cyrilzakka/clinical-trials huggingface dataset:
Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy.

The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Adult women, aged 18 to 80 years old, who will undergo mastectomy.
2. Willing to comply with all study procedures and be available for the duration of the study.
3. Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
4. No distant metastases.
5. Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
6. Subject is medically stable.

Exclusion Criteria:

1. Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
2. Past ketamine or phencyclidine misuse or abuse.
3. Schizophrenia or history of psychosis.
4. Known sensitivity or allergy to ketamine.
5. Liver or renal insufficiency.
6. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
7. Pregnancy or nursing women
8. BMI\>35.
9. Currently participating in another pain interventional trial.
10. Unwillingness to give informed consent.
11. Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages
Skills Training for Adolescents With ADHD

The proposed study will be an initial test of a cognitive-behavioral intervention for adolescents with ADHD who are receiving medication treatment. It is based on our successful work with adults with ADHD who have been treated with medicines but are still having symptoms. It involves learning skills for organization and planning, attention, and mood.

Attention Deficit Hyperactivity Disorder (ADHD) is a prevalent, distressing, and interfering condition that affects between 2% and 6% of adolescents. Although medications have been widely used as an effective treatment for many years as the sole treatment for ADHD, for many, clinically significant and interfering continued symptoms remain. Even after medication treatment, adolescents still experience residual ADHD symptoms and continue to have problems with inattention, concentration, disorganization, and other symptoms. However, research suggests that adolescents who have received some benefit from medication treatment can then experience further symptom reduction from participation in skills-based cognitive behavioral therapy. This study, adapted from a similar research study for adults with ADHD, will examine whether cognitive behavioral therapy (CBT) plus medication is more effective at treating ADHD than medication therapy alone in adolescents with ADHD.

Eligible participants will be randomly assigned to receive twelve weekly treatment sessions either immediately upon enrolling in the study or after a four-month waiting period. Questionnaires (that participants complete and ones that are done with an interviewer) will be used to assess participants' ADHD symptoms at study entry, after receiving the treatment, and at 4 month follow-up. Parents will have some involvement in therapy.

Note: participants must be able to come to Boston or another study location in the Greater Boston area for 4 assessment visits and 12 weekly therapy visits in order for participation to be feasible.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 14 and 18
* In high school
* Principal Diagnosis of ADHD
* Stable prescription of Medications for ADHD
* ADHD has childhood onset
* Clinically significant ADHD symptoms

Exclusion Criteria:

* Organic Mental Disorders
* Active Substance Abuse or Dependence
* Diagnosis of Conduct Disorder
* Mental Retardation or Pervasive Developmental Disorder
* Active Suicidality
* Previous History of CBT Therapy in adolescence
* Other condition interfering with consent or participation
Pilates Versus Eccentric Exercises on Multiple Sclerosis

This study aims to determine whether Pilates-based stability or eccentric training is more effective for patients with multiple sclerosis(MS) with chronic non-specific low back pain(NSLBP).

Thirty adult patients with multiple sclerosis with chronic NSLBP verified diagnosis of MS by a specialized neurologist will be questioned and screened according to inclusion and exclusion criteria.

Patients were randomly allocated to one of two groups: (Pilates or Eccentric). Every individual in both groups will be examined before and after the 6-week treatment program.

The handheld dynamometer assessed isometric trunk flexion and extension strength Pain intensity by casual analog scale (VAS). The Trunk Impairment Scale (TIS) evaluates static and dynamic sitting balance and trunk coordination in a seated position.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18 to 40 years.
* Relapsing-remitting free for at least 90 days before testing.

Exclusion Criteria:

* Having a neurologic disease other than MS.
* A relapse within 3 months.
Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC "

Mirror movements are involuntary, symmetrical and simultaneous movements occurring on one side of the body that accompany controlateral voluntary movements. Congenital mirror movements (CMM) are characterized by childhood onset and the absence of additional manifestations. The aim of this study is to unravel the pathophysiology of the CMM that remains poorly elucidated. The combination of imaging studies and neurophysiological studies using transcranial magnetic stimulation in a homogeneous and relatively large group of patient is likely to allow us to better understand the underlying pathophysiology of the disorder. Using a linkage analysis approach we will try to identify a locus associated with CMM and related candidate genes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 11 to 82 years
* Members of the family of interest displaying mirror movements or being obligatory asymptomatic carrier, without additional manifestation or malformation; or patient with genetically proven Kallmann syndrome and mirror movements.
* No contraindication for MRI or TMS study

Exclusion Criteria:

* inability to provide an informed consent
* Simultaneous participation in another clinical trial
* Treatment that modulate cortical excitability (for the TMS part of the study only)
Improving Effectiveness: Treatment Outcome Research

