cyrilzakka/clinical-trials huggingface dataset:
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

The aim of this prospective, multi-centered, double-blind, randomized, delayed-stimulation/ Sham-stimulation controlled 12-month study is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.

In a double-blind fashion, half the subjects will receive active DBS therapy, while half will receive sham stimulation. After the 12-month endpoint, all subjects will be unblinded to their treatment group, and subjects in the control arm will receive active DBS therapy.

Eligibility Criteria:
* Inclusion Criteria:

  1. The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.
  2. The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes.
  3. The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose.
  4. Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit
* Exclusion Criteria:

  1. Pregnant or those who plan to become pregnant during study
  2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation in the study or interfere with adherence to the study protocol.
  3. Current or lifetime history of psychotic features in any Major Depressive Episode.
  4. Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.
  5. Significant acute suicide risk.
  6. Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).
  7. Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system.
  8. Treatment with another investigational device or investigational drugs.
Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery

Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a difference between the two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male aged between 40-70 years old, females and males are eligible
2. A history of \> 6 months of conservative care treatment for lateral hip pain, including but not limited to local anaesthetic and steroid injections into the trochanteric bursa
3. Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks
4. Willing to comply with the protocol and follow-up visits
5. Signed the Independent Ethics Committee (IEC) approved Informed Consent Form

Exclusion Criteria:

1. Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons
2. Subjects with sero-positive or sero-negative arthropathy
3. Long term steroid use \> 6 weeks
4. Allergy to drugs to be used in the procedure
5. Medical co-morbidities that preclude surgical intervention
6. Inability to understand or respond to the study questionnaires
7. Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe
8. Subjects who are simultaneously participating in another device or pharmaceutical investigation

Intra-operative Exclusion:

1. Abductor tears
2. Severe tendinopathy
Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring

This study test the agreement and precision of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against another pulse contour CO monitoring ( EV-1000, Edwards Lefesciences, USA)

Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for major surgery which requires a CO and PPV monitoring as standard of care

Exclusion Criteria:

* patients with arrhythmias like atrial fibrillation
* patients with valvular insufficiency
Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.

The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.

The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine.

Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II, III.
* Patients undergoing lung cyst excision.
* Patients undergoing Patent Ductus Arteriosus ligation.

Exclusion Criteria:

* Preoperative mechanical ventilation.
* Preoperative inotropic support
* History of mental retardation or delayed development that may interfere with pain intensity assessment
* Known or suspected coagulopathy,
* Any congenital anomalies of the sacrum or any infection at the site of injection.
* Known or suspected allergy to any of the studied drugs.
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

Therapeutic inertia may result from providers, patients, and/or systems, but can be detrimental to a patients' health by putting them at risk for diabetes complications, though addressing it early can mitigate some of its effects. In Type 2 diabetes (T2D) care, this may look like failure to initiate metformin therapy early in the disease course. This project aims to evaluate the effects of proactive outreach by a non-physician clinician (Accountable Population Manager \[APM\]) to patients with newly diagnosed Type 2 diabetes. The team hypothesizes individuals receiving proactive outreach by an APM will be more likely to achieve glycemic targets at 6 months following start of the intervention.

This is a 3-arm randomized clinical trial comparing patients in the following arms: 1) usual Type 2 diabetes care, 2) primary care physicians have been exposed to physician education on therapeutic inertia, and 3) primary care physicians have been exposed to physician education on therapeutic inertia and patients are referred to APM proactive outreach. The APM is a non-physician clinician, including clinical pharmacists and nurses. Eligible members will be identified via electronic health record (EHR) data in two stages: 1) identification of individuals with newly diagnosed T2D, 2) identification of the subset of newly diagnosed individuals with metformin-related therapeutic inertia. The content of the APM visit will be the same as what currently occurs in standard diabetes care, including discussing the risks and benefits of pharmacologic treatment and initiating treatment (with patient agreement), supporting medication adherence, and providing education and support for overall T2D management. The main outcome will be HbA1c at 6, 12, and 18 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente Northern California (KPNC) member age 18-74
* Incident Type 2 Diabetes
* Patient of primary care physician (PCP) working in the randomized service areas
* Identified metformin-related therapeutic inertia
* At least one A1c 6.5-7.9 from 4 months post-diagnosis up to the time of randomization

Exclusion Criteria:

* Evidence of preceding T2D diagnosis
* Pregnant at the time of T2D diagnosis
* Likely to have Type 1 diabetes
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.

The purpose of the study is as follows:

* To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects.
* To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.

This study will be conducted in two stages:

At 10 months age, half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide (PS) vaccine at 10 months age.

At 15 to 18 months age (DTP booster phase), all subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib2.5.

Eligibility Criteria:
Inclusion criteria:

• Healthy child 10 months that participated in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001), written informed consent obtained from the parents.

Exclusion criteria:

* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during study period.
* Chronic administration (\> 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
* Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal disease and/or Hib since the last visit of study 759346/001.
* History of/known exposure to diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal and/or Hib disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Effectiveness of Mobilization With Movement Along With Sensory Motor Training in Patients With Knee Osteoarthritis

to find out the Effectiveness of Mobilization With Movement Along With Sensory Motor Training in Patients With Knee Osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

* Both genders between age of 45 and 70 with knee pain more than 3 months of presentation in outpatient department. They were also required to stand independently from sitting and prone lying

Exclusion Criteria:

* Patients with any lower limb fractures, any neurological condition, contraindication to manual therapy, post traumatic Knee osteoarthritis, total knee replacement, uncontrolled hypertension, and radiating leg pain
Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices

The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is agnostic across devices.

Prior to randomization, all patients meeting the inclusion criteria stratified into two strata and two blocks within each strata. The first stratum will consist of all patients on 1 to 3 medications for cardiovascular or other non-depression chronic conditions who are suboptimally adherent to these therapies. The second stratum will include all patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the week and can therefore only be used once per day, each stratum will be further stratified into two separate blocks based on the frequency with which the study participants' medications are (or could possibly be) taken. Patients who are on a medication that is used more than once daily will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox, or to continue with usual care. Patients for whom all medications are dosed once daily will be randomized in a 2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to continue with usual care.

Eligibility Criteria:
Inclusion Criteria:

* Have 1 to 3 oral maintenance medications for chronic disease in the 12-month period prior to study eligibility evaluation

  * Cardiovascular disease (defined as hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, or diabetes); OR
  * Another non-depression chronic condition (defined as breast cancer, benign prostatic hypertrophy, schizophrenia, bipolar disorder, anxiety, arrythmia; Parkinson's disease, seizure, and epilepsy); OR
  * Depression
* Be suboptimally adherent to their qualifying medications, defined as a Medication Possession Ratio between 30% and 80% during the 12 months preceding identification of study eligibility
* Eligible for pharmacy benefits during the 12 months prior to being identified as being eligible for the study and expected to be eligible for pharmacy benefits through the end of the evaluation period.

Exclusion Criteria:

* Enrolled in Ready Fill at Mail (a pharmacy benefit program whereby members elect to have medications shipped automatically to them at the time of refill due date or prescription renewal).
Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion

Transudative pleural effusions are a common manifestation of patients with congestive heart failure. Severe dyspnea and respiratory failure may develop in those with large effusions, which in general show poor response to medical treatment. Therapeutic thoracenteses (TT) may be indicated in these patients and can produce marked relief of symptoms. However, the underlying effect of TT on gas exchange and respiratory mechanics in theses patients remains unclear. The researchers' hypothesis is that,TT may improve arterial oxygenation and respiratory mechanics in patients with congestive heart failure complicated by large pleural effusions.


Eligibility Criteria:
Inclusion Criteria:

* transudative pleural effusion established by the criteria of Light
* the effusion occupying at least half of one hemithorax shown on chest radiography
* symptoms of respiratory distress
* diagnosis of congestive heart failure

Exclusion Criteria:

* severe uncontrolled coagulopathy
* unstable hemodynamics
* diagnosis of liver cirrhosis, chronic obstructive pulmonary disease,asthma and/or any parenchymal lung disease, such as pneumonia, fibrosis or malignancy.
Large Burn Outcome Study

To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want to learn about thoughts, feelings, coping style, social support, and overall adjustment following burn injury.

To evaluate the long term quality of life of adolescents and adults who suffered severe pediatric burns. This study will include an array of physical and psychosocial assessments, thus providing a unique and complete set of information on the long term outcomes in this population.

Eligibility Criteria:
Inclusion Criteria:

* At least 60% third degree total body surface area
* Acute burn treatment at Shriners Burns Hospital for Children - Galveston between 1986-2005
* Three years post injury
* Current age of at least 16 years

Exclusion Criteria:
Preload Dependence During Prone Position In ARDS Patients

Preload dependence assessment is difficult during prone position, and to date, no hemodynamic parameters have been validated to rationalize fluid loading in that position. This study aims to validate several hemodynamic parameters, using continuous cardiac output by pulse contour analysis and transpulmonary thermodilution.


Eligibility Criteria:
Inclusion Criteria:

* ARDS patient
* mechanically ventilated in prone position
* sedated and paralyzed
* with continuous cardiac output monitoring by transpulmonary thermodilution and pulse contour analysis
* fluid loading as indicated by attending physician

Exclusion Criteria:

* Age below 18
* no affiliation to social security
* Vena cava obstruction
* previous inclusion in protocol
Efficacy of Almonds Added to Chronic Statin Therapy

The purpose of the study is to evaluate the effects of 100-110 grams of almonds (about ¾ cupful) daily on the lipoprotein profile when given to patients on a statin drug. The study will compare the effects on the lipoprotein profile to patients who eat almonds and those patients not eating almonds.

The primary objectives of this study are to determine the changes in the lipid profile \[LDL-C, HDL-C, triglycerides, total cholesterol\], LDL-C particle size, and the emerging risk factor Lp(a) when 100-110 g of almonds daily are added to statin therapy. Also, all subjects will receive Step I dietary counseling.

Eligibility Criteria:
Inclusion Criteria:

* Stable on current statin regimen for at least 8 weeks with plans to continue on the same dose while participating in the study
* Male or non-pregnant female - Women are eligible if they are surgically sterile or postmenopausal not using hormone replacement therapy (HRT) or using a stable, consistent does of HRT with intentions to continue therapy throughout the course of the study. Females of childbearing potential are eligible if using an effective form or contraception and intention to continue use through the study
* Mentally competent to understand study
* Speak and read English
* Able to maintain current medication regimen throughout study duration

Exclusion Criteria:

* LDL-C levels \<70mg/dL
* Currently taking lipid-lowering agents other than statins including niacin, bile-acid sequestrants, ezetimibe, fibrates, high-dose Omega-3 fish oils (\>1500mg of combined EPA/DHA daily) and policosanol
* Adherence to specialized diet regimes, i.e., multiple food allergies or nut allergy, vegetarian, macrobiotic, fad or popular diets, taking diet pills, etc.
* Already consuming nuts more than twice a week
* Active liver disease or a history of liver disease
* Chronic disease involving, hepatic, renal or coronary artery disease
* Currently taking systemic steroidal drugs
* Dependence on alcohol (\> 10 drinks per week) or illicit drugs
* Participation in any other clinical trial within the last 30 days
* Engages in moderate intensity exercise for \> 30 minutes each day
* Presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study
Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity

Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).

This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain.

It induces a loss of sensitivity and likely reorganization of brain activity that are causing pain and which are the subject of this study.

Previous studies in functional neuroimaging has focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally. The authors failed to assess the part of the effect of the loss of sensory afferents (deafferentation) and the basal brain function.

Indeed, the operation without any sensory stimulation is not known yet is the initial level of activity which is the benchmark for studying brain function during stimulation. The objective of this study is to understand what are the cortical systems of allodynic dysfunctional in patients compared with controls at baseline.


Eligibility Criteria:
Inclusion Criteria for patients :

* major
* with nervous pain : chronic or peripheric
* treatment not stable opioid since one week
* signed consent

Inclusion Criteria for witnesses :

* major
* without chronic pain
* signed consent

Exclusion Criteria for 2 groups :

* severe psychiatric history
* presence of an active nervous lesion
* subject with morphine treatment
* contraindication to MRI scan
Primary Progressive Aphasia Multicomponent Language Treatment Study

Primary progressive aphasia (PPA) is a progressive neurological disorder that causes a gradual decline in communication ability as a result of selective neurodegeneration of speech and language networks in the brain. PPA is a devastating condition affecting adults as young as in their 50's, depriving them of the ability to communicate and function in society. As a result of improved diagnostic precision, PPA is now identified with greater accuracy and frequency and, increasingly, patients and their families seek options for behavioral treatments to ameliorate the devastating effects on their communication, prolong speech language skills, and maximize quality of life. Speech-language treatment outcomes from our group and others are encouraging, confirming that behavioral intervention may lead to improvements in trained behaviors and, for some interventions, lasting and generalized benefit. Most speech-language interventions for individuals with PPA that have been explored in the literature are restitutive, or impairment-based in nature, and have not addressed the full range of severity and phenotypic variability in this population. The investigators will evaluate the utility of a novel, multicomponent intervention that incorporates elements of restitutive (e.g., word finding strategic training, script training), compensatory (e.g., multimodal communication, communication book), and care partner-focused treatment to meet the needs of individuals varying in clinical presentation and severity.


Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
* Scores of 10 or higher on the Mini-Mental State Examination
* Has a study partner who can consistently attend sessions

Exclusion Criteria:

* Other neurological or psychiatric diagnosis that may contribute to cognitive-linguistic deficits
* Significant, uncorrected visual or hearing impairment that would interfere with participation
* Score of less than 10 on the Mini-Mental State Examination
* Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)