cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device

Many post-operative complications arise from patients who breathe inadequately. Inadequate respiration, whether the result of surgery or the anesthesia, causes a decrease in blood oxygen saturation and an increase in carbon dioxide partial pressure. Both of these surrogate measurements of respiration may pose a challenge to measure. Some administer exogenous oxygen to all patients as they leave the operating room in order to maintain the blood oxygen saturation. This renders the oximeter a less sensitive metric of depressed respiration. In the face of decreased respiration, the carbon dioxide levels continue to increase slowly and often go undetected unless blood gases are measured. Indeed carbon dioxide blood levels are the only metric to detect inadequate ventilation using this surrogate index.

Monitoring ventilation is a serious challenge outside of critical care settings. In fact, there are no monitors available that can measure tidal volume or relative tidal volume outside of these settings.

Linshom is a novel instrument that tracks relative respiration by measuring the excursions of the temperature swings between inspiration and expiration and normalizing them to the patient's breathing. This monitor may be the first non-invasive monitor to measure relative tidal volume in non-critical care settings.

The purpose of this study is to determine whether a non-invasive, temperature-based respiratory instrument can track tidal volume (Vt) in patients.

The investigators hypothesize that the Linshom device can accurately and consistently track tidal volume as measured by closed loop mechanical ventilator.

Forty volunteers will be enrolled in this open label, prospective study to determine the correlation between the tidal volumes measured with the Linshom detector and those measured with the mechanical ventilator. after Institutional Review Board (IRB) approval and written informed consent from the volunteers.

The Linshom detector, which is comprised of two rapid responding medical-grade thermistors in close proximity to the mouth/nose (sensor) and a thermistor remote to the airway, will be mounted in the continuous positive airway pressure (CPAP) face mask to measure the temperature during breathing. The CPAP will be connected to a Servo-I ventilator (Maquet) with a circuit and disposable filter. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card. The temperature profiles from the sensors and the relative tidal volume will be correlated with the tidal volumes measured by the ventilator.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* pregnant
* suffer from claustrophobia
* had recent respiratory illness
* had recent gastrointestinal illness
* unable to provide informed consent
Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels

The aim of study was to assess the efficiency and safety of oral IL-1βinhibitor in combination with urate lowering therapy on joint pain intensity,urate control, global assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers and symptoms improving related life quantity in gouty patients.

This was a randomized single-dose, open-label and active-controlled study which was carried out in 96 primary gout patients. Subjects and doctors have no access to randomization sequence which is determined by the primary investigator.All patients received an open-label febuxostat 40mg daily during the whole study. Healthy control were 32 age-matched men from volunteers in the medical health center.Two primary end points included pain intensity measurement which was recorded at each visit and subsequently acute flare times which was recorded at home and reported to investigator.

Eligibility Criteria:
Inclusion Criteria:

All participants who were allocated to the study all had a history of taking tolerable and adequate dose of urate lowering therapy including febuxostat 40-80mg daily or allopurinol 200-300 mg daily for at least 4 weeks and were defined as difficult to treat or refractory gout patients. All patients had a negative of rheumatoid factor and antinuclear antibody, Hb\>100g/L, total leukocyte count≥3.5×109, PLT≥80×109, serum creatinine\<133umol/L, transaminases\<60U/L and fasting urate≥6.0mg/dL.

Inclusion criteria for the gouty patients were age≥18 years old, BMI(18-30kg/m2). All participants enrolled in our study fulfilled American College of Rheumatology criteria for primary gout.

Exclusion Criteria:

Exclusion criteria included secondary gout (because it is always associated with some underlying renal disease), a history of congestive heart failure, serum creatinine≥133umol/L (because the patients have underlying risks if NSAID needed) or the use of glucocorticoid\>15mg daily,colchicine, uricosuric drugs, chemotherapy or immunosuppressive therapy in the past three months.
Prospective Validation of an Acute Pulmonary Embolism Severity and Prognosis Prediction Model

The purpose of this study is to prospectively validate the first PUMCH model for acute PE severity and prognosis prediction based on multi-center data constructed in the pre-project period based on national population data, and to optimize the PUMCH model based on artificial intelligence clustering algorithm.

Patients with pulmonary embolism and aged 18 years or older were enrolled in this study.Patient demographic characteristics(age, sex, department, diagnosis), basic vital signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope, laboratory examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT,CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were prospectively collected. Patients were followed up every 1/3/6 months to obtain survival outcomes.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA) containing any of the following conditions.

  1. primary acute PTE combined with or without DVT
  2. recurrent acute PTE with a history of previous PTE or DVT
* signed informed consent form

Exclusion Criteria:

* blinded to any diagnostic or therapeutic test (VTE or other conditions)
* unable to complete follow-up (due to cognitive or behavioral limitations, etc.)
ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography

The primary objective of the ASA-3C trial is to evaluate the role of aspirin and high-intensity statin therapy, respectively, in individuals with severe coronary calcification (coronary calcium score ≥400) to prevent atherosclerotic cardiovascular disease (ASCVD) events with severe coronary calcification (CAC ≥400).


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be aged between 40 and 70 years.
2. Patients who have coronary artery calcium score ≥400 Agatston Unit on coronary calcium computed tomography.
3. Patients who have 1 or more CVD risk factors in below;

   * dyslipidemia or,
   * diabetes or,
   * hypertension or,
   * family history of CVD or,
   * smoking
4. Patients agree to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Patients who are symptomatic.
2. Patients who have documented clinical ASCVD: previous myocardial infarction, acute coronary syndrome, stable angina, coronary revascularization and other arterial revascularization procedures, stroke and Transient ischaemic attack, \>50% carotid stenosis or previous carotid endarterectomy or stenting, aortic aneurysm and peripheral artery disease.
3. Patients who have evidence of myocardial ischemia on non-invasive stress test including stress single photon emission CT myocardial perfusion imaging (SPECT MPI), cardiovascular magnetic resonance (CMR) imaging, stress echocardiography, or treadmill test, or on invasive stress test including Fractional flow reserve (FFR) \< 0.80 on invasive coronary angiography (diameter stenosis\>50% without objective evidence of ischemia could be enrolled).
4. Patients at high risk of bleeding: gastrointestinal hemorrhage or peptic ulcer within the previous 6 months; active hepatic disease such as cirrhosis or active hepatitis; use of warfarin, or other anticoagulant therapy; or has a history of aspirin allergy.
5. Patients with atrial fibrillation.
6. History of allergy or severe adverse reaction to aspirin or statin
7. History of myositis or myopathy with active disease in the 180 days prior to study entry.
8. Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
9. Concurrent medical condition with a life expectancy of less than 1 years
10. Pregnant and/or lactating women
11. Patient was unable to provide written informed consent or participate in log-term follow up.
Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions

The proposed research will focus on the development of a brief emotion-coaching (EC) parenting program (which directly targets child emotion awareness/recognition and affective empathy), that will be combined with a well-established parent management training program (Helping the Noncompliant Child; HNC) for treating oppositional defiant disorder (ODD) in children who also have limited prosocial emotions (e.g., lack of guilt and empathy, callous use of others).


Eligibility Criteria:
Inclusion Criteria:

* Child with oppositional defiant disorder and low prosocial emotions

Exclusion Criteria:

* Unable to speak/understand English
* Significant developmental delay or autism spectrum disorder
Tuberculosis (TB) Immunotherapy Phase 2 Study

This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
* TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
* TB score status at baseline.
* Agreement to participate in the study and to give a sample of blood for lab testing.
* Readily available home or other address where patient can be found.

Exclusion Criteria:

* Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
* Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
* Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes

This study aims to look at the impact on patient outcomes arising from measures implemented during the COVID-19 pandemic. The information and knowledge from this study will be useful for the management and allocation of hospital resources and patients in tne event of a disease outbreak.


Eligibility Criteria:
Inclusion Criteria:

* This study involves the extraction of patient records from the enterprise dataware house. As such, we do not stipulate the age limits.
* Patients who had the following surgeries during over the period of 1 Jan 2017 to 31 December 2020
* From the identified surgical procedure type or the following cancer-related procedures:

  1. Breast
  2. Colon
  3. Liver
  4. Rectum
* Selected non-cancer surgeries:

  1. Abdominal Wall
  2. Gallbladder
* Patients from SGH and its related institute NCC
* Only local Singapore Citizens

Exclusion Criteria:

* No exclusion criteria
The Power of Self-efficacy-based Interventions in Fostering Caring Self-efficacy and Overcoming Job-related Stress and Perceived Stigma Among Psychiatric Nurses

People with high self-efficacy set goals to challenge and improve their task achievement rate; however, people with low self-efficacy tend to have fluctuation in their ways of thinking, which results in dampened spirits. Self-efficacy affects mental health. Therefore, psychiatric nurses' achievements that affect their self-efficacy may differ from those of general workers or other nurses. In such a situation, psychiatric nurses feel that uncertainty of care and an unmotivated appearance of the patient can lead to reduced self-efficacy. Consequently, nurses are likely to give up active involvement with patients who will not be leaving the hospital.

The intervention aims at increasing self-efficacy and consists of Cognitive Behavioural Therapy (CBT)-based exercises related to sources of self-efficacy beliefs: 1) mastery experiences, 2) vicarious experiences, 3) verbal persuasions, and 4) emotional and physiological states.

Eligibility Criteria:
Inclusion Criteria:

* Only psychiatric nurses.
* Still working at the time of data collection
* Willing to participate in the study
The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome

The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome.

Fifty-three, fibromyalgia syndrome participants were randomized to receive either: 1) probiotic 4×1010 CFUs per day 2) 10 g dose prebiotic (inulin) per day or 3) placebo for 8 wk. Fibromyalgia Impact Questionnaire (FIQ), Visual Analogical Pain Scale (VAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburg Sleep Quality Index (PSQI) and quality of life (SF-36) were measured during the baseline, 4 weeks and 8 weeks intervention phases. Finally, the adverse effects will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20-65 years.
2. Signature of informed consent by the patient.
3. Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
4. Participants should be diagnosed with fibromyalgia at least 1 year ago.

Exclusion Criteria:

1. using of antibiotic and nutritional supplements
2. being pregnant or breastfeeding
3. the presence of any allergies
4. being involved in any medical or psychological research
5. the presence of severe gastrointestinal diseases
6. psychiatric illness other than depression and anxiety.
Bile Acids As Determinants of Postprandial Metabolism

This study aims to understand how bile acids (BAs) appear in the bloodstream after eating and how this might affect inflammation and metabolism. To do this, we will measure changes in BA levels in 100 healthy women after they eat a high-fat and high-carbohydrate meal. Blood samples (a small amount of 500 µL) will be collected from a finger prick at 7 time points over 5 hours. In the second part of the study, 40 women will be invited back-20 with the highest and 20 with the lowest increases in BAs. These participants will eat the same test meal, and blood samples will be taken from a vein to study markers of health, metabolism, inflammation, and the gut microbiome. By exploring how BAs work in the body, this study hopes to find new ways to understand and prevent chronic diseases.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 70 years
* Body mass index (BMI) between 18.5 and 34.9 kg/m²

Exclusion Criteria:

* Pregnant women
* History of bariatric surgery and/or intestinal resection
* Inflammatory bowel disease
* Celiac disease
* Liver disease
* Type 2 diabetes mellitus
* Casein allergy
* Alcohol consumption \>30 g/day
* Use of antimicrobial therapy within the past two months

Note: The use of dietary supplements was not considered an exclusion factor. The use of medication for the treatment of chronic diseases was evaluated on a case-by-case basis and did not constitute, a priori, an exclusion factor.
Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation

Patients with lumbar disc herniation suffer from pain and morbidity. Surgical intervention can be a quick and effective relief, however some individuals experience less favorable outcome.

This study tries to investigate and test the differences in pain perception and pain modulation between individuals. Using PET/CT scans the investigators try to visualize pain perception and -modulation in the CNS. This is subsequently correlated with a battery of pain tests and the surgical outcome of disc herniation surgery.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Clinical and radiological indication for LDH surgery, assessed by an experienced spinal surgeon
* Age 40-65 years
* Able to comply with regulations regarding medicine consumption (stated below)

Exclusion Criteria:

* History of previous spine surgery
* General contra-indication for spine surgery
* Greatly reduced kidney function
* Diagnosis of psychiatric disorder
* Current malignant disease
* History of radiation therapy
* Current chemotherapy
* History of spinal fracture
* Hematologic disease
* Current pregnancy or breast-feeding
* Chronic, generalized connective tissue disorders or chronic, non-specific pain disorders (fibromyalgia, whiplash (WAD I-V), etc.)
Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia

Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics.

Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have PANSS negative≥21 and PANSS positive\<24. Patients will be recruited from both academic and private research centers.

Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.

Concurrent Control: The study group will receive active rTMS treatment and the control group will receive an inactive, sham treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
2. Right hand dominant.
3. Scores in PANSS negative questionnaire above 21.
4. Gave informed consent for participation in the study.
5. Negative answers on safety screening questionnaire for transcranial magnetic stimulation
6. stable on the same antipsychotic medication for at least two months prior to entering the study.
7. Negative answers to all questions in the TMS safety questionnaire (attached ).

Exclusion Criteria:

1. Diagnosed as suffering from another axis 1 disorder .
2. Scores in PANSS positive questionnaire above 24.
3. History of epilepsy, seizure, or hot spasm.
4. History of epilepsy within first-degree relatives.
5. History of head injuries.
6. History of metal in the head (outside the mouth space).
7. History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
8. History of migraines.
9. History of hearing loss (not due to aging) or cochlear implants.
10. History of drug or alcohol abuse during the last year.
11. Women - Pregnancy or not using a reliable method of birth control.
12. Inability to achieve satisfying level of communication with the subject.
13. suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
14. Custodians.
15. Participation in another medical study during the experiment.
Fatty Acid Quality and Overweight (FO-study)

The purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals.


Eligibility Criteria:
Inclusion Criteria:

* no use of medication, healthy, 27\<BMI\<40

Exclusion Criteria:

* pregnant and lactating women, chronic diseases.
Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease

The aim of this study is to evaluate the effect of a 3-month walking program on brain energy metabolism in patient with mild Alzheimer's disease (AD). Two groups of sedentary patients with mild AD are followed and compared over a 3-month period of time: Control (non-active) and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks) groups. All the participants are evaluated on their cognition, brain volumes (MRI) and brain fuel consumption (PET scan with 18-FDG and 11C-AcAc) at the beginning and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild Alzheimer's disease (NINCDS-ADRDA criteria)
* Taking cholinesterase inhibitors
* Sedentary
* Ability to do physical exercise

Exclusion Criteria:

* Parkinson disease
* Down syndrome
* Epilepsy or concussion
* Drug or alcohol abuse
* Past psychiatric history
* Vitamin B12 Deficiency
* Uncontrolled diabetes or thyroid function
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.
2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory cytokines. Presence of these abnormalities would make patients with ulcerative proctitis and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* No any systemic diseases;
* no proctitis or proctosigmoiditis;
* no history of gastrointestinal surgery;
* no symptoms of diarrhea or fecal urgency during the past 2 weeks;
* not taking any medications except contraceptives during the past 2 weeks;
* age 18-65.

Exclusion Criteria:

* None.