cyrilzakka/clinical-trials huggingface dataset:
Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following Dexmedetomidine administration in patients with septic shock.

Prospective randomized double blinded study. Investigators planned to enroll 60 cases diagnosed with septic shock All patients will be sedated with Midazolam and remifentanyl in accordance with a local unit protocol.

After a period of six hours of hemodynamic stability, patients were randomized to receive either continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl (DEX group) or a continuous infusion of a Midazolam and remifentanyl (MDZ Group).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Septic shock requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65mm Hg despite appropriate volume resuscitation (fluid challenge of 20 mL/kg-40 mL/kg)
* Septic shock criteria were defined according to the new Sepsis-3 definition

Exclusion Criteria:

* pregnancy
* uncontrolled hemorrhage
* terminal heart failure
* significant valvular heart disease
* documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve
* refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment)
* 2nd and 3rd degree of AV-block ,the onset of septic shock more than 24 h before enrollment ,
* APACHE II \> 30 at enrollment
* Severe liver cirrhosis (Child B or C)
* New onset of myocardial infarction within 30 days or heart failure (NYHA 4)
* attending other trial in ICU within one month
* allergic history to dexmedetomidine
Precise Transvaginal Tape Placement Trial

This purpose of this study is to study is to see if intra-operative urethral length measurement with the Foley catheter will improve the placement of a synthetic sling in the mid-urethra.

This study will assess the effect of intraoperative measurement of the urethral length with the Foley catheter in optimization of sling placement in the mid female urethra. Of note, the Foley catheter is well-tolerated, placed routinely during surgery to drain the bladder and has no complications associated with it. Women who have chosen to undergo trans-vaginal tape sling (TVT) for stress urinary incontinence will be asked to enroll in this randomized trial by the study team during their clinic visit. Randomization will be performed by the FPMRS study nurse coordinator after a woman has given her informed consent and meets the study criteria. Twenty women will be randomized to undergo measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made and twenty women will have our usual pre-operative assessment (which does not include intraoperative measurement of the urethral length with the Foley catheter) for the treatment of symptomatic stress urinary incontinence All women participating in the study will receive an intra-operative 3-D trans-vaginal ultrasound (BK Flex Focus ultrasound with the 8838 transvaginal probe). The image will be stored and reviewed for; urethral length, urethral sphincter complex length and width. All women in the study will have an ultrasound at the end of their surgical procedure and a follow-up ultrasound at 2 weeks post operatively to assess for sling migration. Of note, transvaginal ultrasound is well-tolerated and has no complications associated with it. All ultrasound measurements will be done by a four qualified surgeons, Dr. Elizabeth Mueller Dr. Ahmed Akl, Dr. Tanaka Dune, and Dr. Susanne Taege who have been trained on ultrasound measurements. In addition, women will complete questionnaires assessing their pelvic floor symptoms pre-operatively and at 2 week following surgery. Instruments used will be the Pelvic Floor Disorders Inventory (PFDI), Medical Epidemiologic and Social Aging (MESA) and the Patient Global Impression of Improvement (PGII) \[11, 12\].

Eligibility Criteria:
Inclusion Criteria:

* Candidates for TVT
* \>=18 years of age to participate

Exclusion Criteria:

* Inability to give informed consent
* Previous SUI(stress urinary incontinence) treatment including TVT, Burch or urethral bulking agents
* Previous bladder, urethral malignancies or vaginal/pelvic radiation treatment.
* Pregnant women cannot participate
Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD (Colour COPD)

The primary objective of this study is to determine if a sputum colour chart can aid patient self-management of COPD exacerbations, such that use of the chart is non-inferior to usual care with respect to hospital admissions. There are also a range of other secondary objectives as detailed in the secondary outcomes section. An integral pilot phase, economic evaluation and process evaluation are also included.

This study is a pragmatic, individually randomized trial, set in primary care, comparing usual care to the use of a sputum colour chart in patients at risk of hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD), with the hypothesis that use of a colour chart will be non-inferior to usual care with respect to hospital admission rate after 12 months of follow-up, this being the primary outcome measure. Use of a chart might reduce antibiotic use, and thus might also change patterns of antibiotic resistance long term, such that these are important secondary outcomes. There is an internal pilot phase, a detailed process evaluation and a cost-effectiveness study.

The trial protocol also includes three sub-studies: 1) using a daily electronic symptom diary capable of picking up symptom defined (but potentially unreported) AECOPD, since these are an important prognostic marker (section 3); 2) collecting sputum samples from patients to assess patterns of antibiotic resistance and 3) a qualitative study which will include staff (for example, healthcare staff delivering the intervention) and patients.

This trial uses a sputum colour chart as part of a self-management intervention that enables patients with COPD to determine whether they have an exacerbation, and whether this requires antibiotic treatment. The 5 point sputum colour chart, adapted from Bronkotest® is being used.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed COPD, confirmed by a medical record of post-bronchodilator spirometry denoting obstruction.
* ≥2 AECOPD in the 12 months prior to screening according to the patient or ≥1 hospital admission for AECOPD (i.e. Global Initiative for Chronic Obstructive Lung Disease- GOLD; C or D).
* Able to safely use SM plan in the view of their usual care practitioner
* Able to use sputum colour chart; this will be confirmed by a sight test if there is any doubt on initial assessment by the usual care or research team. Patients who report being colour blind will have their ability to use the chart tested at the screening visit.
* Written Informed consent given

Additionally, to participate in the E-diary sub-study. - Access to smartphone/tablet and an email address.

Additionally, to participate in the Sputum sub-study.

- Chronic bronchitis, defined by self-reported sputum production for at least 3 months in each of 2 consecutive years or more.

Exclusion Criteria:

* Household member already participating in the study.
Body Composition: a Predictor of Mortality in Subjects Over 65 Years

The purpose of this study is to evaluate whether body composition is associated with a higher risk of mortality in subjects ≥ 65 years.

Study centre: University Hospitals of Geneva Study type: retrospective study Study duration (anticipated): 1 year for collection of data(1.10.2011-1.12.2012)and 3 months for statistical analysis and writing, leading to the completion of the study by march 2013 Study hypothesis: A low fat-free mass (FFM) and a high fat mass (FM) are associated with a higher risk of mortality in subjects ≥ 65 years.

Aims: The primary objective is to evaluate the relationship between body composition and mortality in men and women ≥ 65 years, while taking into account co-morbidities. The secondary objectives are to compare this relationship a) with the relationship of body mass index (BMI) and mortality, b) with the relationship of body composition changes and mortality, c) between healthy subjects and subgroups of patients with chronic diseases Methods: Included are all subjects who had a measurement of body composition by bioelectrical impedance analyses, performed in the HUG from 1990 until december 2011. Excluded are subjects living abroad. Body composition measurements will be retrieved from DPI and 4D which preceded the use of DPI in nutrition and is presently only used for research. Diseases and specific laboratory values at time of body composition measurement will be retrieved simultaneously. Mortality will be retrieved from the population registers for death.

Statistics: The relationship between body composition and mortality, in the total population and subgroups of patients with chronic diseases, will be evaluated by Cox regression, adjusted for age, gender and co-morbidities. The variance of mortality (adjusted R2) related to FFM will be compared to that related to BMI and FFM loss.

Eligibility Criteria:
Inclusion Criteria:

* All subjects ≥ 65 years included in previous studies on body composition by bioelectrical impedance analysis performed in the Nutrition Unit since 1990 until December 2011.
* All patients ≥ 65 years who had a measurement of body composition by bioelectrical impedance analysis performed in clinical routine by the Nutrition Unit and the dietitians of the University Hospital of Geneva since 1990 until December 2011, while hospitalized or not.

Exclusion Criteria:

* Subjects living in another country than Switzerland at time of body composition measurement
Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes

The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

The aim of this phase III study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patients with type 2 diabetes who were not adequately controlled for blood glucose by the combination of D150 and D745 25mg .

Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of actual drug as an oral hypoglycemic agent.

Eligibility Criteria:
Inclusion Criteria:

* Between 19 years and 75 years old(male or female)
* Type Ⅱ diabetes mellitus
* The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
* Body Mass Index between 21kg/㎡ and 40kg/㎡
* C-peptide \> 1.0 ng/ml
* Agreement with written informed consent
* HbA1c 7 to 10% after Run-in period

Exclusion Criteria:

* Type I diabetes or secondary diabetes
* Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
* Treatment with Thiazolidinedione within 3months or patient who has experience such as hypersensitivity reaction, serious adverse event with Thiazolidinedione(TZD), sodium glucose cotransporter 2(SGLT2) inhibitor, Biguanide.
* Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
* Treatment with anti-obesity drugs within 3months
* Past history: lactic acidosis, genetic problem such as galactose intolerance, etc.
* Acute or chronic metabolic acidosis including diabetic ketoacidosis
* History of proliferative diabetic retinopathy
* Patient with severe infection, severe injury
* Patients with urinary tract infection including urinary tract sepsis and pyelonephritis
* Malnutrition, weakness, starvation, hyposthenia, pituitary insufficiency or adrenal insufficiency
* History of malignant tumor within 5years
* Drug abuse or history of alcoholism
* Severe pulmonary dysfunction
* Severe GI disorder
* History of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage or unstable angina within 6 months
* Abnormal lab result: ① Fasting Plasma Glucose \> 270 mg/dl ② Triglyceride ≥ 500 mg/dl ③ Significant liver dysfunction or AST(Aspartate transaminase)/ALT(Alanine transaminase) ≥ normal range\*3 or Total bilirubin ≥ normal range\*2 ④ Hemoglobin\<10.5g/dL ⑤ Abnormality of thyroid function(significantly out of normal TSH(Thyroid Stimulating Hormone) range)
* eGFR(Estimated glomerular filtration rate) is less than 60ml/min/1.73m\^2
* Pregnant women or nursing mothers
* Fertile women who not practice contraception with appropriate methods
* Participated in other trial within 4 weeks or participating in other trial at present
* In investigator's judgment
ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia

This study aims to be a randomized, controlled study of ANI-guided opioid administration versus standard clinical practice in surgical patients undergoing general anesthesia with balanced sevoflurane-fentanyl. Patients will be randomly assigned to 2 groups- ANI vs. standard care. The intraoperative and postoperative management of all patients will be standardized by protocol. The PACU nurses and postop assessor will be blinded as to which group the patient is in.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* ASA 1-2
* BMI 19-35 kg/m2
* Patients undergoing surgery with general anesthesia with sevoflurane- fentanyl
* Planned abdominal or spinal surgery lasting 1-3 hours
* Willing and able to consent in English or Spanish
* No current history of advanced pulmonary or cardiovascular disease

Exclusion Criteria:

* Age less than 18 or older than 75
* Patient does not speak English or Spanish
* Patient refusal
* Monitored anesthesia care (MAC) or regional anesthesia planned
* Pregnant or nursing women
* "Stat" (emergent) cases
* ECG rhythm other than regular sinus rhythm
* Implanted pacemakers
* On antimuscarinic agents, alpha 2 agonists, antiarrhythmics, or beta blockers
* Presence of pacemaker
* Autonomic nervous system disorder
* Use of chronic opioids
Intrawound Administration of Vancomycin in THA

The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18;
2. Total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head.

Exclusion Criteria:

1. Diminished mental capacity
2. Vancomycin allergy
3. Chronic kidney disease stage III and stage IV
Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE).

Systemic lupus erythematosus (SLE) is a chronic, multisystem, disabling autoimmune condition, which predominantly affects women of childbearing years. Treatment options for SLE remain relatively limited. Regardless of the specific therapy chosen, the majority of patients continue to require long term immunomodulatory or cytotoxic therapy, resulting in long-term morbidity and mortality. Brentuximab vedotin is an antibody-drug conjugate (ADC) consisting of: 1) the chimeric immunoglobulin (Ig) G1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10. Since CD30 and/or CD30-expressing immune cells may play significant key roles in the pathogenesis of SLE, brentuximab vedotin may be an efficacious therapy. This study intends to explore the potential for brentuximab vedotin as a therapy for SLE.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* Diagnosis of SLE for at least 6 months prior to screening
* Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening
* Must have failed a treatment for SLE after a trial of at least 3 months

Exclusion Criteria:

* The subject has any serious health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study
* Subject has had recent serious or ongoing infection, or risk for serious infection
* Subject has a history of new or recurrent malignancy within the past 5 years
* The subject is pregnant and/or breastfeeding
* The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study
* The subject has urgent, severe SLE disease activity, which, in the opinion of the Investigator, warrants immediate immunosuppressive therapy and would not be appropriate for the study
Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)

The purpose of this study is to investigate the effect of bioptron light therapy on pregnancy related carpal tunnel syndrome

Carpal tunnel syndrome (CTS) is a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized by hand pain, numbness, and tingling in the distribution of the median nerve (thumb, index, middle finger, and the radial side of the ring finger) and a reduction in grip strength and hand function. The severity of symptoms can be clinically categorized into mild, moderate, and severe Bioptron phototherapy acts as a "sterile" trigger on human in vitro isolated peripheral blood mononuclear cells (PBMCs), affecting their cytokine production and driving the immune response towards an anti-inflammatory/reparative profile and representing a non-pharmaceutical and non-invasive option for several clinical conditionsA randomized control study, the women will be randomly assigned into two groups, (31 women for each group) equal in number. Group (A) will include 31 women will receive Bioptron light combined with advice and patient education (10 minutes per session, 3 sessions per week, for 4 weeks). Group (B) will be receiving advice only for same duration as group (A)

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females clinically daignosed with carpal tunnel syndrome at least 1 month
* age will range from (25-35) years.
* body mass index (BMI) will be (BMI ≤ 35 kg/m2)

Exclusion Criteria:

* history of neurologic disease
* hand surgery
* hand trauma,
* diabetes mellitus
* cervical spondylosis
* osteoarthritis of cervical spine and wrist joint
* chronic renal failure
* heart failure
* connective tissue disorders
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following schedules:

at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Note that no new subjects will be recruited in this extension phase studies.

The expected total enrolment for the primary studies was as follows:

rota-028: 5700 rota-029: 3018 rota-030: 1102

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 12 weeks of age in Hong Kong and Taiwan or 11 to 17 weeks of age in Singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules.
* Written informed consent obtained from the parent or guardian of the subject, prior any study procedure.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Child is unlikely to remain in the study area for the duration of the study
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins is allowed.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
* First or second degree of consanguinity of parents.
Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Lung Cancer

Among all cancers, lung cancer is the most common disease on the planet, accounting for 13% of the cases, and leading the number of deaths from malignant diseases. In Brazil, it is estimated that its incidence between 2018 and 2019 could be 18,704 new cases in men and 12,503,000 new cases in women. These data take into account an estimated risk of 18.16 new cases for 100,000 men and 11.81 for 100,000 women, respectively occupying the second and fourth most frequent cases of the disease according to gender .

Surgeries, however aggressive they may be, are one of the most viable alternatives for patients with PC, provided it is performed in the milder or early phase of the disease, since after such period this procedure may have a period degree greater than the other forms of treatment.

As a consequence, the injuries that the surgical procedure can cause to patients, pain is one of the most influential in the patient's quality of life. It can lead the individual to a marked state of disability both functional and psychological, thus being determinant for the suffering related to the disease, thus comprising its multifactorial character, involving physical, emotional, socio-cultural and environmental aspects .

For the control of pain, physiotherapy appears with features such as transcutaneous nerve electrostimulation, where its use for the suppression of pain has become quite feasible due mainly to the ease of its handling, to be noninvasive and to serve to reduce acute pain and chronic.

The use of conventional transcutaneous nerve electrostimulation to support the use of analgesics reduced the intensity of pain in patients of the second day of thoracotomy, but for a longer extension of their effects, it would take a longer time to apply the resource, something around 24 -48 hours.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Primary Lung Cancer; male over 18 years and less than 59 years old, in an immediate postoperative period in the ward of the Hospital thoracic clinic.
* Evaluation of pain through the visual analogue scale equal to or greater than moderate or intense.
* Percentage equal to or greater than 70% in all the items assessed by the Performance Status functional capacity scale.

Exclusion Criteria:

* Patients with immediate postoperative complications
* Unconscious or sedation patients
* Patients with invasive mechanical ventilation
* Patients who present lesions that make it difficult to handle and place electrodes.
* Patients who use pacemakers and metal plates.