This proposal seeks to increase the effectiveness of an existing treatment strategy, cognitive processing therapy (CPT), for the remediation of Posttraumatic Stress Disorder among crime victims by varying the duration and content of the intervention in accordance with participants' needs. A secondary goal is to identify predictors of duration of treatment necessary to achieve good end state functioning, including individual and trauma variables, cognitive and emotional variables, and Axis II pathology. Finally, by including a sample of male participants, the generalizability of CPT will be tested. It is anticipated that these modifications will speed the dissemination of CPT to community practice thus benefiting more trauma victims. Fifty subjects will be randomly assigned to either the modified CPT condition or to a symptom-monitoring, minimal attention condition designed to control for the effects of the daily monitoring and the passage of time. Utilizing a semicrossover design, the control condition will be crossed over to the active treatment, allowing for a replication within the study. The entire treated sample (N = 50) will be compared to a sample (N = 50) receiving strict 12-session protocol-driven CPT through the course of a recent study conducted at the same site using the same primary outcome measures. Conducting the proposed study will have important implications on advancing the ecological validity and effectiveness of applied research on PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be survivors of interpersonal assault, who are at least three months post-crime at the time of their participation and who meet criteria for a diagnosis of PTSD. There is no upper time limit on time since crime for participation.

Exclusion Criteria:

* Exclusion criteria for participants include psychosis, mental retardation, active suicidality, parasuicidality, or current addiction to drugs or alcohol. In the case of apparent illiteracy, we will try to accommodate the individual as much as possible to maximize success in the program. In addition, participants cannot be in a currently abusive relationship or being stalked. For marital rape or domestic violence, the participant must have been out of the relationship for at least three months. Participants may continue the use of any medications throughout the study. However, participants must be willing to keep the medication usage stable for the duration of the study and must be stabilized on any new medication for one month prior to initial assessment. Participants will sign a contract to this effect. All medication use will be tracked throughout the course of the study on the daily symptom monitoring diaries, including over the counter medications. Finally, participants can have received any therapy in the past with the exception of CPT. They may be receiving concurrent therapy as long as it is not trauma-focused. Allowing subjects to continue with concurrent therapy offers them the option to continue with established supports and more closely mimics clinical practice and the generalizability of the results.
Clinical Outcome at 5 Years After Implantation of the Liberty677MY Multifocal Intraocular Lens

The study will assess visual outcomes, light disturbances and patients' satisfaction after implantation with the Liberty677MY multifocal IOL, as well as protection of PCO development within 5 year follow-up.

The Liberty677MY multifocal IOL is designed for restoring near, intermediate and distance vision. The technology of Liberty 677MY is based on the elevated phase shift technology (patent pending). Previous evaluations showed the strength of studied IOL both in laboratory and clinical conditions.

Patients will be examined 5 years after implantation. The examination will include the measurement of the best corrected distance, intermediate and near visual acuity (assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts), intraocular pressure (contact Goldman tonometry), biomicroscopic and fundocsopic examination, contrast sensitivity (CSV-1000), defocus curve, reading capability, pupilometry in different light conditions and PCO evaluation, Nd:YAG capsulotomy rate, photo-documentation of anterior segment. YAG capsulotomy will be indicated in case of posterior capsule opacification (PCO). The criteria for YAG capsulotomy will be visual acuity decreased 2 or more lines when using (ETDRS) charts. Details of all related and unrelated complications will be documented, including severity, time of onset, specific treatment and clinical outcome. The investigators will also record whether the capsulorhexis is on or partially off the optic.

Eligibility Criteria:
Inclusion Criteria:

* pseudophakic patients implanted with Liberty 677MY in 2014-2015 during the study under the ethical approval: 059823/2014/OTIG

Exclusion Criteria:

* diabetic retinopathy
* iris neovascularisation
* serious intraoperative complications
* congenital eye abnormality
* glaucoma
* pseudoexfoliation syndrome
* amblyopia
* uveitis
* long-term anti-inflammatory treatment
* AMD (advanced AMD)
* retinal detachment
* prior ocular surgery in personal medical history (except cataract surgery aiming the implantation of the multifocal IOL)
* previous laser treatment
* corneal diseases
* severe retinal diseases (dystrophy, degeneration)
* severe myopia (if required IOL power is lower than 10 D)
* inadequate visualization of the fundus on preoperative examination
* patients deemed by the clinical investigator because of any systemic disease.
* pregnancy
* eye trauma in medical history
* current use of systemic steroids or topical ocular medication
* preoperative smaller pupil size of 6 mm under topical mydriasis
* kappa angle \>5°
EEG Phase Synchrony, Sedation and Delirium in the CVICU

EEG phase synchrony and variability has had limited investigation during transition from coma to wakefulness in response to sedation and analgesia. Studying changes in phase synchrony and variability during and after sedative-induced coma is an exciting opportunity to better understand EEG changes during transitions in states of arousal. It is expected that consciousness should be higher in entropy and greater in complexity in the number of configurations of pairwise connections as compared to sedative-induced coma. If sufficiently sensitive, it may be possible to identify states of lower entropy and fewer configurations when patient are aroused but with altered sensorium (e.g. delirium).

Aim 1: To quantify EEG phase synchrony changes, both globally and locally by brain region, during emergence from medically induced coma required for performance of a cardiovascular related operation (deep sedation defined as a Riker Sedation-Agitation Scale \[SAS\] of 1-2).

