cyrilzakka/clinical-trials huggingface dataset:
Effect of C1-esterase Inhibitor on Systemic Inflammation in Trauma Patients With a Femur or Pelvic Fracture

Trauma and major operation are associated with an excessive inflammation reaction due to tissue injury. This overwhelming immune response is considered to be a major risk factor in the pathogenesis of late inflammatory complications such as acute respiratory distress syndrome (ARDS), multiple organ dysfunction syndrome (MODS) and sepsis.

The investigators hypothesize that administration of C1-esterase inhibitor (C1-INH) will attenuate the humane inflammatory response and, thereby, reduce the risk of inflammatory complications due to surgical interventions in trauma patients with a femur or pelvic fracture

Systemic inflammation in response to a femur or pelvic fracture and fixation is associated with complications, such as acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The injury itself, but also the additional fixation procedure give a release of pro-inflammatory cytokines, in particular interleukin (IL)-6. This results in an aggravation of the initial systemic inflammatory response, and will cause in some patients an increased risk on the development of inflammatory complications, like ARDS and MODS. Which can lead to higher morbidity, mortality and prolonged hospital stay.

Various strategies, such as damage control orthopedics, have been proposed to prevent these complications. Another strategy is to decrease the inflammatory reaction caused by the surgical procedure, and by interventions focused on inhibition of the innate inflammatory response. This will lower the risk of complications.

A promising candidate is the endogenously produced serum protein C1-esterase inhibitor (C1-INH). This protein is an acute phase protein, produced by the liver in response to inflammatory conditions. C1-INH is a major inactivator of the complement system, but important additional anti-inflammatory properties have been demonstrated. A previous study of from our laboratory showed that administration of the drug C1-INH significantly reduced the concentration of circulating pro-inflammatory cytokines such as IL-6, during human experimental endotoxemia. Treatment with C1-INH has been proven to be safe in treatment with humans, even in high dosages and in pregnant patients with C1-INH deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Multi trauma patients
* Femur or pelvic fracture
* Injury Severity Score (ISS) ≥ 18
* Age 18-80 yrs

Exclusion Criteria:

* Congenital C1-inhibitor deficiency
* Use of immune suppressants
* Pregnancy
* Known hypersensitivity for blood products
* Fixation of femur fracture with external fixation or osteosynthesis
Ketamine in Severe Traumatic Brain Injury

Traumatic brain injury (TBI) accounts for approximately 2.5 million visits to emergency departments in the United States each year. After decades of research, management strategies for severe TBI (sTBI) patients are still evolving. Optimizing intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are paramount in the management of these patients and placement of these monitors is the current standard-of-care. However, monitoring brain oxygenation (PbtO2) with invasive intraparenchymal monitors is currently under investigation in the management of severe TBI and placement of these monitors is gaining widespread use. This has opened the door for the use of tiered therapy to optimize ICP and PbtO2 simultaneously. Current evidence indicates that correction of ICP, CPP and PbtO2 in sTBI requires optimized analgesia and sedation. Ketamine is one of the few drugs available that has both sedative and analgesic properties and does not commonly compromise respiratory drive like opioids and sedative-hypnotics. However, traditionally, ketamine has been viewed as contraindicated in the setting of TBI due to concerns for elevation in ICP. Yet, new data has cast this long-held assumption into significant doubt. Hence the present pilot study will characterize the neurophysiological response to a single dose of ketamine in critically-ill TBI patient with ICP and PbtO2 monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Severe traumatic brain injury
* Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation
* Age greater than or equal to 18 years

Exclusion Criteria:

* Documented allergy to ketamine
* Sinus tachycardia with sustained heart rate \>120
* Any episode of non-sinus tachycardia
* Documented history of schizophrenia
* Systolic blood pressure \> 180, diastolic blood pressure \> 120
* Documented episode(s) of ICP elevations \>25 mm Hg sustained greater than 5 minutes within 24 hours
* Similar episodes as above of PbtO2 \<15 mmHg
* Positive pregnancy test and/or is currently breast-feeding
Study of Patient Use and Perception of the Travatan Dosing Aid

The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.

Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):

1. Fully functional Travatan compliance monitor
2. Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
3. Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.

At end of study, patients fill out questionnaire assessing

1. Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
2. patient's belief as to whether their compliance was monitored or not

Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.

The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.

