cyrilzakka/clinical-trials huggingface dataset:
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* The patient is male or female 18 to 65 years of age, inclusive.
* The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
* The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.

Exclusion Criteria:

- History of or evidence for a diagnosis of borderline personality disorder (BPD).
Incidence and Outcome of Reintubation in the PACU

This study evaluated the occurrence of reintubation after planned extubation (RAP), the impact of RAP on duration of PACU stay,length of stay,length of postoperative stay,inpatient healthcare costs, unanticipated ICU admission and readmission.

The study was carried out in Wuhan City, China at a general public university hospital with 62 clinical departments, 99 surgical rooms, and 38 beds in the PACU. The total number of operations performed in this hospital is more than 90,000/year. The study was approved by the hospital ethics committee and was deemed that written patient consent was not required. The adverse events, including RAP, in all patients in the PACU were recorded on a standardized form in a database by pre-trained qualified nurses and/or anesthesiologists at the time of care from January 1, 2017 to December 31, 2019.

Data, including patient demographic and surgical and anesthesia parameters, were obtained from the anesthesia information system. Adverse events management and duration of PACU stay were also documented. For three years, all collected data were filed in a computer every day and were summarized and analyzed every month. Data, such as demographics, airway, oxygen saturation, consciousness, treatment, vital signs, and fast-track criteria scores, were recorded for all patients in the PACU. The first part contained preoperative and intraoperative data, which were entered into the database by the anesthesiologists involved in the patients' intraoperative care from the time of PACU admission. The second part were recorded by nurse and comprised postoperative data from the PACU to the ward or ICU. The third part were recorded by the surgeons and/ or surgical nurses and comprised postoperative data. The criteria for tracheal extubation in the operating room(OR) and the timing of transfer to the PACU were the responsibility of the anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring stay in PACU

Exclusion Criteria:

* Patients were transferred directly from the operating room to the ward or icu
* non-postoperative patient
Prediction of Outcomes Following Total Knee Replacement

This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. You may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. The last visit will be about 1 year after surgery. You may be eligible if you are 50 or older, will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or older
* Meet the American College of Rheumatology criteria for knee osteoarthritis
* Scheduled to undergo total knee arthroplasty
* Facility with the English language that is adequate to complete study procedures

Exclusion Criteria:

* Cognitive impairment preventing completion of study assessment procedures
* Myocardial infarction within the past 12 months
* Severe raynaud's or severe neuropathy
* Active vasculitis or severe peripheral vascular disease
* Current infection
* Use of oral steroids
* Recent history of substance abuse or dependence
* Confirmed diagnosis of periodic limb movement disorder or restless legs syndrome
* Systemic inflammatory or autoimmune disorders such as rheumatoid arthritis, lupus, etc.
* Known anemia
V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infant per investigator, 6 through 12 weeks of age

Exclusion Criteria:

* History of congenital abdominal disorders, intussusception, or abdominal surgery
* Known or suspected impairment of immunological function
* Known hypersensitivity to any component of the rotavirus vaccine
* Prior administration of any rotavirus vaccine
* Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa
* Any infant born from a known HBsAg-positive mother
* Prior administration of any oral polio vaccine
* Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study
* Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization
* History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
* Clinical evidence of active gastrointestinal illness
* Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination
* Infants residing in a household with an immunocompromised person
* Prior receipt of a blood transfusion or blood products
* Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study
* Any infant who cannot be adequately followed for safety by a contact visit
* History of seizure disorders or prior history followed for safety by a contact visit
* Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 to \< 65 years of age
* Rheumatoid Arthritis (RA) of \> 6 months duration at baseline (American College of Rheumatology criteria)
* Willing to receive immunization with pneumococcal polysaccharide and tetanus toxoid adsorbed vaccines
* Previous immunization with pneumococcal polysaccharide must have occurred ≥ 3 years of baseline, with tetanus containing vaccine ≥ 5 years
* Methotrexate therapy for at least 8 weeks prior to baseline at stable dose of 7.5-25 mg/week (oral or parenteral)
* Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline
* Oral corticosteroids must be at stable dose of \< 10 mg/day prednisone or equivalent
* Body weight ≤ 150 kg at screening

Exclusion Criteria:

* Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 8 weeks after baseline
* History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA
* Pre-existing central nervous system demyelinating or seizure disorders
* Active current or history of recurrent bacterial, viral fungal, mycobacterial and other infections
* Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to baseline or oral antibiotics within 2 weeks prior to baseline
* Active tuberculosis requiring treatment within 3 years prior to baseline
* Primary or secondary immunodeficiency (history or currently active)
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the Chinese Population

This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.

This is a prospective, multi-center, open-label, randomized, controlled, non-inferiority clinical trial designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter compared to PIVC in the Chinese population in order to support the product's registration in China.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age;
2. Inpatient with a need for intravenous infusion for an expected period of more than 4 days but no more than 28 days;
3. The veins in the upper limbs is suitable for puncture and catheterization of both the investigational device and the control device;
4. Willing to provide written Informed Consent and complete the study per the protocol.

Exclusion Criteria:

1. Coagulation disorder or active bleeding;
2. Skin injury, infection, or dermatosis at the site to be punctured;
3. History of radiotherapy, thrombosis, or vascular surgery; arteriovenous fistula or phlebitis history at the area and/or vein to be catheterized;
4. History of mental illness;
5. End stage renal disease requires vein protection;
6. Conditions with decreased venous flow in the extremity, such as lymphedema of the arm, etc.;
7. Infusions of vesicant or irritant drugs, hyperosmotic infusate (the osmotic pressure \>900mOsm/L in this study), parenteral nutrition, etc., which are not suitable for peripheral intravenous infusion (If other appropriate venous access is established for the aforementioned infusates, the patient may be enrolled).
8. The evaluation of the upper limb veins is Grade II, the evaluation grade is as following:

   * 0 Veins are obviously bulged on the skin surface. The veins are touchable, thick, straight, soft, elastic and fixed.
   * I Veins are relatively full and faintly touchable. The veins are less elastic or slide easily.
   * II Veins are not full or collapsed and untouchable. The veins are hard or sliding. Phlebitis.
9. Self-reported being pregnant or lactating;
10. Other conditions that the investigator considers improper for the study;
11. Participating in another study or already enrolled.
Effect of an Extract of Green Tea on Adults With Type 2 Diabetes

The objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.

Background: Recent evidence suggests that tea from Camellia Senensis (e.g., green, oolong and black tea) may have a hypoglycemic effect.

Objective: We evaluated the ability of an extract of green and black tea to improve glucose control over a three month period using a double blinded randomized multiple dose (either placebo, 375mg or 750mg) study in adults in with Type 2 Diabetes.

Patients: The 49 subjects who completed this study were predominantly whites with an average age of 65, a median duration of Diabetes of 6 years, and 80% reported using hypoglycemic medication.

Measurements: HbA1c at three months was the primary endpoint. Results: After three months the mean changes in HbA1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms, respectively. The changes were not significantly different between study arms.

Limitations: Evaluation of a particular extract that contained components of black teas as well as green tea. Power insufficient to detect changes in HbA1c \< 0.5.

Conclusions: We did not find a hypoglycemic effect of extract of green tea in adults with Type 2 Diabetes, but cannot rule out the possibility that tea may have a small beneficial effect.

Eligibility Criteria:
Inclusion Criteria:

* Adults with Diabetes not taking insulin

Exclusion Criteria:

* pregnancy, warfarin therapy
Temporal and Kinematic Analysis of Timed Up and Go Test in Chronic Low Back Pain Patients

Kinematic and temporal analysis of the movement helps researchers and clinicians to better understand the way humans move and interact within the environment in which they live, better describe the alterations coming from impairments, and finally allow to better tailor interventions for patients. In this perspective, motion analysis has become, in the last 30 years, a remarkable and important field of research. Even if movement assessment should be a cornerstone for definition and modulation of rehabilitation interventions, there are still few motion analysis devices that are able to influence the clinical decision process; motion analysis labs are among those, but their use is unfortunately limited due to the costs of instruments and analysis. Other small unobtrusive wearable devices, easier to use and cost-effective, have been developed, like Inertial measurement units (IMU), composed by accelerometers and gyroscopes. They could therefore represent an incentive for a more widespread use of motion analysis within daily clinical activity in Rehabilitaion.

Timed Up and Go Test (TUG) is a simple, widely used, functional test which involves standing up from a chair, walking three meters, turning, and going back to sit. It is used to evaluate movement, mobility, dynamic and static balance in people with musculoskeletal impairment, neurological diseases, aging related conditions, and the quality of life in people with low back pain. The only and easy outcome considered is the time to completion. Nevertheless, the application of an IMU to a subject performing TUG can provide other objective, quantitative data, like temporal and kinematic parameters of the whole test and its sub-phases. The instrumented TUG (iTUG) has already been applied, mainly in the neurorehabilitation field, in particular for Parkinson's disease and for post-stroke impairments.

cLBP is one of the most burdensome health problem worldwide. cLBP has been considered a bio-psycho-social disease, characterized by pain in the lumbar region, functional impairments, and condition-related disability. Despite the obvious motor problems affecting people with cLBP, to the best of our knowledge, chronic low back pain (cLBP) has not yet been explored using iTUG.

The aim of study is to analyse temporal and kinematic parameters of cLBP subjects compared to BMI and age-matched healthy subjects, through iTUG and to explore the correlations of those parameters with pain and disability.