Hypothesis: The global R-index will be increased above baseline at multiple frequency bandwidths and the magnitude of R-index will correlate with the sedative dosage (as a crude measure of depth). The rate of fluctuations of the R-index will decrease with deeper sedation.

Aim 2: To compare the magnitude of the EEG phase synchrony globally and locally in patients emerging from coma; a patient's pre-anesthesia phase will serve as a control.

Hypothesis: Fluctuations in R-index will vary; fluctuations will be greater in awake adults as compared to while comatose or emerging from coma.

Aim 3: To determine EEG phase synchrony changes in patients with and without delirium during their CVICU stay.

Hypothesis: Lower scores of R-index consistent with increased phase synchrony and lower spatio-temporal variability will be seen while delirious as compared to days when patients are not delirious.

Eligibility Criteria:
Inclusion criteria:

* Age 30 - 65 years
* Scheduled for first-time CABG or single valve replacement

Exclusion criteria:

* Previous stroke
* Severe pre-existing cognitive impairment (TICS score \< 24)
Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee Osteoarthritis

This study will evaluate the acute effects of vibration (whole body vibration and local muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics linked to osteoarthritis development in individuals with anterior cruciate ligament reconstruction. Subjects will be randomly assigned to control (no vibration), whole body vibration, and local muscle vibration groups, and the aforementioned characteristics will be assessed prior to and following the respective interventions.

Quadriceps muscle dysfunction and proprioceptive deficits following knee injuries alter walking gait biomechanics in manners that contribute to development of knee osteoarthritis. Current rehabilitation techniques are minimally effective for addressing these complications and preventing knee osteoarthritis. Anterior cruciate ligament reconstruction dramatically increases the risk of knee osteoarthritis, and represents an ideal model for evaluating novel rehabilitation techniques for preventing knee osteoarthritis.

Direct (local muscle vibration) and indirect (whole body vibration) vibratory stimuli enhance quadriceps function and proprioception, and may improve rehabilitation and reduce the risk of knee osteoarthritis. The purpose of this investigation is to determine and compare the acute effects of whole body vibration and local muscle vibration on quadriceps function, knee proprioception, and gait biomechanics in individuals with anterior cruciate ligament reconstruction. The investigators hypothesize that vibratory stimuli will enhance quadriceps function, knee proprioception, and gait biomechanics in manners that would reduce the risk of developing knee osteoarthritis, and that whole body vibration and local muscle vibration will produce equivalent improvements in these characteristics.

Eligibility Criteria:
Inclusion Criteria:

* age 18-35 years
* undergone unilateral ACLR within 5 years prior to participation
* at least 6 months post-ACLR
* Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report survey Pain subscale score \> 53.1 and Symptom subscale score \> 44.9
* cleared by a physician for return to physical activity, and currently participating in at least 20 minutes of physical activity 3x per week.

Exclusion Criteria:

* central activation ratio (CAR) \> 95%
* history of ACL graft rupture or revision surgery, neurological disorder, or injury to either leg within 6 months prior to participation (other than the initial ACLR)
Compensatory Mechanisms in Parkinson Disease (PD)

Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Patients presenting doparesponsive Parkinson's disease
* Patient's age between 40 and 70 years old
* Absence of other neurological or psychiatric disease
* Absence of cognitive decline ( MATTIS \> 130)
* For women of childbearing age a pregnancy test and a contraceptive method will be required
* Informed consent sign

Healthy subjects

* subject's age between 40 and 70 years old
* Absence of neurological or psychiatric disease
* Absence of cognitive decline ( MATTIS \> 130)
* For women of childbearing age a pregnancy test and a contraceptive method will be required
* Informed consent sign

Exclusion Criteria:

Patients

* patient's age \< 40 years old or \> 70 years old
* Other neurological or psychiatric disease
* Cognitive decline (MATTIS \< 130).
* Having participated to a PET or SPECT study in the last 12 months
* Pregnancy
* Severe concomitant disease

Healthy subjects

* subject's age \< 40 years old or \> 70 years old
* Neurological or psychiatric disease
* Cognitive decline (MATTIS \< 130).
* Having participated to a PET or SPECT study in the last 12 months
* Pregnancy
* Severe concomitant disease
Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC

Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.

50 left sided breast cancer patients will be randomized to receive breast/chest wall irradiation with or without ABC. Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.

After the completion of radiation therapy, patients will be seen on the following schedule:

A follow up examination will take place every 3-6 months for the first two years, then every 4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur annually. A SPECT scan will be obtained at 6 months post therapy.

Patients must be 18 and older and must have histologically confirmed (by routine H\&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

Patients must have also undergone a segmental mastectomy (SM) or Mastectomy.

Patients must not have received prior radiation therapy to the breast at any time for any reason.

Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 and older
* Patients must have histologically confirmed (by routine H\&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.
* Patients must have undergone a segmental mastectomy (SM) or Mastectomy
* Patients must not have received prior radiation therapy to the breast at any time for any reason.
* Any patient with active local-regional disease prior to registration is not eligible.
* Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy.
* Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
* All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* Patients requiring oxygen
* Sarcoma or Squamous Cell pathology
* Right-sided breast cancers
* Metastatic disease to the breast