cyrilzakka/clinical-trials huggingface dataset:
Auxiliary Anesthesia Technique for Extracting Advanced Hemodynamic Parameters Based on Peripheral Arterial Waveform Photography

In this study, the arterial blood pressure waveform was digitized by snapshots or videos of the patient monitor to further estimate advanced hemodynamic parameters, so as to realize continuous and automatic monitoring of advanced hemodynamics on mobile devices to assist anesthesia, with a view to developing an Android/iOS application for mobile devices and application in patient management.


Eligibility Criteria:
Inclusion Criteria:

* Invasive blood pressure monitoring
* Aged 18-65 years
* ASA class I-III

Exclusion Criteria:

* Spontaneous breathing
* Prone position
* Non-radial artery cannulation
* Aortic regurgitation
* Heart arrhythmia
* Heart rate \> 100/min
* Intra-aortic balloon pump
* Peripheral vascular disease
* Body weight \< 40 kg
Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice

The purpose of this study was to evaluate physical activity and its changes in participants with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.

This post-marketing observational study was conducted in a multi-country, multi-center and single-arm format. Data were collected prospectively. Adult participants with diagnosis of RA who were assigned for treatment with adalimumab (Humira®) were eligible for participation. During this period four follow-up visits were planned for observation of the participant and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).

Eligibility Criteria:
Inclusion Criteria:

* Had rheumatoid arthritis (RA) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines
* Had been started on adalimumab therapy no more than one (1) month prior to the study enrolment
* Had negative result of tuberculosis (TB) screening test or was receiving TB prophylaxis as per local guidelines
* Had provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion Criteria:

* Was unable to walk either due to RA or a comorbid condition
* Was unable to perform basic self-care activities
* Had contraindications for treatment with adalimumab
Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis

Peripheral facial palsy is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is performed to treat peripheral facial palsy because it increases blood flow and promotes nerve regeneration.Facial Nerve Block worked with elimination of local inflammation of nerve and oppression. Facial nerve block is a treatment that inject drugs into the damaged nerve around to eliminate local inflammation and compression of the nerve.


Eligibility Criteria:
Inclusion Criteria:

Diagnosed by clinical and neurological assessment as one-sided simple facial

* Age 18 to 75 years
* HBGS above Ⅳ
* the course of IFP not over 7 days.

Exclusion Criteria:

* Coagulation dysfunction
* plate plate plate shape, quantity or abnormal function
* mental system diseases
* Gillan-Bahrain syndrome
* cancer, mumps, shingles infection, jaw facial pus lymph nodeitis, encephalitis, -cerebral hemorrhage and other diseases
* local infection or systemic infectious disease at the puncture site
* can not accept to nerve block
CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) non-small cell lung cancer (NSCLC)
* No prior systemic therapy for NSCLC
* Male or female ≥ 18 years of age
* Anticipation of more than 3 months survival
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
* Adequate organ and bone marrow function

Exclusion Criteria:

* Anticipation of need for a major surgical procedure or radiation therapy during the study
* Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
* History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I congestive heart failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (COPD) or asthma)
* Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
* Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
* Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBs)- or hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)- positive and receiving antiretroviral therapy
* Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
* Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
* Treatment with thiazolidinediones (TZDs) within 4 weeks prior to start of study treatment
* History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
* Poorly-controlled blood pressure as judged by the Investigator
Photodynamic Therapy for Cholangiocarcinoma

Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.

Cholangiocarcinoma is a malignant tumor originating from the bile duct epithelium, accounting for about 70% of the malignant tumors of the bile duct system. Patients have no obvious clinical symptoms in the early stage. After late diagnosis, the effective treatment is surgical resection and \& or liver transplantation, and chemotherapy is only used as adjuvant or palliative treatment. Some types of cholangiocarcinomas, such as hilar cholangiocarcinomas, are difficult to achieve radical resection due to their anatomical location, early invasions and are prone to recurrence with a poor long-term efficacy after surgery. Therefore, the comprehensive treatment of cholangiocarcinoma by multiple means urgently needs to be explored. In recent years, photodynamic therapy (PDT), as a new local treatment method, has attracted increasing attention.

This study investigates the bile duct patency and effectiveness of photodynamic therapy compare with ordinary ERCP treatment for cholangiocarcinoma including the median survival, overall survival, and other indicators of side effects.