Eligibility Criteria:
Inclusion Criteria (for Chronic Low Back Pain population):

* Pain from at least 3 months
* Numerical Pain Rating Scale (NPRS) ≥ 4

Exclusion Criteria (for Chronic Low Back Pain population):

* History of neurological impairment or disease,
* Other orthopaedic impairment within the past 6 months or surgery in the previous 6 months.
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction

The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin.

The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.


Eligibility Criteria:
Inclusion Criteria:

* 15 - 65 years of age
* In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery
* Undergoing primary unilateral ACL reconstruction using an allograft (patellar tendon bone, Achilles tendon, tibialis tendon, or hamstring)
* Able to participate in the study rehabilitation protocol
* and other inclusion criteria

Exclusion Criteria:

* No allergies to any of the individual ingredients in OMS103HP
* No medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
* No associated knee injuries likely to interfere with evaluation of the study drug
* and other exclusion criteria
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.

OBJECTIVES: I. Determine the feasibility and toxicity of using allogeneic peripheral blood stem cell transplantation after intensive, but non-myeloablative chemotherapy with fludarabine/cyclophosphamide in patients with advanced chronic lymphocytic leukemia. II. Determine the engraftment kinetics and degree of chimerism available with this strategy.

OUTLINE: This is a nonrandomized, dose-seeking study. Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest. Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days, with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined. Three days after intensive chemotherapy, allogeneic stem cells are infused. Responding patients who do not experience worse than grade 1 acute graft-vs.-host disease receive additional stem cell infusions after 60 and 120 days. Patients are followed monthly for 4 months, at 6 and 12 months, then yearly for 5 years.

PROJECTED ACCRUAL: Up to 25 patients will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Advanced chronic lymphocytic leukemia (Rai stage 3 or 4) with at least one of the following high-risk factors: Beta-2 microglobulin 3 or greater Abnormalities of chromosome 17 Other cytogenetic abnormalities Refractory to fludarabine-based chemotherapy or failure to achieve complete remission after 6 courses of a fludarabine-based regimen HLA-identical sibling donor willing and able to undergo apheresis for harvest of G-CSF-stimulated peripheral blood stem cells

PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1 Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease Other: No active uncontrolled infection

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Wearable Sensors and Machine Learning for the Assessment of Biomechanical Risk in Lifting Tasks

Lifting loads can cause work-related musculoskeletal disorders. The National Institute for Occupational Safety and Health (NIOSH) established a methodology for assessing lifting actions by means of a quantitative method based on intensity, duration, frequency, and other geometrical characteristics of lifting. Body-worn inertial sensor technology provides a number of opportunities to advance the safety and health of workers engaged in physical work. Motion-tracking systems together with Machine learning (ML) algorithms are used in the ergonomic field for biomechanical risk assessment by means of data acquired by wearable inertial systems. The investigators posed the question whether it is possible to classify lifting tasks belonging to different risk classes according to the value of LI using a machine learning approach by means of features extracted from raw signals. Aim of this study was to develop and validate, through ML algorithms, a non-invasive detection system of kinetic-kinematic parameters using IMU and EMG sensors, for the ergonomic assessment of the risk associated with a load lifting activity.

The study envisages the voluntary enrollment of healthy subjects, referring to treatment clinics for work-related pathologies (excluding subjects aged \<18 or \> 65 years, and those with musculoskeletal pathologies or other disabling pathologies in progress), to carry out two repeated lifting tests. The two tests are set up to correspond respectively to the two NIOSH risk classes (LI\<1, NO RISK; and LI\>1, RISK). The IMU sensors provide wirelessly a series of data from which it is intended to extract a number of features (feature extraction) that have a high predictive power, through the digital signal processing technique using dedicated software (i.e. Matlab, SPSS). In a second step, data obtained from EMG sensors will be added to the analysis. Among the different artificial intelligence algorithms, the investigator will look for those most able to discriminate the various risk classes on the basis of the parameters extracted from the signals detected during the motor task.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* subjects with musculoskeletal pathologies or other disabling pathologies in progress
The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus

A randomized single-blind study with the use of different lancing devices equipped with personal lancets to determine and to compare the amount of capillary blood volume and perceived pain after a single lancing of the fingertip.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the informed consent.
* Must currently be diagnosed with either Type I or Type II diabetes mellitus.
* Otherwise in good physical and mental health.
* Must currently be performing self-monitoring of blood glucose (self reported).
* Must be between 18-75 years of age (inclusive).
* Ability to read and follow study instructions.

Exclusion Criteria:

* Pregnancy (self reported).
* Severe poor blood circulation in the fingers.
* Any skin condition on his or her fingers that prevents blood sampling.
* History of a bleeding disorder.
* Neuropathy or other condition affecting sensation in the hands.
* Self-reported blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
* Currently participating in another study.
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse.
* Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study.
* Any prescription or OTC medication within two days of starting the study which might affect pain perception (for example, ibuprofen or paracetamol).
* Alcohol 48 hours before study start.