written informed consent not obtained in the prospective cohort.
OTO-104 for the Treatment of Meniere's Disease

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
* Subject has experienced active vertigo during the lead-in period.
* Subject has documented asymmetric sensorineural hearing loss.
* Subject agrees to maintain their current treatments for Meniere's disease while on-study.
* Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

Exclusion Criteria:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has a history of previous endolymphatic sac surgery.
* Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
* Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
* Subject has experienced an adverse reaction to IT injection of steroids.
* Subject has used an investigational drug or device in the 3 months prior to screening.
* Subject has previously been randomized to a trial of OTO-104.
Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision

Prospective, randomized, case-controlled trial study. Observation post-operatively:

Aims: This study aimed to compare the effectiveness of the caudal block CB with other methods of postoperative pain release.

a study Sample size: all patients, for a total of 90 boys going for circumcision surgery. I was recruited over the course of four months, starting on 1 May 2023. The patients will be divided into three groups: A caudal block(CB), B systemic opioids, and C dorsal penile block (DPNB) Techniques used in pediatric surgeries to provide analgesia for penile surgery such as circumcision. All patients had operations and were observed, and the three groups were compared based on hemodynamic stability, pain scores, duration of sedation, analgesia need, and parental satisfaction. where the Face, Leg, Activity, and Cry Consolability (FLACC) pain scale and behaviors were used to observe and compare the three groups. Pain scores were recorded by separate anesthesiologists or nurses in the post-anesthesia care unit. All statistical work will be carried out using Spss version 27 (Spss Inc., Chicago, USA) and Prism GraphPad version 9.4.1 (GraphPad, San Diego, USA) The categorical and numerical variables and demographic data of three groups were collected and reviewed by two authors. the study has shown that the caudal block produces higher levels of analgesia and a longer period of pain release than the penile block, even if both methods help relieve pain during pediatric surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status classification one
* aged from three months up to three years

Exclusion Criteria:

* allergic to local anesthetics,
* bleeding diatheses,
* coagulopathy,
* infection at the injection site,
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)

Phase I Dose Escalation:

Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension.

Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine

Phase I Extension:

Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.

Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.


Eligibility Criteria:
Inclusion criteria:

1)

Phase I Dose Escalation:

* Male or female patients \>/= 18 years of age with relapsed or refractory AML
* Male or female patients \>/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy

Phase I Extension and Phase II:

-- Male or female patients \>/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy

2) Histologically or cytologically confirmed AML according to the WHO classification 3) Patients must be eligible for treatment with decitabine 4) Eastern co-operative oncology group (ECOG) performance score \</=2 at screening Further inclusion criteria apply.

Exclusion criteria:

1. Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
2. Patients who are candidates for allogeneic stem cell transplantation.
3. Active chronic graft versus host disease requiring immunosuppressive treatment.
4. Phase I extension and Phase II only:

   Prior treatment with a hypomethylating agent, such as prior treatment for Myelodysplastic Syndrome (MDS).
5. Prior treatment with Cluster of differentiation 33 (CD33) antibody. Further exclusion criteria apply.
Rosehip Powder for Knee Osteoarthritis

The aim of this study is to compare three combinations of preparations in a comparative trial program on rosehip powder for knee OA. The trial is a comparative, 12-week, randomized, double-blind, active-controlled trial, designed to determine the comparative efficacy and safety of these preparations in patients with pain from knee OA.

Complementary or alternative therapies (incl. nutraceuticals - functional ingredients sold as powders, pills, and other medicinal forms not generally associated with food) for OA are commonly used, and it is therefore important that health care providers are aware of the evidence supporting the claims. One proposed nutraceutical which has shown promising results in OA patients, is the hip powder of Rosa canina.

The findings from a previous meta-analysis of rosehip powder from Rosa canina for symptomatic treatment of OA was a small but potentially relevant reduction of pain and a statistically significant reduction in use of analgesics.

The present study is undertaken to compare two different products, one of which is tested in two different doses, in a non-inferiority design.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age and have clinical evidence (diagnosed according to the American College of Rheumatology \[ACR\] criteria) and radiographic evidence of OA.
* Eligible patients have a self-reported pain level corresponding to at least 40 mm on a 100 mm VAS when screened

Exclusion Criteria:

* Patients will not be considered eligible if they are considered morbidly obese -having a body mass index (BMI) above 40 kg/m2, concurrent medical or arthritic conditions that could confound evaluation of the index joint, or coexisting disease that could preclude successful completion of the trial.
* Patients who already take a rosehip powder as a dietary supplement; have inability to speak Danish fluently; or have a mental state impeding compliance with the program will not be considered eligible for inclusion.
Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.

Randomized study investigating alterations in muscle protein metabolism at provision of parenteral nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Major gastrointestinal surgery
* Assumed need of post-operative artificial nutrition.

Exclusion Criteria:

* Insulin dependent diabetes
* Steroid medication
Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects

The available medications used to treat HoFH are targeted at reducing circulating levels of total and LDL-cholesterol. These measures can retard the progression of cardiovascular disease, however, they are unlikely to regress existing disease due to years of cholesterol accumulation in the vessel walls and therefore cannot adequately reduce the existing risk for an ischemic event. HDL has multiple actions that could lead to plaque stabilization and regression, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI measurements in patients with HoFH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject 12 years or older
* Subject presents with Homozygous FH

Exclusion Criteria:

* Weight \>100 kg
* Subjects with significant health problems in the recent past including blood disorders, cancer, or digestive problems
* Female subjects of child-bearing potential
* Known major hematologic, renal , hepatic, metabolic, gastrointestinal or endocrine dysfunction
* Contraindication to MRI scanning that would preclude the use of contrast-enhanced 3TMRI
Study to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome

RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)

STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 6 and 30 years old.
* Clinical diagnosis of Angelman Syndrome and molecular confirmation of diagnosis.
* The participant has an acceptable guardian can give consent on behalf of the participant.