Eligibility Criteria:
Inclusion Criteria:

* ERCP cholangiocarcinoma（the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery）;

Exclusion Criteria:

* Proximal cholangiocarcinoma (Bismuth type Ⅲ-Ⅳ, or intra-hepatic cholangiocarcinoma);
* Patients with Karnofsky Performance Scale (KPS) score≤70；
* Expected survival≤3months；
* Patients with porphyria；
* Coagulation dysfunction (INR\> 1.5) and low peripheral blood platelet count(\<50×10\^9 / L) or using anti-coagulation drugs；
* Bilirubin could not be reduced to less than 100mmol/L within 1 month after drainage；
* Patients have intrahepatic metastasis or distant metastasis；
* Patients with no pathological diagnosis；
* known to allergic to study drug(porphyrin drugs) or other similar and related compounds；
* Other photosensitizers have been used within 4 weeks prior；
* Metal biliary stents were placed previously；
* Patients with contraindications to ERCP；
* Patients with HIV infection；
* Pregnant, parturient, or breastfeeding women；
* Patients complicated with other malignant tumors；
* Patients with severe liver function damage；
* Patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate PDT；
* Patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects；
* Patients with other contraindications for photodynamic therapy.
Short Course Radiation Therapy in Palliative Treatment of Abdominal Cancer

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic abdominal malignant lesions

Standard treatment for abdomen lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility Criteria:
Inclusion Criteria:

* symptomatic abdomen malignant lesions (primary solid tumor or metastases from solid tumor)
* age\>18 years
* ECOG performance status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region
The Vienna Prograf and Endothelial Progenitor Cell Extension Study

Conversion of renal transplant recipients from either tacrolimus or cyclosporin A to tacrolimus modified release to investigate the effects of the MDR1/CYP450 genotype on the trough blood levels of tacrolimus with modified galenic (tacrolimus MR4; Advagraf®).

The study concerns the conversion of immunosuppressive agents among participants in the clinical trial "The Vienna Prograf and Endothelial Progenitor Cell Study - The Vienna PEP Study" at the end of the study after 2 years in the extension study PEP-X.

The aim of the conversion is to investigate the effects of the multi-drug resistance (MDR1, gene symbol ABCB1) genotype on the trough blood levels of tacrolimus modified release (TAC MR4; Advagraf®). Analyzes of the effects of the genotype on the concentration/dose ratio (\[ng/mL\]/\[mg/d\]) will be carried out, as well as studies on existing polymorphisms in the MDR1 gene. The written informed consent to conversion of either tacrolimus (TAC; Prograf®) or cyclosporin A (CSA; Sandimmun Neoral®) to TAC MR4 will be obtained.

Upon completion of 24 months of study participation of the PEP-study, and consent to convert the immunosuppressant therapy of either TAC or CSA to TAC MR4, it will be used as indicated by the manufacturer. In patients treated with CSA, the initial dose will be 0.1-0.12 mg TAC MR4 per kg of body weight per day with oral morning administration. In patients who are already treated with TAC, the conversion to TAC MR4 will be performed in a 1:1 ratio.

The dosage data for the conversion of CSA to TAC MR4 are taken from the documents of the European Medicines Agency homepage (http://www.emea.europa.eu/index/ indexh1.htm, retrieved 26.09.2007), those on the safety and equivalence of the achieved areas under the curve (AUC) of both TAC formulations from Alloway et al. (Transplant Proc 2005; 37: 867-870).

The conversion will be performed by Univ. Prof. Dr. Gere Sunder-Plassmann, and Dr. Markus Riegersperger, respectively, both Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna. The desired trough level is set at 4.0-8.0ng/mL according to the usual clinical standards for long-term transplant patients at the investigators center. The trough level analyses are performed at the Medical University of Vienna, according to the following schedule: 1 week after conversion, 2 weeks after conversion, 4 weeks after conversion, 12 weeks and 12 months after conversion.

Eligibility Criteria:
Inclusion Criteria:

* Any stable long-term kidney transplant recipient who participated in the Vienna Prograf and Endothelial-Progenitor Study (Vienna PEP Study; EudraCT identifier 2004-82 004209-98)
* Written informed consent to have the immunosuppression converted from either cyclosporin A or tacrolimus to tacrolimus modified-release

Exclusion Criteria:

* Graft failure
* Contraindication to receive immunosuppression
Enhancing Medication-based Analgesia in Humans- STUDY 2

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.

This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75
* Urine sample tests negative for common illicit substances of abuse, including cannabis
* Medically cleared to take study medications
* Are not pregnant or breast feeding
* Willing to comply with the study protocol.

