cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine Sedation in Orthopedic Surgery

60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery

Exclusion Criteria:

Patient denial, contraindication of spinal anesthesia or any of the agents used in the protocol, BMI above 30, Serious psychiatric, mental and cognitive disorders, Language barrier, illicit substances abuse,
Very Brief Smoking Reduction Intervention

A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years old;
2. Smoked more than 10 cigarettes per day in the past month.
3. Have no intent to smoking cessation now.
4. Agreed to participate in the follow-up, offer telephone number and signed an informed consent form.

Exclusion Criteria:

1. Smoked less than 10 cigarettes per day in the past month.
2. Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible.
3. Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably).
4. Pregnant females.
Evaluation of CPD MNV as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)

The investigators hypothesize that CPD parameters will provide improved prediction of sepsis compared to currently employed laboratory parameters. These studies hold the potential to shape practitioner guidelines and improve the timeliness and accuracy with which patients with sepsis are treated today.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 to 90 years)
* Patients presenting to the Emergency Department
* CBC (Complete Blood Count) with differential testing performed and CPD data retrieved

Exclusion Criteria:

* Previously enrolled in this study
Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD

The purpose of this study was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD).

Objective: To examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD).

Method: Eighteen adolescents with ADHD were randomized to treatment or control intervention for seven weeks. Outcome measures were cognitive test, symptom and motivation questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. a clinical diagnosis of hyperkinetic disorder (F90.0, corresponding to ADHD combined type) (WHO, 1993);
2. age between 14-17 years;
3. IQ \> 80.

Exclusion Criteria:

1. pharmacological treatment other than methylphenidate, dexamphetamine and/or atomoxetine;
2. comorbid conduct disorder, autism spectrum disorders or major depression;
3. history of head trauma or verified neurological disease;
4. motor or perceptual disabilities which prevented the use of a computer;
5. medical illness that required treatment;
6. no access to a computer and internet at home.
Stress Management and Resiliency Training for Physicians

This study is to evaluate the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.

Burnout is a serious problem in healthcare, resulting in absenteeism, decreased job satisfaction, decreased empathy, anxiety, depression, increased medical errors and decreased patient satisfaction. A growing number of studies have demonstrated that programs incorporating mind-body practices increase resilience in healthcare providers and can reduce burnout and perceived stress while increasing empathy. The Benson-Henry Institute for Mind Body Medicine (BHI) has developed a clinical program for patients known as the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP or SMART Program for short). This study is to evaluate the effect of the SMART-3RP on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Physicians and academic faculty of Brigham and Women's Hospital and Newton-Wellesley Hospital

Exclusion Criteria:

* None
Cardiotoxicity in the Elderly

CARTIER (Cardiotoxicity in the elderly) is a prospective cohort study of newly diagnosed elderly cancer patients equal or greater than 65 years of age conduced in one tertiary center (Hospital Universitario de Salamanca at Spain. The study is academically funded in its integrity by The Instituto de Salud Carlos III (Spanish Ministry of Science, Innovation and Universities). The investigators of the study are the only responsible for the study design, data collection, and data interpretation. All study participants provide written informed consent. All enrolled patients will undergo serial surveys, 6-minutes walking test (6MWT), electrocardiogram, echocardiogram, blood samples, CMR, physical examinations and multidisciplinary clinical evaluations; before each chemotherapy cycle and at 3, 6, 9 and 12 months, 3 years and 5 years after finalization of chemotherapy, except for MRI that will be performed before 1st, 3rd, 5th cycles and at 3, 6, 9,12 months, 3 years and 5 years after chemotherapy ending

Surveys completion and examinations will be obtained at the same day: within 72 hours before each cycle of treatment or at 3, 6, 9, 12 months, 3 years and 5 years' follow-up after ending the whole antitumoral course of treatment. A fully dedicated research nurse will play a vital role in ensuring that the study run smoothly and that all participants will be safe and fully informed. Questionnaires completion and quality of life assessment will initially be performed followed by the 6MWT. Participants blood pressure measurement, electrocardiogram and echocardiogram will be then taken \>30 minutes after finishing the walking test. Blood sample extraction will be performed after echocardiography to finalize with cardiac magnetic resonance. A complete medical history, physical examination and evaluation of these examinations for each participant will be performed by a cardiologist at the cardio-oncology unit, where prevention and treatment protocols for cardiotoxicity will be applied and discussed in a multidisciplinary way with referral oncologists and hematologists before every cycle of treatment and after course of antitumoral ending follow-up.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed cancer initiating antisudoral treatment
* capability to sign the informed consent
* capability to realize 6 minutes walking test

Exclusion Criteria:

* previous chemotherapy
* contraindications to undergo cardiac magnetic resonance (CMR)
* enrollment in onco-hematologist current clinical-trials
* clinical situation making difficult the realization of the proposed examinations or the course of chemotherapy.
The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in NPC Patients

To evaluate the efficacy of sodium fluoride to preventing radiation caries for patients with nasopharyngeal carcinoma receiving radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* a. Patients with histologically confirmed non-keratinizing NPC (including differentiated type and undifferentiated type, world health organization \[WHO\] II or III).

  b. Original clinical staged as II-IVa (according to the 8th AJCC edition) c. Male or female who are not pregnant. d. No evidence of distant metastasis (M0). e. Age between 18-60 years. f. WBC≥4×109/L, PLT≥100×109/L, HGB≥90g/L. g. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.

  i. With normal renal function test (creatinine clearance rate≥60 ml/min or creatinine\< 1.5×ULN.

  j. The Eastern Cooperative Oncology Group (ECOG) Performance status less or equal to 1.

  k. Patients must be informed of the investigational nature of this study and give written informed consent.

  l. Patients receive nasopharyngeal and neck radiotherapy. m. After pre-radiotherapy oral examination, no less than 2 functional teeth in any 1/6 segment of the mouth.

Exclusion Criteria:

* a. With clinical stage of I and IVb (according to the 8 th AJCC edition). b. Patients with tumor recurrence or distant metastasis. c. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

  d. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).

  e. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. f. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).

  g. Fewer than 2 functional teeth in any 1/6 segment of the mouth after pre-radiotherapy scaling.

  h. Lesions of infection in the oral cavity at baseline, severe gingivitis (gingival index = 3, i.e., severe inflammation of the gums, marked redness, swelling or ulceration of the gums, and a tendency to bleed automatically).

  i. Age \< 18 or age \> 60. j. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and mental disturbance.
Exploring the Effects of Muse and Spire on Stress Management

The goal of this study is to evaluate the effectiveness of Spire and Muse on stress management. The study will be implemented as a 2-arm randomized controlled pilot study to assess the effect of either device on stress management from the end of baseline to closeout.

Both Muse and Spire are recent technologies that could improve our understanding of stress management and enhance quality of healthcare. The goal of this study is to evaluate if Spire and Muse help individuals self-manage stress. Spire has been designed as a discrete clip-on tracker that monitors changes in respiration rate. With the companion app, this device displays breathing rates in real time and alerts the user through push notification in times of tension. Studies show that controlled breathing reduces stress. On the other hand, Muse is a headset device that uses EEG (electroencephalogram) sensors that measures electric brain frequencies. Muse guides the user in a form of simplified meditation by giving feedback in real time (i.e. calm, neutral, active) and audio clues to improve concentration. Previous studies have shown that engaging in meditation has the potential to reduce anxiety and stress.

Eligibility Criteria:
Inclusion Criteria:

* Registered for Partners HealthCare Connected Health Symposium 2016
* Over 18 years old
* Able to read and speak English
* Own a smartphone and have internet connection
* Willing to wear a Spire device during all hours (except sleep)
* Willing to use the Muse device (Group 2 ONLY)
* Willing to participate in a research study and sign the consent form

Exclusion Criteria:

* Not Registered for Partners HealthCare Connected Health Symposium 2016
* Under 18 years old
* Not able to read and speak English
* Do not own a smartphone and have internet connection
* Not willing to wear a Spire device during all hours (except sleep)
* Not willing to use the Muse device (Group 2 ONLY)
* Not willing to sign the consent form
Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)

Efficacy:

To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.

Major structural bone parameters which determine bone strength and predict fracture risk earlier and more precisely are measurable in vivo by 3DpQCT.

Safety:

To assess the tolerability and safety of ibandronate therapy


Eligibility Criteria:
Inclusion Criteria:

* Age between 60 and 75 years
* Menopause \> 5 years
* Spine (L1 - L4) or hip BMD ≤ -2.0 and \> -3.5 SD T-score measured by DXA
* Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration
* Written informed consent
* 3DpQCT measurable at both skeletal sites, distal tibia and radius

Exclusion Criteria:

* Spine or hip BMD ≤ -3,5 SD T-Score measured by DXA
* Vertebral fractures
* Multiple (\>2) low trauma peripheral fractures
* Disease/disorder known to influence bone metabolism
* History of major upper gastro-intestinal (GI) disease
* Diagnosed malignant disease within the previous 10 years
* Previous treatment with a bisphoshonate at any time
* Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration)
* Treatment with PTH and similar agents or strontium ranelate at any time
* Treatment with other drugs affecting bone metabolism within the last 6 months
* Chronic systemic corticosteroid treatment
* Estrogens, progestins, SERMs, anabolic steroids, active vitamin D analogues/metabolites, calcitonin
* Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
* Total serum calcium \< 2.2 mmol/l or \> 2.6 mmol/l
* Vitamin D deficiency (serum 25-hydroxy vitamin D \< 12 ng/ ml)
* ALT above triple upper limit of normal range
* Renal impairment (serum creatinine \> 210 µmol/l)
* Contra-indications for ibandronate, calcium or vitamin D
* Employees of the Centre for Muscle and Bone Research, or their relatives
Immunological Consequences of Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in recognition and awareness. OSA is associated with the development of hypertension and other cardiovascular diseases (1,2). OSA has pathophysiologic characteristics that are known to negatively impact immune function. Both sleep deprivation and hypoxia, hallmarks of OSA, impair immune responses (6,8,11). In addition, patients with OSA are frequently obese and obesity may be associated with increased chance of infections and immune impairment (14,15). Adipose cells are known to secrete cytokines and hormones that are involved in the immune response such as leptin, tumor necrosis factor alpha and interleukin-6 (16-19). Thus, it seems very likely that OSA may impact antigen-specific immune responses. Although it is known that characteristics of OSA impact immune function, it is not known what effects clinical OSA has on immunity.

The central hypothesis of this application is that that patients with obstructive sleep apnea will have attenuated cell-mediated and humoral immune responses to influenza vaccine compared to matched control subjects. Our hypothesis has been formulated on the basis that patients with OSA are sleep deprived and experience repeated hypoxemia that negatively impact both humoral and cell-mediated immune responses.


Eligibility Criteria:
Inclusion Criteria:

* Absence of any immunocompromising diseases or medical conditions
* Not taking any immune modifying medications or supplements
* Significant obstructive sleep apnea as verified by complete overnight polysomnography with apnea-hypopnea index (AHI) \> 15 events per hour (sleep apnea subjects)
* Free of sleep disordered breathing verified by complete overnight polysomnography (AHI \< 5 events per hour) or oximetry (\< 5 desaturations per hour) (control subjects)

Exclusion Criteria:

* Documented history of allergy to influenza vaccine or any of its components
Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation

This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21
2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
3. Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
4. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
5. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
6. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
7. Medically stable
8. ≥ 10° finger extension
9. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of

   ≥1 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
10. Skin intact on hemiparetic arm, hand and scalp
11. While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
12. No significant visual or hearing impairment

Exclusion Criteria:

1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis).
2. Uncontrolled seizure disorder
3. Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
4. Cardiac pacemaker or other implanted electronic device and/or stent
5. Pregnant
6. Intramuscular botox injections in any upper extremity muscle in the last 3 months
7. Insensate arm, forearm, or hand
8. Severely impaired cognition and communication
9. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
10. Severe shoulder or hand pain (unable to position hand in the workspace without pain)
11. Metal implant in the head
Care Managers for Perinatal Depression (CMPD)

The investigators will evaluate effects of introducing the care manager on:

1. Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
2. Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).

The first two specific research aims of this proposed randomized study will evaluate the benefits of introducing site specific care managers into established multi-component enhancements of perinatal depression care. The four study sites are members of the IMPLICIT perinatal quality improvement network and provide prenatal care to a diverse population of low income minority women using a common set of care processes within diverse practice models including Obstetric, Family Medicine, and Nurse Practitioner/Midwifery settings. The established processes of care include evidence based screening, diagnosis, treatment protocols and quality improvement care teams.

The investigators will evaluate effects of introducing the care manager on:

1. Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
2. Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).

For the third and fourth specific research aims we will conduct supplementary econometric and qualitative analyses to aid in understanding the provider and system context in which this intervention is implemented across the four study sites. Results of this evaluation will be used to understand for whom and in which systems of care this model is most successful as well as the costs of delivering this intervention.

Specifically the investigators will:

1. Employ econometric techniques to quantify the costs of implementing and maintaining the IMPLICIT collaborative care maternal depression intervention; and
2. Develop institutional ethnographies of the four study sites and identify factors associated with relative success in implementing perinatal depression care managers and improving timely diagnosis, initiation, and continuity of depression care.

Achieving these aims will provide the foundation for dissemination of this innovative approach to perinatal depression care delivery throughout the entire growing IMPLICIT network which now extends across the northeast and mid-Atlantic regions of the US; sites which provide perinatal care for low income minority women in urban, rural, and suburban communities. These sites include prenatal practices in the Robert Wood Johnson Foundation Aligning Forces for Quality initiative, the Healthy York County Coalition which is partnering with us to disseminate this work in their region.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Current pregnancy or experienced pregnancy in the past 6 weeks
* Score \>= 12 on PHQ9

Exclusion Criteria:

* \< age 13
* Mental illness
* Primary language other than English or Spanish