Eligibility Criteria:
Inclusion Criteria:

* Open angle glaucoma or ocular hypertension
* Presently using Travatan eye drops

Exclusion Criteria:

* Allergy to prostaglandin
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies

This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies


Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 18 years of age at screening (16 years of age for C3G), able to provide written informed consent, and able to understand and comply with all scheduled procedures and other requirements of the study by the opinion of Principal Investigator (PI)
* Patients must have a diagnosis of IgAN, LN, Primary MN, or C3G confirmed by renal biopsy and required measurements performed prior to study participation

  * IgAN: Prior biopsy results for C3 and C4d staining should be made available
  * LN: Diagnostic biopsy showing proliferative focal, diffuse, or membranous lesions (Class III, IV or V, respectively) by renal biopsy. Subject should have either a biopsy in the last 6 months, or evidence of disease activity (nephritic changes on urinalysis or nephrotic changes)
  * Primary MN: PLA2R positive titer plus nephrotic range proteinuria (defined as uPCR \>2350 mg/g)
  * C3G plus one of the following: Low serum C3 level or historical renal biopsy within the last 3 years
* Have proteinuria \>750 mg/g (calculated by uPCR on 24 hour urine collection) collected during the first screening visit (Visit 3a).
* eGFR≥30mL/min/1.73 m2 calculated by CKD-EPI creatinine equation at screening visit 3a and currently not on dialysis
* Must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the PI, for at least 2 months prior to the first dose of APL-2 (Visit 4); treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives and/or anti-proteinurics.
* Willing to receive vaccinations against Neisseria meningitidis at least 2 weeks prior to dosing on Day 1 with a booster on Day 56 (for both vaccinations) and Pneumococcal and Hib vaccines at least 2 weeks prior to dosing on Day 1.

Exclusion Criteria:

* Absolute neutrophil count \<1000 cells/mm3 at screening Visits 3a and 3b
* ALT or AST \>3.0 x the upper limit of normal at screening Visits 3a and 3b
* Previous treatment with APL-2
* History of solid organ transplant
* Diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening Visits 3a and 3b (previous HBV or HCV diagnosis cleared by treatment is allowed)
* Renal disease secondary to another condition (e.g. infection, malignancy, monoclonal gammopathy, or a medication)
* Presence or suspicion of active bacterial or viral infection or severe recurrent bacterial infections
* Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period
* Unwillingness to receive or intolerant of SC infusions of study medication or known allergy to ingredients in APL-2.
Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage

Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.

Stroke is a major cause of death and disability. According to the Ministry of Health and Welfare in Taiwan, stroke accounted for 6.8% of all deaths and was the 4th leading cause of death in Taiwan in 2020. Stroke can be divided into acute, subacute, and chronic stages, and the initial severity of stroke affects recovery from sequelae. Therefore, how to effectively improve the sequelae and accelerate the recovery of patients through early interventions is an important issue. This study aimed to investigate the effect of early acupuncture treatment in the acute stage of hemorrhagic stroke. Subjects will be divided into two main groups by random assignment. The intervention group will be treated with traditional acupuncture, while the control group will be treated with pseudo-acupuncture(superficial acupuncture). The treatment frequency was 3 times a week for at least one week. Consciousness, neurological status and disability status were assessed before treatment, at the end of the first week, the second week and the third week, and biomarker were examined before and after treatment

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemorrhagic stroke by a specialist
* Age over 20 years and below 85 years
* GCS between 5-13

Exclusion Criteria:

* Intracranial hemorrhage resulted from vascular anomalies
* Pregnant patients
* Intracranial tumor related hemorrhage
* Other diseases that can cause neurological deficits, such as old cerebrovascular disease, poliomyelitis, cerebral palsy, spinal cord injury
* Organ damage or terminal illness (heart or kidney failure or malignancy)
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with functioning graft who had completed the 6-month treatment period of core study
* Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study
* Patients who signed the informed consent of the present study extension

Exclusion Criteria:

- Women who were pregnant, lactating or who wished to became pregnant.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Follicular Volume at the Time of Final Oocyte Maturation in Poor Responders, and Its Correlation With Oocyte Maturity

Women with a severely diminished ovarian reserve and monofollicular growth are at a higher risk of premature ovulation as well as poor quality oocytes. Our group showed previously that women with severely diminished ovarian reserve benefit from receiving the final oocyte maturation at smaller follicle sizes in terms of reducing the risk of premature ovulation and finding mature oocytes even out of small size follicles.

Adding the measurement of the follicular volume at the time of final oocyte maturation might provide more information on the proper timing of trigger administration compared to the follicular size alone, hormonal profile as well as previous stimulation attempts. Setting a cutoff value of follicular volume for trigger might help to avoid premature ovulation and possibly increase the chances of ending up with a euploid embryo.


Eligibility Criteria:
Inclusion Criteria:

* Reproductive age group: 18 -48
* undergoing ovarian stimulation for oocyte vetrification
* undergoing IVF/ ICSI with PGT-A / PGT-M / PGT- Sr
* less than or equal to 3 AFC on initiation of stimulation
* follicular phase stimulation

Exclusion Criteria:

* surgically retrieved sperm
Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes

RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary.