Exclusion Criteria:

* Meet DSM-5 criteria for alcohol/substance use disorder
* Taking opioids for pain
* Previous adverse reaction to a cannabinoid product
* Prescribed and taking stimulants or benzodiazepines
* Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
* Self-report any illicit drug or cannabinoid use in the past 7 days
* Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
* History of seizure disorder
* Have a known allergy to the study medications or sesame seed oil
* ALT or AST levels \>3x ULN and/or Bilirubin levels \>2x ULN during Screening
* Current (past 60-day) suicidal thoughts or past year history of suicidal behavior
* Taking medications contraindicated with hydromorphone or cannabidiol
* Have a history of clinically significant cardiac arrhythmias or vasopastic disease
* Have an abnormal and clinically-significant ECG
Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO17)

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products

The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity.

The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.


Eligibility Criteria:
Inclusion Criteria

1. Must have a health status of "healthy" assessed by the investigator and defined as no clinically significant deviation from normal medical history, physical examination, vital signs, and clinical laboratory determinations.
2. Must be male, Caucasian, between 18 and 55 years of age (inclusive) at the time of the screening.
3. Must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2 with a minimum weight of 110 pounds (50 kg) at screening.

Exclusion Criteria

1. A positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
2. A history of any drug allergy, hypersensitivity, or intolerance to acetaminophen, morphine, or capsaicin or to any of the excipients in the IV or oral formulations used.
3. A positive test result for drugs of abuse, alcohol, or cotinine.
4. Fitzpatrick Skin Type V or VI (based on a Skin Type score of greater than 30.
5. A history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
6. Any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.
Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity

The presented study is an experimental in-vitro study without intervention in-vivo. The effects of nitric oxide and prostacyclins, 5-hydroxymethylfurfural and alpha-ketoglutarate, volatile anaesthetics on haemoglobin oxygen (HbO2) affinity will be investigated in-vitro. Venous blood samples of 20 healthy young volunteers (10 female, 10 male) will be collected twice in the period of one week. Informed consent will be given. Every blood collection will be accompanied by a venous blood gas analysis. The blood samples will be transferred to the laboratory for in-vitro recording of the complete oxygen dissociation curve (ODC). A newly developed in-vitro method will be used. On the first study day the blood samples will be exposed to three different concentrations of nitric oxide during the measurement, followed by two different vapourized prostacyclins. In addition, different concentrations of 5-hydroxymethylfurfural and alpha-ketoglutarate will be given to the blood samples for ODC recording. On the second study day the dose dependent effects of three different volatile anaesthetics will be investigated by exposing the blood samples to these drug while the measurements. Following these ODC recordings, aliquots of the blood samples will be frozen and investigated for storage related changes in HbO2 affinity.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* ASA 1 (American Society of Anesthesiologists classification)

Exclusion Criteria:

* Any drug intake within 10 days prior to blood collection
* Smoking
* Haemoglobinopathy
* Acute inflammatory disease within 14 days prior to blood collection
* Pregnancy or breastfeeding
* Severe trauma or blood loss within 14 days prior to blood collection
* Participation in any other clinical study
* High altitude sojourn for several days (\> 3,000 m) within four weeks prior to blood collection
Genetic Diagnosis in Inborn Errors of Metabolism

Inborn Errors of metabolism comprise a large number of rare conditions with a collective incidence of around 1/2000 newborns. Many disorders are treatable provided that a correct diagnosis can be established in time, and for many diseases novel therapies are being developed. Without treatment, many of the conditions result in early death or severe irreversible handicaps.

The Centre for Inherited Metabolic Diseases, CMMS at Karolinska university hospital, is an integrated expert center where clinical specialists work closely together with experts in laboratory medicine, combining clinical genetics, clinical chemistry, pediatrics, neurology, and endocrinology. The center serves the whole Swedish population with diagnostics and expert advice on IEM and has a broad arsenal of biochemical investigations designed to detect defects in intermediary metabolism.

Approximately one in two thousand infants is born with a metabolic disorder that often leads to brain damage. By means of high-tech genetic mapping using whole genome sequencing (WGS), we have discovered the molecular foundations for several of these diseases.

For investigation of mitochondrial diseases, mitochondria are isolated from muscle biopsies for analysis of ATP production using a range of substrate combinations, determination of activities of respiratory chain complexes, and analysis of nuclear and mitochondrial DNA.

The center also performs the national neonatal screening program, currently comprising 26 treatable diseases. Dried blood spot samples (DBS) are stored in the phenylketonuria (PKU) biobank, currently (2024 january) holding around 4.9 million of Sweden's 10.6 million inhabitants.

Many metabolic disorders, however, lack effective counter-measures.

Eligibility Criteria:
Inclusion Criteria:

* Medical inferral, suspicion metabolic disease incl epilepsy and their relatives

Exclusion Criteria:

* Disease other than metabolic