Exclusion Criteria:

* Patients with hypersensitivity to tetracyclines.
* Patients with impaired hepatic or renal function and in those with mainly drug allergy history.
* Any other condition that in the opinion of the investigator is considered clinically relevant and that administration of minocycline contraindicated
Effect of CSII and CGM on Progression of Late Diabetic Complications

The purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes

80 type 1 diabetic patients with kidney function (GFR \> 45 ml/min), but with urine albumin excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily insulin injections (control group) or insulin pump therapy plus continued glucose monitoring (CGM) (intervention group). Patients must be in stable RAAS blockade before entering the study.

Before the study is initiated all patients receive education in intensive diabetes treatment and self-care including carbohydrate counting.

Patients return to the clinic after 1,3,6,9, and 12 months for measurement of urine albumine excretion, clinical examination including blood pressure, CGM sensor readings, four-point self monitored blood glucose (SMBG) profiles, blood samples and fulfillment of questionnaire to assess quality of life. At entry and after 12 months, eye fundus foto, 24-hour blood pressure, GFR, and carotis intima media thickness (CIMT)are also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age,
* Type 1 diabetes according to WHO criteria,
* Urin albumine \> 30 mg/g (albumine/creatinine ratio),
* HbA1c \> 7.5 \< 13.0%,
* No change in RAAS blocking treatment at least 4 weeks prior to screening.

Exclusion Criteria:

* Kidney disease other that diabetic nephropathy,
* Recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator,
* Use of insulin pump within 12 months,
* Acute myocardial infarction within 3 months,
* Severe arteriosclerosis as judged by the investigator,
* Heart failure (NYHA class 3 or 4),
* Abuse of alcohol or drugs,
* Any cancer diagnosis unless in remission at least 5 years prior to screening,
* Participation in other intervention studies,
* Pregnant or lactating women,
* Any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.
Coronary Hemodynamics by Coronary Angiography

Study for developing techniques to evaluate coronary artery hemodynamic profiles by conventional angiography without more dedicated measuring devices.

\* Methods: Compare TIMI frame count, coronary clearance frame count in baseline/hyperemic coronary angiography with FFR, CFR, IMR and derive correlation, receiver-operating characteristic curve to find new tools estimating coronary hemodynamics by conventional angiography only.

A TIMI frame count is measured by counting the angiographic image cine frames during a head of radiocontrast column runs from the entry of left anterior descending artery (LAD) to the distal end.

A coronary clearance frame count is measured by counting the angiographic image cine frames during a tail of radiocontrast column runs from the entry of LAD to the distal end.

Baseline angiography is performed without any stimulation and hyperemic angiography is performed after intracoronary injection of adenosine 300ug or nicorandiol 2mg.

Inclusion criteria

* Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography

Exclusion criteria

* ST elevation myocardial infarction
* Cardiogenic shock
* Congestive heart failure with pulmonary edema
* LVEF \< 30%
* Previous history of coronary revascularization
* Chronic total occlusion
* 3 vessel disease
* Target lesion at distal segments or branches

Eligibility Criteria:
Inclusion criteria

* Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography

Exclusion criteria

* ST elevation myocardial infarction
* Cardiogenic shock
* Congestive heart failure with pulmonary edema
* LVEF \< 30%
* Previous history of coronary revascularization
* Chronic total occlusion
* 3 vessel disease
* Target lesion at distal segments or branches
Premature Atherosclerosis in Systemic Lupus Erythematosus

Patients with SLE have increased rates of atherosclerosis, while the risk factors for atherosclerosis in those patients were not fully revealed. This study is an observational study to investigate the natural process and risk factors for atherosclerosis based on a Chinese SLE cohort. Carotid intima media thickness (CIMT) and brachial-ankle pulse wave velocity (baPWV) will be measured for each patient at baseline and 5-year follow-up. Blood tests including cholesterol levels, fasting plasma glucose levels and etc. will also be performed.

Accelerated atherosclerosis is a major complication of systemic lupus erythematosus (SLE), and it leads to increased cardiovascular morbidity and mortality in patients with SLE. Prevention and intervention of premature atherosclerosis is beneficial for prognosis and survival of patients with SLE.

The primary aim of this study was to investigate the natural progress of carotid intima media thickness (CIMT) in 5 years, and examine the risk factors for progression of CIMT and atherosclerotic plaques based on a Chinese SLE cohort. The secondary aims of the study were to investigate progression of brachial-ankle pulse wave velocity (baPWV), and to examine the risk factors for increasing baPWV in patients with SLE.

Based on sample size calculation, 440 patients who meet the eligibility criteria will be enrolled in this study. All patients will be enrolled from Peking Union Medical College Hospital. After informed consent is obtained, the patients will be comprehensively evaluated from demographic characteristics, medical history, clinical assessments, laboratory tests results, CIMT and baPWV at baseline and 5-year follow-up. Descriptive analysis, univariate analysis, and multivariate analysis will be used to analyze the correlation between potential risk factors and CIMT/baPWV.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* Fulfillment of clinical classification criteria of SLE (four or more 1997 American College of Rheumatology classification criteria)
* Provision of signed written informed consent

Exclusion Criteria:

* Clinically overt coronary artery disease
* A history of cardiovascular disease (previous stroke, heart failure, myocardial infarction, angina, or symptomatic PAD)
* Malignancy
* Pregnant/lactating women