PURPOSE: This clinical trial is comparing a skin conduction device with a hot flash diary as a way of measuring hot flashes in postmenopausal women with hot flashes.

OBJECTIVES:

* Correlate hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary in postmenopausal women with hot flashes.
* Determine the comfort, obtrusiveness, and feasibility of using the skin conductance recording tool for measuring hot flashes when worn daily for five weeks in these patients.

OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 5 weeks.

Patients complete hot flash diaries once daily for 5 weeks. Patients also complete the Comfort, Bother, and Weight Questionnaire at the end of week 5.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of bothersome hot flashes, defined by their occurrence of ≥ 4 times/day

  * Daily hot flashes have been present for ≥ 1 month

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal
* ECOG performance status 0-1
* No history of allergic or other adverse reactions to adhesives
* No other medical condition known to cause sweating and/or flushing
* Willing to record hot flashes in a hot flash diary daily for 5 weeks
* Willing to wear a skin conductance device 24 hours a day for 5 weeks
* No implanted pacemakers or metal implants
* No reliance on other electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors)

PRIOR CONCURRENT THERAPY:

* Not specified
BMS-646256 in Obese and Overweight Type 2 Diabetics

This is a placebo-controlled, randomized, double-blind, parallel arm, multicenter, dose-ranging phase IIb trial to assess glycemic and weight loss efficacy and safety of BMS-646256 in overweight and obese patients with type 2 diabetes who have been treated with diet and exercise only or with half-maximal or greater metformin (≥1500mg/day) or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c \>7% and HbA1c\<10%).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 years and BMI ≥27 with type 2 diabetes who have been treated with diet and exercise only or with half maximal or greater metformin or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c \>7% and HbA1c\<10%).

Exclusion Criteria:

* Pregnancy
* Anti-diabetic medications other than baseline metformin or sulfonylurea monotherapy
* History of myocardial infarction in the prior six months/ History of heart failure defined as New York Heart Association Functional Class I, II, III or IV/ History of symptomatic arrhythmia
* Active hepatic disease/ Any documented muscle disease
* History of multiple sclerosis/ Baseline history of tremors, ataxia, anxiety or dizziness
* Seizures within the last year, stroke, and transient ischemic attack/ Known history of schizophrenia, dementia, or bipolar disorder as defined by DSM IV criteria.
* Currently depressed subjects or a CES-D score greater or equal to 16 at the screening visit or at baseline (Day 1)/ History of suicide attempt or ideation
* Previous history of surgical procedures for weight loss (e.g. stomach stapling, bypass)/ Weight loss greater than 5 kg in the prior 3 months
Non-invasive Diagnosis of Cold Urticaria

The investigators subjected 63 patients (39 with typical Cold urticaria and 24 with atypical Cold urticaria ) and 15 healthy controls to TempTest® cold stimulation tests and critical temperature threshold assessments. Blood microcirculation photoplethysmography measurements were performed 5 min before and 10 min after the ice cube on the volar forearm.


Eligibility Criteria:
Inclusion Criteria:

* Cold urticaria

Exclusion Criteria:

-
Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation

The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).

This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.

Eligibility Criteria:
Inclusion Criteria:

* age from 18 years;
* non-smokers;
* have good general health;
* present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.

Exclusion Criteria:

* • positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;

  * positive history of allergies at using Triclosan;
  * pregnant or lactating patients;
  * patients in use of fixed orthodontic appliance.
Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica

The aims of the study are:

To study the pain efficacy of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.

To study the efficacy on function of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 50 years old.
* Diagnosis of sciatica

Exclusion Criteria:

* Pregnancy.
* Fear of needles.
* Coagulation disorders.
Intervention Study of Mind-Body Physical Activity in Frail Institutionalized Elderly

Few previous studies have explored the effects of mind body approaches on health-related quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while functioning. A new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled "cognition-action." The investigators aimed to explore the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized elderly.

The investigators' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve HRQoL.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and older
* Institutionalized
* Ability to get up alone or with technical or human help if necessary and ability to understand basic motor commands
* Have given a signed consent

Exclusion Criteria:

* Terminally ill and bedridden patients
* Unable or unwilling to sign the consent
* Have participated in a study in the past 3 month
European Myeloma Network (EMN) Sample Project

This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.

This study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples


Eligibility Criteria:
Inclusion Criteria:

* Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+/- EMD), plasma cell leukemia (PCL) (+/- EMD)
* Subjects are ≥ 18 years old.
* Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures.

  1. Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and
  2. subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.

Exclusion Criteria:

* Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care).
* Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events.
* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule.